**Quality Assurance Plan**

**for HUD Healthy Homes Initiative and Lead Technical Studies Grantees
and Contractors**

**TEMPLATE**

**VERSION 2.1**

**November 2005**

**PREFACE**

HUD Healthy Homes Initiative (HHI) and Lead Technical Studies grantees
and contractors should develop a Quality Assurance Plan (QA Plan) before
collecting any data for their grant. The attached template has been
written to assist grantees and contractors in developing the QA Plan.
This template can be downloaded from HUD's Office of Healthy Homes and
Lead Hazard Control website
([www.hud.gov/offices/lead](http://www.hud.gov/offices/lead)).

Standard text is provided throughout each section of this QA Plan
template. Grantees and contractors should modify the text as appropriate
to fit the needs of their organization and project. The specific writing
responsibilities of the grantee or contractor are highlighted in ***bold
italics*** throughout this document. If a particular sub-section is not
applicable to the project, a sentence to this effect should be provided
in the sub-section (that is, the sub-section should not be deleted).

The QA Plan is made up of four sections. The first, "Project
Management," contains information on management of the project,
including personnel, data, and records. The second, "Measurement/Data
Acquisition," provides detailed plans for the collection of the data. In
the third section, "Assessment/Oversight," such assessment activities as
audits, corrective actions, and reports to management are described.
Finally, the fourth section, "Data Verification and Usability," outlines
the checks and verification activities that will be performed to ensure
that the collected data are of the expected quality to meet the grant's
objectives.

The Data Quality Objectives (DQOs) specified in Section 1.5 are a very
important part of the QA Plan. They are used to establish quality
control measures (described in Section 2.5) and data verification
procedures (described in Section 4.2). Each Section addresses a
different component of the DQOs. This assures that the user objectives
are considered throughout the study so that the resulting data are of
the desired quality.

This template is a streamlined version of the U.S. Environmental
Protection Agency (EPA) Quality Assurance Project Plan (QAPP)
guidelines. EPA's Office of Environmental Information website
([www.epa.gov/quality](http://www.epa.gov/quality)) can be consulted for
additional information on implementing quality assurance programs and
writing quality assurance documents. Specifically, the EPA *Requirements
for Quality Assurance Project Plans for Environmental Data* (EPA
publication QA/R-5), and *Guidance for Quality Assurance Project Plans*
(EPA publication QA/G-5) documents, which provide EPA requirements and
guidance on writing QAPPs, can be downloaded from this website. Note
that the EPA QA/R-5 document contains a good glossary of quality
assurance (QA) and quality control (QC) terms used throughout this
template. Examples of actual QAPPs also can be found on EPA's website.

***\[Insert Title of Specific Project\]***

***\[Insert Organization Name and Address\]***

***\[Insert Grant or Contract/Task Order Number\]***

Approval for ***\[Insert Name of Organization\]:***

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

Principal Investigator Date

***\[Insert Name\]***

Approval for HUD Office of Healthy Homes and Lead Hazard Control:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date

***\[Insert Name\]***

**TABLE OF CONTENTS**

1.0 PROJECT MANAGEMENT

1.1 Distribution List

1.2 Project Organization

1.3 Problem Definition/Background

1.4 Project Description and Schedule

1.5 Quality Objectives and Criteria for Measurement Data

1.6 Special Training/Certification

1.7 Documentation and Records

1.8 Human Subjects Research

2.0 MEASUREMENT/DATA ACQUISITION

2.1 Experimental Design

2.2 Sampling and Survey Methods

2.3 Sample and Data Handling/Custody

2.4 Analytical Methods

2.5 Quality Control

2.6 Instrument/Equipment Testing, Inspection, and Maintenance

2.7 Instrument/Equipment Calibration and Frequency

2.8 Use of Existing Data

> 2.9 Data Management

3.0 ASSESSMENT/OVERSIGHT

3.1 Assessments and Response Actions

3.2 Reports to HUD

4.0 DATA VERIFICATION AND USABILITY

4.1 Data Review and Verification

4.2 Verification Methods

4.3 Reconciliation with User Objectives

**TABLE OF CONTENTS**

**Continued**

**APPENDICES**

APPENDIX A INSTITUTIONAL REVIEW BOARD APPROVAL

APPENDIX B SAMPLING PROTOCOLS

APPENDIX C ANALYTICAL METHODS

APPENDIX D SAMPLE LABELS

APPENDIX E SAMPLE CUSTODY FORMS

APPENDIX F SURVEY INSTRUMENTS

***\[Note: Add additional appendices as needed\]***

**1.0 PROJECT MANAGEMENT**

**1.1 [DISTRIBUTION LIST]{.underline}**

Individuals who will receive copies of the approved QA Plan and any
subsequent revisions are listed in Table 1-1. Each individual's role on
the project and the organization to which he/she belongs also are
provided. Note that "HUD OHHLHC" is the abbreviation for HUD's Office of
Healthy Homes and Lead Hazard Control, and "HUD GTR" refers to the HUD
Government Technical Representative for the grant.

**Table 1-1. Distribution List for QA Plan**

  ---------------------- ----------------------- ------------------------
  **Individual**         **Organization**        **Project Responsibility
                                                 / Role**

                         HUD OHHLHC              HUD GTR

                                                 Principal Investigator

                                                 Quality Assurance
                                                 Manager

                                                 Field Operations Manager

                                                 Laboratory Director

                                                 Data Management
                                                 Coordinator
  ---------------------- ----------------------- ------------------------

***\[Grantees and contractors should include all persons who are
responsible for implementation of the project, including managers, QA
managers, and representatives of all groups involved. Examples of the
types of people to include are provided in the table. Grantees and
contractors should add to and delete from this table as appropriate for
their individual project. Responsible managers also should be added to
the approval page preceding the Table of Contents.\]***

**1.2 [PROJECT ORGANIZATION]{.underline}**

***\[Insert name of principal investigator\]*** will have overall
responsibility for this study. The individuals who will assist the
principal investigator are listed below, followed by a brief description
of their responsibilities. Figure 1-1 displays the organizational
relationships among these individuals.

***\[Grantees and contractors should use the example organizational
chart as a guide, adding or deleting individuals as necessary for the
project. Grantees and contractors will identify all individuals or
organizations participating in the project and briefly describe their
specific roles and responsibilities. Grantees and contractors should
ensure that the study QA manager is independent of the organizational
unit that is generating the data. Grantees and contractors should
provide an organizational chart showing relationships and lines of
responsibility and communication among project participants, data users
outside the organization generating the data, and any subcontractors,
subgrantees and subcontractors involved in collecting or processing
data.\]***

**INSERT Figure 1-1.**

**Organizational Structure for *\[Insert Organization Name, Grant Name,
Grant or Contract/Task Order Number\]***

**1.3 [PROBLEM DEFINITION/BACKGROUND]{.underline}**

***\[Provide a one-paragraph summary on the background of the technical
studies that will be performed. Discuss the reasons for undertaking the
project. It is likely that much of the background write-up can be taken
from the grant proposal accepted by HUD. Sample language is provided
below for several projects.\]***

# *\[Sample language for an asthma/allergen related study\]* More than 17 million persons in the United States are estimated to have asthma (CDC, 1998a), and among children, it is the most common chronic illness (NAS, 2000). Furthermore, a substantial body of research, including population-based studies of school-aged children and young adults, indicates that the prevalence and severity of asthma have increased dramatically over the last several decades (CDC, 1998b). These increases in asthma prevalence and severity have occurred despite general reductions in levels of most air pollutants outdoors; therefore, many researchers instead point to coinciding changes in the home environment as potentially important, and possibly more important, factors in determining asthma risk. The strongest established risk factors for development of asthma are family history of allergic disease and sensitization (development of an allergic reaction) to one or more indoor allergens. Common indoor allergen sources include dust mites, cockroaches, animals (domestic animals and pests such as rodents), and mold. Research also indicates that other factors can exacerbate asthma symptoms, such as respiratory tract infections, bacterial endotoxins, indoor pollutants (environmental tobacco smoke, nitrogen oxides/indoor combustion products, formaldehyde, VOCs, pesticides), and outdoor pollutants that penetrate the indoor environment (sulfur oxides, ozone, particulate matter). \[Sources: CDC. 1998a. *Forecasted State-Specific Estimates of Self-Reported Asthma Prevalence \-- United States, 1998*. MMWR. December 4, 1998: 47(47); 1022-1025; CDC. 1998b. *Surveillance for asthma-United States, 1960-1995*. In: CDC Surveillance Summaries, MMWR. April, 1998: 47(no. SS-1); NAS. 2000. *Clearing the Air: Asthma and Indoor Air Exposures*. National Academy of Sciences Institute of Medicine, Division of Health Promotion and Disease Prevention. National Academy Press, Washington, D.C. 438 pp.\]

***\[Sample language for a study focusing on mold\]*** People are
routinely exposed indoors and outdoors to over 200 species of mold (NAS,
2000). Molds are usually saprophytes (i.e., they feed on dead organic
matter) and, when provided with sufficient moisture, can live off of
many materials found in homes, such as wood, cellulose in the paper
backing on drywall, insulation, wallpaper, glues used to bond carpet to
its backing, and everyday dust and dirt. Research indicates that certain
molds can cause a variety of adverse human health effects, including
allergic reactions and immune responses (e.g., asthma), infectious
disease (e.g., histoplasmosis), and toxic effects (e.g.,
aflatoxin-induced liver cancer) (ACGIH, 1999). Molds are thought to play
a role in asthma in several ways. They are known to produce a large
number of compounds that are potentially allergenic, and there is
sufficient evidence to support associations between fungal allergen
exposure and asthma exacerbation and upper respiratory disease (NAS,
2000). In addition, molds may play a role in asthma via release of
irritants that increase potential for sensitization, or release of
toxins (mycotoxins) that affect immune response (NAS, 2000). Finally,
mold toxins can cause direct lung damage leading to pulmonary diseases
other than asthma (NAS, 2000). \[Sources: ACGIH. 1999. *Bioaerosols:
Assessment and Control*. (J. Macher, ed.). American Conference of
Governmental and Industrial Hygienists, Cincinnati, Ohio; NAS. 2000.
*Clearing the Air: Asthma and Indoor Air Exposures*. National Academy of
Sciences Institute of Medicine, Division of Health Promotion and Disease
Prevention. National Academy Press, Washington, D.C. 438 pp.\]

***\[Sample language for a study focusing on carbon monoxide\]*** Carbon
monoxide (CO) is a colorless, odorless, and poisonous gas that is
produced as a by-product of incomplete combustion of carbon-based fuels
such as natural or liquefied propane (LP) gas, oil, wood, or coal. When
inhaled, CO readily combines with oxygen-binding proteins in the
bloodstream (e.g., with hemoglobin to form carboxyhemoglobin). This
interferes with oxygen being carried to the tissues and organs of the
body, and leads to adverse health effects, such as neurological
impairment, and eventually, at high enough levels, causes death by
asphyxiation. Although unintentional CO deaths have decreased steadily
over the past decade, an estimated 11,000 people were treated in
emergency rooms for suspected non-fire carbon monoxide poisoning in 1997
(NSC, 2000). According to the Consumer Product Safety Commission,
between 1991 and 1995, the total number of unintentional non-fire CO
poisoning deaths averaged about 560 annually (NSC, 2000). The majority
(66%) of these deaths occurred in the home. In the home, major sources
of CO include tobacco smoke, combustion appliances that are either
unvented (e.g., gas or kerosene space heaters) or that have improperly
installed or malfunctioning ventilation, and vehicle start-up and idling
in attached garages. CO levels also can become elevated in buildings
where backdrafting is occurring as a result of a constricted or poorly
functioning chimney; improperly designed or maintained venting systems;
or other house depressurization created by the operation of household
equipment such as exhaust fans, clothes dryers, and fireplaces.
\[Sources: National Safety Council, *Injury Facts 2000 edition*\]

***\[Sample language for a study focusing on lead\]*** Lead poisoning is
a continuing environmental health concern in the United States.
Reductions in blood-lead levels have been achieved through efforts to
remove lead from gasoline, food cans, and other consumer products.
However, the threat of lead poisoning still exists today through
exposure to lead-based paint. HUD estimates that 38 million homes
contain lead-based paint, and 26 million of these homes have significant
lead-based paint hazards (HUD, 2001). The primary concern with
lead-based paint is that paint dust is harmful when swallowed,
especially by children under the age of six. When ingested, lead can
affect children's developing nervous systems, resulting in learning
disabilities and a reduced IQ. \[Sources: HUD. 2001. *National Survey of
Lead and Allergens in Housing*. Office of Healthy Homes and Lead Hazard
Control, U.S. Department of Housing and Urban Development.\]

**1.4 [PROJECT DESCRIPTION, OBJECTIVES, AND SCHEDULE]{.underline}**

***\[Provide a one-page project description. In many cases, the project
description and objectives can be taken from the grant work plan
accepted by HUD. Alternatively, use the text/instructions provided below
to describe the project and how it will be conducted.\]***

This project will be conducted to investigate activities on
housing-related health and safety issues. ***\[Add a sentence or two
describing the specific HHI or lead activity being studied\]*** The
study will be conducted over a ***\[insert study length\]*** period
beginning in ***\[insert start month/year\]***. The following paragraphs
describe the work that will be performed.

***\[Provide an overall, concise description of the project. Include
project objectives; measurements to be made; applicable technical,
regulatory or program-specific quality standards, criteria, or
objectives; any special personnel and equipment requirements; assessment
tools needed; and project and quality records required, including the
types of reports needed.\]***

***\[If the study involves the collection of data from the general
public, discuss the process for working with HUD to obtain any required
approval from the U.S. Office of Management and Budget (OMB). (Note:
This is not required for grantees. You should check with your GTR or GTM
if you have any question regarding the need to obtain OMB***

***approval .)\]***

***\[If the study fits the broad definition of human subject research
(as defined by the Department of Health and Human Services (45 CFR 46)),
indicate whether IRB approval has been obtained (see section 1.8,
below)).\]***

The schedule for completing the various tasks associated with this study
is illustrated in Figure 1-2. ***\[Briefly discuss key milestones and
how they fit into the schedule. The schedule can be portrayed by
inserting the project's benchmark spreadsheet. (The financial
information can be omitted. Templates and sample benchmark spreadsheets
are at the OHHLHC website,
[www.hud.gov/offices/lead](http://www.hud.gov/offices/lead).) Figure 1-2
below is another example of how this schedule can be portrayed. Grantees
and contractors should tailor the schedule to fit the project's needs,
adding to, or deleting from, the sample project activities as necessary,
and should portray the schedule in whatever visual format they wish
(i.e., not necessarily the example "table" format).\]***

+-----------------------+-----------------------------------------------+
| **Project Activity**  | **Activity Period (Months After Project       |
|                       | Initiation)**                                 |
+-----------------------+-----------------------------------------------+
|                       | **0 3 6 9 12 15 18 21 24**                    |
+-----------------------+-----------------------------------------------+
| Study Design, Develop | (\-\-\--)                                     |
| QA Plan               |                                               |
|                       | (\-\-\-\-\-\--)                               |
| OMB/IRB Approval      |                                               |
|                       | (\-\-\-\-\-\-\-\-\-\-\-\                      |
| Enrollment of         | -\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--) |
| participants          |                                               |
|                       | (\-\-\-\-\-\-\-\-\-\-\-\                      |
| Sample Collection     | -\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--) |
|                       |                                               |
| Laboratory Analysis   | (\-\-\-\-\-\-\-\-\-\-\-\                      |
|                       | -\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--) |
| Database Management   |                                               |
|                       | (                                             |
| Statistical Analysis  | \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\ |
|                       | -\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--) |
| Report Writing        |                                               |
|                       | (\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--)       |
|                       |                                               |
|                       | (\-\-\-\-\-\-\-\-\--)                         |
+-----------------------+-----------------------------------------------+

**Figure 1-2. Schedule of Accomplishments and Milestones**

**1.5 [QUALITY OBJECTIVES AND CRITERIA FOR MEASUREMENT
DATA]{.underline}**

The objectives of this study are described in Section 1.4. These
objectives will be addressed by collecting data on ***\[specify a brief
description of types of data measurements\]***. In regard to collecting
these data, this study is intended to satisfy the following data quality
objectives (DQOs).

-   ***\[Specify DQO 1\]***

-   ***\[Specify DQO 2\]***

-   ***...***

-   ***\[Specify DQO n\]***

\[As described by EPA, DQOs are qualitative and quantitative statements
that clarify the study objective; define the most appropriate type of
data to collect; determine the most appropriate conditions from which to
collect the data; and specify tolerable limits on decision errors which
will be used as the basis for establishing the quantity and quality of
data needed to support the decision. The DQOs are then used to develop a
scientific and resource-effective data collection design.\]

\[DQOs must clearly spell out how the data collected for the study will
be used for decision-making. They may be quantitative or qualitative,
depending on the nature of the research. For example, a pilot study to
determine the feasibility and acceptance of a new sampling method might
specify many qualitative DQOs related to information on ease of use,
field technician acceptance, inconvenience to occupants, etc. On the
other hand, a study addressing whether a new sampling method provides
equivalent results to an established method would require quantitative
DQOs addressing accuracy, precision, and the power to detect differences
of a specified magnitude. If desired, EPA's "Guidance for the Data
Quality Objectives Process" document (QA/G-4) can be consulted for a
more technical discussion of DQOs, as well as a description of EPA's
7-step DQO process
([www.epa.gov/quality/qs-docs/g4-final.pdf](http://www.epa.gov/quality/qs-docs/g4-final.pdf)).\]

\[Points to remember in specifying DQOs include:

1)  Clearly state the decision that will be made using the data.

2)  Clearly state the statistical or non-statistical analysis that will
    be used as the basis of the decision.

3)  Clearly state any minimum data quality requirements for the analysis
    in #2.

DQOs should be specified, regardless of whether the study involves data
from sampling, surveys, or some other assessment method. Even if the
study data will not be used to make specific decisions, DQOs still are
necessary to document the systematic planning that occurred in designing
the study's data collection procedures. To aid in writing DQOs, a few
examples are provided to show the types of quantitative and qualitative
statements that can serve as study DQOs.

> ***[Sample DQOs]{.underline}:***

-   ***Based on a survey of residents, establish if a statistically
    significant correlation exists between knowledge of proper cleaning
    techniques (as measured by a rating of 1-5 using our knowledge
    index) and reduced instances of asthma (as measured by self-reported
    days of work or school due to asthma).***

-   ***Based on interviews with field technicians and occupants,
    determine whether a new field sampling protocol for collecting dust
    samples is feasible. At least 3 different technicians and 10
    occupants must be interviewed. Feasibility will be determined by: no
    respondents finding the method "excessively burdensome", average
    sampling time estimated to be less than 1 hour per house, and no
    safety issues identified.***

-   ***Determine whether the lead hazard control interventions performed
    on the study homes resulted in a statistically significant reduction
    in average dust-lead levels. This will be assessed by conducting a
    t-test on the log-transformed data with a minimum of 20 dust samples
    collected pre- and post-intervention. The observed variability must
    be such that there is at least 80% power to detect a 50% reduction
    in dust-lead levels.***

-   ***Collect side-by-side dust samples from residential units to
    determine whether the slope of a relationship between samples
    analyzed for target allergens by ELISA and by particle
    immunostaining is significantly different from 1.0 at the 0.05 level
    of significance, with 80% power.***

-   ***Collect dust samples from residential units to determine with 95%
    confidence whether a unit has an average dust mite level above the
    exacerbation level of 10 μg/g, thus requiring a hazard control
    intervention.\]***

In addition to the above DQOs, the data to be collected in this study
will need to satisfy the following criteria on quality:

\[The quality criteria to be presented here represent standards that the
collected data need to achieve in order to be acceptable for their
particular use on this study. Typically, the QA Plan will specify
minimum criteria for such data quality measures as precision, bias,
sensitivity, representativeness, completeness, and comparability,
although the specific set of quality measures may differ among different
types of studies. (These example measures tend to be used most often
when collecting and analyzing environmental and biological samples; some
of these measures may not be relevant for other types of studies such as
surveys or visual inspections.) To help illustrate how to specify
minimum criteria on these data quality measures, an example is provided
from a study that involves collecting household dust samples for
allergen analysis. In place of the example, grantees and contractors
should supply appropriate criteria for those quality measures that are
applicable to the data to be collected on their study. In doing so,
grantees and contractors working with contracted analytical laboratories
should contact laboratory representatives to get information on the
quality guidelines kept by the laboratories on the data that they will
generate. For more information and definitions on measures of data
quality, see the EPA "Guidance on Data Quality Indicators" document
(QA/G-5i).\]

[Precision]{.underline} - a measure of agreement among repeated
measurements of the same property, under identical or substantially
similar conditions. This is the random component of error associated
with the measurements; typically expressed as a range, standard
deviation, or coefficient of variation. ***At one randomly selected
location in each house, side-by-side dust samples will be collected for
analysis. Results for these two samples that are above the MDL and have
a coefficient of variation greater than 50% and will indicate potential
problems with the analytical results for the entire batch of samples (it
is also possible that this could be an indication of large spatial
variability -- both alternatives should be investigated.)\]***

[Bias]{.underline} - the systematic or persistent distortion of a
measurement process that causes error in one direction. It can be
determined from measurements associated with blank or spiked samples.
***One field blank sample will be submitted with each batch of collected
dust samples. In addition, one field spike sample will be submitted with
every 10^th^ batch of samples. Blank samples exceeding the detection
limit or spike samples outside ±20% of the known value will indicate
potential problems with the analytical results for the entire batch of
samples.***

[Sensitivity]{.underline} - the capability of a method or instrument to
discriminate between measurement responses representing different
levels. ***Discrimination will be assessed by examining a control curve
containing 11 points. The curve will be formed by analyzing a
concentration of 10x the standard and ten additional concentrations
created by repeated dilutions by a factor of 2.***

[Representativeness]{.underline} - a qualitative term that expresses the
degree to which data accurately and precisely represent a characteristic
of a population, parameter variations at a sampling point, a process
condition, or an environmental condition. ***Samples will be collected
from a random sample of houses known by the health department to be
inhabited by a child with asthma. Thus, the sample results will
represent allergen levels of dust found in study-area homes of a child
known to be asthmatic.***

[Completeness]{.underline} - a measure of the amount of valid data
obtained from a measurement system compared to the amount that was
expected to be obtained under correct, normal conditions. ***Valid
analytical results for 95% of samples from 95% of the sampled houses are
required.***

[Comparability]{.underline} - a qualitative term that expresses the
measure of confidence with which data from one data set can be compared
to another. ***All sampling personnel will receive training in and will
use the same sampling protocols (Section 2.2), and field audits will
periodically occur to ensure that sampling personnel are following the
prescribed protocols. In addition, all samples will be submitted to the
same accredited laboratory for analysis by the same method, thus data
results will be comparable.***

**1.6 [SPECIAL TRAINING/CERTIFICATION]{.underline}**

The responsibility of addressing training and certification needs will
be handled by ***\[Grantee should specify person(s) and organizational
unit(s) responsible for identifying, ensuring, and documenting that
personnel and organizations have and maintain the appropriate knowledge,
skill, and statutory, regulatory, professional or other certifications,
licenses, or other formal qualification necessary for performing their
specific tasks. Specify the accreditation/certification/recognition
status of personnel and laboratories used for sampling and/or
measurement of analytes (e.g., lead-based paint inspection
certification, NLLAP recognition, or EMLAP accreditation). Furthermore,
identify and describe any specialized training or certification
requirements necessary for conducting this study and discuss how such
training will be provided and how the necessary skills will be assured
and documented.\]***

***\[In some environmental data operations, special training and/or
certification requirements may be necessary in order to ensure the
health and safety of field sampling and/or laboratory personnel.
Grantees and contractors should consult the following web sites and
other relevant sources for information on pertinent training
opportunities and guidance, and indicate in this section any procedures
that will be implemented and followed to ensure the health and safety of
field sampling and laboratory personnel working on this project.***

> ***Occupational Safety and Health Administration (OSHA)***

[www.osha.gov/fso/ote/training/training_resources.html](http://www.osha.gov/fso/ote/training/training_resources.html)

> ***National Institute for Occupational Safety and Health (NIOSH)***
>
> [www.cdc.gov/niosh/training.html](http://www.cdc.gov/niosh/training.html)
>
> ***U.S. Environmental Protection Agency (EPA)***
>
> [www.epa.gov/lead/leadcert.htm](http://www.epa.gov/lead/leadcert.htm)
>
> ***American Association for Laboratory Accreditation (A2LA)***
>
> [www.a2la2.net/training/Courses2003.cfm](http://www.a2la2.net/training/Courses2003.cfm)
>
> **American Industrial Hygiene Association (AIHA)**
>
> [www.aiha.org](http://www.aiha.org/)

***\[The Grantee or contractor's goal should be to provide a safe
working environment for personnel working on the project, whether in the
laboratory or in the field, as well as ensuring the safety and care of
study subjects and property.\]***

**1.7 [DOCUMENTATION AND RECORDS]{.underline}**

The following documentation will be maintained in the data records from
this study. ***\[Grantees and contractors should state the information
and records to be included in the data records. Possible records to be
included are field operation records (e.g., sample collection records,
chain-of-custody records, QC sample records, general field procedures
and corrective action reports), survey forms, laboratory records (e.g.,
sample data, sample management records, test methods, and QA/QC
reports), data handling records (e.g., protocols used in data reduction,
verification, and validation), and records associated with IRB approval
and continuing oversight .\]*** These records will be reported in the
following formats: ***\[Grantees and contractors should state the
desired reporting format for hard copy and electronic forms.\]***

***\[Grantees and contractors should identify any other records and
documents applicable to the project, such as audit reports, quarterly
progress reports, and final reports, that will be produced.***

***Specify or reference all applicable requirements for the final
disposition of records and documents, including location of records and
length of retention period.\]***

**1.8 [HUMAN SUBJECTS RESEARCH]{.underline}**

If the study requires Institutional Review Board (IRB) approval because
it involves human research as defined by the Department of Health and
Human Services (DHHS) (see 45 CFR 46 as codified by HUD at 24 CFR 60),
provide a copy of the approval of the research from an Institutional
Review Board that is registered with DHHS (see Appendix A). Also,
provide evidence that your organization has an institutional assurance
that it will comply with the federal policy for the protection of human
subjects, that has been approved by the DHHS Office of Human Research
Protections (i.e., provide the assurance number). ***\[You should
describe how you will ensure that your consent process will be
understood by study participants and how you will ensure that you follow
through with promises made to study participants (e.g., that they will
be provided with the results of environmental sampling in a timely
manner). Also, indicate how compliance with IRB requirements will be
monitored during implementation of the study.\]***

Grantees that must comply with the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule should describe the procedures
that will be followed to ensure compliance with these regulations.

**2.0 MEASUREMENT/DATA ACQUISITION**

**2.1 [EXPERIMENTAL DESIGN]{.underline}**

In order to meet the objectives specified in the Project Management
section above, the project experimental design is as follows.
***\[Grantees and contractors should describe the experimental design or
data collection design for the project and classify all measurements as
critical (i.e., required to achieve project objectives) or non-critical
(i.e., for informational or background purposes only). All relevant
components of the experimental design should be described and
rationalized, including the target group or population to be addressed;
type and number of samples to be collected and analyzed; key parameters
to be estimated; and date, location, and procedure for sample
collection.\]***

**2.2 [SAMPLING AND SURVEY METHODS]{.underline}**

Procedures to be used for sample collection are described below.
***\[For each biological/ environmental sample type, grantees and
contractors should describe the procedures for collecting samples and
identify the sampling methods and equipment. If the method is standard
(e.g., an ASTM, ANSI, NIOSH, EPA, or CDC method), the organization name,
standard number, title, date, and regulatory citation (as appropriate)
are sufficient description. If a standard method will be modified
slightly for this study, the standard method should be cited along with
a description of the modification. If a non-standard method, or a
significantly modified standard method, will be used, provide a brief
description of the procedures to be used here (with references cited as
appropriate), and details on the procedures to be used in the study in
an appendix. The details for sampling procedures should include any
implementation requirements; support facilities; determination of sample
areas, volumes, or masses; materials and processes for selecting,
preparing, and decontaminating sample containers; sample preservation
requirements; and, if appropriate, disposal of decontamination
by-products.\]***

***\[For studies that include surveys, grantees and contractors should
describe the procedures for administering the survey. This should
include the survey sampling methodology and weighting factors. A copy of
the survey instrument should be provided in the appendix. If computers
(e.g., laptops, handheld PCs) will be used to collect the survey
responses, then requirements for using the software should be described.
Address the validity/reliability of the survey/assessment instrument.
Grantees and contractors should use validated survey instruments or
validate their instrument (i.e., determine that it is measuring what it
is intended to measure and that the specific measures are
reliable).\]***

***\[Additionally, grantees and contractors should describe specific
performance requirements for the method, and address what to do when a
failure in the sampling occurs, who is responsible for corrective
action, and how the effectiveness of the corrective action shall be
determined and documented.\]***

3.  **[SAMPLE AND DATA HANDLING/CUSTODY]{.underline}**

To ensure sample integrity throughout the collection and analysis
process, the following sample handling and custody requirements will be
followed***. \[Grantees and contractors should describe requirements and
provisions for sample handling and custody in the field, laboratory, and
transport, taking into account the nature of the samples, the maximum
allowable sample holding times before extraction or analysis, and
available shipping options and schedules. Grantees and contractors
utilizing electronic equipment for collecting survey data should
describe requirements for uploading the data and procedures (e.g.,
backups) for preventing any loss of data in the field. Specify titles of
responsible personnel (listed in Table 1-1) for each component of sample
handling and custody.\]***

***\[Grantees and contractors also should include examples of sample
labels, chain-of-custody forms, and sample custody logs in appendices to
the QA Plan.\]***

4.  **[ANALYTICAL METHODS]{.underline}**

Analytical methods and equipment required for this project include
***\[Grantees and contractors should identify the analytical methods and
equipment required. If the method is standard (e.g., an ASTM, ANSI,
NIOSH, EPA, or CDC method), the organization name, standard number,
title, date, and regulatory citation (as appropriate) are sufficient
description (if applicable, also state the particular options of the
method that will be used). If a standard method will be modified
slightly for this study, the standard method should be cited along with
a description of the modification. If a non-standard method, or a
significantly modified standard method, will be used, provide a brief
description of the procedures to be used here (with references cited as
appropriate), and details on the procedures to be used in the study in
an appendix. The details also should include subsampling or extraction
methods, laboratory decontamination procedures and materials (such as
the case of hazardous samples), waste disposal requirements (if any),
and specific performance requirements for the method.\]***

***\[For non-standard methods, such as unusual sample matrices and
situations, appropriate method performance study information is needed
to confirm the performance of the method for the particular matrix. If
previous performance studies are not available, they must be developed
during the project and included as part of the project results.\]***

***\[Grantees and contractors should specify the laboratory turnaround
time(s) needed, if important to the project schedule. Grantees and
contractors also should address what to do when a failure in the
analytical system occurs, who is responsible for corrective action, and
how the effectiveness of the corrective action shall be determined and
documented.\]***

**2.5 [QUALITY CONTROL]{.underline}**

Quality control (QC) procedures to be implemented during this project
are ***\[Grantees and contractors should identify the required
measurement QC checks for both the field and the laboratory; the
frequency of analysis for each type of QC check; the spike materials,
sources, and levels (if spike samples are to be used); whether
replicates will be used; the statistical procedures to be used; the
required control limits for each QC check (either explicitly or by
reference); the corrective action required when control limits are
exceeded; and how the effectiveness of the corrective action shall be
determined and documented, using the specified measurement performance
criteria from Section 1.5 above.\]***

6.  **[INSTRUMENT/EQUIPMENT TESTING, INSPECTION, AND
    MAINTENANCE]{.underline}**

***\[Grantees and contractors using laboratories that successfully
participate in an appropriate lab QA program (e.g., NLLAP recognition,
or EMLAP accreditation) need only cite that successful participation
here. Alternatively, use the text/instructions below to describe the
planned instrument/equipment testing, inspection, and maintenance
procedures.\]***

To verify that all instruments and equipment are maintained in sound
operating condition and are capable of operating at acceptable
performance levels, the following inspections and acceptance testing
procedures will be followed. ***\[Grantees and contractors should
describe the performance and documentation of inspections and acceptance
testing of environmental sampling and measurement systems and their
components.\]***

***\[Grantees and contractors should describe methods for resolving
deficiencies and when re-inspection will be performed.\]***

***\[Grantees and contractors should describe or reference how periodic
preventive and corrective maintenance of measurement or test equipment
will be performed. Equipment and/or systems requiring periodic
maintenance shall be identified.\]***

**2.7 [INSTRUMENT/EQUIPMENT CALIBRATION AND FREQUENCY]{.underline}**

***\[Grantees and contractors using laboratories that successfully
participate in an appropriate lab QA program (e.g., NLLAP recognition,
EMLAP accreditation) need only cite that successful participation here.
Alternatively, use the text/instructions below to describe the planned
instrument/equipment calibration and frequency procedures.\]***

Calibration procedures shall be performed on the following measurement
equipment: ***\[Grantees and contractors should identify all
instruments, tools, gauges, and other sampling, measuring, and test
equipment used for data collection activities affecting quality that
must be controlled and, at specified periods, calibrated to maintain
performance within specified limits.\]*** Calibration procedures to be
performed on the equipment to be used for instrumental analytical
methods and other measurement methods include ***\[Grantees and
contractors should document the intended calibration procedure(s) that
will be used for each instrument. If the calibration procedure is
standard (e.g., an ASTM, ANSI, NIOSH, EPA, or CDC method), the
organization name, standard number, title, date, and regulatory citation
(as appropriate) are sufficient description. If a standard method will
be modified slightly for this study, the standard method should be cited
along with a description of the modification. Grantees and contractors
also should describe how often each measurement instrument will be
calibrated.\]***

***\[Grantees and contractors should identify the certified equipment
and/or standards used for calibration. Grantees and contractors should
describe or reference how calibration will be conducted using certified
equipment and/or standards with known, valid relationships to nationally
recognized performance standards. If no such nationally recognized
standards exist, grantees and contractors should document the basis for
the calibration. Grantees and contractors also should indicate how
records of calibration shall be maintained and be traceable to the
instrument.\]***

**2.8 [USE OF EXISTING DATA]{.underline}**

Previously collected data, literature files, and other sources of
outside information to be used in this project include: ***\[Grantees
and contractors should identify any types of data needed for project
implementation or decision making that are obtained from such
non-measurement sources as literature files and historical databases,
and provide the documentary citations.\]***

***\[Additionally, grantees and contractors should define the acceptance
criteria for the use of such data in the project and discuss any
limitations on the use of the data resulting from uncertainty in their
quality. Examples of relevant acceptance criteria categories are
representativeness, bias, and precision; project-specific quantitative
criteria should be provided.\]***

9.  **[DATA MANAGEMENT]{.underline}**

Once the raw ("as collected") data have been collected, they will be
handled according to the following data management procedures.
***\[Grantees and contractors should describe the project data
management scheme, tracing the path of the data from their generation in
the field or laboratory to their final use and archiving. Grantees and
contractors should describe or reference the standard record-keeping
procedures, document control system, and approach to be used for data
storage and retrieval on electronic media. For standard methods, if a
method allows the user to select from various options, then the method
citation should state exactly which options are being selected. Data
entry procedures for ensuring the quality of entered data (e.g.,
double-data entry, range checks, etc.) should be discussed.\]***

***\[Grantees and contractors should discuss the control mechanism for
detecting and correcting errors and for preventing loss of data during
data reduction, data reporting, and data entry to forms, reports, and
databases. See above regarding standard procedures. Grantees and
contractors should provide examples of any forms or checklists to be
used for these purposes.\]***

***\[Grantees and contractors should identify and describe all data
handling equipment and procedures to process, compile, and analyze the
data, including any required computer hardware and software. See above
regarding standard procedures. Grantees and contractors should address
any specific performance requirements and describe the procedures that
will be followed to demonstrate acceptability of the hardware/software
configuration required.\]***

**3.0 ASSESSMENT/OVERSIGHT**

**3.1 [ASSESSMENTS AND RESPONSE ACTIONS]{.underline}**

Evaluation and validation of this project will be ensured through the
use of internal and external assessment activities. These assessment
activities will ensure that all elements of the QA Plan have been
correctly implemented, implementation of the QA Plan has generated data
of adequate quality, and the necessary corrective actions have been
implemented in a timely and effective manner. For this project,
assessment activities to be performed include ***\[Grantees and
contractors should identify and describe each assessment activity to be
performed in this project, as well as how frequently each activity will
be performed. Possible assessment activities include, but are not
limited to, field audits, management reviews, and laboratory audits.
EPA's "Guidance on Technical Audits and Related Assessments" document
(QA/G-7) can be consulted for information on conducting audits
([www.epa.gov/quality/qs-docs/g7-final.pdf](http://www.epa.gov/quality/qs-docs/g7-final.pdf)).
This section should include a discussion of the information expected,
the success criteria (e.g., goals, performance objectives), and the
responsible person(s) who will conduct the assessment for each
assessment proposed.\]***

The schedule for audit activities is ***\[Grantees and contractors
should list the approximate schedule of activities.\]*** Assessment
personnel will include ***\[Grantees and contractors should identify the
potential organizations and participants who will perform the
assessments and to whom they will report their findings within the
organizational structure presented in Figure 1-1.\]***

The individual responsible for ensuring that corrective action is taken
is ***\[Grantees and contractors should identify who is responsible for
overseeing the response action to non-conforming conditions.\]*** The
protocol for effectively addressing corrective actions is ***\[Grantees
and contractors should discuss how response actions to non-conforming
conditions shall be addressed and describe how response actions shall be
verified and documented.\]***

**3.2 [REPORTS TO HUD]{.underline}**

Written reports covering the progress made and the results of this study
will be delivered to the HUD GTR on a regular basis. The schedule for
these reports is provided in Table 3-1.

**Table 3-1. Schedule of Reports for *\[Insert Project Name\]***

+--------------------------------+-------------------------------------+
| **Report**                     | **Due Date**                        |
+--------------------------------+-------------------------------------+
| QA Plan                        |                                     |
+--------------------------------+-------------------------------------+
| Quarterly Progress Reports     |                                     |
+--------------------------------+-------------------------------------+
| Tenant/Owner Notifications     |                                     |
| report/manuscript (draft)      |                                     |
|                                |                                     |
| Journal                        |                                     |
|                                |                                     |
| Manuscript (draft)             |                                     |
+--------------------------------+-------------------------------------+
| Final report/manuscript        |                                     |
| (draft)                        |                                     |
+--------------------------------+-------------------------------------+
| Final report/manuscript        |                                     |
| (final)                        |                                     |
+--------------------------------+-------------------------------------+
| Data Report                    |                                     |
+--------------------------------+-------------------------------------+

As shown in the table, various types of reports will be written.
Descriptions of these reports are as follows.

-   [QA Plan]{.underline} -- this document

-   [Quarterly Progress Report]{.underline} -- a brief report that
    updates HUD on the work that has been performed over the last
    quarter. Items such as number of samples collected and analyzed,
    number of surveys completed, problems encountered in the field or
    laboratory, and comparisons with schedule and budget milestones will
    be included.

-   [Tenant/Owner Notifications]{.underline} -- a document that reports
    the analytical results to the tenant and/or owner of the residential
    unit where sampling or visual inspections occurred (may not be
    applicable to all grants).

-   [Final Report]{.underline} -- a document that provides a complete
    description of the project, including the results of evaluation
    activities and overall conclusions with respect to original
    objectives and hypotheses.

-   [Journal Manuscript]{.underline} -- a manuscript that documents the
    work performed, results obtained, and conclusions reached for the
    study. The manuscript will be suitable for publication in a
    scientific, peer-reviewed journal ***\[add text specifying the names
    of likely journals\]***. Based on discussions with the GTR, it may
    be agreed that one or more manuscripts may be submitted as a final
    report.

-   [Data Report]{.underline} -- a fully documented electronic dataset
    of the data collected during the study. A CD ***\[specify different
    media if necessary\]*** containing the study data will be produced
    that is suitable for distribution to the public. ***\[Specify data
    format (e.g., ASCII comma-delimited text file, Excel spreadsheet,
    Access database, SAS export data file, etc.) for each component of
    the dataset.\]*** In addition to the data files, an electronic data
    dictionary that describes the contents of each data field (including
    the data format) will be included on the CD.

***\[Reports listed above are routinely expected to be provided.
Grantees and contractors should consult with their GTR for final
guidance on what specific documents are required under their grant and
when those documents must be submitted.\]***

**4.0 DATA VERIFICATION AND USABILITY**

**4.1 [DATA REVIEW AND VERIFICATION]{.underline}**

In order to determine if data collected during the project meet the
stated data quality objectives (Section 1.5), the Study QA Manager will
subject all data to a verification process. Data will be reviewed using
the criteria specified below, and any data that fail to meet any of the
criteria will be investigated as described in Section 4.2. If data
errors cannot be corrected (i.e., errors other than calculation errors,
data entry errors, transcription errors, etc.), those data will be
excluded from final analyses.

***\[Grantees and contractors should state here the criteria used to
review and validate data.\]***

**4.2 [VERIFICATION METHODS]{.underline}**

Data verification will be performed to ensure that the criteria
specified in Section 4.1 have been met. Methods for verifying the
compliance, correctness, consistency, and completeness of the data are
described below.

***\[Each verification element is defined below. In place of each
definition, supply the appropriate details on how the verification will
occur, as applicable to this study. EPA's "Guidance on Environmental
Data Verification and Validation" document (QA/G-8) can be referenced
for additional details about these verification elements
([www.epa.gov/quality/qs-docs/g8-final.pdf](http://www.epa.gov/quality/qs-docs/g8-final.pdf)).***

[Compliance]{.underline} - ***verifies that the values of individual
data points meet the criteria specified in the QA Plan and that data
collection adheres to standard operating procedures (SOPs).***

[Correctness]{.underline} - ***evaluates whether data collection
protocols were followed and basic operations and calculations were
performed correctly.***

[Consistency]{.underline} - ***evaluates the comparability of data
reported over multiple places and collection sites, determining whether
collection procedures were followed in the same manner.***

[Completeness]{.underline} - ***obtains all required data and reports
deficiencies.***

***Grantees and contractors should provide examples of any
project-specific calculations and any forms or checklists to be used in
performing the verification.\]***

***\[The following text may not be applicable to every grantee or
contractor. Grantees and contractors should add to, delete from, and
expand on the discussion that is provided.\]***

Visual and electronic comparisons of sample data against raw data
collection forms, review of QC-charts and other data plots, and outlier
checks will be performed to identify possibly erroneous data. When data
problems are found, the Study QA Manager will notify the responsible
person for the data (field coordinator, data management coordinator,
laboratory director, etc.). This individual will attempt to resolve the
data problem. Possible solutions include correcting a mistake in a
spreadsheet formula, correcting a calibration curve, and correcting data
entry errors due to sloppy handwriting on data collection forms.
Corrected data will be re-submitted to the Study QA Manager for
verification again.

Data that are confirmed to be in error but cannot be corrected (e.g.,
sample was contaminated in laboratory) will be removed from the study
database and replaced with a flag indicating the specific problem. Data
that appear suspicious but have no reason for which to invalidate them
will be reported in the database accompanied by a flag that indicates
their possible outlier status. Analysts and users of the data will need
to consider how to include these data points in their analyses.

**4.3 [RECONCILIATION WITH USER OBJECTIVES]{.underline}**

Reconciliation with the data quality objectives specified in Section 1.5
will be performed once all data problems have been resolved.
***\[Grantees and contractors should provide details on how this
reconciliation will occur. Methods to analyze the data and determine
possible anomalies or departures from assumptions established in the
planning phase of data collection should be outlined. A discussion of
how issues will be resolved and how limitations on the use of the data
also should be provided.\]***

***\[Grantees and contractors should state under what circumstances
re-sampling will be performed for cases where the collected data do not
meet the stated data quality objectives.\]***

**APPENDICES**