PCD PC&TC 2009-08-19 Webex

Patient Care Device Domain

Meeting Purpose

Joint meeting of the PCD Planning Committee

Replaces the regular PC meeting

WebEx Information

Topic: PCD Committee Tcons

Date: Wednesday, August 19, 2009

Time: 11:00 am, Eastern Time (New York )

Duration: 60 Minutes

Proposed Agenda

Please Add Your Suggestions

1. Review of Discussion Summaries PCD PC 2009-08-05 Webex and PCD TC 2009-08-12 Webex

2. PCD Issues (for details see below and Todd's email of August 12).

- Validation vs. Verification Testing

- One problem - multiple PCD TF solutions!

o ACM/DEC

- Profile Option Specification and Testing

- Keeping our House in Order

- Reduced Weight PAM for DEC

3. Update on White Papers and Supplements:

• Ballots

o WAN PCD/Continua, IDCO, Pump passed

o RTM open

o MEM to come

• ACM Open Issues / Extensions
• DPI
• Medical Equipment Management
• PIV/Infusion Pump Open Issues / Extensions
• RTM Open Issues / Extensions
• IDCO
• WCM
• Medical Device Semantic Architecture
• Regulatory Considerations

4. Continua

5. Connectathon/Showcase regular meetings

• PCD Showcase Planning with HIMSS began yesterday

6. ARRA/Meaningful Use

Discussion Summary and Action Items from Previous Meetings

See PCD Planning Committee Action Items and PCD Technical Committee Action Items page.

Significant changes, other than dates, will be in bold.

Participants

Chair: Todd Cooper

• Jon Blasingame, Anupriyo Chakravarti, Todd Cooper, Bikram Day, Al Engelbert, Robert Flanders, John Garguilo, Christoff Gessner, Chad Hays, Rich Hillman, Yarisa Jaroch, Roy Kerns, Brad Lunde, Steve Merritt, Gary Meyer, Mary Moewe, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Greg Staudenmaier, Sandy Weininger, Manny Furst

Discussion

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Accepted	Action(s):
2	Discussion Summary - Chair	Status/Discussion: Accepted summaries of the August 5 PC and the August 12 TC meetings. Action(s):
3	Issues for Joint Meeting - Chair	Status/Discussion - Issues for this joint meeting led by Todd: One problem - multiple PCD TF solutions! The most recent discussion of this is around the use of either PCD-01 or PCD-04 to communicate event data (e.g., transitions in an med admin protocol, such as switching from a secondary/piggyback to a primary source). We need to take a look at the clinical work flow that can involve numerous profiles and specify when one approach should be used over another. Also we need to determine how best to capture these specifications and test for conformance (perhaps a Volume IV?) - Choosing among multiple TF solutions (e.g., ACM vs DEC). How best to address information that could be sent in several days. E.g., PIV may want to send event reporting and could choose between ACM and DEC. Jeff Rinda added that currently pump systems send only status with DEC. Todd asked if they would want to be able to sent event notices in the future and he doesn’t see this as an alarm. Paul noted that this is a time point event similar to periodic blood pressure data in PCD-01 and would provide a good record of pump activity. Todd suggested that a message requiring clinician interaction would appropriately be addressed with PCD-04. Paul suggested that PCD-04 could be used to ask the clinician to log something; this would require adding another low level to alarms. He added that this would be useful in WCM. Profile Option Specification and Testing - this is a major issue with the existing Kudu tool that we must resolve as much as possible this year and hopefully even more next year. For example, saying you passed the DEC tests is not enough. Saying you passed the DEC-PIB is better. Saying DEC-PIB-PAM is even better. But then we sill have a "PAM profile" that we build to (IOW - not all of PAM is implemented). How does that work?! Also, there are some components that are too granular and may never be called out in formal option testing, but are very important to end users specifying and purchasing equipment. Perhaps we should consider "profile conformance statement templates" that could be provided say in the Users Guide. - How to provide information to the users about options so they can select/purchase – conformance profile templates? In users guide or …? E.g., a light weight version of PAM for DEC. Al noted that PAM has two transactions (ITI-30, ITI-31), that ITI-30 has two options, and the ADT system at the Connectathon/Showcase provided only one and it was not the one called out in PIB. He suggested that one approach is to require ITI-31 instead of ITI-30 in the TF. Manny to ask Steve if ITI-31 vendors were available last year and will be this year. Can we specify just this portion of PAM and how do we handle this. Some would prefer not to use A40 because they don’t store records. Robert will develop a paragraph summarizing an approach. Validation vs. Verification Testing - or "yeah, we implemented the TF spec - but does it actually solve the problems identified in the profile's use cases?!" We are working on enhancing the V&V / conformance testing model that is used within PCD and to ensure that it is harmonized with what MDMs use in product development! - needs to dovetail with the Connectathon and other activities and to obtain maximum benefit for developers’ investment. John Garguilo noted that unit and message testing requires careful definition of requirements. For medical devices this is more rigorous than for IHE alone. Paul noted that testing will also have to address the WAN communications of Continua (PHD) and PCD (Enterprise) devices. John Garguilo indicated that validation from his standpoint is to standards. Ken has an action item to develop a description of validation and verification from a manufacturer’s point of view. Should PCD move to another terminology that would be appropriate and meaningful to regulators and clinicians? Semantic/Content Testing vs. Connectivity/Syntactic Testing. Keeping our House in Order - The Technical Framework, under revision and "clean-up", is currently embodied in two volumes. We have always planned on 3 (with Volume III focusing on Semantic Content), and now possibly Volume IV for composite profile clinical work flow scenarios). There must be consistency across all the volumes, though, and minimized or eliminated duplication of information. And how do you relate semantic content (Volume III) with transactions & encodings (Volume II) with clinical scenarios (volume IV). - TF Organization – possibly 4 volumes: Volume 1 addresses transactions, Volume 2 for transactions and encoding messaging, Volume 3 (planned) for semantic content. Todd asked if we should now consider Volume 4 for composite clinical workflow scenarios. Questions came up: How do other domains address clinical workflow? How to treat uni- and bi-directional data flow? Does RAD-08 offer guidance? Other suggestions: provide PCD-01 implementation subsection for different types of messages (events, episodic data, periodic, …). Ensure maximum consistency with what other IHE domains are doing. Decisions/Issues: Action(s):
4	Next Meetings - Chair	Status/Discussion: Next week's meeting is cancelled (TC) The September 2 meeting will be a joint PC and TC meeting Decisions/Issues: Action(s):

Next Meeting

The next meeting will be September 2, 2009: PCD PC 2009-09-02 Webex.

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