# American Health Information Community

# Workgroup on Biosurveillance

# 

# Summary of the Web Conference Held on Friday, October 20, 2006

# 10^th^ Meeting of This Workgroup

## PURPOSE OF MEETING

The primary purposes of the Biosurveillance Workgroup (BSV WG) meeting
were:

-   To receive and discuss the Biosurveillance Data Steering Group's
    (BDSG) Final Report and Letter of Recommendation to the Secretary
    and the Community for the Community's October 31, 2006 meeting

-   To review and discuss Priority Area Rankings and the Biosurveillance
    Priority Matrix (of Four Priority Areas)

-   To review and discuss the Visioning Matrix (of Four Priority Areas)
    and attendant Barriers and Enablers

-   To discuss Next Steps: the BSV WG's Presentation to the Community on
    October 31, 2006, Development of a Detailed Work Plan for 2006/2007,
    and the Addition of Members as Needed.

## KEY TOPICs

### 1. BDSG Final Report and Letter of Recommendation

BDSG Co-chair Art Davidson gave the BDSG's Final Report in a slide
presentation. Separate documents also provided were the BDSG's Letter of
Recommendation, Preconditions for Deciding on Minimum Data Set (MDS)
Elements, MDS Specifications, a Preparedness Functional Area Matrix, and
DHS National Planning Scenarios for Deciding on Minimum Data Set.

When formed in June 2006, BDSG was charged with identifying the
requirements for data from ambulatory care, emergency departments, and
laboratories necessary for multi-jurisdictional biosurveillance
programs. BDSG proceeded to identify an MDS and to determine MDS
feasibility and filtering requirements, coordinating its efforts with
the Health Information Technology Standards Panel Technical Committee on
Biosurveillance (HITSP-TC).

BDSG's final list of data elements includes some not previously
identified by HITSP-TC or the BSV WG. The BDSG used a set of 18
preconditions, a sampling of five of 15 National Planning Scenarios, gap
analysis, functional analysis, and expert testimony to help guide its
deliberations. It then refined the MDS by looking at feasibility
(whether the data element could be transmitted electronically by 25
percent of reporting facilities with currently available resources in
the short term \[less than 1 year\] or longer term \[1--2 years\] or not
beyond 2 years). Filtering criteria were also applied (e.g., a given
data element is not essential for public health functions or is too
sensitive to share for biosurveillance purposes).

BDSG concluded that a biosurveillance program MDS is necessary to enable
key public health functions, leading to five recommendations, as
follows:

-   "Recommendation 1.0 -- The Secretary of the Department of Health and
    Human Services should adopt the Minimum Data Set to guide data
    collection in biosurveillance programs that involve the simultaneous
    sharing of clinical data from health care providers to authorized
    local, State, and Federal public health agencies."

-   "Recommendation 1.1 -- By September 2007, the U.S. Department of
    Health and

> Human Services, in collaboration with State and local governmental
> public health agencies, should work with clinical care partners to
> implement the short-term \[feasible in 1 year for 25 percent of
> facilities\] Minimum Data Set and enable simultaneous data access to
> local, State, and Federal public health entities for biosurveillance
> purposes."

-   "Recommendation 1.2 -- By March 2007, the U.S. Department of Health
    and

> Human Services, in collaboration with State and local governmental
> public health agencies and clinical care partners, should evaluate
> implementation models, costs, and determine availability of resources
> and establish a plan to effect a short-term Minimum Data Set
> implementation."

-   "Recommendation 2.0 -- Public health agencies and partners who
    implement the short-term Minimum Data Set should filter out some
    components of the following data elements as appropriate: date of
    birth, age, zip code, diagnosis/injury code, and laboratory
    test/procedure codes."

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-   "Recommendations 3.0 -- CDC \[Centers for Disease Control and
    Prevention\] should, no less than annually, involve local, State,
    and Federal public health agencies and clinical care partners in an
    MDS monitoring process for biosurveillance usefulness and make
    appropriate modifications as evidence develops to support such
    modifications."

Dr. Davidson commented that the challenge of implementing even the
short-term MDS will be enormous.

*Comments/Questions/Discussion*:

Workgroup members discussed the need for the BDSG to note in its
Community presentation that the proposed biosurveillance system would
serve as an adjunct to, not a replacement for, other public health
investigative systems. Dr. Davidson will make this adjustment and also
summarize other aspects of the preconditions document of concern, such
as the use and collection of secondary clinical data and the role of
State public health authorities.

#### **DECISION POINT:** It was agreed that the BSV WG would endorse the BDSG's Final Report and Letter of Recommendation to the Community. 

### 2. Priority Area Rankings and the Biosurveillance Priority Matrix

Kelly Cronin noted two documents provided for the meeting, one on
Priority Rankings and one on the Biosurveillance Priority Matrix, which
contains a column of potential areas for recommendations to the
Community in the four most highly ranked priority areas: Adverse Event
Reporting, Bidirectional Communication, Case Reporting, and Response
Management. There were no comments or questions.

The BSV WG will present a narrative based on the Biosurveillance
Priority Matrix to the Community at its October meeting, a summary of
which will be provided to members at the end of the day. The BSV WG's
future workplans in the four priority areas will be noted, including
consideration of the BSV WG's priorities in the context of other
Workgroups' priority areas for some use case and infrastructure
development.

### 3. I. Discussion of Visioning Matrix (of the Four Priority Areas) 

### A. Case Reporting

### B. Bidirectional Communication

### C. Response Management

### D. Adverse Events Reporting 

John Lumpkin led the discussion of the draft visioning document entitled
*Description of Current, Intermediate, and Desired End States for Public
Health Surveillance*, organized by the BSV WG's four Priority Areas and
containing cross-cutting Barriers and Enablers. The document was derived
from the Biosurveillance Priority Matrix and Dr. Lumpkin's presentation
at the September 21, 2006, BSV WG meeting. The document, discussion, and
revisions will inform the BSV WG's detailed work plan for the remainder
of 2006 and for 2007.

###### A. 1. Case Reporting -- Current (2006) Briefing Highlights 

In the current state, case reporting at the local, State, and national
levels is passive, manually processed, and not timely. Electronic
reporting and Web-based systems exist. Many registries, such as for
immunization, exist but are not well-integrated into Electronic Health
Records (EHRs).

###### Case Reporting -- Current (2006) Discussion Highlights 

It was noted that the percentage of diseases reported is a small
fraction of what exists.

###### A. 2. Case Reporting -- Mid-state (2010) Briefing Highlights

The mid-state addresses the development of architecture and standards
for disease reporting and case messaging, such as requirements and
strategies for electronic case reporting (at the Web level versus
automated from EHRs). It also addresses electronic querying and requests
for case and outbreak investigation.

###### Case Reporting -- Mid-state (2010) Discussion Highlights

-   Pulsenet, which would be integrated into the network and universal
    across all 50 States, needs to be defined.

-   The reference to enabling electronic querying by authorized
    individuals for public health investigations will be expanded to
    note the legal authorities involved. The staff will look into an
    Association of State and Territorial Health Officials (ASTHO)
    project involving legal authorities in the States and Territories.
    Larry Biggio will provide information about Wyoming's legal and
    regulatory authorities.

-   It was suggested that remote, secure electronic querying for public
    health investigations be moved to the end state column (2014). A
    decision was made to note an electronic query system for the
    mid-state and an automated query system for the end state.

-   It was suggested that a mid-state goal should be automation through
    EHRs of the top 10 (or some other number to be determined) public
    health reports.

###### A. 3. Case Reporting -- End State (2014) Briefing Highlights

The goals for the end state include everything in the mid-state, with
even more value added. Case definitions and criteria would be built into
decision support algorithms used by EHRs and notify clinicians when a
case fits criteria for reporting to public health. EHRs would initiate
subsequent reports to public health, and public health would be able to
request and receive details electronically to support contact tracing
and investigation of exposure sources.

###### Case Reporting -- End State (2014) Discussion Highlights

-   Given the role that EHRs would play, it will be critical to build a
    use or business case for public health that the health IT industry
    can support and that clinicians and health providers will
    understand. It was noted that EHR capability that benefits case
    reporting and public health also helps clinicians meet reporting
    obligations.

-   It was suggested that the BSV WG reference literature on the cost of
    outbreaks and how such costs could be reduced by the envisioned end
    state. It was proposed that the business case also show how the cost
    of routine matters could be reduced.

-   Reference to provider EHRs will be expanded to include lab
    clinicians, both for case reporting and outbreak investigation.

-   It was suggested that an end state goal should be automation of all
    relevant public health reports through EHRs.

###### B. 1. Bidirectional Communication -- Current State (2006) Briefing Highlights

Technologies to support bidirectional communication (e.g., between
clinicians and public health and back to clinicians) exist, but the
basic infrastructure needed for automation is still under development.

###### B. 2. Bidirectional Communication -- Mid-state (2010) Briefing Highlights

The overall goal would be to establish protocols, directories, and
infrastructure for communication among health departments and clinical
care. Specific goals include linking existing emergency medicine systems
at the regional and State levels into an integrated, standards-based
national network for real-time communication at the pre-hospitalization
level; developing a central Web repository for grouping existing and new
links between clinicians and public health; and addressing pandemic
influenza communication as a prototype and as a priority.

###### Bidirectional Communication -- Mid-state (2010) Discussion Highlights

-   It was noted that the mid-state seems ambitious against current
    state realities and that many barriers and enablers will need to be
    addressed.

-   It was proposed that organizations working on the issues raised in
    the mid-state be convened to reach agreement. A starting point could
    be to examine the CDC's role in developing standards for
    non-clinical settings and to use those standards as a starting point
    to generate compatible reports across jurisdictional lines.

-   It was noted that the IT architecture involved should be compatible
    with and build on what first responders do, to prevent unnecessary
    reinvention.

-   References to registries should mean "all" registries.

###### B. 3. Bidirectional Communication -- End State (2014) Briefing Highlights

Rapid, targeted communications would be an overall goal. For example,
during an outbreak, guidelines and special warnings would be
disseminated to EHRs, clinicians, Personal Health Records (PHRs), and
the general public, and during an outbreak investigation, labs would be
notified to expedite suspect case samples for testing. Updates to
decision support algorithms based on public health case definitions
would be disseminated to EHRs. Reports would be made available to
clinicians based on information reported in real time, with capacity for
feedback and questions from clinicians back to public health.

###### Bidirectional Communication -- End State (2014) Discussion Highlights

-   Real time versus near-real time was discussed in the context of
    making reports available to clinicians.

###### C. 1. Response Management -- Current State (2006) Briefing Highlights

This area is broad and encompasses applications to support registries,
pharmaceutical stockpile management, allocation and distribution of
medical supplies and drugs, and long-term followup. Automated
immunization registries exist but are not complete. Long-term followup
includes those receiving drugs not commonly used. Hospital bed
utilization and staffing availability are monitored.

###### Response Management -- Current State (2006) Discussion Highlights

-   It was agreed that the document should mention how public health
    emergency management and followup occurs within the context of
    broader incidence response (involving, e.g., the Department of
    Defense and Homeland Security).

###### C. 2. Response Management -- Mid-state (2010) Briefing Highlights

Integration standards, workflows, and application requirements would be
established with regard to, e.g., medical supply and demand. The
prophylaxis status of responders and volunteers could be tracked through
a registry. Interoperability and infrastructure requirements for
emergency prophylaxis and treatment systems would be determined and
implemented on the National Health Information Network (NHIN). Drug
product distribution would be tracked through standardized data
exchange. Local, State, and Federal partners would have access to
national systems for medical surveillance or disease outbreak detection
or in the event of potential bioterrorism. Electronic immunization
registries would be expanded to cover more adults, and there would be a
management system for mass vaccination distribution. Early versions of
systems addressing the Community's emergency response use case would be
designed and implemented by using lightweight past medical history and a
patient tracking system.

###### Response Management -- Mid-state (2010) Discussion Highlights 

-   It was noted that eligibility for medical supply could be determined
    through messaging.

-   It was noted that sharing of data from national systems would need
    to be "as appropriate."

-   There was discussion of being able to track isolation and quarantine
    orders. It was noted that systems for tracking isolation,
    quarantine, and alternative care site management are being piloted
    locally. It was agreed, as a placeholder, that the results of the
    pilots would be added to the mid-state and that integration of those
    systems nationally would be added to the end state.

###### C. 3. Response Management -- End State (2014) Briefing Highlights

The end state entails implementing applications and integration
standards to provide ongoing awareness of supply and demand of drug
products, medical personnel, and hospital capacity. Specifically, the
end state would integrate EHRs with immunization registries, enable
interoperability between the commercial-sector supply chain and the
national stockpile, implement hospital bed capacity and resource
monitoring at regional and national levels, integrate response
activities with ongoing monitoring and outreach investigation, and
ensure availability of granular data for each jurisdiction and analytic
data for the entire outbreak.

###### Response Management -- End State (2014) Discussion Highlights

-   Implementation of hospital bed capacity and resource monitoring
    should be automated.

-   Availability of granular data should be ensured to facilitate case
    management and contact tracing.

-   EHRs should be integrated with all appropriate registries.

-   Tracking mass casualties was discussed. It was decided that a
    mid-state goal would be to establish a nationwide death
    certification system and that an end state goal would be to have
    EHRs drive that system.

-   A system to monitor mortuary locations was discussed. One potential
    mid-state goal would be to integrate public health and clinical
    responses at the State and local levels with larger management
    responses at the national level.

###### D. 1. Adverse Events (AE) Reporting -- Current State (2006) Briefing Highlights 

AE reporting is supported in a variety of ways, including through the
Food and Drug Administration's (FDA) Medwatch program, the Nosocomial
Infection Surveillance System, the U.S. Pharmacopeia Medication Errors
Reporting Program, and Patient Safety Organizations. Some State
governments also support reporting of medical errors.

###### D. 2. Adverse Event Reporting -- Mid-state (2010) Briefing Highlights 

Automated reporting of adverse drug events from EHRs would begin,
standards would be developed and existing systems consolidated, and EHRs
would be enabled to query FDA's Structured Product Labeling database to
review drug interactions and allergy information to prevent adverse
events.

###### D. 3. Adverse Event Reporting -- End State (2014) Briefing Highlights 

The goal would be to automate EHR prompting and filing of adverse event
reports for all medical productions, including drugs.

##### Action Item #1: Dr. Lumpkin proposed that Workgroup members and staff reflect on the end state in each of the four priority areas, including additions made today, and backtrack to make any necessary additions to the mid-state, in part to reflect ongoing work that might reach a certain stage of maturity by the mid-state. 

### Access to Large, Aggregated Databases Discussion

Members and invited participants engaged in a lengthy discussion of the
importance of public health access to large, aggregated databases for
data mining and/or signal detection in the interest of protecting public
health and helping to ensure health care quality -- a public health
function not often recognized. It was agreed that this functionality
cross-cuts other BSV WG priority areas as well as topics under
discussion in the newly formed Quality Workgroup. This could be
addressed in overviews provided to the Community and possibly considered
as a mid-state goal with end state implications. It was recognized that
there are potential barriers to realizing this kind of functionality,
including questions of appropriate use of secondary data and the need to
protect patient privacy.

##### Action Item #2: Pursuant to discussion of the need to mention mental health and technologies that currently exist to assist mental health efforts by public health, Leah Devlin will assist in ensuring that appropriate footnotes, including those referring to mental health response management, are appended to the matrix document. 

### 3. II. Discussion of 

### Visioning Matrix Barriers 

### Visioning Matrix Enablers

###### II. A. Barriers Discussion 

Dr. Lumpkin drew attention to **Barriers** for the current, mid-, and
end states listed on page 8 of the document and asked for proposed
changes/additions.

Proposed changes to Barriers include adding:

-   "Privacy" to both the mid- and end states as a "dis-enabler"

-   "Lack of a clearly described business case" for public health needs
    that articulates for hospital executives the tangible benefits of
    public health reporting and the benefits to them and to public
    health of automation

-   "Cost"; how to incorporate "legacy systems"; and "workforce
    development, education, and training," including for public health

-   How to account for undocumented aliens

-   The need to make the case for a public health system built on
    current disease reporting systems that is in use routinely yet also
    has the resources and capabilities in place to be scaled up quickly
    for emergencies (with the caveat that such a system should not add
    steps to the clinical process)

-   The need for the Commission on Certification of Health Information
    Technology (CCHIT) to be presented with a compelling business case
    and to require the necessary flexibility and adaptability in EHRs

-   The need for the business case to note the predominance of under
    reporting, the ease and cost-benefit of using EHRs for reporting,
    and the benefits of facilitating bidirectional communication

-   The need to protect the confidentiality of public health data

-   The need to address inconsistency in accumulation and storage of
    data

-   The need for higher adoption of technological tools by practitioners
    and by public health, particularly at the local level at the
    mid-state

-   The issue of whether data systems are "smart" and specific enough to
    give public health the information it needs in the way it needs it
    to do its work properly, such as followup

-   The issue of a situation where public health is getting more data
    and is able to discern what needs response, but its response
    capacity remains constrained

-   The conflict between vertical and horizontal IT standardization

-   The issue of public health information systems not having enough
    priority and/or authority within their local or State organizations
    (subject to further editing to finesse the language)

-   Lack of clarification of roles at different governmental levels of
    public health (local, State, Federal).

### Business Case: Further Discussion

There was extensive discussion of the business case, including possibly
asking professional organizations to list the top 10 reports they would
like to get from public health. The need to build a business case for
intermediaries, such as health information network service providers
that interconnect providers in different parts of the system, was
discussed in the interests, in part, of encouraging intermediary
services that relieve clinician reporting burdens.

###### II. B. Enablers Discussion 

Dr. Lumpkin turned members' attention to **Enablers** for the current,
mid-, and end states, and the .proposed changes. It was proposed that:

-   The first bullet point under the current state be amended to read
    "Certification of some public health information systems by
    CCHIT/CDC"

-   Public health systems be certified

-   The Public Health Information Network, mentioned in the current
    state, have a greater presence at the local level by the mid-state

-   Data sharing and information flow among governmental agencies as
    well as between the public and private entities be noted in the
    current state and that progression in this area be mentioned in
    later states

-   The current state note that local public health is beginning to
    develop business processes and that the mid-state include
    accreditation of these processes

-   Intermediaries, such as clearinghouses, be accredited by the
    mid-state, including against public health-oriented criteria

-   There be standardization of the roles of data exchange organizations
    by mid-state

-   Regional Health Information Organizations include public health.

###### 4. Next Steps: A. BSV WG's Presentation to the Community on October 31, 2006; B. Development of a Detailed Work Plan for 2006/2007; and C. Addition of Members as Needed

##### 

##### Action Item \# 3: Today's meeting discussion will be used to make the Visioning Matrix, including Barriers and Enablers, ready for presentation to the Community on October 31, 2006. 

##### 

##### Action Item #4: After the presentation and the Community's reaction, the BSV WG will determine its detailed workplan for 2006/2007, driven, in large part, by consideration of future recommendations to the Community. 

##### 

##### Action Item #5: Members will communicate recommendations for additional members to Ms. Cronin or Judy Sparrow. 

### 5. Public Comment

Sally Johnson of the Rhode Island Department of Health proposed that BSV
WG discussion of EHRs include consideration of health information
exchanges (HIEs) as central repositories of information.

Ms. Cronin noted that many of the intermediaries envisioned by the BSV
WG include NHIN service providers that could operate at national,
regional, or local levels. Ensuring that NHIN could be used by the
mid-state by all entities to report adverse events is seen as a
cross-cutting enabler, and that will be communicated in the Visioning
Matrix presentation to the Community on October 31, 2006.

## SUMMARY OF DECISIONS/ACTION ITEMS

#### 

#### **DECISION POINT:** It was agreed that the BSV WG would endorse the BDSG's Final Report and Letter of Recommendation to the Community. 

##### Action Item #1: Dr. Lumpkin proposed that Workgroup members and staff reflect on the end state in each of the four priority areas, including additions made today, and backtrack to make any necessary additions to the mid-state, in part to reflect ongoing work that might reach a certain stage of maturity by the mid-state. 

##### 

##### Action Item #2: Pursuant to discussion of the need to mention mental health and technologies that currently exist to assist mental health efforts by public health, Leah Devlin will assist in ensuring that appropriate footnotes, including those referring to mental health response management, are appended to the matrix document. 

##### Action Item \# 3: Today's discussion will be used to make the Visioning Matrix, including Barriers and Enablers, ready for presentation to the Community on October 31, 2006. 

##### 

##### Action Item #4: After the presentation and the Community's reaction, the BSV WG will determine its detailed workplan for 2006/2007, driven, in large part, by consideration of future recommendations to the Community. 

##### 

##### Action Item #5: Members will communicate recommendations for additional members to Ms. Cronin or Ms. Sparrow. 

**Biosurveillance Workgroup**

**Members and Designees Participating in the Web Conference**

**October 20, 2006**

*Co-chairs:*

John Lumpkin Robert Wood Johnson Foundation

*Staff of Co-chairs:*

Jeff Cohen (for Charles "Chip" Kahn) Federation of American Hospitals

Laura Conn (for Julie Gerberding) HHS/CDC

Brian Carnes (for Mitchell Roob) Indiana Family and Social Services
Administration

*ONC Director:*

Kelly Cronin HHS/ONC

*Members:*

Maureen Allen (for Michael Barr) American College of Physicians

Michelle Meigs (for Scott Becker) Association of Public Health
Laboratories

Larry Biggio State of Wyoming

Leah Devlin North Carolina Department of Health and

Human Services

Brian Keaton American College of Emergency Physicians

John Loonsk HHS/ONC

Edward Sondik HHS/CDC

Captain Rich Harbinger (for Lieutenant Department of Defense (DoD)

Colonel David Parramore)

*Presenters, Speakers, and Other Invited Participants*:

Ed Barthell American College of Emergency Physicians

Kevin Carr BearingPoint, Inc.

Art Davidson Denver Public Health Department

Roland Gamache Indiana State Department of Health

Vonna Henry Sherburne County Public Health

Scott Holter HHS/ONC/Project Manager

Sally Johnson State of Rhode Island Health Department

Marion Kainer Tennessee Department of Health

Sherri McDonald National Association of County Health Officials

Lisa Rovin Food and Drug Administration

Lynn Steele HHS/CDC

Meagan Treber Pennsylvania Department of Health

Robert Tuch DoD

**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 the HHS; nor does mention
of trade names, commercial practices, or organizations imply endorsement
by the U.S. Government.*