# American Health Information Community

# Population Health and Clinical Care Connections Workgroup

# Summary of the 17th Meeting of this Workgroup

# Wednesday, May 16, 2007

## Purpose of Meeting

-   Review and discuss the work of the Population Health and Clinical
    Care Connections (PHCCC) Adverse Events (AE) Ad Hoc Workgroup (WG)
    on draft AE Recommendations to the American Health Information
    Community (AHIC).

-   Review and discuss the work of the PHCCC Response Management (RM) Ad
    Hoc Workgroup on draft RM Recommendations to the AHIC and future RM
    testimony.

-   Decide on the next steps.

## Key Topics

### 1. Meeting Opening

*Federal Advisory Committee Act (FACA**) ***-- AHIC Director Judy
Sparrow noted that AHIC WG meetings are designed to meet FACA
requirements and therefore are publicly broadcast over the Internet,
recorded, and transcribed for later access at the AHIC Website
([www.hhs.gov/healthit/ahic](http://www.hhs.gov/healthit/ahic)). In
addition, public comments are invited at the end of each meeting.

*Opening Remarks by WG Co-chairs* -- It was noted that Co-chair Chip
Kahn has stepped down. A replacement will be sought to continue the
clinical provider prospective.

Co-chair John Lumpkin outlined the agenda and the meeting purpose and
noted that the presentation on the Survey on Public Health Involvement
with Regional Health Information Organizations (RHIOs), a collaboration
of the Association of State and Territorial Health Officials (ASTHO) and
the National Association of City and County Health Officials, has been
delayed. He also urged all members to attend in person the June 15, 2007
WG meeting to take further testimony on RM.

The March 2, 2007, and March 29, 2007, WG Draft Meeting Summaries were
approved.

### 

### 2. Review and Discuss the Work of the AE Ad Hoc Workgroup 

Co-chair Steve Solomon reviewed the work of the AE Ad Hoc Workgroup to
date regarding AE Recommendations to the AHIC in light of AE testimony
given at the WG's February 2, 2007, meeting and the Secretary's recent
remarks on the importance of developing recommendations that can be
implemented in a reasonable time frame (see also
<http://www.hhs.gov/healthit/ahic/population/pop_archive.html#23>).

######  

###### Scope 

The potential scope of AE recommendations is as follows:

-   AEs involving medical products, including drugs, devices, biologics,
    and perhaps tissues and organs (e.g., post-marketing surveillance of
    drugs)

-   AEs involving nosocomial infections (surveillance of health
    care-associated infections was proposed but is still under debate)

The Ad Hoc Workgroup has concluded that AEs associated with medical
practice -- "medical errors," such as misuse or misadministration of
drugs and wrong site surgery -- should be considered out of scope due to
process-related issues that are being addressed in many different
venues.

###### 

###### Discussion Points and Issues

Discussion points and issues identified by the Ad Hoc Workgroup are as
follows:

\(1\) Standards for detection of AEs. They should focus on looking for
specific outcomes, including looking at sentinels for AEs. The Ad Hoc
Workgroup concluded that identification of previously unsuspected or
unexpected AEs is too complex in terms of scope and, rather, focused on
identification of what may be expected or suspected AEs, as well as
being able to respond to signals in a targeted fashion.

\(2\) Promoting pilot or demonstration projects and disseminating best
practices for wider use. The Department of Veterans Affairs (VA) System
and leveraging National Health Information Network (NHIN) pilots with
Health Information Exchanges (HIEs) were cited as possible ways to do
proof of concept for AE detection and reporting through RHIOs.

\(3\) Data-driven triggers. The concept refers to particular
constellations of findings in data, as in syndromic surveillance, that
would suggest an AE.

\(4\) Development of standards for data, messaging, and reporting of AEs
(moving data from clinical care to public health). This involves
codifying, cataloguing, and encouraging ongoing work, in addition to
automated reporting through electronic health records (EHRs, active or
query based).

The key issues in Discussion Point 4 are (1) supporting and promoting
continued use and dissemination of standards, such as those represented
by ICSR \[ Individual Case Safety Reports\] and Basal Adverse Event
Reports for the earliest possible movement of data into the appropriate
public health sphere; and (2) the need to achieve balance between active
surveillance (push of data to public health through, for example,
automated reporting from EHRs) and some type of query-based system (pull
of data to public health) that permits looking back to individual cases
where necessary.

\(5\) Levels of access by public health for different purposes
(specifying the roles of public health and needs for access to data,
such as for research and AE detection, reporting, and prevention). The
well-established Federal role in drug and device monitoring was
discussed, as were Federal and State roles regarding other aspects of AE
to be considered depending on the final determination of the scope. The
needs and roles of State and local agencies will be taken into full
account in the draft recommendations.

\(6\) A distributed model versus a centralized model. The difficulty of
maintaining large, centralized datasets was discussed, as was the need
for Federal regulatory access to a broad range of data for, for example,
drug and device monitoring.

\(7\) Assurance of the capacity to look back.

\(8\) Promoting pilot or demonstration projects, as previously
mentioned.

\(9\) Harmonization of standards through the Health Information
Technology Standards Panel. This involves advance implementation of the
standards more broadly and promoting subsequent development of criteria
for, for example, certifying vendor systems.

*Timeline:* (1) Present draft AE recommendations to the WG for
discussion no later than the WG's June 15, 2007 meeting. (2) Make a
final draft available for comment at the WG's July 19, 2007 meeting. (3)
Present final recommendations at the AHIC's July 31, 2007, meeting.

###### WG Discussion 

***Public health requirements**.* Kelly Cronin proposed that the Ad Hoc
Workgroup work to identify the specific needs of public health in terms
of access to and management of AE-relevant data and how those needs can
be addressed, including pilots involving HIEs.

***Pending Federal legislation*.** Lisa Rovin noted U.S. Senate
legislation that would change the U.S. Food and Drug Administration's
(FDA) post-marketing surveillance in part through provisions regarding
public-private partnerships. Ms. Cronin asked FDA to outline its
priorities to the Ad Hoc Workgroup to inform its recommendations work.

***Nosocomial infections issues.*** Ms. Cronin asked that the VA System
Program Manager join Ad Hoc Workgroup deliberations on nonsocomial
infections, near-term standardization, and the feasibility of automated
EHR detection and reporting. Dr. Lumpkin suggested that the Federation
of American Hospitals and the AHIC Quality Workgroup be involved as well
and invited WG members to contact him with further thoughts on these
issues.

#### ACTION ITEM #1: Ms. Cronin will contact Nancy Foster of the American Hospital Association (AHA), a Quality Workgroup member, to assist AE Ad Hoc Workgroup deliberation of nonsocomial infections issues.

### 

### 3. Review and Discuss the Work of the RM Ad Hoc Workgroup 

Scott Becker provided a summary of Day 1 testimony on RM given at the
WG's March 29, 2007, meeting; a summary of issue and recommendations
areas; and a timeline for RM recommendations (see also
<http://www.hhs.gov/healthit/ahic/population/pop_archive.html#23>).
Plans for Day 2 testimony on RM were also discussed.

###### Summary of Day 1 Testimony

Outbreak and Event Management:

-   Clinical data is insufficient for outbreak management.

-   Federal support is needed for improved outbreak management tools,
    such as the Center for Disease Control and Prevention's (CDC)
    Outbreak Management System 1.2.

-   Management and tracking of exposures in health care settings is
    needed through capture and easy access to information on patient and
    staff movements.

-   A flexible and secure NHIN is needed.

-   Consistent implementation of standards is needed.

-   Common terminology usage and definitions are needed.

-   Shared infrastructure is needed (policy, governance, workforce,
    software, IT hardware and services such as authentication, routing,
    transport, and directories).

Lab Response:

-   Refinement and implementation of lab standards is needed.

-   Lab data need to be integrated with epidemiological case data.

-   Sentinel lab capacity and capabilities (including on the clinical
    hospital side) need to be tracked.

-   The full breadth of lab functions and capabilities -- animal, water,
    environmental testing -- need to be considered.

-   Evaluation is needed on how to achieve uniform reporting across
    agencies -- harmonizing requirements across agencies for reporting.

-   Process and funding are needed for sustained support of IT and
    informatics.

-   Implementation of uniform minimum data elements within State law for
    reportable conditions is recommended.

-   Research on predictive trend analysis and statistical sampling for
    monitoring health of population needs to be supported.

-   Support is needed for a National OID \[Object Identifier\] solution
    for lab service and medical service providers.

###### Challenges

Challenges primarily involving Lab Response include the following:

-   Large commercial labs often must report across States with specific
    reporting requirements but lack a central router for report
    dissemination or retrieval.

-   FDA approval of public health assays in a timely manner,
    particularly to support rapid, emergency response, is needed.

-   Workforce development -- recruitment and retention of lab scientists
    and developing expertise in next generation of public health leaders
    -- is needed (such workforce issues cut across Outbreak and Event
    Management and Lab Response).

-   Critical public health information, tracking, and communications
    need to be integrated in a secure, efficient, and accessible format.

###### Key High-Level Issues

-   Infrastructure at local and State levels is often inadequate (the Ad
    Hoc Workgroup will define this further).

-   Consistent implementation of nationally recognized data standards,
    common vocabulary standards and definitions, and systems to support
    response is needed.

-   Federal agencies and other levels of public health have disparate
    business requirements. Harmonization of reporting requirements
    across agencies is needed to reduce reporting burdens for health
    care organizations and support automated reporting, but required
    local functions (e.g., contact tracing and case management) also
    need to be incorporated in vendor-based information system
    solutions.

###### Recommendations 

Categories discussed during Ad Hoc Workgroup deliberations include:

-   Harmonization and implementation or adoption of standards

-   Capacity for lab reporting, contact tracing, and exchange of
    possible cases -- key to sentinel capacity for the public health
    system

-   Interagency coordination, such as the Integrated Consortium of
    Laboratory Networks

*Timeline:* (1) Recommendations for Outbreak and Event Management and
Lab Response will continue to be discussed. (2) RM testimony on
Countermeasure Allocation, Distribution, and Administration and Registry
Integration will be heard at the WG's June 15, 2007, meeting. (3) The Ad
Hoc Workgroup then will review that testimony and draft recommendations
in those areas in late August. (4) Plans are to present a final draft of
all RM recommendations during the WG's September 5, 2007, meeting and to
present at the AHIC's September 18, 2007, meeting.

*Plans for June 15, 2007, Testimony:* Dr. Lumpkin stated that the
meeting will begin at 10 a.m. and end at 2:30 or 3 p.m. Members should
plan to attend in person.

####### WG Discussion of June 15, 2007, Testimony

It was proposed that the national organization representing State and
Territorial EMS Directors be asked to present. James Pearsol of ASTHO
offered to assist the contact. It was also proposed that the
organization representing State emergency preparedness directors be
asked to present.

### 4. Next Steps

*A.* Hear Day 2 RM testimony at the June 15, 2007, WG meeting.

*B.* Give final review to AE recommendations at the July 19, 2007, WG
meeting.

*C.* Plan to present AE recommendations to the AHIC at its July 31,
2007, meeting.

*D.* Plan to present RM recommendations to the AHIC at its September 18,
2007, meeting.

###### Next Phase of WG Priority Setting

Office of National Coordinator (ONC) staff is working on the next phase
of WG work priorities. WG member input will be sought. Clinical decision
support (CDS) is a topic of interest across most of the AHIC WGs. The
Quality WG has taken a lead in this topic to date due to its Broad
Charge. WG Co-chairs and some subject matter experts held a planning
session to assist coordination of work of this type across the AHIC.
More public/private coordination may be involved.

It was decided that WG members and staff will engage in e-mail
communication between now and the next WG meeting to help identify the
next round of key work priorities, including Bi-Directional
Communications from a population health perspective and CDS. Further
discussion may be held at the next WG meeting (June 15, 2007).

##### DECISION POINT: The PHCCC WG e-mail chain will be open between now and the next WG meeting on June 15, 2007, for discussion of the next round of key work priorities.

Brian Keaton asked that consideration be given to the need for true
bidirectional, near real-time communications from and between emergency
departments and through incident command structures in high-consequence
events. Lengthy discussion ensued on the topic, the conclusion of which
was that some time in the near future, the WG may be briefed on the
PAHPA \[Pandemic and All-Hazards Preparedness Act\] preparedness
implementation plan and perhaps other relevant Federal agency activities
in this area.

### 5. Adjournment 

Dr. Lumpkin thanked the participants and the meeting was adjourned.

## SUMMARY OF DECISION POINTS AND ACTION ITEMS

#### ACTION ITEM #1: Ms. Cronin will contact Nancy Foster of AHA, a Quality Workgroup member, to assist AE Ad Hoc Workgroup deliberation of nonsocomial infections issues. 

##### DECISION POINT: The PHCCC WG e-mail chain will be open between now and the next WG meeting on June 15, 2007, for discussion of the next round of key work priorities.

**Meeting Materials**

Agenda

Summary of Testimony from the 3/29 PH/CCC Meeting

Meeting Slides

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

**[Members and Designees Participating in the Web
Conference]{.underline}**

**[Wednesday, May 16, 2007]{.underline}**

*Co-chairs*

Steve Solomon (for Julie Gerberding) CDC

John Lumpkin The Robert Wood Johnson Foundation

*ONC Staff*

Laura Conn ONC

Kelly Cronin, Director Office of Programs and Coordination

Sunanda (Shu) McGarvey Lead Staff, contractor to ONC

Judy Sparrow AHIC Director

*Members*

Michael Barr and Maria Rudolph American College of Physicians

Scott Becker Association of Public Health Laboratories (APHL)

Theresa Cullen HHS/Indian Health Service

Jon Einbinder Partners HealthCare

Amy Helwig HHS/Agency for Healthcare Research and Quality

Brian Keaton American College of Emergency Physicians

Martin LaVenture Minnesota Department of Health

John Loonsk ONC

Bob Martin HHS/CDC/National Center for Health Informatics

Lisa Rovin HHS/Food and Drug Administration

LuAnn Whittenburg (for David Parramore) Department of Defense

*Ex-Officio Members*

Angela Fix and James Pearsol The Association of State and Territorial

> Health Officials (ASTHO)

Michelle Meigs Association of Public Health Laboratories (APHL)

**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.*