PCD PC&TC 2010-10-18 to 22 F2F

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Meeting Objectives

These face-to-face meetings have a number of objectives depending on the committees involved:
  • Planning Committee: Review overall PCD activities, review Cycle 6 proposals
  • Technical Committee: Review all materials slated for publication Fall 2010 and resolve any issues so that final editing and publication may proceed.

Location

Meetings will take place at ECRI Institute, 5200 Butler Pike, Plymouth Meeting, PA 19462.

https://www.ecri.org/About/Visiting/Pages/Directions.aspx (610) 825-6000
Please reserve a place at the table as early as possible so that logistical planning can accommodate your attendance. Send your anticipated arrival and departure dates/times, cell phone number and hotel to Manny Furst. If you would like more information contact Manny.
Many in the group will stay at the Marriott Courtyard, 651 Fountain Road, Plymouth Meeting, PA 19462.

Related Documentation

The current version of the Technical Framework: http://www.ihe.net/Technical_Framework/index.cfm#pcd
Work Item Proposals: http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_6
IHE Webinars related to Profiles in all domains, the upcoming Connectathon and Showcase: http://www.ihe.net/Events/webinars2010.cfm

Schedule & Agenda

Daily Schedule
Meeting generally runs from 8:30 to 5:00 PM
Monday - 08:30 - 10:00 is an introductory meeting.
- Official meeting start is 11:00.
Friday - Meeting adjourns at 12:30.
General Schedule:
08:00 - 08:30 Meet at ECRI Institute
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
NOTE: Friday the meetings will end by 12:30.


Date Hours Committees Topics
Monday Morning

2010.10.18

08:30 - 10:30 New Attendees, ECRI Staff, Visitors
  • Introduction to IHE and the PCD Domain
Monday

2010.10.18

11:00 - 17:00 PCD Planning Committee
  • Greeting & Introductions
- Introduce the Cochairs (Election Review)
- Roadmap Review
- Schedule / Milestones Review
- Active Profiles
- Medical Device Aquisition (Guide)
- Continua Coordination
- White Papers
Tuesday Morning

2010.10.19

08:30 - 12:00 PCD Planning and Technical Committees
- Introduce the Cochairs (Election Review)
Tuesday Afternoon

2010.10.19

13:00 - 14:00 PCD Planning and Technical Committees
  • Tour of ECRI Facility
Tuesday Afternoon

2010.10.19

14:00 - 17:00 PCD Planning and Technical Committees
  • IHE IP Management Process
  • Technical Framework Final Text Discussion
  • 2011 HIMSS Showcase Discussion
  • 4 PM T-con PCD Showcase Planning
Wednesday Morning

2010.10.20

08:30 - 12:00 PCD Technical Committee (TC)
- Tooling update - NIST HL7 V2, RTMMS (ISO-IEEE x73, SNOMED CT, LOINC)
- Test Agents (Cycle 6; 2010-2011)
- Message Wrapper(s) Discussion
Wednesday Afternoon

2010.10.20

13:00 - 17:00 PCD TC WG Meetings
  • IHE IP Management Process
  • General topic of "Really Consistent" system time and time error propagation: what refinements are needed, when is defined worst-case maximum time error in whole system crucial?
  • (2:00 Webex) Device-Patient Association Use Cases and Issues
  • How to report data when the patient is unknown (Jeff Rinda)
  • ECM: Event Communication Management (preliminary name)
- Infusion Pump Event Communication (Jeff Rinda)
- Generalizing Event Communication (Rhoads)
- How do existing receiving systems use (1) aperiodic measurements (2) general events?
- How will this change in the future with additional clinical decision support capabilities?
Thursday Morning

2010.10.21

08:30 - 12:00 PCD TC WG Meetings
- WCM: technical discussion (Fuchs - 1 hr)
- ACM review and prospect: (Pattillo)
- RTLS: Industry Status Update (Pattillo)
- DEC: Future refinements and capabilities; strengthing event handling (?)
- RCT: More on time management and "Really Consistent Time" - use cases, DEC enhancements for time management
- MEM: how much can we do with DEC?
- Security: requirements, time frames
- SNMP et al.: Network Configuration Management needs? Flexible network discovery and configuration?
- WS*: strategy for using "quasi-standards"
Thursday Afternoon

2010.10.21

13:00 - 17:00 PCD TC WG Meetings
- (1:30 Webex) Domain Analysis Model / Detailed Clinical Models for Medical Devices (Singureanu and team)
- Device Point-of-Care Integration / Integrated Clinical Enviroment / Rapid Device Configuration
- HL7 / IEEE 11073 meetings in Cambridge (Rhoads)
- General Overview of Activities in Personal Health Devices: 11073-20601 Personal Health Device standards, Continua status (Schluter)
- Korea 2010 Slides
  • Report from IHE Int'l Board Meeting (earlier in the day)
  • Asynchronous Data Query - can general data query be strengthened to accomodate it?
  • Public Review Process Discussion
  • Quo Vadimus? What is the long term PCD Vision? Do we have one? Need to get one?
  • Is "certification" crucial? If so, how do we get there from here?
Friday

2010.10.22

08:30 - 14:00 PCD Technical Committee
  • IHE IP Management Process
  • ECRI Pump Safety Discussion: (Erin)
  • SOA Discussion: WP Development?
  • TF Appendices: OID Usage
  • Cycle 6 Work Program Review
  • Any technical items we still haven't discussed
  • Planning Wrap-up
  • 2011 F2F Meeting Planning
  • 2011 International Connectathon and Showcase Plans?
  • Review Deadlines for Supplements, Connectathon
  • Minutes / Resolutions / Action Item Review

Attachments / Materials

Ken Fuchs - IHE PCD Introductory Presentation

Folder for Presentations from 2010 October meetings at ECRI, Plymouth Meeting, PA

EventComm subfolder

PatientDeviceAssociation subfolder

documents and subfolders:

Excel spreadsheet has table of contents for MEM Security WP
ACM Update folder
Event Communication folder
NIST Presentations folder
Patient Device Association folder
Rosetta Update folder
Other Presentations

Participants

Monday: Orientation - participants not PCD members:

  • Local: John Sokalsky (Lehigh Valley Health Network), Richard Tevis (Geisinger Medical Center) and Scott M. Leshner (Hospital of the University of Pennsylvania)
  • Webex: Al Gould (Nebraska Medical Center)

Participants in the regular meeting, following the orientation:

  • Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Steve Merritt, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim (representing AAMI), Richard Tevis, Scott Zaffrin, John Zaleski ,Vaughan Zakian, Manny Furst. Participants introduced themselves.

Tuesday:

  • Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, Colin FX Garstka, Khalil Maalouf, Barb Majchrowski, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim, Vaughan Zakian, Manny Furst.

Wednesday:

  • Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Colin FX Garstka, Chris Lavanchy (ECRI Institute), Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim, Kristina Wilson, Vaughan Zakian, Manny Furst.
  • Device-Patient Association Webex: Gary Meyer led discussion and these others participated via Webex: Robert Britton, Eric Chetwynd, Robert Flanders, Sarah Hopkins, Roger Kittelson, Brad Lunde, Nuno Pino, Greg Scott, Lee Suprenant, Khalid Zubaidi.

Thursday:

  • Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Erin Sparnon, Kristina Wilson, Manny Furst.
- Jay Lyle (Department of Veterans Affairs) participated in the afternoon via Webex.

Friday:

  • Jon Blasingame, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Erin Sparnon, Manny Furst.


Action Item Summary

F2F Number Action Owner Participants Due Date PC, TC, WG or Closed? Comments
1 Update Roadmap and cycle 6 schedule Ken 11/10/10 OPEN Monday, Oct. 18: Ken will make sure the roadmap is posted to the ftp site, noting there are substantial changes. John noted that changes overlap with RDC.
2 Integration Statements John Rhoads Greg Staudenmaier and Steve Merritt 11/10/10 OPEN Monday, Oct. 18:
3 Use Cases for RTLS and patient location (PCD-04) Steve Merritt MEM WG 11/10/10 OPEN Monday, Oct. 18: Develop additional use cases for RTLS and patient location (PCD-04) (per Monroe)
4 Ballot Cycle 6 Work Manny 11/10/10 OPEN Monday, Oct. 18: Manny to draft ballot for prioritizing Cycle 6 work. Ballot will address Priority and Commitment (i.e., willingness of company to support the effort). See Wiki page http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_6.
5 Share IP policy (w/ Technical Committee) Manny 11/10/10 OPEN Tuesday, Oct. 19:
6 Glossary Steve Merritt 11/10/10 OPEN Tuesday, Oct. 19: Determine if a Glossary is still desired (possibly addressed by other groups).
7 Promoting PCD to ONC Cochairs 11/10/10 OPEN Tuesday, Oct. 19: The PCD will send an email to Joyce and Elliot will speak with her, for HIMSS/Joyce to promote devices and related systems. Cochairs. Manny to send email to Joyce and Elliot. John Garguilo suggested that Todd’s technical note be a vehicle for communication - TN 905.
8 PCD Schedule Ken 11/10/10 OPEN Tuesday, Oct. 19: Update Wiki page schedule, w/ key dates. Transfer the schedule to IHE wiki page(s)
9 Proposals Placed on FTP Manny Ken 11/10/10 OPEN Tuesday, Oct. 19: Verify that all proposals are on the ftp site: email received after the meeting from Steve Moore urgently requested that Proposals be placed on the ftp site.
10 Ballot TF Final Text 11/10/10 OPEN Tuesday, Oct. 19: Prepare and send ballots for the Final Text versions. These will go to the TC and, following approval, to the PC.
11 Connect, the Federal Government’s Common Standard Elliot Manny 11/10/10 OPEN Tuesday, Oct. 19: Manny to ask Elliot to lead a discussion at a Wednesday meeting.
12 NIST Tests Cycle 5 (Pre-Connectathon) John Garguilo 11/10/10 OPEN Wednesday, Oct. 20: Discussion of the existing static tests will be provided in the Tuesday PCD Connectathon/Showcase WG meeting November 2. It will include determination of the device identification to be used in messages this cycle and use of device IDs (e.g., EUI-64).
13 NIST Extensions John Garguilo Sandra Martinez 11/10/10 OPEN Wednesday, Oct. 20: NIST Test Agent extension work for all Integration Profiles will be discussed with each WG
14 Prioritize Escalated Alarms Monroe ACM WG 11/03/10 OPEN Wednesday, Oct. 20: ACM - AC will prioritize alarm and communication when messages are escalated. ACM will add a requirement to notify the person receiving an escalated message that the alarm has been escalated and has an associated delay from the initial alarm. The AC may make decisions on how to prioritize and escalate the message. This may have implications for the AM and perhaps AR.
15 Messages Without Patient Demographics Jeff Rinda Pump WG 11/17/10 OPEN Wednesday, Oct. 20: Pumps (and other devices) sending device data in absence of patient demographics. (PIV initiated, to be discussed in Nov. 17th TC meeting)
16 WCM Attributes Paul Schluter Ken Fuchs 11/10/10 OPEN Thursday, Oct. 21: Document ways of representing waveform attributes. Ken suggested similar action for PCD-02. To be discussed Nov 3rd TC meeting.


17 PCD Vision John Rhoads PC 11/10/10 OPEN Thursday, Oct. 21: Develop a vision statement.
18 Certification John Rhoads PC 11/10/10 OPEN Thursday, Oct. 21: How do/should we address? Address via Meaningful Use.
19 Recruit Moberg Research John Garguilo Manny 11/10/10 OPEN Friday, Oct. 22: Invite Moberg.org to participate in IHE-PCD domain. They may support the PCD HIMS11 demonstration with an epilepsy detection system.
20 OIDs for PCD John Garguilo John Rhoads 11/10/10 OPEN Friday, Oct. 22: OID development/guidance/recommendations.
21 Recruit CMMS Vendors for Event Communication Steve Merritt Manny 11/10/10 OPEN Friday, Oct. 22: Recruit CMMS vendors for Event Communication
22 Ballot Sring F2F Manny 11/10/10 OPEN Friday, Oct. 22: Three invitations will be considered: Philips Bothell, WA, Philips Boca Raton and Cerner, KC. Manny will check with Cerner (not present), ballot preferences among sites, several dates. HL7 meeting is in mid-May in FL. F2F meeting should be at the end of April or beginning of May.
23 Recruiting Before HIMSS11 Erin, Ken, Steve, Jon, Khalil PC 11/10/10 OPEN Friday, Oct. 22: Develop materials, strategy in lead-up/pre-Spring F2F and pre-HIMSS11. Discussion tied to HIMSS '11. o Ask for input from HIMSS attendees about items for F2F discussions.
- Include MU? Input from HIMSS.
- Can this be combined with item(s) above?
- Erin, Ken, Steve, Jon, Khalil will address recruiting and orientations.
24 RFP Matrix Erin Jon Blasingame, Khalil, Ioana 11/10/10 OPEN Friday, Oct. 22: Develop, publish RFP Matrix (Hospitals and Vendors) - Infusion and Vital Signs
25 HIMSS 11: Develop MU Wall John Rhoads Todd, Lisa Carnahan, John Garguilo (proposed) 11/10/10 OPEN Friday, Oct. 22: Seek volunteers to develop MU wall.
26 International Connectathons, Showcases Manny Cochairs 11/10/10 OPEN Friday, Oct. 22: Ask Lisa Spellman about non-US Connectathon and Showcases. Is there a role for Todd Cooper (e.g., his recent work w/ IHE-Korea and IHE-Japan)? Learn more about IHE pre-qualification "to be involved with a Connectathon..." Course (cost involved). Ask Lisa for update on results of non-US Connectathon/Showcase.


27 Develop PCD/FDA Communications Cochairs 11/10/10 OPEN Friday, Oct. 22: Relationship of IHE-PCD w/ FDA – Does IHE have a liaison? PCD could, for example, send updates to IHE/FDA liaison, if a liaison can be established.


28 11/10/10 OPEN Friday, Oct. 22:
29 11/10/10 OPEN Friday, Oct. 22:
30 11/10/10 OPEN Friday, Oct. 22:


Discussion Monday October 18 (Planning Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Orientation
- Chair
Status/Discussion:

The cochairs welcomed participants and presented an introductory session for those new to PCD and those interested, in person and over Webex (Al Gould). The slides are available at ftp.IHE.net/Patient_Care_Devices/Presentations

Decisions/Issues:

Action(s):

2 Introductions, Agenda Review and Intellectual Property Policy
- Ken Fuchs
Status/Discussion:

The regular meeting convened at about 11:10 am with review of the Planning Committee agenda.

Participants in the regular meeting, following the orientation:

  • Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Steve Merritt, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim (representing AAMI), Richard Tevis, Scott Zaffrin, John Zaleski ,Vaughan Zakian, Manny Furst. Participants introduced themselves.
- Participants in the orientation who did not participate further on this day: Jim Keller, John DeGrandpre.
- Ken Fuchs chaired the meeting.

Ken provided the slides and presented the IHE Intellectual Property policy.

Ken described the IHE process and workflow leading from ideas and concepts to projects and technical solutions.

  • IHE USA: Elliot described the current status of IHE USA, where he is a member of the board. It is set up as a 501 (c) 3 organization and is now a separate organization. The IHE-USA is a national deployment organization, will have its own organization and role to play, and will launch a website next month. National deployment organizations will be responsible for the national differences as well as Connectathons that take place in its borders as well as related activities. There are likely to be membership fees.

Decisions/Issues:

  • Agenda approved

Action(s):

3 PCD Roadmap
- Ken
Status/Discussion:

PCD Roadmap:

  • Ken then reviewed the current version of the PCD Roadmap, offering suggestions for changes to reflect current efforts before proceeding to develop the updated version. He noted that the schedule posted to ihe.net should be updated and Cycle 6, 2011 schedule added. He noted that links to Profiles in development. John Rhoads added that the RDC effort has sufficient overlap with the RDC effort (largely focused on ventilators) to enable combined, cooperative effort. This is an extremely complex and difficult effort. IDCO has posted the nomenclature for IEEE ballot. MEM WP is largely done, and TI Supplements are in development. PIV is addressing Event Communication which will later support other profiles. RTM is extending parameters and the Continua LAN tables will become available. WCM will be discussed this week and readied for TI.

Decisions/Issues:

Action(s):

  • Ken will update and post the roadmap changes discussed.
4 Work In Progress
- Ken
Status/Discussion:
  • Implementation Guide: John Garguilo described this as a needed “how-to” guide for vendors to help them develop code, to help interpret and understand constraints within standards and TFs. Other domains have looked at this, but none have begun development.
  • Medical Device Acquisition Guide: Erin indicated that work continues on developing RFPs for various device types.
  • Continua Coordination: Paul described their work to develop alarm communications, largely motivated by the UK’s NHS. He expressed hope that RTM table for this purpose will result in common PCD/Continua compatibility.
  • MEM Security WP: Steve described the six functions and use cases, with proposed timeline for development. Two brief profile proposals follow this week (below).


Decisions/Issues:

Action(s):

5 Web/Wiki/FTP reviews
-
Status/Discussion:
  • Domain Name: Ken noted that various documents, files, web sites, etc. have the domain name as singular and plural. Today’s discussion indicated the preferred name will be the plural in the future (Patient Care Devices).
  • Integration Statements:
- Ken noted that potential purchasers have to devote much effort to learn about a product’s conformance, and this is not desirable. There are many ways to obtain information, but many are incomplete and require further research. Comments from others noted that users are not likely to know where to look and what to look for.
- The Integration Statement is only an attestation that your system meets the requirements; it does not mean successful Connectathon testing but can provide a link to Connectathon results. Ken asked how to make information readily available: how does a purchaser know what is conveyed in the statement? He noted that this issue is also critical for vendors: once companies test a profile a number of years they may not continue, and this would remove opportunities for new vendors to test against partners. Manny and Paul suggested that the statement include additional information about where and what was tested. Elliot suggested that more frequent opportunities to test, the use of virtual Connectathons, etc. will make changes necessary. He added that the international applications further complicate the issues.
- Extensive discussion followed, with issues of policy and participation, addressing motivation, costs, necessity to test new profiles/options, etc. There are a number of reasons why an active vendor may no longer participate in addition to costs: e.g., as a vendor and system adds profiles and options, time at the Connectathon may not be sufficient to test a profile again. The PCD domain may need to lead the way to assure that users can easily and intelligently purchase systems and new vendors will have test partners and be able to indicate implementation and marketing devices/systems.
- Paul suggested that vendors need to at least participate in Virtual Connectathons between Connectathons or following a minimum number of in person Connectathons.
- John Rhoads suggested that PCD begin by defining minimum information to be included in the Integration Statement. He further suggested that PCD develop a supplementary statement.
- Steve noted that most PCD vendors that have participated are not listed in the existing directory (http://product-registry.ihe.net) . Apparently, most systems are not yet commercially available even though the vendors have multiple years’ experience in testing.
- Ken suggested that this needs to be taken to the Domain Coordination Committee.
- Elliot noted that NIST will certify the certification bodies.

Decisions/Issues:

Action(s):

  • Action Item: PCD will establish a group to develop the PCD Supplement to the Integration Statement.
6 Profiles and White Papers to be considered for Cycle 6
- Ken, Steve Merritt
Status/Discussion:
  • Existing profiles to be considered for Cycle 6 (see link, above):
- DPI: No work has been accomplished in Cycle 5.
- Device Integration Profiles Guidance: No work has been accomplished in Cycle 5.
  • New or updated/reconsidered profiles:
- Location Tracking: ITI was asked to participate, but did not made this a priority. PCD developed requirements, use cases. This wasn’t a priority in the past due to lack of RTLS vendor resources. Steve Merritt has gathered a group of RTLS and CMMS system vendors to develop the Supplement or to repurpose an existing profile.Monroe suggested an additional use case: when an alarm is sent (PCD0-04) the location will be included.
- Query for Bulk Data: Ken described the use cases. Elliot suggested changing “forensic” to “archival”. Jon suggested that this can also be used in an investigation of an adverse event.
- Device to Patient Association (PoC ID Management): Richard Swim indicated that this is a big issue for Baylor and the loss of data. Robert Neff noted that it is important that data be associated with the correct patient. John Rhoads noted that PCD-01 requires patient id, but there are complications with adding and removing devices.
  • From the Parking Lot:
- Asynchronous Data Query: Ken suggested that QBD should be able to meet this need. Discussion addressed time stamps and enterprise time which may differ and will need to be considered. Discussion followed regarding how devices would communicate their time accuracy (when, to which synchronized, etc.). Ken asked if time management should become a separate work item.
- MEM: Aspects other than those discussed above are deferred.
- Enterprise ACM: Will remain deferred.
  • Existing White Papers to be considered for Cycle 6:
- DPI
- Semantic Architecture (Todd will provide introduction in TF Volume 3 TI version).
- Regulatory Considerations will be covered in a 510K to FDA for a virtual device. The idea is to help develop the FDA’s criteria for their requirements for 510K submissions of complex devices which are systems of systems and may be closed loop. This is not an IHE effort, but will address issues that had been anticipated for this WP. Sandy Weininger and John Murray of the FDA are involved.
  • New White Papers:
- Medical Device Cybersecurity: this is fairly well along.

Decisions/Issues:

Action(s):

  • Additional use case for RTLS – provide location of patient in PCD-04.
  • Manny to draft ballot for prioritizing the work.

Discussion Tuesday Morning, October 19 (Joint Planning and Technical Committees)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Introductions, Agenda Review and Intellectual Property Policy
- Chair
Status/Discussion:

Ken chaired the morning meeting, repeating the IP management process.

Decisions/Issues:

  • Agenda approved

Action(s):

2 Marketing IHE and PCD
- Erin
Status/Discussion:
  • Erin indicated that she is participating in the IHE marketing effort.
  • Elliot described Connect – the federal agencies that came together to comply with government standards for healthcare decided to collaborate with open standards work rather than develop their own. Elliot is on the steering committee, and has advocated PCD’s work. The group includes CMS, FDA, CDC, NASA, Social Security and others; www.connectopensource.org. A number of companies and state HIEs are collaborating with Connect. He noted that PCD collaboration with Connect would be worthwhile. They sponsor student activities and Elliot included a PCD component in this year’s competition. They also participate in the HIMSS Showcase. David Reilly is the Director, Greg Fairnak is the chief architect (http://www.gov2expo.com/gov2expo2010/public/schedule/speaker/75861 and http://www.interoperabilityshowcase.org/himss10/docs/summary/NHINandCONNECTProject/Connect%20Project%20Educational%20Sessions%20Brochure.pdf). Ioana added that Continuity of Care was the focus of the last presentation of David Reilly’s that she heard. Elliot offered to share PCD information at the upcoming European research group as well.

Decisions/Issues:

Action(s):

  • Connect, the Federal Government’s Common Standard for Interoperability: Manny to ask Elliot to lead a discussion at a Wednesday meeting.
3 Funding
- Ken
Status/Discussion:
  • Ken summarized the source of PCD’s funds and the desire to secure additional funds from AAMI and ACCE to support staffing to enable faster progress. Jon is leading the ACCE marketing effort and is seeking funding for a variety of ACCE activities. ACCE will be recruiting corporate members. Discussion continued about the potential collaboration that PCD can provide to benefit vendors with AAMI and HIMSS. Discussion revealed that AAMI’s position on standards for interoperability is significantly different from IHE’s.

Decisions/Issues:

Action(s):

4 Roadmap and Schedule:
- Ken
Status/Discussion:
  • Glossary may no longer be needed; has been addressed by others? Note that the IHE Domain Cochairs will be sensitive to consistency across domains.
  • PCD-01 will be in Final Text (FT) for the first time in Cycle 5 (existing cycle).
  • PCD-02 will likely not reach FT until Cycle 6. [At the Oct. 27 PC/TC Webex Manny noted that since last week analysis of Gazelle registration revealed vendors registering for the Connectathon for the first time have registered as DOCs with this option, making it possible to test in January and that potentially makes inclusion in FT possible afterward. However, John Garguilo added that NIST may not be ready in time for Pre-Connectathon testing.]
  • Alarm Communication Management (ACM) components: AC in cycle 5, AM to AR in cycle 6, AA in cycle 7.
  • Device Content Management: Patient – Device Binding: PIB was removed in favor of a new effort – Device Patient Association
  • Medical Equipment Management (MEM): WP in cycle 4, Security WP in cycle 5, Point of Care PIB (ITI Bar Coding?), RTLS starting in cycle 5. Future areas of attention: Patch Management, Battery Management, Operational Status, …
  • Device Point of Care Integration (DPI): A number of items are on the existing roadmap, but have not been addressed. John Rhoads noted that work with ICE-PAC will include some aspects of PoC. ICE-PAC and DPI have been tightly tied. All items will be retained, but delayed.
  • Content Management: Rosetta Terminology Mapping Project is moving forward and will eventually be transferred to NIST. Several specific areas of development are noted. Volume 3 of the TF will include a portion of what had been included the Semantic Architecture WP. Device Document Template (Volume 3) and Device Specializations are placed in cycles 6-8.
  • Device Extra-Enterprise Communications: These are in support of Continua’s, CMS’s, VA’s efforts related to home care. Elliot noted that FCC and CMS have allocated funds related to home care and commissioned a study. ONC and FDA are coordinating as well.
  • Device Order Management: Pump group items remain.
  • Quality: Nothing at this time.
  • HL7 version 3 and CDA are placed in cycle 7.

Elliot suggested that PCD identify a way to work with ONC on devices. ONC’s recognition of PCD profiles for Meaningful Use is the desired approach, believing that this will motivate certification bodies to develop the means and processes.

Decisions/Issues:

Action(s):

  • Manny to check with Steve Merritt regarding whether the Glossary is still needed.
  • Promoting PCD to ONC: The PCD cochairs will send an email to Joyce and Elliot will speak with her, to set a discussion to promote PCD at the table.
  • Update PCD_Schedule Wiki page.
  • Verify that all proposals are on the ftp site: email received after the meeting from Steve Moore urgently requested that Proposals be placed on the ftp site.


5 IHE and PCD Process
- John Rhoads
Status/Discussion:
  • John Rhoads reviewed the IHE processes, noting the various responsibilities and requirements. These can be found on the IHE Wiki from the Process link on the left. Specifically, the transition of the Technical Framework (TF) from Trial Implementation (TI) to Final Text (FT) is relevant to the current effort. The TF TI was recently updated and published. The TF FT is now available for review; the PCD needs to issue a ballot.
- The Wiki Main Page link to Process is at http://wiki.ihe.net/index.php?title=Process

Decisions/Issues:

Action(s):

  • Manny will prepare and send ballots for the FT versions. These will go to the TC and, following approval, to the PC.
6 The Joint Planning and Technical Committee adjourned.
- Ken
Status/Discussion:

Decisions/Issues:

Action(s):


Discussion Tuesday Afternoon, October 19 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Tour of ECRI Institute
- Erin
Status/Discussion:

The meeting resumed following the tour.

There was no need to repeat the IP policy. No additional people were present.

Decisions/Issues:

Action(s):

2 Connectathon, Pre-Connectathon and Showcase
- Manny
Status/Discussion:

Manny provided an update on Connectathon, Pre-Connectathon and Showcase

  • Registrations brought new companies, new parameters (hearing screening). PCD members agreed to support the parameters to enable testing and demonstration while not within their business plans.
  • Pre-Connectathon tests will hopefully be available around November 1.
  • Connectathon tests will follow.
  • Showcase demonstration will not include IDCO. The fourth wall could be Meaningful Use; we will need volunteers to develop that use case. It will include appropriate devices.
  • When time permits, a review and update of devices/systems registered following the official deadline may reveal an opportunity to add a scenario with Continua.
  • Similarly, there may be one or more DOCs implementing PCD-02 – which had not been the case up to the deadline.
  • John Rhoads recommended that participants arrange to penetrate their firewall when possible.
  • John Rhoads asked, and participants agreed that HL7 v2.6 is the version for testing this cycle.

Decisions/Issues:

Action(s):

3 Entity Identifier
- yyy
Status/Discussion:

Entity Identifier:

  • The TF had stated a preference for EUI-64. Others are accepted, and should be a universal ID as shown in the HL7 table.

Decisions/Issues:

Action(s):

4 Agenda for Remaining Days
- John Rhoads
Status/Discussion:

John Rhoads described the agenda for the rest of the week.

Decisions/Issues:

Action(s):


Discussion Wednesday October 20 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Introductions, Agenda Review and Intellectual Property Policy
- John Rhoads
Status/Discussion:

John Rhoads chaired the meeting, repeating the IP management process.

Decisions/Issues:

  • Agenda approved yesterday.

Action(s):

2 NIST Tools
- John Garguilo, Sandra Martinez
Status/Discussion:

John Garguilo and Sandra presented the NIST Test Tools including present status and future directions. The slides are available at ftp://iheyr2@ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2010-10-18PlymouthMeetingPA/. Discussion revealed subtle issues which will be addressed by NIST.

  • Extensions to the NIST tool (Behavior Testing) should be available for the 2012 test cycle and available at the Connectathon. A preliminary test may be available in January.
  • John Garguilo noted that there are a number of issues related to the wrappers that are provided in the web services messages (e.g., WS addressing, security, coding, etc.) and will need to be addressed, especially when Continua’s messages are considered. NIST is addressing this, and PCD messages will be considered in the future.

Decisions/Issues:

Action(s):

  • John Garguilo will lead a discussion of the existing static tests on November 2 in the PCD Connectathon and Showcase WG meeting, and include determination of the device identification to be used in messages this cycle.
  • John and Sandra will discuss these extensions with the individual WGs (ACM, IDCO, PIV).


3 Rosetta Terminology Mapping Management System (NIST) and RTM
- John Garguilo, Paul Schluter
Status/Discussion:

RTMMS

Rosetta Update:

- Brief introduction to RTM
- Vendor VMD
- LOINC terms (infant screening) – column added, at least temporarily – Paul recommended that LOINC and SNOMED terms go directly into the RTMMS rather than into RTM and then into RTMMS.
- RTM Respiratory and Ventilator – making excellent progress on “ventilator mode” then will be followed by breath-by-breath modeling.
- RTM for events (pumps first) – ACM and the new Event Communication profile; content models, including cardinality.
- PHD devices (Continua 1.5 WAN) – using IEEE standard PHD specializations. Dot level 2 is not used, so the OBX-3 has zero to represent the missing level (e.g., 1.0.1); therefore representations with PCD messages are consistent. Paul indicated that time stamp can be included in the measurement wrapper. Paul noted the Continua terms will be available to the public.

Decisions/Issues:

Action(s):

4 Brief Work Item Proposals
- As Noted
Status/Discussion:

Time Synchronization White Paper

  • WP will review the Use Cases and create guidelines to handling unsynchronized time sources and address the required accuracy to meet clinical needs. If the device itself cannot support the accurate time with the CT profile, this will address how to provide a “best effort” value.

Device Patient Association:

  • Gary led the discussion.
  • Gary Meyer and these others participated via Webex: Robert Britton, Eric Chetwynd, Robert Flanders, Sarah Hopkins, Roger Kittelson, Brad Lunde, Nuno Pino, Greg Scott, Lee Suprenant, Khalid Zubaidi.
  • Ruth had proposed that the identifier be coded as RI (resource identifier) type. This approach requires two PID segments. Gary noted several concerns (see the document). Several PCD members indicated they are not in favor of the A24 message.
  • A second approach is to use one of the Patient Schedule messages (for appointments). This has the advantage of addition, cancellation. Robert noted that some CIS systems won’t support this message type.
  • A third approach is to use Observation Messages. Christof suggested that an observation type message with an SPM segment would be beneficial. Gary noted that the ORU message requires the patient identification section. Thiswould be an Unsolicted or a Solicited ITI-30 or -31 message.
  • The fourth approach is to use Patient Registration, A04 messages. This requires HL7 clarification (see document page 7 of 9). If the PRT segment is available, this would provide all information needed. The only question is whether a new ADT message should be proposed to segregate device identification from other such messages.
  • Gary proposed the use of the ADT A04 with PRT segment, within HL7 v.2.7. Monroe suggested that PRT is not used for assigning this type of relationship. Gary responded that the definition “Identifier for the device participating” appears to leave room for this application. Gary suggested that a member of HL7 explore the intention behind this broad definition; John Rhoads indicated that an HL7 member will follow up.
  • Monroe asked how devices would be disassociated. Gary noted that the PRT segment has an action code that can be used to disconnect the device. The Observation option (third one above) does not have this action item. Monroe suggested that the Scheduling option has symmetry for adding and removing the association.
  • It was suggested that ITI be consulted and that other domains might want additional components for billing or other applications.
  • Discussion followed regarding whether associating the patient and device removed from the physical device introduces the possibility of error in the association. [Note: the discussion was continued later.]

Event Communication

  • Jeff led the discussion, referring to the Infusion Pump Event Communication, version 09242010. The events are milestone events (e.g., infusion start, stop). He noted that the pump and its messages know about the pump’s operation, but not about the clinical application. With three basic operation, start, stop, complete. Pause is the same as stop. This does not preclude the pump systems from sending an alarm for the same event (i.e., when the infusion supply needs to be replaced).
  • Extensive discussion addressed whether every transition should have a start and stop, as contrasted with an event that includes a change in rate within an existing event.
  • John Rhoads led discussion of Events, including definitions, types, attributes, etc. The slides are found at ftp://iheyr2@ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2010-10-18PlymouthMeetingPA/ - Questions arose, some which should be included as requirements for the TF or Implementation Guide. Among the questions: should the escalated message contain information that time has elapsed and this is the escalated message; this might have clinical implications.

Decisions/Issues:

Action(s):

  • Gary will provide an updated document on Device Patient Association.
  • Alarm Communication: Monroe will include the escalation item along with indication that the AC may want to make decisions on how to prioritize and escalate the message.


Discussion Thursday, October 21 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Introductions, Agenda Review and Intellectual Property Policy
- Chair
Status/Discussion:

Decisions/Issues:

  • Agenda approved previously.
  • John Rhoads chaired the morning meeting. It was unnecessary to repeat the IP management process because no newcomers were present.

Action(s):

2 Profile Proposals for Cycle 6
- As Noted
Status/Discussion:

WCM (continued):

  • Ken discussed the WCM profile, specifically the public comments received. The primary issue was grouping – how to change some attributes of certain parameters without having to affect all of them during a single series of data messages. The current approach is that if any attributes change a new waveform group is required.
  • Paul suggested that each message contain an OBR setting the dot level, while Ken believed that subsequent OBRs would continue at the prior level. Ken had proposed sending each channel individually, thus not requiring data within each channel’s data messages to require an OBX if unchanged. Ioana suggested that it is not necessary to have a single approach as long as each approach is carefully detailed. Paul suggested that other waveforms may shed light on options – e.g., trends. Paul suggested that waveform group identifier would always be known to be at dot level 3, with the waveform data at dot level 4. Ken suggested that dot levels could float depending upon channels, vmds. Dot level 3 would then be a waveform “wrapper”. Among the issues will be whether OBRs can float. Christof’s email expressed concern about OBR nesting. Ioana noted that some parsers don’t support this. Ioana added that the rules make it possible for NIST test tools to verify compliance. John Garguilo agreed with John Rhoads that an implementation guide is needed to address this and this would permit future flexibility. He added that clear, unambiguous rules permit testing. Paul noted that existing use of channel levels prevent waveforms at that level – waveforms might be contained within a message that uses channel level (e.g., ventilator data). Further, if the waveform wrapper is at dot level 4, like metrics, then waveform data would be at dot level 5. Paul recommended input from a few of ASN1 and Continua experts.
  • Paul described two approaches using ventilator messages. He asked if waveforms can be included in the same channel as numerical data, or if a separate channel is required. John Rhoads responded that the latter is the case. Paul noted that this means the waveform data then needs to be one level further down. If at dot level four, this would preclude wrappers.
  • Paul summarized two approaches:
Method 1, Wave message, dot level 3 or 4
- filters, attributes (or pointers to) (N.M.X.Y)
- ECG lead = “1”
- ECG lead = aVR
- ECG lead = VL
Method 2, OBX-17 observation message (Ioana), dot level 4
- MDC_ECG_WAV_AVR (dot level 4)
- filters, attributes (or pointers to) (N.M.X.Y)
- Filter Seq
- Filter
- Filter
- Gain
- Color
- MDC_ECG_WAV_AVL (dot level 4)
- filters, attributes (or pointers to) (N.M.X.Y)
- Filter Seq
- Filter
- Filter
- Gain
- Color
- Issues include conformance to IEEE 11073, ASN1, whether OBX can contain a pointer for a filter (one of many available). Iona elaborated saying that waveforms and filters be declared and then referenced.
- Using a ventilator example, he described how waveforms would be at dot level 4 with filters at dot level 5, and waveform attributes could be coded as facets. Ken raised the question - in the absence of an OBR, how to define filters? Paul responded that filters, at dot level 5, would be defined under the first time it is used; and will require a pointer afterward. This would permit overwriting with new attributes.

Pump STAT Application (Messages without patient identification):

  • Jeff and Kristina reported request for sending device data in the absence of patient identification when device-patient association is not available. PCD-01 currently requires data to ba associated with a patient, even if that is a John Doe type of patient identification. Discussion revealed that there are vendors who want to later associate the patient with the data. Extensive discussion followed. Issues: should this be permitted, how specific fields are coded, and how to communicate to the purchaser in the conformance statement so that the purchaser understands the functionality available. Ioana suggested that HL7 v.2.8 provides a way to address this issue. John Rhoads suggested that this be an option; this minimizes the change to the TF. Erin noted that this ties into the discussion on Monday related to PCD’s changes to the Interoperability Statement. Khalil asked that the implementation reveal when and how the association was accomplished.

HL7 Domain Analysis Model

  • This was developed by the Veteran’s Administration. Ioana led discussion. Links to the Medical Devices DCM discussed this afternoon:
- GForge project site: http://gforge.hl7.org/gf/project/dcmmd/frs/?action=FrsReleaseBrowse&frs_package_id=148
- HL7 Ballot: http://www.hl7.org/v3ballot/html/dams/uvmd/uvmd.htm
- This will be sent to HL7 ballot in May, planning to include additional use cases.

ACM:

  • Monroe presented the updates to the ACM profile (see slides). Monroe asked about MSH-21 which identifies the profile. John Garguilo suggested that the PCD OID could fill this need. Jhn Rhoads added that this should be incorporated into the TF or the Profile and this would enable testing.

Remote Monitoring for Chronic Care:

  • Paul Schluter noted that 11073 PHD is used, and trimmed in conformance with reduced need for complexity.

Ken then added proposals that have not yet been discussed.

Additional Proposals:

  • ADQ: A combination of QBD and --- john zaleski’s --- to yield Asynchronous Data Query (ADQ).
  • RCT: Really ConsistentTime (not a fully completed proposal): This is a new proposal.

Deferred to Friday:

  • PCD Vision: John Rhoads asked: does PCD need one? John Garguilo suggested this be a PC item.
  • Certification: John Rhoads asked: is this crucial and how will it be addressed?


Decisions/Issues:

Action(s):

  • Paul will prepare a brief document with criteria to be met in the profile with regard to waveform attributes. Ken suggested that PCD-02 also provide waveform filtering.
  • Schedule discussion of WCM for TC meeting Nov. 3 and ballot.
  • Schedule discussion of Pump STAT Application for TC meeting Nov. 17 and ballot.
  • Manny to draft Ballot to select Proposals for Cycle 6. Ballot will address Priority and Commitment (i.e., willingness of company to support the effort).
- See Wiki page http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_6. A two part ballot will be provided.
  • Deferred to Friday:
- PCD Vision: John Rhoads asked: does PCD need one? John Garguilo suggested this be a PC item.
- Certification: John Rhoads asked: is this crucial and how will it be addressed?

Discussion Friday, October 22 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Introductions, Agenda Review and Intellectual Property Policy
- Chair
Status/Discussion:

Decisions/Issues:

  • Agenda reviewed
  • John Garguilo chaired the meeting. It was unnecessary to repeat the IP management prolicy because no newcomers were present.

Action(s):

2 Announcements
- John Garguilo
Status/Discussion:

Moberg Research:

  • John Garguilo led review of discussions that took place with Dick Moberg and staff last night at Moberg Research. There is a desire to have their participation in PCD and IHE. John Rhoads noted that they have participated in DPI and ICE-PAC. They believe the issue preventing IHE PCD participation is availability of their time. Khalil noted that while they are expert in IEEE 11073 they have not used HL7.
  • Erin summarized the recent FDA/AAMI Infusion Pump meeting. She noted the summary on the http://www,AAMI.org website. That page lists 13 priorities for infusion pump safety. The FDA wants to see safety assurance documents from vendors, and these would include clinical evaluations, but did not provide details on what that contains. The FDA had previously presented their point of view, the recent meeting provided opportunities for vendors and users to present their points of view.

Decisions/Issues:

Action(s):

  • John Garguilo will invite Moberg Research to join IHE and the PCD Google Groups. Manny will follow up.
3 OIDs
- John Garguilo
Status/Discussion:

OIDs:

  • There is a need to define the tree for IHE PCD OIDs and national extensions. Ioana suggested that the cochairs control the issue of an OID for profiles, etc. John Garguilo noted that OIDs will be useful in testing.

Decisions/Issues:

Action(s):

  • John and John Rhoads will develop a proposal for the TC.
4 Profiles for Cycle 6 (Continued)
- As Noted
Status/Discussion:

Profiles:

  • MEM Security White Paper:
- Steve sent an outline of this WP (Excel spreadsheet) ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2010-10-18PlymouthMeetingPA/
  • RTLS: No comments were received; MEM is trying to gather technical resources from the stakeholders.
- From Steve via email: He seeks more collaboration from CMMS vendors on the Event Communication work. This would be a huge win for management of devices. If the use cases cannot be accomplished with Event Communication MEM will need device and CMMS vendors to provide an alternate messaging profile.

Decisions/Issues:

Action(s):

  • Recruit CMMS vendors.
5 Spring F2F
- John Garguilo
Status/Discussion:
  • Potential Locations: Cerner Kansas City, Philips Bothell, Philips Andover, Philips Emergin, Boca Raton, ECRI Institute
- Discussion included the length of the meeting, reaching out to clinicians, including message to visitors at HIMSS (Showcase, CE-IT Symposium) about the Spring F2F, need to develop preliminary Spring F2F agenda in December (first day anyway and consider Webex).

Decisions/Issues:

Action(s):

  • Manny will check with Cerner, ballot several dates with PCD. HL7 meeting is in mid-May in FL. Meeting should be at the end of April or beginning of May.
6 Recruiting and Orientations
- Erin
Status/Discussion:
  • In December PCD should address the next PC F2F, prepare to leverage HIMSS11 as a venue for recruitment, consider a Webex to recruit users and vendors, leverage IHE Marketing (Erin a member) and ECRI Institute (would include Continua, MD PnP). Volunteers: Erin, Ken, Steve, Jon, Khalil
- Discussion included the length of the meeting, reaching out to clinicians, including message to visitors at HIMSS (Showcase, CE-IT Symposium) about the Spring F2F, need to develop preliminary Spring F2F agenda in December (first day anyway and consider Webex).

Decisions/Issues:

Action(s):

  • Volunteers: Erin, Ken, Steve, Jon, Khalil will address recruiting and orientations.
7 Connectathon and Showcase
- Manny
Status/Discussion:

Connectathon:

  • Pre-Connectathon tests should be available approximately Nov. 1. Connectathon tests shortly afterward.
  • John Rhoads noted that IHE developed a course to qualify Connectathon leaders for international Connectathons.

Showcase:

  • Mother/baby

Manny will explore Continua link again. We will need to emphasize Meaningful Use to show devices are important. Manny to solicit volunteers to develop a scenario and coordinate on other scenarios. John Rhoads volunteered. Manny to ask Todd, Sarah, Gary, Lisa Carnahan.

Decisions/Issues:

Action(s):

  • Ask Lisa Spellman to project other, non-US Connectathons, Showcases – which, when. How did the Korean Connectathon and Showcase work out?
8 FDA and PCD
- Khalil
Status/Discussion:

FDA and PCD:

  • Khalil asked if the PCD has a relationship with the FDA.

Decisions/Issues:

Action(s):

  • Manny to ask Joyce and Elliot if this is in place within IHE or can be arranged.

Next Meeting

The next meetings are: A joint PC and TC meeting on October 27, 2010 PCD PC&TC 2010-10-27 Webex

TC November 3, 2010 PCD TC 2010-11-03 Webex

PC meeting November 10, 2010 PCD PC 2010-11-10 Webex

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