# American Health Information Community

# Population Health and Clinical Care Connections Workgroup

# Summary of the 16th Meeting of this Workgroup

# Thursday, March 29, 2007

## Purpose of Meeting

-   Hear and discuss testimony on outbreak and event management from the
    perspectives of local, State, and Federal public health.

-   Hear and discuss testimony on laboratory response from the
    perspectives of State public health labs and the Centers for Disease
    Control and Prevention (CDC).

-   Discuss testimony on both outbreak and event management and
    laboratory response.

-   Identify additional testimony needed in the priority area of
    response management.

-   Discuss and schedule testimony on communications and countermeasure
    allocation, distribution, and administration.

## Key Topics

### 1. Meeting Opening

*Federal Advisory Committee Act (FACA)* -- American Health Information
Community (AHIC) Director Judy Sparrow noted that all AHIC Workgroup
(WG) meetings are designed to meet the requirements of the FACA and
therefore are publicly broadcast over the Internet and recorded and
transcribed for later access via the publicly available AHIC Web site
([www.hhs.gov/healthit/ahic.html](http://www.hhs.gov/healthit/ahic.html)).

*Opening Remarks from Workgroup Co-chairs* -- WG Co-chair John Lumpkin
noted that the Population Health and Clinical Care Connections (PHCCC)
WG has made recommendations to AHIC in the areas of case reporting and
bidirectional communications, and is in the process of developing
recommendations to AHIC on adverse events reporting. In addition, today
and in the near future the WG will take day-long testimony in key areas
of response management, first on outbreak and event management and
response and then on communications and countermeasure allocation,
distribution, and administration. This testimony will lead to the
development of recommendations to AHIC.

### 2. Hear and Discuss Testimony on Outbreak and Event Management

###### A. Local Public Health

*A. 1.* Paula Soper, Senior Analyst for Public Health Informatics,
National Association of County and City Health Officials (NACCHO), gave
a slide presentation entitled

"The Role of Local Public Health in Outbreak and Event Management" (see
<http://www.hhs.gov/healthit/achic/materials/03_07/phccc/soper.ppt>).

Local public health departments (LHDs) tend to be on the front line of
outbreak protection and outbreak and event management, with most
conducting environmental health and communicable or infectious disease
surveillance themselves or with State health departments. Data are
commonly needed from labs and the private-health sector, including
hospitals. Disease reporting is still by and large a paper-and-pencil
endeavor, and lack of local control over information management
resources presents a challenge to the perceived need for standards-based
Outbreak Management Systems (OMSs) that would enable electronic linkage
and data exchanges across cases, exposures, and providers. Findings from
the 2005 National Profile of LHDs indicated that 9 percent of those
surveyed had implemented Federal health information technology (HIT)
standards, and 29 percent were using electronic health records (EHRs).
Very early results from an ongoing survey indicates 19 percent of LHDs
engage in data exchanges with Regional Health Information Organizations
(RHIOs)/Health Information Exchanges (HIEs), and 42 percent use this for
disease reporting and biosurveillance.

*A. 2.* Annie Fine, MD, Medical Epidemiologist, New York City (NYC)
Department of Health and Mental Hygiene, gave a slide presentation
entitled "Information Needs in Outbreak Management: A Local Perspective"
(see
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/layton.ppt>).

Recent outbreaks in NYC involved many challenges, including tracking lab
data; linking epidemiology with lab data (unique identifiers on
specimens would have been useful); demand for daily data reports; and
lack of robust information systems to help manage data volume, multiple
data sources, and data sharing, including across jurisdictions. Major
gaps in current capabilities need to be addressed through flexible,
scalable databases; workflow management support; and enhanced
bidirectional messaging with other databases. Continued Federal funding
of the CDC's OMS is needed or LHD access to another OMS with similar
functions tailored to user needs, as well as strengthening of State and
LHD IT infrastructure. Access to EHRs would be useful but not wholly
sufficient to close outbreak management gaps.

###### B. State Public Health

*B. 1.* Janet Hamilton, Communicable Disease Surveillance and Reporting
Manager, Florida Department of Health, Bureau of Epidemiology, gave a
slide presentation entitled "Outbreak Management: Merlin Outbreak
Module" (see
[http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/hamilton.ppt](http://www.hhs.gov/healthit/achic/materials/03_07/phccc/hamilton.ppt)).

State health departments provide significant support to LHDs during
outbreak investigations and engage in information exchange when
investigations cross jurisdictions. Merlin, the Florida Bureau of
Epidemiology's Web-based surveillance, reporting, and outbreak
management system, is used by 67 counties as well as State-level
entities; contains large modules for lead poisoning and perinatal
hepatitis B prevention, rabies prevention, and electronic lab reporting;
and has been evaluated against Public Health Information Network (PHIN)
early event detection standards (which pinpointed needed enhancements).
Merlin was first used to manage SARS cases and has proved useful in
multi-county outbreaks involving *E. coli*/hemolytic-uretic syndrome and
cyclospora. At present, for notifiable disease reporting, Merlin
receives information from medical facilities and labs routed through
LHDs then generates reports directly to the CDC. This part of the system
is not yet bidirectional.

*B. 2.* Marion Kainer, MD, MPH, Medical Epidemiologist/Infectious
Diseases Physician Director, Hospital Infections and Antimicrobial
Resistance Program, Tennessee Department of Health, gave a slide
presentation entitled "Outbreak and Case Management: A State
Perspective" (see
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/kainer.pdf>).

Dr. Kainer detailed Tennessee's experience using the CDC's OMS for a
complex tuberculosis contact investigation, noting the OMS's many
attributes and that Version 1.2 has a lab and countermeasures module
(treatment, vaccination, and isolation/quarantine). Results of a
February 2007 Council of State and Territorial Epidemiologists (CSTE)
assessment (50 States and six large cities) indicated overwhelming
support for a system such as the CDC's OMS, as many jurisdictions do not
have in-house solutions for data management of large, complex outbreaks.
Recommendations include reinstating Federal support for Version 1.2
deployment and training; reconvening the OMS Working Group; and priority
consideration of high-value enhancements, such as OMS ability to
exchange messages with surveillance and laboratory systems.

###### C. Federal Public Health

Tim Morris, Director, Division of Informatics Shared Services, National
Center for Public Health Informatics, CDC, gave a slide presentation
entitled "Public Health Response Information Management" (see
[http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/morris.ppt](http://www.hhs.gov/healthit/achic/materials/03_07/phccc/morris.ppt)).

Mr. Morris noted the CDC's public health response activities and
information needs on national and international levels, emphasizing the
need for information standards, consistency, and interoperability.
Anthrax, monkey pox, SARS, and Hurricane Katrina posed information
challenges, such as multiple partners and data flows, lack of case
definitions, and lack of public health infrastructure redundancy.
Current public health response information challenges include the need
for multi- and cross-jurisdictional data sharing, distributed systems,
and system integration and the need to address information complexity
and volume, spreadsheet-level outbreak management tools, communications
infrastructure, human and physical resources, and HIT redundancy. A
flexible and secure nationwide network is needed, as well as consistent
standards implementation across domains; common terminology usage and
definitions; common data syntax and information semantics;
infrastructure supporting discovery of exchange partners and services;
shared infrastructure for user and system authentication; and available
systems and infrastructure at local, regional, and national levels.

###### Testimony Comments, Questions, Discussion

There was discussion of interoperability; gaps in standards, such as for
messaging involving immunization data; and the need for implementation
guidance. It was noted that while Health Level Seven (HL7) messaging
standards exist, they are not widely used in clinical settings at
present; nor do most State immunization registries process these
standards. Other challenges include lack of consistency in States'
interface engines and the lack of standard coding for vocabulary that
impedes data exchange.

Discussion ensued on public health systems' capability to exchange
possible cases with each other in a way that is immediately useful and
the degree to which contact tracing is currently a computer-supportable
function, nationally. The CDC's initial development of an HL7, version
3, case notification message and work on an outbreak message as part of
PHIN were mentioned but also that current public health infrastructure
is insufficient to implement these messages. The CDC's OMS system was
mentioned as providing robust contact tracing support. Also mentioned
was the need for contact tracing improvements at the State level to
assist patient follow-up.

The status of the CDC's OMS and implementation of its outbreak message
system was discussed. Mr. Morris suggested contacting Scott McNabb,
Director of Integrated Surveillance, CDC, for further information. It
was noted that the OMS can create prepackaged sets of questions that
would facilitate standardization of data collection across
jurisdictional lines.

Last, there was discussion of the status of an "epi-outbreak system"
that can accept and use electronic lab results (ELR). Key points
included:

-   Florida's system currently does not allow attachment of a lab report
    to a true outbreak case, but that capability is under development.
    In addition, the State plans to implement a procedure for searching
    the State lab's database for non-reportable diseases.

-   Dr. Kainer commented that she knows of no State management system
    that currently receives ELR messages.

-   NYC has ELR reporting to its surveillance system but not to a single
    outbreak database.

-   The CDC's Division of Integrated Surveillance may have useful data
    with regard to ELRs.

-   Integrated EHRs that contain lab data and can interact
    bidirectionally with other reference labs could be useful to public
    health, but the perceived priority at present is to enable exchange
    of lab and surveillance information.

###### Conclusion

Dr. Lumpkin asked testifiers and their organizations to assist the WG in
fashioning possible recommendations to AHIC regarding Outbreak and Event
Management.

### 3. Hear and Discuss Testimony on Laboratory Response

###### A. State Public Health Labs

*A. 1.* Norman Crouch, PhD, Assistant Commissioner, Health Protection
Bureau, Minnesota Department of Health, Association of Public Health
Laboratories (APHL), gave a slide presentation entitled "Response to
Outbreaks and Events: State Public Health Laboratory Perspective" (see
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/crouch.ppt>).

Emphasized was the importance of networks between public health and
other public labs (veterinary, agriculture, and environmental) and
between public health and private labs, principally hospital-based
clinical care and commercial labs. Few States have finely tuned
networks; others are moving in that direction through existing networks
such as for the Laboratory Response Network (LRN) and Pulse-net
(National Molecular Subtyping Network). In the LRN, Results Messenger
allows for direct communication to the CDC, but interchange between
public health and sentinel labs is also important. Barriers to
integrated data networks include rapidly changing IT; lack of public
health lab (PHL) standards; system development and maintenance costs;
limited State PHL input; and, as pertains to large commercial labs, lack
of reporting standards; need for multi-State reporting; State-specific
reporting requirements; and lack of acceptable receiving sites for
reports.

*A. 2.* Steve Hinrichs, MD, Director, Center for Biosecurity; Director,
Nebraska Public Health Laboratory; APHL, continued the slide
presentation entitled "Response to Outbreaks and Events: State Public
Health Laboratory Perspective" with a section entitled "Contributions of
Public Health Laboratories to Event Detection, Response, and Management"
(see
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/crouch.ppt>).

Dr. Hinrichs outlined the electronically available lab data needed for
detection and situational awareness. At present, data regarding
suspected or incidental events are communicated from PHLs by phone,
paper, and electronic transmission to local and Federal stakeholders,
but bidirectional communication is lacking. Mentioned were the APHL's
Informatics Program; an APHL survey of PHLs; and the State, APHL, and
CDC collaborative Public Health Laboratory Interoperability Project
(PHLIP), the goals of which include a uniform, standardized message
structure applicable to flu and all notifiable diseases and a
collaborative resource portal for sharing outcomes, with possible
intersection with RHIOs. Recommendations were the needs for PHL function
and capability to monitor diseases and conditions broadly, including
animal, water, and environmental testing; evaluation of strategies to
achieve uniform reporting requirements (for at least a subset of
diseases and conditions); sustained support of State and local IT
capabilities; for creation of a national database of unique object
identifiers for identifying lab and medical service providers;
implementation of uniform minimum data elements under State law
regulating reportable diseases and conditions; and support of research
on predictive trend analysis and statistical sampling for monitoring
population health.

###### B. CDC

*B. 1***.** J. Michael Miller, PhD, Associate Director for Science,
National Center for Zoonotic, Vector borne, and Enteric Diseases, CDC,
gave a slide presentation entitled "Laboratory Response Capacity:
Coordinating Center for Infectious Diseases" (see
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/miller.ppt>).

Four national centers for different disease organisms are now organized
under a new Coordinating Center for Infectious Diseases (CCID) at the
CDC, where central receiving sites for specimens exist but no core site
or facility to receive/triage outbreak calls from partners, principally
State public health agencies. Dr. Miller detailed previous outbreaks of
unknown etiology, how CCID handles "average" outbreaks -- a largely
manual process -- and surveillance tools for outbreaks, noting that
these tools require complex IT interaction but are not, at present,
interconnected. Challenges in lab response include: resolving outbreaks
of unknown etiology; Good Manufacturing Process development of assays in
a "non-manufacture" arena; U.S. Food and Drug Administration approval of
public health assays (surveillance vs. diagnostic) in a timely manner;
competing resources and reductions in lab capacity and response;
recruitment and retention of top lab scientists and developing the next
generation of public health leaders; the complexity of electronic
communication needs; and integrating critical public health information
and tracking in a secure, efficient, and accessible format -- a primary
challenge.

*B. 2.* Emory Meeks, Enterprise Laboratory Systems Coordinator, National
Center for Public Health Informatics, CDC, gave a slide presentation
entitled "Laboratory Data Exchange" (see also
<http://www.hhs.gov/healthit/ahic/materials/03_07/phccc/meeks.ppt>).

Lab data are central to public health response, but PHLs must be able
electronically to share sample information, test orders, and test
results in real time to enable early detection and response. Also,
industry standards for results reporting are critically needed to ensure
interoperability among labs and across coordinating organizations. The
CDC's informatics goals for LRN are to enable two-way standard
electronic data exchange of lab orders and test results lab-to-lab and
between a given lab and its partners, such as the CDC. LRN Results
Messenger and the Laboratory Information Management System (LIMS)
Integration Project using a lab's own systems are transitions to more
robust IT solutions. LRN plans include enabling LRN labs to set up their
own recipients, such as LHDs; encouraging and assisting lab involvement
in LIMS; and enabling better integration with other PHIN applications
and services and interoperability with other agencies. Lab data exchange
needs/issues include codes harmonization (a primary component of PHLIP
\[see **A. 2.** above\]); an incremental, progressive approach;
prioritization and funding (local, State, CDC) to support
interoperability between networks; and agency-to-agency collaboration
(such as through the Integrated Consortium of Lab Networks) and
interagency data exchange. (It was noted later that all States
participate in LRN and Pulse-net.)

###### Testimony Comments, Questions, Discussion

Possible WG recommendations topics were discussed, including:

-   The need for standards implementation guidance and harmonization

-   The need for every type of specimen, not just human, to be
    considered when discussing IT and preparedness

-   The need for additional standards -- for example, more uniform
    terminology or codes -- particularly to aid exchange of information
    across a wide spectrum of specimens and samples

-   The need to bring providers into a national database for
    identification of labs by number

-   The need for some type of clearinghouse for clinical lab data

-   The need to identify a minimum set of data collected from, for
    example, hospital admissions

-   The need for more State and local PHLs to have resources to
    implement LIMS systems (making better use of existing systems)

-   The need for more State and local PHLs to have resources to move
    toward common standards, such as for messaging, and the need for an
    overarching body, such as the Department of Health and Human
    Services (HHS), to play a role

-   The importance of bidirectional communications between public health
    labs (State to State, States to the CDC, and the CDC back to
    States), such as a "Star LIMS" approach

-   The need to define a process, possibly a Federal agency-wide
    Executive Order, for achieving global interoperability among PHLs --
    including across relevant Federal agencies.

###### Conclusion

Dr. Lumpkin again asked all testifiers on Lab Response for specific
language to help inform WG recommendations to AHIC.

### 4. General Discussion of Outbreak and Event Management and Lab Response Testimony

There was discussion of both sets of testimony heard today. Key points,
potentially for recommendations or background on recommendations to be
discussed further at the May 11, 2007, WG meeting, included:

-   The possible need to fashion a status report with help from CSTE,
    the Association of State and Territorial Health Officials (ASTHO),
    NACCHO, and APHL on the state of IT in local and State public health
    departments and State PHLs, including local and State public health
    departments' involvement with RHIOs

-   The need for basic indicators of the critical importance of outbreak
    and event management-related IT, such as for sharing lab results,
    sharing possible cases across jurisdictions, and assisting contact
    tracing

-   The possible need to address as priorities not only improved
    capacity inside PHLs, for example, but also improvement in
    capabilities provided for others, such as local and State
    epidemiologists

-   The need for a process that makes outbreak and event
    management-related IT improvements a priority, including a process
    of accountability for making such improvements

-   The need to test existing systems through annual measurement of
    basic indicators involving tuberculosis cases

-   The possible need to show examples, such as the LIMS system, of how
    relatively modest investment toward harmonization can save money and
    have a positive cascading effect

-   The need for acceleration in further development of the CDC's OMS
    with prioritization of electronic message exchange

-   Need to address coordination across Federal agencies, such as the
    Environmental Protection Agency, CDC, and their networks to
    standardize lab reporting requirements.

-   The need to build an outbreak and event management infrastructure
    that can withstand an emergency

-   The possible need to address public health priorities through the
    EHR certification process.

#### ACTION ITEM #1: Paula Soper and Angela Fix will try to present further preliminary data on public health departments' involvement with RHIOs at the May 11, 2007, Workgroup meeting. 

###### Conclusion

Dr. Lumpkin concluded with the following comments:

-   By the time the WG is ready to make outbreak and event management
    and lab response recommendations; further status report data should
    be available from CSTE and APHL (as well as more preliminary RHIOS
    data from NACCHO).

-   In the future, more relevant status report data can be expected from
    ASTHO, NACCHO, and APHL working in coordination.

-   Potential areas for outbreak and event management and lab response
    recommendations may fall into three or four categories:

    -   Recommendations related to implementation of standards and
        harmonization

    -   Recommendations related to public health infrastructure capacity
        in terms of basic indicators

    -   Recommendations related to interagency coordination (ICLN and
        the "cross-LIMS system" were mentioned)

    -   Recommendations that address the need to have systems in place
        with sufficiently broad capacity for sharing data to sustain
        response management of emergency events.

**5. Identify Additional Testimony Needed in the Priority Area of
Response Management**

There was discussion of additional testimony needed in the priority area
of Response Management. Key topics included:

-   The need to examine work force and work flow management issues and
    the potential role of HIEs in addressing such issues

-   The need to examine further the concept of a clearinghouse function
    useful to both commercial and public health labs

### 

### 6. Discuss and Schedule Testimony on Communications and Countermeasure Allocation, Distribution, and Administration

There was discussion of topics for the next full day of testimony (June
15, 2007) on Communications and Countermeasure Allocation, Distribution,
and Administration. Key topics included:

-   The need to address testimony on Countermeasure Allocation,
    Distribution and Administration.

-   The need to address testimony on automated integration with
    registries

-   The need for further testimony on bi-directional communications
    issues raised in testimony today, including but possibly not limited
    to the need for unique identifiers (for provider labs), directory
    functions, and data routing functions

-   The need to address communications back to clinicians

-   The need to address communications to and from providers, public
    health, and incident command structures during public health
    emergencies.

It was noted that four AHIC Workgroups, including PHCCC, are working on
various aspects of clinical decision support. Office of the National
Coordinator for Health Information Technology (ONC) staff is in the
process of creating a planning framework to ensure that the work of each
Workgroup around clinical decision support is complementary.

#### 

#### ACTION ITEM #2: Kelly Cronin will follow up with Workgroup members on aspects of clinical decision support to be pursued further by the PHCCC Workgroup.

### 7. Next Steps 

*A.* The next Workgroup meeting will be held May 11, 2007, from 1 to 4
p.m. to review adverse events reporting recommendations and
recommendations resulting from today's testimony on outbreak and event
management and lab response.

*B.* The Workgroup meeting on June 15, 2007, will be held from 10 a.m.
to 3:30 p.m. to take testimony on communications and countermeasure
allocation, distribution, and administration.

### 8. Public Comments 

None.

## SUMMARY OF DECISION POINTS AND ACTION ITEMS

#### ACTION ITEM #1: Paula Soper and Angela Fix will try to present further preliminary data on public health departments' involvement with RHIOs at the May 11, 2007, Workgroup meeting. 

#### 

#### ACTION ITEM #2: Kelly Cronin will follow up with Workgroup members on aspects of clinical decision support to be pursued further by the PHCCC Workgroup.

**Meeting Materials**

Agenda

Soper - The Role of Local Public Health in Outbreak and Event Management

Layton & Fine - Information Needs in Outbreak Management A Local
Perspective

Hamilton - Outbreak Management Merlin Outbreak Module

Kainer - Outbreak & Case Management: A State Perspective

Morris - Public Health Response Information Management

Crouch & Hinrichs - Responding to Outbreaks and Events: State Public
Health Laboratory Perspective

Miller - Laboratory Response Capacity Coordinating Center for Infectious
Diseases

Meeks - Laboratory Data Exchange

**[Population Health and Clinical Care Connections
Workgroup]{.underline}**

**[Members and Designees Participating in the March 2, 2007 Web
Conference]{.underline}**

*Co-chairs*

Steve Solomon (for Julie Gerberding) CDC

Charles (Chip) Kahn Federation of American Hospitals

John Lumpkin Robert Wood Johnson Foundation

*ONC Staff*

Laura Conn ONC

Kelly Cronin Director, Office of Programs and Coordination

Judy Sparrow AHIC Director

Sunanda (Shu) McGarvey Lead Staff, contractor to ONC

*Members*

Scott Becker APHL

Theresa Cullen Indian Health Service

Jon Einbinder Partners Healthcare

Farzad Mostashari NYC Department of Health & Mental Hygiene

(for Thomas Frieden)

Shawn Fultz Department of Veterans Affairs

Amy Helwig Agency for Healthcare and Research Quality

Brian Keaton American College of Emergency Physicians

John Loonsk ONC

Erik Mettler (for Lisa Rovin) U.S. Food and Drug Administration

Edward Sondik CDC

*Ex-Officio Members*

Angela Fix ASTHO

Paula Soper NACCHO

*Presenters*

Norman Crouch Minnesota Department of Health

Annie Fine NYC Department of Health & Mental Hygiene

Janet Hamilton Florida Department of Health

Steve Hinrichs Nebraska Public Health Laboratory

Marion Kainer Tennessee Department of Health

Emory Meeks CDC

J. Michael Miller CDC

Tim Morris CDC

Paula Soper NACCHO

**Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at HHS-sponsored conferences do not
necessarily reflect the official policies of HHS; nor does mention of
trade names, commercial practices, or organizations imply endorsement by
the U.S. Government.*