PCD PC&TC 2013 April 16 to 19 F2F

PCD Home

Meeting Objectives

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

• Planning Committee: Review, plan and initiate PCD activities; contribute to planning of the HIMSS Interoperability Showcase and other Showcases and events; recruit vendors and users.
• Technical Committee: Review and adopt brief profile proposals; contribute to Connectathon test tools, tests, and procedures.

Location & General Schedule

Meeting Location:

West Health Institute

10350 North Torrey Pines Road, La Jolla, California 92037

Hotel Arrangements

Hotel Name: Hilton Garden Inn San Diego Del Mar

Dates - Preliminary committee schedule:

Monday afternoon, April 15 Pump WG meeting

Tuesday April 16 PCD Planning Committee

Wednesday April 17 morning: Joint PC, TC - Tentative

Wednesday April 17 afternoon through Friday: PCD Technical Committee

Daily Schedule - Placeholder

08:00 - 08:30 Meet at West Health, San Diego, CA

Meeting will start promptly at 08:30 Pacific Time 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

Friday the meetings will end by 15:30

Agenda Suggestions

Please submit suggestions for agenda topics here or through emails to the committee co-chairs.

Roadmap Update

Profile Versioning: PC Action Item 107.

Profile Updates, CPs

- ACM (1 hr)

o Rosetta for alarms, events

o Currently Active (outstanding/aware) alarm inventory

o Alarm State (present, start/end, etc.)

o WCM with ACM

- DEC (1 hr)

o POI Option

o WCM Option (Ken)

- IDCO (Brief Update) (30 min)

- IPEC (90 min)

- MEM Cybersecurity (Apr. 17 morning, 30 min)

- PIV - Todd, Jeff (90 min)

o Include: How is piggyback identified when single or second channel or separate device? Monroe and Richard noted that this problem was exhibited in multiple ways at the Connectathon.

- Rosetta (standards update) - 60 minutes

o Overview - Paul 10 minutes

o Migration of hRosetta 11073-10101a - Paul 20 minutes

o IPEC, PIV Terms - 10101a - Todd

- Discussion of the CPs. TC Action Item (1 hr)

o Communication Link Failures, Recovery; should this be part of the PIV profile? (PC 1 hr discuss should applications be in the TF; TC 1 hr discuss specific technical requirements, testing)

Is this more general (other profiles)?

o Indicator for the clinician: device data is being captured by the EHR

- Should profiles include error codes (e.g., leads off)? How to develop?

- Should recovery, reliability become a profile requirement? (moved from below)

- CPs (1 hr)

Updates on WG Progress:

- Deadlines/Calendar; Profile Development

- MEM/Cyber security - Axel (Webex, see above)

- OMS (Optimized Message Syntax) Ken (60-90 minutes)

- Cycle 8 Work Items, Include Parking Lot (90 min)

o Device Point-of-care Integration (DPI) White Paper

o Discovery and Association (DnA)

o DPI-DR Data Reporting

o Event Communication

o Device Specialization - Physiological Monitor

o Device specialization – Ventilator

- Cycle 8 Potentially Activated Work Items

o Location Services

o Device Management Communication

PID Credibility (Showcase Related) (30 min)

- Relationships with administratives systems outside PCD

- PCIM

Other SDOs, Related Work (30 min)

- Update on Continua - Paul

o Potential Collaboration on Alarms, Other

- AAMI

- FDA UDDI

Testing:

- NIST Update (30 min)

- Communication Link Failure, wireless; can this be done with aluminum foil? (15 min)

- Pre-Connectathon/Connectathon/Showcase – Lessons Learned (see TC Feb. 6) (Monroe, 30 min)

o The lack of test partners. Reference implementations or increased incentives? Simulators? Will certification lead to more rigorous Connectathon testing, will peer to peer testing remain the primary approach?

o Implications for the Profiles:

+ Device ID through the EMR or the device or through the RTLS? Device ID mapping.

- Address concerns about pasting messages into Gazelle.

Integration Statements: PC Action Item 108. (30 min)

AAMI Presentations, Demonstrations (90 min)

- Several Presentations: Axel, Ken

- Demonstrations: Existing Profiles, New Directions (Steve)

o Posters; potentially to include the West Health posters

PC, TC Co-Chairs: Elections (15 min, in early part of each meeting)

PC, TC meeting schedules

- Joint April 24; TC May 1, 22; PC May 15

- Next meetings

- Fall F2F Dates, Location

Existing PC, TC Action Items

Webex

Webex meetings have been set up in anticipation of interest. They will be provided when requested in advance; i.e., the log in information is provided here, and the Webex will be initiated for those portions of the agenda that are of interest. Please let the co-chairs and Manny know of your interest and when you are available. The co-chairs will try to arrange the agenda to permit your remote participation.

Reminders: the IP agreement is in force, and participation counts toward voting rights.

Please note: the log in, password and phone number for each meeting is the same as for our WG meetings. These are not provided here for security reasons (this is a public Wiki page).

Monday afternoon: Pump WG: Meeting Number: 927 321 523

Tuesday morning, April 16: PC: Meeting Number: 928 726 346

Tuesday afternoon, April 16: PC: Meeting Number: 926 724 520

Wednesday morning, April 17: Joint PC, TC: Meeting Number: 926 040 631

Wednesday afternoon, April 17: TC: Meeting Number: 928 145 080

Thursday morning April 18: TC: Meeting Number: 926 131 521

Thursday afternoon April 18: TC: Meeting Number: 926 423 580

Friday morning: TC: Meeting Number: 925 025 664

Friday afternoon: TC: Meeting Number: 922 458 427

Attachments / Materials

Documents related to the meeting when established will be found at ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2013-April-SanDiego-F2F/ unless otherwise noted. Documents are available without a password.

The Roadmap and Calendar are at ftp://ftp.ihe.net/patient_care_devices/roadmap_and_calendar/IHE-PCD_Roadmap_F2F_2013-04-16.xls

PCD Schedule/Deadline Information: http://tinyurl.com/PCD-Publication-Deadlines, Schedule/Deadlines: Patient Care Device and Domain Milestones

PCD PC Action Items PCD Planning Committee Action Items. Significant changes, other than dates, will be in bold.

PCD TC Action Items PCD Technical Committee Action Items. Significant changes, other than dates, will be in bold.

The latest versions of published documents are at http://www.ihe.net/Technical_Framework/index.cfm#pcd. The list of CPs, which may, at any given time, affect a published document is at http://wiki.ihe.net/index.php?title=PCD_CP_grid

Detailed Schedule & Agenda

Tuesday

Date	Hours	Committees	Topics
Tuesday Morning 2013 April 16	08:30 - 12:15	PCD Planning Committee (PC)	08:30 Introduction - Welcome, Introductions, Agenda Review - IP Management Review IHE IP Management Process - Meeting Logistics - Review & Approve PC Agenda - Review & Approve Joint PC/TC meeting April 10 PCD PC&TC 2013-04-10 Webex 9:00 PCD Calendar Review 9:30 Greeting and Welcome from WHI CEO Nick Valeriani 10:15 Break 10:30 - Co-chair elections (15 minutes) - AAMI Demonstrations/Posters (30 minutes) - Integration Statements (30 minutes) 12:15? LUNCH - Glider Port at 12:30?
Tuesday Afternoon 2013 April 16	13:30? - 17:00?	PCD Planning Committee (PC)	13:00 Roadmap Review and Update - Are we on target for Cycle 8? - Potential Cycle 9 work? 3:00 Break 3:15 General Profile Updates (more to come in TC portions) - ACM - DEC, POI, WCM - IDCO - IPEC/PIV - PCIM - RDQ - Rosetta - DPI - MEM Whitepaper - Device Management Communications 4:30 or 5:00 Profile Versioning (30 minutes)

Wednesday

Date	Hours	Committees	Topics
Wednesday Morning 2013-04-17	08:00 - 12:30	Joint PCD Planning and Technical Committees	8:00 IHE IP Management Process 8:05 MEM Cybersecurity (Axel Wirth) 8:45 Roadmap Review and Update wrap-upRoadmap Review and Update wrap-up (Pattillo, Merritt) 9:45 Deployment Committees (Pattillo, Merritt) 10:15 Break 11:00 SDO Coordination - UDDI, AAMI - PC Action Items Meeting Dates - April, May PC, TC Meeting Schedule - Location, Dates of the Fall F2F 12:00? Adjourn PC, Lunch
Wednesday Afternoon 2013-04-17	13:00 - 17:00	PCD Technical Committee (TC) Placeholder	IHE IP Management Process 13:00 TC Welcome and Agenda Review (Garguilo/Rhoads) 13:10 Administrative issues - Review Discussion Summary Joint PC/TC Meeting April 10 PCD PC&TC 2013-04-10 Webex - Location, Dates of the Fall F2F - Elections (take office Sept. 2013) CP practices IHE International - General Board Update (TC issuess? - Cooper) Timetable - PCD Key Dates (Cycle 8) - IHE 2013 Publication Schedule [1] 1:45 CPs (new proposed) Misc Topics - Communcation Link Failures, Recovery; should this be part of TF (or Suplementals - e.g.,PIV profile) - Indicator for the clinician: device data being captured by the EHR - Should profiles include error codes (e.g., leads off)? How to develop? - … - ... 3:15 Break 3:30 Cycle 8 Work Items (including Parking lot and items proposed)(Potential) Active Items - Location Services - Device Management Communication Parking Lot - Device Point-of-care Integration (DPI) White Paper - Discovery and Association (DnA) - DPI-DR Data Reporting - Event Communication - Device Specialization - Physiological Monitor - Device specialization – Ventilator - … UCSD Supercomputer Tour

Thursday

Placeholder

Date	Hours	Committees	Topics
Thursday Morning 2013-04-18	08:30 - 12:30	PCD Technical Committee (TC)	8:30 IHE IP Management Process __ Lunch
Thursday Afternoon 2013-04-18	13:30 - 17:00	PCD Technical Committee (TC)	IHE IP Management Process

Friday

Placeholder

Date	Hours	Committees	Topics
Friday Morning 2013-04-19	08:30 - 12:30	PCD Technical Committee (TC)	IHE IP Management Process
Friday Afternoon 2013-04-19	13:30 - 15:00	PCD Technical Committee (TC)	13:30 Etc.: topic overflow time and Issues arising 14:00 Next actions planning 15:00 Adjourn

Note: Additional evening working sessions may be scheduled as needed.

Note: Time slot TBD: IDCO

Participants

Tuesday, April 16

On Site:

Carlene Anteau (AwarePoint); Todd Cooper (Breakthrough Solutions); Sue-fen Cuti (Care Everywhere (Baxter); Bikram Day (Capsule); Paul Elletson (Smiths Medical); Al Engelbert (B Braun); Barrett Franklin (VA, AAMI representative); Ken Fuchs (Mindray); Emanuel Furst (Improvement Technologies); John Garguilo (NIST); Bob Gold(Philips); Jack Hoffman (B Braun); Tom Kowalczyk (Baxter); Richard Lane (West Health); Jeff McGeath (AOI); Monroe Pattillo (Practical Health Interoperability); Doug Pratt (Siemens); Amnon Ptashek (West Health); John Rhoads (Philips); Jeff Rinda (Hospira); Paul Schluter (GE); Paul Sherman (Sherman Engineering); Greg Staudenmaier (VA); Khalid Zubaidi (CareFusion)

Remote:

Chris Courville (Epic); Steve Merritt (Baystate)

Wednesday, April 17

On Site:

Todd Cooper (Breakthrough Solutions); Sue-fen Cuti (Care Everywhere (Baxter); Bikram Day (Capsule); Michael Ekaireb (WHI); Paul Elletson (Smiths Medical); Al Engelbert (B Braun); Barrett Franklin (VA, AAMI representative); Ken Fuchs (Mindray); Emanuel Furst (Improvement Technologies); John Garguilo (NIST); Bob Gold(Philips); Jack Hoffman (B Braun); Vivek Kamak (WHI); Tom Kowalczyk (Baxter); Richard Lane (West Health); Jeff McGeath (AOI); Monroe Pattillo (Practical Health Interoperability); Doug Pratt (Siemens); Amnon Ptashek (West Health); John Rhoads (Philips); Jeff Rinda (Hospira); Paul Schluter (GE); Paul Sherman (Sherman Engineering); Greg Staudenmaier (VA); Khalid Zubaidi (CareFusion)

Afternoon: Jack Hoffman was not present.

Remote:

Chris Courville (Epic); Afternoon: add Robert Olabode (Epic); Ioana Singureanu (Eversolve);

Thursday, April 18

On Site:

Carlene Anteau (AwarePoint); Todd Cooper (Breakthrough Solutions); Sue-fen Cuti (Care Everywhere (Baxter); Bikram Day (Capsule); Paul Elletson (Smiths Medical); Al Engelbert (B Braun); Sergio Enriquez (West Health); Barrett Franklin (VA, AAMI representative); Ken Fuchs (Mindray); Emanuel Furst (Improvement Technologies); John Garguilo (NIST); Bob Gold(Philips); Jack Hoffman (B Braun); Vivek Kamak (WHI); Tom Kowalczyk (Baxter); Richard Lane (West Health); Jeff McGeath (AOI); Darryl Mellott (West Health); Monroe Pattillo (Practical Health Interoperability); Doug Pratt (Siemens); Amnon Ptashek (West Health); John Rhoads (Philips); Jeff Rinda (Hospira); Paul Schluter (GE); Paul Sherman (Sherman Engineering); Greg Staudenmaier (VA); Khalid Zubaidi (CareFusion)

Remote:

Jan Wittenber (Philips); Michael Faughn (NIST, contractor); Chris Courville (Epic)

Friday, April 19

On Site:

Todd Cooper (Breakthrough Solutions); Sue-fen Cuti (Care Everywhere (Baxter); Paul Elletson (Smiths Medical); Emanuel Furst (Improvement Technologies); John Garguilo (NIST); Bob Gold(Philips); Tom Kowalczyk (Baxter); Richard Lane (West Health); Jeff McGeath (AOI); Monroe Pattillo (Practical Health Interoperability); Doug Pratt (Siemens); Amnon Ptashek (West Health); John Rhoads (Philips); Paul Sherman (Sherman Engineering);

Remote:

Chris Courville (Epic); Jeff Rinda (Hospira);

Discussion

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.

Monday

The Pump WG held a F2F meeting on Monday.

Tuesday

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: - Deferred: Joint Planning and Technical Committee April 10. Decisions/Issues: Action(s):
3	Agenda Items - Standards Coordination	Status/Discussion: PCD F2F Tuesday April 16 2013 Introductions - Those present introduced themselves - Monroe reviewed the agenda for the PC and Joint PC/TC portion of the meetings. - Nick Valeriani¸CEO of West Health Institute welcomed the IHE-PCD members. He previously worked in the medical device area at Johnson and Johnson. He indicated the goal of the WHI is to lower the cost of medical care, able to do so because of the generosity of Mary and Gary West. He noted that 75% of health care cost is attributed to chronic disease and described the overall picture. He added that the organization also addresses the wireless effort of West Tech for communication to better provide care at the appropriate time. The third priority is interoperability to improve care, safety and cost. They estimate that interoperability can save $35 B a year. They are working to mobilize stakeholders, including the government, to further this effort. - Monroe led discussion of the IHE IP policy. Monroe reviewed the PCD calendar in detail and emphasized the short time remaining before publication for public comment. ______ add link _______________archive 2012 - Todd indicated that extending / modifying the the pump constrained value sets in Volume 3 may be addressed through CPs or profile supplements; however, CPs are applied directly and immediately to the TF vs. supplements that go out for public comment and are integrated at the appropriate time. Since a more extended review of these updated value sets is desired, he suggested that a supplement process be used instead of a CP process, inviting external review as well as IHE PCD review. Therefore a supplement will be developed and issued for public comment this summer targeting volume 3 only. The first deadline is May 20 for internal review. Co-Chair Elections: - The co-chairs encouraged members to volunteer. - Steve Merritt (PC) and John Rhoads (TC) terms expire this Fall. Jeff McGeath has volunteered for the TC. Elections will take place in August and they will take office September 1. AAMI Demonstration - Manny summarized the New Directions/Work in Process status, with WG meetings on Fridays¸ and the more general demonstration with WG meetings on Tuesdays. He showed a picture from a past meeting and invited additional participation. He indicated that posters will be updated and new ones added. o The goal of the New Directions portion is to generate momentum for development of device condition and location services messages. - Manny to set up meetings following the AAMI meeting. Integration Statements: - Steve described the need for the IS to be current and accurate. He has two concerns: as a user needing the information and as PCD co-chair. Is the statement up to date (e.g., software version). o He asks that the statement be for a commercially available product. o Todd will seek IHE DCC lS requirements to include mandatory fields; and to address various levels of testing and utilization (e.g., certification). The product registry may lead to a listing of commercially available systems. Manny will update Commercially Available list. Roadmap ftp://ftp.ihe.net/patient_care_devices/roadmap_and_calendar/IHE-PCD_Roadmap_F2F_2013-04-16.xls: review of 2012, updates, extensions (if no change it may not appear here): - HL7 v2.9: Remains, discussed yesterday in the Pump WG F2F. - HL7 v3 (FHIR): Remains in ITI. - Security/Privacy Guidelines, WP: Remains, with update later. - DOF: there has been no interest in testing; remains in Cycle 8. Chris Courville indicated that Epic is working on DOF. Paul noted that DOF will be essential when WCM is implemented. - RDQ: Was ADQ: Extend to Cycle 9. - Smart Alarms: Combining, prioritizing among multiple alarms vs. Derived Alarms vs. Awareness (what is currently active). Smart Alarms extended to Cycle 9. Prioritize? - IPEC: Add support for PCA, Syringe. EC will generalize IPEC beyond pumps. A CP will be written to change the name and add some examples for PCD-10. Todd will develop the CP. - Event Comm (EC): will address general events including what is now IPEC. - In PCD use Events communicate to a system, Alarms to a person, with priorities from low to high (rapid response). Discussion addressed these distinctions and in contrast, the more accurate definition of alarms as a subset of events and the optimum wording. John Rhoads cited 11073 for definition. Paul proposed that Alert (commonly equivalent to Event) include these: IEC Alarm High, Medium, Low Notification Multiple priorities - Alternatively, Advisory could be the fourth priority of high, medium, low, notification. - Decision following extensive discussion: Monroe will write a CP to change the names, etc. of the ACM profile to Alert with the message intended for human response (various priorities) and includes physiological and technical alarms and advisories consistent with 11073. Events (Event Communication, EC) will address messages intended for other systems. Monroe will write the CP following review with clinicians. HL7 2.8: ORU R40 is for unsolicited alerts and observations for timely human or application intervention and may replicate OR1. OBX-8 will provide the distinction between alarm and advisory. - It is an open issue whether ORU 42 in HL7 2.9 will modify the above. ORU R42 is an unsolicited observation message intended to communicate ordinary behavior relevant to clinical workflow and not requiring intervention and does not require response. This will be included in Cycle 8. PCIM: Anticipated implementation and testing in Cycles 8, 9. Pumps: - Auto-programming: Cycle 8. - Pump Multi-component Admixture: Cycle 9. MEM: - Security WP – Axel will provide an update tomorrow. - MEM-DCM, RTLS: Refer to the discussion above related to the AAMI meeting demonstration. Move to Cycle 9. - Joint ITI-PCD WP: Move to parking lot with loss of ITI resources. - Device Configuration Programming: Remove. DPI-Device Point of Care Integration WP: Remains Cycle 8. Device-Device Integration: Removed. DnA, Symmetric Communication: Remains RTM: - RTM-Vent: Cycle 9. Terms moved to 10101a. - RTM-PHD: Cycle 9. Terms moved to 10101a. - RTM-Pump: Cycle 9. Terms moved to 10101a. Device Specializations: - Vent: Cycle 9 or 10. - Pumps: Cycle 8. SNOMED <--> Rosetta Equivalency Mapping: mapping along with indication of accuracy of the mapping. NIST has defined the approach, but there is a lack of resources to conduct the mapping. Continua Coordination: Paul will present update tomorrow. Add unsolicited commands. Cycle 9. Meaningful Use: Cycle 10. Coordination: - Sharp: Cycle 10. - AAMI: Continue to Cycle 9. - VA: POI: Profiled, continuing to Cycle 8. - MDICC: Continues. Quality: - EC 8001: Continue Cycle 8 (Alarm Distribution). - Alarm 60601-1-8: Continue Cycle 8 (Alarm Distribution). Decisions/Issues: Decision following extensive discussion: Monroe will write a CP to change the names, etc. of the ACM profile to Alert with the message intended for human response (various priorities) and includes physiological and technical alarms and advisories consistent with 11073. Events (Event Communication, EC) will address messages intended for other systems. Monroe will write the CP following review with clinicians. HL7 2.8: ORU R40 is for unsolicited alerts and observations for timely human or application intervention and may replicate OR1. OBX-8 will provide the distinction between alarm and advisory. Action(s): Manny to set up RTLS, DMC meetings following the AAMI meeting to capitalize on the marketing accomplished there. Improving Integration Statements: Todd will seek IHE DCC lS requirements to include mandatory fields; and to address various levels of testing and utilization (e.g., certification). The product registry may lead to a listing of commercially available systems. Manny will update Commercially Available list before AAMI. IPEC and EC: Todd will develop a CP to change the name and provide some additional changes to convert IPEC to EC. Monroe will write a CP to change the names, etc. of the ACM profile to Alert Communication Managemenbt with the messages intended for human response (various priorities) to include physiological and technical alarms and advisories (cf alarms) consistent with 11073.
4	___	Status/Discussion: http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_8#Cycle_8_WorkItem_Candidates Decisions/Issues: Action(s):

Wednesday Morning (Joint PC/TC)

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda continued Action(s):
2	IP - Chair	Status/Discussion: - Monroe verified that those present were familiar with IHE policy. Decisions/Issues:: Action(s):
3	Agenda Items -	Status/Discussion: Axel discussed progress on Cybersecurity, noting that it has been slow. An MOU for collaboration with the MDISS is in process, approved by MDISS and in the IHE OPS committee. IHE Board approval is expected in May or June. MDISS collaboration will combine resources, healthcare providers are heavily represented there. - The last slide describes the current scope of the white paper. o will describe best practices. o will provide recommendations for profiles. - see Axel’s PPT presentation for a summary. - John Garguilo noted that NIST has established a National Cybersecurity Center of Excellence (NCCoE). Membership must be completed by mid-May (CSRC.NIST.gov/nccoe). - Action Item: Request Cybersecurity Entry for Roadmap ACM Update: - Monroe provided an update and plans for the WG and PCD. Please see the PPT slides for summary. CPs: - Chris Courville submitted a CP. Manny to create a new folder on ftp site. DEC: - John Rhoads indicated that there are no other issues other than CPs. IDCO: - Update will be provided Friday morning. Paul Schluter noted that they are adding terms for Rosetta. They are planning to participate in the Connectathon in January. Todd asked if they were working on time stamps and Paul responded that they will work on this but it isn’t a high priority for them or for the Heart Rhythm Society. IPEC and PIV: - CPs will be discussed tomorrow afternoon. - New Rosetta terms (e.g., pump terms) will be added to 11073 10101a by Todd and Jeff Rinda. New vent terms and others will be added by Paul Schluter and Jan. The intention is to start a semiannual update process. Versioning: - John Rhoads indicated the need for clear identification for TF and Profiles, noting that IHE has a version for FT TF. PCD’s versioning ties to MSH-21 (OIDS). John Garguilo noted that there is a need for versions in the Integration Statement and testing. o Meaningful Use requires tracking versions. o There is a need to track NIST test tools as well. There are implications for or from Gazelle tests as well. - John Garguilo noted that he has proposed an OID tree. - Michael described his need for versioning. He noted the issues that come up with significant changes. John Rhoads described the difference between FT and TI, where there is a need to avoid break changes with FT, but that TI is by definition not at that stage. Michael suggested there be three levels at the message level. - John Garguilo described the OID tree he developed that addresses the fine points discussed. There are several types of profiles including integration, implementation, conformance. - It is necessary to define MSH-21 in detail and mandated in order to make this and device development manageable. John Garguilo noted that this may help address the Integration Statement issues discussed yesterday. - A repository will be required to maintain a database authority to access the latest version, OID. - John Garguilo noted that Implementation Authoring Documents are under development at NIST and these will be relevant in the long term. Michael and John Garguilo will develop the OID management document. Continua Update Provided by Paul Schluter on Behalf of Continua - Please refer to Paul’s slides for the summary. Some specifics: o Monroe and Paul discussed the inability of SMS to wake up Apple devices. Continua will likely have to support two methods. o PCD-01 will be sent like a document (RESTful transport). o hData is a method of exchanging and organizing health data. UDI update presented by John Rhoads: - Please see John’s slides. Decisions/Issues: Action(s): - Request Cybersecurity Entry for Roadmap - Michael and John Garguilo will develop the OID management document.

Wednesday Afternoon (TC)

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	Planning/Technical Committee Summary April 10 was approved this morning - Chair	Status/Discussion: - Planning/Technical Committee Summary April 10 was approved this morning - The F2F PC Meeting Summary and This Morning's Meeting Summary were approved. Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: John Garguilo referred to the IHE IP Policy. Those present expressed familiarity with the policy. John reviewed the TC agenda, noting accommodations for those participating remotely. John Garguilo presented recognition certificates to John Rhoads, Al Engelbert, Monroe Pattillo, Jeff Rinda, Paul Schluter, Steve Merritt, John Garguilo, Todd Cooper POI: - Ioana and Greg provided the update. - Ioana recommended that parameter units of measure be tightly defined (UCUM). - Discussion followed regarding Rosetta for POI. WG meeting, first with NIST, will be required in the near future to address issues. - CPs will be provided. - Paul Schluter requested that Ioana provide corresponding LOINC and IEEE codes for procedure, etc. as needed so that these relationships are defined for any relevant applications. Ioana agreed to do this and added that value sets should be developed. Paul suggested that the VMD be defined for all Rosetta terms, but these are not tested. CPs: MSH-15, 16: Chris Courville: When the ACK is specified it should be as he requests. At present Chris indicates that he has to hack his system to comply with the currently written document because most DORs don’t have the second port. - John Rhoads offered to research the source of the existing requirement in PCD-01. This will be added to a TC agenda and processed accordingly. Also seek consistency with PCD-03’s use of ACKs. - Manny to add to the CP table, Title: Header ACK. Time Zone: Bob Gold and Monroe: Anytime a time is provided it should be accompanied by Time Zone. They will prepare the CP. IHE Board Update Presented by Todd Cooper (see PPT slides and specifics that follow): New Member Organizations: 10-15 new members / month. Occasionally they indicated interest in PCD. Domain: - Surgery is a provisional domain. - Reports: PCD looks good. - Domain Coordination Committee – little actual coordination - TF: Template has been updated, now will develop repository for version management Deployment Committees (Regional): - Assists local groups meet challenges. - Global Deployment Coordination Committee to facilitate collaboration and consistency internationally including National Extensions. There are existing issues where the region / country has violated fundamental requirements of a profile (e.g., the trigger for ACM) and this new committee is intended to address that as well. - Discussion followed about PCD participation in European and other Connectathons. Issues include requirements for Showcase participation in that region, costs, etc. Paul suggested that virtual participation may be a partial solution. The IHE Strategic Plan is available for download from the IHE.net website: o A new logo is available. - Financial Sustainability WG (IHE International): Will have implications for future budgets. o Some national deployment committess have fees. - Success Stories have been posted on the IHE.net site under User Resources. Companies are encouraged to submit. - Web site relaunch. Conformance Assessment: - Pilot certification project, IHE USA/ICSA Labs. - Certification WG. - Connectathons vs. Projectathons vs. ??? o Phases of Interoperability Testing: Example: A Projectathon is testing for a specific goal/environment. How to develop incremental certification, international recognition, etc.? Coordination: - MDISS MOU - IHE-HL7 Pilot Project for Balloting IHE Profiles through HL7. Decisions/Issues: Action(s): - POI: WG meeting, first with NIST, will be required in the near future to address issues. - POI: CPs will be provided. - POI: Ioana will provide corresponding LOINC and IEEE codes. - Header ACK Submitted by Chris: John Rhoads offered to research the source of the existing requirement in PCD-01. This will be added to a TC agenda and processed accordingly. PCD will seek consistency with PCD-03’s use of ACKs. - Header ACK Manny to add to the CP table. - Time Zone: Bob and Monroe will prepare the CP to require Time Zone when a time stamp is provided.
4	___	Status/Discussion: http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_8#Cycle_8_WorkItem_Candidates Decisions/Issues: Action(s):

Thursday

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	____________ - Chair	Status/Discussion: - Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: UML modeling for PCD led by Jan Wittenber: See his email with detail, slides - One goal: automate portions of development and testing - The model includes remote control of devices and raises questions about ownership (remote and on site clinicians), standards, languages as well as development of the messages. - While state models (FSM) may be available for individual portions, a combined state model will be very complex and require participation of many stakeholders. - Time ran out for this portion of the agenda and will be continued in the PCD WG and at IEEE. Rosetta Update and Migration to IEEE 11073-10101a, led by Paul Schluter: - Of the three main areas, Paul focused on ventilator and gas parameters. - Three main areas: See Paul’s presentation - Paul then described Rosetta terms for ACM and EC Phase Transition Identification: o Time Point Events (e.g., atrial fibrillation start and stop times) o Interval Event (Underlying Alarm Condition may be separate) (e.g., update, escalate and these are not mutually exclusive). - Jan asked about the source of these parameters. Paul indicated they are in 11073 and 60601. :- Jan asked where management lies, e.g., remote access. Paul indicated this is within the purview of the regulated device. He provided the example of IPEC: - Returning to the ACM, EC parameters: o IPEC has start, stop; he suggested the Pump WG consider pause. - Discussion indicates that work remains to accomplish the very clear XML descriptions. o Jan asked about the relationship with PCD-01 with regard to VMD, etc. Paul responded that ACM includes much of the structure of PCD-01. It is device centric. IEEE 11073 and HL7 Test Automation Using Wireshark led by Darryl Mellott: - Wireshark software sniffs the network to track the messages. - West Health developed “dissector” software to strip out the medical data. This is a useful development tool, able to log the data automatically. - This potentially can provide the logged data to the NIST tool and Gazelle. o John Garguilo added that this is part of the peer to peer validation and has implications for multiple device testing. o Paul Schluter noted that this doesn’t address that the receiver understood the received message. - see slides for more detail Afternoon: Availabilty of R+ and R2 led by John Garguilo: - The TC determined that it is not necessary to designate the usages of R+ and R2 but rather to continue to use R and RE as currently defined. Alarm and Events led by Monroe: - Monroe displayed a large table of alarms and events. The table is available for review and then will be converted to XML. He also requested vendors enter their alarm conditions or confirm that they are already present and correct. There is a date on the first column showing when the row was last updated. - There is an indication of whether it is an alarm, alert or event (reclassified as alarm, advisory or event after the CP). - A minimum set of alarms for a given device type will evolve. - ACM will not provide priority for individual alarms, leaving that to the vendor and/or user. - Todd noted that many alarms for pumps will not be at the channel level. - The table is located at _________ . Alarm Inventory (Continued existence of the alarm) - Monroe noted that the AM is only aware of alarms that are coming in; may not retain memory of the incoming stage, but rather the output e.g., in order to determine the need for escalation. ACM Update by Monroe (please see slides for more information): - CP to change ACM from Alarm Communication Management to Alert Communication Management with associated changes. Pump WG Update by Jeff Rinda: - CPs to support extensions to PIV: o CP to support PCA pump programming was moved along and discussion will be continued in two weeks. All possible information necessary for programming by all companies for all modes remains TBD. o For all types of pumps: bolus and loading dose. - Several RTM MDX terms are in process for approval for inclusion in the IEEE 11073. o DS-IP-PCA (Device Specialization Infusion Pump PCA) will be discussed at the Atlanta meeting preparing them for 10101a inclusion. o Liquid and other (including weight based) measures - Communication Status Changes: o Is a new OBX required for time stamp for status change? o The Status Enumeration row will be updated with terms in Rosetta. enter summary Ken's OMS presentation Decisions/Issues: Action(s): Action Item: IPEC CP: Table 1.2.1-3: remove last row to indicate that a separate OBX is not used. Jeff/Todd May 1. Action Item: IPEC CP: Update Status row with Rosetta terms. Jeff/Todd May 1.

Friday

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Placeholder Action(s):
2	____________ - Chair	Status/Discussion: - Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: Loss of Connectivity: Richard led off with the observation that loss of connectivity is a reality and this should be addressed in the profiles as well as in IEEE 11073. John Rhoads noted that IHE documents don’t generally address issues other than the messages. Todd agreed, adding that these issues are addressed in deployment of systems rather than in the technical documents. John Rhoads indicated that this may be the time to address it or to do so in a WP or other document. The advantage is that it would be decoupled and it can be tightly linked. Richard responded that this approach will not assure that all implementers will address the issue. Reconnect may lead to requiring additional messages. Jeff asked how we would know which system lost connectivity and therefore is responsible for recovery. Richard added that there needs to be a way to communicate the loss of connectivity. Discussion continued and included that alarms and alerts clearly need this, that delays and other issues need to be addressed. Darryl suggested that the sending device communicate what it will do with the data that wasn’t sent. - Manny will add the aluminum foil test optional in this cycle. - Paul Sherman suggested that companies with medical telemetry may have experience we can draw on. Monroe added that the sending system may flood the receiver with stored data. - Monroe recommended that the broader issue be brought to the DCC. John Rhoads added that the discussion include reference to risk analysis. Todd indicated that the ITI Security Cookbook is the place where risk management is addressed. There is a clause providing a location to address other than security. He suggested that John Moerke would be a useful resource. He added that a separate section in the TF would be appropriate. Todd and John Rhoads will initiate a discussion with John Moerke at the Atlanta meeting. Data Capture Indicator for the Clinician: - Discussion of the concept. - Barrett provided the Welch Allyn VSM example. - PIV is the only PCD profile that addresses the Accept and Application Acks. - Barrett suggested that the two links (device to middleware to EHR) be separately identified for troubleshooting. - Action Item: Ask the EHR vendors about the current state of affairs. Manny to poll EHR and Interface vendors to learn what is in place. Lab data is likely processed with this in mind. This is not an immediate priority item for solution. Should Profiles Include Error Codes? - John Rhoads noted that 60601 addresses this. - Monroe added that an extensive set for alarms and alerts is desirable. - Another approach is local tables (e.g., PIV). - Paul Schluter suggested that higher priority items would be considered alarms and have MDC codes. He recognizes that this provides two parallel approaches and needs to be considered further. - Action: Refer to Pump WG (Jeff and Todd) to ask o is there a reason to retain the existing codes or to handle other than MSA, as alarms. IDCO Update provided by Stephen Swanson: - He began with a short history. - Details provided in the PPT document and some specifics: o Level of importance: likely to be three levels. o Will be physician determined. - Stephen asked if WCM can be used with trended data. o Paul Schluter responded that trend data can be transmitted with WCM and that there is a way to indicate corrupted data as well. Update on Testing: - Manny provided a summary: o DEC, PIV reviewed so far. Will be extended to POI, WCM as appropriate. Updates to Gazelle will occur later, providing time for CPs, other changes. IDCO may be interested in WCM, making that a higher priority than it has been. o Issues discovered with certification: - Discussion of the implications of more reference to the Use Cases and thus implies some issues with Device Specialization: o Richard expressed the desire to see the tests address use cases, including multiple profiles in a test (cf Showcase Testing, Demonstration) or at least refer to the portion of the Use Case that the specific test applies to. o Discussion of the complexity that will result when multiple partners, profiles are involved. o Potential for issues such as the availability of partners when needed. Decisions/Issues: Action(s): - Loss of Connectivity: Manny will add the aluminum foil test optional in this cycle. - Loss of Connectivity: Monroe recommended that the broader issue be brought to the DCC. John Rhoads added that the discussion include reference to risk analysis. Todd indicated that the ITI Security Cookbook is the place where risk management is addressed. There is a clause providing a location to address other than security. He suggested that John Moerke would be a useful resource. He added that a separate section in the TF would be appropriate. Todd and John Rhoads will initiate a discussion with John Moerke at the Atlanta meeting. - Data Capture Indicator for the Clinician: Ask the EHR vendors about the current state of affairs. Manny to poll EHR and Interface vendors to learn what is in place. Lab data is likely processed with this in mind. This is not an immediate priority item for solution. - Should Profiles Include Error Codes?: Refer to Pump WG (Jeff and Todd) to ask o is there a reason to retain the existing codes or to handle other than MSA, as alarms. - Action: Manny, Paul will add reference to the use cases in the test descriptions, Gazelle. - Action: Richard observed that we don’t test all mandatory items in a profile. West Health is working to automate testing, logging. This will provide multiple benefits. This could be applied to the Virtual Connectathon. Manny noted that the Virtual Connectathon is optional and even the Pre-Connectathon (NIST) testing was on the honor system. John Rhoads added that Virtual Connectathons multiple times a year would be beneficial. He added that traceability to the profile (i.e., this part of the test is based upon this part of the profile). - Research the traceability between the NIST test tool and the TF/Profile. Richard and Bob, in May. - Enhancing Pre-Connectathon Testing: Richard and John Garguilo May 10; various components.

Action Items - PC

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.

Action Items - TC and WGs

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.

Next Meetings

Joint Planning and Technical Committee: PC and TC __ PCD PC&TC 2013-04-24 Webex

Joint PC, TC ______

TC _____

PC _______