PCD PC&TC F2F 2019 Oct 15-17 Webex

PCD Home

Please NOTE: Agenda still being edited.

Paul Sherman, PCD TPM

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

Location:

- Boston, MA

Seaport World Trade Center

- One Seaport Lane, Boston, Massachusetts 02210

- Meeting Room: Back Bay 1 (Mezzanine Level)

Rooms available via the Connected Health Conference website [Hotel link]

- Deadline Sept 25.

For those wishing to attend the conference -

- Thom Erickson has arranged registration for on site meeting attendees.

If you haven't signed up for the F2F and want to attend the conference, please do so on our form by COB Oct 11.

Otherwise, you can purchase discounted admission here:

https://www.connectedhealthconf.org/boston/2019/register

Use code 19CHC50 for 50% off.

Dates

Tuesday October 15: Pump Working Group

Wednesday October 16: morning: Joint PCD/PCHA meeting, PCD Planning Committee

Wednesday October 17: afternoon: Joint PCD Planning and Technical Committees

Thursday October 18: PCD Technical Committee

Daily Schedule -

08:00 - 08:30 Meet at Seaport Trade Center, Back Bay 1

Meeting will start promptly at 08:30AM EDT Tuesday and Thursday.

Note: Meeting will start promptly at 08:00AM EDT Wednesday.

08:30 - 10:15 Session #1

10:30 - 12:30 Session #2

12:30 - 13:30 Lunch (Catered on site)

13:30 - 15:15 Session #3

15:30 - 17:00 Session #4

Agenda Suggestions

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

From the PC Action Items PCD Planning Committee Action Items:

168 Execute Stakeholder Survey

From the TC Action Items: PCD Technical Committee Action Items:

196 Add PCD specific values to HL7 table 78

200 MDS and VMD Requirements

201 Pump utilization - publicizing

202 MEMDMC CP to make PID and PV1 segments optional

204 Gazelle and Proxy and NIST Tool improvements

Webex Support

Webex will is available for those who can not attend in person. The links will be provided below.

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 Paul 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 and phone number for each meeting is the same as for our WG meetings. The password is different, and has been included in the email sent to participants. These are not provided here for security reasons (this is a public Wiki page).

The HIMSS Webex page is [HIMSS Webex]

Tuesday morning, Oct 15: Pump WG: Meeting Number: 928 584 535

Tuesday Afternoon, Oct 15: Pump WG: Meeting Number: 923 979 649

Wednesday morning, Oct 16: PC: Meeting Number: 922 817 660

Wednesday afternoon, Oct 16: PC, Joint PC&TC: Meeting Number: 923 832 577

Thursday morning Oct 17: TC: Meeting Number: 928 667 034

Thursday afternoon Oct 17: TC: Meeting Number: 928 667 034

Attachments / Materials

Documents related to the meeting when available will be found at the [ftp site] unless otherwise noted. Documents are available without a password.

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.

Detailed Schedule & Agenda

Tuesday, October 15 (Pump Workgroup)

Date	Hours	Committees	Topics
Tuesday	08:30 - 4:15	Pump workgroup	Morning (08:30-12:00) Introductions - Kurt Agenda review - Kurt IHE IP Management Process - Kurt 8:45 CPs for Channel Relay - 1hr Break (10:15-10:30) CP for TCI - 30 min MEMDMC terms for pumps - 30 min Status update on Multi-step - 30 min Status update on program specific drug library limits - 30 min Lunch (12:00-1:00) Afternoon (1:00-4:00) Pump Terms containment model update - 1hr Use of Systematic names - 1hr Break (3:00-3:15) TBD - 1 hr 4:15 > Meeting Adjournment

Wednesday October 16, 2019

Date	Hours	Committees	Topics
Wednesday Q1	08:00 - 10:00	Joint PCD/PCHA Meeting	08:00 > IHE IP Management Process (Kurt) 08:05 > Introductions and Agenda Review (Kurt and Thom) IHE & PCD Overview (10 minutes) PCHA & Continua Overview (10 minutes) Joint Exploration Committee Overview & Status (20 minutes) (Thom and Todd) - Market Opportunity Analysis - Domain / Subdomain Scoping & Mapping - Test Process & Tooling - MARCOM Vote on Proposal for PCD 2.0 Domain Reorganization - - Rename PCD Domain to "Devices (DEV)" domain - Create (3) DEV Subdomains: Device Point-of-care Interoperability (DPI) - device-to-device Plug-and-play interoperability around bedside Patient Care Devices (PCD) - enterprise integration Personal Connected Health (PCH) - PCHAlliance "Continua" - Create Joint domain-wide coordination committees: Joint Planning Committee, Joint Technical Committee, Domain Coordination Committee Launch Personal Connected Health Subdomain (60 minutes) (PCD and PCH) - Charter - Goals & Objectives - Organization - Work Groups - Roadmap (2019-2020) 10:00 > Adjourn Joint PCD/PCHA Meeting
Break	10:00 - 10:15 AM
Wednesday Q2	10:15 AM - 12:15 PM	PCD Planning Committee (PC)	10:15 > Start PC meeting Introduction - IHE IP Management Process (5 minutes)(Kurt) - Review & Approve PC Agenda (Kurt) "Quiet Hospital" Initiative (30 minutes) - Overview / Update - Approach for QH support in IHE DEV - Roadmap for 2020
Lunch and Exhibit Hall	12:30 PM - 2:00 PM
Wednesday Q3	2:00 - 3:00 PM	PCD Planning Committee (PC)	2:00 > Continue Planning Committee General PCD Work Program Review (statuses, plans only, details during TC sessions): - ACM (Rob W for Monroe P) - MEM DMC (Rob W for Monroe P) - MEM LS (Rob W for Monroe P) - WCM (Paul Schluter) - IDCO (Paul Schluter) - RTM (Paul Schluter) - Vent (Paul Schluter) - PIV (Jeff R) - Pump (Kurt, Jeff R.) - IPEC (Kurt) - RDQ (John R) - Suspended per April F2F. - PCIM (John R) - Physio monitor (John R) - DEC General update PCD TF) (John R) DEC OPTION: FHIR (Todd C) - EC (John R) - DCM Pulse Oximetry Currently waiting for someone to take it to FT. - Review current Action Item: PCD Planning Committee Action Items: 168 Execute Stakeholder Survey 3:00 > Adjourn Planning Committee meeting
Wednesday Q4	3:15 - 5:00 PM	PCD Joint PC/TC	3:15 > Joint PC/TC meeting Introduction - IHE IP Management Process (5 minutes)(Kurt) - Review & Approve Joint PC&TC Agenda (Kurt) Service-oriented Device Point-of-care Interoperability (SDPi) White Paper (30 minutes) - Review PUBLIC COMMENT resolution and "final" draft of white paper - Approve SDPi White Paper for publication - Review Updated Roadmap (from Planning Committee perspective) IHE DEV - DPI Subdomain Launch (Todd) DPI Subdomain Overview SDPi Profile Development (45 minutes) - 2019/2020 Roadmap - Supplement to CAT - TF-1 Supplement - TF-2 Supplement - SDPi & HL7 FHIR (DoF) + V2 "grouped" actors
Wednesday Q5	5:15 - 6:30 PM (if needed)	PCD Joint PC/TC (Continued)	5:15 > Resume Joint PC/TC meeting 6:30 > Adjourn PCD Joint Planning & Technical Committee (PC & TC)

Thursday October 17, 2019

Quarter	Time	Lead	Agenda Items
Thursday Q1	08:30 - 9:45 AM		Connected Health Conference Keynote and Main Stage Activities Continue Joint PC&TC Meeting - IHE IP Management Process (5 minutes)(Kurt) IHE DEV - DPI Subdomain Launch (Cont.)(Todd) TF Organization per Reorganization Plan - How to address a single TF that incorporates DEV general + DPI / PCD / PCH subdomain-specific content - Better use of Word to manage a broader set of developers - Process for TF & profile & testing coordination across domain (from proposing to balloting to publishing to testing) Prepare 2020 IHE Milestones Review 2019 Milestones - [1] Determine 2020 dates POU Supplement - Review & Determination of plan for public comment => TI => CAT testing Survey of device condition and operation messaging (Manny/Paul) Five year plan review All Paul could find is: - 2017 Roadmap - and 2011 Plan Notes Location, Dates of the PCD 2020 Spring F2F Adjourn Joint PC&TC meeting.
Break	09:45 - 10:00 AM
Thursday Q2	10:00 AM - 12:30 PM	PCD Technical Committee (TC)	10:00 > Open PCD Technical Committee (TC) TC Welcome and Agenda Review (Tom Kowalczyk) Announcement – Decision Making meeting (TC Co-Chairs) Proposal Updates - - Sterilizer (Paul) PCD Program review: ACM (Rob W for Monroe P) MEM DMC (Rob W for Monroe P) MEM LS (Rob W for Monroe P) DEC (John R) EC (John R) IPEC (Al E, Jeff R) PIV (Al E) Pump (Al E, Jeff R.) DPI (John R) Physio monitor (John R) PCIM (John R) Vent (Paul Schluter) IDCO (Paul Schluter) RTM (Paul Schluter) Quiet Hospital - Standards Coordination IEEE 11073 SC & PARs & EMBS SC (mobile, IoT, AI/ML) HL7 Devices on FHIR 11:00 > The IHE-PCD Test Tools, IEEE-11073 Nomenclature (-10101), Domain Information Model (-10201), and HL7 message validation – an overview and discussion on NIST’s integration efforts and everything in between. (John Garguilo, Nicolas Crouzier, Michael Faughn) 12:00
Lunch	12:30 - 1:30 PM
Thursday Q3	1:30 - 3:00 PM	PCD Technical Committee (TC)	1:30 > TC Action item review [TC Action items] 196 Add PCD specific values to HL7 table 78 200 MDS and VMD Requirements 201 Pump utilization - publicizing 202 MEMDMC CP to make PID and PV1 segments optional 204 Gazelle and Proxy and NIST Tool improvements 2:15> ACM profile mapping of PCD-04/PCD-07 content into PCD-05 content (Monroe) IHE PCD profile actor keep-alive (Monroe)
Break	3:00 - 3:15 PM
Thursday Q4	3:15 - 5:00 PM	PCD Technical Committee (TC)	SDPi Profile Development (45 minutes)(Todd) - 2019/2020 Roadmap - Supplement to CAT - TF-1 Supplement - TF-2 Supplement - SDPi & HL7 FHIR (DoF) + V2 "grouped" actors > Continued topic discussions F2F Action Review (from this week) PC PC&TC TC > TC Meeting Wrap up and Adjournment (Kowalczyk)
Break	5:00 - 5:15 PM
Thursday Q5	5:15 - !!! PM (If Needed)	PCD Technical Committee (TC)	> TC Meeting Wrap up and Adjournment (Kowalczyk)

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

Note: Time slot TBD: IDCO

Participants

Tuesday, October 15

On Site: Morning: Al Engelbert (BBraun), Brian Witkowski (BBraun), Christophe Fournier (Fresenius), Dan Kernan (Epic), Jeff Rinda (ICU Medical), Ray Kan (Baxter), Tom Kowalczyk (BBraun), Todd Cooper ''

Afternoon: Al Engelbert (BBraun), Brian Witkowski (BBraun), Christophe Fournier (Fresenius), Dan Kernan (Epic), Jeff Rinda (ICU Medical), Paul Schluter (CMI), Ray Kan (Baxter), Tom Kowalczyk (BBraun), Todd Cooper, John Garguilo ''

Remote: "Ali Nakoulima(Cerner), Monroe Pattillo "

Wednesday, October 16

On Site:

Remote:

Thursday, October 17

On Site:

Remote:

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.

Tuesday Pump WG Meeting

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Reviewed IHE IP Management Process Decisions/Issues: Agenda approved Action(s):
2	CPs for Channel Relay and TCI	Status/Discussion: Reviewed content of CP for channel relay - add diagrams to CP and TF - changes based on IPEC supplement, will follow up with John R to incorporate into TF Reviewed content of CP for TCI - changes based on IPEC supplement, will follow up with John R to incorporate into TF
3	MEMDMC terms for pumps	Status/Discussion: - Need to CP profile to clarify from specific to generic. - New event MDCX_EVT_DEVICE_MANAGEMENT replaces other trigger events in existing OBR-4, Trigger events move to an OBX ftp://ftp.ihe.net/Patient_Care_Devices/Devices/InfusionPumps/CommonTerms/New_MEM_terms15OCT19.xlsx
4	Ststus updates	Status/Discussion: Status update on Multi-step CPs have been done for TF, waiting for EMR and pump vendors to implement. Status update on program specific drug library limits tabled for now.
5	Pump Terms/RTMMS	Status/Discussion: Pump Terms containment model update Demonstration of new graphical view Use of Systematic names - Will not use for pump terms. Will make sure we have a revised preamble that takes common terms and has good definition up front. Action(s): See above

Wednesday Joint PCD/PCHA Meeting Summary

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Kurt Elliason reviewed the IHE IP Management Process Introductions and Agenda Review Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: N/A Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: 08:05 > Introductions and Agenda Review (Kurt and Thom) (Slides will be available on the PCD ftp site) IHE & PCD Overview (10 minutes) (Todd) - Todd - 15 years of work. How to ensure cooperation and clear delineation of responsibilities. At the time, most devices were regulated, so was clearer. Went through slides showing PCD process. Described Domains, Deployment Committees and sponsoring organizations. Discussed Plug-a-thons vs. Connectathons and Conformity Assessment. PCHA & Continua Overview (10 minutes) (Thom) - Explained why we’re here. Provided PCHA and Continua difference info; Continua is the engineering side. Provides design Guidelines for manufacturers, etc. Reviewed Implementation Framework. Working to minimize field confusion about who does what and the appearance of conflicting standards. Went over pain points. Reviewed progress to date, determined PCD best landing spot. Will integrate Continua Test Tool into Gazelle. Press release went out yesterday. Reviewed mapping Continua into IHE, fair amount of work to be done. Concern: Many Domains in PCHA could disappear in IHE. This should be discussed and resolved. SDO relationships need to stay well defined. That will be maintained and the relationships emphasized. - Reviewed New Devices Domain and three “subdomains”. Subdomains are new, we may redefine it as needed going forward. Reviewed their foci. Sponsorship overview – new sponsors; OR.net and PCHA. Thom reviewed PCH subdomain. Slides available. Joint Exploration Committee Overview & Status (20 minutes) (Thom and Todd) - Market Opportunity Analysis - Domain / Subdomain Scoping & Mapping - Test Process & Tooling - MARCOM Vote on Proposal for PCD 2.0 Domain Reorganization - - Rename PCD Domain to "Devices (DEV)" domain (Board endorsed) How does this affect naming documents and transactions? - and Create (3) DEV Subdomains: Device Point-of-care Interoperability (DPI) - device-to-device Plug-and-play interoperability around bedside Patient Care Devices (PCD) - enterprise integration Personal Connected Health (PCH) - PCHAlliance "Continua" Vote – Approved unanimously with two abstentions. - Create Joint domain-wide coordination committees: Joint Planning Committee, Joint Technical Committee, Domain Coordination Committee Launch Personal Connected Health Subdomain (60 minutes) (PCD and PCH) - Charter - Goals & Objectives - Organization - Work Groups - Roadmap (2019-2020) Adjourn Joint PCD/PCHA Committee (PC) Decisions/Issues: Voted: Rename PCD Domain to "Devices (DEV)and create (3) DEV Subdomains. - Unanimous approval with two abstentions. Action(s):

Wednesday PC Meeting Summary

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Kurt Elliason reviewed the IHE IP Management Process Introductions and Agenda Review Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: Minutes approved Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: Reviewed current PCD programs - ACM (Rob W for Monroe P) Slides on ftp site PCD 06 and 07 tested? Yes, with multiple participants. 05 has not. Other Domains may need to change how they deliver messages to accommodate these notifications. Concerns for alert/alarm notifications, not really useful for patient safety issues. Has mACM been well tested? Not really, just a couple of data accumulators. No delivery expertise. Can’t really tell how they would use it. Monroe provided mACM background. ACM can add all the capabilities needed easily to PALM and Radiology; the vendors are about 10 years behind us. - MEM DMC (Rob W for Monroe P) Slides on ftp site - MEM LS (Rob W for Monroe P) Slides on ftp site Found ways to implement finding external locations. Teletracking is also involved. Waiting critical mass to bring others on board. It’s getting close - MEM RDC – Slides on ftp site - WCM (Paul Schluter) Pretty stable, promoting its use. - IDCO (Paul Schluter) - Work continuing on, providing new terms. May be close to CN participation. - RTM (Paul Schluter) - Michael Faughn working on it. Paul’s been working on 10101b. 10101r is in IEEE publication. Also working on event and alert terms, collaborating with Stefan. Including about 7000 new terms. May be able to provide medical and technical alert numeric codes, will do it if there is a clear need to do so for Connectathon and Pre-CN. Put event codes in a separate ‘bucket’. Monday discussion at PHD vent meeting. Post meeting comment by Ken “They should at least include some waveforms”. Deeply concerned that they can’t use 90% of existing work. - Vent (Paul Schluter) - PIV (Jeff R) - Two CPs approved earlier this year, will be in - Pump (Al E, Jeff R.) Met yesterday, have two CPs underway, will review them tomorrow - IPEC (Al E) In FT, it can changed in Gazelle as soon as published - RDQ (John R) - Suspended per April 2019 F2F. Can we show it’s suspended? No, nor much need to do so. May have new life in FHIR. - PCIM (John R) Percolating in the background, not much work lately. - Physio monitor (John R) Not much change. Good exemplar in Vol 3. Not much demand yet. - DEC General update PCD TF) (John R) - Well established, very open, easily added to. Some TF additions – Added semantics, no triggering requirement. Good add to MDS attributes following DIM. Have a TC Action Item underway, hope to work on it this year. DEC OPTION: FHIR (Todd C) - Came from Korea CN. They plan on including SDPi. Held the CN at a hospital. Asked to include this in DEC. Asked about difference between FOU and this. Next formal step – PCD Planning Committee approval to go forth. Motion: Start a DEC CP to include an option for HL7 FHIR transport. John Rhoads seconds. Discussion – Another appendix, make sure they are not interoperable. 10 approve, 5 abstain. Passes. - EC (John R) Theoretical except for IPEC. Expresses what it would look at. -Table for future (remove from future agendas. - DCM Pulse Oximetry Currently waiting for someone to take it to FT. - Table for future (remove from future agendas. - Review current Action Item: PCD Planning Committee Action Items: 168 Execute Stakeholder Survey - Manny’s current survey underway and works. Can revisit when MARCOM. Close it. "Quiet Hospital" Initiative (30 minutes) - Overview / Update - Approach for QH support in IHE DEV - Roadmap for 2020 Discussion of Showcase deployment. Likely multiple vignettes, but Phil and Bronwen believe it focusses on one vignette. Alarms will apply across many vignettes anyway. This will be getting ‘ahead of the game’. This work closes the loop, which require work on the device mftcr part. Some regulatory concerns. Will depend on company policies and FDA rulings. The FDA may rule before HIMSS. Todd: In the process, part of a national movement. Many pieces are moving toward it. Can discuss during SPDi session this afternoon. Marketing – Prep a 30 sec or so blurb saying this is on the way. This is a significant part of it – need a multi-vendor group to take this. We need help to prepare it, not getting much yet. Many Showcase vignettes this could apply to. May just need to change the way we talk to them about it. Todd will see if Bronwen is on site, maybe we can meet with her and hammer it out. Since Monroe diagrammed the process, it’s much easier to explain it to others. The pieces are available and being tied together. We need to let clinicians know it’s available. HIMSS is the place to do it. The message needs to come from outside the vendor community (FDA, HIMSS, others). Todd has an HIMSS session approved. Dinner tonight at Trillium Brewing – How many and what time? 10 at 6PM PCD 2.0 (Todd) (45 Minutes) Much detail is in the slides for this session. Reviewed timeline. Don’t need to solve everything today, but we should get this started. Bring both global promotion info together. Specific topics What is a Device? – No regulatory science for Software as a Medical Device (SaMD). Looked at how things changed in the last 15 years, discussed at 11073 meetings. How can we summarize in 1-2 bullet points what we’re trying to achieve? Trying to make our data more accessible? The enterprise piece is well integrated. Need to expand beyond the enterprise, which PCH can address. Subdomains and Governance – How to manage decision making. A lot needs to be addressed. What are the problems? All votes happen at the Domain level, not sub-domain level. Concerns over one sub-domain dominating the overall domain, especially with patient safety awareness or knowledge. Meetings? Meet once a year at least. Different meeting cadences. When to meet next. Single TF or multiple Device use case compendium. Transaction labels. Testing and tooling. Action item Discussion Cochair Action item 106: Activities Promoting PCD Review IHE Milestones IHE 2019 Publication Schedule [2] Adjourn PCD Planning Committee (PC) Decisions/Issues: Action(s):

Wednesday Joint PC&TC Summary

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion:	Decisions/Issues: Introductions Reviewed the IHE IP Management Process Reviewed & approve Agenda (10 minutes) Reviewed and approve PC/TC Meeting discussion summary Reviewed PCD Calendar and Update "PCD ftp site [[3]]" Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion:	Decisions/Issues: Action(s): April 17 PC/TC summary approved
3	Agenda Items -	Status/Discussion:	Placeholder 11:00 > Commence Joint PC&TC meeting Introduction - IHE IP Management Process (5 minutes) 11:05 > - Review & Approve Joint PC & TC Agenda - Review prior PC & TC Meeting Discussion Summary PCD PC&TC 2019-04-17 Webex Todd’s proposal Draft an IHE White Paper that will provide an overview of the SDC standards, the IHE and IHE PCD technical framework architecture and profile specifications, and explore how SDC might be leveraged, including a proposed roadmap for future work. Vote 14 for, 0 against, 0 abstention IHE Int'l Board Listening Session (Todd) Wants to hear what we like and need. Have about 200 steady members. Volunteer recognition program, give Todd feedback. Certification program started 2 weeks ago. Conformity assessment is underway. Link to Certification program IHE Cert Feedback Jeff Rinda – devices not listed in Product registry and had no luck getting it resolved. Value of conformity assessment questionable – Product level certification following ISO process. Customers push for actual implementations, not certification. How well does these systems talk to this other system? Workflow testing, not system testing. Prove to them that you can do it. How is IHE dealing with software changes. NIST: We can do a better job of adding tests. IHE could help by recommending tests. Need a staged process. Vendors don’t bring a complete set of tools to the Connectathon. Have to think about the value proposition for members. What tools can help this process, closing the loop? Note that the original DPI focus was on device-to-device connectivity around a patient in an acute care environment. Integrating device-sourced data at the enterprise level, which is the primary focus of the current IHE TF, is out-of-scope for the SDC standards as illustrated on slide #5 & #8 in the attached presentation "SDC Overview.pdf". "PCD 2.0" - PCD and PCHA working together (Amit, Thom, Michael) (Slides on ftp site) Q – Focus on bringing info in? Can EMRs implement it now. Also have a model to migrate/translate. Q – What devices will be available to map from 11073 to 104? Generally, it doesn’t matter completely what the actual device is. There are some exceptions. They’ve chosen about 6 devices to start with. Want to discuss what profiles fit best in which path. Need to move to a single method that works. Can leverage PCD skills/experience into home/remote care. Concerned FHIR can distract from progress. Working on cell/cloud possibilities. Need to work on regulatory acute care regulations. Discussed low hanging fruit possibilities. Test tools – Documents containment tree. Location, Dates of the PCD 2019 Fall F2F Mayo Clinic, Jacksonville, FL October 15-17, 2019. Adjourn PCD Joint Planning & Technical Committee (PC & TC) Decisions/Issues: Action(s): Draft an IHE White Paper that will provide an overview of the SDC standards, the IHE and IHE PCD technical framework architecture and profile specifications, and explore how SDC might be leveraged, including a proposed roadmap for future work. Continue collaboration between PCD and PCHA, primarily the Task Force meetings.

Thursday TC Meeting Summary

Action(s):

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion:	Decisions/Issues: Agenda approved IHE IP Management Process Announcements – - Decision Making meeting (TC Co-Chairs) Action(s):
2	Discussion Summary - Chair	Status/Discussion:	- Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion:	Placeholder Proposal Update - Silent ICU (John R) Presentation will be on ftp site Reviewed logic and proposal. Discussion – Significant and different effort. Can have a real clinical impact – Joint Commission, etc. SPOK is 100% behind it. We need buy-in. Will take time to implement, but worth it. Our ability to market this is limited. Involving ECRI would help a lot. We have enough vendors to discuss it with the FDA. Explained the difference between silencing and pausing bedside alarming. It’s torture for the patient and their family. Will reduce alarm fatigue. Would need delivery traceabiity. ACM has steered clear of smart alarming. RDC can handle it. Monroe – remote pausing time should match source device. We should focus on ‘pause’, rather than ‘silence’. Need clinical input for this. Develop a working group to focus on it and develop a white paper. Shawn O’Connell (B Braun) – need to review 60601-1-8 (alarms) standard update as well. As a nurse, marketing is not a problem, use nursing organizations to help. Need to fall back on alarming if connectivity is lost. Luis Melendez – Logic and triggering alarm. Ensure alarm/alert is acknowledged (close the loop). This has to address the infrastructure. Paul Schluter – Keep records of all activities and triaging to properly develop. Many permutations deployed, many places won’t have consolidated systems. We should tackle this, but can we? Establish a working group, including clinicians. Next steps? Start the working group, have them identify additional stakeholder. Build a library of existing documents. Members – Rob Wilder (Planning lead), John Rhoads (Tech lead), Monroe, PCD Program review: ACM (Rob W) Presentation on ftp site, includes MEMDMC, MEM LS and MEMRDC MEMLS supports most types of location info, including different types of data and labels. Emphasized need for virtual AC actor (WCTP) for test validation. NIST – should have some resources this year to work on it. MEM DMC (Rob W) MEM LS (Rob W) MEM RDC (Rob W) DEC (John R) Working well, and getting a lot of use. Ongoing challenging becoming one with OBX-4. Need to discuss at a TC meeting. EC (John R) No crying need for a general Profile yet, IPEC is the exemplar. If others develop, they can follow that example. IPEC (Al E) Moving it into Final Text this year PIV (Al E) Covered Tuesday and Wednesday Pump (Al E) Covered Tuesday and Wednesday OMS (Ken F) – No update DPI (John R) Number of long term topics; FHIR, support/tooling, Physio monitor (John R) Further content spec info useful, but not a high priority. PCIM (John R) Need an implementation, fits in with ‘silent hospital’ project. Validated way to ID patient/device relationship. IDCO (Paul Schluter) Looking for 2020 Connectathon testing. RTM (Paul Schluter) Presentation on ftp site. Several groups using terms, sometimes conflicting. Added some new terms. REFID and numeric code are irrevocable; now adding ‘accepted term’, which will go to ballot. Nurse call is possible, but no official participation yet. Discussion that nurse call and beds will escalate. When is 10101b available? Goal – end of September. Pump group needs to work with Michael to come up with terms by September – Can they do that. He will address it during his session. IHE-PCD Test Tools, IEEE-11073 Nomenclature (-10101), Domain Information Model (-10201), and HL7 message validation – an overview and discussion on NIST’s integration efforts and everything in between. (John Garguilo, Nicolas Crouzier, Michael Faughn) Michael – 11073 and… Redesigning RTMMS, looking for input, the earlier the better. Adding a reference site. FHIR – points to a vocabulary service; they need a source and have approached NIST to host/manage it. Showed model in slides. Profile Editor – Almost there, Michael will finish it in 4-5 weeks. Spreadsheets – useful, but not friendly for him. Like a rotary Dial phone. He plans to come up with an API to replace it. Vent (Paul Schluter) Very complete, will be in 10101b. Group not ready to share yet. - Standards Coordination (John R) HL7 FHIR Activities/statement Brian Rheinhold does a LOT of work for us on Devices on FHIR. Point of care devices relies heavily on PCD-01. Good path to add capabilities. Working on others to automate the process more. SMART on FHIR – enables portable devices to access data. What is an alert in FHIR? Have something called ‘Flag’. Had ‘alarm’, but was clinically useless. Working on DEC now, alerts are next. Useless to SPOK right now. PCHA/Continua (Paul Schluter) – addressed already Test tool issue - MEMDMC message failing NIST validation (Monroe) - MEMDMC profile to change via CP to use a message template of ORU_R(TBD) which affords it the ability to make the usage of the PID and PV1 segments as optional for MEMDMC use cases. If PID and/or PV1 segments are present they should be populated per the IHE PCD TF. We did this with ACM, so should be able to do so in MEM. Make a TC Action Item. TC Action item review [TC Action items] 196 Add PCD specific values to HL7 table 78 John will get it in as soon as he can. Review in June 200 MDS and VMD Requirements Related to the OBX-4 question, need to figure out what to do. It is a ‘should’, do we make it a ‘shall’? If so, we need to let implementer know well before Connectathon. Include Lexicographic order. Move out to June meeting. 201 Pump utilization – publicizing Tom has some info. Create a white paper for HIMSS and IHE. Move to June meeting. Sterilization Interoperability (Jad Wafeeq) Instrument Tracking System communication with sterilizer systems is proprietary. Provided a process overview. Many don’t have electronic tracking yet, but it’s getting adopted. Different companies are creating them. Much pressure to develop custom processes. Many players in this, may become more consolidated. Individual or groups of devices? Both, some by RFID or barcode, type usually, but larger systems (endoscopes) are individualizes. Will the UDI effort help this? Not for a while; plus a lot of legacy devices. What do they need to do next? Need use cases and workflows. We know the process to create the messages and profile, the sterilizer group needs to outline the actors and info to communicate. We will use Connectathon/Showcase calls to start the process. Someone in the group will need to Join IHE. Validation tool error related to CWE-23 (Kurt) Jan 22 emails. Per TF, should be in HL7. But it’s not there. Removed during balloting for 2.8 without explanation. Alternate text exists, but were told not to use it. Need to let us use an existing one, or give us a new one. Or edit TF to remove the CWE-23 reference. Foreign languages – need to provide space for a local language. Would need to submit a petition to change V2.8. Alternate Text has definitions that don’t fit our use. Where do we put the other human language text. If we agree that CWE-10 is appropriate then we could use it; it would be IHE compliant, but not HL7. Can we have a 2nd alt text without an Identifier? Create a TC Action Item to work on this Gazelle and Proxy and NIST Tool improvements (Monroe and Paul Sherman) Jan 27 emails. Needs to go to the tooling group, Make it an Action Item. Items not yet addressed: Using HL7 v2.x PL datatype for identifying locations (Dalibor) F2F Action Review (from this week) PC Activities Promoting PCD] Let PCD and AmIt know if you have any ideas on how to promote PCD. Execute Stakeholder Survey Send to Amit. Send a link to Thom. Review at May PC meeting. PC&TC Draft an IHE White Paper that will provide an overview of the SDC standards, the IHE and IHE PCD technical framework architecture and profile specifications, and explore how SDC might be leveraged, including a proposed roadmap for future work. Continue collaboration between PCD and PCHA, primarily the Task Force meetings. TC MEMDMC profile to change via CP to use a message template of ORU_R(as allocated by ONO) which affords it the ability to make the usage of the PID and PV1 segments as optional for MEMDMC use cases. If PID and/or PV1 segments are present they should be populated per the IHE PCD TF. We did this with ACM, so should be able to do so in MEM. Make a TC Action Item Sterilizer messaging – set up time during CN calls to move this forward. Validation tool error related to CWE-23. Make a TC Action Item Gazelle and Proxy and NIST Tool improvements. Make it a TC Action Item. TC Meeting Adjourned Decisions/Issues:

Action Items - PC

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

No new Action Items

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.

MEMDMC profile to change via CP to use a message template of ORU_R(as allocated by ONO) which affords it the ability to make the usage of the PID and PV1 segments as optional for MEMDMC use cases. If PID and/or PV1 segments are present they should be populated per the IHE PCD TF. We did this with ACM, so should be able to do so in MEM.

Validation tool error related to CWE-23.

Gazelle and Proxy and NIST Tool improvements.

Next Meetings

Technical Committee: PCD TC 2019-05-01 Webex

Planning Committee: PCD PC 2019-05-08 Webex

Joint Planning and Technical Committee: PCD PC&TC 2019-05-15 Webex