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# TABLE OF CONTENTS

[1.0 Introduction to the National Program of Cancer Registries
10](#introduction-to-the-national-program-of-cancer-registries)

[1.1 Overview of the National Program of Cancer Registries
10](#overview-of-the-national-program-of-cancer-registries)

[1.2 CDC Health and Programmatic Goals Relating to Cancer
16](#cdc-health-and-programmatic-goals-relating-to-cancer)

[1.3 Organization 16](#organization)

[1.4 Funding Opportunity Announcement (FOA)
19](#funding-opportunity-announcement-foa)

[1.4.1 CDC-NPCR Responsibilities under the Funding Opportunities
Announcement
20](#cdc-npcr-responsibilities-under-the-funding-opportunities-announcement)

[1.4.2 NPCR Funded Central Cancer Registry Activities under the Funding
Opportunities Announcement.
21](#npcr-funded-central-cancer-registry-activities-under-the-funding-opportunities-announcement)

[1.4.3 Funding Restrictions 27](#funding-restrictions)

[1.5 Applicable Federal Laws 27](#applicable-federal-laws)

[1.5.1 HIPAA 28](#hipaa)

[1.5.2 FOIA 29](#foia)

[1.5.3 Office of Management and Budget (OMB)
29](#office-of-management-and-budget-omb)

[1.6 Federal Data Quality Guidelines
30](#federal-data-quality-guidelines)

[1.7 CDC/ATSDR Policy on Releasing and Sharing Data
30](#cdcatsdr-policy-on-releasing-and-sharing-data)

[2.0 NPCR Program Standards 31](#npcr-program-standards)

[2.1 NPCR Program Standards and Reference Manual Links
32](#npcr-program-standards-and-reference-manual-links)

[2.2 Legislative Authority for Central Registry
39](#legislative-authority-for-central-registry)

[2.3 Central Cancer Registry Operations Manual
41](#central-cancer-registry-operations-manual)

[2.4 Management Reports 42](#management-reports)

[2.5 Education and Training 44](#education-and-training)

[3.0 Program Standards for Data Collection
45](#program-standards-for-data-collection)

[3.1 Reportability 45](#reportability)

[3.2 Reference Manuals 47](#reference-manuals)

[3.3 Required Data Items 48](#required-data-items)

[3.3.1 NPCR Data Items Required for Collection
49](#npcr-data-items-required-for-collection)

[3.4 Unresolved Data Item Issues 53](#unresolved-data-item-issues)

[3.5 Data Exchange Format 55](#data-exchange-format)

[3.5.1 Record Layout Format for Registry Data
56](#record-layout-format-for-registry-data)

[3.5.2 Record Layout Format for Pathology Data
56](#record-layout-format-for-pathology-data)

[4.0 Completeness, Quality and Timeliness Requirements
57](#completeness-quality-and-timeliness-requirements)

[4.1 Data Evaluation 57](#data-evaluation)

[4.2 Data Completeness 59](#data-completeness)

[4.2.1 Reporting Sources 59](#reporting-sources)

[4.2.2 Interstate Data Exchange 60](#interstate-data-exchange)

[4.2.3 Death Clearance Activities 60](#death-clearance-activities)

[4.2.4 Data Completeness Audits 61](#data-completeness-audits)

[4.2.5 Data Linkages 61](#data-linkages)

[4.3 Data Quality 62](#data-quality)

[4.3.1 Electronic Reporting Format (Standards III.a-III.d and IV. b.)
62](#electronic-reporting-format-standards-iii.a-iii.d-and-iv.-b.)

[4.3.2 Standardized Data Elements (Standards III.a, IV.a)
62](#standardized-data-elements-standards-iii.a-iv.a)

[4.3.3 Standardized Data Edits (Standards V.b.2 and V.c.5)
63](#standardized-data-edits-standards-v.b.2-and-v.c.5)

[4.3.4 Record Consolidation 63](#record-consolidation)

[4.3.5 Geocoding 63](#geocoding)

[4.3.6 Data Linkages/Coding Algorithms
63](#data-linkagescoding-algorithms)

[4.3.7 Data Quality Audits (Standard VI.a.3)
64](#data-quality-audits-standard-vi.a.3)

[4.4 Data Timeliness 65](#data-timeliness)

[4.4.1 Reporting from Close of Diagnosis Year\
(Standards V.b, and V.c.)
65](#reporting-from-close-of-diagnosis-year-standards-v.b-and-v.c.)

[4.4.2 Reporting in Electronic Format\
(Standards III.a-III.d and IV.b)
65](#reporting-in-electronic-format-standards-iii.a-iii.d-and-iv.b)

[5.0 NPCR-CSS Data Submission 66](#npcr-css-data-submission)

[5.1 Submission Information 66](#submission-information)

[5.1.1 NPCR-CSS Submission Packet 66](#npcr-css-submission-packet)

[5.1.2 NPCR-CSS Data Release Policy 67](#npcr-css-data-release-policy)

[5.2 Utilities 68](#utilities)

[6.0 NPCR Program Evaluation 69](#__RefHeading___Toc207802143)

[6.1 NPCR-CSS Data Evaluation Reports
69](#npcr-css-data-evaluation-reports)

[6.2 NPCR Program Evaluation Instrument (PEI)
70](#npcr-program-evaluation-instrument-pei)

[6.3 Data Completeness and Quality Audits
71](#data-completeness-and-quality-audits)

[7.0 Data Use 72](#data-use)

[7.1 National Data Use -- Electronic Data Release Activities
72](#national-data-use-electronic-data-release-activities)

[7.1.1 Creation of Datasets 72](#creation-of-datasets)

[7.1.2 United States Cancer Statistics (USCS)
73](#united-states-cancer-statistics-uscs)

[7.1.3 U.S. County Cancer Incidence Dataset
73](#u.s.-county-cancer-incidence-dataset)

[7.1.4 CDC WONDER: Online Data-Reporting System
73](#cdc-wonder-online-data-reporting-system)

[7.1.5 Restricted Access File 74](#restricted-access-file)

[7.2 National and International Data Use - Publications
74](#national-and-international-data-use---publications)

[7.2.1 The Annual Report to the Nation on the Status of Cancer
74](#the-annual-report-to-the-nation-on-the-status-of-cancer)

[7.2.2 National Healthcare Quality Report
75](#national-healthcare-quality-report)

[7.2.3 National Healthcare Disparities Report
75](#national-healthcare-disparities-report)

[7.2.4 Cancer Incidence in Five Continents
75](#cancer-incidence-in-five-continents)

[7.2.5 Cancer Incidence in North America
76](#cancer-incidence-in-north-america)

[7.3 Special Studies 76](#special-studies)

[7.3.1 Articles and Monographs 76](#articles-and-monographs)

[7.3.2 Patterns of Care (POC) Studies 76](#patterns-of-care-poc-studies)

[7.3.3 Data Quality Studies 77](#data-quality-studies)

[7.3.4 Reporting Pathology Protocols 78](#reporting-pathology-protocols)

[7.3.5 Economic Analysis 78](#economic-analysis)

[7.3.6 Central Registry Workload Management Study
79](#central-registry-workload-management-study)

[7.3.7 State Cancer Profiles Web site
79](#state-cancer-profiles-web-site)

[7.3.8 American Cancer Society (ACS) Cancer Facts & Figures
79](#american-cancer-society-acs-cancer-facts-figures)

[7.4 State Data Use 80](#state-data-use)

[8.0 Collaborative Relationships 81](#collaborative-relationships)

[8.1 NPCR Work Groups 81](#npcr-work-groups)

[8.2 Indian Health Service 82](#indian-health-service)

[8.3 Multi-Agency Projects 82](#multi-agency-projects)

[8.3.1 TNM Staging Classification 82](#tnm-staging-classification)

[8.3.2 Collaborative Staging System 83](#collaborative-staging-system)

[8.3.3 Multiple Primary and Histology Coding Rules
83](#multiple-primary-and-histology-coding-rules)

[8.4 Modeling Electronic Reporting Project (MERP)
84](#modeling-electronic-reporting-project-merp)

[8.5 North American Association of Central Cancer Registries (NAACCR)
84](#north-american-association-of-central-cancer-registries-naaccr)

[8.6 National Cancer Registrars Association (NCRA)
85](#national-cancer-registrars-association-ncra)

[8.7 International Association of Cancer Registries (IACR)
85](#international-association-of-cancer-registries-iacr)

[8.8 International Union Against Cancer (UICC)
86](#international-union-against-cancer-uicc)

[8.9 National Coordinating Council for Cancer Surveillance
86](#national-coordinating-council-for-cancer-surveillance)

[8.10 State Collaborative Relationships
87](#state-collaborative-relationships)

[9.0 Resources 87](#resources)

[9.1 Technical Assistance for Program Management
88](#technical-assistance-for-program-management)

[9.2 Software Programs for Cancer Registry Data
88](#software-programs-for-cancer-registry-data)

[9.2.1 Registry Plus Software 88](#registry-plus-software)

[9.2.2 EDITS 91](#edits)

[9.3 Annual Program Directors Meeting
91](#annual-program-directors-meeting)

[9.4 NPCR Education and Training 92](#npcr-education-and-training)

[9.4.1 NPCR Education and Training Series (NETS)
93](#npcr-education-and-training-series-nets)

[9.4.2 Educational Materials for Cancer Registrars
94](#educational-materials-for-cancer-registrars)

[9.5 Recruitment Materials 94](#recruitment-materials)

[10.0 Guidance Documents 95](#guidance-documents)

[10.1 Advisory Committee Guidance 95](#advisory-committee-guidance)

[10.2 Attribution Guidelines-Partners
98](#attribution-guidelines-partners)

[10.3 Data Security Guidance 100](#data-security-guidance)

[10.4 Electronic Reporting Guidance 102](#electronic-reporting-guidance)

[10.5 Guidance for Use of NPCR Funding for Data Collection
105](#guidance-for-use-of-npcr-funding-for-data-collection)

[10.6 Physician Reporting Guidance 105](#physician-reporting-guidance)

[Appendix A: Reference List for Chapter 1: Introduction, Overview and
Accomplishments
111](#appendix-a-reference-list-for-chapter-1-introduction-overview-and-accomplishments)

[Appendix B: Inventory of Publications and Professional Presentations\
on CDC-NPCR's Patterns of Care Studies
116](#appendix-b-inventory-of-publications-and-professional-presentations-on-cdc-npcrs-patterns-of-care-studies)

[Appendix C: Organizational Charts
119](#appendix-c-organizational-charts)

[Appendix D: Guidelines for Defining Public Health Research and\
Public Health Non-Research 123](#__RefHeading___Toc207802204)

[Appendix E: Reportable Conditions List 1992 -- 2007
134](#__RefHeading___Toc207802205)

[Appendix F: Full Citation for Reference Manuals
136](#appendix-f-full-citation-for-reference-manuals)

[Appendix G: Timeline of Data Item Requirements: Diagnosis Years
1997-2008
140](#appendix-g-timeline-of-data-item-requirements-diagnosis-years-1997-2008)

[Appendix H: Program Evaluation Instrument (PEI )
145](#appendix-h-program-evaluation-instrument-pei)

[Appendix I: DCPC Forms Recognition Software Analysis
172](#appendix-i-dcpc-forms-recognition-software-analysis)

####### ACRONYMS

  ----------- -----------------------------------------------------------
  ACoS        American College of Surgeons

  ACS         American Cancer Society

  AHRQ        Agency for Healthcare Research and Quality

  AI/AN       American Indian and Alaskan Native

  AJCC        American Joint Committee on Cancer

  ASTCDP      Association of State and Territorial Chronic Disease
              Program Directors

  ATSDR       Agency for Toxic Substances and Disease Registry

  CDC         Center for Disease Control

  CS          Collaborative Staging

  CSB         Cancer Surveillance Branch

  CSS         Cancer Surveillance System

  CSTE        Council of State and Territorial Epidemiologists

  CTR         Certified Tumor Registrar

  DAST        Data Analysis and Support Team

  DCPC        Division of Cancer Prevention and Control

  DCQA        Data Completeness and Quality Audit

  DHHS        Department of Health and Human Services

  FERPA       Family Educational Rights and Privacy Act

  FIPS        Federal Information Processing Standards

  FOA         Funding Opportunity Announcement

  FOIA        Freedom of Information Act

  HIPAA       Health Insurance Portability and Accountability Act

  IACR        International Association of Cancer Registries

  ICD-O-3     International Classification of Diseases for Oncology,
              Third Edition

  IHS         Indian Health Service

  MERP        Modeling Electronic Reporting Project

  MP/H        Multiple Primary and Histology

  NAACCR      North American Association of Central Cancer Registries

  NAPIIA      NAACCR Asian Pacific Islander Identification Algorithm

  NBCCEDP     National Breast and Cervical Cancer Early Detection Program

  NCCCP       National Comprehensive Cancer Control Program

  NCCDPHP     National Center for Chronic Disease Prevention and Health
              Promotion

  NCCCS       National Coordinating Council for Cancer Surveillance

  NCCRC       NPCR Central Cancer Registry Council

  NCHS        National Center for Health Statistics

  NCIC        National Cancer Institute of Canada

  NCRA        National Cancer Registrars Association

  NETS        NPCR Education and Training Series

  NHAPIAA     NAACCR Hispanic and Asian Pacific Islander Identification
              Algorithm

  NHIA        NAACCR Hispanic Identification Algorithm

  NPCR        National Program of Cancer Registries

  ORTAT       Operations Research and Technical Assistance Team

  PEI         Program Evaluation Instrument

  PHIN        Public Health Information Network

  RAF         Restricted Access File

  RRAF        Regional Restricted Access File

  SDRG        Small Data Release Group

  SEER        Surveillance, Epidemiology, and End Results

  SRAF        State-level Restricted Access File

  SRT         Surveillance Research Team

  SWG         Science Workgroup

  TNM         Tumor, Node, Metastasis

  UICC        International Union against Cancer

  USCS        United States Cancer Statistics
  ----------- -----------------------------------------------------------

# 1.0 Introduction to the National Program of Cancer Registries 

\[See [Appendix A](#_Appendix_A:_) for citations.\]

Population-based cancer registries collect data on all cancer cases in a
defined population. This includes data on the occurrence of cancer,
primary site, histology, stage at diagnosis, first course of treatment,
and vital status.^1^ Cancer data are reported to population-based cancer
registries from a variety of medical facilities, including hospitals,
physicians' offices, radiation facilities, freestanding surgical
centers, and pathology laboratories.

Originally, population-based cancer registries were primarily used to
describe cancer patterns and trends. More recently, the role of
registries has expanded to include the planning and evaluation of cancer
control activities.^2^ Currently, information derived from cancer
registries is critical for directing effective cancer prevention and
control programs towards specific geographic areas or populations. These
programs focus on preventing behaviors that increase risk for developing
cancer (e.g., smoking) and on reducing environmental risk factors (e.g.,
occupational exposure to known carcinogens).

Cancer registry information is also essential for identifying
populations who would benefit from enhanced cancer screening efforts,
and for developing and implementing long-term strategies for ensuring
access to adequate diagnostic and treatment services. Local-level data
motivate action at the community level and provide incentives for
community involvement and ownership.^3^ Pooled data at the national,
regional, and state levels enable federal and state public health
professionals to establish, prioritize, and monitor national public
health surveillance initiatives and track progress toward the national
goals and objectives set forth in *Healthy People 2010*, the nation's
health promotion and disease prevention agenda.^4^

## 1.1 Overview of the National Program of Cancer Registries 

Citing the need for a national program of cancer registries that would
provide the local, state, regional, and national cancer incidence data
required for national and state health planning, the U.S. Congress
established the National Program of Cancer Registries (NPCR) in 1992
through Public Law (PL) 102-515, the Cancer Registries Amendment
Act.^9,10^ This law authorized the Centers for Disease Control and
Prevention (CDC) to provide funds to states and territories to improve
existing cancer registries; to plan and implement registries where they
did not exist; to help develop model legislation and regulation for
states to enhance the viability of registry operations; to set standards
for data completeness, timeliness, and quality; to provide training for
registry personnel; and to help establish a computerized reporting and
data processing system.

Public Law (PL) 102-515 requires funded states develop legislation
authorizing the establishment of a central cancer registry and provide
regulations as specified in the law. These regulations assure the
following: case reporting from all facilities and practitioners; access
to medical records; reporting of uniform data; protection of patient
confidentiality; access to data by researchers; authorization to conduct
research; and protection from liability for individuals who abide by the
law. PL 102-515 provides the framework for needed legal support for
operation of central cancer registries. The full text of the act is
available online at
<http://www.cdc.gov/CANCER/NPCR/npcrpdfs/publaw.pdf>.

In 1994, through cooperative agreements, NPCR began providing financial
support and technical assistance to state health departments for the
operation of statewide, population-based cancer registries. In a
cooperative agreement, CDC staff is substantially involved in the
program activities, above and beyond routine grant monitoring. State
health departments or their authorized designees were eligible for one
of two funding categories. The first category of funding supported the
operation of existing cancer registries. These "enhancement" programs
were required to maintain their current (i.e., at the time of initial
CDC funding) level of support, and to contribute (i.e., match) one state
dollar for every three federal dollars of support received. Matching
funds could be in the form of financial or direct (i.e., in kind)
assistance. The second category of funding supported the planning and
implementation of a new cancer registry where none previously existed.

After the first program announcement in 1994 and the approval of a
congressional appropriation of \$16.8 million, 42 states and the
District of Columbia were awarded funds (34 enhancement programs and
nine planning programs). In 1997, three additional states and three
territories were awarded funds (two enhancement programs and four
planning programs). Since 1998, NPCR funds have supported 45 states, the
District of Columbia, and three territories (Pacific Islands, Puerto
Rico, and the Virgin Islands), covering 96% of the US population (Figure
1).

![](media/image4.png){width="6.495833333333334in"
height="4.749305555555556in"}

Figure 1 Map of United States

Program contact and other information, including available [program
highlights](http://apps.nccd.cdc.gov/cancercontacts/npcr/pia/index.asp)
for a specific state or territory, are available on the NPCR website at
<http://www.cdc.gov/cancer/npcr/>. Requests for information may be
submitted to the Program Consultant assigned to individual states or
territories at <cdcinfo@cdc.gov>.

NPCR-funded central cancer registries are required to collect and report
information on all state/territory residents who are diagnosed or
treated with cancer, including residents who are diagnosed and treated
outside of their state/territory of residence.

PL 102-515 defined reportable cancer as "each form of in situ and
invasive cancer (with the exception of basal cell and squamous cell
carcinoma of the skin and carcinoma in situ of the cervix)."

Data required to be collected include:

-   cancer incidence;

-   demographic information;

-   administrative information (including date of diagnosis and source
    of information); and

-   pathologic data (including cancer site, stage at diagnosis, and type
    of treatment).

In response to the need for national population-based incidence data on
all central nervous system (CNS) tumors, Congress passed the Benign
Brain Tumor Cancer Registries Amendment Act in 2002.^11^ This law
changed NPCR's definition of reportable tumors to include benign and
borderline CNS tumors. Both the National Cancer Institute's (NCI)
Surveillance, Epidemiology and End Results (SEER) Program and the
American College of Surgeons (ACoS) Commission on Cancer (CoC) agreed to
require reporting of nonmalignant brain tumors, beginning with cases
diagnosed on or after January 1, 2004.

In 2000, the NPCR-Cancer Surveillance System (NPCR-CSS) was established
to receive, evaluate, and disseminate data from participating central
cancer registries. NPCR-CSS is designed to provide cancer incidence data
to meet CDC's public health surveillance responsibilities and to help
monitor progress toward NPCR goals.

Collaborations among the National Cancer Surveillance Partners

Collaboration among the national cancer surveillance partners has been
formalized in the National Coordinating Council for Cancer Surveillance
(NCCCS).^12^ NCCCS members include the American Cancer Society (ACS),
ACoS, CDC, NCI, National Cancer Registrars Association (NCRA), and the
North American Association of Central Cancer Registries (NAACCR). The
mission of NCCCS is to coordinate cancer surveillance activities within
the United States through communication and collaboration among major
national cancer organizations. In so doing, NCCCS seeks to ensure the
needs of cancer patients and the communities in which they live are
fully served, that scarce resources are maximally used, and that the
burden of cancer in the United States is adequately measured and
ultimately reduced.

NCCCS was created to provide a forum for examining the current state of
cancer surveillance operations and identifying the broad issues
involved, to recommend practical approaches to facilitate the work of
registries, and to contribute to the goal of coordinating data
collection and improving data quality across the nation. The Council
enables these organizations to collaborate on cancer monitoring and
registry operations.

NCCCS has developed consensus reports around such topics as benign brain
tumor reporting and data quality. Through NCCCS, CDC, NCI, and other
partners have collaborated to develop a broad national framework for
cancer surveillance in the United States.^13^ This framework addresses a
continuum of disease progression - from a healthy state to the end of
life - and incorporates primary, secondary, and tertiary prevention. The
framework also addresses crosscutting information needs.

Collaborations among the major national cancer organizations also led to
the publication in 1998 of the first Annual Report to the Nation on the
Status of Cancer ([Section
7.2.1](#the-annual-report-to-the-nation-on-the-status-of-cancer)).^14^
This report documented the beginning of the decline in overall cancer
mortality in the United States. Each year, since 1998, the report has
been published under rotating leadership of CDC, NCI, ACS, and
NAACCR.^15-22^

In 2000, CDC and NCI entered into a Memorandum of Understanding (MOU) to
coordinate cancer surveillance activities around a shared vision for a
comprehensive, federally integrated national cancer surveillance system.
This system builds upon and strengthens the existing infrastructure,
improves the availability of high quality data for measuring the
nation's cancer burden, and advances the capacity for surveillance
research. The scope of this coordinated cancer surveillance system
includes coverage of the entire U.S. population with high quality data
to measure cancer risk, health behaviors, incidence, treatment,
morbidity, mortality, and other outcomes.

NCI and CDC have a joint responsibility for the dissemination of
national cancer surveillance statistics through multiple mechanisms.
NCI's emphasis is on a surveillance research program that characterizes
the nation's cancer burden over time by integrating traditional cancer
statistics, the widest possible collection of cancer-related data, and
in-depth methodological studies in population subgroups. CDC's emphasis
is on its responsibilities for public health surveillance,
characterizing the cancer burden nationwide and in states, and meeting
the needs of state health departments and the nation in developing,
implementing, and evaluating effective cancer prevention and control
efforts. The MOU was the genesis for the annual *United States Cancer
Statistics* (USCS) report, a joint publication of CDC and NCI, in
collaboration with NAACCR.^1^ The first report was published in 2002 and
featured 1999 incidence data from NPCR and SEER cancer registries that
met standards for high quality data.

Highlights of NPCR Accomplishments

-   NPCR continues to fulfill the intent of PL 102-515. NPCR supports
    population-based central cancer registries in 45 states, the
    District of Columbia, and three U.S. territories with funding,
    technical assistance, standards for data collection and use,
    training, and support for establishing computerized reporting and
    data-processing systems. All NPCR programs have authorizing
    legislation for a statewide cancer registry, and have legislation or
    regulations in support of all criteria specified in PL 102-515.

-   By 2005, eight NPCR-funded registries met all NPCR completeness,
    timeliness, and quality standards. This number increased to 24 by
    2007 (<http://www.cdc.gov/cancer/npcr>).

-   CDC's Cancer Surveillance Branch (CSB) implemented NPCR-CSS in 2000
    for receiving, assessing, enhancing, aggregating, and disseminating
    data from NPCR-funded programs. In 2001, NPCR-CSS began to receive
    state cancer registry data annually.
    (<http://www.cdc.gov/cancer/npcr/training/css.htm>)

-   CSB has developed and made available Registry Plus™, a suite of
    publicly available free software programs, for collecting and
    processing cancer registry data
    (<http://ww.cdc.gov/cancer/npcr/tools/registryplus>).

-   CDC and NCI signed a MOU in 2000 to formalize collaboration between
    NCI's surveillance activities and research programs and CDC's NPCR.
    The MOU was renewed for another 5-year period in 2005.

-   Since 2002, CSB, in collaboration with NCI and NAACCR, has published
    *United States Cancer Statistics* a series of annual reports based
    on high-quality NPCR and SEER cancer incidence data
    (<http://apps.nccd.cdc.gov/uscs>), and CDC's National Vital
    Statistics System (NVSS) cancer mortality data
    (<http://www.cdc.gov/nchs/deaths.htm>).^1^ The first report in this
    series provided cancer incidence data covering approximately 78% of
    the U.S. population. The most recent report contains official
    federal government cancer statistics for more than 1.2 million
    invasive cancer cases diagnosed during 2004, covering 98% of the
    U.S. population for incidence and 100% of the population for
    mortality statistics.

-   CDC, NAACCR, NCI, ACS, and central cancer registries collaborated to
    publish monographs on breast, ovarian, and colorectal cancers based
    on high-quality data from the NPCR and SEER programs, in order to
    provide more population-based information about these cancers. The
    breast cancer monograph was published as a series of articles in
    *Cancer Causes and Control* and *Breast Cancer Research and
    Treatment*,^23-28^ and the ovarian^29-37^ and colorectal^38-49^
    cancer monographs were published as special supplements to the
    journal *Cancer*.

-   CDC, NCI, NAACCR and ACS collaborate each year to produce the Annual
    Report to the Nation on the Status of Cancer, a seminal publication
    which includes an update of cancer death rates, incidence rates, and
    trends in the United States. The Annual Report was first published
    in 1998, and addresses a special featured topic each year.^14-22^
    The report can be found at:
    <http://www.cdc.gov/Features/CancerReport/>

-   CSB has completed two patterns of care studies that were conducted
    in conjunction with the international CONCORD study for assessing
    differences in cancer survival between Europe and North
    America.^50-55^

-   CSB is funding and collaborating on the third, and most
    comprehensive, patterns of care study with seven state
    population-based cancer registries to examine patterns of care for
    female breast cancer and prostate cancer. See [Appendix
    B](#_Appendix_B:_) for an inventory of publications and professional
    presentations on CDC-NPCR's Pattern of Care Studies.

## 1.2 CDC Health and Programmatic Goals Relating to Cancer

The NPCR contributes to the achievement of disease prevention and health
promotion goals established through the national planning process
spearheaded by the Department of Health and Human Services (DHHS),
currently embodied in the "Healthy People 2010" document. As noted in
the Funding Opportunities Announcement (FOA) purpose statement for the
NPCR, programmatic goals for NPCR are translated into standards for
central registries to attain to provide measurable outcomes for the
investment of public resources in cancer surveillance activities. NPCR
and central registry activities are centered in a national planning
process, directed toward specific outcomes, and evaluated according to
measurable achievements.

The document and information about the "Healthy People 2010" planning
process and participants are available at
<http://www.healthypeople.gov/Default.htm>.

Information about the CDC agency-wide goals and strategies are available
from the website <http://www.cdc.gov/about/goals/goals.htm>.

The primary goal is to become a performance-based agency focusing on
healthy people, healthy places, preparedness, and global health,
utilizing six key strategies to guide decisions and priorities:

-   Health Impact Focus

-   Customer-Centricity

-   Public Health Research

-   Leadership

-   Global Health Impact

-   Accountability

## 1.3 Organization

CDC includes 11 Centers, Institutes, and Offices which focus on a wide
range of public health concerns ranging from environmental health to
infectious diseases. Each center has divisions that focus on specific
public health areas.

The National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), with 10 divisions, assists States/District of
Columbia/Tribes/Territories to promote health and well-being through the
prevention and control of chronic disease.

The Division of Cancer Prevention and Control (DCPC) is one of these 10
divisions and administers the National Program of Cancer Registries,
within the Cancer Surveillance Branch (CSB).

See [Appendix C](#_Appendix_C:__4) for the organization charts relating
federal health care and how NPCR is positioned to meet the federal
requirements relating to cancer.

As shown in the organizational chart below, the CSB is comprised of the
Office of the Chief and three structural teams: the Operations Research
and Technical Assistance Team (ORTAT), the Data Analysis and Support
Team (DAST), and the Surveillance Research Team (SRT).

CDC - CANCER SURVEILLANCE BRANCH

The CSB is responsible for program management and capacity building
within the participating central cancer registries. CSB surveillance
functions include data collection and enhancement, data receipt and
evaluation, and data analysis and dissemination. The performance of
these functions is distributed among the three structural teams.

ORTAT functions include:

-   leading program management;

-   developing and monitoring program standards;

-   performing quality assurance;

-   coordinating creation of educational products; and

-   coordinating the annual Program Directors meeting.

For each NPCR program, ORTAT functions include:

-   monitoring the accuracy and completeness of data;

-   monitoring work plans and progress;

-   monitoring budgets; and

-   providing technical assistance.

DAST functions include:

-   providing technical, statistical, and data analysis support to CSB
    and DCPC;

-   providing support in the collection, evaluation, and release of
    data;

-   developing and supporting cancer registry software products and
    Web-based applications; and

-   promoting electronic reporting of surveillance data to central
    registries.

SRT functions include:

-   describing cancer incidence and mortality at the state, regional,
    and national levels, and for special populations;

-   promoting the use of surveillance data for cancer prevention and
    control; and

-   building capacity for NPCR registries to conduct advanced
    surveillance research and activities.

Support to NPCR-CSS is provided by a functional team of designated staff
from ORTAT, DAST, and SRT. ORTAT, DAST, and SRT work closely together
and collaborate with other branches in DCPC and with other CDC
Divisions.

## 1.4 Funding Opportunity Announcement (FOA) 

CDC releases a Funding Opportunity Announcement to identify and
establish the long-term goals of the National Cancer Prevention and
Control Program (NCPCP) through performance measures. A work plan is
developed by each Program to measure progress in meeting the
requirements in the FOA.

The Funding Opportunity Announcement CDC-RFA-DP07-703, released in 2007,
incorporated funding guidance for the following three Programs
(<http://www.cdc.gov/cancer/dcpc/about/>
<http://www.cdc.gov/cancer/procontacts.htm>):

-   National Program of Cancer Registries (NPCR)

-   National Comprehensive Cancer Control Program (NCCCP)

-   National Breast and Cervical Cancer Early Detection Program
    (NBCCEDP)

-   

## 1.4.1 CDC-NPCR Responsibilities under the Funding Opportunities Announcement

NPCR staff is substantially involved in the program activities, above
and beyond routine grant monitoring. NPCR activities for the program
include:

-   Provide technical assistance to central cancer registries for
    effective program management including, but not limited to: registry
    operations, data management, and budget management.

-   Develop publicly available software programs for collecting and
    processing cancer registry data.

-   Evaluate, monitor, and report on central cancer registry progress
    toward meeting NPCR Program Standards through review of interim
    progress reports, NPCR Cancer Surveillance System Data Evaluation
    Reports, NPCR Data Completeness and Quality Audit results, site
    visits, NPCR Program Evaluation Instrument, and any other
    CDC-initiated evaluations.

-   Collaborate with national partners and organizations to standardize
    the reporting of cancer, promote education for cancer registrars,
    and advocate for central cancer registries by actively participating
    as chairs/members of committees/workgroups.

-   Conduct site visits of central cancer registries to assess program
    progress, to develop a better understanding of the central cancer
    registry's operations and issues, to review NPCR Data Completeness
    and Quality Audit results, and, if needed, to mutually resolve
    problems.

-   Assess the completeness and quality of central cancer registry data
    by conducting NPCR-sponsored Data Completeness and Quality Audits of
    central cancer registries.

-   Receive, evaluate, and disseminate cancer surveillance data received
    from central cancer registries through the NPCR Cancer Surveillance
    System.

-   Convene a meeting of the Program Directors, at least annually, for
    information sharing and updates, to provide the participants a forum
    to discuss issues of relevance, share successes and challenges, and
    to identify common solutions to problems.

-   Convene an annual train-the-trainer meeting to provide education and
    training to central cancer registry trainers with the goal of
    building capacity within the central cancer registry to provide
    education and training to central cancer registry staff and
    reporters.

## 1.4.2 NPCR Funded Central Cancer Registry Activities under the Funding Opportunities Announcement 

To receive NPCR funding, central cancer registries must engage in a
minimum of activities in each of the following areas:

-   Operations and Administration

-   Data Management

-   Data Quality Assurance

-   Data Linkages

-   Data Submission to NPCR

-   Data Use and Collaborative Relationships

Performance will be measured by the extent to which the program has met
the NPCR Program Standards as evidenced by review of the annual NPCR
Cancer Surveillance System (NPCR CSS) Data Evaluation Reports; the
results of the NPCR Data Completeness and Quality Audit (NPCR DCQA); the
NPCR Program Evaluation Instrument (NPCR PEI); progress reports, and
site visits.

+----------------+-----------------------------------------------------+
| OPERATIONS AND |                                                     |
| ADMINISTRATION |                                                     |
+----------------+-----------------------------------------------------+
| -              |                                                     |
|    Enhancement |                                                     |
|     (Part I)   |                                                     |
|     -- Support |                                                     |
|     and        |                                                     |
|     enhance    |                                                     |
|     the        |                                                     |
|     operation  |                                                     |
|     of an      |                                                     |
|     existing   |                                                     |
|     po         |                                                     |
| pulation-based |                                                     |
|     central    |                                                     |
|     cancer     |                                                     |
|     registry   |                                                     |
|     that has   |                                                     |
|     supporting |                                                     |
|                |                                                     |
|    legislative |                                                     |
|     authority. |                                                     |
|                |                                                     |
| -   Planning   |                                                     |
|     (Part II)  |                                                     |
|     -- Plan,   |                                                     |
|     implement, |                                                     |
|     and        |                                                     |
|     support    |                                                     |
|     the        |                                                     |
|     operation  |                                                     |
|     of a new   |                                                     |
|     or limited |                                                     |
|     po         |                                                     |
| pulation-based |                                                     |
|     cancer     |                                                     |
|     registry   |                                                     |
|     that has   |                                                     |
|     supporting |                                                     |
|                |                                                     |
|    legislative |                                                     |
|     authority. |                                                     |
+----------------+-----------------------------------------------------+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Core Staff     | -   Applicants for Enhancement (Part I) must have   |
|                |     existing adequate and qualified core staff to   |
|                |     support the operations of the central cancer    |
|                |     registry. Core staff must fill the roles of     |
|                |     Program Director/Project Director/Principal     |
|                |     Investigator; Quality Assurance/Control         |
|                |     Manager; and Education/Training Coordinator.    |
|                |     The positions of Quality Assurance/Control      |
|                |     Manager and Education Training Coordinator must |
|                |     be filled by a qualified, experienced CTR.      |
|                |                                                     |
|                | -   Applicants for Planning (Part II) must          |
|                |     demonstrate the ability to hire/contract        |
|                |     adequate and qualified staff to support the     |
|                |     operations of the central registry.             |
+----------------+-----------------------------------------------------+
| Written        | -   Applicants for Enhancement (Part I) must have   |
| Policies and   |     documented and implemented operational policies |
| Procedures     |     and procedures. These must be made available to |
|                |     NPCR upon request.                              |
+----------------+-----------------------------------------------------+
| Hardware and   | -   Applicants for Enhancement (Part I) must have   |
| Software       |     adequate hardware and software resources in     |
| Resources      |     place that support the key central cancer       |
|                |     registry activities including data collection,  |
|                |     database management, quality assurance, data    |
|                |     analysis, and management reports.               |
+----------------+-----------------------------------------------------+

+----------------+-----------------------------------------------------+
| DATA           |                                                     |
| MANAGEMENT     |                                                     |
| ACTIVITIES     |                                                     |
+================+=====================================================+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Co             | -   Ensure the confidentiality of the central       |
| nfidentiality, |     cancer registry data through documented and     |
| Security and   |     implemented policies and procedures in every    |
| Data Release   |     part of registry operations, and through a data |
| Activities     |     release policy and procedure that includes      |
|                |     access to and disclosure of information.        |
|                |                                                     |
|                | -   Ensure the security of both physical and        |
|                |     electronic data through documented and          |
|                |     implemented policies and procedures.            |
|                |                                                     |
|                | -   Data security must include database backup,     |
|                |     storage, and disaster recovery.                 |
+----------------+-----------------------------------------------------+
| Completeness,  | -   Collect complete and timely data from the NPCR  |
| Timeliness     |     reference year forward. At a minimum, the       |
| Activities     |     program should meet the *United States Cancer   |
|                |     Statistics (USCS)* criteria for publication for |
|                |     the 1998 diagnosis year forward.                |
|                |                                                     |
|                | -   Perform death clearance activities (see *NAACCR |
|                |     Standards for Cancer Registries Volume III,     |
|                |     Standards for Completeness, Quality, Analysis,  |
|                |     and Management of Data*                         |
|                |                                                     |
|                |    ([http://ww.naaccr.org](http://ww.naaccr.org/)). |
|                |                                                     |
|                | -   If complete death clearance has not been        |
|                |     performed for all NPCR-diagnosis years, at a    |
|                |     minimum, conduct a linkage with the state's     |
|                |     death records for the NPCR reference year up to |
|                |     the diagnosis year that complete death          |
|                |     clearance was performed. Following this         |
|                |     linkage, at a minimum, update the data fields   |
|                |     Date of Last Contact \[NAACCR Item 1750\],      |
|                |     Vital Status \[NAACCR Item 1760\], and Cause of |
|                |     Death \[NAACCR Item 1910\].                     |
|                |                                                     |
|                | -   At a minimum, exchange data with the central    |
|                |     cancer registries of all bordering states.      |
|                |                                                     |
|                | -   Conduct case finding audits of reporting        |
|                |     sources to make certain all reportable cases    |
|                |     are identified and submitted to the central     |
|                |     cancer registry.                                |
+----------------+-----------------------------------------------------+

+----------------+-----------------------------------------------------+
| DATA QUALITY   |                                                     |
| ASSURANCE      |                                                     |
| ACTIVITIES     |                                                     |
+================+=====================================================+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Consolidation  | -   Perform consolidation of data reported to the   |
|                |     central cancer registry following best          |
|                |     practices or standards as they become           |
|                |     available. Definition of consolidation from the |
|                |     *NAACCR Standards for Cancer Registries Volume  |
|                |     III, Standards for Completeness, Quality,       |
|                |     Analysis, and Management of Data*: "the process |
|                |     of reconciling or compiling data obtained from  |
|                |     more than one source on the same person or      |
|                |     tumor...A large task of the central registry    |
|                |     system is to prepare a composite set of values  |
|                |     for each patient and tumor, incorporating       |
|                |     information from a variety of sources."         |
+----------------+-----------------------------------------------------+
| Edits          | -   Edit central cancer registry data using         |
|                |     computerized standard edits. At a minimum, run  |
|                |     and resolve the NPCR Required Standard Data     |
|                |     Edits on a quarterly basis (see *Standards for  |
|                |     Cancer Registries, Volume IV, NAACCR Standard   |
|                |     Edits*,                                         |
|                |                                                     |
|                |  ([http://www.naaccr.org](http://www.naaccr.org/)). |
+----------------+-----------------------------------------------------+
| Education and  | -   Provide education and training opportunities to |
| Training       |     reporting sources and to the central cancer     |
| Activities     |     registry staff with the goal of improving the   |
|                |     quality of the central cancer registry data.    |
+----------------+-----------------------------------------------------+
| Audits         | -   Central Cancer Registry: Conduct internal       |
|                |     audits and/or quality checks of data collected  |
|                |     and processed by central registry staff,        |
|                |     participate in national quality assurance       |
|                |     studies (e.g. Collaborative Staging Assessment) |
|                |     and conduct external audits of reporting        |
|                |     sources to assure the quality of central cancer |
|                |     registry data.                                  |
+----------------+-----------------------------------------------------+

+----------------+-----------------------------------------------------+
| DATA LINKAGE   |                                                     |
| ACTIVITIES     |                                                     |
+================+=====================================================+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Death Records  | -   Perform central cancer registry data linkage    |
|                |     with the state's death records, at least        |
|                |     annually, to enhance the completeness and       |
|                |     quality of the central registry data. Following |
|                |     this linkage, at a minimum, update the data     |
|                |     fields. Date of Last Contact \[NAACCR Item      |
|                |     1750\], Vital Status \[NAACCR Item 1760\], and  |
|                |     Cause of Death \[NAACCR Item 1910\].            |
+----------------+-----------------------------------------------------+
| NBCCEDP        | -   Perform central cancer registry data linkage    |
|                |     with NBCCEDP awardees in accordance with CDC    |
|                |     specifications, to enhance the completeness and |
|                |     quality of the central registry data. Results   |
|                |     from the linkage between central cancer         |
|                |     registries and the breast and cervical cancer   |
|                |     screening programs should be used to:           |
|                |                                                     |
|                |     -   Update Minimum Data Elements (MDE) data     |
|                |         with central cancer registry data           |
|                |                                                     |
|                |     -   Update cancer registry database as          |
|                |         necessary                                   |
|                |                                                     |
|                |     -   Identify missing cancer cases in the        |
|                |         central cancer registry                     |
|                |                                                     |
|                |     -   Reconcile differences between the two data  |
|                |         sources                                     |
+----------------+-----------------------------------------------------+
| Other          | -   Perform other optional or NPCR required data    |
|                |     linkages that will enhance the completeness     |
|                |     and/or quality of the central registry data.    |
+----------------+-----------------------------------------------------+

+----------------+-----------------------------------------------------+
| DATA           |                                                     |
| SUBMISSION TO  |                                                     |
| NPCR           |                                                     |
+----------------+-----------------------------------------------------+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Data           | -   Submit a data file annually to the NPCR Cancer  |
| Submission to  |     Surveillance System that meets the reporting    |
| the NPCR       |     requirements outlined in the NPCR-CSS           |
|                |     Submission Specifications document and that     |
|                |     meets the criteria for publication in the       |
|                |     *United States Cancer Statistics (USCS)         |
|                |     Report.*                                        |
+----------------+-----------------------------------------------------+

+----------------+-----------------------------------------------------+
| DATA USE AND   |                                                     |
| COLLABORATIVE  |                                                     |
| RELATIONSHIPS  |                                                     |
+================+=====================================================+
| **Activity**   | **Requirement**                                     |
+----------------+-----------------------------------------------------+
| Annual Report/ | -   Produce annual data set(s)/file(s) in an        |
| Data Set       |     electronic format as described in the NPCR      |
|                |     Program Standards.                              |
|                |                                                     |
|                | -   Use the *USCS Report* for comparison with       |
|                |     national and regional data.                     |
+----------------+-----------------------------------------------------+
| Cancer Control | -   Promote the use of the central cancer registry  |
| Activities     |     data for planning and evaluation of cancer      |
|                |     control planning objectives and public health   |
|                |     practice in State/Territory/Jurisdiction/Tribe. |
|                |                                                     |
|                | -   Establish and maintain a collaborative          |
|                |     relationship with the                           |
|                |     State/Territory/Jurisdiction/Tribe's National   |
|                |     Comprehensive Cancer Control Program (NCCCP),   |
|                |     if funded.                                      |
|                |                                                     |
|                | -   Establish and maintain a collaborative          |
|                |     relationship with the                           |
|                |     State/Territory/Jurisdiction/Tribe's National   |
|                |     Breast and Cervical Cancer Early Detection      |
|                |     Program (NBCCEDP), if funded.                   |
+----------------+-----------------------------------------------------+
| NPCR Data      | -   Participate in NPCR data release activities     |
| Release        |     including, but not limited to, the following:   |
| Activities     |                                                     |
|                |     -   Public Use Data Sets                        |
|                |                                                     |
|                |     -   Restricted Access Data Sets                 |
+----------------+-----------------------------------------------------+
| NPCR Economic  | -   Participate in the NPCR Economic Analysis as    |
| Analysis       |     required.                                       |
+----------------+-----------------------------------------------------+
| CDC Meetings/  | -   Appropriate/key central cancer registry staff   |
| Training       |     must attend and participate in CDC Meetings or  |
|                |     trainings.                                      |
|                |                                                     |
|                | -   The Principal Investigator and/or the Program   |
|                |     Director must attend CDC Cancer Conferences, if |
|                |     scheduled, during the budget period.            |
|                |                                                     |
|                | -   Appropriate/key central cancer registry staff   |
|                |     should attend cancer registry related meetings  |
|                |     or trainings.                                   |
+----------------+-----------------------------------------------------+
| Advisory       | -   For Enhancement (Part I) applicants, convene,   |
| Committee      |     at a minimum annually, an advisory committee to |
|                |     assist in enhancing and utilizing the central   |
|                |     cancer registry. Committee members should       |
|                |     include representation from the central cancer  |
|                |     registry, facility cancer registrars, reporting |
|                |     facilities, physicians, pathologists, key       |
|                |     organizations and individuals considered to be  |
|                |     stakeholders in the                             |
|                |     state/territory/jurisdiction/tribe's            |
|                |     comprehensive cancer control effort.            |
|                |                                                     |
|                | -   For Planning (Part II) applicants, establish    |
|                |     and regularly convene an advisory committee to  |
|                |     assist in building consensus, cooperation and   |
|                |     planning for the central cancer registry.       |
+----------------+-----------------------------------------------------+
| Program        | -   Complete and submit the NPCR Program Evaluation |
| Evaluation     |     Instrument by the stated deadline.              |
| Instrument     |                                                     |
| (PEI)          |                                                     |
+----------------+-----------------------------------------------------+
| Advanced       | -   To be eligible for funding of advanced          |
| Activities     |     activities, programs must do the following:     |
|                |                                                     |
|                |     -   Conduct all NPCR Recipient Activities as    |
|                |         described                                   |
|                |                                                     |
|                |     -   Meet the *USCS* publication criteria for    |
|                |         the diagnosis years 1998 and forward        |
|                |                                                     |
|                | -   States applying under Part I -- Enhancement     |
|                |     programs are encouraged to conduct advanced     |
|                |     activities when the central cancer registry     |
|                |     consistently meets and maintains or exceeds the |
|                |     NPCR Program Standards. The purpose of these    |
|                |     activities is to further enhance the central    |
|                |     cancer registry data and/or the use of the      |
|                |     data. Examples of advanced activities include,  |
|                |     but are not limited to, the following:          |
|                |                                                     |
|                |     -   Passive follow-up activities (e.g. NDI      |
|                |         Linkage)                                    |
|                |                                                     |
|                |     -   GIS Analysis and/or Mapping                 |
|                |                                                     |
|                |     -   Special Studies sponsored by the NPCR       |
|                |                                                     |
|                |     -   Data linkages that assist in addressing     |
|                |         other public health issues as they relate   |
|                |         to cancer (tobacco use, obesity)            |
|                |                                                     |
|                | -   Performance of advanced activities will be      |
|                |     measured by the extent to which the program has |
|                |     documented enhancement resulting from the       |
|                |     activities in progress reports.                 |
+----------------+-----------------------------------------------------+

## 1.4.3 Funding Restrictions

The Funding Opportunity Announcement restricts use of funds for several
activities. Recipients may only expend funds for reasonable program
purposes, including personnel, travel, supplies, and services, such as
contractual. Additionally, the direct recipient must perform a
substantial role in carrying out project objectives and not merely serve
as a conduit for an award to another party or provider who is
ineligible.

Recipients are specifically barred from using funds for any research
activities. CDC provides guidance on the definitions for public health
research and public health non-research, which can be found in [Appendix
D](#_Appendix_D_Guidelines_1) or at:
<http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm>

## 1.5 Applicable Federal Laws

As a program within a federal agency, NPCR is constrained by federal
legislation, regulations and guidelines. Those having a significant role
are described in this section; others may be referenced in other
sections of this manual.

## 1.5.1 HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
was enacted to:

-   ensure health insurance coverage after leaving an employer;

-   provide standards for facilitating health-care-related electronic
    transactions in order to improve the efficiency and effectiveness of
    the health-care system; and

-   mandate adoption of federal privacy protections for certain
    individually identifiable health information.

The NPCR-funded registries must be aware of the implications of the
developing electronic data technologies for registry systems and
operations, and the application of data privacy requirements to public
health surveillance and research activities.

HIPAA provides for the study of issues related to the adoption of
uniform data standards for patient medical record information and the
electronic exchange of such information. NPCR promotes electronic data
exchange among central registries and to the NPCR-CSS, and incorporates
new program standards relating to registries' use of electronic data as
enabling technologies are realized.

The HIPAA Privacy Rule addresses the concerns for patient privacy and
data confidentiality that arise with the collection and transmission of
electronic health information. HIPAA recognizes the legitimate need for
public health authorities to have access to personal health information
for the purposes of health surveillance. It authorizes the disclosure of
such information without patient authorization as required by state and
local public health laws, including reporting of cancer surveillance
data to central cancer registries. The Privacy Rule, however, does
require reporting sources to document disclosure of information to the
central registries.

The Privacy Rule also distinguishes between public health practice
(public health surveillance, disease control, or program evaluation) and
activities which may develop into an ongoing research study and are,
therefore, subject to research disclosure provisions.

Further information on the HIPAA Privacy Rule and Public Health is
available in a report prepared by the Epidemiology Program Office of the
CDC and published in the MMWR on April 11, 2003. This report is
available at: <http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm>,
and is intended to help public health agencies and others understand and
interpret their responsibilities under the Privacy Rule.

"Protecting Personal Health Information in Research: Understanding the
HIPAA Privacy Rule", addresses the impact of the Privacy Rule on health
data research activities. This report is available at
<http://privacyruleandresearch.nih.gov/pr_02.asp>.

Fact sheets on "Institutional Review Boards and the HIPAA Privacy Rule"
and "Research Repositories, Databases, and the HIPAA Privacy Rule" are
found at <http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp>
and <http://privacyruleandresearch.nih.gov/research_repositories.asp>.

The full text of HIPAA along with comprehensive Department of Health and
Human Services (DHHS) guidance is located at the HIPAA website of the
Office for Civil Rights, <http://www.hhs.gov/ocr/hipaa/>. Guidance from
the CDC can be found at
<http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm>.

## 1.5.2 FOIA

The Freedom of Information Act (FOIA), 5.U.S.C. § 552, enacted in 1966,
establishes an effective legal right of access to government
information. The 1996 amendments in Public Law 104-231 clarify that FOIA
provisions apply to records maintained in electronic format and also
require agencies to provide reference materials or a guide for
requesting records or information, including an index and description of
all major information systems.

Data collected by state cancer registries and submitted to the NPCR
become Federal record and subject to Federal laws and rules governing
data release and records retention, including the Freedom of Information
Act. The NPCR solicits registry agreement with proposed data re-release
plans in accordance with Federal rules; state registries are responsible
for determining that data agreements are consistent with all state laws
and regulations under which they operate. Data re-release plans describe
the content and format of data to be released as either non-identifiable
public-use data or identifiable/potentially identifiable
restricted-access data.

The Freedom of Information ACT (FOIA) home page for the CDC is
<http://www.cdc.gov/OD/foia/index.htm>. This website also references the
FOIA regulations promulgated by the Department of Health and Human
Services and posted on the DHHS webpage at
<http://www.hhs.gov/foia/45cfr5.html>.

The CDC FOIA staff, Office of Public Affairs, is the focal point for all
CDC FOIA requests; The Director, Office of Public Affairs (OPA), as the
CDC Freedom of Information Act Officer, is the sole official with
delegated authority to release or deny CDC records.

The full text of the FOIA as amended by Public Law 104-231 is available
at <http://www.usdoj.gov/oip/foia_updates/Vol_XVII_4/page2.htm>.

## 1.5.3 Office of Management and Budget (OMB)

The NPCR Is governed by the policies and directives of the Office of
Management and Budget (OMB), which oversees and coordinates the
Administration's procurement, financial management, information, and
regulatory policies. The OMB also evaluates the effectiveness of agency
programs, policies, and procedures. In each of these areas, OMB's role
is to help improve administrative management, to develop better
performance measures and coordinating mechanisms, and to reduce any
unnecessary burdens on the public. The NPCR funding requests are
evaluated by OMB as it assesses competing funding demands among
agencies, and sets funding priorities.

The Office of Information and Regulatory Affairs (OIRA) within the OMB
oversees the implementation of government-wide policies in the areas of
information technology, information policy, privacy, and statistical
policy. OIRA also oversees agency implementation of the Information
Quality Law, including the peer review practices of agencies.

## 1.6 Federal Data Quality Guidelines

Under the Federal Data Quality Guidelines, the Department of Health and
Human Services has a commitment to disseminate "accurate, reliable,
clear, complete, unbiased and useful" information by integrating the
principles of information quality into every aspect of its "creation,
collection, maintenance, and dissemination". The NPCR is in compliance
with these standards in data released to the public, and in turn
promulgates data quality standards for funded registry programs which
facilitate compliance.

The Office of Management and Budget issued data quality guidelines for
all Federal agencies on January 3, 2002, in accordance with Section 515,
the "Data Quality Act", of Public Law 106-554, the Treasury and General
Government Appropriations Act for Fiscal Year 2001. "Guidelines for
Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity
of Information Disseminated by Federal Agencies" is available at
<http://www.whitehouse.gov/omb/fedreg_final_information_quality_guidelines/>.

In accordance with requirements, the Department of Health and Human
Services issued specific agency guidelines, and these are available at:
<http://www.aspe.hhs.gov/infoquality>. The HHS quality website also
provides information on the HHS Peer Review Agenda.

## 1.7 CDC/ATSDR Policy on Releasing and Sharing Data

The NPCR is governed by federal rules and agency policies relating to
the release and sharing of public health data collected in pursuit of
its mission to understand and support programs addressing the cancer
burden within the United States. The CDC policy is available on the
website at <http://www.cdc.gov/od/foia/policies/sharing.htm>. As noted
in the background information:

> "The Centers for Disease Control and Prevention (CDC) and the Agency
> for Toxic Substances and Disease Registry (ATSDR) are the nation's
> principal disease prevention and health promotion agencies. To fulfill
> their missions, these agencies must collect, manage, and interpret
> scientific data.
>
> "CDC believes that public health and scientific advancement are best
> served when data are released to, or shared with, other public health
> agencies, academic researchers, and appropriate private researchers in
> an open, timely, and appropriate way. . . ."
>
> "The goal is to have a policy on data release and sharing that
> balances the desire to disseminate data as broadly as possible with
> the need to maintain high standards and protect sensitive information.
> . . ."

The policy references federal laws and directives with which it ensures
compliance, including the Freedom of Information Act (FOIA), the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), the Family
Educational Rights and Privacy Act (FERPA), and the Office of Management
and Budget (OMB) circulars on release of state-provided data and
ensuring the quality and integrity of released data. Not all federal
laws and directives referenced by this policy directly relate to NPCR. 
However, NPCR policies on releasing and sharing data may be compatible
with the law and/or directives' intentions. Links to pertinent
legislation are provided through the Freedom of Information Act
Requestor Service Center webpage at
<http://www.iimefpublic.usmc.mil/public/iimefpublic.nsf/UnitSites/FOIA>

# 2.0 NPCR Program Standards 

NPCR publishes Program Standards to guide priorities and activities of
funded programs; provide objective measures of program progress; improve
program processes that ultimately affect outcomes; and allow the NPCR to
set and monitor its own goals and objectives.

FOA CDC-RFA-DP07-703 is based on authority provided to the CDC-NPCR
under the Public Health Service Act and its subsequent amendments. The
program standards specified in this announcement apply to all reportable
cancers as defined in the Act and amendments. The NPCR Program Standards
are published as an appendix to the Funding Opportunity Announcement,
but may change during the project period of the cooperative agreement.

All funded programs must meet standards for:

-   Legislative Authority

-   Administration

-   Electronic Data Exchange

-   Data Content and Format

-   Completeness/Timeliness/Quality

-   Quality Assurance

-   Data Use and Data Monitoring

-   Data Submission

-   Collaborative Relationships

The following tables describe each Program Standard and provide the
reference section.

## 2.1 NPCR Program Standards and Reference Manual Links

+-----------------------------------------------------------------------+
| I. LEGISLATIVE AUTHORITY                                              |
+-----------------------------------------------------------------------+
| a.  The state/territory has a law authorizing a population-based      |
|     central cancer registry.                                          |
|                                                                       |
| b.  The state/territory has legislation or regulations in support of  |
|     the Public Law authorizing the National Program of Cancer         |
|     Registries (NPCR).                                                |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 2.2](#legislative-authority-for-central-registry)          |
| > Legislative Authority for Cancer Registry                           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| II\. ADMINISTRATION                                                   |
+=======================================================================+
| a.  The central cancer registry maintains an operational manual that  |
|     describes registry operations, policies and procedures. At a      |
|     minimum the manual contains the following:                        |
|                                                                       |
|     1.  Reporting laws/regulations                                    |
|                                                                       |
|     2.  List of reportable diagnoses                                  |
|                                                                       |
|     3.  List of required data items                                   |
|                                                                       |
|     4.  Procedures for data processing operations including:          |
|                                                                       |
|         i.  Procedures for monitoring timeliness of reporting         |
|                                                                       |
|         ii. Procedures for receipt of data                            |
|                                                                       |
|         iii. Procedures for database management including a           |
|              description of the Registry Operating System (software)  |
|                                                                       |
|         iv. Procedures for conducting death certificate clearance     |
|                                                                       |
|         v.  Procedures for implementing and maintaining the quality   |
|             assurance/control program                                 |
|                                                                       |
|             a.  Procedures for conducting follow-back to reporting    |
|                 facilities on quality issues. These procedures        |
|                 include rules for identifying when action or further  |
|                 investigation is needed                               |
|                                                                       |
|             b.  Procedures for conducting record consolidation        |
|                                                                       |
|             c.  Procedures for maintaining detailed documentation of  |
|                 all quality assurance operations                      |
|                                                                       |
|         vi. Procedures for conducting data exchange including a list  |
|             of states with whom case-sharing agreements are in place  |
|                                                                       |
|     5.  Procedures insuring confidentiality and data security         |
|         including disaster planning                                   |
|                                                                       |
|     6.  Procedures for data release including access to and           |
|         disclosure of information                                     |
|                                                                       |
|     7.  Procedures for maintaining and updating the operational       |
|         manual                                                        |
|                                                                       |
| b.  The central cancer registry has management reports that monitor   |
|     the registry operations and database including processes and      |
|     activities.                                                       |
|                                                                       |
| c.  The central cancer registry has an abstracting and coding manual  |
|     to be disseminated to and used by all reporting sources.          |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 2.3](#central-cancer-registry-operations-manual)           |
| > Expectations for a Written Policy and Procedure Manual              |
| >                                                                     |
| > [Section 2.4](#management-reports) Expectations for Management      |
| > Reports                                                             |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| III\. ELECTRONIC DATA EXCHANGE                                        |
+=======================================================================+
| a.  The central cancer registry uses and requires a standardized,     |
|     NPCR-recommended data exchange record layout for the electronic   |
|     exchange of cancer data. NPCR-recommended data exchange layouts   |
|     include:                                                          |
|                                                                       |
|     1.  For abstract reports: The NAACCR record layout version        |
|         specified in year-appropriate *Standards for Cancer           |
|         Registries Volume II: Data Standards and Data Dictionary*     |
|                                                                       |
|     2.  For pathology reports: *NAACCR Standards for Cancer           |
|         Registries Volume V: Pathology Laboratory Electronic          |
|         Reporting*                                                    |
|                                                                       |
|     3.  At a minimum, 95% of reports from hospitals are submitted to  |
|         the central cancer registry in an electronic format (where    |
|         the medical records are owned by the hospital).               |
|                                                                       |
| b.  At a minimum, 85% of reports from non-hospital reporting sources  |
|     are submitted to the central cancer registry in an electronic     |
|     format (e.g., radiation therapy centers, ambulatory surgery       |
|     centers, and in-state and out-of-state pathology laboratories     |
|     where medical records are owned by the reporting source).         |
|                                                                       |
| c.  At a minimum, 75% of reports from physician offices, identified   |
|     as required to submit cancer cases to the central cancer          |
|     registry, do so in an electronic format (where the medical        |
|     records are owned by the physician). This includes responses from |
|     physicians to central cancer registry inquiries.                  |
|                                                                       |
| d.  The central cancer registry primarily uses a secure               |
|     Internet-based, FTP, or encrypted email mechanism to receive data |
|     from all reporting sources.                                       |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 3.5](#data-exchange-format) Standard for data exchange     |
| > format                                                              |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| IV\. DATA CONTENT AND FORMAT                                          |
+=======================================================================+
| a.  For all NPCR required reportable cases, the central cancer        |
|     registry collects or derives all required data items using        |
|     standard codes as prescribed by NPCR (see III. a).                |
|                                                                       |
| b.  The central cancer registry uses a standardized, NPCR-recommended |
|     data exchange format to transmit data to other central cancer     |
|     registries and NPCR (see III. a.).                                |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 3.0](#program-standards-for-data-collection) Data          |
| > Collection Requirements                                             |
| >                                                                     |
| > [Section 3.1](#reportability) Reportability Standards               |
| >                                                                     |
| > [Section 3.2](#reference-manuals) Reference Manuals                 |
| >                                                                     |
| > [Section 3.3](#required-data-items) Required Data Items             |
| >                                                                     |
| > [Section 3.4](#unresolved-data-item-issues) Unresolved Data Item    |
| > Issues                                                              |
| >                                                                     |
| > [Section 3.5](#data-exchange-format) Data Exchange Format           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| V. DATA COMPLETENESS/TIMELINESS/QUALITY                               |
+=======================================================================+
| a.  Within 24 months of the close of the diagnosis year, at least 75% |
|     of physicians, surgeons, and all other health care practitioners  |
|     diagnosing or providing treatment for cancer patients submit all  |
|     reportable cases to the central cancer registry, except for cases |
|     directly referred to or previously admitted to a hospital or      |
|     other facility providing screening, diagnostic or therapeutic     |
|     services to patients in that State and reported by those          |
|     facilities (based on PL 102-515).                                 |
|                                                                       |
| b.  Within 12 months of the close of the diagnosis year, the central  |
|     cancer registry data meet the NPCR standards for the following    |
|     two data quality criteria:                                        |
|                                                                       |
|     1.  Data are 90% complete based on observed-to-expected cases as  |
|         computed by NPCR.                                             |
|                                                                       |
|     2.  97% pass an NPCR-prescribed set of standard edits.            |
|                                                                       |
| c.  Within 24 months of the close of the diagnosis year, the central  |
|     cancer registry data meet the NPCR standards for the following    |
|     five data quality criteria:                                       |
|                                                                       |
|     1.  Data are 95% complete based on observed-to-expected cases as  |
|         computed by NPCR.                                             |
|                                                                       |
|     2.  There are 3% or fewer death-certificate-only cases.           |
|                                                                       |
|     3.  There is a 1 per 1,000 or fewer unresolved duplicate rate.    |
|                                                                       |
|     4.  The percent missing for critical data elements are:           |
|                                                                       |
|         i.  2% or fewer age                                           |
|                                                                       |
|         ii. 2% or fewer sex                                           |
|                                                                       |
|         iii. 3% or fewer race                                         |
|                                                                       |
|         iv. 2% or fewer county                                        |
|                                                                       |
|     5.  99% pass an NPCR-prescribed set of standard edits.            |
|                                                                       |
| d.  Within 12 months of the close of the diagnosis year, the central  |
|     cancer registry exchanges data with other central cancer          |
|     registries where a data-exchange agreement is in place. The data  |
|     file must also include all cases not previously exchanged.        |
|                                                                       |
|     1.  Regardless of residency, the central cancer registry collects |
|         data on all patients diagnosed and/or receiving first course  |
|         of treatment in the registry's state/territory.               |
|                                                                       |
|     2.  The recommended frequency for data exchange is, at a minimum, |
|         two times a year.                                             |
|                                                                       |
|     3.  Exchanged data must meet the following minimum criteria:      |
|                                                                       |
|         i.  Exchange agreements are in place with all bordering       |
|             central cancer registries.                                |
|                                                                       |
|         ii. Exchanged data include a dataset that consists of NPCR    |
|             core data items.                                          |
|                                                                       |
|         iii. 99% of data pass an NPCR-prescribed set of standard      |
|              edits.                                                   |
|                                                                       |
|         iv. The dataset is transmitted via secure encrypted           |
|             Internet-based, FTP, or encrypted email mechanism.        |
|                                                                       |
|         v.  A standardized, NPCR-recommended data exchange format is  |
|             used to transmit data (see III. a.).                      |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 4.0](#completeness-quality-and-timeliness-requirements)    |
| > Data Completeness, Quality and Timeliness Requirements              |
| >                                                                     |
| > [Section 4.1](#data-evaluation) Data Evaluation                     |
| >                                                                     |
| > [Section 4.2](#data-completeness) Data Completeness                 |
| >                                                                     |
| > [Section 4.3](#data-quality) Data Quality                           |
| >                                                                     |
| > [Section 4.4](#data-timeliness) Data Timeliness                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| VI\. DATA QUALITY ASSURANCE                                           |
+=======================================================================+
| a.  The central cancer registry has an overall program of quality     |
|     assurance that is defined in the registry operations policy and   |
|     procedure manual. The quality assurance program consists of, but  |
|     is not limited to:                                                |
|                                                                       |
|     1.  A designated certified tumor registrar (CTR) is responsible   |
|         for the quality assurance program.                            |
|                                                                       |
|     2.  Qualified, experienced CTR(s) conduct quality assurance       |
|         activities.                                                   |
|                                                                       |
|     3.  At least once every 5 years, case-finding and/or              |
|         re-abstracting audits from a sampling of source documents are |
|         conducted for each hospital-based reporting facility, and may |
|         include external audits (NPCR/SEER).                          |
|                                                                       |
|     4.  Data consolidation procedures are performed according to an   |
|         accepted protocol.                                            |
|                                                                       |
|     5.  Procedures are performed for follow-back to reporting         |
|         facilities on quality issues.                                 |
|                                                                       |
| b.  The central cancer registry has a designated education/training   |
|     coordinator who is a CTR to provide training to the central       |
|     cancer registry staff and reporting sources to assure high        |
|     quality data.                                                     |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 4.3](#data-quality) Data Quality Assurance                 |
| >                                                                     |
| > [Section 2.5](#_2.5__Education) Education and Training              |
| >                                                                     |
| > [Section 4.2](#data-completeness) Data Completeness Audits          |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| VII\. DATA USE                                                        |
+=======================================================================+
| a.  Within 12 months of the end of the diagnosis year with data that  |
|     are 90% complete, the central cancer registry produces            |
|     preliminary pre-calculated data tables in an electronic data file |
|     or report of incidence rates, counts, or proportions for the      |
|     diagnosis year by Surveillance Epidemiology and End Results       |
|     (SEER) site groups as a preliminary monitor of the top cancer     |
|     sites within the state/territory.                                 |
|                                                                       |
| b.  Within 24 months of the end of the diagnosis year with data that  |
|     are 95% complete, the central cancer registry produces            |
|     pre-calculated data in tables in an electronic data file or       |
|     report. The report includes, at a minimum, age-adjusted incidence |
|     rates and age-adjusted mortality rates for the diagnosis year by  |
|     sex for SEER site groups, and, where applicable, by sex, race,    |
|     and ethnicity.                                                    |
|                                                                       |
| c.  The central cancer registry, state health department, or its      |
|     designee annually uses registry data for planning and evaluation  |
|     of cancer control objectives in at least three of the following   |
|     ways:                                                             |
|                                                                       |
|     1.  Comprehensive cancer control                                  |
|                                                                       |
|     2.  Detailed incidence/mortality estimates                        |
|                                                                       |
|     3.  Linkage with a statewide cancer screening program to improve  |
|         follow-up of screened patients                                |
|                                                                       |
|     4.  Health event investigation(s)                                 |
|                                                                       |
|     5.  Needs assessment/program planning                             |
|                                                                       |
|     6.  Program evaluation                                            |
|                                                                       |
|     7.  Epidemiologic studies                                         |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 7.4](#state-data-use) State Data Use                       |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| VIII\. DATA SUBMISSION                                                |
+=======================================================================+
| a.  The central cancer registry annually submits a data file to the   |
|     NPCR-Cancer Surveillance System (CSS) that meets the reporting    |
|     requirements outlined in the NPCR-CSS Submission Specifications   |
|     document and meets criteria for publication in *United States     |
|     Cancer Statistics*.                                               |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| IX\. COLLABORATIVE RELATIONSHIPS                                      |
+=======================================================================+
| a.  The central cancer registry actively collaborates in the state's  |
|     comprehensive cancer control planning efforts.                    |
|                                                                       |
| b.  The central cancer registry establishes a working relationship    |
|     with all components of the National Cancer Prevention and Control |
|     program to ensure the use of registry data to assess and          |
|     implement cancer control activities.                              |
|                                                                       |
| c.  The central cancer registry establishes and regularly convenes an |
|     advisory committee to assist in building consensus, cooperation,  |
|     and planning for the registry. Representation should include key  |
|     organizations and individuals both within (such as                |
|     representatives from all cancer prevention and control            |
|     components) and outside the program (such as hospital cancer      |
|     registrars, the American Cancer Society, clinical-laboratory      |
|     personnel, pathologists, and clinicians). Advisory committees may |
|     be structured to meet the needs of the state/territory such as    |
|     the Comprehensive Cancer Control Program committee structure, an  |
|     advocacy group, or a focus group.                                 |
+-----------------------------------------------------------------------+
| **Program Manual Reference**                                          |
|                                                                       |
| > [Section 7.4](#state-data-use) State Data Use                       |
| >                                                                     |
| > [Section 8.0](#collaborative-relationships) NPCR Collaborative      |
| > Relationships                                                       |
| >                                                                     |
| > [Section 8.10](#state-collaborative-relationships) State            |
| > Collaborative Relationships                                         |
+-----------------------------------------------------------------------+

## 2.2 Legislative Authority for Central Registry

In passing the National Cancer Registries Amendment Act (which can be
found at <http://www.cdc.gov/cancer/npcr/npcrpdfs/publaw.pdf>), Congress
required applicants, under state law, to provide for the authorization
of the statewide cancer registry, including promulgation of eight
categories of regulations to:

-   require reporting of newly diagnosed cancer cases by hospitals and
    other health-care facilities;

-   require reporting of cancer cases by physicians and other
    health-care practitioners;

-   guarantee access by the statewide cancer registry to all records of
    medical status of persons with cancer;

-   require the use of standardized reporting formats;

-   ensure confidentiality of cancer case data;

-   allow use of confidential case data by certain researchers;

-   authorize the conduct of studies using cancer registry data; and

-   ensure protection of persons complying with the law from liability.

On its website page,
<http://apps.nccd.cdc.gov/cancercontacts/npcr/contactlist.asp>, NPCR
maintains a list of contacts for all funded program registries,
including links to their individual website pages. Many programs provide
access to their legislative statutes and regulations via their home
pages. Thus, the NPCR page serves as the primary reference link to the
body of legislation which supports central registry activities at the
state level throughout the United States.

The CDC developed a database of state and federal legislation relating
to cancer prevention and control, including the establishment of
surveillance registries, from 1996 through 2004. This database is no
longer updated, but is maintained as a searchable source of information
with links to state legislature homepages, at
<http://www.cdc.gov/cancer/dcpc/library/legislation/>.

## 2.3 Central Cancer Registry Operations Manual

The Operations Manual provides the essential documentation for the
operation of the cancer registry and ensures consistency of internal
registry operations over time. The manual should include, at a minimum:

-   state legislation;

-   reportability of cancer cases and data included in the registry;

-   a description of the software system in use;

-   database management procedures;

-   quality assurance procedures;

-   procedures for death clearance, data release, and data exchange; and

-   guidelines for confidentiality and security.

The manual should also specify the procedures for maintaining and
updating the information and procedures.

The Operations Manual serves as a training guide for new staff and an
informational resource for data users who need to understand changes in
data items and definitions over time. It provides the documentation
needed to support NPCR program applications and progress reports. The
manual provides documentation of the critical activities of the registry
and can be used to obtain funding support from state, federal, and
private sources.

A standard Abstracting and Coding Manual for data collectors and
reporters is critical in promoting and preserving the reliability and
consistency of cancer data collected and reported. Cancer data are
assembled from many health record sources within single facilities, and
consolidated from many facility abstracts at the central registry.
Comparability and usefulness of the data at state and national levels
can only be achieved through the uniform application of standardized
data definitions and codes. As coding sets are changed with some
frequency, an Abstracting and Coding Manual is essential for uniform
application of these standards.

## 2.4 Management Reports

Management reports can range from simple counts to sophisticated
statistical analyses; they can provide descriptive information about a
system; or compare and cross-tabulate values. Reports can be presented
as tables of data or summary statistics. Data displayed in charts and
graphs may facilitate understanding of report content. Management
information can be used to trigger action or interventions to improve
operations.

The cancer registry software system should generate regular and ad hoc
reports on the state of the registry database, including, but not
limited to the following:

-   numbers of patient and cancer records entered into or deleted from
    the database;

-   abstracts consolidated into single cancers;

-   abstracts flagged for review and reviewed;

-   sources and timeliness of reported records;

-   processing times as abstracts move through the system;

-   completeness of reporting based on expected numbers of cases;

-   receipt and processing of updated records;

-   edit failures/error rates, and corrections made to reported data;
    and

-   staff workload assignments in relation to reported cases.

The cancer registry software system should generate regular and ad hoc
reports on the state of the system, including:

-   user volume and response time;

-   user access and permissions;

-   backup procedures and backup availability; and

-   potential security breaches.

Project management systems should be in place to track the progress of
development activities from initiation to conclusion, such as design,
writing, and implementation of new or enhanced software capability.

Personnel and financial accounting systems should yield regular reports
on employee time assignments and budgeted versus actual expenditures.

NPCR has updated a presentation on management reports, initially
developed by NAACCR under contract with CDC, available at:
<http://www.cdc.gov/cancer/npcr/registry/management/>. This presentation
focuses on the use of management reports particularly for tracking
timeliness and completeness of reporting by submitting facilities, and
for monitoring data quality through the use of edits and visual editing.

The following three NAACCR documents address in detail issues in central
registry data collection and processing and the use of reports to manage
defined registry tasks and procedures:

-   Standards for Cancer Registries Volume III: Standards for
    Completeness, Quality, Analysis, and Management of Data

-   Procedure Guidelines for Cancer Registries: Series III: The Policy
    and Procedure Manual

-   Series IV: Cancer Case Ascertainment

-   These documents are available from the NAACCR website at
    <http://www.naaccr.org/index.asp?Col_SectionKey=28&Col_ContentID=312>.

## 2.5 Education and Training

[]{.mark}

[]{.mark}

[]{.mark}

[]{.mark}

[]{.mark}

[]{.mark}

[]{.mark}

Central registry educators are responsible for developing training plans
and delivering training sessions or workshops to central registry staff
and facility reporters. The sessions should promote the collection of
cancer information that meets standards for timely, complete, and
quality data. NPCR's web site provides a link to a full complement of
training and educational materials. These resources are fully described
in [Section 9.4](#npcr-education-and-training). Affirming its commitment
to the importance of registrar training for the acquisition of
high-quality cancer data, in 2007 the NPCR promulgated Standard VI.b.

In support of Standard VI.b, in the fall of 2006 the NPCR launched the
NPCR Education and Training Series (NETS), a project to assist funded
programs in developing training capacity within their staff members. The
NETS project was designed to:

-   identify and fill the gaps where educational programs may be
    lacking;

-   build the educational capacity in the central registries so there is
    a solid infrastructure to provide education and day-to-day support
    of data collectors;

-   develop a comprehensive training program for NPCR-funded programs;
    and

-   provide the necessary training to support a cadre of highly educated
    trainers in the NPCR-funded programs.

Training plans should be based on needs assessments such as review of
registry data deficiencies, and should anticipate the educational
support needed to introduce new coding structures to reporters. The
training function must be goal-oriented, planned, carried out, and
evaluated for contribution to the collection of quality cancer data.
Training plans may:

-   focus on new coding systems, such as the Multiple Primary/Histology
    rules implemented in 2007
    (<http://www.seer.cancer.gov/tools/mphrules/>);

-   address problems noted in nationwide data reliability studies, such
    as the 2006 assessment for the Collaborative Staging system
    (<http://www.cancerstaging.org/cstage/index.html>);

-   include sessions on basic abstracting principles for new reporters
    and advanced abstracting for experienced registrars; such sessions
    are often presented in the context of comprehensive coding
    instruction on all registry data elements for specific primary sites
    of cancer; and

-   focus on particular issues within cancer registry abstracting, such
    as the application and resolution of edits, the review and revision
    of case finding activities to promote more complete and timely
    collection of data, or the resolution of quality issues identified
    by central registry and NPCR re-abstracting audits or patterns of
    care studies.

# 3.0 Program Standards for Data Collection

The NPCR communicates requirements for data collection to funded
registries through Funding Opportunity Announcements and posted data
submission requirements for the NPCR-Cancer Surveillance System. These
standards include reportability or case definition, data item
definitions and coding structures, data edits, and data transmission
formats.

The NPCR collaborates with other national organizations in creating,
identifying, and publishing data standards. In particular, the NPCR
works through the procedures established by the North American
Association of Central Cancer Registries (NAACCR) to define reportable
cases, to request new data items, to identify NPCR-required data items
in the NAACCR Data Dictionary, and to create and distribute data edits.
NPCR specifies the use of NAACCR-defined data layouts for the electronic
transmission of cancer information between central registries and from
registries to NPCR.

## 3.1 Reportability 

Reportability, within the context of a public health surveillance
system, defines the disease entities whose occurrences within individual
persons must be identified, and about which characteristic data elements
must be collected and reported to the designated public health agency.

## Reference Date

The reference date is the effective date cancer registration starts in a
specified at-risk population or in a specific facility. Each cancer
registry establishes a reference date for reportable cases. According to
the textbook *Central Cancer Registries: Design, Management and Use*,
all reportable cases with a date of diagnosis on January 1^st^ of the
reference year and later are included in the registry database[^1].

NPCR enhancement grants were initially used by funded registries in the
collection of 1995 case data, with registries having the option to
complete retrospective case ascertainment and data abstraction for
previous diagnosis years. States applying for planning grants
established reference dates as their registry programs became
operational. The NPCR reference date for each central registry is
January 1^st^ of the first year in which the registry received NPCR
funding, which may be different from the registry's data collection
reference date.

## Residency

A population-based registry includes all tumors occurring in the at-risk
population, and rules must be in place for determining the members of
that population. The goal of central registries is to include all cases
of disease in state residents diagnosed and treated at facilities within
state boundaries. Through data exchange agreements with other states,
registries also collect data on state residents diagnosed and treated at
facilities outside state boundaries.

Central registries use the same rules for patient address at diagnosis
used by the Census Bureau in enumerating population. The rules guide
registries in making residence decisions for part-year residents,
institutionalized and homeless persons, military personnel, and
students. The web link for the US Census Bureau is:
[http://www.census.gov](http://www.census.gov/)

Reportable Conditions

Public Law 102-515 and its amendments identify reportable conditions for
the National Program of Cancer Registries. The *International
Classification of Diseases for Oncology*, Third Edition (ICD-O-3) is the
standard classification system used to determine reportability. NPCR
requires reporting of:

-   all diseases listed in the ICD-O-3 with a behavior code of "/2", in
    situ disease; or "/3", malignant disease; except:

-   basal and squamous cell carcinomas of skin;

-   carcinoma in situ of cervix uteri and cervical intraepithelial
    neoplasia; and

-   prostatic intraepithelial neoplasia.

-   all solid tumors of brain and central nervous system, including the
    meninges and intracranial endocrine structures, listed in the
    ICD-O-3 with behavior codes of:

-   "/0" benign disease;

-   "/1" disease of uncertain malignant potential;

-   "/2", in situ disease; or

-   "/3", malignant disease.

Note: North American standard setters have agreed juvenile astrocytoma,
listed in the ICD-O-3 with a behavior code of "/1"; will be reportable
with a behavior code of "/3". See [Appendix E](#_Appendix_E:__5):
Reportable Conditions List 1992 -- 2007

Determining Number of Primary Cancers

Implemented for cancers diagnosed 1/1/2007 and later, the 2007 *Multiple
Primary and Histology Coding Rules* contains site-specific standards for
determining the number of primary cancers in an individual and for
assigning ICD-O-3 histology codes to the diagnosed cancers. The rules
are found at <http://www.seer.cancer.gov/tools/mphrules/>.

The *SEER Rules for Determining Multiple Primaries* are the standard
accepted by central registries and by NPCR for the diagnosis years prior
to 2007. These rules can be found within the appropriate editions of the
*SEER Program Code Manual* available at:
<http://www.seer.cancer.gov/tools/codingmanuals/historical.html>.

## 3.2 Reference Manuals 

NPCR Required Manuals for cancers diagnosed 2007 and later are listed
below.

+-----------------------------------------------------------------------+
| **DATA STANDARDS AND DATA DICTIONARY**                                |
+-----------------------------------------------------------------------+
| *NAACCR Standards for Cancer Registries, Volume II. Data Standards    |
| and Data Dictionary. Eleventh Edition, current.*                      |
|                                                                       |
| >                                                                     |
|  <http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=133> |
+-----------------------------------------------------------------------+
| *2007 Multiple Primary and Histology Coding Rules*.                   |
|                                                                       |
| > <http://www.seer.cancer.gov/tools/mphrules/>                        |
+-----------------------------------------------------------------------+
| **DISEASE CLASSIFICATIONS**                                           |
+-----------------------------------------------------------------------+
| *International Classification of Diseases for Oncology*. Third        |
| Edition.                                                              |
|                                                                       |
| Geneva: World Health Organization, 2000**.** Fritz A, Percy C, Jack   |
| A, Shanmugaratnam K, Sobin L, Parkin D, Whelan S, eds.                |
|                                                                       |
| > Available to order at: <http://www.iacr.com.fr/icdo3.htm>           |
+-----------------------------------------------------------------------+
| **STAGE AND EXTENT OF DISEASE MANUALS**                               |
+-----------------------------------------------------------------------+
| *SEER Summary Staging Manual - 2000: Codes and Coding Instructions.*  |
|                                                                       |
| > <http://www.seer.cancer.gov/tools/ssm>                              |
+-----------------------------------------------------------------------+
| *Collaborative Staging Manual and Coding Instructions*. NIH Pub. No.  |
| 04-5496, 2006.                                                        |
|                                                                       |
| > <http://www.cancerstaging.org/cstage/manuals.html>                  |
|                                                                       |
| *AJCC Cancer Staging Manual, Sixth Edition, 2002*                     |
|                                                                       |
| > [http://www.cancerstaging.org](http://www.cancerstaging.org/)       |
+-----------------------------------------------------------------------+
| **CANCER TREATMENT -- SEER DATABASES**                                |
+-----------------------------------------------------------------------+
| *SEER\*Rx Interactive Drug Database*                                  |
|                                                                       |
| > <http://www.seer.cancer.gov/tools/seerrx/>                          |
+-----------------------------------------------------------------------+
| **CANCER TREATMENT -- COMMISSION ON CANCER MANUALS**                  |
+-----------------------------------------------------------------------+
| *FORDS Facility Oncology Registry Data Standards. Revised for 2007*   |
|                                                                       |
| > <http://www.facs.org/cancer/coc/fordsmanual.html>                   |
+-----------------------------------------------------------------------+
| **ADDRESS CODING**                                                    |
+-----------------------------------------------------------------------+
| *Postal Addressing Standards. U.S.P.S. Pub 28, November 2000.*        |
|                                                                       |
| > <http://pe.usps.gov/cpim/ftp/pubs/Pub28/pub28.pdf>.                 |
+-----------------------------------------------------------------------+
| **OCCUPATION AND INDUSTRY CLASSIFICATION AND CODING**                 |
+-----------------------------------------------------------------------+
| *U.S. Census Bureau, Housing and Household Economic Statistics        |
| Division. Census 2000, "Alphabetical Indexes of Industries and        |
| Occupations."*                                                        |
|                                                                       |
| > <http://www.census.gov/hhes/www/ioindex/view.html>.                 |
+-----------------------------------------------------------------------+

\[Refer to [Appendix F](#_Appendix_E:_) for Full Citations of Reference
Manuals\]

## 3.3 Required Data Items 

Volume II in the NAACCR Data Standards for Cancer Registries series,
*Data Standards and Data Dictionary,* lists all cancer items defined for
data collection and reporting by the national standard setters: SEER,
ACoS Commission on Cancer (CoC) and NPCR. Data items are defined with
their coding structures or references to appropriate coding manuals.
Tables show the placement of data items in the NAACCR record layout (the
format used for electronic transmission of registry information), and
requirements for data collection and transmission established by SEER,
CoC, and NPCR. Revised editions of the data dictionary and corresponding
record layout are released on an annual basis. Historic and current
versions of the dictionary and record layout are maintained on the
NAACCR website at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=133>.

The following chart lists the standard data items required by NPCR by
diagnosis year. The table provides the name of the data item and the
specific reporting requirements established by NPCR. Bolded item names
have been identified for collection by NPCR for all years of the program
to date.

\[See [Appendix G](#_Appendix_F:__2) for Required Status Data Item Table
for Diagnosis Years 1997-2008--NPCR\]

### 3.3.1 NPCR Data Items Required for Collection

  ---------------- --------------------------------------------------------------
  **Requirements   
  Legend**         

  R                Required

  R\*              Required when available

  R\^              These text fields may be met by one or several text block
                   fields

  R+               Required by diagnosis year

  RH               Historically collected, transmitted

  RH\*             Historically collected, transmitted when available

  RS               Required, site specific

  D                Derived value

  O                Optional

  S                Supplementary/recommended

  \#               May code using SEER or CoC data item and associated rules

  **.**            Not in data set
  ---------------- --------------------------------------------------------------

+-----+--------------------------------+---------+---------+---------+
| *   |                                |         |         |         |
| *Ta |                                |         |         |         |
| ble |                                |         |         |         |
| 3   |                                |         |         |         |
| .3. |                                |         |         |         |
| 1** |                                |         |         |         |
|     |                                |         |         |         |
| **N |                                |         |         |         |
| PCR |                                |         |         |         |
| Re  |                                |         |         |         |
| qui |                                |         |         |         |
| red |                                |         |         |         |
| D   |                                |         |         |         |
| ata |                                |         |         |         |
| Ite |                                |         |         |         |
| ms\ |                                |         |         |         |
| (   |                                |         |         |         |
| NAA |                                |         |         |         |
| CCR |                                |         |         |         |
| Rec |                                |         |         |         |
| ord |                                |         |         |         |
| Lay |                                |         |         |         |
| out |                                |         |         |         |
| )** |                                |         |         |         |
+=====+================================+=========+=========+=========+
| **  |                                | *       | *       | *       |
| DIA |                                | *2008** | *2007** | *2006** |
| GNO |                                |         |         |         |
| SIS |                                |         |         |         |
| YEA |                                |         |         |         |
| R** |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| **I | **Item Name**                  | **Co    | **Co    | **Co    |
| tem |                                | llect** | llect** | llect** |
| \   |                                |         |         |         |
| #** |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 70  | **Addr at DX\--City**          | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Addr at DX\--No & Street**   | R       | R       | R       |
| 330 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 100 | **Addr at DX\--Postal Code**   | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 80  | **Addr at DX\--State**         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | Addr at DX\--Supplemental      | R       | R       | R       |
| 335 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 230 | **Age at Diagnosis**           | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 430 | **Behavior (92-00) ICD-O-2**   | RH      | RH      | RH      |
+-----+--------------------------------+---------+---------+---------+
| 523 | Behavior Code ICD-O-3          | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 240 | **Birth Date**                 | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 250 | **Birthplace**                 | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Cause of Death**             | R       | R       | R       |
| 910 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 120 | **Census Cod Sys 1970/80/90**  | RH\*    | RH\*    | RH\*    |
+-----+--------------------------------+---------+---------+---------+
| 364 | Census Tr Cert 1970/80/90      | RH\*    | RH\*    | RH\*    |
+-----+--------------------------------+---------+---------+---------+
| 365 | Census Tr Certainty 2000       | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 110 | **Census Tract 1970/80/90**    | RH\*    | RH\*    | RH\*    |
+-----+--------------------------------+---------+---------+---------+
| 130 | Census Tract 2000              | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 610 | **Class of Case**              | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 200 | **Computed Ethnicity**         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 210 | **Computed Ethnicity Source**  | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 90  | **County at DX**               | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Tumor Size                  | R       | .       | .       |
| 810 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Extension                   | R       | R       | R       |
| 810 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Tumor Size Ext/Eval         | R       | .       | .       |
| 820 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Lymph Nodes                 | R       | R       | R       |
| 830 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Mets at DX                  | R       | R       | R       |
| 850 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Site-Specific Factor 1      | RS      | RS      | RS      |
| 880 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Site-Specific Factor 3      | RS      | RS      | RS      |
| 900 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Version 1st                 | R       | R       | R       |
| 935 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | CS Version Latest              | R       | R       | R       |
| 936 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Date Case Report Exported**  | R       | R       | R       |
| 110 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Date Case Report Loaded**    | R       | R       | R       |
| 112 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Date Case Report Received**  | R       | R       | R       |
| 111 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 580 | Date of 1^st^ Contact          | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Date of 1st Crs RX\--COC**   | R#      | R#      | R#      |
| 270 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 390 | **Date of Diagnosis**          | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Date of Initial RX\--SEER**  | R#      | R#      | R#      |
| 260 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Date of Last Contact**       | R       | R       | R       |
| 750 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Date Tumor Record Availbl**  | R       | R       | R       |
| 113 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **DC State File Number**       | R       | R       | R       |
| 380 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 3   | Derived SS2000                 | D       | D       | D       |
| 020 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 3   | Derived SS2000\--Flag          | D       | D       | D       |
| 050 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 490 | **Diagnostic Confirmation**    | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | Follow-up Source               | R\*     | R\*     | RH      |
| 790 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | Follow-up Source Central       | R       | R       | R       |
| 791 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 366 | GIS Coordinate Quality         | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 440 | **Grade**                      | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 522 | Histologic Type ICD-O-3        | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 420 | **Histology (92-00) ICD-O-2**  | RH      | RH      | RH      |
+-----+--------------------------------+---------+---------+---------+
| 1   | **ICD Revision Number**        | R       | R       | R       |
| 920 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | ICD-O-3 Conversion Flag        | R       | R       | R       |
| 116 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 192 | IHS Link                       | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 280 | **Industry Code\--Census**     | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 300 | **Industry Source**            | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 410 | **Laterality**                 | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | Latitude                       | R\*     | R\*     | R\*     |
| 352 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | Longitude                      | R\*     | R\*     | R\*     |
| 354 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Medical Record Number**      | R       | R       | R       |
| 300 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 470 | Morph Coding Sys\--Current     | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 50  | **NAACCR Record Version**      | .       | .       | .       |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Name\--Alias**               | R       | R       | R       |
| 280 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Name\--First**               | R       | R       | R       |
| 240 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Name\--Last**                | R       | R       | R       |
| 230 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Name\--Maiden**              | R       | R       | R       |
| 390 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Name\--Middle**              | R       | R       | R       |
| 250 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 191 | NHIA Derived Hisp Origin       | D       | D       | D       |
+-----+--------------------------------+---------+---------+---------+
| 45  | NPI\--Registry ID              | .       | .       | .       |
+-----+--------------------------------+---------+---------+---------+
| 545 | NPI\--Reporting Facility       | R\*     | R\*     | .       |
+-----+--------------------------------+---------+---------+---------+
| 330 | **Occup/Ind Coding System**    | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 270 | **Occupation Code\--Census**   | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 290 | **Occupation Source**          | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Over-ride Age/Site/Morph**   | R       | R       | R       |
| 990 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Histology**        | R       | R       | R       |
| 040 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Ill-define Site**  | R       | R       | R       |
| 060 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Leuk, Lymphoma**   | R       | R       | R       |
| 070 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Report Source**    | R       | R       | R       |
| 050 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride SeqNo/DxConf**     | R       | R       | R       |
| 000 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Site/Behavior**    | R       | R       | R       |
| 071 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Site/Lat/Morph**   | R       | R       | R       |
| 074 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Site/Lat/SeqNo**   | R       | R       | R       |
| 010 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Site/Type**        | R       | R       | R       |
| 030 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Over-ride Surg/DxConf**      | R       | R       | R       |
| 020 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 20  | **Patient ID Number**          | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Place of Death**             | R       | R       | R       |
| 940 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 630 | Primary Payer at DX            | R\*     | R\*     | R       |
+-----+--------------------------------+---------+---------+---------+
| 400 | **Primary Site**               | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 160 | **Race 1**                     | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 161 | Race 2                         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 162 | Race 3                         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 163 | Race 4                         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 164 | Race 5                         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | Rad\--Regional RX Modality     | R       | R       | R       |
| 570 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Reason for No Surgery**      | R       | R       | R       |
| 340 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 10  | Record Type                    | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 40  | **Registry ID**                | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 540 | **Reporting Facility**         | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 3   | RuralUrban Continuum 1993      | D       | D       | D       |
| 300 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 3   | RuralUrban Continuum 2003      | D       | D       | D       |
| 310 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Coding System\--Current** | R       | R       | R       |
| 460 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--BRM**              | R       | R       | R       |
| 410 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Chemo**            | R       | R       | R       |
| 390 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Hormone**          | R       | R       | R       |
| 400 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Other**            | R       | R       | R       |
| 420 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Scope Reg LN Sur** | R       | R       | R       |
| 292 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Surg Oth Reg/Dis** | R       | R       | R       |
| 294 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Surg Prim Site**   | R       | R       | R       |
| 290 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | **RX Summ\--Surg/Rad Seq**     | R       | R       | R       |
| 380 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 1   | RX Summ\--Systemic/Sur Seq     | R       | R       | R       |
| 639 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 3   | RX Summ\--Transplnt/Endocr     | R       | R       | R       |
| 250 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--BRM**              | R\^     | R\^     | R\^     |
| 660 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Chemo**            | R\^     | R\^     | R\^     |
| 640 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Hormone**          | R\^     | R\^     | R\^     |
| 650 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Other**            | R\^     | R\^     | R\^     |
| 670 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Radiation (Beam)** | R\^     | R\^     | R\^     |
| 620 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Radiation Other**  | R\^     | R\^     | R\^     |
| 630 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **RX Text\--Surgery**          | R\^     | R\^     | R\^     |
| 610 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 760 | **SEER Summary Stage 1977**    | RH      | RH      | RH      |
+-----+--------------------------------+---------+---------+---------+
| 759 | SEER Summary Stage 2000        | RH      | RH      | RH      |
+-----+--------------------------------+---------+---------+---------+
| 380 | **Sequence Number\--Central**  | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 220 | **Sex**                        | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 450 | Site Coding Sys\--Current      | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Social Security Number**     | R       | R       | R       |
| 320 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 190 | **Spanish/Hispanic Origin**    | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX Proc\--Lab Tests** | R\^     | R\^     | R\^     |
| 550 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX Proc\--Op**        | R\^     | R\^     | R\^     |
| 560 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX Proc\--Path**      | R\^     | R\^     | R\^     |
| 570 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX Proc\--PE**        | R\^     | R\^     | R\^     |
| 520 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX Proc\--Scopes**    | R\^     | R\^     | R\^     |
| 540 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--DX                    | R\^     | R\^     | R\^     |
| 530 | Proc\--X-ray/Scan**            |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--Histology Title**     | R\^     | R\^     | R\^     |
| 590 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--Primary Site Title**  | R\^     | R\^     | R\^     |
| 580 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 2   | **Text\--Staging**             | R\^     | R\^     | R\^     |
| 600 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| 320 | **Text\--Usual Industry**      | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 310 | **Text\--Usual Occupation**    | R\*     | R\*     | R\*     |
+-----+--------------------------------+---------+---------+---------+
| 500 | **Type of Reporting Source**   | R       | R       | R       |
+-----+--------------------------------+---------+---------+---------+
| 1   | **Vital Status**               | R       | R       | R       |
| 760 |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
|     |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+
| **  |                                |         |         |         |
| Bol |                                |         |         |         |
| d - |                                |         |         |         |
| It  |                                |         |         |         |
| ems |                                |         |         |         |
| in  |                                |         |         |         |
| d   |                                |         |         |         |
| ata |                                |         |         |         |
| set |                                |         |         |         |
| for |                                |         |         |         |
| ev  |                                |         |         |         |
| ery |                                |         |         |         |
| d   |                                |         |         |         |
| iag |                                |         |         |         |
| nos |                                |         |         |         |
| tic |                                |         |         |         |
| yea |                                |         |         |         |
| r** |                                |         |         |         |
+-----+--------------------------------+---------+---------+---------+

\[Refer to [Appendix G](#_Appendix_F:__2) for a Timeline of Data Item
Requirements: Diagnosis Years 1997-2008\]

## 3.4 Unresolved Data Item Issues

For the following data items, NPCR has coding instructions that may
differ from other standard setters. Chapter V in the NAACCR *Data
Standards and Data Dictionary* discusses current inconsistencies among
coding standards adopted by the standard setting organizations.

Patient ID Number NAACCR Item 20

NPCR requires the patient ID number remain the same regardless of
diagnosis or data collection year, or software change. The registry must
not re-use patient ID numbers when records are deleted from the registry
database.

County at DX NAACCR Item 90

NPCR requires the use of Federal Information Processing Standards (FIPS)
codes for cancers diagnosed January 1, 2002, and later, with the
addition of code "999" for unknown.

Spanish/Hispanic Origin NAACCR Item 190

Computed Ethnicity NAACCR Item 200

Computed Ethnicity Source NAACCR Item 210

NHIA Derived Hispanic Origin NAACCR Item 191

NPCR requires collection and reporting of each of these data fields.
Registries agree on the coding structure for Spanish/Hispanic Origin,
but vary in how Spanish/Hispanic Origin is determined. Registries may
collect ethnicity directly from the medical record, impute ethnicity
based on other record information, derive ethnicity from matching
surnames to a list of Spanish surnames, or derive ethnicity based on
application of a computer algorithm to other available data items. The
fields Computed Ethnicity, Computed Ethnicity Source, and NHIA Derived
Hispanic Origin are included in an attempt to capture the methodology
used in coding Spanish ethnicity.

Occupation Code Census NAACCR Item 270

Industry Code Census NAACCR Item 280

Occupation Source NAACCR Item 290

Industry Source NAACCR Item 300

Text\--Usual Occupation NAACCR Item 310

Text\--Usual Industry NAACCR Item 320

Occup/Ind Coding System NAACCR Item 330

PL 102-515 requires collection of "information on the industrial or
occupational history of the individuals with the cancers, to the extent
such information is available from the same record." NPCR requires
reporting of the seven listed data fields *when they are available*,
including text descriptions. U.S. Census Bureau codes from the 1990
Census should be used for reportable cases diagnosed before 1/1/2003,
and U.S. Census Bureau codes from the 2000 Census should be used for
cases diagnosed 2004 and later. NPCR encourages states to update
occupation and industry data items when performing death certificate
linkage.

Sequence Number---Central NAACCR Item 380

Sequence Number\--Central is defined as sequencing of all reportable
neoplasms over the lifetime of a person.

SEER Summary Stage 2000 NAACCR Item 759

SEER Summary Stage 1977 NAACCR Item 760

Derived SS2000 NAACCR Item 3020

NPCR requires collection and reporting of seven of 15 Collaborative
Stage data items, one derived stage field (Derived SS2000), one derived
stage flag, and codes for the Collaborative Stage version used for data
collection and stage derivation.

Treatment Data Items

NPCR requires collection and reporting of summary treatment data items
for the first course of definitive treatment when available. NPCR also
requires the data item RX Coding System\--Current, NAACCR 1460, which
identifies the SEER and COC manuals used to code treatment.

Date of Initial RX---SEER NAACCR Item 1260

Date of 1st Crs RX---COC NAACCR Item 1270

NPCR allows use of either SEER's or CoC rules and definitions to code
treatment. SEER includes all treatment occurring within one year of
diagnosis in the first course of treatment when no other information is
available to define first course. CoC includes all treatment occurring
within four months of date of diagnosis in the absence of a specified
treatment plan. SEER codes date of first course of treatment as zeroes
when no treatment is given: CoC codes the date of decision for no
treatment as the date of first course of treatment.

RX Summ---Surg/Rad Seq NAACCR Item 1380

NPCR requires registries to follow the CoC FORDS definition (FORDS page
164) for code \"9\". SEER and NAACCR code \"9\" as sequence unknown, but
both surgery and radiation were given. CoC code \"9\" is defined as
unknown if radiation or surgery given.

Vital Status NAACCR Item 1760

NPCR requires code "0" to indicate the patient is dead.

## 3.5 Data Exchange Format

NPCR requires registries use NAACCR's standardized data exchange record
layout for the electronic exchange of cancer data. NAACCR has approved
two record layout types for use:

-   ASCII-delimited layout for registry abstract data; and

-   HL7 message standard for pathology report data.

Note: An ASCII-delimited layout for pathology report data is available
for laboratories and/or registries unable to use HL7. More information
can be found at:
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=501>

## 3.5.1 Record Layout Format for Registry Data

The ASCII-delimited layout for registry abstract data is updated on an
annual basis and released by NAACCR in April for implementation with
cases diagnosed January 1st of the following year. NAACCR publishes
technical descriptions of the record layouts in *Standards for Cancer
Registries, Volume I: Data Exchange Standards and Records Descriptions*.
NAACCR publishes detailed specifications and codes for each data item in
the data exchange record layout in *Standards for Cancer Registries,
Volume II: Data Standards and Data Dictionary*.

Historic and current versions of Volume I are maintained on the NAACCR
website at
[http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=125](http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=133).

Historic and current versions of Volume II are maintained on the NAACCR
website at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=133>.

## 3.5.2 Record Layout Format for Pathology Data 

NPCR recommends use of *NAACCR Standards for Cancer Registries Volume
V:* *Pathology Laboratory Electronic Reporting.* *Version 2.0* contains
specifications for electronically transmitting pathology reports based
on Health Level 7 (HL7) Version 2.3.1, as well as an alternative ASCII
delimited layout.

Historic and current versions of Volume V and the *Electronic Pathology
Reporting Guidelines* are maintained on the NAACCR website at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=122>

# 4.0 Completeness, Quality and Timeliness Requirements

NPCR Program Standards specify the requirements for data completeness,
timeliness, and quality by which data submissions will be evaluated. The
data evaluation results are used as a component in NPCR's overall
evaluation of central registry program performance. Data evaluation
results are also used to determine registry data eligibility for
inclusion in national cancer data publications.

## 4.1 Data Evaluation

The following methodologies are used to determine whether the registry's
data submission meets the requirements for NPCR standards of
completeness and quality:

+-----------------------------------------------------------------------+
| **COMPLETENESS OF CASE ASCERTAINMENT**                                |
|                                                                       |
| **Standard**: **Data completeness/Timeliness/Quality:** V.a, V.b.1,   |
| V.c.1                                                                 |
|                                                                       |
| Method: NAACCR method for estimating completeness of case             |
| ascertainment.                                                        |
|                                                                       |
| The rate is adjusted for duplicates if the duplicate rate is derived  |
|                                                                       |
| from a sample of the incidence file, but is not adjusted if the       |
|                                                                       |
| duplicates are identified and corrected on the entire database.       |
|                                                                       |
| Documentation for the NAACCR method is available on the NAACCR        |
| website at                                                            |
| <http://www.naaccr.org/index.asp?Col_SectionKey=11&Col_ContentID=447> |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **RECORDS FAILING EDITS**                                             |
|                                                                       |
| **Standard: Data Completeness/Timeliness/Quality:** V.b.2, V.c.5.     |
|                                                                       |
| Method: Calculating the number of records failing any core edit       |
| divided by                                                            |
|                                                                       |
| the total number of records reported, converted to a percentage.      |
|                                                                       |
| Rate = number of records failing any core edit \* 100                 |
|                                                                       |
| total number of records                                               |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **PERCENTAGE OF DEATH CERTIFICATE ONLY CASES**                        |
|                                                                       |
| **Standard: Data Completeness/Timeliness/Quality:** V.c.2             |
|                                                                       |
| Method: Calculating the number of death-certificate-only cases        |
| divided by                                                            |
|                                                                       |
| the total number of records, converted to a percentage.               |
|                                                                       |
| Rate = number of death-certificate-only cases \* 100                  |
|                                                                       |
| total number of records                                               |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **UNRESOLVED DUPLICATE RATE**                                         |
|                                                                       |
| **Standard: Data Completeness/Timeliness/Quality:** V.c.3             |
|                                                                       |
| Method: NAACCR Duplicate protocol: evaluate the number of duplicate   |
|                                                                       |
| records in the registry that have not been identified or corrected    |
|                                                                       |
| using regular matching, linkages, or other registry protocols.        |
|                                                                       |
| Forms are available in the NPCR-CSS Submission Packet at              |
| <https://www.npcrcss.org/docserver/>                                  |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **UNKNOWN AGE; SEX; RACE; COUNTY RATE**                               |
|                                                                       |
| **Standard: Data Completeness/Timeliness/Quality:** V.c.4             |
|                                                                       |
| Method: Determined separately for each of four listed data items      |
| (age, sex,                                                            |
|                                                                       |
| race and county).                                                     |
|                                                                       |
| Calculating the number of records with unknown values for each of     |
|                                                                       |
| the items divided by the total number of records, converted to a      |
|                                                                       |
| percentage.                                                           |
|                                                                       |
| Rate = number of records with unknown value \* 100                    |
|                                                                       |
| total number of records                                               |
+-----------------------------------------------------------------------+

## 4.2 Data Completeness

NPCR program requirements support the attainment of standards for data
completeness in the following data collection activities:

-   health care facilities and physician offices reporting;

-   death clearance;

-   data exchange among central registries in bordering states;

-   case finding audits of reporting sources; and

-   data linkages with other federally funded programs identifying
    cancers.

## 4.2.1 Reporting Sources

Standard V.a., Completeness/Timeliness/Quality, describes reporting
requirements for physicians, surgeons, and all other health care
practitioners diagnosing or providing treatment for cancer patients, as
well as for hospitals or other facilities providing screening,
diagnostic, or therapeutic services to patients. The standard reiterates
the language of Public Law 102-515.

## 4.2.2 Interstate Data Exchange

Standard V.b., in the box above, describes the requirements for data
exchange among central registries of bordering states. Implementation of
this standard may require enabling legislation or formal agreements
between states to allow the release of patient-identifiable information
from one state registry to another state registry.

## 4.2.3 Death Clearance Activities

Death clearance is defined as the process of matching registered deaths
in a population against reportable conditions in the central cancer
registry database for two purposes: 1) ascertainment of vital status for
persons in the registry (death clearance match); 2) identification of
all deaths with a reportable condition mentioned as a cause of death
which are not found in the central cancer registry (death clearance
followback). A Death Certificate Only (DCO) case is a reportable case
for which the Death Certificate is the only source of information. By
Standard V.c.2, "Death certificate only" cases must represent 3% or
fewer of total cases in the registry database.

NPCR will adopt the minimum requirements for conducting death clearance
as established by the *Death Clearance Manual* to be published by NAACCR
June 2008.

The Funding Opportunity Announcement requires the central registry
perform a data linkage with the state's death records at least annually
to enhance the completeness and quality of central registry data.
Following this linkage, the central registry, at a minimum, must update
the NAACCR fields Date of Last Contact (Item 1750), Vital Status (Item
1760), and Cause of Death (Item 1910).

## 4.2.4 Data Completeness Audits

Data completeness audits assess the central registry's activities for
identifying and collecting all reportable cancers. Routine case finding
may be organized as a collaborative activity between reporting agencies
and the central registry. For example, pathology laboratories may submit
electronic data files of pathology reports, and the central registry may
identify the reportable cancer diagnoses from these electronic data
streams. On a periodic basis the central registry staff may conduct
formal case finding audits, through review of original sources of
information used by the reporting facilities, to assure all eligible
cases are identified and reported. The audits require central registry
staff have access to primary data sources, such as disease indexes,
pathology reports, and treatment logs. Central registries must have an
appropriate mechanism for tracking reported versus non-reported cancers
and cancers not eligible for inclusion in the registry. Mechanisms must
also be in place to request new cancer reports for eligible cases which
have not been submitted.

Standard VI.a.3, Data Quality Assurance, requires a case finding and/or
re-abstracting audit based on a sampling of source documents be
conducted for each hospital-based reporting facility at least once every
five years. These audits may include manual review of source documents,
as well as data linkages of electronic files from submitting facilities
with the central cancer registry database. NPCR program requirements
specify registries participate in an NPCR-sponsored independent Data
Completeness and Quality Audit, which is conducted by a CDC-approved
organization/entity on a five-year cycle.

## 4.2.5 Data Linkages

The NPCR requires central registries perform data linkage with state
programs funded by the National Breast and Cervical Cancer Early
Detection Program (NBCCEDP). This linkage may identify cancer cases
missing in the registry database or discrepancies in diagnostic and
treatment information between the NBCCEDP and the central registry
database. The NBCCEDP programs are required to collect and report a set
of minimal data elements for all client participants.

The NPCR encourages central registries to perform other data linkages as
identified to enhance the completeness of central registry data.
Examples of partners for such linkages may be:

-   a tertiary care facility;

-   a regional health care system; or

-   a health statistics agency within the Health Department.

## 4.3 Data Quality

The NPCR program has established requirements to help ensure data
quality. These requirements include:

-   electronic reporting format;

-   standardized record layout;

-   standardized data elements;

-   standardized data edits;

-   consolidation of multiple records into a single tumor record using
    best practices;

-   geocoding to specify geographic locations of address at diagnosis;

-   data linkages and algorithms to assign race and ethnicity; and

-   data audits.

## 4.3.1 Electronic Reporting Format (Standards III.a-III.d and IV. b.)

Electronic reporting reduces the opportunities to introduce variability
or errors into data through manual procedures. Electronic reporting
depends on the specification of uniform transmission formats for data,
so that senders and receivers correctly identify the same data items and
values. The use of a standard transmission format facilitates the
communication of cancer surveillance data between reporting facilities
and the central registries, and between the central registries and the
NPCR.

## 4.3.2 Standardized Data Elements (Standards III.a, IV.a)

NPCR references the NAACCR year-appropriate *Standards for Cancer
Registries Volume II: Data Standards and Data Dictionary* as the source
of information for the prescribed data transmission layouts. The *Data
Dictionary* specifies code structures and provides field descriptions
for all data elements. Individual data items and reportability
requirements for each standard setter, including the NPCR, are displayed
in the "Required Status Table" in Volume II. Current and previous
versions of the NAACCR Data Dictionary are available at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=133>.

## 4.3.3 Standardized Data Edits (Standards V.b.2 and V.c.5)

The Funding Opportunity Announcement requires programs use computerized
standardized edits, and at a minimum, run the NPCR edits on a quarterly
basis. The NPCR edits are collected in an edit set, labeled as "Central:
Vs \[current version\] NPCR Req-Consol-All Edits", in the current
version of the Edits metafile. NPCR also publishes core and advanced
edits requirements in the submission specifications for the annual call
for data for the NPCR-Cancer Surveillance System. The Edits metafiles
are maintained and published by NAACCR at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=136>.

##  4.3.4 Record Consolidation

NPCR requires registries perform consolidation of reported data
following best practices or standards as they become available. The NPCR
has adopted the definition of consolidation as stated in the *NAACCR
Standards for Cancer Registries, Volume III, Standards for Completeness,
Quality, Analysis, and Management of Data*: "The process of reconciling
or compiling data obtained from more than one source on the same person
or tumor" or the preparation of "a composite set of values for each
patient and tumor, incorporating information from a variety of sources".
Case consolidation is a major activity of central registries, and the
balance between computerized and manual practices varies widely among
registries. This variation in practice makes it extremely important for
each registry to establish and follow consistent procedures.

##  4.3.5 Geocoding

Geocoding is the process of assigning geographic identifiers to patient
address at diagnosis. Identifiers include [geographic
coordinates](http://en.wikipedia.org/wiki/Geographic_coordinates)
expressed as [latitude](http://en.wikipedia.org/wiki/Latitude) and
[longitude](http://en.wikipedia.org/wiki/Longitude), and census tract,
which can be determined from the coordinates. NPCR requires reporting of
census tract, and census tract certainty for each cancer diagnosis;
latitude and longitude are required as available. Reviewing and updating
address at diagnosis coding on individual records in preparation for
geocoding improves information in existing data fields. Latitude and
longitude information facilitates spatial analysis of cancer data in
geographic information systems. Census tract identification facilitates
analysis of cancer diagnosis and treatment using socioeconomic
variables. The NPCR identifies GIS (Geographic Information System)
analysis and/or mapping as an advanced activity registries are
encouraged to undertake when they consistently meet or exceed the NPCR
program standards. A NAACCR document on *Using Geographic Information
Systems Technology in the Collection, Analysis, and Presentation of
Cancer Registry Data: A Handbook of Basic Practices* is available at
[http://www.naaccr.org/filesystem/pdf/GIS%20handbook%206-3-03.pdf](http://www.naaccr.org/filesystem/pdf/GIS handbook 6-3-03.pdf).

## 4.3.6 Data Linkages/Coding Algorithms

Linkages conducted by the central cancer registry improve the quality of
data within the registry database.

The NPCR-required data linkage with the NBCCEDP database may reveal data
differences between the registry and the program data set which must be
reconciled.

The NPCR may require central registries perform data linkages between
the Indian Health Service (IHS) patient registration database and the
registry databases in order to improve the identification and
classification of American Indians and Alaska Natives by the cancer
registries. The IHS website <http://www.ihs.gov/MedicalPrograms/EPI>
provides further information on cooperative agreements with the CDC.

The NPCR requires registries to process data using the NAACCR Hispanic
Identification Algorithm (NHIA) to improve the coding of ethnicity data.
Information on NHIA is available at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=73>.

Other data linkages which may provide useful information to the registry
include:

-   local tribal registration lists;

-   hospital discharge data systems;

-   healthcare facility billing systems;

-   driver license and voter registration lists; and

-   vital statistics.

## 4.3.7 Data Quality Audits (Standard VI.a.3)

NPCR program requirements specify registries perform case-finding and/or
re-abstracting audits of hospital-based reporting facilities at least
once every 5 years. These external audits assure the quality and
completeness of central registry data.

Re-abstracting and recoding studies are audit procedures whose purposes
are to:

-   standardize interpretation and abstracting of the medical record;

-   estimate rates of agreement; and

-   identify problems in data collection and interpretation.

Registry options for conducting external audits of reporting sources
include:

-   reliability studies developed by the CCR for reporting entities;

-   visual review of all reports from new abstractors with follow-back
    on data quality issues;

-   sampling of cases from facilities with visual review of coded data
    and text;

-   selection of certain sites/histologies for annual review, such as
    all unknown primaries; and

-   reconciliation of conflicting data between registries reporting the
    same case.

Registries have many options for conducting internal audits, such as:

-   periodic random review of coding of pathology reports sent directly
    to the CCR;

-   systematic random review of case consolidation performed by CCR
    staff;

-   quality checks of data collected and processed by central registry
    staff;

-   participation in national quality assurance studies; and

-   systematic random review of case information collected by CCR staff.

Registry staff members have opportunities to audit and improve their own
abstracting skills by participating in reliability studies offered by
the standard setters for new or revised coding systems, such as the
Collaborative Staging Assessment and the Multiple Primary/Histology
Rules Reliability Study offered by SEER.

## 4.4 Data Timeliness

The NPCR program has established standards to help ensure cancer data
are available for use in a timely manner. Standards include completeness
requirements by diagnosis year, and reporting in electronic format.

## 4.4.1 Reporting from Close of Diagnosis Year (Standards V.b, and V.c.)

Data should be 90% complete within 12 months of end of diagnosis year.
Data should be 95% complete within 24 months of end of diagnosis year.

Completeness of data is based on the calculation of observed to expected
cases by NPCR. NPCR uses the NAACCR method of estimating case
completeness. The NAACCR method is described in Appendix G of *NAACCR
Standards for Cancer Registries, Volume III, Standards for Completeness,
Quality, Analysis, and Management of Data,* at\
[http://www.naaccr.org/filesystem/pdf/NAACCR%20Volume%20III%20Final%20PDF%20File%2011-29-04.pdf](http://www.naaccr.org/filesystem/pdf/NAACCR Volume III Final PDF File 11-29-04.pdf)*.*

## 4.4.2 Reporting in Electronic Format (Standards III.a-III.d and IV.b)

NPCR program standards place emphasis on electronic reporting to
increase the efficiency of registry operations. Increased efficiency of
operations and the use of computerized technology to create, format,
transmit, and process cancer registry data files, in turn, facilitate
the timeliness of reporting.

# 5.0 NPCR-CSS Data Submission

The National Program of Cancer Registries-Cancer Surveillance System
(NPCR-CSS) began collecting data from central cancer registries in 2001.
The rationale and approach for this national surveillance system are
described in a document available on the NPCR website at
<http://www.cdc.gov/cancer/npcr/training/css.htm>.

The goal of NPCR-CSS is to allow the analysis of aggregated data from
NPCR-funded states on a regional or national level, as a statistical
basis for the planning and implementation of cancer prevention and
control initiatives. Analysis of aggregated data provides more accurate
and stable estimates of cancer incidence for population groups including
racial and ethnic minorities, medically underserved groups, and other
subpopulations. Analysis of aggregated data also reveals geographic
variability in cancer treatment practices, use of state-of-the-art
cancer treatment, and deviations from standards of cancer care. The
public-use data files from the CSS provide greater access to cancer data
for the public, scientists, and policy makers.

## 5.1 Submission Information

Submission requirements, Data Release Policy, and Utilities to aid in
the preparation of the submission are available on the Utilities page of
the CSS website, at <https://www.npcrcss.org/docserver/>. A login and
password is required to access this site.

## 5.1.1 NPCR-CSS Submission Packet

The NPCR-CSS Submission Packet includes submission specifications, data
items, data edits, all submission forms, confidentiality, data security,
data set participation information, and frequently asked questions.

The NPCR-CCS submission specifications address these areas:

Reportable cases and data elements:

-   diagnosis years to be reported;

-   reportable diagnoses based on ICD-O codes, with any exclusions
    noted;

-   data items to be reported by diagnosis year, with coding standards
    noted;

-   conversion of county codes if release of county designations
    prohibited by state law;

-   required algorithmic processing for indicated data fields, such as
    the NHIA algorithm for deriving Hispanic origin; and

-   required data linkages, for example linkage with the Indian Health
    Service database for determining Native American origin.

Editing standards:

-   core edits to be applied to data to assess compliance with NPCR
    program standards;

-   advanced edits to be applied to data to assist in improving overall
    data quality;

-   inter-record edits to be applied to data; and

-   identification of duplicate records using NAACCR protocol.

Report Format:

-   electronic record layout.

Submission administration:

-   submission dates;

-   preparation of submission;

-   file transfer instructions;

-   data security;

-   transmittal forms;

-   questions; and

-   references.

Data Evaluation:

-   data standards to be applied in evaluation of submissions, by sets
    of criteria; and

-   measurement error by criteria.

## 5.1.2 NPCR-CSS Data Release Policy 

The NPCR-CSS Data Release Policy describes the planned release of data
submitted to CDC as part of the annual NPCR-CSS data submission. This
policy, which originally took effect October 2003, is updated annually.
NPCR grantees are asked to complete and return the NPCR-CSS Data Set
Participation Agreement as part of their annual CSS data submission.

## 5.2 Utilities

As a service to participating central cancer registries, NPCR offers the
following utilities specific to the submission year. The website can be
found at: <https://www.npcrcss.org/docserver/>. A login and password is
required to access this site.

ICD-O-2 to ICD-O-3 Conversion Program

NPCR requires the conversion of histology codes from ICD-O-2 to ICD-O-3
for all cancers diagnosed before 2001.

NHIA V2 SAS Program

All NPCR registries are required to use Version 2 of the NAACCR Hispanic
Identification Algorithm (NHIA) SAS program or equivalent and record the
NHIA variable in the NPCR-CSS data submission. NAACCR has combined the
NHIA program with the NAACCR Asian Pacific Islander Identification
Algorithm (NAPIIA), into a single NAACCR Hispanic and Asian Pacific
Islander Identification Algorithm (NHAPIIA). A copy of the SAS program
and the associated files required to run the program are available from
the NAACCR Web site under the heading \"Cancer Research,
[Data](http://www.naaccr.org/index.asp?Col_SectionKey=11&Col_ContentID=447)
Analysis Tools.\" A SAS license is required to run the SAS program.

GenEDITS Plus with the NPCR Core and Advanced Edits Metafile

GenEDITS Plus is a Windows-based stand-alone program packaged with the
EDITS metafiles to run the NPCR core and advanced, single field and
inter-field edits on a NAACCR record layout file. The program produces
summary and detailed reports of core and advanced edit errors. The
README.TXT file contains installation and usage information.

NPCR-CSS Edits Metafiles

The runtime EDITS metafiles for the NPCR core and advanced single field
and inter-field edits are provided for use by registries which have
implemented the EDITS engine outside of the GenEdits Plus program.

NPCR-CSS Call for Data Edits Online Help

The Online Help program installs a Windows help file containing
information that may be useful to registries when preparing their
NPCR-CSS submission. Installation instructions are included in the zip
file.

Inter-Record Edits Standalone Program (ICD-O-2/ICD-O-3)

The Inter-Record Edits Standalone Program validates the consistency of
data between multiple records for a patient. The program produces
summary and detailed reports of inter-record errors. After program
installation, a help file is available describing its use. The
Inter-Records Edits program should be run after the NPCR core and
advanced edits have been run and errors have been corrected. The program
can also be configured and used during preparations for the NAACCR
submission.

Data Extraction Utility

The utility is an executable file containing the NPCR Data Extraction
Utility for the submission. The program will read the current NAACCR
record layout and write a new file containing only data items requested
for the submission. After program installation, a help file is provided
describing its use.

Northcon11 Record Conversion Program

For those registries with data files in a NAACCR version lower than v11
format, a free-standing Windows program is available to convert files of
cancer registry records in NAACCR data formats. Input files may contain
NAACCR version 6, 7, 8, 9, 10, or 11. Converted output files can be
NAACCR version 7, 8, 9, 10.2, or 11.

# 6.0 NPCR Program Evaluation

The NPCR evaluates program participants to ensure that their data meets
the standards for completeness, quality and timeliness. The NPCR also
assesses each cancer registry's operations to monitor that its long term
goals are met.

## 6.1 NPCR-CSS Data Evaluation Reports

Following each data submission, registries receive the NPCR-CSS Data
Evaluation Reports (DERs) detailing the completeness, accuracy and
timeliness of the five-year period under evaluation. The DERs show the
program's progress in meeting the following standards:

-   Percent Completeness Adjusted for Duplicates: The percentage of
    observed to expected, unduplicated cases where the expected cases
    are estimated using methods developed by the North American
    Association of Central Cancer Registries (NAACCR)
    (<http://www.naaccr.org/>). Annual case completeness evaluation is
    based on the current NAACCR method.

-   Unresolved Duplicate Rate: Because some cancer patients receive
    diagnostic or treatment services at more than one reporting
    facility, cancer registries perform a procedure to identify and
    resolve duplicate case reporting to ensure each cancer case is
    counted only once. Prior to the NPCR-CSS data submission, each
    registry performs a protocol developed by NAACCR for assessing
    duplicate cases. This information is reported to NPCR with the data
    submission.

-   Percent Death Certificate Only Cases: Another measure of
    completeness of case ascertainment is the proportion of cases
    ascertained solely on the basis of a death certificate, with no
    other information on the case available after the registry has
    completed a routine procedure known as "death clearance and follow
    back".

-   Percent Missing Critical Data Elements (Age, Sex, Race and County):
    The proportion of cases missing information deemed critical for the
    reporting of population-based cancer incidence data.

-   Percent Passing Edits: Edits test the validity and logic of data
    components. Edits are applied to single field variables, inter-field
    variables and to multiple records (each record denotes a case of
    cancer in a patient) in those instances where a patient has multiple
    cancer diagnoses. Inter-record (IR) edits are run on the entire data
    submission from the reference year through the most current 24-month
    data. There are two types of edits: core edits applied to variables
    deemed necessary for reporting incidence data; and advanced edits
    applied to variables used for advanced surveillance activities such
    as survival analyses. At this time, it should be noted there are no
    standards for advanced edits.

## 6.2 NPCR Program Evaluation Instrument (PEI)

The NPCR PEI assesses central cancer registry system attributes,
including:

-   simplicity (the structure and ease of operation);

-   program flexibility;

-   data quality activities;

-   acceptability;

-   activities affecting surveillance sensitivity;

-   representativeness;

-   timeliness; and

-   program stability. 

The instrument consists of a series of questions designed to provide a
consistent approach to evaluating programs across NPCR, and is
administered through a secure web-based system. For both funded programs
and NPCR, the PEI assesses whether the program's design and purpose are
clear and defensible, and whether valid long-term goals are met. The PEI
focuses on how well the system operates to meet its purpose and
objectives. 

Formalization of program evaluation using the PEI is intended to develop
defensible and consistent progress toward funded programs meeting NPCR
Program Standards and toward NPCR meeting program goals.  The PEI
provides NPCR the information needed to focus attention on:

-   strategic planning;

-   meaningful performance measures for funded programs and NPCR;

-   program results; and

-   appropriate technical assistance that can improve data quality and
    program efficiency and usefulness.

When states complete the PEI, immediate access to a PDF of state
information is provided. The information should be used for
self-assessment of program goals and operations. PEI results may be
reviewed by both central registry and NPCR staff in preparation for site
visits.

An example of the PEI can be found in [Appendix H](#_Appendix_H:__1).

## 6.3 Data Completeness and Quality Audits

Discrepancies in the completeness and quality of cancer data among
states have made analysis of cancer patterns by state and by geographic
region difficult. As a consequence, there is an on-going need to assess
the completeness and quality of cancer reporting, case finding, and data
abstracting.

NPCR Data Completeness and Quality Audit (DCQA)

NPCR conducts a continuous program of data assessment through the DCQA
process, with the following characteristics:

-   programs are audited once every five years;

-   completeness and data accuracy of all sites are reviewed;

-   treatment data are evaluated;

-   focus is on reporting hospitals; and

-   auditors conduct a post-audit debriefing with the central registry.

Special Audits

NPCR conducts special audits to assess registry performance in response
to significant changes in cancer data standards, or to investigate
registry operations of special concern.

The Reportable Hematopoietic Diseases audit in 2004~~:~~

-   included three states for the 2002 diagnosis year;

-   reviewed malignant conditions originating in the bone marrow, blood,
    spleen, and reticuloendothelial or hematopoietic systems;

-   focused on hospitals and specialty physicians (hematologists,
    oncologists); and

-   identified common coding mistakes and training needs.

The Targeted Casefinding Audit in September 2005 through March 2006 was:

-   conducted in eight states;

-   directed to impact their CSS submission to meet NPCR standards for
    24 month data;

-   identified barriers and problems affecting case completeness; and

-   focused on both hospital and non-hospital facilities.

# 7.0 Data Use 

A primary NPCR goal is to provide data to public health planners and
others monitoring the burden of disease and planning effective cancer
prevention and control programs. NPCR has received data annually from
funded programs, from their NPCR reference year forward.

## 7.1 National Data Use -- Electronic Data Release Activities

Currently, NPCR has four products for electronic data release. These
products are updated annually to include the most recent year of data.
All data represented in these products must meet NPCR quality standards
and their use must be authorized in writing by participating states. The
data products described in subsections 7.1.1 -- 7.1.5 have been created
with the assistance of the NPCR Scientific Working Group and the Small
Data Release Group.

## 7.1.1 Creation of Datasets

Prior to inclusion in a public data set, data files submitted by each
participating registry are checked for data format, record layout, data
consistency (reasonableness), and confidentiality in a Pre-Edit
Verification. If any records in a file contain discrepant or
confidential data, the whole file is rejected and the State notified.

Records in the retained data files are next checked for reportability
criteria. Records are flagged for non-reportability if they show:

-   State of diagnosis differing from submission State;

-   diagnosis year earlier than State reference year;

-   benign or borderline histology, except for CNS tumors diagnosed in
    2004 and later and borderline ovarian histology diagnosed from 1992
    through 2000 (coded using ICD-O-2 criteria);

-   basal or squamous cell carcinoma of skin;

-   carcinoma in situ of cervix, AIN III, CIN III, VIN III, VAIN III; or

-   PIN III diagnosed 2001 and later.

Reportable records are processed through the EDITS program, using NPCR
core and advanced edit sets, and edit set results are flagged for each
record.

The Analytic File is created using the cases flagged as reportable. For
this file, in situ bladder cancers are recoded to malignant cancers.
Pilocytic astrocytomas (coded as 9421/1 in ICD-O-3) are re-coded during
abstraction and reported by central registries as malignant (9421/3).
Based on EDITS results, records are excluded from the file for:

-   invalid, missing, or unknown age;

-   coding errors in single fields: primary site, race, and sex;

-   inter-field edit errors:

    -   age/birth date/diagnosis date;

    -   age/site/morphology;

    -   birth date/diagnosis date; or

    -   sex/primary site;

-   cases submitted less than 24 months from date of diagnosis.

## 7.1.2 United States Cancer Statistics (USCS)

Since 2002, CDC and NCI, in collaboration with NAACCR, have combined
their data sources to publish the official annual federal cancer
statistics in the *United States Cancer Statistics (USCS): Incidence and
Mortality* report. This publication is available at
[http://www.cdc.gov/cancer/npcr/uscs/.](http://www.cdc.gov/cancer/npcr/uscs/)
The report includes cancer incidence from registries with high-quality
data with the latest report representing 98% of the U.S. population. 
Cancer mortality statistics in the USCS publication are based on
information from all death certificates filed in the 50 states and the
District of Columbia and processed at the National Center for Health
Statistics (NCHS). For consistency with the cancer incidence data in
USCS, cancer sites in mortality data were grouped according to the
revised SEER recodes dated January 27, 2003.  Because NCHS uses
different groupings for some sites, the death rates in the USCS
publication may differ slightly from those published by NCHS. Online
access to the USCS is available at <http://apps.nccd.cdc.gov/uscs> and
additional information on NCHS is available at
<http://www.cdc.gov/nchs>.

## 7.1.3 U.S. County Cancer Incidence Dataset

This dataset consists of aggregate cancer incidence rates and case
counts for major cancer sites for selected counties in the United
States. The purpose of this release is to provide aggregated
county-level data for cancer control planning, policy-making, and
monitoring. Examples of current users include state cancer control
planners, state legislators and policy-makers, and the American Cancer
Society (ACS). The dataset can be accessed at the State Cancer Profiles
website, <http://www.statecancerprofiles.cancer.gov/>. This website is
maintained by the National Cancer Institute, and provides data from both
the SEER and the NPCR cancer databases.

## 7.1.4 CDC WONDER: Online Data-Reporting System

CDC has collaborated with NPCR-funded programs to define, test, and
release NPCR data in CDC WONDER, an online reporting system hosted at
CDC. Launched in early 2006, CDC WONDER allows greater access to NPCR
data than is available through the County Cancer Incidence Dataset.
Users can obtain reports containing age-adjusted rates, crude rates, and
case counts, requested by state, large metropolitan statistical areas,
year of diagnosis, sex, race, and age for both adult and childhood
classifications of cancer. This system provides easy access to critical
data that can help guide and evaluate interventions focused on cancer
prevention and control. The CDC Wonder web address is
<http://wonder.cdc.gov/cancer.html>.

## 7.1.5 Restricted Access File 

Since 2004, NPCR and the NPCR Small Data Release Group (SDRG) have
collaborated to define procedures for release of NPCR data at the
individual record level as a Restricted Access File (RAF). Great care
has been taken to balance data release procedures and data items with
the need to maintain confidentiality. The data included in the RAF have
met or exceeded the NPCR's data quality standards. In addition, cancer
registries have authorized the release of their data in these files.

There are currently two RAFs. The state-level RAF (SRAF) is a file with
state as the smallest identified geographic unit. To protect
confidentiality, significant review of proposals is required before this
file will be released. More recently, the Regional RAF (RRAF), defined
by the United States Census regions (Northeast, South, Midwest, and
West) as the smallest identified geographic unit, was developed. Because
the broader level of geographic specificity in the RRAF effectively
reduces the potential of identifying an individual, the review process
is abbreviated. In most other respects, the two files are identical and
the RRAF is a good resource for many analyses that do not utilize
state-level data. By the fall of 2006, SRAF application was available to
all NPCR registries, the ACS, and SEER. SRAF and RRAF application
availability is planned for all researchers with an approved proposal
and a signed data release agreement.

Documentation for the RAF contents and applications for SRAF and RRAF
data releases are available at the NPCR web site:
<https://www.npcrcss.org/docserver/>. A login and password is required
to access this site.

## 7.2 National and International Data Use - Publications

NPCR data are included in national and international compilations of
cancer information in addition to *United States Cancer Statistics
(USCS)* (<http://apps.nccd.cdc.gov/uscs/>). NPCR data are also included
in national compilations of healthcare information in which cancer care
is one of many healthcare issues addressed.

## 7.2.1 The Annual Report to the Nation on the Status of Cancer

CDC, NPCR and the National Center for Health Statistics (NCHS)
collaborate with ACS, NAACCR, and SEER to produce the *Annual Report to
the Nation on the Status of Cancer,* first published in 1998. The
published volumes are:

-   Annual Report to the Nation on the Status of Cancer, 1973-1996, with
    a Special Section on Lung Cancer and Tobacco Smoking.

-   Annual Report to the Nation on the Status of Cancer, 1973-1997, with
    a Special Section on Colorectal Cancer.

-   Annual Report to the Nation on the Status of Cancer, 1973-1998,
    Featuring Cancers with Recent Increasing Trends.

-   Annual Report to the Nation on the Status of Cancer, 1973-1999,
    Featuring Implications of Age and Aging on U.S. Cancer Burden.

-   Annual Report to the Nation on the Status of Cancer, 1975-2000,
    Featuring the Uses of Surveillance Data for Cancer Prevention and
    Control.

-   Annual Report to the Nation on the Status of Cancer, 1975-2001, with
    a Special Feature Regarding Survival.

-   Annual Report to the Nation on the Status of Cancer, 1975-2002,
    Featuring Population-Based Trends in Cancer Treatment.

-   Annual Report to the Nation on the Status of Cancer, 1975-2003,
    Featuring Cancer among U.S. Hispanic/Latino Populations.

The current report is available at
<http://seer.cancer.gov/report_to_nation/>. Previous reports are
available at <http://seer.cancer.gov/report_to_nation/archive.html>.

## 7.2.2 National Healthcare Quality Report 

Since 2003 the Agency for Healthcare Research and Quality (AHRQ) has
published a National Healthcare Quality Report (NHQR). This report is
published on behalf of the U.S. Department of Health and Human Services
(DHHS) in collaboration with an HHS-wide Interagency Work Group. The
NHQR examines and tracks the quality of health care in the United
States, using the most scientifically credible measures and data sources
available. Measures of healthcare quality address the extent to which
providers and hospitals deliver evidence-based care for specific
services, as well as the outcomes of care provided. The NPCR is a
contributing source of data for the reports, which are listed at
[http://www.qualitytools.ahrq.gov](http://www.qualitytools.ahrq.gov/).

## 7.2.3 National Healthcare Disparities Report

A companion report to the NHQR, the National Healthcare Disparities
Report is a comprehensive national overview of disparities in access to
and quality of healthcare among racial, ethnic, and socioeconomic
groups, as well as among subpopulations such as children and the
elderly. The NPCR is a contributing source of data for these reports.
The web link is
[http://www.qualitytools.ahrq.gov](http://www.qualitytools.ahrq.gov/)[.]{.underline}

## 7.2.4 Cancer Incidence in Five Continents

*Cancer in Five Continents* presents comprehensive data, published every
five years, on cancer incidence for over 200 populations worldwide. For
each population, age-specific, standardized and cumulative incidence
rates are given by sex, for different types of cancer. NPCR registries
meeting the following criteria may have their data represented in
*Cancer in Five Continents:*

-   IACR member;

-   data meet *United States Cancer Statistics* publication criteria;
    and

-   permission granted for publication.

The IACR website is [http://www.iacr.com.fr](http://www.iacr.com.fr/).

## 7.2.5 Cancer Incidence in North America

NPCR registries that submit data to NAACCR and meet the criteria for
silver or gold certification are eligible to have their data included in
the annual publication, *Cancer Incidence in North America (CINA)*. The
monographs present cancer incidence and death rates by race and
ethnicity, gender, and geographic areas. The information can be used by
national, state, provincial, and local health professionals for policy
development, hypothesis generation, and as a resource for the cancer
registry or the general public. The publication is accessed at:
<http://www.naaccr.org/index.asp?Col_SectionKey=11&Col_ContentID=50>.

## 7.3 Special Studies 

NPCR and central registry staff participate in active research and
publication in the cancer registry field. NPCR registries meeting
established criteria may apply for NPCR funding of special studies.
These studies may encompass the collection and analysis of additional
cancer case data, with publication of findings to the larger registry
community.

## 7.3.1 Articles and Monographs 

The NPCR webpage, "Scientific Articles by the National Program of Cancer
Registries", provides a complete list of scientific articles by NPCR
authors with links to PubMed citations. The web link is**:**
<http://www.cdc.gov/cancer/dcpc/library/articles/npcr.htm>.

Included in the list of publications are citations for a series of
twelve articles which appeared as a monograph on colorectal cancer,
published in the journal *Cancer*, 2006; 107 (S5). The monograph,
developed in coordination with NCI, central cancer registries, academic
institutions, and the ACS, was designed to highlight the magnitude of
the national burden of colorectal cancer and to guide cancer control and
prevention activities for this disease.

## 7.3.2 Patterns of Care (POC) Studies

NPCR has funded central registries to conduct studies examining the care
provided to cancer patients. Two studies were initiated in June, 2001,
and a third study in May, 2005:

-   Breast, Colon, Prostate Cancer Data Quality and Patterns of Care
    Study,

-   Ovarian Cancer Patterns of Care Study; and

-   Breast and Prostate Cancer Data Quality and Patterns of Care Study.

The Breast, Colon, Prostate Cancer Data Quality and Patterns of Care
Study was designed to assess the quality and completeness of stage at
diagnosis, and the treatment data collected by the participating
registries. The study goal was to determine the extent to which patients
received guidelines-based, stage-specific treatments for localized
breast and prostate cancers and stage III colon cancer. The study design
also included participation in the CONCORD Study, a multi-national
project. The CONCORD Study purpose was to identify international
differences in survival, and to enable direct comparison of cancer
survival within and between countries using standardized data collection
protocols, quality control procedures, and central analysis of
individual cancer records. As a separately funded activity, NPCR
recipients could also conduct an optional linkage with the state Breast
and Cervical Cancer Early Detection Program data to validate the
accuracy of comparable information within the two databases. Several
manuscripts have been published, with several presentations made at
conferences. See [Appendix B](#_Appendix_B:__1) for an inventory of
publications and professional presentations on CDC-NPCR's Pattern of
Care Studies. Further information about the Breast/Colorectal/Prostate
POC Study is available at
<http://www.cdc.gov/cancer/npcr/publications/pocstudy.htm>.

The Ovarian Patterns of Care study was designed to evaluate medical
record information on ovarian cancer and the stage and treatment data
reported to the registry. Findings of the study were presented at the
American Society of Clinical Oncology (ASCO) annual meeting in 2006. The
published article is available in *Journal of Clinical Oncology*, 2006
ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20
Supplement), 2006: 15031

The Breast and Prostate Cancer Data Quality and Patterns of Care Study
supports enhanced surveillance and operations research to improve the
completeness, timeliness, quality, and use of first course of treatment
and stage data. The study is expected to describe treatment patterns and
determinants of receipt of guideline-concordant treatments for breast
cancer and appropriate therapy for prostate cancer. There will be a
particular focus on whether disparities in care exist among
racial/ethnic and age groups, geographic areas, or socio-economic
levels. The study will evaluate the quality and availability of existing
data from a variety of sources, including cancer registries, medical
records, and insurance claims, to support such analyses, and will
identify ways to strengthen the data infrastructure for cancer care
assessment. A long term goal of this study is to strengthen the use of
data among NPCR-funded state cancer registries for the improvement of
cancer care.

## 7.3.3 Data Quality Studies

The Oral/Pharyngeal Data Quality study, initiated in 2001, was designed
to identify and provide solutions for a range of quality issues related
to information collected for these cancers, including strategies for
obtaining stable incidence rates.

## 7.3.4 Reporting Pathology Protocols

NPCR has funded a series of Reporting Pathology Protocols (RRP) projects
to implement a new means of collecting and transmitting pathology
information using the SNOMED CT-encoded College of American Pathologists
(CAP) cancer checklists and HL7 messages. The CAP checklists enable
pathologists to provide needed information in a clear and consistent
manner, ensuring that cancer diagnoses will be recorded and coded using
a fixed set of data items at the pathology laboratory.

An initial pilot project was initiated in 2001, focusing on colon and
rectum cancers. Participating pathology laboratories in two states used
an electronic version of the checklists, and the information was
formatted into a project standard HL7 message using Logical Observation
Identifiers Names and Codes (LOINC) as the questions and SNOMED CT codes
as the answers. The "Report on the Reporting Pathology Protocols for
Colon and Rectum Cancers" is available at
<http://www.cdc.gov/cancer/npcr/npcrpdfs/rpp_report_121605.pdf>.

The second project, focusing on cancers of the breast, prostate, and
melanoma, started in 2003 with the participation of three state
registries. Project participants include representatives from NPCR and
hospital registries, hospital anatomic pathology laboratories,
laboratory information system vendors, SNOMED International, and HL7
messaging consultants. The participants' Messaging Work Group is tasked
with defining the common HL7 message data items and associated structure
of the CAP checklist data. The Evaluation Work Group will establish
evaluation measures for the validity and reliability of this method of
electronically capturing cancer data.

Related to the RRP projects, NPCR has funded the Veterans Administration
Medical Center of Atlanta to implement SNOMED-encoded cancer checklists
in the VA pathology laboratory. The project provides the opportunity to
see the benefits and challenges of using the checklists in a busy
laboratory, and to compare the completeness and quality of traditional
reports with the information obtained from the checklists.

## 7.3.5 Economic Analysis

NPCR is conducting a multi-year economic analysis of program activities
to compare operating costs for registries that have achieved standards
for high-quality data with costs for registries that have not. The study
will examine:

-   the cost of performing core surveillance activities;

-   the cost of enhancing the infrastructure and operation of NPCR
    registries; and

-   the cost of performing advanced surveillance activities.

Researchers will determine factors and variables influencing costs, and
will develop a resource-allocation model based on cost-effectiveness.
The first report from this study, "The National Program of Cancer
Registries: Explaining State Variations in Average Cost per Case
Reported", published in Preventing Chronic Disease, online serial, Vol.
2, No. 3, July 2005, is available at
<http://www.cdc.gov/pcd/issues/2005/jul/04_0124.htm>

The second report from this study, "Economic Assessment of Central
Cancer Registry Operations, Part I: Methods and Conceptual Framework"
was published in the Journal of Registry Management, Fall, 2007; Volume
34, Number 3. A copy of this report can be obtained at
<http://www.ncra-usa.org/i4a/pages/index.cfm?pageid=3307>.

## 7.3.6 Central Registry Workload Management Study

Number range CHAPTERNPCR is conducting a workload and time management
study to assess the current practices of central cancer registries. The
study purpose is to document the staffing requirements, task by
task−case finding, abstracting, follow-up, quality assurance, data usage
and reporting, conference/committee activity, management and
administration, training, other activities−required of central
registries. These staffing requirements will then be studied as a
function of co-variables.

The study will include:

-   Workload Current Practices Survey

-   Workload Guidelines/Time Standards

-   Workload Standards Brochure

The guide will be a self-help manual on Workload and Time Management and
will be customized to the registries' tasks and circumstances. The
brochure will be suitable for explaining the registry workload to
interested parties.

## 7.3.7 State Cancer Profiles Web site

NPCR contributes in the development of the State Cancer Profiles Web
site, which provides a system to characterize the cancer burden in a
standardized manner in order to motivate action, integrate surveillance
into cancer control planning, characterize areas and demographic groups,
and expose health disparities. The focus is on cancer sites for which
there are evidence based control interventions. Interactive graphics and
maps provide visual support for deciding where to focus cancer control
efforts. The State Cancer Profiles can be found at:
<http://statecancerprofiles.cancer.gov/>.

## 7.3.8 American Cancer Society (ACS) Cancer Facts & Figures

NPCR participates in the development of the American Cancer Society
Cancer Facts and Figures which presents data on cancer incidence,
mortality, survival, cancer risk factors, and annual estimates of
expected new cases and deaths. Findings for the US population as a
whole, along with detailed state-by-state data on cancer cases and
deaths are included. The ACS Cancer Facts and Figures can be found at:
<http://www.cancer.org/docroot/STT/STT_0.asp>.

## 7.4 State Data Use

+-----------------------------------------------------------------------+
| **VII . DATA USE**                                                    |
+-----------------------------------------------------------------------+
| > c\. The central cancer registry, state health department, or its    |
| > designee annually uses registry data for planning and evaluation of |
| > cancer control objectives in at least three of the following ways:  |
| >                                                                     |
| > 1\. Comprehensive cancer control                                    |
| >                                                                     |
| > 2\. Detailed incidence/mortality estimates                          |
| >                                                                     |
| > 3\. Linkage with a statewide cancer screening program to improve    |
| >                                                                     |
| > follow-up of screened patients                                      |
| >                                                                     |
| > 4\. Health event investigation(s)                                   |
| >                                                                     |
| > 5\. Needs assessment/program planning                               |
| >                                                                     |
| > 6\. Program evaluation                                              |
| >                                                                     |
| > 7\. Epidemiologic studies                                           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **IX . COLLABORATIVE RELATIONSHIPS**                                  |
+-----------------------------------------------------------------------+
| > a\. The central cancer registry actively collaborates in the        |
| > state's comprehensive cancer control planning efforts.              |
| >                                                                     |
| > b\. The central cancer registry establishes a working relationship  |
| > with all components of the National Cancer Prevention and Control   |
| > program to ensure the use of registry data to assess and implement  |
| > cancer control activities.                                          |
+-----------------------------------------------------------------------+

Standard VII.c, Data Use, enumerates required data uses by participating
program registries. The Funding Opportunity Announcement for the funding
cycle commencing in 2007 specifies registries describe their efforts to
promote the use of registry data for planning and evaluation of cancer
control activities. In addition, Standard IX, Collaborative
Relationships, specifies that funded registries must establish and
maintain collaborative relationships with Comprehensive Cancer Control
Programs and National Breast and Cervical Cancer Early Detection
Programs, if funded.

Data collected by state cancer registries enable public health
professionals to better understand and address the cancer burden.
Registry data are critical for programs focused on risk-related
behaviors or on environmental risk factors. Such information is also
essential for identifying when and where cancer screening efforts should
be enhanced, and for monitoring the treatment provided to cancer
patients. In addition, reliable registry data are fundamental to a
variety of research efforts, including those aimed at evaluating the
effectiveness of cancer prevention, control or treatment programs.

The NPCR report, "Data for Cancer Control Planning and Evaluation:
Partners' Meeting", March 2002, provides a blueprint for the integration
of cancer registry data into cancer control activities. The report is
available at <http://www.cdc.gov/cancer/npcr/partners.htm>.

State Registry Contacts

Each central registry may use its website to present its own
information, activities, and publications featuring data quality, data
use, and other studies. NPCR provides links to each central registry
website at\
<http://apps.nccd.cdc.gov/cancercontacts/npcr/contactlist.asp>. The NPCR
contact list also provides an important link to the individual cancer
registry programs supported by NPCR.

# 8.0 Collaborative Relationships

NPCR works with national organizations, state registries, and other key
groups to develop, implement, and promote effective cancer surveillance
practices and activities. The NPCR website at
<http://www.cdc.gov/cancer/npcr/partners.htm> lists DCPC partners and
highlights collaborative activities focusing on cancer surveillance
issues.

NPCR collaboration occurs in many forms:

-   providing funding and technical support for studies performed by
    collaborating agencies;

-   recruiting program states for collaborative studies;

-   requiring the collection of data items or data linkages to support
    other agency goals;

-   providing technical advice on surveillance issues;

-   working with many agencies to effect a major change in surveillance
    models, coding systems, or rules;

-   sponsoring and participating in national organizations;

-   publishing data cooperatively with other organizations; and

-   co-sponsoring conferences to define directions for cancer
    surveillance policies and activities.

## 8.1 NPCR Work Groups

**Collaborators:** NPCR and state program representatives

NPCR formed two workgroups, the NPCR Central Cancer Registry Council
(NCCRC) and the Scientific Workgroup (SWG). Each workgroup provides a
forum for information sharing and discussion. The NCCRC focuses on
issues related to the implementation of new or changed data item
collection and/or submission requirements, program standards, and
quality control activities as they relate to NPCR data. The NCCRC,
co-chaired by members of NPCR's ORTAT and SRT, consists of
representatives from NPCR-funded programs. State representatives serve
rotating two-year terms to provide an opportunity for participation from
all funded programs. The SWG is led by a member of the SRT and focuses
on issues related to data use, analysis, and linkage to other data sets.

## 8.2 Indian Health Service

**Collaborators:** NPCR and Indian Health Service (IHS)

"Nationally, American Indian and Alaskan Native (AI/AN) communities have
lower rates of cancer. However, in certain regions such as Alaska and
the Northern Plains states, AI/AN cancer incidence and mortality rates
exceed those for the US general populations. As a response to these
disparities, the CDC supports numerous cancer surveillance, prevention
and control projects in Indian Country through an Inter-agency agreement
between the Indian Health Service (IHS) and the CDC's Division of Cancer
Prevention and Control, National Center for Chronic Disease Prevention
and Control." <http://www.ihs.gov/MedicalPrograms/EPI> \[click on
Cancer\].

Data for Native Americans are included in *United States Cancer
Statistics* (USCS) (<http://apps.nccd.cdc.gov/uscs/>). NPCR may require
programs to conduct data linkages between the IHS patient registration
database and the central registry databases to improve identification
and classification of American Indians and Alaska Natives in the cancer
registries.

## 8.3 Multi-Agency Projects

NPCR collaborates with other national and international organizations on
several projects to develop standards and rules to ensure consistent
data collection.

## 8.3.1 TNM Staging Classification

**Collaborators:** CDC, International Union against Cancer (UICC)
(<http://www.uicc.org/>), and the American Joint Committee on Cancer
(AJCC) (<http://www.cancerstaging.org/>). This collaborative effort has
multiple goals:

-   develop and maintain a standardized staging classification suitable
    for cancer registries and screening programs compatible with Tumor
    Node Metastasis (TNM) and capable of ensuring stability of criteria
    over time;

-   monitor the utilization of the TNM classification to detect problems
    in interpretation and application of TNM standards;

-   expand the TNM classification to include more anatomic sites and
    tumor types;

-   continue to evaluate existing classifications for their relevance in
    view of new developments in imaging, diagnosis, and management;

-   disseminate updated information through appropriate publications;
    and

-   assess prognostic factors' information and develop a system to serve
    as a prognostic index.

## 8.3.2 Collaborative Staging System

**Collaborators**: NPCR, AJCC, the National Cancer Registrars
Association (NCRA), SEER, NAACCR, the National Cancer Institute of
Canada (NCIC), CoC

The goal of this collaborative effort is to develop, produce, and
maintain the Collaborative Staging (CS) system, an innovative approach
to collecting stage data uniformly in cancer registries throughout the
United States and Canada. This system has replaced separate stage data
collection by the AJCC's Tumor, Node, Metastasis (TNM) system, the SEER
Extent of Disease (EOD) coding scheme, and two versions of a summary
staging system used by many state central cancer registries. The CS
system collects several discrete data elements related to extent of
disease and their determination by clinical or pathologic criteria;
these elements are then evaluated by a computer algorithm to derive
stage classifications needed for data analysis. The Collaborative
Staging system was implemented for cancers diagnosed as of January 1,
2004. Information on Collaborative Staging is available on the AJCC
website at <http://www.cancerstaging.org/cstage/index.html>.

## 8.3.3 Multiple Primary and Histology Coding Rules

**Collaborators**: NPCR, SEER, CoC, AJCC, NCRA, NAACCR, and Statistics
Canada

The goal of this collaborative effort is to develop, produce, and
maintain Multiple Primary and Histology (MP/H) coding rules. These rules
represent a revised system for determining the number of primary cancers
occurring in an individual over the course of a lifetime and applying
the appropriate ICD-O-3 topography and morphology codes to each primary.

The system replaces generic rules for all cancer sites with a new series
of both generic and site-specific rules, and addresses the appropriate
application of ICD-O-3 codes for complex morphologies. The rules are
designed to be translatable into computerized algorithms applied to
cancer database records. The Multiple Primary and Histology Coding Rules
system was implemented for cancers diagnosed beginning January 1, 2007.
Information on the MP/H rules is available on the SEER website at
<http://www.seer.cancer.gov/tools/mphrules/>.

NPCR provided additional support for nationwide training of cancer
registrars in the application of the new rules by funding attendance at
"train the trainer" sessions for NPCR-funded central registry personnel.
The designated trainers, in turn, provide training for registrars
reporting to the central registries.

## 8.4 Modeling Electronic Reporting Project (MERP)

**Collaborators**: NPCR, NCI-SEER, CoC, NAACCR, SNOMED, software
vendors, hospital cancer registries, and central cancer registries

The purpose of this project is to advance the cancer surveillance
community's efforts to capture electronically available data from the
electronic health record and other data sources. Project objectives are
to:

-   create robust, scalable and transportable models for electronic case
    ascertainment in hospitals;

-   create Public Health Information Network (PHIN)-compliant data
    exchange messages using standard vocabularies between hospital and
    central cancer registries;

-   contribute toward a national plan and model that will provide an
    infrastructure for electronic data exchange among cancer registries;
    and

-   assess the feasibility and utility of the model through an
    implementation pilot.

Information on the MERP project is available on the NPCR website at
<http://www.cdc.gov/cancer/npcr/tools/merp/>.

## 8.5 North American Association of Central Cancer Registries (NAACCR) 

"NAACCR is a professional organization that develops and promotes
uniform data standards for cancer registration; provides education and
training; certifies population-based registries; aggregates and
publishes data from central cancer registries; and promotes the use of
cancer surveillance data and systems for cancer control and
epidemiologic research, public health programs, and patient care to
reduce the burden of cancer in North America."

NPCR currently funds NAACCR under CDC's Standards Development and
Maintenance for Cancer Surveillance cooperative agreement to provide
resources for standard-setting activities related to the operation of
population-based cancer registries. The stated purposes of the
cooperative agreement are to:

-   improve the quality of population-based central cancer registry data
    and operations through data item and transmittal standards;

-   facilitate coordination and communication from health care
    facilities to (and among) central cancer registries; and

-   promote the use of cancer incidence data for cancer control such as
    health care interventions planning, resource allocation, program
    evaluation, and research.

NPCR contributes to the definition of data standards maintained and
published by NAACCR, and in turn uses protocols and methodologies
published by NAACCR for the evaluation of data submitted to the
NPCR-CSS. NPCR staff members actively participate on NAACCR committees
and workgroups to develop consensus standards for the cancer registry
community.  NAACCR also collaborates in the publication of the annual
*United States Cancer Statistics* (USCS) report
(<http://apps.nccd.cdc.gov/uscs/>).

The NAACCR website is [http://www.naaccr.org](http://www.naaccr.org/).

## 8.6 National Cancer Registrars Association (NCRA)

"NCRA is a not-for-profit association representing cancer registry
professionals and Certified Tumor Registrars (CTR). NCRA's primary focus
is education and certification with the goal to ensure all Cancer
Registry professionals have the required knowledge to be superior in
their field. Worldwide, there are over 4,200 NCRA members and over 4,000
CTRs. Cancer Registrars capture a complete summary of the history,
diagnosis, treatment, and disease status for every cancer patient.
Registrars' work leads to better information that is used in the
management of cancer, and ultimately, cures."

CDC provides funds to support the NCRA annual conference. This
conference advances professional development of cancer registrars by
providing an educational opportunity for registrars in hospitals and
central registries to increase their knowledge and expand their
professional expertise.

The website for NCRA is
[http://www.ncra-usa.org](http://www.ncra-usa.org/).

## 8.7 International Association of Cancer Registries (IACR)

"The International Association of Cancer Registries (IACR) was founded
in 1966, as a professional society dedicated to fostering the aims and
activities of cancer registries worldwide. It is primarily for
population-based registries, which collect information on the occurrence
and outcome of cancer in defined population groups (usually the
inhabitants of a city, region, or country). To ensure that cases are
properly recorded, and that the statistical data gathered are complete
and can be used to make valid comparisons, cancer registries must
conform to accepted working practices and standards. The Association was
created to foster the exchange of information between cancer registries
internationally, so improving quality of data and comparability between
registries. The Association is a non-governmental organization which has
been in official relations with the World Health Organization since
January 1979."

CDC provides funds to support the IACR annual conference. This
conference advances professional development by providing an educational
opportunity for cancer registrars from international cancer registries
to increase their knowledge and expand their professional expertise.
Support of this conference is consistent with CDC's mission to support
population-based cancer registries worldwide. The IACR is headquartered
in Lyon, France.

The IACR website address is <http://www.iacr.com.fr/>.

## 8.8 International Union Against Cancer (UICC) 

"The UICC is the leading international non-governmental organization
dedicated exclusively to the global control of cancer. Its vision is of
a world where cancer is eliminated as a major life-threatening disease
for future generations. UICC's mission is to build and lead the global
cancer control community engaged in sharing and exchanging knowledge and
competence; transferring scientific findings to clinical, patient and
public settings; systematically reducing and eliminating disparities in
prevention, early detection and treatment; and delivering the best
possible care to people living with cancer in every part of the world."

The CDC played an active role in planning a conference track addressing
public health, cancer prevention, and early cancer detection during the
2006 UICC Quadrennial Congress and Cancer Organizations Combined
Conference. This conference, held in Washington D.C., brought together
leading clinicians, practitioners, organization leaders, patient care
experts, and public health experts from around the world to discuss
current strategies to translate what is known and proven about cancer
control into action for diverse economic communities worldwide. The UICC
is headquartered in Geneva, Switzerland.

The UICC website address is [http://www.uicc.org](http://www.uicc.org/).

## 8.9 National Coordinating Council for Cancer Surveillance

"The mission of the National Coordinating Council for Cancer
Surveillance (NCCCS) is to coordinate cancer surveillance activities
within the United States through communication and collaboration among
major national cancer organizations, ensuring that the needs of cancer
patients and the communities in which they live are fully served; that
scarce resources are maximally used; and that the burden of cancer in
the United States is adequately measured and ultimately reduced. The
NCCCS was created to provide a forum for examining the current state of
cancer surveillance operations, identify the broad issues involved, and
recommend practical approaches that will facilitate the work of
registries and contribute to the goal of coordinating data collection
and improving data quality across the nation. The council enables these
organizations to collaborate on cancer monitoring and registry
operations."

NPCR participates with the ACS, CoC, SEER, NCRA, and NAACCR on the
NCCCS.

## 8.10 State Collaborative Relationships

NPCR Standard IX.c, listed in the box above, requires the central cancer
registry to establish a committee to advise the registry and assist in
building consensus and planning. This committee, composed of community
members, medical professionals, and registry professionals, serves as a
resource for the central registry in gaining community and legislative
support for its programs; the committee also assists the registry in
developing long-range priorities and in monitoring progress toward
attainment of goals. The registry may consult its advisory committee
for:

-   assistance in responding to citizen concerns about data privacy;

-   assistance in lobbying for state funding; or

-   guidance in selecting among competing priorities for use of scarce
    resources.

Through collaboration with committee members, the registry gains access
to a diversity of viewpoints reflecting community needs, develops
advocates, and widens opportunities for promoting data use.

# 9.0 Resources

Public Law 102-515 states in Sec. 399J, Technical Assistance in
Operations of Statewide Cancer Registries: "The Secretary, acting
through the Director of the Centers for Disease Control, may, directly
or through grants and contracts, or both, provide technical assistance
to the States in the establishment and operation of statewide
registries, including assistance in the development of model legislation
for statewide cancer registries and assistance in establishing a
computerized reporting and data processing system."

NPCR's responsibilities are defined in the current Funding Opportunity
Announcement. NPCR is responsible for the following activities:

-   Technical assistance to central cancer registries for effective
    program management including, but not limited to: registry
    operations, data management, and budget management.

-   Development of publicly available software programs for collecting
    and processing cancer registry data.

-   Convene a meeting of the Program Directors, at least annually, for
    information sharing and updates, to provide the participants a forum
    to discuss issues of relevance, share successes and challenges, and
    to identify common solutions to problems.

-   Convene an annual train-the-trainer meeting to provide education and
    training to central cancer registry trainers with the goal of
    building capacity within the central cancer registry to provide
    education and training to central cancer registry staff and
    reporters.

## 9.1 Technical Assistance for Program Management

NPCR provides general technical assistance to all program registries
through:

-   participating in standard-setting activities;

-   publishing program requirements in grant applications;

-   developing software programs to support registry activities;

-   hosting conferences addressing public health surveillance issues;

-   participating in research; and

-   publishing materials focused on registry operations and procedures.

In addition to these general programmatic activities, NPCR program
consultants are available to consult directly with registry management
staff to resolve issues which may be affecting the registry's ability to
attain or to adhere to program standards. NPCR monitors performance of
participating programs by routine reports and by on-site and
reverse-site visits.

## 9.2 Software Programs for Cancer Registry Data

NPCR supports the development of software to aid central registries in
the collection and processing of cancer data. The software is
distributed free to the public health community.

## 9.2.1 Registry Plus Software 

Registry Plus is a suite of publicly available, free-of-charge
Windows-based software programs used for collecting and processing
cancer registry data. Registry Plus currently includes nine applications
(see Table below), plus various utility programs. All programs are
compliant with national standards and can be used separately or together
for both routine and special data collection. In addition, the
applications are fully customizable for user/registry-specific needs.

A CDC security assessment of the Web Plus component was completed in
September 2007. Web Plus met all NIST SP 800-37 Guide for Security
Certification and Accreditation of Federal Information Systems and FIPS
200 Minimum Security Requirements for Federal Information and
Information Systems. Security scans were run that tested the program
code and ensured no vulnerabilities exist in the code itself. It is the
responsibility of installing organizations to secure their own
infrastructure.

# REGISTRY PLUS SUITE OF SOFTWARE PROGRAMS

+-----------+----------------------------------------------------------+
| **        | **FUNCTION AND USE**                                     |
| PRODUCT** |                                                          |
+===========+==========================================================+
| *         | -   Used to abstract and code cancer cases using         |
| *Abstract |     standard data items and codes                        |
| Plus**    |                                                          |
|           | -   Customized by central registries for distribution to |
|           |     and use by hospitals and other reporting sources to  |
|           |     abstract reports of cancer, as well as for           |
|           |     abstraction at the central registry                  |
|           |                                                          |
|           | -   Also used for special projects and start-up          |
|           |     registries                                           |
+-----------+----------------------------------------------------------+
| **Web     | -   Used to abstract, code, and collect cancer data      |
| Plus**    |     securely over the Internet                           |
|           |                                                          |
|           | -   Customized by central registries for abstracting and |
|           |     reporting cancer by physician's offices, low-volume  |
|           |     facilities, and for follow-back efforts aimed at     |
|           |     increased cancer reporting                           |
|           |                                                          |
|           | -   Supports upload of files of abstracts in NAACCR      |
|           |     format; used by hospitals and non-hospital reporting |
|           |     sources for submission of files of cancer reports to |
|           |     central registries                                   |
|           |                                                          |
|           | -   Eliminates need to distribute and maintain software  |
|           |     at reporting facilities                              |
+-----------+----------------------------------------------------------+
| **Prep    | -   Used to receive and apply data quality and           |
| Plus**    |     completeness edits to batches of abstracts           |
|           |                                                          |
|           | -   Customized by central registries for processing,     |
|           |     reviewing, and editing reported abstracts            |
+-----------+----------------------------------------------------------+
| **CRS\*   | -   Used to link and consolidate edited abstracts in the |
| Plus**    |     central registry                                     |
|           |                                                          |
| **(       | ```{=html}                                               |
| including | <!-- -->                                                 |
| TLC\*     | ```                                                      |
| Plus)**   | -   Customized by central registries for creating        |
|           |     consolidated patient and tumor tables for the same   |
|           |     person and tumor with the best values from multiple  |
|           |     sources                                              |
|           |                                                          |
|           | -   Provides for automatic determination of multiple     |
|           |     primary tumors and consolidation of data items from  |
|           |     multiple case reports into incidence records         |
|           |                                                          |
|           | -   Produces extracts for NPCR and NAACCR call-for-data  |
|           |     submissions                                          |
|           |                                                          |
|           | -   Provides standard management reports                 |
+-----------+----------------------------------------------------------+
| **Link    | -   Uses probabilistic methods to link records           |
| Plus**    |                                                          |
|           | -   Configured by central registries for:                |
|           |                                                          |
|           | \- Detecting duplicates within the registry to reduce    |
|           | over-counting of cancers                                 |
|           |                                                          |
|           | \- Linking cancer registry files to external files for   |
|           | follow-back and research purposes                        |
+-----------+----------------------------------------------------------+
| *         | -   Used to look-up abstraction and coding information   |
| *Registry |                                                          |
| Plus**    | -   Contains current versions of all standard            |
|           |     abstracting and coding manuals (NAACCR, FORDS, CS,   |
| **Online  |     ICD-O-3, SEER, ROADS)                                |
| Help**    |                                                          |
|           | -   Facilitates abstraction by centralizing information  |
|           |     into one easy-to-use resource                        |
|           |                                                          |
|           | -   Eliminates need to purchase and maintain manuals in  |
|           |     hardcopy form                                        |
+-----------+----------------------------------------------------------+
| **HL7     | -   Used to view and work with HL7 files and messages    |
| Mapper    |                                                          |
| Plus**    | -   Imports HL7 files manually/directly from PHIN MS     |
|           |     queue                                                |
|           |                                                          |
|           | -   Tests messages for required data items; searches     |
|           |     cancer terms to mark potential cases                 |
|           |                                                          |
|           | -   Parses HL7 messages and maps HL7 data elements to    |
|           |     NAACCR data elements                                 |
|           |                                                          |
|           | -   Builds a pathology lab database (MS Access, SQL      |
|           |     Server, or Oracle)                                   |
|           |                                                          |
|           | -   Will include abstracting module                      |
+-----------+----------------------------------------------------------+
| **Edit    | -   Used to define data items and record layouts,        |
| Writer3** |     specify editing algorithms, logic, and               |
|           |     documentation, and generate metafiles                |
+-----------+----------------------------------------------------------+
| *         | -   Used to apply data quality edits to data files using |
| *GenEDITS |     metafiles and to generate error reports for error    |
| Plus**    |     resolution                                           |
+-----------+----------------------------------------------------------+
| *         | -   Single, integrated, user-friendly online help system |
| *Registry |     for Windows                                          |
| Plus      |                                                          |
| Online    | -   Includes standard coding manuals that are            |
| Help**    |     cross-referenced, indexed, and context-linked        |
|           |                                                          |
|           | -   Embedded in Registry Plus applications and is also   |
|           |     available as a free-standing product                 |
+-----------+----------------------------------------------------------+
| **Utility | -   Small programs performing variety of useful          |
| P         |     functions for Registry Plus programs                 |
| rograms** |                                                          |
|           | -   File Identifier (Recnizer) -- identifies files in    |
|           |     NAACCR-prescribed formats                            |
|           |                                                          |
|           | -   Record Converter (Northcon 11) -- converts files     |
|           |     between NAACCR layout versions                       |
+-----------+----------------------------------------------------------+

\*CRS: Central Registry System, TLC: Tumor Linkage and Consolidation

Registry Plus Training Manuals

Training manuals are available for Abstract Plus and Web Plus (for both
users and administrators). Manuals for Prep Plus, CRS Plus, and Link
Plus are under development. The training manuals are available from the
NPCR website, and can be downloaded for each application.

Obtaining Registry Plus Programs

More information about the various Registry Plus programs, as well as
installation files for Abstract Plus, Link Plus, Registry Plus Online
Help, EDITS Tools, and Utility Programs can be downloaded from the
Registry Plus section of the NPCR website:
[[http://www.cdc.gov/cancer/npcr/tools/registryplus/]{.underline}](http://www.cdc.gov/cancer/npcr/tools/registryplus/).

Registries interested in obtaining other Registry Plus programs, or
having questions about any Registry Plus programs, may contact NPCR at:
<cancerinfo@cdc.gov>.

## 9.2.2 EDITS

EDITS software programs provide tools to improve data quality by
standardizing the way data items are checked for validity. These tools
can be built into interactive data collection systems to achieve
real-time field-by-field editing during data entry. They can also be
used in batch-editing processes for data already collected. EDITS
provides software to support three types of data activities: defining
standards for data quality, creating data collection processes, and
analyzing data. The EDITS programs include EditWriter, the EDITS
Application Program Interface, and GenEditsPlus.

EditWriter is a versatile and complete development environment for
defining, testing, documenting, and distributing data standards and
maintaining standard data definitions. EditWriter produces metafiles (a
compiled database which contains all the logic, tables, and values
needed to check data fields for validity) that can be used on many
operating systems and hardware platforms. Single-item, cross-field, and
inter-record checks can be included in metafiles. Standard metafiles are
distributed to the registry community through postings on the NAACCR
website at
<http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=136>. A
new metafile is released to accompany every new NAACCR layout,
containing all the edits approved by the standard setters. Central
registries may also develop and distribute customized metafiles to
support state data requirements.

The EDITS Application Program Interface (API), a library of C language
functions, can be incorporated into programs of many descriptions,
including programs for interactive data entry, after-the-fact
verification of data, recoding, reformatting, and vertical or horizontal
subsetting. GenEditsPlus, the generic EDITS driver program, is a batch
application for editing any data file with any
[Metafile](http://www.cdc.gov/cancer/npcr/tools/edits/editmeta.htm).
Records gathered under different circumstances using different programs
can be interpreted in a uniform way when validated with the same
metafile.

Additional information about the EDITS programs, and software downloads,
are found at <http://www.cdc.gov/cancer/npcr/tools/edits/>. Originally
written as MS-DOS programs, EDITS modules have been converted to the
Windows operating environment.

An EDITS Online Help, which will link into the Registry Online Help, is
under development. The EDITS Online Help will provide the edit logic to
assist users in understanding why edits failures occur and how to
resolve them.

## 9.3 Annual Program Directors Meeting

NPCR convenes a meeting of Program Directors at least annually for
information sharing and updates. The meeting provides the participants a
forum to discuss issues of relevance, to share successes and challenges,
and to identify common solutions to problems. Participation of
appropriate staff is a required recipient activity, and NPCR funds
travel for up to two persons from each participating program for this
meeting.

## 9.4 NPCR Education and Training

NPCR emphasizes the critical importance of training for cancer
registrars to support the collection of reliable, consistent,
high-quality data needed for cancer prevention and control activities.
NPCR develops and produces training materials using multiple
communication technologies to reach the training audience. The NPCR
Training web page is at <http://www.cdc.gov/cancer/npcr/training>.

NPCR embraces these education core values:

-   Education is an essential element in achieving data quality,
    completeness, and timeliness.

-   Content of education programs and products must respond to issues
    identified in quality assurance activities.

-   Educational opportunities must be offered continuously in diverse
    formats and methods of access.

Education objectives include:

-   providing resources through sponsoring training opportunities,
    developing materials, and funding registries to participate in
    educational sessions;

-   building the capacity of NPCR registries to provide education within
    their community of reporting facilities;

-   monitoring the educational infrastructure for gaps in access to
    education; and

-   searching for methods and technology to improve access to education
    for the entire cancer surveillance community.

NPCR supports in-person meetings and training for participating states,
including:

-   required trainer attendance at an annual Train-the-Trainer meeting
    in Atlanta;

-   recommended attendance of at least one program registry
    representative at the annual NAACCR meeting;

-   recommended attendance of at least one program registry
    representative at the annual NCRA meeting; and

-   recommended attendance at training sessions for application of new
    or revised coding and data collection rules.

NPCR supports web-conferencing and/or teleconferencing for trainer
meetings, and has also adopted the use of webcasts for training
sessions. All training materials are accessible at the NPCR training web
page, and provided at no cost.

## 9.4.1 NPCR Education and Training Series (NETS) 

The NETS modules are a series of educational tools for state trainers to
support central cancer registries in their role of providing education
to staff and reporters. Each module provides specific instructions for
the presenter(s), a comprehensive overview with Power Point slides,
complete speaker's notes, case scenarios, and exercises with answer
sheets that include the rationale for each answer. The modules cover the
entire spectrum of education, from basic incidence reporting to advanced
abstracting, and include topics of special interest for central registry
staff. As each module is completed, it will be posted to:
<http://www.cdc.gov/cancer/npcr/training/> .

Training for the Trainer

"Building a Quality Presentation" provides information on identifying
what training is needed, training methods, building Power Point
presentations, and developing exercises.

Abstracting for the Beginner

"Beginner Module for Reporters" includes what registries do, why cancer
data is collected, information flow from facility to the national level,
confidentiality of health data, casefinding, reportable cases, coding,
how cancers grows and spreads, and how to complete the electronic cancer
reporting form.

Training for Central Registry Staff

"Quality Control of Data in the Central Cancer Registry" provides an
overview of the principles of quality, use of data management reports,
and various audit methods. "Validating Data with Text" includes the
importance of text, how to record text, and what text to record.

Advanced Abstracting

Modules are available for head and neck, colorectal, lung, breast,
gynecologic, and genitourinary. Each module includes anatomy and cancer
characteristics, determining and coding primary site, stage and
treatment, and multiple primaries. The modules also address such areas
as interpreting diagnostic tests, determining metastases, and
identifying first course of treatment versus secondary treatment.
Modules are available at
<http://www.cdc.gov/cancer/npcr/training/abstracting/>.

Data Use

"Uses of Cancer Registry Data" includes examples of data use for cancer
control monitoring, health event investigations, geographic information,
legislation and funding documentation, public health initiatives,
interacting with the media, data linkages, statistics, data management
reports, marketing the central cancer registry, and marketing data
reporter and facility services.

## 9.4.2 Educational Materials for Cancer Registrars

NPCR has published additional materials to support registrar training,
focusing on basic information for new registrars and coding for benign
tumors of the central nervous system, which became reportable in 2004.

Fundamentals of Registry Operations

Available at:
<http://www.cdc.gov/cancer/npcr/training/training-sessions.htm>, this
series of downloadable tutorials is intended to be used as a training
resource for new employees and as reference materials for experienced
central registry or hospital registry professionals. The tutorials
address various cancer registry functions and the necessary procedures
for each. Subjects covered include:

-   Case Ascertainment

-   Principles of Abstracting

-   Data Editing and EDITS

-   Coding and Visual Editing

-   Follow-up: Active and Passive

-   Casefinding and Reabstracting

-   Data Collection and Coding: Race and Ethnicity

-   Basic Cancer Epidemiology and Biostatistics

Brain Tumor Registry Reporting Training Materials

NPCR developed training materials covering data collection for benign,
borderline, and malignant central nervous system tumors, and is
available at <http://www.cdc.gov/cancer/npcr/training/btr/>. All cancer
registry standard-setting organizations have agreed to use these
training materials to promote consistency in training. In addition to
NPCR, these materials have been approved by the CoC, SEER, and NAACCR.

The slide presentation available at
<http://www.cdc.gov/cancer/npcr/training/btr/ppt/> was developed through
a contract with NAACCR and reviewed by a NAACCR Registry Operations
Committee's Brain Tumor subcommittee, which included representation from
all cancer registry standard-setting organizations.

## 9.5 Recruitment Materials

Recognizing the implications of a cancer registrar shortage, NPCR
developed a cancer registrar recruitment project with NCRA. "Quality
Cancer Data Saves Lives: The Vital Role of Cancer Registrars in the
Fight Against Cancer", is a set of three Power Point presentations of
various length designed to describe the cancer registry career option to
Health Information Management students and other allied health
professionals. These presentations are available at:
<http://www.cdc.gov/cancer/npcr/registry/QualityData>.

# 10.0 Guidance Documents

NPCR provides guidance documents to further assist the central
registries in meeting the standards for participation. They are a more
comprehensive discussion of the standard and include specific
instructions for implementation.

## 10.1 Advisory Committee Guidance 

I. Background and Purpose

> In 2007, with the new Program Announcement, the Centers for Disease
> Control and Prevention (CDC) National Program of Cancer Registries
> (NPCR) will implement new standards that require central cancer
> registries (CCRs) to have an advisory committee. NPCR has always
> recognized the important role an advisory committee can play in
> supporting the CCR, and NPCR program announcements have consistently
> stated that funded programs (Recipient Activities) are responsible for
> establishing or enhancing, and regularly convening, an advisory
> committee. However, this activity has not been included in previous
> NPCR program standards.
>
> NPCR offers the following suggestions to CCRs who do not have
> procedures in place to meet this standard. CCRS that have an advisory
> committee may find these suggestions helpful in making the committee
> more useful. NPCR is not requiring a specific structure for Advisory
> Committees. The purpose of this document is to provide ideas so that
> states can maximize the usefulness of their Advisory Committee.

II\. Program Standards: Collaborative Relationships

> The central cancer registry establishes and regularly convenes an
> advisory committee to assist in building consensus, cooperation, and
> planning for the registry. Representation should include key
> organizations and individuals both within (such as representatives
> from all cancer prevention and control components) and outside the
> program (such as hospital cancer registrars, the American Cancer
> Society, clinical-laboratory personnel, pathologists, and clinicians).
> Advisory committees may be structured to meet the needs of the state
> or territory, such as the Comprehensive Cancer Control Program
> committee structure, an advocacy group, or a focus group.

III\. General Committee Structure

> Examples of possible structures include:
>
> **Official state government advisory committee**

-   Structure: Committee follows state regulations for advisory
    committees. (These usually require legislative representation.)

-   Advantages:

    -   The requirements of the state may stipulate participation of
        representation from the legislature, therefore ensuring their
        participation.

    -   Legislative participation may facilitate direct communication to
        local and national legislators regarding CCR issues.

    -   Legislators can report on other pending legislation that may
        affect the CCR.

-   Disadvantages:

    -   Getting committee approval may be cumbersome, and representation
        may be limited.

    -   Committee member appointment may also be cumbersome and not done
        in a timely manner.

    -   Committee cannot lobby Congress; however, individual members
        can.

    -   Legislating committee members from various state agencies does
        not ensure interest in the program, and input may be minimal.

> **Part of the Comprehensive Cancer Control (CCC) Program**

-   Structure: One of the Comprehensive Cancer Control Program
    committees may form a subcommittee to advise the CCR.

-   Advantages: Members of the CCR advisory committee may be on other
    CCCP committees, and meeting can be scheduled in conjunction with
    other committee meetings to improve attendance and decrease
    expenses.

-   Disadvantages: None identified at this time.

> **Independent public committee**

-   Structure: Advisory committee is established as a public advocacy
    committee.

-   Advantages:

    -   The committee is more independent.

    -   CCR may have greater in-put on committee membership.

    -   Committee members may lobby local and national legislators.

-   Disadvantages:

    -   Expenses must be provided by the CCR or another supporting
        organization such as the American Cancer Society.

> **Hybrid**

-   The committee may incorporate aspects of several of the models
    mentioned.

IV\. Purposes of a CCR Advisory Committee

-   Assist in building consensus, cooperation, and planning for the CCR.

-   Assist the CCR in setting goals and evaluating the efficiency and
    effectiveness of the CCR.

-   Advocate for needed legislative changes.

-   Serve as a CCR data request review committee.

-   Recommend policies on data use.

-   Address problem-reporting issues and advocate solutions to
    identified problems. For example, a hospital administrator might
    address the problem of a hospital's non-compliance, and a physician
    might address physician reporting through direct contact with
    individual physicians or physician groups.

-   Provide spokespersons for the CCR to make presentations at state
    medical association and other professional meetings.

V. Suggestions for Establishing an Advisory Committee

-   Establish the responsibility, accountability, and multidisciplinary
    membership using a method appropriate to the CCR's organizational
    structure.

-   Identify appropriate committee representatives, such as

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-   All components of the state's cancer prevention and control
    programs.

-   Other state programs that may have relevant interaction with the
    CCR, such as the Tobacco Control Program.

-   Cancer surveillance partners, such as hospital cancer registrars,
    the American Cancer Society, clinical and laboratory personnel,
    pathologists, and clinicians. These partners may serve as subject
    matter experts.

-   Legislators.

-   Legal counsel (from CCR agency).

-   Other members as required by state legislation or regulations.

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-   Determine the meeting format (face-to-face meetings or conference
    calls) and frequency.

-   Determine the advisory committee's mission. Example mission
    statements may be:

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-   The mission of the (CCR) advisory committee is to coordinate cancer
    surveillance activities within the state through communication and
    collaboration among major cancer organizations. In so doing, the
    (CCR) seeks to ensure the needs of cancer patients and the
    communities in which they live are fully served, scarce resources
    are used maximally, and the burden of cancer in the state is
    adequately measured and ultimately reduced.

-   The (CCR) advisory committee was created to provide a forum for
    examining the current state of cancer surveillance operations and
    identifying the broad issues involved, to recommend practical
    approaches to facilitate the work of the (CCR), and to contribute to
    the goal of coordinating data collection and improving data quality
    across the state. The (CCR) advisory committee enables these
    organizations to collaborate on cancer monitoring and registry
    operations.

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-   Determine the naming format and structure for the committee. The
    standard was designed to provide programs with the flexibility to
    structure and name their advisory committee in a way that meets the
    needs of the program.

-   Establish the funding mechanism.

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-   Will committee member travel be reimbursed? By whom?

-   Who will provide meeting space?

-   Will refreshments or meals be provided? If so, who will provide
    funding?

-   What is required by state legislation or regulations?

VI\. Monitoring Compliance

-   Compliance with this standard will be monitored through
    self-assessment on the NPCR Program Evaluation Instrument.

**Note:** This document has been reviewed and edited by the NPCR Cancer
Registry Council (formerly known as the NPCR Logistics Workgroup).

## 10.2 Attribution Guidelines-Partners

I. Background

> In 1992, Congress responded to the need for local, state, regional and
> national cancer incidence data by passing the Cancer Registries
> Amendment Act, Public Law 102-515. The act authorized the Centers for
> Disease Control and Prevention (CDC) to establish the National Program
> of Central Registries (NPCR). Funds are provided through Congressional
> appropriation to the Division of Cancer Prevention and Control (DCPC),
> Cancer Surveillance Branch (CSB). CDC's NPCR supports central
> registries and promotes the use of registry data in 45 states, the
> District of Columbia, Puerto Rico and the Pacific Islands
> Jurisdictions.
>
> CDC-NPCR funds are used to support activities of partners within the
> cancer surveillance community. Support of these partnerships is
> essential to NPCR accomplishing its mission.
>
> In order to demonstrate the effectiveness of the use of program funds
> and to assure continued Congressional financial support, proper
> acknowledgment of products and activities supported through NPCR
> funding is critical. This document provides guidance, developed by
> DCPC, CSB, for partners to follow in providing appropriate
> acknowledgment of CDC-NPCR support.

II\. General Guidelines

> The guidelines outlined in this document are to be used by CDC-NPCR
> partners when CDC-NPCR funds are applied to cancer surveillance
> activities:

-   Conducting an educational meeting or national conference

-   Developing Web site content (e.g., central registry or state health
    department Web sites)

-   Developing, producing and/or distributing articles, reports,
    publications and other products (e.g., Journal articles, annual
    reports)

III\. Specific Guidelines

> **Contracts**

-   All contract deliverables must comply with U.S. Department of Health
    and Human Services (DHHS) and CDC logo requirements. In general, the
    DHHS and CDC logos must appear on products, publications,
    announcements, and Web site postings.

-   All documents and presentations developed and delivered under
    contract for CDC's use should contain no brand or marking of
    contractors who developed the material. Materials of this type
    should be marked with CDC logos and information only.

-   All contract deliverables must comply with funding attribution
    verbiage as listed within the notice of contract award (e.g., "This
    project was supported by contract number xxx-xxxx-xxxxx from Centers
    for Disease Control and Prevention.)".

-   The title, content and attribution of the products, publications,
    announcements and Web site postings are expected to reflect that it
    is a CDC-NPCR funded product or activity.

> **Cooperative Agreements**
>
> All cooperative agreement activities and products (e.g., publication
> of annual reports, CCR program manual) must comply with funding
> attribution verbiage as listed within the notice of grant award (e.g.,
> "We acknowledge the Centers for Disease Control and Prevention, for
> its support of the xxxxxxxx, and the printing and distribution of the
> xxxxxxxx under cooperative agreement xxx/xxxxxx-xx awarded to xxxxxxx.
> The findings and conclusions in this report are those of the author(s)
> and do not necessarily represent the official position of the Centers
> for Disease Control and Prevention").
>
> **Data Use in Research Activities and Publications**
>
> CDC-NPCR provides funding and technical support to states, territories
> and numerous national partners. Support for cancer registries is a
> line item in the budget from Congress, and these dollars are used to
> promote the collection of complete, timely, and high quality
> population-based cancer data for CDC-NPCR. When the data, that are
> collected and reported through support from CDC-NPCR, are used for
> research and publication, acknowledgment of CDC-NPCR in the text is
> critical. Text similar to the following sentence should be included:
> "These data were collected by xxxxxxx Cancer Registry participating in
> the National Program of Cancer Registries (NPCR) of the Centers for
> Disease Control and Prevention (CDC)." (e.g., CDC-NPCR should be
> described in the Technical Notes).

## 10.3 Data Security Guidance

I. Background and Purpose

> In 2007, the Centers for Disease Control and Prevention (CDC) National
> Program of Cancer Registries (NPCR) implemented new standards that
> include requirements for data security procedures. This document is
> provided to help Central Cancer Registries (CCRs) meet the NPCR
> standards and help CCRs transmit cancer data more securely.

II\. Standards for Data Security

> The central cancer registry primarily uses a secure Internet-based,
> FTP, or encrypted e-mail mechanism to receive data from all reporting
> sources.

III\. Data Security Issues

> Confidential medical information that may contain patient names,
> addresses, birthdates, and social security numbers is transmitted
> frequently to and from the CCR via the postal system. This presents a
> large risk to the CCR that confidential medical records may be
> intercepted and used for identity theft, or confidential medical
> information may be revealed. Submission of non-encrypted electronic
> registry data on disks or CDs via the postal system presents the same
> risks as submitting paper records.

-   NPCR strongly recommends these alternatives to sending medical
    information via the postal system:

    -   WebPlus provides secure electronic data submission for reporters
        with Internet access.

    -   CCR can provide a secure Internet-based FTP or Web site where
        data can be posted.

    -   Encrypted files can be attached to an email message.

    -   CCRs can encourage reporters to use the encryption options
        provided by their software vendors.

    -   CCR can provide an encryption program for all electronic
        reporters.

    -   Encrypted data can be submitted via disk or CD if Internet
        access is not available.

-   All states have small-volume reporters that may send paper copies of
    patient information through the mail to the CCR to be abstracted by
    CCR staff. In addition, paper copies of pathology reports are
    frequently sent to the CCR through the mail. Pathology report and
    death clearance follow-back letters are also sent and returned to
    the CCR via the postal system.

    -   Alternatives to sending medical information via the postal
        system:

        -   WebPlus provides secure electronic data submission. If the
            CCR prefers, reporters can complete the demographic
            information and place other cancer information in the text
            fields for coding by CCR staff.

        -   In some instances the installation and training required for
            WebPlus for facilities with very few cases a year may not be
            appropriate. Also, some reporters may not have internet
            access. If WebPlus is not an option, Abstract Plus can be
            used in the same way, but data must be encrypted and
            submitted as either an e-mail attachment or on disk or CD.
            NPCR considers this electronic reporting even when the CCR
            staff does the coding.

        -   A PDF file can be attached to an e-mail message if medical
            records are being sent to the CCR from hospitals or
            physician offices. This may also be an option for receiving
            pathology reports. This method is more secure than the
            postal system, but is not considered electronic transmission
            because the information must be keyed in to the CCR registry
            system.

        -   Follow-back letters can be sent and received via an e-mail
            attachment. Forms can be completed electronically (such as
            in a Microsoft^®^ Word document) and returned to the CCR as
            an e-mail attachment.

        -   The use of a secure fax is another option. This can be via a
            standard or encrypted fax (which is fairly expensive). The
            fax machine must be located in a secure area. Medical
            records can be faxed to the CCR and the CCR can fax
            follow-back forms to reporters. The standard fax is not very
            secure, but it is better than the postal system.

## 10.4 Electronic Reporting Guidance

I. Background and Purpose

> In 2007, the Centers for Disease Control and Prevention (CDC) National
> Program of Cancer Registries (NPCR) implemented new standards that
> require electronic reporting. This document is provided to help
> Central Cancer Registries (CCRs) meet the NPCR standard.

II\. Standards for Electronic Reporting

-   At a minimum, 95% of reports from hospitals are submitted to the
    central cancer registry in an electronic format (where the medical
    records are owned by the hospital).

-   At a minimum, 85% of reports from non-hospital reporting sources are
    submitted to the central cancer registry in an electronic format.
    (E.g., radiation therapy centers, ambulatory surgery centers, and
    in-state and out-of-state pathology laboratories where medical
    records are owned by the reporting source.)

-   At a minimum, 75% of reports from physician offices, identified as
    required to submit cancer cases to the central cancer registry, do
    so in an electronic format (where the medical records are owned by
    the physician). This includes responses from physicians to central
    cancer registry inquiries.

III\. Clarifications for Electronic Reporting Requirements

> Electronic data exchange is a broad term used to describe methods of
> transferring data that do not require manual data entry to create an
> abstracted record.

-   Electronic reporting standards apply to all data submitted to the
    CCR regardless of whether it is proactive (data routinely submitted)
    or reactive (response to follow-up for pathology reporting or death
    certificate clearance).

-   Examples of electronic reporting:

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-   Encrypted NAACCR-formatted cancer data submitted on a disk or
    CD-ROM.

-   Data entered using Web-Plus or another CCR online reporting program.

-   Data submitted (preferably to a secure fax machine) from a facility
    or physician's office on a data form that can be scanned and uses
    forms recognition software to create an electronic data file.

-   Data CCR staff abstracted from a source document (either at the
    facility or from mailed copies of records) on a laptop or directly
    into a CCR database. In this case, the CCR has "an agreement with
    the facility to do their reporting" similar to other abstracting
    arrangements. NPCR has issued guidance on when CCRs can use NPCR
    funds to support this type of arrangement on a limited basis; see
    *Guidance on Direct Data Collection.*

-   Pathology reports submitted in HL7 or other electronic media
    requiring conversion to NAACCR or another CCR software file format.

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-   Methods of electronic data exchange that do not meet the electronic
    reporting standard:

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-   A facility sends in a paper abstract form.

-   A pathology laboratory sends paper copies of pathology reports.

-   A physician's office or facility sends a standard paper form with
    patient information that must be manually keyed in to a CCR
    database.

-   CCR personnel call a facility or physician for primary patient
    information (not just for clarification of conflicting data).

IV\. Challenges to Electronic Reporting

> Many CCRs use printed forms to collect some information. These forms
> may be an abstract form completed by a small-volume hospital or
> physician's office to report cases, or a form sent by the CCR to
> obtain follow-back information for pathology reports or death
> certificate clearance. These forms are not considered electronic
> reporting because the information received must be keyed in to the CCR
> registry software.

-   Alternatives to non-electronic reporting:

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-   NPCR's Web Plus online abstracting capability is ideal for complying
    with electronic reporting requirements for reporting from
    physicians'

-   If WebPlus is not a suitable option (the facility does not have
    Internet access, or the case load is too small to justify training),
    the use of forms recognition software allows the CCR to receive a
    faxed or e-mailed form that can be written to the database
    automatically. The information is considered electronic reporting
    and is much more efficient, saving the time needed to key in the
    information.

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-   Electronic forms (such as in Microsoft^®^ Word) distributed via the
    Internet provide the highest efficiency. The CCR can e-mail a form
    containing known information to the reporter, who can then complete
    their portion electronically, eliminating the problems of
    handwriting recognition. As an option to Internet transmission, the
    reporter can be mailed a blank electronic form on CD or disk), which
    they can complete on their computer and fax to the CCR.

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-   NPCR is providing this analysis of forms recognition software. The
    report identifies potential forms recognition products in the
    market, compares their strengths and weaknesses, and provides cost
    estimates. When using forms recognition software, the following tips
    will increase accuracy:

    -   Use check boxes when possible.

    -   Understand that every character may not be interpreted
        accurately; visual comparison of the original and the electronic
        form will be necessary.

    -   Use a word processor instead of handwriting to complete forms.
        Handwritten responses present significant problems in
        interpretation.

    -   A program to convert the forms recognition output into a NAACCR
        or CCR software format will be needed.

    -   NPCR is happy to provide you with a forms recognition software
        report prepared by Northrop Grumman. The recommendations
        included in the report are those of the Northrop Grumman Web
        Applications Team. NPCR does not recommend or endorse any
        software.

Additional information on DCPC Forms Recognition Software Analysis can
be found in [Appendix I](#_Appendix_I:_).

## 10.5 Guidance for Use of NPCR Funding for Data Collection

> As a general rule, NPCR dollars should not be used for data collection
> (abstracting) from reporting facilities.
>
> Exceptions can be made by specific request with adequate
> justification.
>
> Unobligated funds can be used on a one-time basis to catch up on
> delinquent cases.
>
> Justification must be provided on a site-by-site basis for why it is
> more efficient and cost effective for CCR staff to do data collection.
>
> Acceptable justification includes:

-   All other means of obtaining the cases have been exhausted.

-   Reporting facility has a very small number of reportable cases.

-   Frequent turn over in non-cancer registry reporting facility
    requires repeated on-site training.

## 10.6 Physician Reporting Guidance

I. Background and Purpose

> In 2007 the Centers for Disease Control and Prevention (CDC) National
> Program of Cancer Registries (NPCR) implemented new standards that
> emphasize non-hospital reporting, including specific physician
> reporting requirements. NPCR legislation requires funded states to
> have "A means to assure the **complete reporting** of cancer cases to
> the statewide cancer registry **by physicians, surgeons, and all other
> health care practitioners** diagnosing or providing treatment for
> cancer patients, **except** for cases directly referred to or
> previously admitted to a hospital or other facility providing
> screening, diagnostic or therapeutic services to patients in that
> State and reported by those facilities". The 2007 NPCR standards
> require **at least 75 percent of physicians, surgeons, and all other
> health care practitioners** to report required cases **within 24
> months of the close of the diagnosis year**.
>
> For CDC to monitor compliance with this standard, each central cancer
> registry (CCR) must provide an accurate count of these reporters to
> use as a denominator, and to monitor reporting compliance and
> timeliness.
>
> Complete implementation will vary by state. NPCR offers the following
> suggestions to states that do not have procedures in place to meet
> this standard.

II\. Suggestions for Implementing Physician Reporting

-   Implement physician reporting gradually to make the process more
    manageable.

    -   Start the reporting with one specialty physician or group and
        then move on to the second, etc.

    -   Train office staff to report one site at a time and then add
        more sites?

-   Determine the **physician specialties** that represent the greatest
    number of missed cases by evaluating

    -   Follow-back requirements for pathology reports.

    -   Follow-back requirements for death certificates.

    -   Rates for individual cancers compared to national rates to
        identify physician specialties where cases may be missing, such
        as urology (prostate) or dermatology (melanoma).

-   Target the physician specialty with the highest number of missed
    cases first, and add additional specialties in an ongoing process.

-   CCRs may want to require larger physician practices to report
    proactively, and other small-volume reporters to report in response
    to inquiries from the CCR. Regardless of their reporting
    requirements, they will be counted in the denominator for
    determining NPCR standard compliance.

-   Develop physician reporting procedures.

    -   Develop a data and software manual for physician office staff.

-   Send new physician reporters a letter of introduction explaining the
    CCR law that requires that physicians report all cases not reported
    by other facilities, procedures for how and when to report, and a
    copy of the reportable list. Include a copy of the law, HIPAA
    information, and any state-specific documents, or copies of the
    HIPAA legislation information available on the NAACCR Web site.

    -   Have letters sent to physicians from state officials outlining
        reporting requirements.

    -   Have CCR administrator send letters to potential reporters.

    -   Send letters with information on the CCR and direct letters to
        Medical Director or Office Manager.

    -   Arrange to make presentations on the importance of physician
        reporting to various physician association meetings. Include
        example of how data are used. Possible meetings include:

        -   State AMA meeting

        -   State or local Urology meeting

        -   State or local Dermatology meeting

        -   State or local Oncology Association meeting

    -   Follow up with a personal contact with the physician or practice
        manager. Focus on the impact of physician reporting on cancer
        surveillance and the importance of population-based cancer data
        for cancer control efforts, and list the reports that are
        available as a result of reporting.

-   Use NPCR software Web Plus for physician reporting when possible.
    This program uses the Internet for reporting, and all software and
    case information are maintained on a CCR server providing data
    security. Provide demonstrations of available tools.

-   Use NPCR software Abstract Plus for physician reporting if the
    physician office does not have access to the Internet.

-   Link with ICD-9 or CPT billing codes to generate CCR casefinding
    list

-   Provide training with targeted, clear, and concise educational
    materials and provide ongoing support.

    -   Offer to provide training for the physician office staff
        learning how to abstract reportable information.

-   Provide on-going communication

    -   Keep lines of communication open even if e-reporting is in
        place.

    -   Send letters of recognition for good reporters

-   Try to achieve links to licensure based on reporting compliance in
    states that require licensure. (i.e., Licensing is contingent on
    meeting all state reporting rules.) CCR sends a list of noncompliant
    physicians to the state licensing board.

-   Communicate with other central registries about physician reporting
    to exchange tips, ideas for success, etc.

-   See NPCR website <http://www.cdc.gov/cancer/npcr/> for additional
    information on all CDC products including Web Plus and Abstract
    Plus.

III\. Methods for Identifying Physicians

-   Use follow-back for pathology reports and death clearance to
    identify new physician sources

-   Use your state's physician licensing agency list, which may be
    available electronically to identify new physicians and update
    mailing information. This database may be available within the
    Health Department. Each state should review the physician license
    list to ascertain its usability for identifying physicians and their
    contact information.

    -   Set up a continual process to include newly practicing
        physicians, and exclude physicians who no longer practice in
        that State.

-   Look for other state programs/associations/societies which may
    already have physician directories that can be shared.

-   Obtain hospital staff physician lists that may be updated annually.

-   Investigate the use of physician address services.

-   Use M.D.s on the advisory committee to advocate for physician
    reporting. Physicians could also offer counseling to the CCR on how
    to achieve compliance, or offer to make presentations to specialty
    organizations.

IV\. How to Count Physicians for PEI and NPCR Standards Compliance

-   **Multiple physicians** **that practice in a clinic or other
    practice:** The entity responsible for reporting is the clinic or
    practice, even if it is owned by a physician or multiple physicians.
    The clinic or practice owns the records, not each individual
    physician. The clinic is also counted as one reporting source, like
    an ambulatory surgery center that may have multiple surgeons.

-   **Physicians with more than one office or practice address:**
    Reporting depends on ownership of the records. If an individual
    physician has multiple offices, reporting requirements are
    determined by the CCR. It may be the responsibility of each office
    (because that's where the records are located), or the physician if
    all records are maintained in a single record-keeping system. It is
    possible for a single physician to be counted multiple times if
    reporting comes from several offices.

V. How to Establish a Data Reporter's Database

-   Determine if the physician database is to be separate, or part of a
    database that includes other reporters such as ambulatory surgery
    centers and radiation oncology centers.

-   Find out if any other department maintains a physician database that
    could be used (such as departments responsible for physician
    licensing or for emergency medical services).

-   Develop a new database if necessary using Microsoft^®^ Access^®^,
    Microsoft^®^ Excel, or similar software products.

    -   CCR software may allow the generation and incorporation of a
        single Doctor file which provides information on the central
        registry's reporting physicians; this information is then
        available within the applications for reports, etc.

-   Update the database on an ongoing basis (as responses are returned)
    and at least annually.

-   Include information required to complete the NPCR Program Evaluation
    Instrument (PEI). Suggestions for other information include:

    -   Physician or facility identification number

    -   Contact information, including the entire address and the name
        of the person responsible for responses

    -   Reporting source, which can be an individual physician, clinic,
        or physician group; one physician can be listed with multiple
        clinics or practices

    -   Physician specialty

    -   Reporting status (proactive, response to inquiries, does not
        respond)

    -   Method of reporting (Web Plus, electronic form, or other)

    -   Date last updated

    -   Initials of person updating

    -   Source of update

    -   Use follow-back for information to complete missing fields.

VI\. How to Improve Reporting Compliance --\
Suggestions from the 2007 Program Directors' Meeting

-   If state laws prohibit sending information electronically, work to
    change laws. If non-hospital sources are prohibited from sending via
    internet, offer alternative methods that would enable centers to do
    electronic reporting (use of disks, Web Plus, etc.)

-   Levy fines for non compliance

-   Urge the DOH to give law some teeth

-   Involve the advisory committee

-   Find vocal professional groups supportive of the CCR

-   Standardize text

-   Address issues of data release

-   Invite reporters to annual workshops and training

-   Define the benefits for non-hospital sources

-   Offer feedback for non-hospital sources -- running data reports,
    creating report cards

-   Build a rapport

-   Develop a newsletter

# Appendix A: Reference List for Chapter 1: Introduction, Overview and Accomplishments

# Appendix B: Inventory of Publications and Professional Presentations on CDC-NPCR's Patterns of Care Studies 

[Publications]{.underline}

Alley LG, Chen VW, Wike JM, Schymura M, Rycroft RK, Shen T,
Bolick-Aldrich S, Roshala W, Fulton J. CDC-NPCR's Breast, Colon, and
Prostate Cancer Data Quality and Patterns of Care Study: Overview and
Methodology. *Journal of Registry Management*, 34(4): 148-157, 2007.

Stewart SL, Wike JM, Cress R, O'Malley C, Neloms S, Kahn AR, Schymura
MJ. Ovarian cancer treatment patterns and outcomes in the United States:
A National Program of Cancer Registries (NPCR) study. *Journal of
Clinical Oncology*, 24(No. 18S): 15031, 2006 (ASCO Annual Meeting
Proceedings Part I).

McDavid K, Schymura MJ, Armstrong L, Santilli L, Schmidt B, Byers T,
Steele CB, O'Connor L, Schlag NC, Roshala W, Darcy D, Matanoski G, Shen
T, Bolick-Aldrich S, and The Breast, Colon, and Prostate Cancer Data
Quality and Patterns of Care Study Group. Rationale and design of the
National Program of Cancer Registries' breast, colon, and prostate
cancer patterns of care study. *Cancer Causes and Control*, 15:
1057-1066, 2004.

[Oral Presentations]{.underline}

Kahn AR. "Patient and Provider Factors Associated with Treatment for
Ovarian Cancer." NAACCR annual meeting, June 5, 2007.

German RR, Wu X, Cress RD, Schymura MJ, Stewart SL, Chen VW. "Using
Cancer Registry Data to Describe Treatment Patterns for Breast,
Prostate, Colon, and Ovarian Cancers." CDC Cancer Partners Summit, July
13, 2006.

Cress RD. "Adjuvant Chemotherapy for Patients with Stage III Colon
Cancer: Preliminary Results from the NPCR Patterns of Care Study."
NAACCR annual meeting, June 15, 2006.

Chen VW. "Enhancing Populations-based Registry Data to Assess Cancer
Care: Strengths and Challenges." NAACCR annual meeting, June 13, 2006.

Wu XC. "Dissemination of Guideline Therapy for Localized Breast Cancer
Patients: (Preliminary) Results from a NPCR's Patterns of Care Study."
NAACCR annual meeting, June 13, 2006.

Schymura MJ. "Factors Associated with Initial Treatment for Clinically
Localized Prostate Cancer: Preliminary Results from the NPCR Patterns of
Care Study (PoC1)." NAACCR annual meeting, June 13, 2006.

German RR. "The Quality of Cancer Registry Data: Preliminary Results
from the CDC-NPCR's PoC Study." NAACCR annual meeting, June 13, 2006.

Alley LG. "Using NPCR Data to Describe Patterns of Care for Three
Cancers." NAACCR annual meeting, June 2005.

Alley LG. "The Importance of Conducting Population-Based Patterns of
Care (PoC) Studies: Improving Cancer Patient Care." Federal Special
Interest Group (SIG) of the NCRA Annual Educational Conference, April
2005.

Alley LG. "Overview of CDC's Patterns of Care Cancer Studies". CDC-NPCR
Program Directors' Meeting, March 2004.

[Posters]{.underline}

Alley AG, Chen VW, Fulton J, Kahn AR, Roshala W, Rycroft RK, Shen T,
Wike JM, German RR, Bolick-Aldrich S. *CDC/NPCR Patterns of Care (POC)
Study For Breast, Prostate, and Colon Cancers: Challenges and Lessons
Learned*. NAACCR annual meeting, June 2007.

Alley AG, German RR, Wike J, Stewart SL, Richardson LC, Wilson R, Van
Heest S, Chen VW, Cress R, Sabatino S, Schymura MJ. *National Program of
Cancer Registries (NPCR) Patterns of Care Study for Breast, Prostate,
and Colon Cancers: An Overview.* American Public Health Association
annual meeting, November 2006.

Stewart SL, Wike JM, Cress R, O'Malley C, Neloms S, Kahn AR, Schymura
MJ. *Treatment Patterns and Outcomes of Ovarian Cancer Patients By
Histology: Data from the NPCR Patterns of Care Study*. NAACCR annual
meeting, June 2006.

Kahn AR, Schymura MJ, Solghan SM, and the NPCR Ovarian Cancer Treatment
Patterns and Outcomes Study Group. *Ovarian Cancer Treatment in New
York*. NAACCR annual meeting, June 2006.

German RR, Byers T, Wolf H, Wike J, Alley LG, Almon L, Stewart SL. *The
Quality of Cancer Registry Data: Design and Interim Findings from the
CDC-NPCR's PoC Study*. NAACR annual meeting, June 2005.

Alley LG, Wike J, Stewart SL, German RR, Ahmed F, Almon L, Wingo P,
Friedman C. *Using NPCR Data to Describe Patterns of Care for Three
Cancers*. CDC-NPCR Program Directors' Meeting, May 2005.

Alley LG, Wike J, Stewart S, Friedman C. *Using Cancer Registry Data to
Describe Disparities in Patterns of Care for Breast, Colon, and Prostate
Cancers*. National Conference on Chronic Disease Prevention and Control,
February 2005.

# Appendix C: Organizational Charts  

U.S. Department of Health and Human Services (DHHS) Organization Chart

![](media/image7.png){width="6.999305555555556in"
height="5.3597222222222225in"}

Centers for Disease Control and Prevention (CDC) Organizational Chart

![](media/image8.png){width="6.388194444444444in"
height="4.6305555555555555in"}

CDC's National Center for Chronic Disease Prevention and Health
Promotion Organization Chart

![](media/image9.png){width="6.1715277777777775in"
height="3.665277777777778in"}

CDC's Division of Cancer Prevention and Control Organization Chart

![](media/image10.png){width="6.0055555555555555in"
height="3.433333333333333in"}

Cancer Surveillance Branch Organization Chart

![](media/image11.png){width="6.163194444444445in"
height="2.8979166666666667in"}

# Appendix D: Guidelines for Defining Public Health Research and Public Health Non-Research 

Revised October 4, 1999

**Purpose**

The Centers for Disease Control and Prevention (CDC) is committed to
preventing disease and injury and improving health for all Americans.
CDC is also committed to protecting individuals who participate in all
public health activities. In the conduct of public health research, CDC
follows the Code of Federal Regulations, Title 45, Part 46, The Public
Health Service Act as amended by the Health Research Extension Act of
1985, Public Law 99-158, which sets forth regulations for the protection
of human subjects.

This document, *Defining Public Health Research and Public Health
Non-Research*, sets forth CDC guidelines on the definition of public
health research conducted by CDC staff irrespective of the funding
source (i.e., provided by CDC or by another entity). Under Federal
regulations (45 CFR 46), the final determination of what is research and
whether the Federal regulations are applicable lies with CDC and,
ultimately, with the Office for Protection from Research Risks (OPRR).
Thus, this document is intended to provide guidance to state and local
health departments and other institutions that conduct collaborative
research with CDC staff or that are recipients of CDC funds. The
guidelines are intended to ensure both the protection of human subjects
and the effective practice of public health.

**Background**

In 1974, the Department of Health and Human Services (formerly the
Department of Health, Education and Welfare) developed regulations to
assure the protection of human subjects from research risks. These
regulations were developed to address ethical issues raised in
connection with biomedical or behavioral research involving human
subjects. Because most biomedical research is funded by the National
Institutes of Health (NIH), the regulations were developed to deal
specifically with the types of research funded by NIH. The regulations
have been revised several times; currently the Department is operating
under Title 45 Code of Federal Regulations Part 46, 1991 revision. The
regulations will be referred to as 45 CFR 46.

The practice of public health poses several challenges in implementing
45 CFR 46. Although some public health activities can unambiguously be
classified as either research or non-research, for other activities the
classification is more difficult. The difficulty in classifying some
public health activities as research or non-research stems either from
traditionally held views about what constitutes public health practice
or from the fact that 45 CFR 46 does not directly address many public
health activities. In addition, the statutory authority of state and
local health departments to conduct public health activities using
methods similar to those used by researchers is not recognized in the
regulations. Human subject protections applicable for activities
occurring at the boundary between public health non-research and public
health research are not readily interpretable from the regulations.

The regulations state that \"research means a systematic investigation,
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.\" Obtaining and
analyzing data are essential to the usual practice of public health. For
many public health activities, data are systematically collected and
analyzed, blurring the distinction between research and non-research.
Scientific methodology is used both in non-research and research
activities that comprise the practice of public health. Because
scientific principles and methodology are applied to both non-research
and research activities, knowledge is generated in both cases.
Furthermore, at times the extent to which that knowledge is
generalizable may not differ greatly in research and non-research. Thus,
non-research and research activities cannot be easily defined by the
methods they employ. Three public health activities - surveillance,
emergency responses, and evaluation - are particularly susceptible to
the quandary over whether the activity is research or non-research.

The key word in the regulations' definition of research for the purpose
of classifying public health activities as either research or
non-research is \"designed.\" The major difference between research and
non-research lies in the primary intent of the activity. The primary
intent of research is to generate or contribute to generalizable
knowledge. The primary intent of non-research in public health is to
prevent or control disease or injury and improve health, or to improve a
public health program or service. Knowledge may be gained in any public
health endeavor designed to prevent disease or injury or improve a
program or service. In some cases, that knowledge may be generalizable,
but the primary intention of the endeavor is to benefit clients
participating in a public health program or a population by controlling
a health problem in the population from which the information is
gathered.

Classifying an activity as research does not automatically lead to
review by an institutional review board (IRB) for the protection of
human subjects. Once an activity is classified as research, two
additional determinations must be made: (1) does the research involve
human subjects and, if so, (2) does the research meet the criteria for
exemption from IRB review. This policy deals only with the first
determination of whether a public health activity is research or
non-research.

**Definitions**

Research - As defined in 45 CFR 46, research means \"a systematic
investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.\"

Human Subjects - As defined in 45 CFR 46, a human subject means \"a
living individual about whom an investigator conducting research obtains
(1) data through intervention or interaction with the individual or (2)
identifiable private information. Intervention includes both physical
procedures by which data are gathered and manipulations of the subject
or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between
investigator and subject. Private information includes information about
behavior that occurs in a context in which an individual can reasonably
expect that no observation or recording is taking place, and information
which has been provided for specific purposes by an individual and which
the individual can reasonably expect will not be made public (for
example, a medical record). Private information must be individually
identifiable (i.e., the identity of the subject is or may readily be
ascertained by the investigator or associated with the information) in
order for obtaining the information to constitute research involving
human subjects.\"

Surveillance - The ongoing, systematic collection, analysis, and
interpretation of outcome-specific data, closely integrated with the
timely dissemination of these data to those responsible for preventing
and controlling disease or injury (Thacker and Berkelman, 1988).

Emergency Response - A public health activity undertaken in an urgent or
emergency situation, usually because of an identified or suspected
imminent health threat to the population, but sometimes because the
public and/or government authorities perceive an imminent threat that
demands immediate action. The primary purpose of the activity is to
document the existence and magnitude of a public health problem in the
community and to implement appropriate measures to address the problem
(Langmuir, 1980).

Program Evaluation -- An essential organizational practice in public
health using a systematic approach to improve and account for public
health actions (Centers for Disease Control and Prevention, 1999)

Evaluation - The systematic application of scientific and statistical
procedures for measuring program conceptualization, design,
implementation, and utility; making comparisons based on these
measurements; and the use of the resulting information to optimize
program outcomes (Rossi and Freeman, 1993; Fink, 1993).

**Policy**

CDC is required to and has an ethical obligation to ensure that
individuals are protected in all public health research activities it
conducts. All CDC activities must be reviewed to determine whether they
are research involving human subjects. When an activity is classified as
research involving human subjects, CDC and its collaborators will comply
with 45 CFR 46 in protecting human research subjects.

Some surveillance projects, emergency responses, and evaluations are
research involving human subjects; others are not. Each project must be
reviewed on a case-by-case basis. Although general guidance can be given
to assist in classifying these activities as either research or
non-research, no one criterion can be applied universally. The ultimate
decision regarding classification lies in the intent of the project. If
the primary intent is to generate generalizable knowledge, the project
is research. If the primary intent is to prevent or control disease or
injury or to improve a public health program, and no research is
intended at the present time, the project is non-research. If the
primary intent changes to generating generalizable knowledge, then the
project becomes research.

**Guidance for Compliance**

**I. General**

The Human Subjects Contact (HSC) in each Center, Institute, or Office
(CIO) determines whether the project constitutes research. If the HSC is
unclear about classifying a project, the HSC should consult with the
CDC's Deputy Associate Director for Science. This determination is made
by examining the intent of the project. What is the primary purpose for
which the project was designed?

General Attributes of Public Health Research - Intent of the project is
to generate generalizable knowledge to improve public health practice;
intended benefits of the project may or may not include study
participants, but always extend beyond the study participants, usually
to society; and data collected exceed requirements for care of the study
participants or extend beyond the scope of the activity. Generalizable
knowledge means new information that has relevance beyond the population
or program from which it was collected, or information that is added to
the scientific literature. Knowledge that can be generalized is
collected under systematic procedures that reduce bias, allowing the
knowledge to be applied to populations and settings different from the
ones from which it was collected. Generalizable, for purposes of
defining research, does not refer to the statistical concept of
population estimation or to the traditional public health method of
collecting information from a sample to understand health in the
population from which the sample came. Holding public health activities
to a standard of studying every case in order to classify an activity as
non-research is not practical or reasonable.

General Attributes of Non-Research - Intent of the project is to
identify and control a health problem or improve a public health program
or service; intended benefits of the project are primarily or
exclusively for the participants (or clients) or the participants'
community; data collected are needed to assess and/or improve the
program or service, the health of the participants or the participants'
community; knowledge that is generated does not extend beyond the scope
of the activity; and project activities are not experimental.

Other attributes, such as publication of findings, statutory authority
(see discussion in next section), methodological design, selection of
subjects, and hypothesis testing/generating, do not necessarily
differentiate research from non-research because these types of
attributes can be shared by both research and non-research projects.

A non-research project may generate generalizable knowledge after the
project is undertaken even though generating this knowledge was not part
of the original, primary intent. In this case, since the primary intent
was not to generate or contribute to generalizable knowledge, the
project is not classified as research at the outset. However, if
subsequent analysis of identifiable private information is undertaken to
generate or contribute to generalizable knowledge, the analysis
constitutes human subjects research that requires IRB review.

If a project includes multiple components and at least one of those
components is designed to generate generalizable knowledge, then the
entire project is classified as research unless the components are
separable.

**II. Specific**

A.  Surveillance - Surveillance is a term describing a method for public
    health data collection. Surveillance systems may be either research
    or non-research. Surveillance systems are likely to be non-research
    when they involve the regular, ongoing collection and analysis of
    health-related data conducted to monitor the frequency of occurrence
    and distribution of disease or a health condition in the population.
    Data generated by these systems are used to manage public health
    programs. They have in place the ability to invoke public health
    mechanisms to prevent or control disease or injury in response to an
    event. Thus, the primary intent of these surveillance systems is to
    prevent or control disease or injury in a defined population by
    producing information about the population from whom the data were
    collected. These attributes of surveillance that is non-research are
    generally found in state statute or regulation where the intent of
    the activity, its purposes, and uses of the data are specified.
    Surveillance systems that most easily fit into this category are
    ones in which the data are limited to describing the occurrence of a
    health-related problem (disease reporting) and systems in which no
    analytic (etiologic) analyses can be conducted. Subjects are rarely
    selected according to a design; rather, all cases are entered into
    the surveillance system because they are passive reporting systems.
    Hypothesis testing is not part of the system.

Surveillance systems are likely to be research when they involve the
collection and analysis of health-related data conducted either to
generate knowledge that is applicable to [other]{.underline} populations
and settings than the ones from which the data were collected or to
contribute to new knowledge about the health condition. The information
gained from the data collection system may or may not be used to invoke
public health mechanisms to prevent or control disease or injury, but
this is not a primary intent of the project. Thus, the primary intent of
these surveillance systems is to generate generalizable knowledge.
Characteristics of surveillance systems that most easily fit into this
category are: longitudinal data collection systems (e.g., follow-up
surveys and registries) that allow for hypothesis testing; the scope of
the data is broad and includes more information than occurrence of a
health-related problem; analytic analyses can be conducted; and cases
may be identified to be included in subsequent studies.

In general, lawful state disease reporting, monitoring requirements and
other data collection activities conducted under state statute or under
recognized public health authority are non-research. Disease reporting
activities are not research. Disease reporting, for these purposes, is
defined narrowly to include the reporting of the specific health
condition or disease, demographic information; and accepted, known risk
factors as specified in state statutes or regulations. When reporting
systems collect data beyond standard reporting information, the
reporting activity is not automatically considered to be non-research.
Collection of data that would allow etiologic analysis is likely to be
research.

If other activities are added to a surveillance project with the
specific intent of generating new or generalizable knowledge, these
additional activities are considered to be research. It becomes
important to distinguish between disease reporting activities that are
non-research and uses of the reported data that may be either
non-research or research.

Sometimes, CDC funds state and local health departments to establish
surveillance systems with dual intentions on the part of CDC: to build
state capacity in disease reporting and for CDC to generate new
knowledge. Disease reporting activities conducted at the state level are
generally non-research. However, if CDC uses the data collected through
such reporting to generate new knowledge, CDC would be engaged in
research. CDC may consider state health departments to be engaged in the
research depending upon their role. If state health departments are
participating beyond merely providing the data, they may be considered
as engaged in the research. Institutions providing information to state
health departments would not be considered engaged in the research (see
OPRR memorandum dated 1/26/99).

Some surveillance projects do not fit easily into the categories
described above. For these projects, the primary intent and elements of
the project must be examined carefully.

B.  Emergency Responses - Most emergency responses tend to be
    non-research because these projects are undertaken to identify,
    characterize, and solve an immediate health problem and the
    knowledge gained will directly benefit those participants involved
    in the investigation or their communities. However, an emergency
    response may have a research component if: 1) samples are stored for
    future use intended to generate generalizable knowledge or 2)
    additional analyses are conducted beyond those needed to solve the
    immediate health problem. When investigational new drugs are used or
    drugs are used off-label, the emergency response is almost always
    research. The same applies to medical devices. For emergency
    responses, whenever a systematic investigation of a non-standard
    intervention or a systematic comparison of standard interventions
    occurs, the activity is research.

C.  Evaluation -- The terms \"evaluation\" and \"program evaluation\"
    are used interchangeably. Yet, there are subtle differences between
    the two terms (see definitions and reference provided above).
    Evaluation is a term, broad in meaning, that refers to the
    systematic use of scientific methods to measure efficacy,
    implementation, utility, and so on of a program in its entirety or
    its components. Evaluations may or may not be research. Program
    evaluations are a subset of evaluations. As defined here program
    evaluations are almost never research.

When the purpose of an evaluation is to test a new, modified, or
previously untested intervention, service, or program to determine
whether it is effective, the evaluation is research. The systematic
comparison of standard or non-standard interventions in an
experimental-type design is research. In these cases, the knowledge
gained is applicable beyond the individual, specific program. Thus, the
primary intent is to generate new knowledge or contribute to the
knowledge in the scientific literature. Further, it is intended to apply
the knowledge to other sites or populations.

When the purpose is to assess the success of an established program in
achieving its objectives in a specific population and the information
gained from the evaluation will be used to provide feedback to that
program, the evaluation, referred to as program evaluation, is
non-research. In the non-research scenario, the evaluation is used as a
management tool to monitor and improve the program. The evaluation
activity is often a component of the regular, ongoing program.
Information learned from the evaluation has immediate benefit for the
program and/or the clients receiving the services or interventions. The
information is often not generalizable beyond the individual program.
Interventions and services that are evaluated are never experimental or
new; they are known (either from empirical data or through consensus) to
be effective.

Sometimes, the term \"formative evaluation\" is used to describe data
collection activities that occur prior to the implementation of an
intervention, service, or program. Whether the \"formative evaluation\"
is research or non-research depends upon its intent. If the evaluation
is conducted prior to implementing a new, modified, or previously
untested intervention, the evaluation is part of the overall research
project. If the evaluation is conducted to provide information on how to
tailor a proven-effective intervention, service, or program in a
specific setting or context, the evaluation is not research.

Evaluations of CDC's national programs, i.e., programs that CDC funds to
all state health departments and in which evaluation is one component,
are not research. These evaluation activities are on-going and involve
generally the collection of minimal, standard data elements across all
sites. The data are generally used at the local level as a management
tool as well as at the national level for the same purpose. Sometimes,
data from these evaluation activities will be aggregated at CDC and used
for other purposes. When this occurs, subsequent use of the data may be
research.

In some cases, program activities and evaluation activities are
separable. For example, interventions or services are being provided;
they have a history of being provided and there is an intention to
continue to provide them. An evaluation is conducted to determine the
efficacy of these program activities. In another example, a public
health department, under its public health authority, may provide an
untested intervention in an outbreak situation. An evaluation component
is added. In both of these examples, because the intervention and
evaluation activities are undertaken with different intentions and are
separable, the intervention activities are not research but the
evaluation activities are research.

**Appendix**

Examples of CDC surveillance, emergency responses, and evaluation
activities that are non-research and research.

**Surveillance:**

**Non-research** -

**National Notifiable Diseases Surveillance System (NNDSS)** - States
and territories have asked CDC to act as a common data collection point
for data on nationally notifiable diseases. A notifiable disease is
considered by the Council of State and Territorial Epidemiologists to be
a condition for which regular, frequent, and timely information about
individual cases is necessary at the national level for the prevention
and control of disease. NNDSS data are collected and published weekly in
the Morbidity and Mortality Weekly Report and annually in the Summary of
Notifiable Diseases, United States. The NNDSS is essential to the day to
day practice of public health. The primary intent of the surveillance
system is to provide CDC and state and local health officials with
information to detect and control outbreaks of disease. The NNDSS is
also used to measure the impact of programs such as immunization. The
intended benefits resulting from the NNDSS are for the residents of the
states and local areas who contribute data to the system.

**Diabetes Surveillance Report** - Using public use data from several
national surveys, a national diabetes surveillance system is produced.
Data from the surveillance system are used to describe the burden of
diabetes and its complications on a national and state level. The
primary intent of the surveillance system is to provide information for
the development of national and state public health priorities and
policies regarding the prevention and control of diabetes. The intended
benefits are for those who have diabetes or those who are at risk of
developing diabetes.

**Research** -

**A Sentinel Surveillance System for Lassa Fever in the Republic of
Guinea** - Four study sites were selected to identify and describe cases
of Lassa fever. Cases were identified from hospital and outpatient
admissions. The purpose of the project was to generate baseline
information on the Lassa virus and human clinical Lassa fever in the
Republic of Guinea. No public health interventions were planned as part
of this project; there was no direct benefit for study participants.
Thus, the primary intent was to contribute to the knowledge of Lassa
fever.

**Developmental Disabilities in Very Low Birthweight Children: Linkage
of the Georgia Very Low Birthweight Study and the Metropolitan Atlanta
Developmental Disabilities Surveillance Program** - The Metropolitan
Atlanta Developmental Disabilities Surveillance Program, an ongoing CDC
surveillance program to monitor trends in the occurrence of selected
developmental disabilities in children living in the metropolitan
Atlanta area, and the Georgia Very Low Birthweight Study, conducted in
the 1980s to investigate the environmental and other risk factors for
very low birthweight were linked for specific investigations of adverse
developmental outcomes. Linkage of these primary files provides a unique
opportunity to assist efforts to assess the occurrence of selected
developmental disabilities in metropolitan Atlanta children and to
identify causes of these conditions without the additional time and
resource expenditure of additional field data collection. For these
investigations involving secondary analyses of the linked primary data
sets, no individuals were contacted; only information available from the
linkage were used. The purpose of the project was to estimate the
prevalence of cerebral palsy, mental retardation, and hearing and visual
impairments and to identify pre- and perinatal medical and
sociodemographic risk factors for these disabilities in a
population-based cohort of very low birthweight children in Atlanta. The
primary intent was to generate generalizable knowledge about
developmental disabilities.

**Emergency Responses:**

**Non-research** -

**Outbreak of Gastroenteritis** - Three days after a cruise ship left
Los Angeles, California for several ports in Mexico, CDC was notified
that 24 of 1,899 passengers and 6 of 670 crew had presented to the
ship=s infirmary with gastrointestinal illness. The purpose of the
investigation was to determine the cause and extent of the outbreak and
to prevent and control gastrointestinal illness among the ships
passengers and crew. Although this type of investigation is often
undertaken after the outbreak has occurred and therefore information
gained is likely to benefit the ship=s next set of cruise passengers and
crew, the primary intent of the investigation is to assist in
controlling the current disease outbreak.

**Recall of Six Lots of Influenza Vaccine** - One of the pharmaceutical
companies who manufactures influenza vaccine instituted a voluntary
recall of six lots of influenza vaccine. The lots were recalled due to
decreased potency of the A/Nanchang/933/95 (H3N2) component of the
vaccine. CDC was notified by a state health department that a nursing
home had vaccinated its residents with the recalled vaccine. The purpose
of the investigation was to determine whether residents of this nursing
home who received the vaccine had a suboptimal immune response and
required revaccination. The primary intent of this investigation was to
prevent the occurrence of influenza among the participants if they
demonstrated a suboptimal immune response; there was a potential for
participants to receive a direct benefit in the form of revaccination if
they participated.

**Research** -

**Childhood Exposure to Nicotine-Containing Products in Rhode Island** -
Between January 1, 1995 and June 30, 1996, 90 cases of
nicotine-containing products were reported to the Rhode Island Poison
Control Center. No known population-based investigation has been
conducted to determine risk factors associated with nicotine-containing
products poisoning. The purpose of the Epi-Aid was to determine risk
factors associated with childhood exposure to nicotine-containing
products, and to develop appropriate control measures. Although there
may be some benefit to the 90 children exposed in Rhode Island, the
benefits from this study extend beyond the study participants to the
population of children who are at risk of exposure to
nicotine-containing products. In addition, there was no immediate health
problem to be controlled. Thus, the primary intent of the investigation
was to generate generalizable knowledge about the risk factors
associated with childhood exposure to nicotine-containing products.

**Azithromycin Used as Prophylaxis Against the Spread of Illness Due to
Mycoplasma Pneumoniae in the Setting of an Outbreak** - During the first
week of freshman entering a post high school academic institution, a
cluster of respiratory illness was recognized by the infirmary staff.
Early serologic testing suggest Mycoplasma pneumoniae as the etiologic
agent. About four weeks later 42% of the freshman and 17% of the
upperclassmen reported a respiratory illness; 50% of those tested had
serologic evidence of Mycoplasma pneumoniae infection. The lower attack
rate among upperclassmen was likely a consequence of them returning to
campus 15 days after the freshmen arrived. A trial of chemoprophylaxis
with azithromycin was proposed. Highly effective control measures in the
setting of an outbreak have not been described. There is limited
information about the role of antimicrobials in controlling an epidemic
of Mycoplasma pneumoniae. Thus, the primary intent of the investigation
was to generate generalizable knowledge about the efficacy of
azithromycin to prevent the spread of Mycoplasma pneumoniae in an
outbreak situation.

**Program Evaluation:**

**Non-research** -

**Evaluation of School-based HIV Prevention Program** - As part of the
evaluation of the school-based HIV prevention program in Denver public
schools, principals, teachers, student contact staff, students, and
parents were interviewed. HIV program efforts in policy awareness, staff
development, curriculum implementation, and status of students receiving
HIV prevention education were assessed.

The purpose (primary intent) of the program evaluation was to provide
information to Denver public schools that will be used to improve their
school-based HIV prevention programs. The results from the evaluation
were used to assess the success of the interventions in a specific
population (Denver public school children) and to refine the
interventions in that population.

**IMPACT Progress Reports** - The Office on Smoking and Health awarded
32 states and the District of Columbia health departments cooperative
agreements to build capacity to conduct tobacco use prevention and
control programs. These cooperative agreements are part of CDC=s
Initiatives to Mobilize for the Prevention and Control of Tobacco Use
(IMPACT), which is a nationwide effort to establish comprehensive,
coordinated tobacco use prevention programs. Evaluation of IMPACT is
comprised of awardees submitting semi-annual progress reports.
Information in the evaluation includes staffing, coalition composition
and efforts, status of a state tobacco control plan, development of a
resource center, training efforts, community outreach and mobilization,
and participation in CDC national campaigns.

The primary intent of these state tobacco control program evaluations is
to assess the success of the intervention activities within each state.
The information gained from the evaluation is used to refine the
interventions in that state. In addition, the information is used
nationally to evaluate the success of the IMPACT program.

**Research** -

**Evaluation of Community Based Organization Intervention to Reduce
Sexually Transmitted Disease (STD) Rates Among STD Patients in Miami -**
Male STD Patients were randomized to either the standard HIV prevention
counseling or intensive counseling comprised of four sessions of HIV
counseling from a community based organization. STD clinic records were
reviewed to determine whether there was a difference in return rates
with new STDs between the groups. The objective of intervention and
evaluation is to determine whether intensive counseling reduces the
acquisition of new STDs among high risk people attending a STD clinic.
The purpose of the project was to evaluate a new intervention for
reducing the transmission of STDs. Knowledge gained from this evaluation
would be used to generalize to other sites.

**A Comprehensive Evaluation for Project DIRECT (Diabetes Intervention:
Reaching and Educating Communities Together)** - Project DIRECT is a
community diabetes demonstration project targeting African American
adults residing in Raleigh, North Carolina. The project is three-tiered
and addresses diabetes care, community screening for persons at high
risk for developing diabetes, and population based approaches to
increase physical activity and reduce dietary fat intake (two risk
factors for diabetes). The goals of the community project are to reduce
preventable complications of diabetes via a health systems approach,
increase the proportion of persons at risk for diabetes who are
screened, and increase the proportion who participate in regular
vigorous physical activity and eat a reduced fat diet. Baseline and
follow-up population-based surveys are planned to evaluate the community
intervention. The purpose of this project is to evaluate new and
innovative interventions to prevent diabetes and its complications.
Knowledge gained from this project will be used to develop similar
intervention projects in other communities.

### References 

Fink, A. Evaluation fundamentals. Newberg Park: California: Sage
Publication, Inc., 1993

Centers for Disease Control and Prevention. Framework for program
evaluation in public health. MMWR 1999;48(No. RR-11):1-40.

Langmuir, AD. The Epidemic Intelligence Service of the Center for
Disease Control. Public Health Reports 1980;95:470-7.

[OPRR Memorandum. Engagement of Institutions in Research, January 26,
1999](http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm)

Rossi, PH and Freeman, HE. Evaluation: A systematic approach. Newberg
Park, California: Sage Publications, Inc., 1993.

Thacker, SB and Berkelman, RL. Public health surveillance in the United
States. Epidemiologic Review, 1988;10:164-190.

 

Page last reviewed: March 31, 2008\
Page last modified: September 21, 2006\
Content source: Office of the Chief Science Officer (OCSO)

# Appendix E: Reportable Conditions List 1992 -- 2007 

+-------------------------+--------------------------------------------+
| **DIAGNOSIS YEARS**     | **REPORTABLE CONDITIONS**                  |
+-------------------------+--------------------------------------------+
| For cases diagnosed     | **all diseases** listed in ICD-O-2 with a  |
| between January 1, 1992 | behavior code of:                          |
| through December 31,    |                                            |
| 1993                    | -   "/2", in situ disease, or              |
|                         |                                            |
|                         | -   "/3", malignant disease                |
|                         |                                            |
|                         | -   **Except for:**                        |
|                         |                                            |
|                         |     -   basal and squamous cell carcinomas |
|                         |         of the skin                        |
+-------------------------+--------------------------------------------+

**Program Announcement 426 in 1994** excluded "carcinoma in situ of the
cervix uteri" from the reportable list "because it has been well
documented that routine collection of such data is incomplete due to
inconsistent collection of other High Grade Neoplasia. In addition,
these data are not comparable over time because of changing terminology
and diagnostic criteria."

+-------------------------+--------------------------------------------+
| **DIAGNOSIS YEARS**     | **REPORTABLE CONDITIONS**                  |
+-------------------------+--------------------------------------------+
| For cases diagnosed     | **all diseases** listed in ICD-O-2 with a  |
| between January 1, 1994 | behavior code of:                          |
| through December 31,    |                                            |
| 2000                    | -   "/2", in situ disease, or              |
|                         |                                            |
|                         | -   "/3", malignant disease                |
|                         |                                            |
|                         | -   **Except for:**                        |
|                         |                                            |
|                         |     -   basal and squamous cell carcinomas |
|                         |         of the skin                        |
|                         |                                            |
|                         |     -   carcinoma in situ of the cervix    |
|                         |         uteri                              |
+-------------------------+--------------------------------------------+

**NAACCR 2001 Implementation Guide** introduced ICD-O-3 as the standard
for coding primary site and morphology.

+-------------------------+--------------------------------------------+
| **DIAGNOSIS YEARS**     | **REPORTABLE CONDITIONS**                  |
+-------------------------+--------------------------------------------+
| For cases diagnosed     | **all diseases** listed in the ICD-O-3     |
| January 1, 2001 and     | with a behavior code of                    |
| later                   |                                            |
|                         | -   "/2", in situ disease, or              |
|                         |                                            |
|                         | -   "/3", malignant disease                |
|                         |                                            |
|                         | -   **Except for:**                        |
|                         |                                            |
|                         |     -   basal and squamous cell carcinomas |
|                         |         of the skin                        |
|                         |                                            |
|                         |     -   carcinoma in situ of the cervix    |
|                         |         uteri and cervical intraepithelial |
|                         |         neoplasia                          |
|                         |                                            |
|                         |     -   prostatic intraepithelial          |
|                         |         neoplasia                          |
+-------------------------+--------------------------------------------+

**Public Law 107-260 in 2002** expanded the reportable definition to
include "malignant brain-related tumors" and "benign brain-related
tumors", \[brain, meninges, spinal cord, cauda equina, a cranial nerve
or nerves, or any other part of the central nervous system", "pituitary
gland, pineal gland, or craniopharyngeal duct\]."

+-------------------------+--------------------------------------------+
| **DIAGNOSIS YEARS**     | **REPORTABLE CONDITIONS**                  |
+-------------------------+--------------------------------------------+
| For cases diagnosed     | **all diseases** listed in the ICD-O-3     |
| January 1, 2004 -       | with a behavior code of                    |
| present                 |                                            |
|                         | -   "/2", in situ disease, or              |
|                         |                                            |
|                         | -   "/3", malignant disease                |
|                         |                                            |
|                         | -   **Except for:**                        |
|                         |                                            |
|                         |     -   basal and squamous cell carcinomas |
|                         |         of the skin                        |
|                         |                                            |
|                         |     -   carcinoma in situ of the cervix    |
|                         |         uteri and cervical intraepithelial |
|                         |         neoplasia                          |
|                         |                                            |
|                         |     -   prostatic intraepithelial          |
|                         |         neoplasia                          |
|                         |                                            |
|                         | **all solid tumors of the brain and        |
|                         | central nervous system**, including the    |
|                         | meninges and intracranial endocrine        |
|                         | structures, listed in the ICD-O-3 with     |
|                         | behavior codes of                          |
|                         |                                            |
|                         | -   "/0" benign disease,                   |
|                         |                                            |
|                         | -   "/1" uncertain malignant potential of  |
|                         |     the disease                            |
|                         |                                            |
|                         | -   "/2", in situ disease, or              |
|                         |                                            |
|                         |     -   "/3", malignant disease            |
+-------------------------+--------------------------------------------+
|                         | **Note:** \[U.S. standard setters have     |
|                         | agreed that Juvenile astrocytoma, listed   |
|                         | in the ICD-O-3 with a behavior code of     |
|                         | "/1", will be reportable with behavior     |
|                         | code of "/3".\]                            |
+-------------------------+--------------------------------------------+

# Appendix F: Full Citation for Reference Manuals

+------------------------------------------------------+---------------+
| **DISEASE CLASSIFICATIONS**                          | **DATE RANGE  |
|                                                      | FOR USE**     |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2007-current  |
| *Multiple Primary and Histology Coding Rules.*       |               |
| Bethesda, MD: National Cancer Institute, January     |               |
| 2007.                                                |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2001-2006     |
| "Coding Complex Morphologies", 2001.                 |               |
+------------------------------------------------------+---------------+
| Fritz A, Percy C, Jack A, Shanmugaratnam K, Sobin L, | 2001-current  |
| Parkin D, Whelan S, eds. *International              |               |
| Classification of Diseases for Oncology*. Third      |               |
| Edition. Geneva: World Health Organization, 2000.    |               |
+------------------------------------------------------+---------------+
| Percy C, VanHolten V, Muir C, eds. *International    | 1992-2000     |
| Classification of Diseases for Oncology*. Second     |               |
| Edition.                                             |               |
|                                                      |               |
| Geneva: World Health Organization, 1990.             |               |
+------------------------------------------------------+---------------+
| **STAGE AND EXTENT OF DISEASE MANUALS**              |               |
+------------------------------------------------------+---------------+
| Collaborative Staging Task Force of the American     | 2004-current  |
| Joint Committee on Cancer. *Collaborative Staging    |               |
| Manual and Coding Instructions*. NIH Pub. No.        |               |
| 04-5496, 2006.                                       |               |
|                                                      |               |
| <http://www.cancerstaging.org/cstage/manuals.html>   |               |
+------------------------------------------------------+---------------+
| Collaborative Stage Task Force of the American Joint | 2004-2006     |
| Committee on Cancer. *Collaborative Staging Manual   |               |
| and Coding Instructions*. NIH Pub. No. 04-5496,      |               |
| 2004.                                                |               |
|                                                      |               |
| <http://www.cancerstaging.org/cstage/manuals.html>   |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2001-2003     |
| Young J Jr, Roffers S, Ries L, Fritz A, Hurlbut A,   |               |
| eds. *SEER Summary Staging Manual - 2000: Codes and  |               |
| Coding Instructions*. Bethesda, MD: National         |               |
| Institutes of Health, National Cancer Institute, NIH |               |
| Pub. No. 01-4969, 2001.                              |               |
|                                                      |               |
| <http://www.                                         |               |
| seer.cancer.gov/tools/codingmanuals/historical.html> |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 1977-2000     |
| Shambaugh E, Weiss M, Axtell L, eds. *Summary        |               |
| Staging Guide.* Bethesda, MD: National Institutes of |               |
| Health, National Cancer Institute, April 1977. NIH   |               |
| Pub. No. 86-2313. (Reprinted July 1986.). SEER       |               |
| Program, National Institutes of Health, April 1977.  |               |
|                                                      |               |
| <http://www.                                         |               |
| seer.cancer.gov/tools/codingmanuals/historical.html> |               |
+------------------------------------------------------+---------------+
| **CANCER TREATMENT -- SEER MANUALS**                 |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2005-current  |
| SEER\*Rx - Interactive Antineoplastic Drugs          |               |
| Database.                                            |               |
|                                                      |               |
| <http://seer.cancer.gov/tools/seerrx/>               |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results          | 1994-2005.    |
| Program*. SEER Program Self Instructional Manual for |               |
| Tumor Registrars, Book Eight: Antineoplastic Drugs*, |               |
| Third Edition. Bethesda, MD: National Institutes of  |               |
| Health, National Cancer Institute, NIH Pub. No       |               |
| 94-2441, 1994.                                       |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2004-current  |
| Johnson C, ed. *The SEER Program Coding and Staging  |               |
| Manual 2004*, Revision 1. Bethesda, MD: National     |               |
| Institutes of Health, National Cancer Institute, NIH |               |
| Pub. No. 04-5581.                                    |               |
|                                                      |               |
| <http://www.seer.cancer.gov/tools/codingmanuals/>    |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 2003          |
| *SEER Program Code Manual*. Third Edition, Revision  |               |
| 1, [SEER Field and Code Changes for                  |               |
| 2003](http://www.seer                                |               |
| .cancer.gov/tools/SEER2003.code.changes.122302.pdf). |               |
|                                                      |               |
| <http://www.                                         |               |
| seer.cancer.gov/tools/codingmanuals/historical.html> |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 1998-2003     |
| Fritz A, Ries L, eds*. The [SEER Program Code        |               |
| Manua                                                | 1998-2002     |
| l](http://www.seer.cancer.gov/manuals/codeman.pdf)*. |               |
| Third Edition. Bethesda, MD: National Institutes of  | 2003          |
| Health, National Cancer Institute, January 1998.     |               |
|                                                      |               |
| Site-Specific Surgery Codes (Appendix D)             |               |
|                                                      |               |
| SEER Site-Specific Surgery of Primary Site Codes     |               |
| (Appendix F)                                         |               |
|                                                      |               |
| <http://www.                                         |               |
| seer.cancer.gov/tools/codingmanuals/historical.html> |               |
+------------------------------------------------------+---------------+
| Surveillance, Epidemiology, and End Results Program. | 1992-1997     |
| Cunningham J, Hankey B, Lyles B, Percy C, Ries L,    |               |
| Seiffert J, Shambaugh E, Van Holten V, eds. *The     |               |
| SEER Program Code Manual*, Revised Edition.          |               |
| Bethesda, MD: National Institutes of Health,         |               |
| National Cancer Institute, June 1992.                |               |
|                                                      |               |
| <http://www.                                         |               |
| seer.cancer.gov/tools/codingmanuals/historical.html> |               |
+------------------------------------------------------+---------------+
| **CANCER TREATMENT -- COMMISSION ON CANCER MANUALS** |               |
+------------------------------------------------------+---------------+
| Commission on Cancer. *FORDS Facility Oncology       | 2004-current  |
| Registry Data Standards*. Revised for 2004. Chicago: |               |
| American College of Surgeons, 2002.                  |               |
|                                                      |               |
| <http://www.facs.org/cancer/coc/fordsmanual.html>    |               |
+------------------------------------------------------+---------------+
| Commission on Cancer. *FORDS Facility Oncology       | 2003          |
| Registry Data Standards*. Chicago: American College  |               |
| of Surgeons, 2002.                                   |               |
|                                                      |               |
| <http://www.facs.org/cancer/coc/fordsmanual.html>    |               |
+------------------------------------------------------+---------------+
| Commission on Cancer*. Standards of the Commission   | 1998-2002     |
| on Cancer Volume II: Registry Operations and Data    |               |
| Standards (ROADS), Revised 1/1/98.* Chicago:         | 2000-2002     |
| American College of Surgeons, 1998.                  |               |
|                                                      | 2000-2002     |
| -   [Update Pages (dated August                      |               |
|     2000)](http://www.                               | 2000-2002     |
| facs.org/cancer/coc/roads/roadsreplacementpages.pdf) |               |
|                                                      |               |
| -   [Update Pages for Appendix D, Site-specific      |               |
|     Surgery Codes (dated August                      |               |
|     2000)]                                           |               |
| (http://www.facs.org/cancer/coc/roads/appendixd.pdf) |               |
|                                                      |               |
| -   [Race 1-5 (dated January 2001, for               |               |
|     implementation with 2000                         |               |
|     diagno                                           |               |
| ses)](http://www.facs.org/cancer/coc/roads/race.pdf) |               |
|                                                      |               |
| <http://www.facs.org/cancer/coc/roads.html>          |               |
+------------------------------------------------------+---------------+
| Commission on Cancer. *Data Acquisition Manual.*     | 1994-1995     |
| Revised Edition. American College of Surgeons,       |               |
| September 1994.                                      |               |
+------------------------------------------------------+---------------+
| Commission on Cancer. *Standards of the Commission   | 1996-1997     |
| on Cancer Volume II: Registry Operations and Data    |               |
| Standards (ROADS).* Chicago: American College of     |               |
| Surgeons, 1996*.*                                    |               |
|                                                      |               |
| <http://www.facs.org/cancer/coc/roads.html>          |               |
+------------------------------------------------------+---------------+
| **OCCUPATION AND INDUSTRY CLASSIFICATION AND         |               |
| CODING**                                             |               |
+------------------------------------------------------+---------------+
| U.S. Census Bureau, Housing and Household Economic   |               |
| Statistics Division. Census 2000 "Alphabetical       |               |
| Indexes of Industries and Occupations."              |               |
| <http://www.census.gov/hhes/www/ioindex/view.html>.  |               |
+------------------------------------------------------+---------------+
| **ADDRESS CODING**                                   |               |
+------------------------------------------------------+---------------+
| U.S. Postal Service. *Postal Addressing Standards.*  |               |
| U.S.P.S. Pub 28, November 2000.                      |               |
| <http://pe.usps.gov/cpim/ftp/pubs/Pub28/pub28.pdf>.  |               |
+------------------------------------------------------+---------------+
| **NAACCR STANDARDS**                                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2007          |
| Registries. Havener L, Hultstrom D, eds. *Standards  |               |
| for Cancer Registries, Volume I. Data Standards and  |               |
| Data Dictionary*. Eleventh Edition, Version 11.1.    |               |
| Springfield, IL: NAACCR, April 2006.                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2006          |
| Registries. Hultstrom D, Havener L, eds. *Standards  |               |
| for Cancer Registries, Volume I. Data Standards and  |               |
| Data Dictionary*. Tenth Edition, Version 11.         |               |
| Springfield, IL: NAACCR, November 2004.              |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2005          |
| Registries. Hultstrom D, Havener L, eds. *Standards  |               |
| for Cancer Registries, Volume I. Data Standards and  |               |
| Data Dictionary*. Ninth Edition, Version 10.2.       |               |
| Springfield, IL: NAACCR, March 2004.                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2004          |
| Registries. Hultstrom D, Havener L, eds. *Standards  |               |
| for Cancer Registries, Volume I. Data Standards and  |               |
| Data Dictionary*. Eighth Edition, Version 10.1.      |               |
| Springfield, IL: NAACCR, March 2003.                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2003          |
| Registries. Hultstrom D, ed. *Standards for Cancer   |               |
| Registries, Volume I. Data Standards and Data        |               |
| Dictionary*. Seventh Edition, Version 10.            |               |
| Springfield, IL: NAACCR, March 2002.                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2002          |
| Registries. Hultstrom D, ed. *Standards for Cancer   |               |
| Registries, Volume I. Data Standards and Data        |               |
| Dictionary*. Sixth Edition, Version 9.1.             |               |
| Springfield, IL: NAACCR, March 2001.                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2001          |
| Registries. Johnson CH, ed. *Standards for Cancer    |               |
| Registries, Volume I. Data Standards and Data        |               |
| Dictionary*. Fifth Edition, Version 9. Sacramento,   |               |
| CA: NAACCR, May 2000.                                |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 2000          |
| Registries. Johnson CH, ed. *Standards for Cancer    |               |
| Registries, Volume II. Data Standards and Data       |               |
| Dictionary*. Fourth Edition, Version 8. Sacramento,  |               |
| CA: NAACCR, March 1999.                              |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 1998-1999     |
| Registries. Seiffert J, ed. *Standards for Cancer    |               |
| Registries, Volume II. Data Standards and Data       |               |
| Dictionary*. Third Edition, Version 6. Sacramento,   |               |
| CA: NAACCR, March 1998. Changed Data Dictionary      |               |
| entries, April 1998.                                 |               |
+------------------------------------------------------+---------------+
| North American Association of Central Cancer         | 1997          |
| Registries. Seiffert J, ed. *Standards for Cancer    |               |
| Registries, Volume II. Data Standards and Data       |               |
| Dictionary*. Second Edition, Version 5.1.            |               |
| Sacramento, CA: NAACCR, March 1997.                  |               |
+------------------------------------------------------+---------------+
| American Association of Central Cancer Registries.   | 1994-1996     |
| Menck HR, Seiffert J, eds. *Standards for Cancer     |               |
| Registries, Volume I. Data Standards and Data        |               |
| Dictionary*. Version 3.0. Sacramento, CA: AACCR,     |               |
| February 1994.                                       |               |
+------------------------------------------------------+---------------+

# Appendix G: Timeline of Data Item Requirements: Diagnosis Years 1997-2008

  -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                          **NPCR REQUIRED                                                                                                                                                    
                                          STATUS TABLE -                                                                                                                                                     
                                          NAACCR LAYOUTS 5                                                                                                                                                   
                                          through 11.2**                                                                                                                                                     
  ------------- ------------------------- ------------------- --------------------------- ------------- ---------- ---------- ---------- ---------- ---------- ---------- ------------ ---------- ---------- ------------
                                                                                                                                                                                                             

  **NAACCR                                                                                              **11.2**   **11.1**   **11.0**   **10.2**   **10.1**   **10.0**   **9.0, 9.1** **8.0**    **7.0**    **5.0, 6.0**
  LAYOUT**                                                                                                                                                                                                   

  **DIAGNOSIS                                                                                           **2008**   **2007**   **2006**   **2005**   **2004**   **2003**   **2001-2**   **2000**   **1999**   **1997-8**
  YEAR**                                                                                                                                                                                                     

                                                                                                                                                                                                             

  **Item \#**   **Item Name\***                                                           **Source of                                                                                                        
                                                                                          Standard**                                                                                                         

                                                                                                                                                                                                             

  10            Record Type                                                               NAACCR        R          .          .          .          .          .          .            .          .          .

  20            **Patient ID Number**                                                     Reporting     R          R          R          R          R          R          R            S          S          S
                                                                                          Registry                                                                                                           

  35            *FIN Coding System*                                                       NAACCR        .          .          .          S          S          S          S            S          S          .

  40            **Registry ID**                                                           NAACCR        R          .          .          S          S          S          S            S          S          S

  45            NPI\--Registry ID                                                         NAACCR        .          .          .          .          .          .          .            .          .          .

  50            **NAACCR Record Version**                                                 NAACCR        R          .          .          R          R          R          S            S          S          S

  60            *Tumor Record Number*                                                     NAACCR        .          .          .          S          S          S          S            S          S          S

  70            **Addr at DX\--City**                                                     COC           R          R          R          R          R          R          R            R          R          R

  80            **Addr at DX\--State**                                                    COC           R          R          R          R          R          R          R            R          R          R

  90            **County at DX**                                                          FIPS/SEER     R          R          R          R          R          R          R            R          R          R

  100           **Addr at DX\--Postal                                                     COC           R          R          R          R          R          R          R            R          R          R
                Code**                                                                                                                                                                                       

  110           **Census Tract                                                            SEER          RH\*       RH\*       RH\*       RH         RH         RH         R            R          R          R
                1970/80/90**                                                                                                                                                                                 

  120           **Census Cod Sys                                                          SEER          RH\*       RH\*       RH\*       RH         RH         RH         R            R          R          R
                1970/80/90**                                                                                                                                                                                 

  130           Census Tract 2000                                                         NAACCR        R          R          R          R          R          R          .            .          .          .

  150           *Marital Status at DX*                                                    SEER/COC      .          .          .          S          S          S          S            S          S          S

  160           **Race 1**                                                                SEER/COC      R          R          R          R          R          R          R            R          R          R

  161           Race 2                                                                    SEER/COC      R          R          R          R          R          R          R            S          .          .

  162           Race 3                                                                    SEER/COC      R          R          R          R          R          R          R            S          .          .

  163           Race 4                                                                    SEER/COC      R          R          R          R          R          R          R            S          .          .

  164           Race 5                                                                    SEER/COC      R          R          R          R          R          R          R            S          .          .

  .190          **Spanish/Hispanic                                                        SEER/COC      R          R          R          R          R          R          R            R          R          R
                Origin**                                                                                                                                                                                     

  191           NHIA Derived Hisp Origin                                                  NAACCR        D          D          D          R          .          .          .            .          .          .

  192           IHS Link                                                                  NPCR          R\*        R\*        R\*        .          .          .          .            .          .          .

  200           **Computed Ethnicity**                                                    SEER          R          R          R          S          S          S          S            S          S          S

  210           **Computed Ethnicity                                                      SEER          R          R          R          S          S          S          S            S          S          S
                Source**                                                                                                                                                                                     

  220           **Sex**                                                                   SEER/COC      R          R          R          R          R          R          R            R          R          R

  230           **Age at Diagnosis**                                                      SEER/COC      R          R          R          R          R          R          R            S          S          S

  240           **Birth Date**                                                            SEER/COC      R          R          R          R          R          R          R            R          R          R

  250           **Birthplace**                                                            SEER/COC      R\*        R\*        R\*        R\*        R\*        R\*        R\*          S          S          S

  270           **Occupation                                                              Census/NPCR   R\*        R\*        R\*        S          S          S          S            S          S          S
                Code\--Census**                                                                                                                                                                              

  280           **Industry                                                                Census/NPCR   R\*        R\*        R\*        S          S          S          S            S          S          S
                Code\--Census**                                                                                                                                                                              

  290           **Occupation Source**                                                     NPCR          R\*        R\*        R\*        S          S          S          S            S          S          S

  300           **Industry Source**                                                       NPCR          R\*        R\*        R\*        S          S          S          S            S          S          S

  310           **Text\--Usual                                                            NPCR          R\*        R\*        R\*        R\*        R\*        R\*        R\*          R\*        R\*        R\*
                Occupation**                                                                                                                                                                                 

  320           **Text\--Usual Industry**                                                 NPCR          R\*        R\*        R\*        R\*        R\*        R\*        R\*          R\*        R\*        R\*

  330           **Occup/Ind Coding                                                        NPCR          R\*        R\*        R\*        S          S          S          S            S          S          S
                System**                                                                                                                                                                                     

  364           Census Tr Cert 1970/80/90                                                 SEER          RH\*       RH\*       RH\*       RH         RH         RH         R            .          .          .

  365           Census Tr Certainty 2000                                                  NAACCR        R          R          R          R          R          R          .            .          .          .

  366           GIS Coordinate Quality                                                    NAACCR        R\*        R\*        R\*        .          .          .          .            .          .          .

  380           **Sequence                                                                SEER          R          R          R          R          R          R          R            S          S          S
                Number\--Central**                                                                                                                                                                           

  390           **Date of Diagnosis**                                                     SEER/COC      R          R          R          R          R          R          R            R          R          R

  400           **Primary Site**                                                          SEER/COC      R          R          R          R          R          R          R            R          R          R

  410           **Laterality**                                                            SEER/COC      R          R          R          R          R          R          R            R          R          R

  420           **Histology (92-00)                                                       SEER/COC      RH         RH         RH         RH         RH         RH         R+           R          R          R
                ICD-O-2**                                                                                                                                                                                    

  430           **Behavior (92-00)                                                        SEER/COC      RH         RH         RH         RH         RH         RH         R+           R          R          R
                ICD-O-2**                                                                                                                                                                                    

  440           **Grade**                                                                 SEER/COC      R          R          R          R          R          R          R            R          R          R

  442           Ambiguous Terminology DX                                                  SEER/COC      .          .                                                                                         

  443           Date of Conclusive DX                                                     SEER/COC      .          .                                                                                         

  444           Mult Tum Rpt as One Prim                                                  SEER/COC      .          .                                                                                         

  445           Date of Multiple Tumors                                                   SEER/COC      .          .                                                                                         

  446           Multiplicity Counter                                                      SEER/COC      .          .                                                                                         

  447           Number of Tumors/Hist                                                     SEER/COC      .          .                                                                                         

  450           Site Coding Sys\--Current                                                 NAACCR        R          R          R          S          S          S          S            .          .          .

  470           Morph Coding                                                              NAACCR        R          R          R          S          S          S          S            .          .          .
                Sys\--Current                                                                                                                                                                                

  490           **Diagnostic                                                              SEER/COC      R          R          R          R          R          R          R            R          R          R
                Confirmation**                                                                                                                                                                               

  500           **Type of Reporting                                                       SEER          R          R          R          R          R          R          R            R          R          R
                Source**                                                                                                                                                                                     

  522           Histologic Type ICD-O-3                                                   SEER/COC      R          R          R          R          R          R          R+           .          .          .

  523           Behavior Code ICD-O-3                                                     SEER/COC      R          R          R          R          R          R          R+           .          .          .

  540           **Reporting Facility**                                                    COC           R          R          R          S          S          S          S            S          S          S

  545           NPI\--Reporting Facility                                                  NAACCR        R\*        R\*        .          .          .          .          .            .          .          .

  550           *Accession Number\--Hosp*                                                 COC           .          .          .          S          S          S          S            S          S          S

  560           *Sequence                                                                 COC           .          .          .          S          S          S          S            R          R          R
                Number\--Hospital*                                                                                                                                                                           

  580           **Date of 1st Contact**                                                   COC           R          R          R          R          R          R          R            R          R          R

  600           *Date of Inpatient Disch*                                                 COC           .          .          .          .          .          .                       S          S          S

  610           **Class of Case**                                                         COC           R          R          R          S          S          S          S            S          S          S

  630           *Primary Payer at DX*                                                     COC           R\*        .          R          .          .          .          .            .          .          .

  759           SEER Summary Stage 2000                                                   SEER          RH         RH         RH         RH         RH         R          R+           .          .          .

  760           **SEER Summary Stage                                                      SEER          RH         RH         RH         RH         RH         RH         R+           R          R          R
                1977**                                                                                                                                                                                       

  780           *EOD\--Tumor Size*                                                        SEER/COC      .          .          .          .          .          S          S            S          S          S

  790           *EOD\--Extension*                                                         SEER          .          .          .          .          .          S          S            .          .          .

  800           *EOD\--Extension Prost                                                    SEER          .          .          .          .          .          S          S            .          .          .
                Path*                                                                                                                                                                                        

  810           *EOD\--Lymph Node Involv*                                                 SEER          .          .          .          .          .          S          S            .          .          .

  820           *Regional Nodes Positive*                                                 SEER/COC      .          .          .          S          S          S          S            S          S          S

  830           *Regional Nodes Examined*                                                 SEER/COC      .          .          .          S          S          S          S            S          S          S

  1200          *RX Date\--Surgery*                                                       COC           .          .          .          S          S          S          S            S\*        S\*        S\*

  1210          *RX Date\--Radiation*                                                     COC           .          .          .          S          S          S          S            S\*        S\*        S\*

  1220          *RX Date\--Chemo*                                                         COC           .          .          .          .          .          .          S            S\*        S\*        S\*

  1230          *RX Date\--Hormone*                                                       COC           .          .          .          .          .          .          S            S\*        S\*        S\*

  1240          *RX Date\--BRM*                                                           COC           .          .          .          .          .          .          S            S\*        S\*        S\*

  1250          *RX Date\--Other*                                                         COC           .          .          .          S          S          S          S            S\*        S\*        S\*

  1260          **Date of Initial                                                         SEER          R#         R#         R#         \#         \#         \#         \#           #\*        #\*        #\*
                RX\--SEER**                                                                                                                                                                                  

  1270          **Date of 1st Crs                                                         COC           R#         R#         R#         \#         \#         \#         \#           #\*        #\*        #\*
                RX\--COC**                                                                                                                                                                                   

  1280          *RX Date\--DX/Stg Proc*                                                   COC           .          .          .          .          .          .          .            #\*        #\*        #\*

  1290          **RX Summ\--Surg Prim                                                     SEER/COC      R          R          R          R          R          R          R            #\*        #\*        #\*
                Site**                                                                                                                                                                                       

  1292          **RX Summ\--Scope Reg LN                                                  SEER/COC      R          R          R          R          R          R          R            #\*        #\*        #\*
                Sur**                                                                                                                                                                                        

  1294          **RX Summ\--Surg Oth                                                      SEER/COC      R          R          R          R          R          R          R            #\*        #\*        #\*
                Reg/Dis**                                                                                                                                                                                    

  1296          *RX Summ\--Reg LN                                                         COC           .          .          .          RH         RH         .          R            #\*        #\*        #\*
                Examined*                                                                                                                                                                                    

  1310          *RX Summ\--Surgical                                                       COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Approch*                                                                                                                                                                                     

  1320          *RX Summ\--Surgical                                                       COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Margins*                                                                                                                                                                                     

  1330          *RX Summ\--Reconstruct                                                    COC           .          .          .          .          .          .          S            #\*        #\*        #\*
                1st*                                                                                                                                                                                         

  1340          **Reason for No Surgery**                                                 SEER/COC      R          R          R          S          S          S          S            R\*        R\*        R\*

  1350          *RX Summ\--Dx/Stg Proc*                                                   COC           .          .          .          .          .          .          .            #\*        #\*        #\*

  1360          *RX Summ\--Radiation*                                                     SEER/COC      D          .          .          .          .          .          S            #\*        #\*        #\*

  1370          *RX Summ\--Rad to CNS*                                                    SEER/COC      .          .          .          .          .          .          .            #\*        #\*        #\*

  1380          **RX Summ\--Surg/Rad                                                      SEER/COC      R          R          R          S          S          S          S            R\*        R\*        R\*
                Seq**                                                                                                                                                                                        

  1390          **RX Summ\--Chemo**                                                       SEER/COC      R          R          R          S          S          S          S            #\*        #\*        #\*

  1400          **RX Summ\--Hormone**                                                     SEER/COC      R          R          R          S          S          S          S            #\*        #\*        #\*

  1410          **RX Summ\--BRM**                                                         SEER/COC      R          R          R          S          S          S          S            R\*        R\*        R\*

  1420          **RX Summ\--Other**                                                       SEER/COC      R          R          R          S          S          S          S            R\*        R\*        R\*

  1430          *Reason for No Radiation*                                                 COC           .          .          .          S          S          S          S            #\*        #\*        #\*

  1440          *Reason for No Chemo*                                                     COC           .          .          .          .          .          .          S            #\*        #\*        #\*

  1450          *Reason for No Hormone*                                                   COC           .          .          .          .          .          .          S            #\*        #\*        #\*

  1460          **RX Coding                                                               NAACCR        R          R          R          R          R          R          R            S          S          S
                System\--Current**                                                                                                                                                                           

  1500          *First Course Calc                                                        NAACCR        .          .          .          .          .          .          .            S          S          S
                Method*                                                                                                                                                                                      

  1570          Rad\--Regional RX                                                         COC           R          R          R          S          S          S          .            .          .          .
                Modality                                                                                                                                                                                     

  1639          RX Summ\--Systemic/Sur                                                    COC           R          R          R          .          .          .          .            .          .          .
                Seq                                                                                                                                                                                          

  1640          *RX Summ\--Surgery Type*                                                  SEER          .          .          .          .          .          .          .            #\*        #\*        #\*

  1642          *RX Summ\--Screen/BX                                                      COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Proc1*                                                                                                                                                                                       

  1643          *RX Summ\--Screen/Bx                                                      COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Proc2*                                                                                                                                                                                       

  1644          *RX Summ\--Screen/Bx                                                      COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Proc3*                                                                                                                                                                                       

  1645          *RX Summ\--Screen/Bx                                                      COC           .          .          .          .          .          .          .            #\*        #\*        #\*
                Proc4*                                                                                                                                                                                       

  1646          *RX Summ\--Surg Site                                                      SEER/COC      .          .          .          RH         RH         RH         .            .          .          .
                98-02*                                                                                                                                                                                       

  1647          *RX Summ\--Scope Reg                                                      SEER/COC      .          .          .          RH         RH         RH         .            .          .          .
                98-02*                                                                                                                                                                                       

  1648          *RX Summ\--Surg Oth                                                       SEER/COC      .          .          .          RH         RH         RH         .            .          .          .
                98-02*                                                                                                                                                                                       

  1750          **Date of Last Contact**                                                  SEER/COC      R          R          R          R          R          R          R            R          R          R

  1760          **Vital Status**                                                          SEER/COC      R          R          R          R          R          R          R            R          R          R

  1791          Follow-up Source Central                                                  NAACCR        R\*        R          R          .          .          .          .            .          .          .

  1860          *Recurrence Date\--1st*                                                   COC           .          .          .          S          S          S          .            .          .          .

  1880          *Recurrence Type\--1st*                                                   COC           .          .          .          S          S          S          .            .          .          .

  1910          **Cause of Death**                                                        SEER          R          R          R          R          R          R          R            R          R          R

  1920          **ICD Revision Number**                                                   SEER          R          R          R          R          R          R          R            S          S          S

  1940          **Place of Death**                                                        NPCR          R          R          R          S          S          S          S            S          S          S

  1990          **Over-ride                                                               SEER          R          R          R          R          R          R          R            S          S          S
                Age/Site/Morph**                                                                                                                                                                             

  2000          **Over-ride                                                               SEER          R          R          R          R          R          R          R            S          S          S
                SeqNo/DxConf**                                                                                                                                                                               

  2010          **Over-ride                                                               SEER          R          R          R          S          S          S          S            S          S          S
                Site/Lat/SeqNo**                                                                                                                                                                             

  2020          **Over-ride Surg/DxConf**                                                 SEER          R          R          R          R          R          R          R            S          S          S

  2030          **Over-ride Site/Type**                                                   SEER          R          R          R          R          R          R          R            S          S          S

  2040          **Over-ride Histology**                                                   SEER          R          R          R          R          R          R          R            S          S          S

  2050          **Over-ride Report                                                        SEER          R          R          R          R          R          R          R            S          S          S
                Source**                                                                                                                                                                                     

  2060          **Over-ride Ill-define                                                    SEER          R          R          R          R          R          R          R            S          S          S
                Site**                                                                                                                                                                                       

  2070          **Over-ride Leuk,                                                         SEER          R          R          R          R          R          R          R            S          S          S
                Lymphoma**                                                                                                                                                                                   

  2071          **Over-ride                                                               SEER          R          R          R          R          R          R          R            S          S          S
                Site/Behavior**                                                                                                                                                                              

  2072          *Over-ride Site/EOD/DX                                                    SEER          .          .          .          S          S          S          S            S          S          S
                Date*                                                                                                                                                                                        

  2073          *Over-ride Site/Lat/EOD*                                                  SEER          .          .          .          S          S          S          S            S          S          S

  2074          **Over-ride                                                               SEER          R          R          R          R          R          R          R            S          S          S
                Site/Lat/Morph**                                                                                                                                                                             

  2110          **Date Case Report                                                        NPCR          R          R          R          S          S          S          S            S          S          S
                Exported**                                                                                                                                                                                   

  2111          **Date Case Report                                                        NPCR          R          R          R          R          R          R          R            S          S          S
                Received**                                                                                                                                                                                   

  2112          **Date Case Report                                                        NPCR          R          R          R          S          S          S          S            S          S          S
                Loaded**                                                                                                                                                                                     

  2113          **Date Tumor Record                                                       NPCR          R          R          R          S          S          S          S            S          S          S
                Availbl**                                                                                                                                                                                    

  2116          ICD-O-3 Conversion Flag                                                   SEER/COC      R          R          R          R          R          R          R            .          .          .

  2120          *SEER Coding                                                              NAACCR        .          .          .          S          S          S          S            S          S          S
                Sys\--Current*                                                                                                                                                                               

  2130          *SEER Coding                                                              NAACCR        .          .          .          S          S          S          S            S          S          S
                Sys\--Original*                                                                                                                                                                              

  2140          *COC Coding                                                               COC           .          .          .          S          S          S          S            S          S          S
                Sys\--Current*                                                                                                                                                                               

  2150          *COC Coding                                                               NAACCR        .          .          .          S          S          S          S            S          S          S
                Sys\--Original*                                                                                                                                                                              

  2230          **Name\--Last**                                                           NAACCR        R          R          R          R          R          R          R            R          R          R

  2240          **Name\--First**                                                          NAACCR        R          R          R          R          R          R          R            R          R          R

  2250          **Name\--Middle**                                                         COC           R          R          R          R          R          R          R            R          R          R

  2280          **Name\--Alias**                                                          SEER          R          R          R          S          S          S          S            S          S          S

  2300          **Medical Record Number**                                                 COC           R          R          R          S          S          S          S            S          S          S

  2310          *Military Record No                                                       COC           .          .          .          .          .          .          .            S          S          S
                Suffix*                                                                                                                                                                                      

  2320          **Social Security                                                         COC           R          R          R          R          R          R          R            R          R          R
                Number**                                                                                                                                                                                     

  2330          **Addr at DX\--No &                                                       COC           R          R          R          S          S          S          S            S          S          S
                Street**                                                                                                                                                                                     

  2335          Addr at DX\--Supplemental                                                 COC           R          R          R          S          S          S          .            .          .          .

  2350          *Addr Current\--No &                                                      COC           .          .          .          .          .          S          .            .          .          .
                Street*                                                                                                                                                                                      

  2352          Latitude                                                                  NAACCR        R\*        R\*        R\*        .          .          .          .            .          .          .

  2354          Longitude                                                                 NAACCR        R\*        R\*        R\*        .          .          .          .            .          .          .

  2380          **DC State File Number**                                                  State         R          R          R          S          S          S          S            S          S          S

  2390          **Name\--Maiden**                                                         SEER          R          R          R          S          S          S          S            S          S          S

  2520          **Text\--DX Proc\--PE**                                                   NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S

  2530          **Text\--DX                                                               NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S
                Proc\--X-ray/Scan**                                                                                                                                                                          

  2540          **Text\--DX                                                               NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S
                Proc\--Scopes**                                                                                                                                                                              

  2550          **Text\--DX Proc\--Lab                                                    NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S
                Tests**                                                                                                                                                                                      

  2560          **Text\--DX Proc\--Op**                                                   NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S

  2570          **Text\--DX Proc\--Path**                                                 NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S

  2580          **Text\--Primary Site                                                     NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S
                Title**                                                                                                                                                                                      

  2590          **Text\--Histology                                                        NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S
                Title**                                                                                                                                                                                      

  2600          **Text\--Staging**                                                        NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S

  2610          **RX Text\--Surgery**                                                     NPCR          R\^        R\^        R\^        R\^        R\^        R\^        R\^          S          S          S

  2620          **RX Text\--Radiation                                                     NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S
                (Beam)**                                                                                                                                                                                     

  2630          **RX Text\--Radiation                                                     NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S
                Other**                                                                                                                                                                                      

  2640          **RX Text\--Chemo**                                                       NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S

  2650          **RX Text\--Hormone**                                                     NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S

  2660          **RX Text\--BRM**                                                         NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S

  2670          **RX Text\--Other**                                                       NPCR          R\^        R\^        R\^        S          S          S          S            S          S          S

  2680          *Text\--Remarks*                                                          NAACCR        .          .          .          S          S          S          S            S          S          S

  2690          *Text\--Place of                                                          NAACCR        .          .          .          S          S          S          S            S          S          S
                Diagnosis*                                                                                                                                                                                   

  2800          *CS Tumor Size*                                                           AJCC          R          .          .          S          S          .          .            .          .          .

  2810          CS Extension                                                              AJCC          R          R          R          R          R          .          .            .          .          .

  2820          *CS Tumor Size/Ext Eval*                                                  AJCC          R          .          .          S          S          .          .            .          .          .

  2830          CS Lymph Nodes                                                            AJCC          R          R          R          R          R          .          .            .          .          .

  2840          *CS Reg Node Eval*                                                        AJCC          .          .          .          S          S          .          .            .          .          .

  2850          CS Mets at DX                                                             AJCC          R          R          R          R          R          .          .            .          .          .

  2860          *CS Mets Eval*                                                            AJCC          .          .          .          S          S          .          .            .          .          .

  2880          CS Site-Specific Factor 1                                                 AJCC          RS         RS         RS         RS         RS         .          .            .          .          .

  2890          *CS Site-Specific Factor                                                  AJCC          .          .          .          S          S          .          .            .          .          .
                2*                                                                                                                                                                                           

  2900          CS Site-Specific Factor 3                                                 AJCC          RS         RS         RS         RS         RS         .          .            .          .          .

  2910          *CS Site-Specific Factor                                                  AJCC          .          .          .          S          S          .          .            .          .          .
                4*                                                                                                                                                                                           

  2920          *CS Site-Specific Factor                                                  AJCC          .          .          .          S          S          .          .            .          .          .
                5*                                                                                                                                                                                           

  2930          *CS Site-Specific Factor                                                  AJCC          .          .          .          S          S          .          .            .          .          .
                6*                                                                                                                                                                                           

  2935          CS Version 1st                                                            AJCC          R          R          R          R          R          .          .            .          .          .

  2936          CS Version Latest                                                         AJCC          R          R          R          R          R          .          .            .          .          .

  2940          *Derived AJCC T*                                                          AJCC          .          .          .          D          D          .          .            .          .          .

  2950          *Derived AJCC T                                                           AJCC          .          .          .          D          D          .          .            .          .          .
                Descriptor*                                                                                                                                                                                  

  2960          *Derived AJCC N*                                                          AJCC          .          .          .          D          D          .          .            .          .          .

  2970          *Derived AJCC N                                                           AJCC          .          .          .          D          D          .          .            .          .          .
                Descriptor*                                                                                                                                                                                  

  2980          *Derived AJCC M*                                                          AJCC          .          .          .          D          D          .          .            .          .          .

  2990          *Derived AJCC M                                                           AJCC          .          .          .          D          D          .          .            .          .          .
                Descriptor*                                                                                                                                                                                  

  3000          *Derived AJCC Stage                                                       AJCC          .          .          .          D          D          .          .            .          .          .
                Group*                                                                                                                                                                                       

  3010          *Derived SS1977*                                                          AJCC          .          .          .          D          D          .          .            .          .          .

  3020          Derived SS2000                                                            AJCC          D          D          D          D          D          .          .            .          .          .

  3030          *Derived AJCC\--Flag*                                                     AJCC          .          .          .          D          D          .          .            .          .          .

  3040          *Derived SS1977\--Flag*                                                   AJCC          .          .          .          D          D          .          .            .          .          .

  3050          Derived SS2000\--Flag                                                     AJCC          D          D          D          D          D          .          .            .          .          .

  3170          *RX Date\--Most Defin                                                     COC           .          .          .          S          S          S          .            .          .          .
                Surg*                                                                                                                                                                                        

  3230          *RX Date\--Systemic*                                                      COC           .          .          .          S          S          S          .            .          .          .

  3250          RX                                                                        COC           R          R          R          S          S          S          .            .          .          .
                Summ\--Transplnt/Endocr                                                                                                                                                                      

  3300          RuralUrban Continuum 1993                                                 NAACCR        D          D          D          D          D          D          .            .          .          .

  3310          RuralUrban Continuum 2003                                                 NAACCR        D          D          D          D          D          D          .            .          .          .

                                                                                                                                                                                                             

                                                              \* Bold - Items in data set                                                                                                                    
                                                              for every diagnostic year                                                                                                                      

                                                              Italic - Items not in                                                                                                                          
                                                              current data set                                                                                                                               

                                                                                                                                                                                                             

                                          **Codes for                                                                                                                                                        
                                          Recommendations**                                                                                                                                                  

  R                                                           Required                                                                                                                                       

  R\*                                                         Required when available                                                                                                                        

  R\^                                                         Required, requirement may                                                                                                                      
                                                              be met with one or several                                                                                                                     
                                                              text block fields                                                                                                                              

  R+                                                          Required by diagnosis year                                                                                                                     

  RH                                                          Historically collected,                                                                                                                        
                                                              transmitted                                                                                                                                    

  RH\*                                                        Historically collected,                                                                                                                        
                                                              transmitted when available                                                                                                                     

  RS                                                          Required, site specific                                                                                                                        

  D                                                           Derived value                                                                                                                                  

  O                                                           Optional                                                                                                                                       

  S                                                           Supplementary/recommended                                                                                                                      

  \#                                                          Treatment information may                                                                                                                      
                                                              be coded with SEER or COC                                                                                                                      
                                                              codes                                                                                                                                          

  .                                                           Not in data set                                                                                                                                
  -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

# Appendix H: Program Evaluation Instrument (PEI)

**PURPOSE STATEMENT**

The NPCR Program Evaluation Instrument (PEI) is a web-based survey
instrument designed to evaluate NPCR-funded registries' operational
attributes and their progress towards meeting program standards. The PEI
also provides information about advanced activities and "success
stories" that highlight ways registry data is being used.

Based on *CDC's Updated Guidelines for Evaluating Public Health
Surveillance Systems*,
(<http://www.ihs.gov/MedicalPrograms/InjuryPrevention/Documents/rr5013a1.pdf>),
the PEI monitors the integration of surveillance and health information
systems, the utilization of established data standards, and the
electronic exchange of health data. Data provided by this report can be
used for public health action, program planning and evaluation, and
formulating research hypotheses.

Specific knowledge about operational activities NPCR registries are
engaged in is used to provide valuable insight to CDC regarding
programmatic efficiencies/deficiencies that have contributed to the
success/challenges of the NPCR. The results of this instrument inform
CDC and NPCR Program Consultants where technical assistance is most
needed in order to continue to improve and enhance the NPCR.

Many of the questions in the 2007 PEI provide baseline data that will be
used when measuring future progress with the NPCR Program Standards
expected to be implemented this year. These questions, and the standard
they reference, are noted throughout the instrument (e.g., *"Program
Standard I.a."*)

Using all available information as of **June 30, 2007**, the appropriate
Central Cancer Registry (CCR) staff should complete the PEI.

ADMINISTRATIVE DATA

  ------------------------------- ---------------------------------------
  State / Territory               

  NPCR reference year             

  Registry reference year         

  Registry Program Director       

  Cooperative Agreement \#        U58/DP000

  Most Current Grant Award Amount \$

  CDC Program Consultant          

  Your name                       

  Title                           

  Phone number                    

  Date completed                  
  ------------------------------- ---------------------------------------

### STAFFING

### 

**The following questions** use the concept of a \"Full-time
Equivalent\" also known as an \"FTE\". In each question you will be
asked to report the total number of FTEs (FTE count). To do this, please
convert each position to the appropriate FTE using the guidelines below,
rounding each position to the nearest quarter of an FTE (e.g., 34
hrs/week would convert to 0.75 FTE, whereas 35 hrs/week would convert to
1.0 FTE):

0.25 FTE = 10 hrs/week

0.50 FTE = 20 hrs/week

0.75 FTE = 30 hrs/week

1.00 FTE = 40 hrs/week

Then add each converted position for the total number of FTEs. For
example, if the CTR works 35 hours a week and another CTR works 25 hours
a week, the combined hours for the CTR positions = 60 hours = 1.5 FTEs.

1.  On **June 30, 2007,** how many total FTE central cancer registry
    (CCR) staff positions were **funded**? In this table, *you may
    include positions outside the registry***, *ONLY IF the registry
    pays a portion of the salary.*** *Remember to use the calculation
    method above when computing partial FTEs.*

  ------------------------------------------------------ ------------ ------------
                                                         **Total      
                                                         Count FTEs** 

  **Funding Category**                                   **Filled**   **Vacant**

  Number of **NPCR-funded (non-contracted)** FTE                      
  positions                                                           

  Number of **NPCR-funded, Contracted** FTE positions                 

  Number of **State-funded (non-contracted)** FTE                     
  positions                                                           

  Number of **State-funded, Contracted** FTE positions                

  Number of **non-contracted** FTE positions **funded by              
  other sources**                                                     

  Number of **Contracted** FTE positions **funded by                  
  other sources**                                                     

  **TOTALS**                                                          
  ------------------------------------------------------ ------------ ------------

2.  Please complete this table with the number of FTEs who *work in the
    capacity of* the position titles listed. In this table, **include
    both filled and vacant,** as well as ***access to* these staff
    (outside the registry),** **regardless of funding,** in your total
    FTE count. So, if a position is vacant, it still counts as a
    position. **Remember to use the same FTE calculation method as
    described above. *Please note CTR credentials may be held by several
    registry positions and should be counted accordingly.***

+--------------------------------------------+--------------+----------+
| **Total Count FTEs**                       |              |          |
+--------------------------------------------+--------------+----------+
| **Position (FTE or percentage of FTE)**    | **Non-       | **Cont   |
|                                            | Contractor** | ractor** |
+--------------------------------------------+--------------+----------+
| Principle Investigator                     |              |          |
+--------------------------------------------+--------------+----------+
| Program Director                           |              |          |
+--------------------------------------------+--------------+----------+
| Registry Administrator                     |              |          |
+--------------------------------------------+--------------+----------+
| Program Manager                            |              |          |
+--------------------------------------------+--------------+----------+
| Budget Analyst                             |              |          |
+--------------------------------------------+--------------+----------+
| CTR Quality Control Staff                  |              |          |
+--------------------------------------------+--------------+----------+
| Non-CTR Quality Control Staff              |              |          |
+--------------------------------------------+--------------+----------+
| CTR Education/Training Staff               |              |          |
+--------------------------------------------+--------------+----------+
| Epidemiologists                            |              |          |
+--------------------------------------------+--------------+----------+
| Statisticians                              |              |          |
+--------------------------------------------+--------------+----------+
| Computer/IT/GIS Specialists                |              |          |
+--------------------------------------------+--------------+----------+
| Other staff, specify:                      |              |          |
+--------------------------------------------+--------------+----------+
|                                            | **Total      |          |
|                                            | Count CTRs** |          |
|                                            |              |          |
|                                            | **No         |          |
|                                            | n-Contracted |          |
|                                            | Contracted** |          |
+--------------------------------------------+--------------+----------+
| **Total Number CTRs** (may overlap with    |              |          |
| above categories)                          |              |          |
+--------------------------------------------+--------------+----------+

**Staffing Section Comments** (You may add comments regarding your
responses in the "Staffing" section above)

### LEGISLATIVE AUTHORITY

3.  Does your state/territory have a current law authorizing a
    population-\
    based central cancer registry? *(Program Standard I.a.)*

> Yes
>
> No

4.  Does your state/territory have current legislation or regulations in
    support\
    of all 8 criteria of the Public Law authorizing the NPCR? *(Program
    Standard I.b.)*

> Yes
>
> No

+------------------------------------------------+-----------+---+---+---+---+
| 5.  a.  Are there any penalties in place       |           |   |   |   |   |
|         regarding reporting compliance as      |           |   |   |   |   |
|         mandated by\                           |           |   |   |   |   |
|         current legislation or regulations?    |           |   |   |   |   |
|                                                |           |   |   |   |   |
| > Yes                                          |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > No                                           |           |   |   |   |   |
|                                                |           |   |   |   |   |
| b.  If "Yes", in which law/regulations are the |           |   |   |   |   |
|     penalties included? **(check only one)**:  |           |   |   |   |   |
|                                                |           |   |   |   |   |
| > Cancer-specific reporting law/regulations    |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > General public health law/regulations        |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > Both                                         |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > None of the above                            |           |   |   |   |   |
|                                                |           |   |   |   |   |
| c.  If "Yes," have you had to impose the       |           |   |   |   |   |
|     penalty?                                   |           |   |   |   |   |
|                                                |           |   |   |   |   |
| > Yes                                          |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > No                                           |           |   |   |   |   |
+------------------------------------------------+-----------+---+---+---+---+
| 6.  a.  With passage of Public Law 107-260     |           |   |   |   |   |
|         (the Benign Brain Tumor Cancer         |           |   |   |   |   |
|         Registry Amendment Act), NPCR-funded   |           |   |   |   |   |
|         registries are required to collect     |           |   |   |   |   |
|         data on benign brain tumors beginning  |           |   |   |   |   |
|         in diagnosis year 2004. Do regulations |           |   |   |   |   |
|         or legislation in your State or        |           |   |   |   |   |
|         territory authorize you to collect     |           |   |   |   |   |
|         data on benign brain tumors?           |           |   |   |   |   |
|                                                |           |   |   |   |   |
| > Yes                                          |           |   |   |   |   |
| >                                              |           |   |   |   |   |
| > No                                           |           |   |   |   |   |
+------------------------------------------------+-----------+---+---+---+---+

b.  If "No," what are your plans, including timeframes, to modify your
    State or Territory's legislation or regulations to allow you to
    collect benign brain tumor data?

> Specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

7.  Does your State or Territory have legislation or regulations
    prohibiting you from reporting county level data?

> Yes
>
> No

8.  Does your state law/regulations protect your cancer registry data
    from the Freedom of Information Act (FOIA)?

> Yes
>
> No

9.  a.  Does your state law/regulations protect your cancer registry
        data from

> subpoena?
>
> Yes
>
> No

b.  If no, are data received through interstate data exchange protected
    from

> subpoena?
>
> Yes
>
> No

**Legislation Section Comments** (You may add comments regarding your
responses in the "Legislation" section above)

### ADMINISTRATION

10. Does your CCR maintain an operational manual that describes registry
    operations, policies and procedures that, at a minimum, contains the
    following?\
    *(Program Standard II.a.) **Check all that apply:***

+------------------------------------------------------------+----+----+
|                                                            | *  | ** |
|                                                            | *Y | NO |
|                                                            | ES | ** |
|                                                            | ** |    |
+------------------------------------------------------------+----+----+
| Reporting laws/regulations                                 |    |    |
+------------------------------------------------------------+----+----+
| List of reportable diagnoses                               |    |    |
+------------------------------------------------------------+----+----+
| List of required data items                                |    |    |
+------------------------------------------------------------+----+----+
| Data processing operational procedures for (check all that | [  | [  |
| apply):                                                    | ]{ | ]{ |
|                                                            | .m | .m |
|                                                            | ar | ar |
|                                                            | k} | k} |
+------------------------------------------------------------+----+----+
| a\. Monitoring timeliness of reporting                     |    |    |
+------------------------------------------------------------+----+----+
| b\. Receipt of data                                        |    |    |
+------------------------------------------------------------+----+----+
| c\. Database management including a description of the     |    |    |
| Registry Operating System (software)                       |    |    |
+------------------------------------------------------------+----+----+
| d\. Conducting death certificate clearance                 |    |    |
+------------------------------------------------------------+----+----+
| Procedures for Implementing and maintaining a quality      | [  | [  |
| assurance/control program including (check all that apply, | ]{ | ]{ |
| f-h)                                                       | .m | .m |
|                                                            | ar | ar |
|                                                            | k} | k} |
+------------------------------------------------------------+----+----+
| f\. Conducting follow-back to reporting facilities on      |    |    |
| quality                                                    |    |    |
|                                                            |    |    |
| assurance issues                                           |    |    |
+------------------------------------------------------------+----+----+
| g.  Conducting record consolidation                        |    |    |
+------------------------------------------------------------+----+----+
| > h\. Maintaining detailed documentation of all quality    |    |    |
| >                                                          |    |    |
| > assurance operations                                     |    |    |
+------------------------------------------------------------+----+----+
| Procedures for insuring confidentiality and data security  |    |    |
| including disaster                                         |    |    |
|                                                            |    |    |
| planning                                                   |    |    |
+------------------------------------------------------------+----+----+
| Procedures for data release including access to and        |    |    |
| disclosure of                                              |    |    |
|                                                            |    |    |
| information                                                |    |    |
+------------------------------------------------------------+----+----+
| Procedures for maintaining and updating the operational    |    |    |
| manual                                                     |    |    |
+------------------------------------------------------------+----+----+

11. Do you believe that your CCR policies and procedures are sufficient
    and clear as to what data may and may not be disclosed and how this
    should occur?

> Yes
>
> No

12. Do you believe that your CCR policies and procedures are sufficient
    and clear for protection of confidentiality for all routine registry
    activities?

> Yes
>
> No

13. Do you believe that your CCR staff possesses sufficient knowledge
    and resources to meet risk-appropriate threats to security and
    confidentiality?

> Yes
>
> No

14. Does your CCR produce reports that are used to monitor the registry
    operations and database, including processes and activities?
    *(Program Standard II.b.) **Check all that apply:***

> Quality control report (central registry)
>
> Quality control reports for each facility
>
> Data completeness report for each facility
>
> Timeliness of data report for each facility
>
> Data workflow report
>
> Other, specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None of the above

15. Does your CCR have an abstracting and coding manual that is provided
    for use by all reporting sources? *(Program Standard II.c.)*

> Yes
>
> No

**Administration Section Comments** (You may add comments regarding your
responses in the "Administration" section above)

### REPORTING COMPLETENESS

16. What types of facilities and health care providers report to your
    CCR? Please list the percentage of facilities, by type, that
    actually reported in the past year (do not record the percentage
    reporting according to your CCR's timeliness schedule), and
    calculate what percentage of the reports, by facility type, are
    received electronically.

> ***Note:***

-   *\"Hospital cancer registry\" is defined as one (single or joint
    institution) who collects data to be used internally and who would
    continue to do so regardless of the central cancer registry
    requirements to collect and report cancer data.*

-   *Provide the number of facilities required to report and, where
    indicated, use your best estimate if the exact number is not
    available.*

-   *For those facilities which are not applicable to your
    state/territory (e.g., IHS Hospitals), record zero (0) in 'Number
    Required to Report' and 100 in 'Percent Compliant with Reporting'.
    In these instances, 'Percent Reports Received Electronically' is to
    be left blank and will be validated against the 'Number Required to
    Report'. (Program Standards III.a-c)*

  ------------------------------------ ----------------- ----------------- ------------------
  **Facilities Required to Report      **Number Required **Percent         **Percent Reports
  Cancer Cases by Type**               to Report         Compliant by      Received
                                       (Denominator)**   Reporting\*\***   Electronically**

  Hospitals with a cancer registry                                         
  (non-federal)                                                            

  Hospitals without a cancer registry                                      
  (non-federal)                                                            

  VA Hospitals                                                             

  IHS Hospitals                                                            

  Tribally Owned Hospitals                                                 

                                                                           

  Health Centers (IHS, Tribal)                                             

  Surgery Centers                                                          

  Independent Radiation Therapy                                            
  Centers                                                                  

                                                                           

  In-State Independent Pathology                                           
  Laboratories                                                             

  Out-of-State Independent Pathology                                       
  Laboratories\*                                                           

                                                                           

  Dermatologists\*                                                         

  Urologists\*                                                             

  Oncologists\*/Hematologists\*                                            

  Other Physicians\*                                                       

                                                                           

  Other facilities, specify:                                               
  ------------------------------------ ----------------- ----------------- ------------------

*\*Provide best estimate \*\*Those facilities who report rather than
those reporting in a timely manner*

17. Within 24 months of the close of the diagnosis year, what percentage
    of physicians, surgeons, and all other health care practitioners
    diagnosing or providing treatment for cancer patients submit all
    reportable cases to your CCR? ***Exception:*** Physicians are not
    required to report cases directly referred or previously admitted
    to, and reported by, a hospital or other facility providing
    screening, diagnostic or therapeutic services to patients in that
    State/Territory? *(Program Standard V.a.) **Check only one:***

  --- -------------------------------------------------------------------
      100%

      75% - 99%

      51% - 74%

      10% - 50%

      1% -- 9%

      None
  --- -------------------------------------------------------------------

18. Of the pathology lab reports your CCR receives, what percentage are
    in the College of American Pathologists (CAP) cancer protocol
    checklist format? ***(Provide best estimate)***

  --- -------------------------------------------------------------------
      100%

      75% - 99%

      51% - 74%

      10% - 50%

      1% -- 9%

      None
  --- -------------------------------------------------------------------

19. Do you require that non-analytic (classes 3 and 4) cases be reported
    to your CCR?

  ---- ------------------------------------------------------------------
       Yes

  ---- ------------------------------------------------------------------

No

20. a.  Do you receive data from the **Department of Defense's**
        Automated\
        Central Tumor Registry (ACTUR) dataset? ***(If "No," skip 20b --
        20d)***

> Yes No

b.  If yes, how often? **Please check only one.**

+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| c.  If yes, have these data proven to be helpful in finding new       |
|     incident cases?                                                   |
+-----------------------------------------------------------------------+

> Yes
>
> No

d.  If not, why not? (**Please check all that apply)**

  ---- ------------------------------------------------------------------
       Data are incomplete.

       Data are not in the proper format for us to consolidate with
       existing records.

       We don't have time to deal with it.

       Other, specify: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
  ---- ------------------------------------------------------------------

+-----------------------------------------------------------+----------+
| 21. To how many VA facilities do you currently send       | **Number |
|     central registry staff for data                       | of       |
|     collection/abstracting?                               | Faci     |
|                                                           | lities** |
+-----------------------------------------------------------+----------+
| 22. At how many VA facilities are data collected by a     |          |
|     combination of VA facility staff and central registry |          |
|     staff?                                                |          |
+-----------------------------------------------------------+----------+
| 23. How many VA facilities currently report to your CCR   |          |
|     indirectly from the VA central cancer registry in     |          |
|     Washington, DC?                                       |          |
+-----------------------------------------------------------+----------+

24. If there are VA facilities not reporting, please explain why in the
    space\
    provided below:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

25. Based on historical data, how many cases per diagnosis year do you
    estimate are missed (i.e., not ever received) by your CCR because of
    non-reporting by VA facilities?

Number of cases missed: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Reporting Completeness** **Section Comments** (You may add comments
regarding your responses in the "Reporting Completeness" section above)

### DATA EXCHANGE 

26. Does your CCR use and require the standardized, NPCR-recommended
    data exchange record layout for the electronic exchange of cancer
    data for *(Program Standards III.a.):*

    a.  Abstract reports (*The NAACCR record layout version specified in
        Standards for Cancer Registries Volume II: Data Standards and
        Data Dictionary*)?

> Yes
>
> No

b.  Pathology reports *(NAACCR Standards for Cancer Registries Volume*
    *V: Pathology Laboratory Electronic Reporting*)?

> Yes
>
> No
>
> Not Applicable, not receiving electronic pathology reports

27. Does your exchanged data meet the following minimum criteria?

*(Program Standards V.d.)***:**

a.  Within 12 months of the close of the diagnosis year, your CCR
    exchanges data with other central cancer registries where a data-
    exchange agreement is in place (the data file includes all cases not
    previously exchanged):

> Yes
>
> No

b.  **Regardless of residency**, your CCR collects data on all patients
    diagnosed and/or receiving first course of treatment in the
    registry's state/territory:

> Yes
>
> No

c.  The recommended frequency of data exchange is at least two times per
    year. Your CCR exchanges data at the following frequency:

> Annually
>
> Biannually (two times per year)
>
> Other, explain
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

d.  Exchange agreements are in place with all bordering central cancer

registries:

> Yes, with all bordering CCRs
>
> No, *not all*
>
> List existing agreements here:
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

e.  Exchanged data includes a dataset that consists of NPCR core data
    items:

> Yes
>
> No

f.  99% of exchanged data passes an NPCR-prescribed set of standard
    edits:

> Yes
>
> No

g.  Exchanged data are transmitted via a secure encrypted Internet-based
    system:

> Yes
>
> No

h.  The standardized, NPCR-recommended data exchange format is used to
    transmit data reports (*The NAACCR record layout version specified
    in Standards for Cancer Registries Volume II: Data Standards and
    Data Dictionary*):

> Yes
>
> No

**Data Exchange Section Comments** (You may add comments regarding your
responses in the "Data Exchange" section above)

**DATA CONTENT AND FORMAT**

28. Does your CCR collect or derive all required data items using
    standard codes as prescribed by NPCR?

> Yes
>
> No

29. Is your CCR able to receive secure, encrypted cancer abstract data
    from reporting sources via the Internet?

> Yes
>
> Currently being developed and/or implemented
>
> No, not able to receive

No, able to receive, but not receiving

30. What is the primary software system used to process and manage
    cancer data in your CCR? **Please check only one:**

> Commercial Vendor
>
> In-House Software
>
> Registry Plus
>
> Abstract Plus
>
> Prep Plus
>
> CRS Plus
>
> Link Plus
>
> Web Plus

**Data Content and Format Section Comments** (You may add comments
regarding your responses in the "Data Content and Format" section above)

**DATA QUALITY ASSURANCE**

31. Does your CCR's quality assurance program consist of, but is not
    limited to: *(Program Standard VI.a.)*

  ----------------------------------------------------------- --------- --------
                                                              **YES**   **NO**

  A designated CTR is responsible for the quality assurance             
  program                                                               

  Qualified, experienced CTRs conduct quality assurance                 
  activities                                                            

  At least once every 5 years, case-finding and/or                      
  re-abstracting audits from a sampling of source documents             
  are conducted for each hospital-based reporting facility,             
  and may include external audits (NPCR/SEER)                           

  Data consolidation procedures are performed according to an           
  accepted protocol                                                     

  Procedures are performed for follow-back to reporting                 
  facilities on quality issues                                          
  ----------------------------------------------------------- --------- --------

32. Does your CCR have a designated education/training coordinator, who
    is a CTR, to provide training to CCR staff and reporting sources to
    assure high quality data? *(Program Standard VI.b.)*

> Yes
>
> No

33. In the past year, which of the following type of quality control
    audits or activities did your CCR conduct?

Yes No

> Casefinding
>
> Re-abstracting
>
> Re-coding
>
> Visual editing

34. Does your CCR match *all causes of death* against your registry data
    to identify a reportable cancer?

> Yes
>
> No

35. a.  Does your CCR update the CCR database following death
        certificate matching:

> Death information Yes No
>
> Missing demographic information Yes No

b.  If "Yes", what percentage(s) is updated manually or electronically?:

*(Provide best estimate; may be some overlap between automation and\
manual review)*

Death information: Manually \_\_\_\_\_\_% Electronically \_\_\_\_\_%

Demographic information: Manually \_\_\_\_\_\_% Electronically
\_\_\_\_\_%

36. Does your CCR perform record consolidation on the following:

**Data Group** **Electronic Manual Both Neither**

Patient

Treatment

Follow-up

37. a.  Does your CCR provide a registry-specific edit set to your
        reporting facilities and/or vendors for use prior to data
        submissions to your CCR?

> Yes
>
> No

b.  If "Yes," are facilities **required** to run registry-specific edits
    prior to their data submission to your CCR?

> Yes
>
> No

**Data Quality Assurance Section Comments** (You may add comments
regarding your responses in the "Data Quality Assurance" section above)

### DATA USE 

38. Within 12 months of the end of the diagnosis year with data that are
    90% complete, did your CCR produce pre-calculated data in tables in
    an electronic data file or report of incidence rates, counts, or
    proportions for the diagnosis year for Surveillance Epidemiology and
    End Results (SEER) site groups as a preliminary monitor of the top
    cancer sites within your state/territory? *(Program Standard
    VII.a.)*

> Yes
>
> No

39. a.  Within 24 months of the end of the diagnosis year with data that
        are 95% complete, did your CCR produce pre-calculated data in
        tables in an electronic data file or report? (The report should
        include, at a minimum, age-adjusted incidence rates and
        age-adjusted mortality rates for the diagnosis year by sex for
        SEER site groups, and, where applicable, by sex, race, and
        ethnicity).\
        *(Program Standard VII.b.)*

> Yes
>
> No

b.  What is the most current diagnosis year a data file or report is
    available?\
    \
    Year \_\_\_\_\_

c.  In what format is this report available?

> Hard copy
>
> Electronic word-processed file
>
> Web page/query system

40. a.  Has the CCR, state health department, or its designee used
        registry data *for planning and evaluation of cancer control
        objectives* in ***at least three*** ***of the following ways in
        the past year:*** Comprehensive cancer control detailed
        incidence/mortality estimates, linkage with a statewide cancer
        screening program to improve follow-up of screened patients,
        health event investigation(s), needs assessment/program
        planning, program evaluation, or epidemiologic studies?
        *(Program Standard VII.c.)*

> Yes
>
> No

b.  If "yes," indicate the number of times data was used for each
    category in the table below:

  ------------------------------------------------------- ---------------
  **Data Use Category**                                   **Number per
                                                          Year**

  Comprehensive cancer control                            

  Detailed incidence/mortality estimates                  

  Linkage with a statewide cancer screening program       

  Health event investigation(s)                           

  Needs assessment/program planning                       

  Program evaluation                                      

  Epidemiologic studies                                   

  Other, describe:                                        
  ------------------------------------------------------- ---------------

41. a.  Have any of the above uses of data been included in a journal
        publication

> Yes
>
> No

b.  If "yes," please list the citation(s) in the space provided:

```{=html}
<!-- -->
```
42. During the past year, for which areas of registry data utilization
    did your CCR acknowledge CDC-NPCR funding, as required in the Notice
    of Cooperative Agreement Award? ***Check all that apply:***

> Publications (e.g.; journal articles, annual report, other reports)
>
> Web site
>
> Presentations, posters
>
> Release of data
>
> Education meeting, training program, conference
>
> Press releases, statements
>
> Requests for proposals, bid solicitations
>
> None

43. Does your CCR use *United States Cancer Statistics* (USCS) data when
    performing comparative analyses?

> Yes
>
> No, explain:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Data Use Section Comments** (You may add comments regarding your
responses in the "Data Use" section above)

### **COLLABORATIVE RELATIONSHIPS** 

44. Does your CCR actively collaborate with your state/territory's
    comprehensive cancer prevention and control (CCC) planning efforts,
    including establishing a working relationship to ensure the use of
    registry data to assess and implement cancer control activities?
    *(Program Standards IX.a.,b.)*

> Yes
>
> No
>
> ***Please check all of the ways you collaborate:***
>
> Member of our state/territory's comprehensive cancer control (CCC)
> planning\
> group (coalition, committee, or workgroup)
>
> Provide data for CCC planning
>
> Provide data for CCC Activities
>
> Provide technical assistance and collaborate on data analyses for
>
> CCC program publications
>
> Data linkages
>
> Other, specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None, Explain
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

45. Has your CCR established and regularly convened an advisory
    committee to assist in building consensus, cooperation, and planning
    for the registry? (Representation should include key organizations
    and individuals both within and outside the program. Advisory
    committees may be structured to meet the needs of the
    state/territory such as the CCC Program committee structure, an
    advocacy group, or a focus group). *(Program Standard IX.c.)*

> Yes
>
> No

### **The Advisory Committee includes representation from (check all that apply):**

> Representatives from all cancer prevention and control components
>
> Vital Statistics
>
> Hospital cancer registrars
>
> American Cancer Society
>
> Clinical-laboratory personnel
>
> Pathologists
>
> Clinicians
>
> Researchers
>
> Other, specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

46. If you have an Advisory Committee, how often does this group
    convene, including in-person and teleconferences? ***Please check
    only one:***

> Quarterly
>
> Annually
>
> Biannually
>
> Other, specify \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

47. In what ways does your CCR collaborate with the National Breast and
    Cervical Cancer Early Detection Program (NBCCEDP) and the National
    Comprehensive Cancer Control Program (NCCCP)?

> ***Please check all that apply:***
>
> Regular meetings with NBCCEDP and/or NCCCP departmental staff
>
> Provides assistance in staging NBCCEDP cases
>
> Provides training/technical assistance to NBCCEDP and/or NCCCP staff
>
> Provides data to NBCCEDP and/or NCCCP
>
> Provides technical material for publications
>
> Provides subject matter expertise to NBCCEDP and/or NCCCP
>
> Data linkages (NBCCEDP database, Minimum Data Elements (MDE) Study
>
> Other, specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None of the above, explain
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Collaborative Relationship Section Comments** (You may add comments
regarding your responses in the "Collaborative Relationship" section
above)

**ADVANCED ACTIVITIES**

As the capacity of central cancer registries to collect and maintain
population-based cancer data increases, so does their ability to engage
in new activities designed to improve the completeness, timeliness,
quality, and use of their data. In this section, we are interested in
learning more about your \"advanced activities.\"

48. Please complete the table below regarding CCR receipt of electronic
    records from the reporting sources listed. **For each facility type,
    either check "Yes" and enter the format, as text, in which the
    electronic records are received, or check "No". No line is to be
    left blank.**

  ---------------------------------- --------- ----------------------- --------
  **Facility Type**                  **YES**   **Specify Type of       **NO**
                                               Electronic Format**     

  Hospital Radiation Therapy Dept.                                     

  Physician Offices                                                    

  State-wide Disease Index                                             

  Freestanding Radiation Centers                                       

  Hospital Disease Indices                                             

  Nuclear Medicine Facilities                                          

  Other, specify                                                       
  ---------------------------------- --------- ----------------------- --------

49. If your CCR receives electronic pathology reports, in which format
    are these received? (**Please check all that apply)**

> NAACCR, HL7 Format (Volume V)
>
> NAACCR, Pipe Delimited Format (Volume V)
>
> NAACCR, HL7 Format (NAACCR Volume II, Version 10, Chapter VI)
>
> NAACCR, Pipe Delimited Format (NAACCR Volume II, Version 10,
>
> Chapter VI)
>
> Other, specify:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Not applicable

50. What method is used to identify reportable conditions from pathology
    lab reports:

> Manual review
>
> Search routine based on NAACCR search term list
>
> Other, specify
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

51. For which of the following cancer surveillance needs has your CCR
    been in contact with your Health Department's PHIN / NEDSS staff?

> **Please check all that apply.**
>
> Pathology laboratory reporting
>
> Physician disease reporting
>
> Other healthcare data reporting
>
> None of the above

52. Has your CCR planned or developed a cancer data collection system
    that will be integrated into a Public Health Information Network
    (PHIN) compatible health surveillance system?

> Yes
>
> No

53. Does your CCR conduct at least one of the following advanced
    activities:\
    ***Check all that apply:***

> Survival analysis
>
> Quality of care studies
>
> Clinical Studies
>
> Publication of research studies using registry data
>
> Geo-coding to latitude and longitude to enable mapping
>
> Other healthcare data reporting
>
> Other innovative uses of registry data,
> describe\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None of the above

54. How often does your CCR link to the National Death Index (NDI)?\
    ***Please check only one. (If Never, skip to question 57.)***

> Every year
>
> Every other year
>
> Every 3-5 years
>
> Other, specify \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Never

55. For which of the following has the NDI linkage proven to be useful?\
    ***Check all that apply:***

> Casefinding
>
> Survivorship
>
> Data quality
>
> Research
>
> Other, please
> specify:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Not applicable

56. Does your CCR update your database following NDI linkage?

> Yes
>
> No
>
> Not applicable

57. With which *databases* has your CCR linked its records in the past
    year (2006) for follow-up or some other purpose? ***Check all that
    apply:***

> State Vital Statistics
>
> National Death Index
>
> Department of Motor Vehicles
>
> Department of Voter Registration
>
> Indian Health Service
>
> Medicare (Health Care Financing Administration)
>
> Medicaid
>
> Managed Care Organizations
>
> Breast and Cervical Cancer
>
> Blue Cross/Blue Shield
>
> Hospital Discharge
>
> Other, specify:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None

58. a.  As noted in an August 13, 2004 e-mail, CDC-NPCR has negotiated
        an agreement with SNOMED International for several tools for use
        by NPCR registries. Has your CCR downloaded any of these tools
        (the SNOMED CT CLUE Browser, the SNOMED CT Technical Reference
        Guide, the ICD-O topography to SNOMED CT Map, the SNOMED CT
        User's Guide, and the full set of the 42 SNOMED CT encoded CAP
        cancer protocols and checklists)?

> Yes
>
> No

b.  Does your CCR use any of these SNOMED tools?

> Yes
>
> No

c.  If "No," does your CCR have plans to use them in the next year?

> Yes
>
> No

d.  Does your CCR need additional information or training on these
    tools?

> Yes
>
> No

**Advanced Activities Section Comments** (You may add comments regarding
your responses in the "Advanced Activities" section above)

### **SUCCESS STORIES**

59. Please provide a summary, as a separate document, of innovative
    activities in which your CCR has been engaged within the past year.
    This can include ways in which cancer registry data has been used,
    journal citations, as well as other activities that may be of
    interest to other central registries and to NPCR (e.g., advances in
    any area of electronic reporting, GIS activities, death clearance
    activities, automated database activities that have improved data
    processing efficiencies, any other activities that have improved
    data quality, completeness, or timeliness advances in data security,
    or implementation of cancer inquiry response system, or success in
    job re-classifications) in the format suggested below:

**Suggested format:**

The registry highlights should fit on one page, in 12-point font and
single-spaced. Information needs to be in simple language and should
avoid public health jargon and scientific language.

**Suggested components:**

1.  The name of the NPCR registry program.

2.  Contact name, phone number, and e-mail address for further
    information

3.  Title of the initiative, project, or type of data use

4.  General timeframe (year(s) or month(s) during which the
    initiative/project/data use occurred)

5.  A statement of the cancer surveillance issue, concern, or problem

6.  Evidence that the activity was effective in addressing the above
    (#5)

7.  Implications regarding the success of this activity or increased
    data use.

Please contact your NPCR Program Consultant if you need more detailed
information about the submission of your cancer registry \"success
story\".

**Success Stories Section Comments** (You may add comments regarding the
"Success Stories" section above; do not record the success story in this
comment box)

60. Please comment below about your experience completing this
    evaluation instrument by selecting the choice which best represents
    your thoughts and experience:

    a.  All or most of the questions are clearly stated

> Agree Disagree

b.  I understand the importance of all or most of the questions

> Agree Disagree

c.  For the most part, I found the web technology of the instrument to
    be\
    user-friendly

> Agree Disagree

d.  For the most part, I consider the time spent completing the
    instrument to be a worthwhile contribution to NPCR and the cancer
    surveillance community

> Agree Disagree

e.  Our central registry uses data that is collected in this instrument

> Agree Disagree

### **OPTIONAL**

61. I would like to participate in discussions regarding next year's
    evaluation instrument.

> Yes *Please enter your name and phone number here:*
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> No

62. I have the following suggestions/revisions for questions or web
    formatting regarding next year's evaluation instrument (please
    comment in the space provided below):

***Thank you for participating in the NPCR Program Evaluation!***

# Appendix I: DCPC Forms Recognition Software Analysis

> **September 2006**
>
> Northrop Grumman Web Applications Team\
> National Center for Chronic Disease Prevention and Health Promotion
> (NCCDPHP)\
> Centers for Disease Control and Prevention (CDC)

Disclaimers

> *All software products and company names mentioned herein are
> considered trademarks or registered trademarks of their respective
> companies. In regards to privacy, select information gathered from
> telephone interviews or complied from internal documentation has been
> paraphrased in order to appropriately protect the explicit or implied
> confidentiality of individuals and/or entities that provided
> information on any of the product(s) referenced herein.*

Overview

> The Division of Cancer Prevention and Control (DCPC) have implemented
> standards requiring state Central Cancer Registries (CCR) to
> electronically receive cancer incidence reports. Many CCRs will host a
> web application that will allow hospitals, physicians, etc. to submit
> reports via the internet. Because small physician's offices, etc. do
> not always have internet access, DCPC is requesting the analysis of
> forms recognition software options that would allow the CCRs to
> receive forms via fax and eliminate the need for manual data entry.

Project Goals

> The goal of this analysis is to eliminate manual data entry for the
> CCRs. For offices that do not have internet access, they would ideally
> fax the completed form to the CCR and it would be received by the
> forms recognition application, parsed, and automatically written to
> the database. A second option would be for the CCR to physically take
> the faxed form and scan it. The data would then be parsed by the forms
> recognition application and automatically written to the database.

Forms Recognition Software Solution Selection

> The software evaluation was focused on identifying potential forms
> recognition products in the market to meet the CCRs needs. Based on
> the research to date, the recommended forms recognition solution is
> ***ReadSoft Documents for Forms**.*

Evaluation Approach

> The starting point for the evaluation began with a meeting with the
> DCPC stakeholders to gain a solid understanding of the objectives in
> order to evaluate a viable solution.
>
> After gaining an understanding of the specific business needs and the
> desired approach, the next step was researching the various forms
> recognition software packages available in the market and identifying
> the products that met the requirements of the evaluation. From that
> selection, a group of top contenders were chosen for a more detailed
> evaluation including product comparison, platform support, ease of
> use, support, and cost analysis. The detailed evaluation involved
> researching online documentation as well as telephone and email
> correspondence with sales and technical contacts to gain specific
> knowledge about each product.
>
> After reviewing the information, additional research was conducted to
> validate the viability of each solution. Two approaches have been
> identified to potentially meet the needs of the CCRs.
>
> **Approach 1:** A centralized forms recognition server (fax server)
> would receive all incoming faxes from one or multiple fax lines. The
> data could be stored in a centralized database and each CCR would have
> access to the database.
>
> The main advantage of this approach is having centralized software and
> data, and this approach is less expensive compared to the other
> options.
>
> The main disadvantage of this approach is data ownership. All data
> would be stored at a central site rather than stored at each CCR. Due
> to the sensitivity of the data, this may not be a viable solution.
>
> **Approach 2:** In this approach a desktop version of the forms
> recognition software would be installed and housed at each CCR. The
> incoming fax would be received by the desktop version of the Forms
> Recognition software via:

1.  *User intervention*: Each CCR would have a scanner and a desktop
    version of the forms recognition software installed. Upon reception
    of the incoming fax, the document would be manually scanned, and the
    data would be automatically sent to the forms recognition software.
    The software would process the document, and store the data in the
    CCRs database.

2.  *Electronic fax*: This approach would eliminate the need for user
    intervention. The incoming electronic fax (i.e. eFax) would forward
    an email to the desktop forms recognition software hosted by the
    CCR. The software would process the data and store the data in the
    database.

> The advantage of using the automated electronic fax is that it would
> eliminate the need to have a user scan all incoming faxes. Scanning
> could potentially affect the quality of the scanned document which in
> turn could adversely affect data quality.

Solution Comparison

> The solution comparison provides information on several products
> available in the market today and is focused on the CCR desktop
> implementation of the forms recognition software.
>
> The following products were reviewed in order to determine the most
> appropriate solution for DCPC's forms recognition software initiative:

+------------+---------------------+-----------------+-----------------+
| **         | > **PROS**          | > **CONS**      | > **PRICE**     |
| SOFTWARE** |                     |                 |                 |
+============+=====================+=================+=================+
| [ABBYY     | -   Product is very | -   Product is  | -   FormReader  |
| FormR      |     good            |                 |     6.5 Desktop |
| eader](htt |                     |   comparatively |     Edition:    |
| p://www.ab | -   Built for large |     very        |     \$7,500     |
| byy.com/fo |     volume          |     expensive   |                 |
| rmreader/) |     transactions    |                 | -   FormReader  |
|            |                     |                 |     6.5         |
|            | -   Provides .Net   |                 |     Enterprise  |
|            |     support for     |                 |     Edition:    |
|            |     integration     |                 |     \$12,500    |
|            |     with other      |                 |                 |
|            |     applications or |                 | -   FormReader  |
|            |     custom          |                 |     6.5         |
|            |     programming     |                 |     Developer   |
|            |                     |                 |     Edition     |
|            | -   Exports data to |                 |     (API):      |
|            |     flat files such |                 |     \$4,900     |
|            |     as .CSV or XML  |                 |                 |
|            |     or writes       |                 |                 |
|            |     directly to a   |                 |                 |
|            |     database using  |                 |                 |
|            |     Open Database   |                 |                 |
|            |     Connectivity    |                 |                 |
|            |     (ODBC) or       |                 |                 |
|            |     automated       |                 |                 |
|            |     scripts         |                 |                 |
+------------+---------------------+-----------------+-----------------+
| [          | -   Product is very | -   They do not | -   FormStorm   |
| CharacTell |     good            |     offer a     |     Enterprise  |
| FormStorm  |                     |     desktop or  |     Server:     |
| Ent        | -   Built for large |     scaled down |     \$4950      |
| erprise](h |     volume          |     edition of  |                 |
| ttp://www. |     transactions    |     the product |                 |
| charactell |                     |                 |                 |
| .com/FormS |                     | -   Sales and   |                 |
| tormEnterp |                     |     support     |                 |
| rise.html) |                     |     were not    |                 |
|            |                     |     easily      |                 |
|            |                     |     accessible  |                 |
|            |                     |                 |                 |
|            |                     | -   Requires    |                 |
|            |                     |     the         |                 |
|            |                     |     purchase of |                 |
|            |                     |     additional  |                 |
|            |                     |     components  |                 |
|            |                     |     along with  |                 |
|            |                     |     the         |                 |
|            |                     |     enterprise  |                 |
|            |                     |     edition of  |                 |
|            |                     |     the         |                 |
|            |                     |     software    |                 |
|            |                     |                 |                 |
|            |                     | -   The product |                 |
|            |                     |     is very     |                 |
|            |                     |     expensive   |                 |
|            |                     |     compared to |                 |
|            |                     |     other       |                 |
|            |                     |     solutions   |                 |
|            |                     |                 |                 |
|            |                     | -   The price   |                 |
|            |                     |     to value    |                 |
|            |                     |     ratio       |                 |
|            |                     |     compared to |                 |
|            |                     |     other       |                 |
|            |                     |     solutions   |                 |
|            |                     |     is low      |                 |
+------------+---------------------+-----------------+-----------------+
| [Creative  | -   Provides        | -   The         | -   EzData      |
| ICR Inc    |     complete        |     solution    |     Plus:       |
| EzData]    |     support for the |     appears     |     \$299.00    |
| (http://ww |     creation and    |     highly      |                 |
| w.creative |     processing of   |     dependent   |                 |
| icr.com/ez |     forms created   |     upon the    |                 |
| data.html) |     by EzData       |                 |                 |
|            |                     |  manufacturer's |                 |
|            | -   Automatic       |     standard    |                 |
|            |     Microsoft       |     form        |                 |
|            |     Access          |     templates,  |                 |
|            |     compatible      |     although it |                 |
|            |     database        |     is stated   |                 |
|            |     generation      |     that custom |                 |
|            |                     |     form        |                 |
|            | -   The price is    |     template    |                 |
|            |     low compared to |     support is  |                 |
|            |     the other       |     provided    |                 |
|            |     products        |                 |                 |
|            |                     | -   Unable to   |                 |
|            |                     |     reach sales |                 |
|            |                     |     support     |                 |
|            |                     |                 |                 |
|            |                     | -   Unable to   |                 |
|            |                     |     verify any  |                 |
|            |                     |     experience  |                 |
|            |                     |     working     |                 |
|            |                     |     with the    |                 |
|            |                     |     CDC or      |                 |
|            |                     |     other       |                 |
|            |                     |     federal     |                 |
|            |                     |     agencies    |                 |
|            |                     |                 |                 |
|            |                     | -   Unclear     |                 |
|            |                     |     whether     |                 |
|            |                     |     programming |                 |
|            |                     |     interfaces  |                 |
|            |                     |     are         |                 |
|            |                     |     available   |                 |
|            |                     |     for product |                 |
|            |                     |                 |                 |
|            |                     |   customization |                 |
|            |                     |                 |                 |
|            |                     | -   Unclear     |                 |
|            |                     |     whether the |                 |
|            |                     |     product     |                 |
|            |                     |     supports    |                 |
|            |                     |     database    |                 |
|            |                     |     platforms   |                 |
|            |                     |     other than  |                 |
|            |                     |     Microsoft   |                 |
|            |                     |     Access      |                 |
+------------+---------------------+-----------------+-----------------+
| [Kofax     | -   Very stable and | -   SQL Server  | -   Desktop     |
| Ascent     |     widely used in  |     support is  |     edition:    |
| Capt       |     Enterprise      |     only        |     \$995.00    |
| ure](http: |     applications    |     available   |     for 5K of   |
| //www.kofa |                     |     in the      |                 |
| x.com/prod | -   Both enterprise |     enterprise  |  scanning/month |
| ucts/ascen |     and desktop     |     edition of  |                 |
| t/capture/ |     editions are    |     the product | -   Developer   |
| index.asp) |     available       |                 |     API:        |
|            |                     | -   No          |     \$2695.00.  |
| ####       | -   The desktop     |     experience  |                 |
|            |     edition stores  |     working     |                 |
|            |     meta-data in a  |     with CDC    |                 |
|            |     flat file       |                 |                 |
|            |                     | -   Product is  |                 |
|            | -   Developer's     |     overkill    |                 |
|            |     package is      |     for a       |                 |
|            |     available for   |     desktop     |                 |
|            |     an additional   |     edition     |                 |
|            |     fee             |                 |                 |
|            |                     | -               |                 |
|            |                     |   Comparatively |                 |
|            |                     |     very        |                 |
|            |                     |     expensive   |                 |
+------------+---------------------+-----------------+-----------------+

Recommended Solution

+------------+---------------------+-----------------+-----------------+
| **         | > **PROS**          | > **CONS**      | > **PRICE**     |
| SOFTWARE** |                     |                 |                 |
+============+=====================+=================+=================+
| [ReadSoft  | -   Easy to         | -   More costly | -   \$2700 per  |
| Documents  |     automatically   |     compared to |                 |
| for        |     get information |     EzData or   |    installation |
| Forms](htt |     from any        |     Kofax       |                 |
| p://www.re |     document        |                 |    (salesperson |
| adsoft.net |     (email, web,    |                 |     willing to  |
| /products/ |     fax, paper,     |                 |     negotiate   |
| forms.htm) |     etc.) using the |                 |     price based |
|            |     latest data     |                 |     on volume)  |
|            |     capture         |                 |                 |
|            |     technology      |                 | -   ReadSoft is |
|            |                     |                 |     currently   |
|            | -   Data is easily  |                 |     working     |
|            |     extracted,      |                 |     with the    |
|            |     interpreted,    |                 |                 |
|            |     verified and    |                 |    Coordinating |
|            |     transferred     |                 |     Centers for |
|            |     into any        |                 |     Health      |
|            |     computer system |                 |     Promotion   |
|            |                     |                 |     on          |
|            | -   Robust product  |                 |     enterprise  |
|            |     that provides   |                 |     wide        |
|            |     an open         |                 |     license     |
|            |     programming     |                 |                 |
|            |     interface (API) |                 |                 |
|            |     for easy        |                 |                 |
|            |     integration     |                 |                 |
|            |                     |                 |                 |
|            | -   Sales support   |                 |                 |
|            |     is excellent    |                 |                 |
|            |     and very prompt |                 |                 |
|            |     to respond      |                 |                 |
|            |                     |                 |                 |
|            | -   Has a CDC       |                 |                 |
|            |     designated      |                 |                 |
|            |     account manager |                 |                 |
|            |                     |                 |                 |
|            | -   Other program   |                 |                 |
|            |     areas at CDC    |                 |                 |
|            |     (NCID, PEMS,    |                 |                 |
|            |     HIV, etc.) have |                 |                 |
|            |     been trained    |                 |                 |
|            |     and are         |                 |                 |
|            |     currently using |                 |                 |
|            |     the software    |                 |                 |
|            |                     |                 |                 |
|            | -   Natively        |                 |                 |
|            |     supports        |                 |                 |
|            |     Microsoft SQL   |                 |                 |
|            |     as underlying   |                 |                 |
|            |     database        |                 |                 |
|            |     (unlike other   |                 |                 |
|            |     solutions)      |                 |                 |
|            |                     |                 |                 |
|            | -   Support staff   |                 |                 |
|            |     is willing to   |                 |                 |
|            |     work with CCRs  |                 |                 |
|            |     in redesigning  |                 |                 |
|            |     the initial     |                 |                 |
|            |     form so that it |                 |                 |
|            |     works           |                 |                 |
|            |     effectively     |                 |                 |
|            |     with their      |                 |                 |
|            |     software        |                 |                 |
+------------+---------------------+-----------------+-----------------+

Technical Evaluation

Hardware / Software Requirements

> **System recommendations for a full installation**
>
> **Recommended PC configuration:**

-   Pentium family processor, 2.8 GHz

-   256 MB RAM (512 MB RAM\*)

-   Color monitor with SVGA graphics with resolution set to 1024 x 768

-   Hard disk with at least 40 GB free disk space

-   Mouse

-   CD-ROM drive

> **Minimum PC requirements:**

-   Pentium family processor, 450 MHz (766 MHz\*)

-   128 MB RAM (256 RAM\*)

-   Color monitor with VGA, with resolution set to at least 800 x 600

-   Hard disk with at least 200 MB free disk space

-   Mouse

-   CD-ROM drive

> **Databases**

-   RDM Server 4.0 (from FORMS 5-2 SP6)

-   Velocis 2.1 on Win NT4.0 SR6

-   MS SQL Server 2000

-   MS SQL Server 2005 Standard and Enterprise (FORMS 5-2 SP12 and
    later)

> **Certified scanners**
>
> Scanner models from the following manufacturers are certified for use
> with FORMS 5-2:

-   Böwe Bell + Howell

-   Canon

-   Fujitsu

-   InoTec

-   Kodak

-   Panasonic

-   Ricoh

> **Scanner interfaces**

-   SCSI: Adaptec 2940AU, 29160N, 29160

-   FireWire IEEE 1394

-   Kofax: Adrenaline and KF series • USB 2

> **Scanner drivers**

-   SCSI/FireWire: ISIS Pixel, or ISIS-compatible driver

-   Kofax: ImageControls 3.2 or later, VRS 3.x or later

-   USB: Manufacturers' standard scanner installations are supported

> **Operating systems**

-   Microsoft Windows 2000 Prof (recommended)

-   Microsoft Windows XP Prof (from FORMS 5-2 SP4)

-   Microsoft Windows Server 2003 Standard Edition (servers only) (From
    FORMS 5-2 SP9)

-   Microsoft Windows 98 & ME

-   Microsoft Windows NT 4.0

> **Network compatibility**

-   Microsoft networks, IP and SMB

Cost Estimating

> Depending upon geographic location, direct and indirect costs of the
> recommended solution may vary.

Cost Considerations

+----+-----------------------------+----------------------------------+
| It | Locally Installed Forms     | Notes                            |
| em | Recognitions Software Cost  |                                  |
|    | Component                   |                                  |
+----+-----------------------------+----------------------------------+
| 1. | ReadSoft Documents for      | Cost of the core software        |
|    | Forms                       | package                          |
+----+-----------------------------+----------------------------------+
| 2. | Yearly Maintenance          | Provides access to upgrades for  |
|    |                             | the system                       |
+----+-----------------------------+----------------------------------+
| 3. | Yearly Software Support     | Provides access to the vendor's  |
|    |                             | customer support team            |
+----+-----------------------------+----------------------------------+
| 4. | Initial Installation and    | Applies when vendor is used to   |
|    | Configuration               | assist with installation and     |
|    |                             | configuration of product         |
+----+-----------------------------+----------------------------------+
| 5. | CDC Certification and       | This CDC C&A process typically   |
|    | Accreditation               | takes 4-6 months if software has |
|    |                             | not already been through the C&A |
|    |                             | process                          |
+----+-----------------------------+----------------------------------+

Conclusion

> *ReadSoft Documents for Forms* is an effective, user-friendly solution
> for automating forms recognition. This solution has been adopted by a
> number of federal, state, and local government agencies including
> other program areas at CDC. ReadSoft has been successful implementing
> similar solutions across CDC.

[]{#_2.5__Education .anchor}

[^1]: Menck H, Deapen D, Phillips JL, Tucker, T, eds. *Central Cancer
    Registries: Design, Management and Use. 2^nd^ Edition.* Iowa:
    Kendall/Hunt, 2007.