# Presentation: 433634

## American Health 

**American Health **
**Information Community**
**PH/CCC Workgroup Meeting**
**05/16/2007**

## Goals for this meeting

- Provide updates on:
- Progress of Ad-hoc workgroup for Adverse Events
- Response management activities and planning

## Recommendations – overarching guidelines

- Finding and disseminating best practices
- Proactive
- Short time-frame
- Actionable

## Update on Adverse Events Recommendations

***Steve Solomon, CDC***
***Scope***
***Discussion points***
***Timeline***

## Scope

- Medical Products – including drugs, devices, biologics, and perhaps tissues and organs.  This would include, but not necessarily be limited to, post-marketing surveillance of drugs.
- Nosocomial infections - Surveillance of healthcare-associated infections was proposed.
- *	Adverse events associated with medical practice—i.e., “medical errors”, such as misuse/misadministration of drugs, wrong site surgery, etc.—were proposed as being out of scope.

## Discussion points – Adverse Events Detection

- Standards for detection of AEs
- Compelling testimony in this area from Regenstrief, discussions with David Bates and Jon Einbinder
- AE detection does not address initial detection of previously unknown or unsuspected problems.
- Should focus on looking for specific outcomes -  including looking at sentinels for AEs
- Promoting pilot and/or demonstration projects.
- VA System (reporting?)
- Leverage NHIN pilots with HIEs as proof of concept for AE detection and reporting through RHIOs/HIEs.
- Data Driven Triggers
- Clearly define what is meant by data-driven triggers in this domain.

## Discussion points – Adverse Events Reporting

- Develop standards for data, messaging and reporting of adverse events.
- Codify and catalogue and further encouraged on-going work
- Automated reporting through EHRs. Active (push) vs. query-based (pull)
- Levels of access by public health for different purposes
- Research
- Adverse Event detection, reporting and prevention
- Distributed vs. centralized model
- Assurance of look-back capability in database
- Promoting pilot and/or demonstration projects.
- VA System
- Leverage NHIN pilots with HIEs as proof of concept for AE detection and reporting through RHIOs/HIEs.
- Harmonization of standards through HITSP
- Advance implementation of the standards more broadly
- Promote subsequent development of certification criteria for use in certifying vendor systems (for example)

## Proposed Timeline – AE Ad-hoc group

- Ad-hoc	5/1	4:00-5:00 	Scope and schedule
- Ad-hoc	5/9	2:00-3:00
- PH/CCC	5/16	1:00-3:00  	Update to Workgroup on progress
- Ad-hoc 	5/18	11:30-12:30
- Ad-hoc 	6/1	2:30-3:30
- Ad-hoc 	6/8	2:30-3:30
- PH/CCC	6/15	10:00-3:30	Review rough draft of recs
- Ad-hoc 	6/22	2:30-3:30
- Ad-hoc 	6/29	2:30-3:30
- Ad-hoc 	7/6	2:30-3:30	Review next iteration of draft recs
- Ad-hoc 	7/13	2:30-3:30	Review final draft of AE letter
- PH/CCC	7/19	1:00-4:00  	Review AE Presentation and 				letter with PH/CCC WG and
- 				finalize
- Ad-hoc 	7/20	11:30-12:30	Apply final updates
- AHIC 	7/31		Present recommendations for AE

## Update on Response Management progress and plans 

***Scott Becker, APHL***
***John Lumpkin, The Robert Wood Johnson Foundation***
- Summary of testimony from 3/29/07 PH/CCC Meeting
- Timeline for recommendations
- Plans for June 15th Testimony

## Summary of Testimony – 3/29/07

**Five presentations were given on Outbreak and Event Mgmt**
**Paula Soper - ***The Role of Local Public Health in Outbreak and event Management *
**Dr Marci Layton and Dr Annie Fine - ***Information Needs in Outbreak Management: A Local Perspective*
**Ms Janet Hamilton*****, *****MPH - ***Surveillance Section Administrators, Florida Department of Health*
**Dr Marion Kainer - ***Outbreak and Case Management: A State Perspective*
**Mr. Tim Morris - ***Public Health Response Information Management*

## Outbreak & Event Mgmt summary - Needs

- Clinical data insufficient for outbreak management
- Need federal support for improved outbreak management tools, such as CDC’s OMS 1.2
- Need to manage and track exposures in healthcare settings – capture and easily access info on patient/staff movements
- Flexible and secure NHIN
- Consistent implementation of standards
- Common terminology usage and definitions
- Shared infrastructure (policy, governance, workforce, software, information technology (hardware, services such as authentication, routing, transport, directory)

**Notes:**
Recommended that Federal support be reinstated for CDC’s OMS 1.2.  In addition, it was recommended that:
Reconvene working group
Prioritize high value enhancements such as messaging

## Summary of Testimony – 3/29/07 – cont.

**Four presentations were given on Laboratory Response**
***Dr Steven Hinrichs -****Contribution of Public Health Laboratories to Event Detection, Response and Management*
***Dr Norman Crouch - ****Responding to Outbreaks and Events: State Public Health Laboratory Perspective*
***Emory Meeks - ****Laboratory Data Exchange *
***Dr Michael Miller - ****Laboratory Response Capacity Coordinating Center for Infectious Diseases*

## Lab Response summary - Needs

- Refine and implement lab standards
- Integrate lab data with epi case data
- Track sentinel lab capacity and capabilities
- Consider full breadth of lab functions and capabilities - animal, water, environmental testing
- Evaluate how to achieve uniform reporting across agencies–harmonize requirements across agencies for reporting
- Process and funding for sustained support of IT and informatics
- Recommend implementing uniform minimum data elements within state law for reportable conditions
- Support research on predictive trend analysis and statistical sampling for monitoring health of population
- Support national OID solution for lab service providers and medical service providers

## Lab Response - Challenges

- Challenge of large commercial labs: reporting is across states with specific reporting requirements; no central place to send reports for dissemination or retrieval.
- FDA approval of PH assays within a timely manner – especially to support emergency response
- Workforce development - recruitment and retention of lab scientists and developing expertise in next generation of PH leaders
- Integrating critical PH info, tracking and communications in a secure, efficient and accessible format

## Key Issues - Draft

- Infrastructure at local and state levels is often not adequate. Infrastructure includes at least the following: policy, governance, workforce, hardware, software, services (for authentication, routing, transport, directory).
- There is a need for consistent implementation of nationally recognized data standards, common vocabulary standards and definitions, and systems available to support response.
- Federal agencies and agencies at different levels of public health have disparate business requirements.  While there is a need to harmonize reporting requirements across agencies to reduce overall reporting burden for healthcare organizations and support automated reporting, there is also a need to assure that required local functions (e.g., contact tracing and case management) can be incorporated in vendor-based information system solutions.

## Recommendations

**Categories discussed during deliberations:**
- Harmonization and implementation or adoption of standards
- Capacity: lab reporting, contact tracing, exchange of possible cases = sentinel capacity for the PH system
- Interagency coordination such as ICLN
**Current outline of recommendations****:**
- Outbreak and Event Management
- Laboratory Response
- Countermeasure Alloc, Dist, Admin
- Registry Integration

## Proposed Timeline – RM Ad-hoc group

- Ad-hoc	5/11	3:00-4:00 		Scope and schedule
- Ad-hoc	5/22	11:30-12:30	Outbreak and Event Mgmt recs
- Ad-hoc 	6/7	11:30-12:30	Laboratory Response recs
- PH/CCC	6/15	10:00-2:30(?)
- Ad-hoc 	7/10	11:30-12:30	Countermeasure recs
- PH/CCC	7/19	1:00-4:00(?)  Review 6/15 testimony 				& draft recs
- Ad-hoc 	7/24	11:30-12:30	Registry integration recs
- Ad-hoc 	8/7	1:30-12:30		Review complete draft of letter
- Ad-hoc 	8/21	11:30-12:30	Finalize draft for AHIC				presentation
- PH/CCC	9/5	1:00-4:00		Present final draft to workgroup
- AHIC 	9/18			Present recommendations for RM

## Plans for 6/15/07 - Day 2 of RM testimony

- Countermeasure Allocation, Distribution and Administration
- Integration with registries
- Overview of scope and requirements for this domain
***2*** ***Local***
***2 State***
***2 CDC***
***Others??***
- We recommend deferring testimony on Bi-directional communications until a later date.

## Next Steps

- June 15, 2007 –Day 2 Response management testimony – in-person, on-site
- July 19, 2007 – final review of AE recommendation letter
- Target AE recommendation letter for July 31 AHIC meeting
- Target RM recommendation letter for Sep 18 AHIC meeting