PCD PC&TC 2008-10-21 to 23 F2F

Meeting Objectives

The PCD needs to evaluate profile proposals for Cycle 4 (2009/2010) development. These meetings will provide opportunity for the Planning Committee to review brief / detailed profile proposals, discuss these jointly with the Technical Committee, and for the Technical Committee to assess development difficulty.

The output from these F2F meetings will be a vote by 2008.10.31 establishing the Cycle 4 PCD Work Plan.

NOTE: Profile & White Paper proposal submission deadline: 2008.10.15

Schedule

Date	Hours	Committees	Topics
2008.10.21	08:00 - 17:00	Planning Committee	Review & Approve Agenda ... HIMSS '09 Showcase Scenario Discussion
2008.10.21	18:00 - 20:30	TF Update WG	Technical Framework Working Session
2008.10.22	08:00 - 12:00	Planning & Technical Committees	...
2008.10.22	13:00 - 17:00	Technical Committee	...
2008.10.23	08:00 - 12:00	Technical Committee	...

NOTE: The DPI Working Group is scheduling a follow-on meeting Thursday afternoon & all day Friday. Friday may be at a different venue to facilitate participation by additional experts.

Location Information

Technology in Medicine, Inc.

325 Hopping Brook Road

Holliston, MA 01746

(508) 893-9500

More detailed location information is available on the TiM web site.

Agenda

2008.10.21 Tuesday

08:00 - 09:45

• Welcome & Introductions (Zambuto) [10 minutes]
• Agenda Review (Fuchs) [5 minutes]
• PC Co-Chair Election Status Update (Furst) [5 minutes]
• Review IHE PCD Scope + Organizational Relationships (Cooper/Zambuto)

- PCD Scope Statement & coordination with other IHE domains [10 minutes]

- HITSP Update (esp. RMON) [5 minutes]

- AHIC II (esp. CDC & CDT gap/extension) [5 minutes]

- Continua Update [5 minutes]

- CIMIT/MDPnP (incl. "MD FIRE")

• PCD Roadmap Review & Planning (Cooper / Fuchs / Zambuto)

- 2008 Stakeholder Survey [10 minutes]

- Profile Framework [15 minutes]

- White papers (incl. Process) [5 minutes]

- User Handbooks

• Profile Proposals Process - Schedule Plan [5 minutes]
• DEC Profile Extensions (Cooper / Fuchs / Schluter) [15 minutes]

- Options: PIB & SPD

- Option inclusion in revised TF

- SPD Predicate Support

• ACM Extensions (Patillo) [15 minutes]
• PIV Extensions (Rinda / Zaffrin) [15 minutes]

10:00 - 12:00

• Device Point-of-care Integration (DPI)Proposals [30 minutes] PCD_Profile_Device_Point-of-Care_Integration_(DPI)

- Scope & Use Case Review

- DPI White Paper

- Profile Framework (e.g., DPI-PnP, DPI-PIB, ...)

• Medical Equipment Management (MEM) Proposals [30 minutes] PCD_Profile_MEM_Proposal_Brief
• Waveform Communication Management (WCM) Proposal (see BoG) PCD_Brief_Profile_Proposal_2008_WCM
• Real-time Archival (& Retrieval) Management (RAM)(see BoG) PCD_Brief_Profile_Proposal_2008_RAM
• 11073 DIM to HL7 RIM Mapping (DRM) Proposal [5 minutes]
• HL7 Cliinical Observations Template (COT)for PCD device data Proposal [5 minutes]
• White Paper: Medical Device Semantic Architecture [10 minutes]
• White Paper: Regulatory Considerations for IHE PCD Profile Implementers [10 minutes]
• SoA Update: IHE, IHE PCD, HITSP, SDO Summit, HL7 ... [10 minutes]

13:00 - 14:45

• PCD Showcase Discussion (Fuchs / Furst) Note: WebEx Session

- Systems Diagram Review

- Scenario / Act(s) Discussion

15:00 - 16:30

• BoG: Medication Administration Use Cases (beyond PIV)
• BoG: Waveform Communication Management (WCM) + Real-Time Archival & Retrieval Use Cases

16:30 - 17:00

• BoG Reports
• Device Specialization Profile Proposals

18:00 - 20:30

• Technical Framework Update "Work Party"!!!

2008.10.22 Wednesday

Note: Wednesday A.M. is joint with PC & TC.

08:00 - 09:45

• Introductions & Agenda Review (Zambuto) [5 minutes]
• IHE International Update (Didi Davis) [15 minutes]

- IHE organizational changes

- Promotional / Marketing Opportunities

- Response to CIMIT/MDPnP "FIRE" Project

• IHE PCD Governance Update (Co-Chairs) [15 minutes]

- Domain Scope / Charter

- Coordination with IHE Domains

- Member Participation

- "Outside" Expert Participation

10:00 - 12:00

• Technical Framework Update Review [15 minutes]

- Outlines

- Volume 1

• DPI & "Transaction Packages"
• Showcase Planning (Davis / Fuchs)

- Showcase Workshop 2008.10.29 - 31

- Systems Diagram Review + Booth Layout

- Vendor Equipment Display Policy

• RTM & Semantics Support

- Tooling (incl. Terminology Authoring) [NIST]

• NIST Test Tooling Update [Garguilo]
• IEEE-IHE MoU Status Update
• Wiki Meetings Page Update
• Medication Administration (infusion pumps) Gap Issues

NOTE: Available schedule time was exceeded at this point - the following joint PC/TC agenda items were not addressed.

• PCD Work Products Review

- Review ITI TF Webpages Document

- IHE & Open Source

• Ventilator Terminology Status & Strategy
• Recruitment (providers & vendors)

- Update re. IHE Internationl & IHE USA Activities [Davis]

- Participation in existing supplements (e.g., SPD & ACM (AC / AA), etc.) - what are the blockers?

- Provider Recruitment Brainstorming

• Joint Discussion of Proposed Cycle 4 Profiles

- Supplement Process for Cycle 4 (review wiki use, document templates, etc)

- PCD Milestones Review

• New issues / business discussion
• Adjourn IHE PCD Planning Committee meeting

NOTE: Afternoon sessions are only TC.

13:00 - 14:45

• Welcome & Introductions (Zambuto)
• Agenda Review (Cooper)
• TC Co-Chair Election Update
• RTM Update

- RTM Content Update (Schluter)

- UoM status resolution ("vote off the island...")

- Approach for "Boolean" type values

- Relationship to Transactional Profiles (mandatory compliance?)

- Conformance Testing (Cycle 3 & beyond)

• IHE & Open Source

15:00 - 17:00

• HITSP RMON Response Discussion
• SoA Archictures & PCD Profiles
• MWB Library supporting PCD Transactions

- Presentation of issue resolution [Garguilo / Engelbert]

- MWB "Advanced" Demonstration [TBD]

• PCD Transaction Registration

- Review PCD-01 issues and determine whether they shall result in changes to the TF

- Determine appropriate version of HL7 for the DEC profiles (2.6?)

- Plan the registration for additional PCD transactions

• PIV TI Review

- Seek agreement on how to handle error messages

- Update or review suggestions for changes to profile

2008.10.23 Thursday

08:00 - 09:45

• Review Issues Arising from Previous Discussions

- Technical Framework Vol 2 Issues

- Review Votes from Wednesday & Quorum Requirements

- Approach for "Boolean" type values

10:00 - 12:00

• Review Issues Arising from Previous Discussions (cont'd)

- Approach for "Boolean" type values

• RMON Public Comment Feedback
• Waveform Comm. - HL7 v2 Proposal Review

NOTE: Available schedule time was exceeded at this point - the following joint PC/TC agenda items were deferred to the afternoon.

• Enterprise vs. PoC Architectural Definitions
• Query Bulk Data (a.k.a. Archival...)

NOTE: Available schedule time was exceeded at this point - the following joint PC/TC agenda items were not addressed.

• MEM White Paper Outline Discussion
• Regulatory Considerations WP
• Medical Device Semantic Architecture WP
• PCD Milestones Review
• IHE.net web & wiki review

- Top level wiki pages review

- Supplement Page Support

- Minutes pages (agenda vs. minutes, see DCC wiki page approach)

• Action Item Review (incl. Assignment & Scheduling)
• Adjourn IHE PCD Planning Committee meeting

NOTE: DPI WG Sessions immediately follow after lunch.

Attachments / Materials

Placeholder

Planning Committee Minutes Tuesday, October 21

Planning Committee Meeting

Objectives

Placeholder

Attending

Blasingame, Jon (Philips); Borchers, Steve (Spacelabs); Cooper, Todd (Breakthrough Solutions); Day, Bikram (Capsule Tech); Dern, Jeff (Cardinal); Engelbert, Al (Protolink); Fuchs, Ken (Draeger); Furst, Manny (PCD); Garguilo, John (NIST); Garstka, Colin FX (Cerner); Hillman, Rich (Spacelabs); Hotchkiss, John (LiveData); Merritt, Steve (Baystate); Meyer, Gary (Cardinal); Rhoads, John (Philips); Rinda, Jeff (Hospira); Schluter, Paul (GE); Zaffrin, Scott (B Braun); Zambuto, Ray (Technology in Medicine/ACCE); Zubaidi, Khalid (Cardinal)

Joining on line for the Showcase discussion: Robert Flanders (GE), Sarah Hopkins (Cerner), Kristina Wilson (Hospira)

Discussions
Agenda Review/Approval

Ray presented the agenda and it was approved.

Notes from breakout session(s) are found at the end of this day's minutes.

Elections

Manny provided an update on the election status. The nominations are closed and ballots will be sent this week, and are due back November 17.

Domain Overview Wiki Page

Todd reviewed the Domain Overview (Scope)Wiki page (Patient_Care_Device) indicating that this needs to be reviewed and updated. Clarification should be provided for the Point of Care related to lab, as well as personal health and home health devices. John Hotchkiss volunteered to draft an update: The Patient Care Device Domain is concerned with use cases in which at least one actor is a regulated medical device. Other actors involved are information systems, other medical devices, or actors from the IT Infrastructure Domain or clinical specialty based domains. The PCD domain coordinates with other domains, such as Radiology (medical imaging), Laboratory, and Cardiology to ensure consistency in use cases involving regulated medical devices as they occur throughout the Enterprise.

HITSP RMON Update

Todd reviewed the HITSP RMON effort. Continua suggested that the actual devices are not in scope and “interface 2”, System Data Exchange #2, would take information from a hub/aggregator and send it to the Remote Monitoring Management System (RMS). PCD proposed using PCD-01 with a subset for simple devices. This would use a tested protocol, the same as used within the receiving facility (e.g., hospital EHR), and would also support more complex devices. Both use IEEE 11073 formats and Continua indicated they will use RTM.

AHIC Update

Todd described the AHIC II effort, with two possible approaches, CDC and CDT: Common Data ___ and Common Data Terminology _______ .

MD PnP Update

Todd introduced the MD PnP “MD Fire” templates and processes for purchasing interoperable devices. Julian Goldman, MD recently made this available.

Stakeholder Survey

Ray provided the 2008 survey results. There were only a small number of vendors responding. Results indicate that interoperability is more visible. Several possible ways to increase participation were discussed, including asking HIMSS analytics to send targeted emails when the next survey is conducted. The survey indicates greater awareness of the need for devices to become integrated. Priorities for which devices has not changed greatly from 2006, but there was an overall increase in nearly all priorities and interest. Additional device types were added. Survey results are available at ftp://ftp.ihe.net/Patient_Care_Devices/Stakeholder%20Surveys/ . Ray observed that it would be helpful to have increased physician input as well.

Existing Profiles for Further Development

• PIB and SPD are options. In revising the TF, consideration will be given to making these required transactions. Paul suggested that the DOF should be able to send more than the query requests. E.g., significant data due to changed conditions or preventing an unsafe request.

• PIV extension: defer extension to syringe and other pumps. To move PIV, a pharmacy WG within HL7 needs to be involved to overcome the limitations of HL7. CPOE, BCMA and other systems also limit the commercial feasibility of PIV.

• ACM extension to develop the AM  AC transactions, add waveforms - WCM, and then vendor’s participation in getting the clinician’s response (accept, reject) back to the AR (recruiting companies)

New Profiles

• DPI: Initial work will focus on specific use cases.

• MEM: many, large areas have been proposed; MEM may be helpful in compliance with ISO 80001 as well.

White Papers

• DPI
• PHD to DEC White Paper

Scenario

Joining on line for the Showcase discussion: Robert Flanders (GE), Sarah Hopkins (Cerner), Kristina Wilson (Hospira)

Ken described the overall scenario and the draft block diagram. This and later versions will be available at ftp://ftp.ihe.net//Patient_Care_Devices/Showcases/HIMSS2009April/

• Discussion included:

• 3 pumps at each location as illustration – has benefits (rotation, shows interoperability, clinical sites) but problems (space, staffing esp. if multiple simultaneous acts)
• How to display Cerner’s product
• How to accommodate multiple IOPs with appropriate space,
• Are the IOPs handheld or stationary

• Mobile implies unreliable wireless (IOP, AC actors)

• Epic will do ADT registration
• Achieving balance among vendors will be more complex, with additional ARs
• LiveData as AM need not be a physical connection (it need not be displayed)
• Use of three walls, adding “dividers” with RTM and to permit multiple simultaneous acts (reduce noise interference)
• Question: should new directions elements be a separate wall or integrated into the three clinical areas, with additional signage indicating that it is present to demonstrate the new work PCD is undertaking?
• Are the ARs appropriately distributed?
• Number of acts – use two sites in each (OR/ICU and ICU/SD) to show flow of information; possibly three (SD/OR)
• Ken led discussion of Clinical Scenario.

• Alarm possibilities will need to be storyboarded.
• Will need to lay out walls early, as space may become an issue in defining options.

• Ken noted that it is getting to the point that within the IHE booth area we need to have a wireless coordination plan. We should also bring tools to HIMSS to be able to see what our neighbors are doing and try to manage their wireless us as well. Maybe this is something that needs to be done at the HIMSS level since there are many companies that want to use wireless and their demos are defeated due to interference from others trying to do the same thing.

Profile Breakouts

Waveform Communication Management (WCM)

• Diagnostic Report (Annotated Waveform)
• Communication of Waveform Information/Snapshot
• Communication of Waveform Information/Continuous

Real Time Archival and Retrieval Management (RAM) – pointer may change, name changed later

• Focus will be on the real-time piece at this time – focus on query process.
• Need chunks of data (selection by time interval, parameter, event, etc.) which are defined in real time

Point of Care Infusion Verification (PIV)

• Possible extensions: different types of pumps (e.g., syringes) and different types of infusions
• Need to know more about how the pharmacy works.
• Need more information from BCMA vendors.
• DOR as a current status transaction does not permit subscription to certain types of events, e.g., infusion start, stop times. This could be an event driven extension of DOR actor or expansion of SPD. Things like event driven reporting are not on a periodic basis. Paul noted that this is similar to discussion of retrospective data retrieval. For the pump, the periodic report with all information that happened with the pump is provided (e.g., event that occurred during the reporting period would be reported with time).
• PIV needs near-real-time reporting of certain events.

• One possibility is to provide a “report on change” for some or all of pump data. It may need to be a higher priority message and may need to permit the filter to provide more information than subscribed to, under certain conditions (super positive).

Device Specialization Profiles

• Semantic content was intended as volume 3 of TF. Appendix D was a short time, temporary approach and placeholder. Profile proposal is to develop comprehensive approach and samples.
• Paul suggested that this could be developed as a computable document within the RTM profile.
• Todd, Paul, John Rhoads, John Garguilo will provide a brief profile proposal.

DEC CP for the Framework will be led by John Rhoads (see TC meeting later)

Todd assumed responsibility for learning the process for CPs and shared that information later.

PIV working group meeting summary

Summary - Current state of PIV profile

• profile is not mature
• PIV is the first IHE effort to create standards involving medication administration
• intentionally simple; scope limited to general purpose pumps (excluded PCA, syringe, ambulatory)
• relatively simple to extend to syringe pumps by adding syringe size and possibly manufacturer/model
• limited by HL7 v2 in terms of the data that the message can support (device identification and infuser parameters)
• need to investigate how v3 supports medication administration concepts
• limited by how CPOE, pharmacy, and BCMA systems support continuous medication administration concepts and lack of support for infusion settings
• HL7 needs vendors (BCMA and pump) to better define what is needed (e.g. specific fields for loading dose, VTBI, therapy modes and pump settings)

Discussed possible extensions to PIV

• Pump types

• Syringe – may be possible to support with few or no modifications
• PCA
• Epidural

• Program types and programming options

• bolus
• rate change (when no order is available to BCMA)
• multi-step
• channel sequencing
• delayed start
• ramp/taper

• Conclusions

• all (other than syringe pump) would require changes to order entry, pharmacy, BCMA systems in order to provide needed parameters
• all (other than syringe pump) would require changes to HL7 standards
• multi-step, sequenced, delayed, and ramp/taper would require changes to pumps
• No extensions are currently feasible

Discussed PIV Trial Implementation version 2 possible BCMA implementations for PIV

• send order and wait
• send order and don't care (Epic) - infusion documented via status (PCD-01)

Since the clinician can modify the program at any time before infusion is started, the BCMA really needs to wait for infusion start event (PCD-01) to document what actually happened on infuser rather than notification of receipt of the infusion program.

Proposal: eliminate second ACK (RGV message) Expected action: IOC validates message receipt; notifies sender of any error Required actions

• check for missing or malformed segments
• check for missing or malformed fields
• check for presence of required fields
• check for incorrect data types

Optional actions - IOC vendor can check for error conditions and report as an application internal error (not an exhaustive list)

• check whether device is known
• check to ensure that the dose/rate, volume are within vendor parameters for the device type
• check whether drug is present in library

Discussed the need for “near-real-time” event reporting

• The DOR/DOF provide the current pump state but need to be extended to accommodate event type subscriptions so hat consumer can receive events of interest (e.g. infusion started, infusion complete, rate change, bag change, etc).
• Two ways to accomplish:

• DOR - event driven
• DOF - use SPD to get event info as it occurs (consumer can define the events of interest)
• Follow up : after the meeting we found that the existing TF already supports reporting of event-driven transactions by the DOR. Excerpt from TF Volume 2 Sec 3.1.7.1:

Trigger events The ORU^R01_ORU_R01 message is an unsolicited update. An application which implements the DOR receives data from one or more PCDs using either standards based or proprietary protocols which are outside the current scope of the IHE PCD TF. In general, the DOR sends periodic reports at a minimum interval of 10 seconds (high acuity) and a maximum interval of 24 hours (chronic, home health) with a typical interval of 1 minute. The minimum and maximum intervals are configured at implementation. The DOR may also send periodic reports for "event type” information. The DOR does not do interpolation of data received from the PCD source. The DOF receives messages from the DOR and provides the same capabilities as the DOR regarding sending of reports. The DOR adds the service of filtering the message stream based on a predicate negotiated at run-time.

Action Items:

• Evaluate MD Fire to see if we can assist, provide a sample table, consider the consumer side as well. Assign to Ken, who will discuss with Didi. Paul suggested that IHE could distribute a document addressing the entire enterprise. Paul suggested this is what IHE should be doing. A letter to Julian about the broader approach could be sent from IHE cochairs or the board. A broad document would be a marketing element for IHE.

• AHIC CDC review: set conference call since Elliot is not available.

• Discuss with Didi – survey show a lack of provider awareness of the benefits of interoperability. Perhaps a meeting around the time of the Connectathon would reach people and serve to increase attendance at HIMSS / Showcase as well.

• Brief Profile Proposals will be posted by October 31 and email ballot will be sent to determine rResources (interest), ask for all PCD interested to send response, will set priority by official ballot. Encourage non-member organizations to join IHE.

• Todd to make sure Polycom will work toward open transactions.

• Steve Merritt will convene a group to begin drafting a detailed proposal and a white paper for this cycle.

• What is CP process

• From the PIV Breakout, Jeff Rinda will write a change proposal for PIV Trial Implementation version including

• elimination of the second ACK
• other minor editorial suggestions that have been received
• update to reflect changes from v2.5 to v2.6 (capture tables and field descriptions from new TF based on v2.6 documentation). Relevant changes include
• OBX-20-25
• TS datatype changed to DTM
• CE changed to CNS or CWE (3 additional fields above CE)

TC Minutes Tuesday Evening Technical Framework Revision Session

After the main meetings Tuesday, a group met to review the PCD TF proposed revisions.

• Action Plan

- Review "template documents" (incl. new LAB TF as a key example w/ 3 volumes)

- Establish New Outlines

- Draft Text ...

• Start with content changes (w/red lined comparisons)
• Upgrade to 2.6 (verify table changes between 2.5 & 2.6)
• "Upgrade" to latest IHE tech framework template (based on Lab published final text.

- Sync with other PCD profiles

• PIV
• ACM

• Migrating from 2.5 to 2.6

- Note: General changes identified in 2.6(1.2)

- MSH-21 is in 2.5

- OBX-20 was deferred to 2.6 (reserved in 2.5)

- Should review usage of OBX-21 - 25 re. DEC

- 2.6, section 1.2

• TS changed to DTM
• CE changed to CNE/CWE

Note: PAM is based lined on 2.5. Should review potential issues / changes to DEC(PIB) as a result.

ACTION: Submit a CP to ITI to add 2.6 components to PAM.

• Volume I

- Sync front matter & boiler plate w/ latest versions

- Update to HL7 v2.6

- DEC-PIB

Fold in glossary

Update dependency section

Update lines 261 - 276 as needed

Update Actors section

Include transactions table w/ dependency & optionality

- DEC-SPD

Sync SPD w/ published TI version content

• Volume II

- Update to HL7 v2.6

- Sync front matter & boiler plate w/ latest versions

- Update message Examples

- DEC-PIB: No content to Volume II

- Move Appendix D to Vol III

- DEC-SPD: Update with TI version content

• Volume III

- Migrate current Vol II appendix D content

- Proposed Outline:

Overview

Abstract Semantic Model

Device Context Information

Rosetta Terminology Mapping

Clinical Clusters

11073 DIM to HL7 v3 RIM Mapping

HL7 CDA Clinical Statements Template

Joint Planning and Technical Committees Minutes Wednesday A.M., October 22

Planning & Technical Committee Meeting

Objectives

Placeholder

Attending

Blasingame, Jon; Borchers, Steve; Cooper, Todd; Davis, Didi (HIMSS); Day, Bikram; Dern, Jeff; Engelbert, Al; Fuchs, Ken; Furst, Manny; Garguilo, John; Garstka, Colin FX; Hotchkiss, John; Merritt, Steve; Meyer, Gary; Rhoads, John; Rinda, Jeff; Schluter, Paul; Wittenber, Jan; Zaffrin, Scott; Zambuto, Ray; Zubaidi, Khalid

Discussions

Action Items are grouped at the end of this section

IHE International Update

Didi provided an IHE update. A press release for the Continua/IHE MOU is ready and will likely go out this week. Paperwork for incorporation of IHE is nearly ready. The delay is slowing other efforts.

• Marketing

Todd introduced marketing ideas for IHE: the FIRE document from MD PnP provides an opportunity. IHE has discusses being more proactive in engaging users and vendors. Didi noted the CE-IT group supported by Crystal Anderson at HIMSS, having about 30 health care organizational members. She suggested that recruiting and marketing be started or linked in with this membership group. Paul suggested IHE promulgating a table like that in the PnP document, with more detail and colored flags indicating level of manufacturer adoption/implementation of profiles. Scott asked how the general public and vendors are made aware of the IHE, Connectathon and Showcase. At HIMSS 09 there will be a four hour workshop and users will be invited. HIMSS and RSNA have outreach efforts at meetings. Didi asked that PCD help identify opportunities (blogs, linkedin, etc.). She noted that only final text documents be cited. She also noted that PCD members need to be advocates within their organizations (e.g., with vendor marketing people, user clinicians). Didi invited PCD to suggest a meeting during the Connectathon. Another possibility is a presentation near in time to the Connectathon to reach out and raise awareness in advance of the HIMSS meeting and Showcase. Ray noted that the CE-IT group has a hardware/software WG, that PCD/HIMSS has provided sessions at AAMI and had a booth at AAMI. Crystal can do strategic searching of the HIMSS membership for HIMSS targeted emails, e.g., clinicians, CE/IT. Steve Merritt said a user handbook will be very useful. Didi noted that Radiology has a document that may be helpful. Didi suggested that work supported by the CE-IT Community will be more easily accepted.

PCD Governance Update

PCD Governance Scope Revision was posted to the Patient Care Device Wiki page http://wiki.ihe.net/index.php?title=Patient_Care_Device#Domain_Overview_.28Scope.29 : The Patient Care Device Domain is concerned with use cases in which at least one actor is a regulated patient-centric point-of-care medical device that communicates with at least one other actor such as a medical device or information systems. The PCD domain coordinates with and supports other domains, such as Radiology (medical imaging), Laboratory, and Cardiology to ensure consistency in use cases involving regulated medical devices as they occur throughout the Enterprise.

Cardiology Domain: Didi indicated that Cardiology Domain will be reconstituted, but will not sponsor the Connectathon or a Showcase. They may not have a dedicated staff person. They will have to develop test tools.

For PCD, WCM has cardiology implications.

Coordination with ITI, SDOs: ACM, for example, can be generalized for use in other domains. Didi requested that PCD identify work that should be done by ITI, PCC and any big gaps that must be addressed by other domains before PCD can accomplish future work. She suggested as long a lead time as possible (e.g., Todd suggested that real time location systems, patch management) is necessary. Didi noted that standards organizations need long lead time to fill standards gaps. IHE has a coordination function.

• Compliance

For F2F and decision meetings attendance is provided to LaVerne to track ability to vote. Abstentions are considered a vote. Cochairs can invite on-members to attend meetings, but preferably not as a permanent way of participating. Didi suggested PCD hold a webinar to encourage IHE membership. Domain votes (in person, conference call or F2F) require 14 calendar days. Non-decision meetings do not require 14 days or a quorum.

Technical Framework Update Review

TF kept as TI, will include DEC, with SPD, PIB options. Potentially final text next year. Other profiles will be separate, trial implementations. When WCM is added, a note may be added to indicate that SPD may be mandatory.

DPI and Transaction Packages DPI will need specific sequence of transactions to support state machine approach. This sets a precedent. PCD will define documentation.

Showcase

Ken’s block diagram was discussed. Detailed steps will be defined next week.

Todd led discussion of the Vendor Display Policy: <not done – only general discussion>

RTM

Goals for 2008-9 and HIMSS09

• Over 400 numeric parameters with UOM and enumerated values
• ISO/IEEE 11073-10101 harmonized with UCUM

Rosetta Teminology Management Service

John Garguilo led discussion of a service to allow vendors and reviewers to access, retrieve and report Proposed Rosetta terminology Management System

• The tool will be a web application to allow vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to RTM.

- Addresses RTM requirement: “Any corrections or additions will be reflected back in the vendor’s table and a new version of the merged table (and XML files) will be created.

• The tool will provide the capability of saving information in XML format as defined by RTM proposal
• The tool will provide the capability to apply XSLT transformations specified by the RTM proposal to harmonize the tables

– Merge individual vendor table(s) into a single table.

• Provide a report identifying differences

– RTM example: “Create a list of the MDC reference identifiers and the vendors that select it, and MDC identifiers that were selected by only a single vendor

--would be examined and compared with similar terms”.

• Provide a report identifying missing or new terms (no mapping).

- RTM requirement: “Any missing or new MDC reference identifiers will be submitted to the appropriate standards group to create and add the new terms to the relevant standard”.

John also presented proposed steps to developing an initial “prototype”, “pilot”, and a web service/system. The merged “harmonized” version will be used as a basis for testing (ICSGenerator, ValidatePDU, and NIST V2 Tools).

John then provided a use case to describe proposed usage and process flow (from user(s) perspective). The proposed RTM Management System Data Model (UML) and first cut database entity relationship diagram was shown and discussed. John requested others in the group to review these models and that any feedback would be greatly appreciated. Lastly John presented the project plan (identified tasks) and estimate of first prototype version in about 2.5 months.

NIST Tools (validation of RTM for this cycle)

John Garguilo provided a brief overview of NIST Tools, mainly the V2 Validation Tools (developed by Robert Snelick). The web site is:http://hl7v2tools.nist.gov/.

• The NIST V2 Tools include functionality to:

• Validate HL7 V2 profiles (Msg_type^Event_type^ e.g., ORU^R01^…)
• Validate HL7 V2 messages (e.g., PCD-01)

Message structure (e.g., MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,…})

• Generate HL7 V2.x messages

John also mentioned that work is proceeding to connect the device level data to the enterprise (via HL7 V2). To accomplish this work, detailed test scenario documents are needed down to the transactional and message level. The context information would provide table data, specific values, other specific PCD information not currently in HL7 tables. The test scenarios should also describe the exact (constrained as much as possible) “failure type” (e.g., version, message structure type_id, message structgure, usage, cardinality, length, data type, data, message validation context, table not found, ambiguous profile) and this information would be provided to the NIST V2 tools via an XML “validation context files”. Such test scenario documents are needed form each of this year’s proposals (i.e., ACM, PIV, and RTM). Note, since RTM has no transactions, that profile would piggy-back off of either ACM or PIV.

John indicated that recent enhancements to ICSGenerator mainly include additional functionality to support PHD (personal health devices such as weight scale, pulse oximeters, etc.) device specializations.

John Garguilo referred to the need to include requiring the receiving system or third party observer to validate message consistency with RTM. This could be achieved in future Connectathons (after the upcoming) using an off-the-shelf network sniffer. The captured message can subsequently be validated for Rosetta Mapping by NIST v2 test tools or the MWB. The likely approach for the current cycle would involve the receiver forwarding the received message or log to a validation engine. John noted that Gazelle intends to support this validation functionality in the future. Manny and John will discuss the test and adding the test to Kudu. Paul noted that the ideal is for consumers to check. Ken will generate letter from PCD PC to Charles Jaffe, liaison to HL7 and can take v3 asking for assistance

RTM: Discuss adding vent RTM to TC F2F agenda

TF Volume 2 <not addressed>

HIMSS/IEEE MOU has minor changes by HIMSS board. LaVerne to schedule a call between Didi and IEEE to discuss.

International efforts on pharmacy interoperability are moving forward. It has focused on provider support and now beginning to look at devices. Will require coordination between pharmacy and patient care groups in ISO. Other than CDA, US is not very interested in HL7 v3, but Europe has required v3. Didi and Todd indicated that there are some requirements that cannot be met with v2 extensions.

Action Items

• PCD will obtain the membership list from Crystal. PCD will suggest targeted emails to HIMSS members and perhaps a meeting in advance of HIMSS 09. PCD to engage CE-IT about device integration, seek support of the work on MD PnP FIRE by CE-IT. Consider a Town Hall at HIMSS, but this may conflict with the FDA/IHE wireless program. Deadline for Town Hall request is November 3.

• IHE and/or PCD to develop a glossary.

• Todd will review the ihe.net/pcd page.

• Go back to IHE TF page to verify correct info. Todd

Didi noted that vendors can publish integration statements against TI versions.

• Need to include requiring the receiving system or third party observer to validate message consistency with RTM. The likely approach for the current cycle would involve the receiver forwarding the received message to a validation engine. Manny and John will discuss the test and adding the test to Kudu.

• Ken will generate letter from PCD PC to Charles Jaffe, liaison to HL7 and can take v3 asking for assistance. <This item was revised during minutes review Nov. 5>

Minutes Wednesday P.M., October 22

Technical Committee Meeting

Objectives

Placeholder

Attending

Blasingame, Jon; Borchers, Steve Spacelabs rep with voting privileges; Cooper, Todd Breakthrough Solutions Rep with voting privileges; Davis, Didi HIMSS rep; Day, Bikram Capsule rep; Engelbert, Al; Fuchs, Ken Draeger rep with voting privileges; Furst, Manny; Garguilo, John NIST rep with voting privileges; Garstka, Colin FX Epic rep with voting privileges; Hotchkiss, John LiveData rep; Merritt, Steve Baystate rep; Meyer, Gary; Rhoads, John Philips rep with voting privileges; Rinda, Jeff Hospira rep with voting privileges; Schluter, Paul GE rep with voting privileges; Wittenber, Jan; Zaffrin, Scott B Braun rep with voting privileges; Zambuto, Ray TiM rep with voting privileges; Zubaidi, Khalid Cardinal rep

Of the above, 10 have voting privileges at this meeting according to LaVerne’s records. 6 are required for a quorum.

Discussions

Action Items are found at the bottom of this section

Election

John Garguilo and John Rhoads have been nominated and accepted their nominations. An email ballot will be sent with a due date of November 17.

RTM

Rosetta is to provide scientifically valid units of measure, enumerated values and body sites as well as standards-based parameter terminology.

• Paul described the RTM tables. Both UCUM and IEEE units of measure are provided.

• Paul reviewed the few units of measure that are not scientifically correct and described his efforts to work with the WG.

The vote to move to correct units of measure for Paul’s identified issue with gf.m instead of g.m was 14 in favor, 2 abstentions. The vote carried.

The vote to end the use of mm for ST deviation was 8; with 7 abstentions. The vote to adopt uV or mV with a follow up ballot to determine if 100.uV is necessary 10 in favor, 3 abstentions, 0 opposed. The vote carried.

The vote to use only L/min instead of that or L for Minute-volume was not resolved; an email ballot is required.

Minute volume: 7 for L/min only, 1 L, 1 for allowing both, 5 abstentions. This leads to future discussion.

End Tidal Airway Concentration: the following will all be permitted: %, mmHg, kPa

Paul noted that there are correct, equivalent units that can be associated with multiple MDC coded parameters: e.g., /min (per minute) can be associated with beats/min, pulses/min, respirations/min. In UCUM, the recommendation will be to use the more granular measure, e.g., {beats}/min.

• Add Paul’s slides (not the RTM tables) by post to ftp site and link -- Paul

MWB Library Supporting PCD Transactions

Pete provided corrections to the MWB with a .exe file provided to Al who will distribute it.

Two issues remain to be resolved to have a formally “implementable” profile. One requires HL7 v2.6. The other issue will be resolved in the near future.

We need to define test scenarios for each OBX segment, and minimize optionality. Resolution of this issue should support registration of the profile.

Didi recommended that this cycle of Connectathon testing incorporate the changes made last night to the TF.

Todd will send the updated TF annotated with last night’s work for consideration in the morning. The next update will be sent via the PCD Connectathon Google Group.

IHE and Open Source

The workshop has a session on open source software. XDS.b is XDS.a with changes in transport architecture. .a is the only one used now, but .b will replace it. .a is IBM’s, .b is Microsoft’s. All test tools are open source. This year IHE has put out a call for open source software to make it well known.

SoA Architecture in IHE

OMG is developing web services architecture for HL7, OASIS. The proposal for XDS.c was tabled. Karen Witting is evaluating this for IHE. OMG may demonstrate new directions. The collaboration between HL7 and OMG can be found at http://hssp.wikispaces.com

PIV TI Review

Jeff Rinda will develop the CP.

Rosetta Terminology Validation

Paul described the process in his Word document RTM.ValidationNotes.1d.doc, below.

Paul requested a vote on: RTM is normative for OBX-3 that matches within the tables. Validation requires conformance with his tables in RTM.ValidationNotes.1d.doc (Case 1.1 – 1.3 are mandatory and others include warnings ) for all PCD profiles starting with the 2009 Connectathon.

Vote: RTM profile as described in Paul’s table for this Connectathon and going forward: 11 in favor, 1 abstention, none opposed. The vote carried.

Policy: To achieve semantic interoperability the content of all IHE PCD transactions shall conform to the semantic content specified in IHE PCD Technical Framework volume 3 and any related electronic artifacts. 11 in favor, 1 abstention, none opposed. The vote carried.

Rosetta Validation Notes (RTM.ValidationNotes.1d.doc) will be posted to ftp as a table

Action Items

• Need to validate voters. Manny to confer with LaVerne.

• Email ballot(s) cited above and upon review of the minutes.

• Two issues remain to be resolved to have a formally “implementable” profile. One requires HL7 v2.6. The other issue will be resolved in the near future. John Garguilo and Al Engelbert.

• Todd will distribute the updated TF for use in this cycle’s implementation for the Connectathon.

• Add Paul’s slides (not the RTM tables) by post to ftp site and link -- Paul

• Paul to call attention to the policy requiring use of RTM coding during the next Wed Connectathon/Showcase Webex.

Minutes Thursday A.M., October 23

Technical Committee Meeting Continued

Attending

Blasingame, Jon; Borchers, Steve; Cooper, Todd; Davis, Didi; Day, Bikram; Engelbert, Al; Fuchs, Ken; Furst, Manny; Garguilo, John; Garstka, Colin FX; Hotchkiss, John; Merritt, Steve; Meyer, Gary; Rhoads, John; Rinda, Jeff; Schluter, Paul; Wittenber, Jan; Zambuto, Ray; Zubaidi, Khalid

Kai Hassing, Philips joined for the last hour of the meeting (beginning with RMON discussion)

Discussions

Todd reviewed the agenda.

Todd led discussion of the TF, beginning with the transition to v2.6. Potential issues are:

1. MSH-21 is in 2.5

2. OBX-20 was deferred to v2.6 (reserved in 2.5)

3. Should review OBX-21 Observation Instance Identifier through 25 for DEC implications

4. Review global changes in 2.6, section 1-2, including

a. TS becomes DTM

b. CE changed to CNE/CWE

5. PAM uses v2.5; so using PAM in v2.6 may be an issue; should review potential changes to DEC (PIB). Mike Henderson is the editor. Karen Witting is a cochair ITI.

a. Submit CP to ITI to add 2.6 components to PAM

6. Update SPD with TI version content; may need fifth dot for attributes associated with a given metric. Harmonize with ACM as well. (OBX-3, 4). This addresses attributes; for example for waveform snippets, several attributes will be required.

7. Should time zone suffix (ZZZZ) be mandatory in MSH-7? Paul suggested that traceable time include ZZZZ, but non-traceable (e.g., wristwatch) would not. Paul noted that a flag indicating accuracy of the time is important. Todd recommends making this conditional, with the ZZZZ suffix indicating sufficient traceabilty (clock believed accurate to 5 seconds).

a. PIV group noted that TF is inconsistent with regard to required/optional elements

b. V2.6, page 32 has inconsistent, showing optional offset and a sentence that says it is required.

8. TF changes will lead to changes in PIV and ACM.

9. CP for SPD: John Rhoads requests that section 3.1.6 (PCD-02), should allow optional field at end for “processing instructions.” This would permit optional information such as time intervals, episodic events. This would permit instructions such as permitting non-periodic information to be inserted in a requested periodic data stream. Paul suggested adding a table to define these options, and that policy issues be defined. Options may also be locally defined.

Options include summary representation of values in a time ingterval (first four) and reporting modality (next five). This may be called the “ActionCode”.

a. Send last measured value

b. Send mean of values sampled during reporting period

c. Min

d. Max

e. Episodic

f. Periodic

g. Periodic + episodic (the DOF will decide how a given parameter will be reported)

h. Extensive (all values during the period)

i. Additional agreed upon options

j. Need to define the default instruction

i. Best effort would be addressed – if DOF cannot provide what is requested, how the DOF responds. Options include “best effort” and “NAK on error”

10. Startup processing could be established by

a. Subscription NAK

b. Include in the first (or all) subscription options

c. Specific transaction e.g., following installation which provides the default setting

d. Decision: Of the above, sending a subscription with a “null” predicate results in the DOF implies “Add”. A “Q” code reslts in the DOF replying with a description of its capabilities.

11. Al asked how to handle a requestfor parameters that are not available: they are just not provided.

12. This needs to be described in the User Handbook.

RMON Public Comments for HITSP Paul reviewed PCD’s position and the response will be to emphasize

• Preference for one, not two protocols – through a unified intgerface

• PCD-01 has been published and has been tested multiple times

• A slimmed down version (subset) would be simple and easily employed

• More complex devices would be supported by simply adding additional OBXs

Paul displayed several slides, including a sample message for a simple parameter (heart rate). PHD devices would have a default MDC identifier for simple devices and Continua’s public slides showing the Evolutionary Path. Paul noted that PCD-01 is able to be validated, while Continua’s example is not.

Legend: DM: Disease Monitoring; HF: health and fitness’ AI: assisted living;

Action Items

• John Rhoads will prepare the CP for SPD.

• Review and take appropriate action on PAM. Take the MSH-7 issue to HL7 -- Todd Dec 1

• Paul will address resolution of “Boolean” type arguments within RTM by mid-November

• Paul will include results in Semantic Architecture White Paper by mid-November

Action Items Summarized

• Evaluate MD Fire to see if we can assist, provide a sample table, consider the consumer side as well. Assign to Ken, who will discuss with Didi. Paul suggested that IHE could distribute a document addressing the entire enterprise. Paul suggested this is what IHE should be doing. A letter to Julian about the broader approach could be sent from IHE cochairs or the board. A broad document would be a marketing element for IHE.

• AHIC CDC review: set conference call since Elliot is not available.

• Discuss with Didi – survey show a lack of provider awareness of the benefits of interoperability. Perhaps a meeting around the time of the Connectathon would reach people and serve to increase attendance at HIMSS / Showcase as well.

• Brief Profile Proposals will be posted by October 31 and email ballot will be sent to determine:

Resources (interest), ask for all PCD interested to send response, will set priority by official ballot. Encourage non-member organizations to join IHE.

• Todd to make sure Polycom will work toward open transactions.

• Steve Merritt will convene a group to begin drafting a detailed proposal and a white paper for this cycle.

• What is CP process

From the PIV Breakout, Jeff Rinda will write a change proposal for PIV Trial Implementation version including

• elimination of the second ACK
• other minor editorial suggestions that have been received
• update to reflect changes from v2.5 to v2.6 (capture tables and field descriptions from new TF based on v2.6 documentation). Relevant changes include
• OBX-20-25
• TS datatype changed to DTM
• CE changed to CNS or CWE (3 additional fields above CE)

• PCD will obtain the membership list from Crystal. PCD will suggest targeted emails to HIMSS members and perhaps a meeting in advance of HIMSS 09. PCD to engage CE-IT about device integration, seek support of the work on MD PnP FIRE by CE-IT. Consider a Town Hall at HIMSS, but this may conflict with the FDA/IHE wireless program. Deadline for Town Hall request is November 3.

• IHE and/or PCD to develop a glossary.

• Todd will review the ihe.net/pcd page.

• Go back to IHE TF page to verify correct info. Todd

• Need to include requiring the receiving system or third party observer to validate message consistency with RTM. The likely approach for the current cycle would involve the receiver forwarding the received message to a validation engine. Manny and John will discuss the test and adding the test to Kudu.

• Ken will generate letter from PCD PC to Charles Jaffe, liaison to HL7 and can take v3 asking for assistance. <This item was revised during minutes review Nov. 5>

• John Rhoads will prepare the CP for SPD.

• Review and take appropriate action on PAM. Take the MSH-7 issue to HL7 -- Todd Dec 1

• Paul will address resolution of “Boolean” type arguments within RTM by mid-November

• Paul will include results in Semantic Architecture White Paper by mid-November

Next Meeting

The next meetings are: Joint Planning and Technical Committee Webex meeting, November 5 at the usual time, 11 am EDT: http://wiki.ihe.net/index.php?title=PCD_PC%26TC_2008-11-05_Webex The Technical Committee will meet November 5 PCD TC 2008-11-12 Webex The Planning Committee will meet November 12 PCD PC 2008-11-19 Webex

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