PCD PC&TC 2010-05-03 to 07 F2F

Meeting Objectives

These face-to-face meetings have a number of objectives depending on the committees involved:

• Planning Committee: Review overall PCD activities, identify strategic next steps and update the "roadmap"
• Technical Committee: Review all materials slated for publication in May / June and resolve any issues so that final editing and publication may proceed.
• SDOs: There may be meetings Friday, Saturday (TBD).

Schedule & Agenda

Daily Schedule

08:00 - 08:30 Check in

Meeting will start promptly at 08:30 each day.

08:30 - 10:30 Session #1

11:00 - 12:30 Session #2

12:30 - 13:30 Lunch (location to be announced)

13:30 - 15:00 Session #3

15:30 - 17:00 Session #4

NOTES:

Most of the materials referenced during the meetings can be found at ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/F2F-May2010/Materials/; some links direct you elsewhere instead of, or in addition to, this location.

1. Additional evening working sessions may be scheduled as needed

2. Thursday the main PCD TC plenary meetings will end by 15:00

3. Friday the DPI / ICE-PAC WG meetings will end by 15:00

4. Thursday we have an optional tour of the simulation facility after 1500

Date	Hours	Committees	Topics
Monday Q1 2010.05.03	08:30 - 10:30	IHE-PCD	IHE PCD Overview (for newcomers)
Monday Q2-Q4 2010.05.03	11:00 - 17:00	PCD Planning Committee	Greeting & Introductions Review & Approve Agenda IHE IP Management Process Review Current PCD Program - Technical Framework Updates - Profile Development: Existing & New - International PCD Activities - Inter-domain Coordination - Continua Coordination - ICE-PAC Coordination Lunch Update from VA (Greg / Ioana) IHE PCD User Handbook Clinical System Integration Workshop - Topic: Data acquisition modalities between enterprise applications & device data sources (e.g., PCD-02 retrospective queries for CDSS support) - Topic: ARRA / HITECH & HIMSS MD&PS Meaningful Use Analysis: Valid? - Topic: HITSP/TN905 Roadmap: Valid? Gaps? - Topic: Medication Administration / Infusion Pump Integration Requirements - Topic: Alarm Management: CE-IT Convergence meets Patient Safety - Topic: Ventilation Requirements - Open Discussion & Prioritization ("What do we need to do immediately?!") Identify Key Interoperability Issues DPI, ICE-PAC requirements Review & Update PCD Roadmap (incl. per TN905 Roadmap)
Tuesday 2010.05.04	08:30 - 12:30	PCD Planning & Technical Committees	PCD Roadmap Update IDCO Status Update (via WebEx) NIST Test Tooling NOTE: Infusion Pump Working Group Breakout Tuesday A.M. The infusion pump breakout has been canceled due to travel issues that have reduced the number of participants. It is anticipated that the proposed topics will be addressed in a number of subsequent WebEx sessions in May and June.
Tuesday 2010.05.04	13:30 - 17:00	PCD Technical Committee	Greeting & Introductions Review & Approve Agenda IHE IP Management Process HIMSS '11 Showcase Discussion - Conceptual Approach AAMI '10 Annual Conference 2011 European Connectathon & PCD PCD-enabled Products PCD Marketing & Funding - PCD "Success Stories" (Sparnon/IHE Marketing Cmte) - Webinars, Presentation Slide Sets & Publications - Web Presence Review PCD Schedule Review 2010/2011 F2F Meetings Scheduling (incl. sync w/ ITI/PCC/QRPH) PCD Technical Framework Status Update Review - Technical Framework Revision - Volume 1 - Volume 2 Issue: Partitioning of HL7 specifications between TF v2 & v3 (& v4)? Issue: Incorporating HL7 v3 specifications? Issue: Single Specification for Generic HL7 v2 "Common Segments"? Issue: HL7 v2.5 => v2.6 ... - OBR Field specifications - RE & "ignore if not specified"? - National Extensions
Wednesday 2010.05.05	08:30 - 17:00	PCD Technical Committee	Technical Framework vol 2 Issue Discussion (continued) DEC Updates - PCD-02 "One Shot" Proposal - Additional PCD-02 Change Proposals - PCD-01 Out-of-Scope Parameter Communication - Enhanced ACK Handling (e.g., on a different pipe) PIB ITI-31 CP ACM Updates ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkForPublicComment/SupplementsYr5-2010-11/ACM-Yr5/ - ORU^R40 Alarm Trigger Change Proposal - PCD-05 Change Proposals - AM-AC Interface
Thursday 2010.05.06	08:30 - 17:00	PCD Technical Committee	Waveform Communication Management (WCM) Final pre-Public Comment Draft Review ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkForPublicComment/SupplementsYr5-2010-11/ Rosetta Updates - Units of Measure - Infusion Pump Terms (incl. events) IHT SDO Coordination Update LOINC Mapping Update Ventilator Modeling Review LUNCH HL7 v2 Data Type Questions (color & NA) Updated Diagram for ACK Discussion Event Communication (EC) Profile ISO/IEEE 11073 Standards Status Update KP Perspective & Charge for IHE PCD (George P.) Adjourn Plenary IHE PCD TC Meetings 15:30 - Tour of KP Sim lab (Garfield Center) Post-Tour Dinner Discussion
Friday 2010.05.07	08:30 - 15:00	PCD Technical Committee	Device Point-of-care Integration (DPI) WG Review PCD DPI Development Status KP Perspective on DPI Review ICE-PAC Activities Identify DPI-related requirements from preceding F2F Discussions DPI Work Plan for 2010/11 Development Cycle - Identify target use cases, esp. ICE functions - Identify potential systems - Detail standards & profile development requirements & milestones Adjourn PCD TC Meetings by 15:00
Friday 2010.05.07	15:30 - 17:00	HL7 DEV WG Out-of-Cycle Meeting	<this session is TBD> ISO/IEEE 11073 & HL7 v3 Projects Adjourn PCD TC Meetings by 15:00
Saturday 2010.05.07	08:30 - 15:00	HL7 DEV WG Out-of-Cycle Meeting	NOTE: The Saturday sessions have been canceled.

Location Information

Kaiser Permanente ("KP")

Meetings will be held at Kaiser's Clinical Technology Offices except on Thursday:

1795 Second St., Berkeley, CA 94710

Meetings Thursday May 6 are at the Sheraton Four Points SF Bay Bridge hotel

1603 Powell St., Emeryville, CA 94608, (510) 547-7888

There is an optional tour of the simulation laboratory late Thursday afternoon.

• IMPORTANT REGISTRATION INFORMATION: Though there are no fees for this meeting, all participants must indicate their intention to attend by sending an advanced notification e-mail to Manny Furst (IHE PCD).

• General location information:

Hotel:

You can make reservations at the Sheraton Four Points, San Francisco Bay Bridge in Emeryville. The hotel address is 1603 Powell St., Emeryville, 94608. Reference "PCD May Group" to make reservations. Group room rate is $95/night from Sunday through Friday. You can call directly to the hotel and ask for reservations: 510.547.7888 or call Sheraton central reservations at 800-325-3535.

Please stay at this hotel to assure that the minimum number of hotel rooms are used – this is required to obtain this low room rate and a reasonable cost for use of the hotel meeting room for Thursday’s meeting.

There is no charge for parking at the hotel.

Travel:

You can efficiently reach the hotel via public transportation from either Oakland International or San Francisco International. Ask for directions to BART (Bay Area Rapid Transit) at the airport and then take a bus. You may obtain detailed directions from Manny Furst (IHE PCD).

There are multiple ways to commute between the hotel and the Kaiser facility. These are about 3 miles apart. Driving (or taxi) will take about 7 minutes (details below). Amtrack is available about an eight minute walk from the hotel, and about a 7 minute walk from the destination station.

Parking is available on the street near the Kaiser office. There’s a parking lot, but currently construction personnel are arriving and filling the lot by 7:30 am. It will be available earlier, and if construction is complete by May 3.

Attachments / Materials

Reference materials can be downloaded from ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/F2F-May2010; some links direct you elsewhere, instead of, or in addition to that folder.

Please note: some of the materials are in the recent Microsoft .docx, pptx formats. These have been converted to the earlier .doc and .ppt formats and are provided on the ftp site as well. Note: the conversions may have resulted in the loss of some details.

Decisions Summary

NOTE: These decisions are NOT formal decisions, but a consensus on how to proceed, and are in addition to the action items listed below.

This section was established to track any items that came up that would require a ballot following the meeting.

No.	Decision	Date	Description
1	CPs	2010.05.03	CPs were reviewed and are to be presented to the TC for ballot.
2	xyz	...	...

Action Items Summary

Action Items listed below were developed during the meetings.

PCD_Planning_Committee_Action_Items and

PCD_Technical_Committee_Action_Items

No.	Action Item	Owner	Participants	Due	Open/Closed	Description/Update
1 (PC)	Develop language for RFPs that is meaningful to clinicians.	Erin	Ioana	-	Open	May 3, 2010
2 (PC)	Explore the possibility that HIMSS’ Patient Safety publication be integrated with the User Handbook.	Christel	-	-	Open	May 3, 2010
3 (PC)	Implementation Guide issues	-	-	-	Open	May 3, 2010: Erin raised the issue of workflow – e.g., infusion pump messaging takes too long, hospitals complain. Christian observed that clinicians need an indication when data is not reliable for the purpose (e.g., latency, other). John Rhoads indicated that applications need to specify their own behavior. John Garguilo suggested that the implementation guide needs to address these issues.
4 (TC)	QoS and a QoD (quality of data) issues need to be addressed within the alarm/alert communications.	Monroe, Ken	-	-	Open	May 3, 2010 afternoon, item 2: (a) build the ability to identify these issues and (b) implement a response. An alert and/or log should be sent/noted when it is needed.
5 (PC)	PCD Meaningful Use - Vendor Recruiting	-	-	-	Open	May 3, 2010: Christian and Barbara Majchrowski will share information and attempt to recruit participants to develop profiles and participate in subsequent activities that increase the profiles, transactions contributing to MU as well as increasing deployment of PCD profiles.
6 (TC)	Open source solution to archiving persistent data	-	-	-	Open	May 3, 2010: Ken and Vaughan will address an open source solution to archiving persistent data.
7 (PC, TC)	Develop a strong core of functionality	-	-	-	Open	May 3, 2010: Develop overarching integration of the various profiles and therefore, have core critical-mass functionality that forms a solid foundation; seek integration with other domains.
8 (PC)	Recruiting: Multiple Approaches	(1) Christel	Anupriyo, Jon, Paul Kelley, Steve, Ken, George, Mike	-	Open	May 3, 2010: (1) Address opportunities to increase clinician involvement; contribute to Use Case development.
9 (Cochairs)	Financial Support of PCD	Cochairs	-	-	Open	May 3, 2010: Global spread of PCD will require support for Connectathons and Showcases overseas; growth is beyond the ability of HIMSS and ACCE to support PCD.
10 (TC)	Review 2010, Develop 2011 Test Cases	Manny	John Garguilo and 2011 participants	-	Open	May 3, 2010: Manny will schedule review of existing test cases and then extensions and new test cases. Manny will add device identification and chain of data to the list of potential changes to testing.
11 (PC)	Marketing IHE	Erin	Scott, Mike, Anupriyo	-	Open	May 4, 2010: Develop Success Stories in support of HIMSS' marketing efforts; should complement PCD recruiting
12 (Cochairs)	PCD Schedule	Cochairs	-	-	Open	May 4, 2010: Schedule needs updating to be consistent with HIMSS' domains' and PCD's plans.
13 (TC)	CPs: PCD-01, PCD-02, ACM, ACK, ITI-31, RTM, other	Multiple	-	-	Open	May F2F: CPs will be submitted, after revisions if necessary. All were supported by those present. Pump WG will address at least two. Monroe will revise ACM TI. Manny to ask John Donnelly to seek vendors to test, implement at Showcase.
14 (TC)	Selection of WCTP by ACM	Todd, Monroe		-	Open	May 5, 2010: Todd will seek the MOU for ACM's WCTP.org issue.
15 (PC)	Recruit WCM Vendors	Manny, Monroe	-	-	Open	May 6, 2010
16 (TC)	Numeric Array (NA) data type	-	-	-	Open	May 6, 2010: Seek restoration of the Numeric Array (NA) data type.
17 (PC)	Value Propositions	?	-	-	Open	May 7, 2010: Need to have a group of users develop a purchasing requirement, publish and disseminate to encourage customers to include it in purchasing language. Vendors could participate. Need someone to organize this.
18 (TC)	DPI/ICE-PAC Project	Tracy, Jon Blasingame (see right column)	Implementers	-	Open	May 7, 2010: Define the next steps and enroll vendors to develop this in time for the Connectathon and Showcase. This would include: a technical report, and possibly technical documents such draft supplements for DPI or other. This would be a demonstration testing for a New Directions wall. Philips and Draeger expressed interest. Draft a project plan targeting (a) specification development over the summer, (b) prototyping in the fall / early winter, (c) demonstration testing event, (d) public demonstration during HIMSS '11 (end of February in Orlando). Jon B. offered to recruit vendors & organize.
19 (TC)	CDA (HL 7 v.3)	John Rhoads	-	-	Open	May 7, 2010: They will set up meetings and Wiki pages. John Rhoads will poll participants to set a meeting time.
20	Roadmap Updates	Ken		-	Open	May 3, 2010: Update following the discussion and adjust to defer some 2010-11 items and be consistent with ARRA/HITECH.

Meeting Minutes

Monday Morning 2010.05.03

Participants, Monday Morning, The Overview:

Christel Anderson (HIMSS), George Bertos (Baxter), Brian Birch (Kaiser), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Christof Gessner (MxDx), Paul Jones (Cisco), Paul Kelley (Washington Medical Center, representing AAMI), Allen King (Sutter), Curt Mah (Cisco), Dennis McIntosh (DocBox), Tapan Mehta (Cisco), Monroe Pattillo (Philips), Tracy Rausch (DocBox), John Rhoads (Philips), Jeff Rinda (Hospira), Christian Saucier (Hill-Rom), Paul Schluter (GE), Ioana Singureanu (VHA), Sjon Smith (Sutter), Erin Sparnon (ECRI Institute), Greg Staudenmaier (VHA), Jerry Tonies (Cisco), Axel Wirth (Symantec), Jan Wittenber (Philips

Webex: Ted Cohen, Ann Farrell, Karl Gumpper, Marcy Harris, Vineeta Khemani, Hank Mayers, Steve Merritt, Eric Nemec, Karen Pope, Connie Saltsman, Karen Sherrerd, Luigi Sison

Chairs: Ken Fuchs, Steve Merritt

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

• Todd presented the overview. The slides are available at IHE PCD Overview (for newcomers). Some of the key discussion points are:

• Promise, yet to be seen, to improve vendors' and users' ability to meet regulatory requirements

• Benefits for companies marketing internationally

• Slides by Luis Melendez and Erin Sparnon illustrate the complexity and difficulty of achieving the promise of interoperable and well designed systems. It includes all the other systems and clinical activities that need to be integrated into the overall solution.

• Ken’s slide “Who means what?” indicates the many ways the problems are cast

• Todd noted the significant differences between enterprise and point of care integration.

• Ken noted that certification is a critical future component; this will assure that systems that are said to be conforming actually meet all requirements.

• Todd noted that the IEEE, CEN, HL7, and IHT SDO are now collaborating within ISO 215 WG7 to seek well coordinated harmonized standards.

Participants, Monday Morning, Scheduled to Follow the Overview:

Christel Anderson (HIMSS), George Bertos (Baxter), Brian Birch (Kaiser), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Paul Jones (Cisco), Paul Kelley (Washington Medical Center, representing AAMI), Allen King (Sutter), Curt Mah (Cisco), Dennis McIntosh (DocBox), Tapan Mehta (Cisco), George Panagiotopoulos (Kaiser), Monroe Pattillo (Philips), Tracy Rausch (DocBox), John Rhoads (Philips), Jeff Rinda (Hospira), Mike Romig (Patient Solutions), Christian Saucier (Hill-Rom), Paul Schluter (GE), Ioana Singureanu (VHA), Sjon Smith (Sutter), Erin Sparnon (ECRI Institute), Greg Staudenmaier (VHA), Jerry Tonies (Cisco), Axel Wirth (Symantec), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Steve Merritt

Chairs: Ken Fuchs, Steve Merritt

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	Opening the PC Meeting	Status/Discussion: Ken opened the meeting by reviewing today’s agenda. Participants introduced themselves. Ken led discussion of the IP Policy, using the slides provided by IHE.
2	European and Asian Activities	Status/Discussion: Christof and Bikram summarized recent European activities. Christof observed the need for more user participation in their effort. Bikram mentioned the small showcase in the Netherlands. Both groups expect more participation next year. Todd noted IHE-Japan’s recent deployment and IHE-Korea will hold its first Connectathon in August. Decisions/Issues: Action(s):
3	IHE Strategic Plan	Status/Discussion: Todd reported that Karen Witting will be ITI’s liaison to PCD for coordination and support as the IHE develops the overarching strategic plan. Decisions/Issues: Action(s):
4	IHE-Continua Collaboration	Status/Discussion: Paul described the IHE-Continua collaboration supporting the use of PCD-01 profile for communication. The MDC Codes for observables and constraints developed by Continua will be made public, enabling a single harmonized Rosetta table supporting home health as well as acute care. PCD-01 was updated via CPs to accommodate this effort as well as several corrections. Decisions/Issues: Action(s):
5	ICE-PAC WG	Status/Discussion: Tracy provided update of the ICE-PAC WG which is a joint WG with ASTM and IHE focused on the point of care (POC). There are implications beyond the POC. The WG has analyzed 7 scenarios in the ASTM F2961 Standard, nearly complete on IV pumps, and conducting analysis of the ventilator process. The ventilator effort is much more complex than the pump effort. The hazard analysis becomes more complex and more hazards arise as multiple device types are included. Their work product will provide requirements for meeting clinical needs, but will not specify the technical solution. Please see the slides for more information _____. Jan noted that ventilator parameters were not well structured when that work began, so much effort has been devoted to this. They have also attempted to represent the many different workflow approaches used and have looked at common elements. Decisions/Issues: Action(s):
6	Veterans Health Administration’s update	Status/Discussion: Greg and Ioana provided the Veterans Health Administration’s update immediately after lunch. The VHA’s stakeholders were surveyed. The VHA is seeking to operationalize IHE profiles, including medical device interoperability. Motivators include moving the existing individual site based approaches to a system wide approach; ARRA; and leveraging the size and influence of the system. Current objectives include stakeholder forum that includes clinical engineers, patient safety, IT in the VHA; communicating with users such as Kaiser and Sutter and with SDOs and others. The effort is focused on using existing standards. Decisions/Issues: Action(s):

Monday Afternoon 2010.05.03

Participants, Monday Afternoon:

Christel Anderson (HIMSS), George Bertos (Baxter), Brian Birch (Kaiser), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Chad Hays (Cerner), Sarah Hopkins (Cerner), Paul Jones (Cisco), Paul Kelley (Washington Medical Center, representing AAMI), Allen King (Sutter), Kurt Mah (Cisco), Dennis McIntosh (DocBox), Tapan Mehta (Cisco), George Panagiotopoulos (Kaiser), Monroe Pattillo (Philips), Tracy Rausch (DocBox), John Rhoads (Philips), Jeff Rinda (Hospira), Mike Romig (Patient Solutions), Christian Saucier (Hill-Rom), Paul Schluter (GE), Ioana Singureanu (VHA), Sjon Smith (Sutter), Erin Sparnon (ECRI Institute), Ken Staudenmaier (VHA), Jerry Tonies (Cisco), Axel Wirth (Symantec), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Chair: Ken Fuchs

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	User Handbook	Status/Discussion: Ken described the User Handbook, its utility and implications for the purchaser. He described the information to be found in the Table of Contents. Erin is developing language for RFPs that is meaningful to clinicians. Ioana offered to help. Christof suggested that HIMSS’ Patient Safety publication be integrated with the User Handbook. Christel noted this; she and Erin described the differences with the CE-IT Quick Start Guide. Erin indicated that the Quick Start Guide looks at ARRA, showing devices do contribute to meaningful use. Decisions/Issues: Action(s): Erin is developing language for RFPs that is meaningful to clinicians. Ioana offered to help. Christof suggested that HIMSS’ Patient Safety publication be integrated with the User Handbook.
2	Clinical System Integration Workshop	Status/Discussion: Topic: Data acquisition modalities between enterprise applications and device data sources (e.g., PCD-02 retrospective queries for CDSS support): Topic: Medication Administration/Infusion Pump Integration Requirements: - Erin raised the issue of workflow – e.g., infusion pump messaging takes too long, hospitals complain. Christian observed that clinicians need an indication when data is not reliable for the purpose (e.g., latency, other). John Rhoads indicated that applications need to specify their own behavior. John Garguilo suggested that the implementation guide needs to address these issues. Topic: Alarm Management: - Brian raised the questions (a) of the ability of the alarm to work when the distances are on the order of 1000 miles, (b) what is the topology for a network that may fail? While wired systems are more reliable, it is necessary to run many systems wirelessly. Monroe noted that priorities established by different devices differ (may want high level alarms on a pump to be different than the high level alarm on a monitor). Christian noted that the rank of the alarm levels may differ between clinical units. The Emergin system includes oversight and notification when the latency exceeds a certain level. Manny asked how 80001 fits into this. 80001helps proactively assess the design and control of these applications. Vaughan mentioned that their system monitors every element on the network. Christian says Hill-Rom’s has built in QoS monitgoring. He asked what built in alarm messages are needed by the User. Anupriyo noted that this should be addressed in the TF for all systems. Todd summarized: (a) build the ability to identify these issues and (b) implement a response. An alert and/or log should be sent/noted when it is needed. Tracy observed that these are two issues: a QoS and a QoD (quality of data) issues. Topic: Ventilation Requirements Topic: ARRA/HITECH & HIMSS MD&PS Meaningful Use Analysis: - Ken and Todd presented a table showing how PCD profiles fit into the schedule for a few years. Refer to HITSP_V1.0_2010… for the US government's goals. For the most part, the PCD will have profiles in place or under development in time to meet HITSP 2011 deadlines. Gaps do exist, more may appear, and will be addressed in the PCD roadmap and various TC agenda items going forward. While in process now, discovery and association issues won't fully be met. - For 2012 many of the additional devices present an issue in locating interested vendors. This includes perinatal, RTLS, other profiles. Christian and Erin suggested middleware vendors would be more likely to participate. Christian and Barbara Majchrowski will share information and attempt to recruit participants. Bikram indicated that Capsule has a product. Comprehensive data archiving also presents a challenge. Vaughan offered his open source solution, including the service API and persistent data interchange format. Ken volunteered to work with Vaughan and noted that QBD (Query Bulk Data) was an early brief profile proposal that didn’t gain traction and might be a useful. John Rhoads joined the effort. The other challenge relates to the Medical IT-network management where wireless medical device networking and QoS alerting have not been addressed. Topic: 800001: - The 80000-1 will go to ballot in a few months. Decisions/Issues: Action(s): Implementation Guide should address issues raised above under Medication Administration/Infusion Pump Integration Requirements. QoS and a QoD (quality of data) issues need to be addressed within the alarm/alert communications. Christian and Barbara Majchrowski will share information and attempt to recruit participants to develop profiles and participate in subsequent activities. Ken and Vaughan will address an open source solution to archiving persistent data. The roadmap needs to be adjusted to defer some 2010-11 items.
3	PCD Roadmap	Status/Discussion: For 2009-10: Ken noted that WCM addresses snippets and continuous data, but doesn’t yet address retrospective data. Other deferred work includes HL7 v3.x wireless. For 2010-11: For MEM Ken suggested that this broad profile is best handled by selecting one or two useful issues. Similarly, POC integration is best handled in segments. Additional work on semantic terminology will be addressed for device specialization and alarm communication, events. It is questionable if pharmacy terminology will be available next year. Several extensions are proposed for PIV, including PCA safety. Jan observed that the roadmap doesn’t include an overarching integration of these various profiles and therefore, have core critical-mass functionality that forms a solid foundation. The solution vendors will provide the additional functionality. The lack of integration with other domains is additional evidence of this need. He recommends that vendors develop this IHE core. Decisions/Issues: Action(s): Develop a strong core of functionality.
4	HITSP TN905 Roadmap	Status/Discussion: Todd asked if the roadmap is valid and if there are any gaps. Discussion did not raise any significant issues. Decisions/Issues: Action(s):
5	Recognition of Paul's Contributions	Status/Discussion: Jan presented an award to Paul Schluter in recognition of his work in developing the Rosetta Terminology project Decisions/Issues: Action(s):

Tuesday Morning PC and TC Meeting 2010.05.04

Participants:

Christel Anderson (HIMSS), George Bertos (Baxter), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Chad Hays (Cerner), Sarah Hopkins (Cerner), Vedran Jukic (Nuvon), Paul Kelley (Washington Medical Center, representing AAMI), Curt Mah (Cisco), Tapan Mehta (Cisco), Monroe Pattillo (Philips), John Rhoads (Philips), Jeff Rinda (Hospira), Mike Romig (Patient Solutions), Paul Schluter (GE), Ioana Singureanu (VHA), Erin Sparnon (ECRI Institute), Ken Staudenmaier (VHA), Kristina Wilson (Hospira), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Al Engelbert, Tom Schultz

Chair: Ken Fuchs

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	Agenda Review	Status/Discussion: Ken led a discussion of the agenda and Todd followed with a brief introduction to the work ahead. Decisions/Issues: Action(s):
2	Clinical System Integration	Status/Discussion: Todd emphasized the need for use cases that emphasize the benefits to clinicians. Jan emphasized the implications for contributions from multiple domains. This Anupriyo, Jon, Paul Kelley, Steve, Ken, George, Mike and Christel will address opportunities to increase clinician involvement (companies have clinicians who will contribute). Christel will coordinate. They will contribute to Use Case development. Decisions/Issues: Action(s):
3	Influences on PCD	Status/Discussion: Todd noted that global spread of PCD will require support for Connectathons and Showcases overseas. Todd noted that additional sponsorship for PCD will be required, since additional support will be required beyond the ability of HIMSS and ACCE to support PCD. Decisions/Issues: Action(s):
4	IDCO Update	Status/Discussion: Tom Schultz provided an update on IDCO: Their nomenclature will be balloted by IEEE, including renewal of their Project Approval Request. They are forming the ballot group, and working with professional organizations to identify clinician participation and to make sure clinicians are well informed. Ken suggested they review the WCM effort to learn if that fits their plans. George asked if IDCO is coordinating with Continua. Tom indicated that there appears to be synergy, and they will look to Paul Schluter for guidance. Paul suggested that the WSI basic profile used by Continua would be appropriate yet not require Continua membership. He recommended WCM for the waveform and annotation and that this would be a good thing to work on in this next cycle. PCD-01 would serve this purpose. Paul suggested that they consider adding lab data. Manny asked what their plans are for the 2011 Connectathon and Showcase. Consistent Time and WCM might fit. Medtronic plans to participate. Decisions/Issues: Action(s):
5	NIST Tools and the 2011 Cycle	Status/Discussion: John Garguilo provided an update on NIST’s work in supporting PCD testing; with primary focus for the upcoming IHE-PCD cycle to verify messages. The web tools (developed last cycle and currently available) are available year ‘round. NIST is collaborating with Steve Moore with regard to the Gazelle work which to date mainly has been developed to superceed the existing IHE the administrative software. His PPT presentation is available on wiki site (see meeting agenda)_________ . Sandra Martinez (NIST) is defining in detail the requirements consistent with the profiles, TF and Supplements. Test Agents, referred to in the slides, are equivalent to Actors in the profiles. NIST has two test tools for PCD: Pre-Connectathon and Connectathon. Work is continuing to develop in software test system “Test Agents” as part of addressing instance and isolated environment type testing. John mentioned the usefulness of the Message Workbench (MWB) developed by Peter Rontey of the VA. The MWB tool has utility for vendors with helping to develop profiles and can be used as an engine for both sending and receiving as a system (actor) (i.e., to test sending and receiving systems). NIST is working to provide this (or a similar) capability, but the no time frame has been identified. Manny noted that PCD participants post their sample messages, but without being assured that the messages are error free. Todd noted that companies address greater rigor in their own testing than PCD is using. He asked if the other domains are seeking the same rigor in NIST’s tools as PCD is seeking, yet likely less than the rigorous testing by vendors. John Garguilo went on to describe NIST Tooling to support the RTM process. This will permit users to add terms and to submit new terms to IEEE ballot process. The Rosetta Terminology Mapping Management System (RTMMS) slides are available on the meeting agenda page of the wiki . The system ‘use case’ works across three primary areas tied to variant user rolses (see slides). The RTMMS will serve vendors proposing additions and deletions as well facilitate discussion. Technical Experts/Reviewers and SDOs would ultimately ‘approve’ the terms as normative additions. General users can download the harmonized Rosetta terms. Jan noted that the RTM tables can be used to map terms and that the FDA will find this useful. This system also goes a long way to providing device terminology and co-constraints to the ITISDO work. John Garguilo then addressed the ICS Generator: Using the device type it will provide the Domain Integration Model (DIM) that will constrain it to fit the model by functionality (e.g., infusion pump). It bridges X73 and IHE specifications (semantic content of HL7 message) and will be integrated with the test tools. John suggested and Manny agreed that we, as a group, will begin meetings to review the existing test cases as well the test plans developed by NIST last cycle. Encourage at least a lead from each Integration Profile; with potentially meetings focused w/ individual Integration Profile groups. Suggested time frame includes later this month or early in June, with consideration of likely extensions as well. That will be followed by development of test cases for WCM. Decisions/Issues: Action(s): Manny will schedule review of existing test cases and then extensions and new test cases.

Tuesday Afternoon TC Meeting 2010.05.04

Participants:

Christel Anderson (HIMSS), George Bertos (Baxter), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Chad Hays (Cerner), Vedran Jukic (Nuvon), Paul Kelley (Washington Medical Center, representing AAMI), Monroe Pattillo (Philips), John Rhoads (Philips), Jeff Rinda (Hospira), Mike Romig (Patient Solutions), Christian Saucier (Hill-Rom), Paul Schluter (GE), Ioana Singureanu (VHA), Ken Staudenmaier (VHA), Axel Wirth (Symantec), Kristina Wilson (Hospira), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Al Engelbert

Chair: Todd Cooper

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	Greetings	Status/Discussion: Todd mentioned the IP requirements. Todd reviewed the agenda for the rest of the week. Decisions/Issues: Action(s):
2	HIMSS11, AAMI10 and Other Showcase Plans	Status/Discussion: Manny discussed the plans for the AAMI Mini-Showcase and for HIMSS11. The plans are available at ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/F2F-May2010/Materials/ and include "AAMI" in the file name. There appear to be four major themes for HIMSS11 and these are indicated with green highlighting. The Continua and Cardiology links may be linked to one wall with a theme of home to hospital communication. Other walls are: - Medication Administration where an additional standalone wall will show a physician CPOE with a hospital pharmacy leading to IOP, IOC, DOR, etc. - CDSS where lab and other domains will be represented at pods or another free standing wall. - Clinical Workflow - Christof provided an update on IHE-Europe’s effort and indicated there will be come country based small demonstrations. Decisions/Issues: Action(s):
3	IHE Marketing	Status/Discussion: Erin requested short “success stories” for HIMSS marketing. Volunteers included Scott Zaffrin (B Braun), Mike (Patient Safe Solutions), Anupriyo (SIS). Decisions/Issues: Action(s): Develop Success Stories - Erin, Scott, Mike, Anupriyo
4	PCD Implementations	Status/Discussion: Devices and Systems release of conforming products: B Braun has already released product; Emergin is releasing product in June; SIS is releasing product in January. Integration Statements Page and Products Registry, under ihe.com is the place for companies to post products. Decisions/Issues: Action(s):
5	PCD Schedule	Status/Discussion: PCD needs to update the Wiki page with the schedule. The group settled on dates for the PC/TC meetings in October and May. An additional TC meeting was to be scheduled for February but that was later placed on hold. Decisions/Issues: Action(s):
XX	TF Update and Revisions	Status/Discussion: John Rhoads suggested that PCD remove items in the messages when not needed. The example offered was removal of specific, unused portions of the ADT demographics specifications. The response was to deemphasize those items without removing them. John Rhoads referred to the transition to HL7 2.6 from 2.5. Ioana suggested that nothing other than the version and additional fields PCD needs will need to be changed as long nothing needed was deprecated. Paul suggested that no additional fields be added to the tables beyond the highest number PCD uses. Todd recommended that all messages with OBXs be discussed in one place, identifying the commonalities and differences. Monroe suggested that this is especially beneficial when commonality exists for multiple transactions (e.g. PCD-01 and -04). PCD placed the device identifier in the universal service id field. John suggested that a better use will be to use what Paul has suggested in the recent CP, recommending __________. John Garguilo suggested this is best handled in implementation guides. Decisions/Issues: Action(s):

Pump Breakout, Tuesday Morning 2010.05.04

Cancelled

|}

Wednesday 2010.05.05

Participants:

George Bertos (Baxter), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Ted Cohen (UCDMC), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Chad Hays (Cerner), Vedran Jukic (Nuvon), Monroe Pattillo (Philips), John Rhoads (Philips), Mike Romig (Patient Solutions), Paul Schluter (GE), Ioana Singureanu (VHA), Axel Wirth (Symantec), Kristina Wilson (Hospira), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Al Engelbert, Brad Lunde, Gary Meyer, John Zaleski

Chairs: Todd Cooper, John Rhoads

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	IHE's IP Requirements	Status/Discussion: Manny reminded the group about the IP requirements. Decisions/Issues: Action(s):
2	TF Revisions	Status/Discussion: John Rhoads continued the discussion about the TF revisions. He noted that the way PCD identifies device data (observation nomenclature and its device source) is not consistent with existing HL7 standards. It is desirable to include the “chain of data” in the received data including such elements as revision level. He, Jan and Todd plan to address this. Todd noted that this can be addressed in the MDS, while the VMD changes as device configuration changes (e.g., modules). E.g., with a gateway at the top level, devices and modules need to addressed in the PCD-01. Refer to the Mind Map that was displayed or other description at ___ John Rhoads noted that we haven’t addressed or tested for this level of detail. Todd and John propose that this be in an OBX that might include other elements in the hierarchy and define an attribute extension of OBX-4 with a pointer. John Rhoads addressed the question of whether alternatives to EUI-64 should be permitted, and if so, what restrictions are required in order to assure unique identifiers for each device. Stock trading symbols and GS1 may be alternatives. Other alternatives will be identified to address issues such as privately held companies. Paul suggested that several identifiers, such as stock symbols, OIDs, and a structured string, be permitted. John will address the sense of his recommendation. Paul noted that the RTM tables contain the space for the manufacturer identifier and that a priority list of identifiers be established (i.e., EUI-64 is preferred, stock symbol next, OID, a manufacturer selected id, etc.). The RTMMS will then be the identifier repository. John Garguilo noted that inter-domain communications raise a complication in that PCD may require this id while it is not required by domains that provide data to PCD. Christof recommended looking at solutions developed in other domains. Paul concluded that an identifier registered with IEEE, for as little as approximately $1000, and can lead to an EUI-64. This second alternative will be the only acceptable alternative. - Todd requested noted that users need to know how end users will know how to interpret optional elements such as this. Where should the information be lodged for user access (implementation guide, user handbook, etc.)? John Rhoads asked whether sample messages should be placed with transactions in volume 2 or elsewhere. The consensus was to include it in volume 2. - Todd noted that volume 3 addresses detailed semantics for data. If it will be in a template, RIM or other locations, where mapping is to other data types this will be in volume 3. General mapping of data types will be placed in volume 3. Decisions/Issues: Action(s): Manny will add device identification and chain of data to the list of potential changes to testing.
3	PCD-02	Status/Discussion: Al presented a CP where the DOC can now specify the interval by placing a value of -1 to indicate that a snapshot is requested. The start and end time would remain, and no data would be sent if there was no data available in that interval – but if the DOF stores data, the data could have been send from the DOR prior to the start time. The DOF would respond with the latest data it had stored or would retrieve data from the DOR. Start and end time is optional when the interval is -1. The existing document provides data within the interval, whether it is no data in the interval or multiple values. It would be unnecessary to resend the filter specification (parameters requested). Anupriyo asked what happens if the start time is in the future. Al responded that data would only be sent in response to a request sent within the start and end times. Manny asked if start and end times have any meaning. The question arose whether a request could be for a snapshot in the future (e.g., at time t, request a snapshot five minutes later). A possible use case is to request a refresh. Todd noted the need for start and end times to be null rather than empty. Monroe suggested that end time could be the maximum time you are willing to wait before the DOF responds. John Zaleski then noted there are several possibilities: - I want the latest information even if stale - I want the latest information, but not if it is stale – query the device (Al noted this is not possible with the existing definition of DOFs which have no ability to query a DOR) - I want data collected within a defined window of time (e.g., use in a CDSS) Al intended that this CP address the request for current data (the first on the above list). Colin FX and Ted noted that in the real world, once a patient is linked to location, subsequent messages provide location, but not MRN data. Gary suggested there are three cases: - Emergency, patient not yet identified - Patient only identified by location or other non-patient-id (and this is temporal), with manual association. - Patient has MRN or other location Issues relating to the first two need to be revisited. Jan noted that this has regulatory considerations. Christof raised questions about the interval, the units (seconds as default if no other is provided), and other questions. One is what if negative intervals (in addition to -1) which can be used to obtain data obtained only within the interval defined by the limited time window this defines. Al responded by adding other constraints to avoid addressing John Zaleski’s other two cases. John Zaleski confirmed other statements that these messages don’t adequately define one or both of the other possible issues. Al confirmed that a request for a snapshot does not interfere with the existing subscription. Yet, the original subscription contained an interval and this, as well as new start and end times, would overwrite the prior values. Al indicated that the CP needs to specify that a snapshot request would not overwrite interval or start and end times. Anupriyo asked about the effect of an A or D action code. Al responded that the result of changing the Action Code is not affected by this CP. Colin FX asked if the Action Code can be used to request a snapshot by adding another code. Al responded with information that would make that undesirable. When a new Action Code is provided there will be a new subscription. With the request to consider filters to individual devices, Jan suggested that the filter be considered a service considering the potential complexity of the filters, with multiple attributes, etc. This would then need to be referred to the HL7 WG addressing services. This has regulatory implications as well as other domains, and other PCD profiles (e.g., WCM). John Zaleski noted there are several use cases. Jan noted there are several priority use cases for current consideration. Todd proposed that a small group consider this and whether a new profile or other approach is required. In the interim, we need a CP to address the specific need. Ken suggested a work item be added to address Jan’s suggestion. He agreed with Manny that a simple modification to PCD-02 with specific scope be adopted as an interim approach. John Zaleski noted that the larger issue leading to CDSS was not approved as a work item. Al agreed to revise the CP to limit the scope. Todd requested that the revision address some specific clarifications, such as latency, which need to be understood in implementation. Decisions/Issues: Action(s):
4	PCD-01 Out-of-Scope Parameters	Status/Discussion: Todd provided background for this discussion and asked how would PCD-01 handle these? They could be (a) reported once, or (b) not reporting them at all. The issue is to achieve consistency and asked how a gateway would know what is within/outside of scope. Paul suggested that all values can be reported with the complete information indicating that values remain not included in all following messages are assumed unchanged unless changed; or that all data is sent in a comprehensive data set. Jan noted that any modification of the data coming from the device in effect transforms the data and extends the range of the medical device, with regulatory implications. Pump data is sent as both periodic and event based (e.g., change in flow rate). Vaughan noted that a pump gateway handling 200 pumps can be overloaded with redundant data. Todd recommended that the Pump WG address this issue in more detail. Decisions/Issues: Action(s):
5	Enhanced ACK Handling	Status/Discussion: Colin FX described the discrepancies in how vendors address application and accept acknowledgement in the PIV profile. See the ftp site at ___ for the description. [email May 4 10:06 am]. If enhanced application acknowledgement is used, a separate port is used for each receiving system, and these systems and the ports would need to be known in advance. Ioana noted that original mode and accept acknowledgement will send the ACK on the same socket it was received. Colin asked if an RRG^O16 is always sent in response to an MSH. The consensus is yes, and typically sent on the same connection. Al noted that enhanced ACK is sent according to PIV. The question is whether it is sent as the same connection. Ioana suggested that the accept acknowledgement is always sent, and typically on the same connection. Decisions/Issues: Action(s): Colin FX will generate a CP that will be reviewed in the Pump WG.
6	Add ITI-31 to the PIB Supplement	Status/Discussion: Robert Flanders submitted a CP adding the PEC actor. Discussion postponed until tomorrow. Decisions/Issues: Action(s):
7	ACM	Status/Discussion: Monroe described the changes proposed for ACM. See ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/F2F-May2010/Materials/2010-05-03_ACM_CR_efforts.ppt. Monroe asked how best to address the PCD-04 filtering needed to avoid the firehose at PCD-05 (or looking at it as requiring a certain response). E.g., the AR and AM needs to know the message was delivered, but may not want to know the entire list of who received it. This closing of the loop is important – was this message received by someone who will do something. The proposed default is that at least one of the intended receiving persons did receive it. The desire is to include this in PCD-04 rather than a separate OBX. The ACM AM was assumed to be the actor that determines who the receiver(s) are. The PRT segment permits the AR actor to identify the receiver. PRT is flexible, permitting an individual, a type of job, etc. The Alarm Archiver (AA) was intended to be the EHRS that records the entire alarm history for the patient perspective(i.e. per patient). The Archiver will play an important role in document retention and litigation support. - Roles/actors can be assembled by systems. We don’t' need to specify a role/actor that is cumulative, like Archiver. - Any alarm should be transparent to the Archiver - Functionally the Archiver is different from an Alarm Manager. - Another actor would interrogate the Archiver (using query message). - PCD-10 transactions would be used to notify the Archiver of every reported alarm. - OBX-3 as ED will allow support for PCD-10 to indicate whether the AC accepted. - The Archiver is not a network sniffer because it does not track every transaction but only the "completed" alarm reports. - ATNA addresses logging in a generic way but it's not equivalent to the Archiver. - An Alarm Manager logger is different but Monroe will take a look at ATNA as a generic mechanism for the "Archiver". ATNA may be too focused on access control to be directly reused but it may be a good example. If the Archiver is intended to keep copies of the records but to record specific events (e.g. alarm successfully processed, alarm resolution incomplete, etc.) then similar to a logger. - Monroe will do more work on the AA and change PCD-04 to PCD-10 and PCD-08 and PCD-10 are optional. Decisions/Issues: Consensus: R01 becomes R40 in PCD-04. R41 or R42 – R41 has a response of assurance of delivery that cannot always be met (e.g., two a pager where no response can be obtained). Therefore, R42 should be used: consensus is to use R42. The R42 can, when appropriate, provide the information required to show details of receipt. PCD-05 relies upon PRT (Participation) segments, coming in v2.7, 2.8. Consensus: PCD-04 will use the PIN/Carrier approach. Modulation of the firehose will be deferred, with the understanding that a QRB message will be used similar to the PCD-02 from AR to AM to configure the desired status reports. PCD-05 content will be resolved in RTM. An MOU or other agreement for use of the transport protocols needs to be investigated. Their IP is copyrighted. The AM will be a client originating the message to the WCTP server in order to reach the AC. The AC will be the server and there are companies that would support the requirements. This is bidirectional, supporting the response. Monroe indicated that other transport protocols were researched, but are not as desirable. PCD-07 is an unsolicited web push response. Only a subset of WCTP is required. Action(s): ACM will provide an update to the Trial Implementation Supplement for public comment. Todd will seek the MOU for the WCTP.org issue.

Thursday 2010.05.06

Participants:

George Bertos (Baxter), Jon Blasingame (Philips), Anupriyo Chakravarti (Surgical Information Systems), Todd Cooper (Breakthrough Solutions), Bikram Day (Capsule), Peter Doyle (Covidien), Ken Fuchs (Draeger), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Colin Gartska (Epic), Christof Gessner (MxDx), Chad Hays (Cerner), Peter Hendler (Kaiser), Michael Ly (Cisco), George Panagiotopoulos (Kaiser), Monroe Pattillo (Philips), John Rhoads (Philips), Mike Romig (Patient Solutions), Paul Schluter (GE), Ioana Singureanu (VHA), Jerry Tonies (Cisco), Axel Wirth (Symantec), Kristina Wilson (Hospira), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Al Engelbert, Robert Flanders, Chad Hays

Chairs: Todd Cooper, John Rhoads

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	WCM Supplement	Status/Discussion: Ken reviewed the WCM draft Supplement, presenting Ioana’s commented version. Ken noted that the present approach addresses: - Unfiltered messages; filtering may be addressed in the future; in the interim the message is defined by the source. - A number of important items were considered for future development and these possibilities were accommodated, providing for backward compatibility. - Similarly, a number of attributes were accommodated, with some optional. There is a correlation table showing the relationship with IEEE standards and how these attributes are mapped to HL7. - HL7 does not have a data type for color; the consensus is to use DICOM unless a better option is available. The IHE Eyecare Domain may have an alternative. - Numeric Array and Color – need to discuss with Ioana. CPs may be required. - X.Y.5.2.2. addresses the need to synchronize the alarm and the waveform. Waveforms would be provided by an AR or DOR. It need not be associated with an alarm or an event – in the future; there are no queries at this time. - Todd asked how the WCM can be tested in the Connectathon and demonstrated at HIMSS. Monroe noted that this will need to be embedded in PCD-04. There is the opportunity to add XML within the existing messages. - We should at least be able to demonstrate ACM with WCM. Monroe, Bikram, Anupriyo, Chet and Vaughan indicated an interest in this. - Todd asked that the Trial Implementation version include the RTM data. Perhaps LiveData and Hill-Rom will be interested in implementation this cycle. Manny will talk with LiveData, Monroe with Hill-Rom. - Ioana’s comments were shown, and the document will be added to the ftp site. Decisions/Issues: Action(s): Manny will talk with LiveData, Monroe with Hill-Rom. A WG meeting will be scheduled with Ioana and the WCM WG.
2	ADT CP	Status/Discussion: Robert described his CP to add ITI-31 PEC. There are two components to this: Adding ITI-31 and how to represent that the data received from the ADT system is used by the PCD systems. An additional complication is the availability of ADT vendors who can provide ITI-31. Robert and Christof indicated that this is the most common ADT source. The consensus is to add this transaction. Todd turned attention to how to handle the “grouped actor” issue in the TF. This can be addressed in a PDA profile where it can be discussed as a way to obtain authentic demographics. He suggested that the TF not show the Patient Demographics Consumer as a grouped actor. Decisions/Issues: Consensus is to proceed with the CP. Consensus is to not include the PDC as a grouped actor. Action(s): Manny to ask John Donnelly to seek vendors to test, implement at Showcase.
3	RTM Update	Status/Discussion: Paul led discussion of the additions. Jan raised the issue of adding individual, very specific nomenclature as opposed to placing these in an information model, cautioning that minor changes in the parameter require an additional term. No consensus was obtained. MOU IEEE with IHTSDO: The MOU has been obtained. LOINC Terms in RTM: Christof is working on a table. Paul noted that a SNOMED table will also be linked. These will be maintained by LOINC and SNOMED and will provide ties between them. He noted that SNOMED is converging on UCUM as well. Ventilator Common Mode Names: Jan described the work in process on the complex set of ventilator terminology. He noted that some of the common clinical terms are not well defined and that tweaking a term implies a need bSee VentModalityRandO_4jw (2).pdf. The WG has developed a database that facilitates defining different modes by selecting different components. Data Types for Color: Ioana was asked to help define these HL7 data types: - Color – she suggested using a color observation rather than a color data type - Numeric Array (NA) which can accommodate RGB – it was deprecated and she recommended restoration; in the interim NM can be used with repeated fields Decisions/Issues: Action(s): Seek restoration of the Numeric Array (NA) data type.
4	Acknowledgement Types (Continued From Wednesday)	Status/Discussion: Colin FX provided additional description (see ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/F2F-May2010/Materials/Workflow_Diagram_of_PIV_ACK_Messages_20100506.pdf). Decisions/Issues: Consensus: Colin’s drawing was accepted and will be reviewed in the next Pump WG meeting. Action(s):
5	Event Communication (EC) Profile	Status/Discussion: John Rhoads described the EC requirements, attributes, etc. Please see ___ at ftp: ___ - Where possible, the EC and ACM profiles should be consistent. - Discussion followed regarding considering one of these as a special case of the other: EC as the broader item, with ACM requiring guaranteed latency, or ACM which requires the higher quality as the higher level. ACM provides priority and serial number. Christgof noted that these can be addressed by having low and other latency actors at the sending and receiving ends. John suggested that ACM and EC can be sent as part of PCD-01. Similarly, the EC can be sent as it occurs, in bursts or in response to a snapshot request. There may be an ITI profile that can be used. The consensus is that this can be accommodated in PCD-04 or PCD-01, with context clarity. This needs unambiguous identification of the message and the potential for annotation. This will be addressed in Volume 3 as will WCM. ACM will remain in Volume 2. John Rhoads will provide more detail and it will go to public comment as a content profile supplement. Decisions/Issues: The consensus is that this can be accommodated in PCD-04 or PCD-01, with context clarity. This needs unambiguous identification of the message and the potential for annotation. This will be addressed in Volume 3 as will WCM. ACM will remain in Volume 2. John Rhoads will provide more detail and it will go to public comment as a content profile supplement. Action(s):
6	Kaiser Point of View	Status/Discussion: George provided an overview of Kaiser’s evolution of interconnected and now interoperable systems. They have developed language for RFPs and Contracts seeking standards-based interoperable systems. While the initial cost may be incrementally more, the lifetime cost will be lower. They need to add standards-specific language to effectively motivate vendors. Decisions/Issues: Action(s):

Friday 2010.05.07

Participants:

George Bertos (Baxter), Brian Birch (Kaiser), Jon Blasingame (Philips), Todd Cooper (Breakthrough Solutions), Manny Furst (Improvement Technologies), Carla Gallegos (Cisco), John Garguilo (NIST), Christof Gessner (MxDx), Peter Hendler (Kaiser), Michael Ly (Cisco), George Panagiotopoulos (Kaiser), Monroe Pattillo (Philips), Tracy Rausch (DocBox), John Rhoads (Philips), Paul Schluter (GE), Ioana Singureanu (VHA), Jerry Tonies (Cisco), Jan Wittenber (Philips), Vaughan Zakian (Nuvon)

Webex: Al Engelbert, Gary Meyer

Chairs: Todd Cooper, John Rhoads

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Friday Focused on the DPI Profile

Item	Topic	Discussion
1	Opening Remarks	Status/Discussion: Todd introduced the DPI work, noting that this has been in development for several years: - HITSP relationship - White paper - Reference to several early DPI Wiki pages o Discovery and Association (DnA) o Basic data reporting o Symmetric communication (two way), including seeking data from another device; Safety interlocks; Setting alarm limits remotely o ID binding - HITSP Connection – see TN905 o Needs/requirements o Gap analysis o Timeline - Regulatory requirements are significantly different for DPI o Bi-directionality, external control, safety interlocks, etc. Opening Remarks - George Panagiotopolous set the stage for the discussion: - Patient-Device Association at the Point of Care (POC) is a major major problem - All HIT resources (e.g., EHR, labs, ...) should be available at the POC without overly complicating / causing distractions in the care context. - Find commonality among device types for simplicity. - Reduce training requirements. - Context Awareness: When a device connects, its information and configuration should be managed based on the clinical context or "awareness" (e.g., patient morbidities, therapeutic intent, drugs being delivered, clinical unit (MICU vs. NICU), patient is ambulatory (data may be lost), etc.) o Medical device operational complexity-b-bad: o Very frustrating for nursing staff, especially varying user interfaces within same modalities o Holds back innovation - Ubiquitous wireless sensors - decouple sensors from gateways to enable more local functions; incl. sensor data not available because patient is out of the bed... - Wireless vs. wired – need normalization, decouple from gateway - Decision support Additional Remarks - Brian Birch / KP (CE perspective) - MEM is very important - Assistance in troubleshooting and early indication of potential failure; device performance monitoring to support "intelligent" PM - Support Quality of Data specifications and monitoring - Standardize the basic data streams in / out: Take care of the "boring" IT stuff! Additional Remarks - Manny (CE perspective) - Alarm management is very important (incl. the AM=>AC interface, reduction in false alarms) - PnP - Rapid device deployment & configuration is also VERY important (e.g., patient transfers to ICU) - PnP - Rapid reconfiguration support (not just hot swapping) Additional Remarks - Peter Hendler / Brian Birch - Must be open standards based - Consistency of information from the same type of device; e.g., data streams are identical - Must make the I.T. connection ... work (baseline functionality) - Data flows should be self-describing w/ metadata - At least baseline functionality should be established w/ open standards-based solutions / higher-level functionality may initially be based on proprietary technology - w/o breaking the baseline o Jan noted that this is difficult to address through a single communication link that accommodates vendor specific functions/data - Note: user interfaces is not directly the subject of IHE PCD efforts (IHE focuses on implementation of standards-based system interoperability, not how those systems support the clinical environment, for example) Decisions/Issues: Action(s):
2	Value Propositions	Status/Discussion: Lengthy DPI Value Propositions Discussion Ensued - Jan: primary persistent problem with DPI is aligning clinical/care provider VPs w/ technology provider VPs to establish the business case for developing, testing and deploying IHE PCD TF profile-based solutions. Jan noted the absence of clear value propositions for users and vendors in DPI. It is very expensive, loaded with regulatory implications. Todd noted that identifying value propositions is one objective of this discussion. Jan noted that getting data to the EHR is a priority for vendors, pushing these other issues out further. - ONC/HITSP? It was hoped that w/ the development of TN905, some VPs from the U.S. national ONC would be realized; however, since HITSP suspended activities there is the perception that this "VP" has disappeared; Tracy R. though reminded us that in Dr. Friedman's FDA (2010.01.25) presentation <see posted materials on the ftp site> he indicated the importance of device interoperability - which based on various discussions, is an educated opinion. George Bertos suggested that the industry not wait for ONC direction. - Note: The "denovo submission" that was proposed at the end of the FDA Workshop in January is the subject of a planning group that meets weekly, including strong industry involvement. - Jan noted device-patient-association would be easier than alarms, noting that effectiveness of this effort would require that all devices participate to make it clinically useful. He noted that the industry has not developed standards classifying life critical alarms. - Jon: Doctors know need ... but not the difficulty in deploying solutions. - George P.: Perhaps take a top-down / bottom-up "sandwich" approach, engaging a clinical group to drive requirements & "need" + technology providers working the solution ... IOW - addressing the chicken/egg problem. - Paul: Continua ... - Manny: Reiterated need for establishing a stronger clinical "users group" - Tracy: The ICE use cases provide a strong VP / motivation (especially the X-Ray / ventilator sync clinical scenario) - Group: DPI needs much better analysis of requirements matched w/ VPs; problem is that PCD focused on the "easy" stuff first ... DPI is hard Achieving significant value propositions: - Need to have an organized user group o Need continuous involvement - Need just to have a few major manufacturers address this - Continua was cited as a successful model, moving quickly to organize o Charged participating companies - Use cases were described, including changes in patient condition (e.g., bp drops), location (elsewhere than the assigned bed), etc. - Discussion elicited that point of care is the place to address the safety and integration requirements rather than reliance upon the enterprise approach. Paul suggested that reliance on the enterprise reduces vendor costs and if the network reliability and other requirements are met this would be the preferred approach and would also accommodate legacy devices. - There is a need to accommodate multiple communications over a single port as well as the other example where multiple ports provide various combinations of data. Jan noted that having multiple modalities on a single port can be a problem. Decisions/Issues: Action(s): Need to have a group of users develop a purchasing requirement, publish and disseminate to encourage customers to include it in purchasing language. Vendors could participate. Need someone to organize this.
3	DPI/ICE-PAC Project	Status/Discussion: DPI/ICE-PAC Project Discussion - DPI: Can we focus on semantic interop first? no need both SI + technical interoperability - PnP - Note: Neither DPI nor ICE framework mandate a non-intermediary architecture (e.g., manager w/ agents) - Multi-protocol support? Yes, but for example, an x-ray machine typically has two ports. One for exchanging imaging information using DICOM, and another service port that can be used for synchronization services. - Briefly reviewed ICE-PAC work to date, focusing on infusion pump & ventilator work flow - Project proposal: Device configuration transfer during patient transfer "handoffs"; semantics would focus on settings, technical interoperability would focus on DPI & facilitation of automated configuration / reconfiguration - Events leading to handoffs: o Device Failure ("hot swapping") o Change in care context (equipment stays in context) o Change in patient condition requiring more sophisticated equipment o Wired-to-wireless transitions o Co-existence of comm technologies: wired + telemetry + wireless Pumps - Simple: change device w/ same make & model (risk management strategy!); proposal includes change between makes & models - Synchronization must include clinical context/intent and not just blind settings - Christof asked if a failure is a special case of device change, since the two devices may not be able to communicate. Thus an intermediary is required. Paul noted that the vast majority of devices and this general use case can be supported with a gateway. Jan suggested this be considered two use cases. He noted that solution requires semantics, etc., and risks and other issues. He noted this is very difficult to achieve, especially across vendors. Christof asked if the patient’s condition / requirements are what is important, and then achieving the same patient’s care is to be achieved rather than specific device settings. Paul noted that RTM is close to having ventilators completed. Jan noted that the patient’s care must be modeled. Decisions/Issues: Action(s): Define the next steps and enroll vendors to develop this in time for the Connectathon and Showcase. This would include: a technical report, and possibly technical documents such draft supplements for DPI or other. This would be a demonstration testing for a New Directions wall. Philips and Draeger expressed interest.
4	ICE-PAC Project Proposal	Status/Discussion: Project Proposal - Next step: Draft a project plan targeting (a) specification development over the summer, (b) prototyping in the fall / early winter, (c) demonstration testing event, (d) public demonstration during HIMSS '11 (end of February in Orlando) - Companies: DocBox, Philips, Draeger, Baxter, Nuvon - End Users (?): KP, Sutter Health, CIMIT, ... - NIST: Will engage as appropriate depending on the project's testing requirements - ACTION: Jon B. will recruit & organize - Meetings: o Use Thursday A.M. DPI session to work on project specifics o Use every other Monday (noon Pacific) to cover general project requirement & planning (esp. clinical participants o Note: the alternating Monday WebEx sessions will be normal ICE-PAC discussions, currently focused on respiratory / vent workflow Decisions/Issues: Action(s):
5	CDA	Status/Discussion: CDA; HL7 v3 John Rhoads summarized the breakout session, noting that there are different perspectives, coming from HL7 v3 coding or device viewpoints. They will set up a weekly meeting to address this. Christof noted that a VHA analyst has proposed an approach (11 pages) (“charter”) to model the information in a device independent way for HL7. The question is whether this will provide an abstract model which would add a layer of abstraction (13606). This model is very complex when the device (e.g., iv pump) has various physiologic meanings depending upon the medication. Device independence methodology is very unclear. Decisions/Issues: Action(s): They will set up meetings and Wiki pages. John Rhoads will poll participants to set a meeting time.

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The next meetings are:

The Planning Committee will hold a webinar meeting May 12, 2010 PCD PC 2010-05-12 Webex

The Technical Committee will hold a webinar meeting May 19 PCD TC 2010-05-19 Webex

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