PCD PC&TC 2014 October 21-24 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, 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:
Philips Healthcare,
951 Yamato Rd, Boca Raton, FL 33431
Suite 175W
- Note: This is a new location
Meeting room


Dates
Monday October 20 Pump Working Group
Tuesday October 21 Joint PCD Planning and Technical Committees
Wednesday October 22 morning: PCD Planning Committee
Wednesday October 22 afternoon through Friday: PCD Technical Committee
Daily Schedule - Placeholder
08:00 - 08:30 Meet at Philips, Boca Raton, FL
Meeting will start promptly at 08:30 Eastern 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 12:00

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:

78. Stakeholder Survey
140. AAMI Alarm Safety Committee
155 VA/Maximo DMC participation
157 Update cookbook to include ACM implementation
162 PCD vignette for Innovation Center
166 Increase notification of intellectual property policy

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

110. WCM Attributes
118. Implementation Guide
136. WCM Parameter List
140. Assemble the Baseline Set of Standards for Easy Reference
141. Create Matrix Matching Profiles to Standards
150. Seek null flavors in HL7 2.9
157. POI Issues
158. POI CPs
159. POI Rosetta Terms
167. Versioning and Archiving
171. Put list of workgroup leaders on PCD wiki
174. POI code validation
175. Develop a PCD UDI whitepaper for IHE
179. IPEC and EC documentation
182 Configure POI document to required format
183 CP for WCM and implementation
186 Review and reformat ftp site

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 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).

Monday morning: Pump WG: Meeting Number: 926 957 072

Monday afternoon: Pump WG: Meeting Number: 921 969 156

Tuesday morning, October 21: Joint PC, TC: Meeting Number: 924 835 272

Tuesday afternoon, October 21: Joint PC, TC: Meeting Number: 925 568 395

Wednesday morning, October 22: PC: Meeting Number: 926 488 924

Wednesday afternoon, October 22: TC: Meeting Number: 929 868 535

Thursday morning October 23: TC: Meeting Number: 927 914 096

Thursday afternoon October 23: TC: Meeting Number: 925 342 671

Friday morning October 24: TC: Meeting Number: 921 023 597

Attachments / Materials

Documents related to the meeting when established will be found at ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2014-October-Boca Raton/ unless otherwise noted. Documents are available without a password.

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.

Detailed Schedule & Agenda

Monday - Pump Workgroup

Date Hours Committees Topics
Monday Morning

2014-03-31

08:30 - 12:30 Pump workgroup
  • AGENDA TOPICS
  • Pump model - discuss and determine best option for channels and containment
  • IPEC - determine changes needed based on revised pump model
  • 12:30 > Lunch
Monday Afternoon

2014-03-31

13:30 - 17:00 Pump workgroup
  • Continue discussions
  • Review of action items
  • Publish document with all pump terms and codes
  • Summarize changes made to pump profiles since last year
  • Wrap-up


Tuesday October 21, 2014

Date Hours Committees Topics


Tuesday Q1 08:30 - 12:30 Joint PCD Planning and

Technical Committees (PC/TC)

  • 08:30 > IHE IP Management Process
  • 08:35 > Introductions and Agenda Review
  • 0900 > PC and TC Co-Chair Recruiting
  • 09:15 > Update from C4MI (Todd)
1. FHIR Update
2. IHE International Update
- Financial Sustainability
- Strategic Coordination
3. FDA @ IHE PCD Update
Break 10:15 - 10:30 AM
Tuesday Q2 10:30 AM - 12:30 PM Joint PCD Planning and

Technical Committees (PC/TC) (Cont)

  • 10:30 > Continue Update from C4MI
4. HL7 @ IHE Coordination WG
5. FDA UDI @ HL7 V2.8.2 & FHIR
6. New Directions Testing & Showcase
7. Medication Administration Clinical Integration White Paper (PCAI 161)
8 Update CP097 and submit for balloting (TCAI 184)
Lunch 12:30 PM - 1:30 PM
Tuesday Q3 1:30 - 3:00 PM Joint PCD Planning and

Technical Committees (PC/TC)

  • 1:30 > Location, Dates of the PCD 2015 Spring F2F
  • 1:45 > Review IHE Milestones from now until Pre-Connectathon
  • 2:30 > CP to Convert IPEC to EC (Todd) (TC Action Item 170)
  • 2:25 > MSH-5 and Connectathon (TC Action Item 178)
Break 3:00 - 3:15 PM
Tuesday Q4 3:15 - 5:00 PM Joint PCD Planning and

Technical Committees (PC/TC)

  • 3:15 > New remote patient monitoring profile (Brian Reinhold, via Webex)
  • 4:00 > Continue MSH-5 discussion

Adjourn Joint PCD Planning and Technical Committees (PC/TC)

Wednesday October 22, 2014

Quarter Time Lead Agenda Items


Wed Q1 08:30 - 10:15 AM PCD Planning Committee (PC)
  • 08:30 > Introduction
- IHE IP Management Process (5 minutes)
  • 08:45 >
- Review & Approve PC Agenda (10 minutes)
- Review Discussion Summary Last PC Meeting PC October 8, 2014 PCD PC 2014-10-08 Webex
  • 09:00 > Review PCD Calendar and Update
- visionary stuff
  • 09:15 > :* Review Current PCD Program:
- ACM (Monroe P)
- DEC (updated PCD TF) (John R)
- IDCO (Paul Schluter)
- PIV (Al E, Paul E)
- IPEC (Al E)
- EC (John R)
- WCM (Ken F)
- OMS (Ken F)
- RTM (Paul Schluter)
- RDQ (John R)
- DPI (John R)
- PCIM (John R)
- MEM DMC (Monroe P)
- MEM LS (Monroe P)Specializations (statuses, plans only, details during TC sessions):
- DCM Pulse Oximetry Integration Supplement(Completed)
- Pump (Al E, Paul E, Jeff R.)
- Physio monitor (John R)
- Vent (Paul Schluter)
Break 10:15 - 10:30
Wed Q2 10:30 - 12:30 PCD Planning Committee (PC)
  • 10:30 > Cycle 10 Work Items (Monroe P)
- Parking Lot Item Review (Monroe)
  • 11:00 > Standards coordination/Continua - overview (Paul Schluter)
- HIMSS/Continua (Paul Schluter)
  • 11:30 > Restoring PCD-05 to ACM (Monroe)
  • > FTP Site Review (Jeff Mc, Paul Sh) (PCAI 163)
  • 11:45 > White paper on PCIM-DEC series to address unknown/no patient challenges (John R)
  • 12:00 > Meet with Alex to discuss Remote Patient Monitoring and DSB
  • 12:30 > Adjourn Planning Committee
Lunch 12:30 - 1:30
Wed Q3 1:30 - 3:00 PM PCD Technical Committee (TC)
Announcement – Decision Making meeting (TC Co-Chairs)
  • 1:40 > TC Welcome and Agenda Review (Jeff McGeath)
- Incoming TC CoChair (Garguilo term completed 1 Sept 2014)
- Intellectual Property Requirements
  • 1:45 > OBX-4 (John Rhoads)
  • 2:15> Identify unique Identifiers (John G) (TC Action Item 189)
  • 2:45 > Describe HL7 Version Implications (John R, John G)(TC Action Item 143)
Break 3:15 - 3:30 PM
Wed Q4 3:15 - 5:00 PM PCD Technical Committee (TC)
  • 3:30 > FDA UDI and how to integrate into PCD messages (John R/Monroe)
  • 4:00 > PCIM white paper (John R)

Thursday October 23, 2014

Quarter Time Lead Agenda Items
Thursday Q1 08:30 - 9:45 AM PCD Technical Committee (TC)
  • ACM (Monroe)
  • RDQ
  • WCM (Ken F)
  • OMS (Ken F)
  • RTM / RTMMS (Paul Schluter)
  • MEM DMC (Monroe P)
  • MEM LS (Monroe P)
Break 09:45 - 10:00 AM
Thursday Q2 10:00 AM - 12:30 PM PCD Technical Committee (TC)
  • 10:00 > Joint PCD PCC meeting (via Webex)
  • Remote Patient Monitoring Profile
  • 10:45 > Device Observation Semantic Bridge Proposal (Alex Lippitt and PCC via Webex)
  • 11:45 >
  • 12:00 > Connectathon and Showcase Update (Sandy via Webex)
Lunch 12:30 - 1:30 PM
Thursday Q3 1:30 - 3:00 PM PCD Technical Committee (TC)
  • 1:30 > Remote Command Control/Continua (Barry Reinhold)
  • 2:30 > Medical device Cybersecurity project (Axel, via Webex)
Infusion Pump use case (John G and Axel)
Break 3:00 - 3:15 PM
Thursday Q4 3:15 - 5:00 PM PCD Technical Committee (TC)
  • 3:15 >
  • Wiki page Maintenance


Friday October 24, 2014

Quarter Time Lead Agenda Items
Friday Q1 08:30 - 10:15 AM PCD Technical Committee (TC)
Break 10:15 - 10:30 AM
Friday Q2 10:30 - 12:00 PM PCD Technical Committee (TC)
  • 10:30 > F2F Action Item Review (from this week)
  • 12:00 > TC + Meeting Adjournment (McGeath)
Lunch 12:00 - 1:00 Paul Sherman
  • Box Lunch (if sufficient number of participants on site)
Friday Q3 1:00 - 3:00 PM Working Groups
Separate WG Meetings if needed


Note: Additional evening working sessions may be scheduled as needed.
Note: Time slot TBD: IDCO

Webex Support

Webex will likely be available for those who could not attend in person. The links will be provided below. Reminder: the IP agreement is in force, and participation counts toward voting rights.

Participants

Tuesday, October 21

On Site:

Todd Cooper, Bikram Day, Paul Elletson, Kurt Elliason, Al Engelbert, John Garguilo, Bob Gold, Joe Good, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Paul Schluter, Paul Sherman

Remote:

Casey Chester (Iatric), Manny Furst, Brian Reinhold, Tom Kowalczyk, Stan Wiley

Wednesday, October 22

On Site:

Bikram Day, Paul Elletson, Kurt Elliason, Al Engelbert, John Garguilo, Bob Gold, Joe Good, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Paul Schluter, Paul Sherman

Remote:

Chris Courville, Manny Furst, Tom Kowalczyk, Alex Lippitt, Stan Wiley


Thursday, October 23

On Site:

Bikram Day, Paul Elletson, Kurt Elliason, Al Engelbert, John Garguilo, Bob Gold, Joe Good, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Paul Schluter, Paul Sherman

Remote:

Manny Furst, Tom Kowalczyk, Alex Lippitt, Brian Reinhold, Ioana Singureanu, Greg Staudenmaier, Sandy Vance, Stan Wiley,

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

Pump Working Group

Item Topic Discussion
1 Introductions & Agenda Review
- Chair
Status/Discussion:

Decisions/Issues:

Agenda approved Placeholder

Action(s):

2 Discussion Summary or Approval of Minutes
- Chair
Status/Discussion:
- Accepted: Planning Committee November 14 Placeholder


Decisions/Issues:

 : 1. Agenda Review
2. IP Patent Disclosure Notification (https://docs.google.com/presentation/d/1w4rDh1jxBLV2w1RL0nGtmCPvKcYAxWqmIO_H5UqS9g4/edit#slide=id.g10b420c04_3_27)
3. General Status Update
- Recap PCD Infusion Pump informatics activities
@ C4MI, engineer has completed comparison / harmonization efforts between the draft -10101a amendment document, the RTMMS definitions and the last Excel file; is now able to re-create the Excel file ... though it is tedious
RTMMS Tagging now provided - thank you Nicolas!!!
MyDevice ready for use in approx. 3 weeks - C4MI will update with pump model (See 2014 Chicago update files)
- IEEE 11073-10417 (?) Insulin Pump Update
ACTION(Todd) Provide draft doc to IP group (Doug, Jeff)
ACTION(Todd) Provide pump model to IEEE PHD group
Todd described activity to the PCD group; no vendors currently involved have these kinds of devices or consume information from these devices (though "home device" divisions may)
- HL7 FHIR Update
See slides from Chicago 2014-09 update
C4MI continues to drive FHIR for Devices standardization & prototyping; also engaged are Epic and Draeger
FHIR DSTU #1 includes 2 Resources for devices (Device, DeviceObservationReport); subsequent prototyping work, though, has resulted in the deprecation of the DeviceObservationReport, which is now being replaced by additional resources and resource profiles that more closely represent the 11073-based information; this includes support for alert communication
Due to this continued evolution, completion of the IHE PCD FHIR White Paper remains on a back burner
NOTE: HL7 FHIR was a major topic at the ONC 10/15 joint PC/SC meetings in D.C. last week, where there are calls to establish open API standards that many identify HL7 FHIR as providing; with device informatics included, this would be an easy way to get device information into the mix
Question: How to get PCD companies to recognize importance?
- AAMI PCA ICS + AAMI/UL 2800
No current engagement in either of these efforts w.r.t. advancing pump informatics from IHE PCD or IEEE 11073
- C4MI Update @ Infusion Pumps
Supporting supporting PCD pump informatics development & IEEE 10101a update
PIM modules @ PCD transactions
FHIR prototyping @ pump informatics
Will leverage all the pump modeling / terminology components in its medical device interoperability (MDI) campaigns.
1. Finalize Channel / Mode Nomenclature
- ACTION (Todd) Replace RTMMS "Vendor VMD" content with containment using updated "labels"
- Channel Discussion:
What does a consuming system need to see from a pump?
- Medication administration information
Focus is the medication
- Device (infusion pump) information
Device type & configuration
Battery status
Alert status
On / Off Line
- Applications (Use cases) to consider
EMR Charting / Flow Sheet
- Infusate / Medication Delivered to Patient
Infusate / Drug / Amount / Timestamp
Patient / Clinician Initiated Dosing
Order ID
Communication Status (staleness of information)
- NOT:
Device type
Fluid Path (e.g., A or B)
General operational mode programming
Billing
- Start of Container delivery (bag is spiked)
- Order ID
- Future: End of Container (easy @ syringe, not available @ bag)
Rx / Manufacturing
- NOTE: pharmacy monitoring when new container medication is needed
- Order ID
- Remaining VTBI
- Remaining Time
- Communication Status (would need to recognize probability that medication is being delivered, though status reporting is not available)
Infusion Administration / Programming
- NOTE: Nurse @ bedside, includes BCMA system usage
- Order ID
- Programmed Settings
- Infusate source (A or B)
-Mode?
Piggyback
Future: multi-step, ...
- Audit Log (Programming changes @ bedside)
Nurse Workflow / Dashboard
- Charting + ...
- Remaining VTBI / Time
- Current Status (infusing / not infusing)
Alarm Communication
- Charting + ...
- Pump alert condition (e.g., occlusion, Air-in-Line, door open, ...)
- Pump Containment Labeling
NOTE: MDC_DEV_PUMP_
Primary Channel => Primary Infusate Source [MDC_DEV_PUMP_INFUSATE_SOURCE_PRIMARY]
Secondary Chanel => Secondary Infusate Source [ MDC_DEV_PUMP_INFUSATE_SOURCE_SECONDARY]
Clinician Dose Channel => Clinician Dose Info [MDC_DEV_PUMP_CLINICIAN_DOSE_INFO]
Patient Dose ("PCA") Channel => Patient Dose Info [ MDC_DEV_PUMP_PATIENT_DOSE_INFO]
Loading Dose Channel => Loading Dose Info [ MDC_DEV_PUMP_LOADING_DOSE_INFO]
Syringe Channel => Syringe Info [MDC_DEV_PUMP_SYRINGE_INFO]
Delivery Channel => Pump Delivery Info [MDC_DEV_PUMP_DELIVERY_INFO]
New: Intermittent Dose Info [MDC_DEV_PUMP_INTERMITTENT_DOSE_INFO]
- This is defined when it can run concurrently with a Primary or Secondary drug source
- Default programmed delivery mode = multi-dosing
- Need to flesh out more complete parameter set as a separate exercise
- Parameters
@ "Source" Info:
- Programmed Delivery Mode: continuous, ramp-taper, multi-step, multi-dosing
Present in ...
- @ Primary / Secondary = all of the above
Not present in "dose info" constructs
- Program Completion Mode: Stop, KVO, Continue
- Flush Enabled: Yes / No
- Current Delivery Status: inter-dose-stop, Priming, flush, KVO, delivering, delaying, not delivering
KVO is optional after completion of the programmed delivery mode
Priming - All other mode / delivery parameters are out-of-scope
- Program Status: Not Started, Active, Complete
ACTION: Remove from Not Infusing Reason "pump-stopped-ready-no-started", "pump-stopped-delayed-start", "pump-stopped-delivery-complete", "pump-stopped-between-doses" ... review entire list for pump-wide vs. programmatic states
- Source Label => "Primary" "Secondary"
- NOTES:
Can have separate KVO optionality settings + different KVO rates on infusate sources [KVO rate may be same as continuous rate]
On PCA, can go into KVO while delivery limited (by dosing parameters) then pick up basal rate, etc.
"Standby" should be handled by using Not Infusing Reason in Delivery Info
@ Delivery Info
- Active Sources: <see list above, except Syringe & Delivery>
- Multi-Source Mode: Single, Piggyback, Concurrent
- Enabled Sources: <see list above, except Syringe & Delivery>
- Question: Where to locate the Drug Library parameters?
MDC_PUMP_DRUG_LIBRARY_CARE_AREA @ Primary & Secondary Sources + Dose Info
MDC_PUMP_DRUG_LIBRARY_VERSION @ Delivery Info
- Question: Infusion Pumps w/ multiple Channels => VMDs: Separate into different PCD-01?
ACTION: In PCD TF-1 binding to Infusion Pump Specialization, limit one TF-3 / VMD (Delivery + sources) per TF-2/ PCD-01 & PCD-10
NOTE: This limitation cannot be generally applied to device data reporting, and thus is not a constraint for TF-2
For infusion pumps, a future TF-1 infusion pump specialization, will bind a constrained value set (TF-3 Infusion Pump) to transactions (TF-2 / PCD-01 or PCD-10), and constrain for an infusion pump that a transaction should only include pump VMD info for a single device.
- Question: Parameters in PCA dose info
ACTION: Harmonize PCA w/ Primary parameters (duplicate Primary & add in PCA specific); review resulting set with group
2. IPEC - determine changes needed based on revised pump model
- NOTE: No changes to IPEC for NA CAT'15
3. Action Plan
- Summarize changes made to pump profiles since last year
ACTION(C4MI) identify differences between RTMMS IP 1.0 & Excel 1.2 & -10101a Draft; review with team
- Compare Excel 1.2 (latest published) vs. current export vs. NA CAT'14 version (1.1 2014.01.15)
ACTION(IP WG) Use the above to finalize the NA CAT'15 infusion pump data set
-Determine CAT'14 version differences and current RTMMS IHE_PCD_IP_REL_1.0
-Decide what will be used for NA CAT'15 ... targeting Excel spreadsheet ver 1.3
- NA CAT'15 ramifications
Question: Given timing (2014.10) ... should all these modifications be held until after NA CAT'15?
- DECISION: Yes. Given the lateness of these changes, it would be too disruptive for the January changes
- NOTE: These changes only impact testing of IPEC (e.g., calls out Pump Mode Set), not DEC (since there are currently no pump specializations)
IF a pump vendor updates their reporting per the above model, it will still be able to pass the NA CAT'15 tests, but this would be an individual basis
ACTION: Discuss with Garguilo (a) profile versioning support; (b) NA CAT'15 ... will there be an impact related to the above changes (esp. updates to RTMMS)
- Finalizing 11073-10101a Amendment
Finalize definitions & document
- ACTION: Update draft -10101a document per the above changes
- Updating Collateral / Publish document with all pump terms and codes
Migrate to RTMMS
Update Vendor VMD with containment
"Tag" pump parameters / UoM / Enumerations in RTMMS for export as a constrained value set
Create updated Excel spreadsheet
- Updating TF (TBD timing)
TF-3 with new pump section
TF-1 with Infusion Pump Specialization(s) (LVP, PCA, Syringe)
Working Plan
- Next steps (near term) ...
Review & Finalize -10101a content
Review & Finalize NA CAT'15 data set
- Update IPEC per new model


Action(s):

3 Agenda Items
- Standards Coordination
Status/Discussion:



Decisions/Issues:


Action(s):


4 ___ Status/Discussion:

http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_8#Cycle_8_WorkItem_Candidates


Decisions/Issues:

Action(s):


Tuesday

Item Topic Discussion
1 Introductions & Agenda Review
- Chair
Status/Discussion:
Monroe reviewed the IHE IP Management Process
Introductions and Agenda Review
- Monroe – Agenda modified to reflect scheduling with presenters and other groups.

Decisions/Issues:

Agenda approved

Action(s):

2 Discussion Summary or Approval of Minutes
- Chair
Status/Discussion:


Decisions/Issues:

Action(s):

3 Agenda Items
-
Status/Discussion:


PC and TC Co-Chair Recruiting
- If interested contact Jeff, Monroe or Paul Sh
- Todd - Modified term limit requirement to recommendation
Update from C4MI (Todd)
- 1. IHE International Update -
450-500 organizational members
- Financial Sustainability
Clear message from HIMSS and RSNA – not funding in perpetuity. Needs to be self supporting
PCD was asked why not meet with other domains at RSNA, etc. Most PCD members don't attend those meetings, no real financial benefit.
IHE sent out a survey early this year – what activities would the members be able to support?
- Set up membership dues and activity fees.
- Service offerings? Like continuous virtual CN. Not put forth as a revenue model yet.
- Other sustainability models? Not sure – check the poll.
- Members discussed the company looking for certificates - is this a possible revenue stream?
International /New countries
- John G – Questions regarding Colombia CN Is ther any formal process, guidelines, etc? Would like to discuss with Todd.
Discussion - Sponsors must be non-commercial. Usually someone on board helps mentor – not required. Vladimir participates quite a bit. Provide deployment committee reports. Board may have someone work with that country.
- Strategic Coordination
Internally – Board retereat early July. Prioritize what needed done. IHE wide integration strategy, nothing currently exists for multi domain profiles. Tooling and reference designs high priority.
Monroe – concern of repeated work; LS and ACM as examples. Some discussion at DCC about this.
TC - can go back before next reteat and bring this up
- 2 FDA @ IHE PCD Update
Got past ANSI process/standard requirement.
FDA asked for a briefing. Slides provided, will be posted to the ftp site. IHE PCD compliant list impacted FDA.
- 3 PIM (Protocol interoperability Manager) - Supports various protocols (HL7, IHE PCD, IEEE 11073, etc.) Package includes source code, risk analysis, support documentation, etc. Hope to have some deliverables mid 2015. Outlined architecture. Submitted standardization projects to IEEE.
- 4 Conformity Assessment – In final stages of progress for IHE Int'l. Will have a CA by CN2015.
Overview of program. (I gone from recorder 1:19 – 1:22). Companies inconsistent. Described deployment process IHE >certification. Plan to get to the actor level. Trying to get a virtual lab at the Innovation center.
- 5 ONC update
Created JASON task force – recommended open source API, HL7 FIHR, not too positive on IHE. Testimony last week – using IHE, well baked. IHE has filed formal response. Not strong device activity. Met with IPSIDOO – interested in device semantics, IEEE 11073, LOINC, etc. Not main focus. Yesterday's pump meeting talked about My Device.
- 6 Monday Pump meeting Summary
Long list of open issues, dealing with modes and status. Made it through the list: Flushing, priming, intermittent delivery. Have a model most agree on, should scale well. Looked at all receiving mechanisms and addressed them. C4MI engineer comparing with RTMMS – should be able to map and export. Will make sure RTMMS is consistent.
For CN: Will compare 1.3 with 1.1 then decide what to use. How it will affect CN – John G: Shouldn't be a problem, as long as all are aware of it. Who is responsible for drafting text? Todd will. Paul Sc has the codes.
- 7 Olympics Demo – Effort to use IHE there. Large healthcare section there. Use EU-US MOU to work on this. A lot of interest and support. GE is the the healthcare provider for the Olympics. Brazil may be too early, but Korea wants to do this for 2019 Olympics. (Gone until 2:30 on recorder)
- 8 FHIR Update – Todd will provide presentation.
Best opportunity to put device informatics into HL7 V.3 – almost for free.
- 9 FDA UDI @ HL7 V2.8.2 & FHIR
John R and Todd worked hard on it. How can you consistently represent UDI in HL7? Drafted an implementation guidance document. John and Todd created a CP for 2.8.2; could be out next year. Use PRT segment to capture UDI, asked them to include devices. PRT10 updated for UDI and other data (bar code, EUI-64). Could this be used for user defined identifiers? Yes. Suggest providing user guidance on how to implement. Concerns about not requiring information placed in PRT segments. That may be in a UDI implementation guide; some profile specific requirements can be placed in the specific domain guidance. ISO will state who 'owns' a segment; will be more specific as it drills down. Can ask a party which one they own. Can we take this 2.8.2 work and specify it in 2.6? Yes, it's quite common.
- 10 HL7 - IHE Coordination
Working on a financial model that works. Need to coordinate between two groups
Now working on this – Todd is HL7 rep to IHE. Slides will be available. Both recognize need, but execution struggling.
-11 Update CP097 and submit for balloting – OBX-4 (TCAI 184)
Dealing with intermediaries. Much is in TF, but not tested yet. The Tiger Team may address this (not started yet). How do device capabilities get advertised? Paul Sc: prepare a list of needs. Can move OBX-4 topic forward to after Brian Reinhold discussion today.
Location, Dates of the PCD 2015 Spring F2F
- Location - Cleveland doesn't meet our participant's cost model. ECRI is available and willing. Paul and Bikram can check on Portland. C4MI San Diego or DC.
- Dates – Week of April 27.
Review IHE Milestones from now until Pre-Connectathon
- * PCD Key Dates (Cycle 9)
Unable to determine at this time – will depend upon proposals and resources available.
- * IHE 2015 Publication Schedule [2]
Monroe will draft and circulate to Paul Sh and Jeff M, then submit to the committees. Will discuss on co-chair call Oct 28
CP to Convert IPEC to EC (Todd) (TC Action Item 170)
- No current progress. Input from pump group. About to do a major rework of the pump profile. Why go to final text now? Most changes are in content, not structure. Some IPEC items may end up device specializations, eventually obsoleting IPEC. Suggest finalizing IPEC within 1-2 years, then create EC with device specializations. Pump group will work on this and come back with a proposal.
MSH-5 and Connectathon (TC AI 178) (Started recording)
- Receiving application – if MSH 5 blank, receiver can do different things, somewhat randomly. (Back at 14 mins). Should know who it's sending to when one to one. Whatever we decide needs to be in sync with NIST. Conclusion: Test to what's registered in Gazelle. If MSH-5, then receiver can send acknowledgement. Add text to
New remote patient monitoring profile (Brian Reinhold, via Webex)
- Done unofficially at CN, not a recognized profile. Want to make this a ratified profile. Brings info from outside the enterprise to within. Meant to be done in stages. This is basic – patient device measurements into an EHR. Low cost home devices interface with hosting device, which would create message to facility. Use case: Ability to monitor patient outside the hospital.
- Discussion
John R – What would be PCD's initial steps? Not exactly sure. JR - Perhaps a workgroup and some use cases? Outline the sequence for a profile. BR - PHMR not in the standard, he's working on that. Introduce necessary text into TF to outline profile and steps needed. Trying to get it alive as an HL7 document. First stage document – Trial implementation documents the flow and this profile. The implementation exists, but isn't official. DSTU is HL7's Trial Implementation, but if standards work isn't done, it's sunsetted. This happened to this process. Paul Sc - Will need to test CDAR2 document. BR – it may exist. PSc – Use existing parts? Good, but not quite complete. MP – Seems like all the pieces are in place, just need official recognition. Get Personal Health folks to recognize PHMR. PSc – Many of the device pieces are in place, many of the challenges are in PCC and ITI domains. Can start with WAN interface and PCD messages. PCD happy with device to hosting/accumulating system then out to WAN. From there on it would be a different domain. PSc – Use new status as part of HIMSS to discuss with big her vendors. Break into two pieces: Med equip to EHR/WAN then EHR/ to HL7 clinical messages and PHMR. Brian will break this into two parts for thursday call with PCC; PCD and PCC. He'll show the original and separated briefs, and send the PCD one to us. For PCD, it could be the DEC profile with the WAN Option added. Would need a CP to the DEC Profile to enable this. Section 4.2 Vol 1 of PCD TF has the actors and options assume MLLP transport. Just add lines using WSI. Vol 3 talks about remote monitoring use case. Can back translate definitions to match up; then PCC can cross reference to their profile.
- MSH-5 and Connectathon (cont from above)
Reviewed proposed additions to tests. Monroe drafted documents. Epic may have concerns with this. MSH-3 on ACK may be an issue. Need to write the rules in the TF to address this. Can we can go from Conditional to RE? Will need to discuss this with EPIC. Suggest rephrasing as Conditional. Reason: Some were blindly posting MSH-5 messages into MSH-3 as ACKs; if blank, then it would trigger an error. Will put 1st sentence in tests and Gazelle.
Do we need anything in MSH-05 if we do MSH-03 correctly? No. 2nd sentence adds clarity. Send to Showcase and Connectathon Google group. Group outlined new structure

Adjourn Joint PCD Planning and Technical Committees (PC/TC)


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Wednesday Morning

Placeholder

Item Topic Discussion
1 Introductions & Agenda Review
- Chair
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Introductions
Monroe reviewed the IHE IP Management Process
Reviewed & approved PC Agenda (10 minutes)
Reviewed and approved Oct 8 PC Meeting discussion summary
Reviewed PCD Calendar and Update "PCD ftp site [[3]]"
- Added 2016, discussion of FHIR/HL7 V3

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2 ____________
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Status/Discussion:
- Cycle 9 -
MDISS security – a white paper drafted, in review (John R)
DPI, CNS – much work focus on tooling support, device support. Could use updating. CNS on hold (John R).
DEC – PCD01 in final text.
PCD-16 and 15 added this cycle
- No new transactions currently. DMIO
ACM – added Alert Inventory; resend with present indication
RDQ – No activity, many senders don't have ability to store historical data. Those that do haven't dedicated resources to send that data. They have about 72 hours of data, more than that would probably be in the realm of research, not enough interest to support. More harmonized interfaces and a 'past' time stamp could help. SPD query type is archaic re HL7.
Question on calendar – the year is effective the Showcase of that year.
PCIM – progress, preliminary WP draft circulated last week. Discussion this afternoon.
Multi component add mixtures – Can move into general PIV enhancements
PCA/Syringe – Done
Med Admin Management white paper – extended.
RTLS/MEMDMC – Available as TI
DPI – Continues
Device Data Reporting – Continues
Content Management -
- 10101A – Balloting starting Nov 2014 Paul Sc ready to take comments from anyone for ballot group to consider. Coordinating Efforts
- UL2800 – Work in process. Not handled that well, going slowly.
Quality - Smart Alarm TIR coming along – meeting in december (Stan W)
- Add row to Coordination to cover Julian's efforts? No – UL2800 and 11073 efforts cover that. Not a lot of IHE meetings with them lately.
Review Current PCD Program:
- ACM (Monroe P) – In TF, some CPs backlog and a CP for alert list, integrated in TF. Resurrection of PCD-05 as a workflow notification; closing loop on notifications. Looking to be used for lab results notification. Discussions? In acm wg calls. Looking at sample messages – not enough, effort stalled. Continued next cycle.
- DEC (updated PCD TF) (John R) – Updated PCD TF should be published soon
- IDCO (Paul Schluter) – Active defining new terms. Craig Reister and Alexander Krauss running group well. Seeing use in research and production environments
- PIV (Al E, Paul E) – PCA and syringe integrated into TF. Confident it's pretty mature.
- IPEC (Al E) – Spent last year discussing how best to define models. Profile will need dissected and rebuilt for new models. Events won't change substantially, but reporting modes will.
- WCM – Two areas discussion getting terms into 10101a. Units of measure for EHRs; can supply in various units to be compatible. Not seeing overwhelming demand for waveform attributes and signal filters. Should we define in general 11073 or have defined attributes? Not a pressing issue – defer and manage in 10101b. Discuss with Epic, Capsule. Continua at about the same stage. Sampling rate question – integers/second; looks to be manageable.
- OMS – None known, seems dormant
- RTM (Paul Schluter) – Almost all work on vents, working with ISO 19223 for cardiopulmonary devices. About the worst for vendors inventing own terms, FDA is watching closely. RTM group aligning work, causing some delay in 10101A work. In about 3 weeks should have a draft ready. Could be used in 2016 CN. Some discussion of LOINC/SNOMED mapping and proposal.


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Wednesday Afternoon

Placeholder

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Item Topic Discussion
1 Introductions & Agenda Review
- Chair
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Agenda approved

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2 Discussion Summary
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3 Agenda Items
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(gone at 1:26) (back at 1:40)


- RDQ (John R)
- DPI (John R)
- PCIM (John R)
- MEM DMC (Monroe P)
- MEM LS (Monroe P)Specializations (statuses, plans only, details during TC sessions):
- Pulse Oximetry (Ioana S)
- Pump (Al E, Paul E, Jeff R.) - Updates to terminology, new intermittent dose parameter set.
- Physio monitor (John R)
- Vent (Paul Schluter) – terms to be submitted to IEEE. Want to build a vent containment model, how to validate for next steps.
Cycle 10 Work Items (Monroe P) – If you have some get them to Jeff, Monroe or Paul Sh.
Parking Lot Item Review (Monroe) – Explained. Don't see any that are likely to be activated.
Standards coordination/Continua - overview (Paul Schluter) –
- HIMSS/Continua -
Most through WAN interface, uses PCD-01. Some work with cell phone vendors, recent work focused on MQTT, a more useful transport mechanism. PCD-01 remains intact, just carried in MQTT. Starting work on remote control and command, including remote turn-on. MQTT will help with that. Proposal going through ITU ballot process. A lot of alignment between the two standards. Unsure of their FHIR interest. Work started on Alerts, events and remote control. Not much resistance to PCD-01. May want to explore xml in the future.
- UL 2800 -
General goal is a set of standards for testing systems of systems, similar to Julian goldman's ICE model. One model is PCA morphine use and patient vital signs feedback. Drafting general, clinical and ICE standard implementations. Multiple sub groups dependent on others. Pressure from AAMI to have standards in place soon, may not be doable on their schedule. Would they use containment models? Yes
- Restoring PCD-05 to ACM (Monroe)
Intended as closed loop delivery confirmation for escalation if needed. It was extracted to get ACM to FT. Don't need brief proposal, go to detailed proposal. Monroe will put one together and send it around. Meaningful and well intended. Vendors testing? Epic wants to receive but there were no senders.
- White paper on PCIM-DEC series to address unknown/no patient challenges (John R)
There is progress. WP draft sent to PC & TC, looking for feedback and improvements. Some items need to be discussed and identified. Need user point of view. Please have clinicians review if possible. Will walk through it this afternoon at TC session. Good candidate for 2016 New Directions? Yes, maybe even 2015. John will send bullet points to Greg S, he will review and discuss with clinicians in his informatics group.
- ftp site review (Jeff M)
Discussed at spring f2f. John R demo'd some flat files. Great data, but a bit tough to read. Could use a different architecture – but need a good view of what we have. Jeff used FreeMind to show the structure. Suggest moving to an archive structure. Archive most and keep some high use areas at the top. Jeff showed several examples. Could organize by cycle – then by activity. Any changes will affect related wiki pages, would need to update those links as well. Not the only domain dealing with this and someone else will not look at it the same way we do. Wiki does support searches and Google does a good job of finding items (today's search for the parking lot items worked well.).
- Meet with Alex to discuss Remote Patient Monitoring and DSB
(Paul Sc) Concerns about PCD message going directly to LOINC and SNOMED. Need high level of abstraction to ensure vendor independence. This effort, as is, will require substantial resources from PCD and would take away from existing efforts. No EPIC interest in LOINC. Need a clear boundary for this to work.

Adjourn Planning Committee

Begin Technical Committee Meeting

- > IHE IP Management Process
Announcement – Decision Making meeting (TC Co-Chairs)
TC Welcome and Agenda Review (Jeff McGeath)
- Incoming TC CoChair (Garguilo term completed 1 Sept 2014)
OBX-4 (John Rhoads) – Relates to CP 097.
- Concern by EPIC that the channel segment could change. Want assurance that it won't, so they don't need to parse the segment for each message. This CP was clarifying existing OBX-4 behavior. Other parameters will assure unique/stable channel segments. Would be good to have limits for complex commands and control. CLOSE AI 184
Identify unique Identifiers (John G) (TC Action Item 189)
- Do people want EUI-64s validated in Connectathon and Pre-connectathon? If so, NIST needs a table with those values for all participants. TF allows for different options – DNS is acceptable. It would remain static for testing. Would need to write into the test case. Not always used outside of PCD or Connectathon. Makes testing more rigorous. Action needed – NIST maintain a table and add that to the test case (preamble). NIST only checks for A value, not a SPECIFIC value. Participants will need to provide that information to NIST. This will provide traceability for healthcare users. Send a message before the Pre-Connectathon. Similar to patient demographics. It will be a test requirement to provide the fields (to be specified) to NIST. NIST will add the value they have to the fields first.
Describe HL7 Version Implications (John R, John G)(TC Action Item 143)
- Do we continue to take out the parts we need, or move our baseline to 2.8. Many consider 2.3 state of the art. The versions are pretty compatible. If this has been working, then we may not want to change yet, stay with consensus version. Doug P will look for when V2.6 will be obsoleted. Resource: For understanding versions - http://www.ringholm.com/ Action: Continue current practice. Will pull in later feaures when needed, update TF to include reference in data segment and data type. Add to TF vol. 2. Make this a CP (Jeff McG). ACTION ITEM
> FDA UDI and how to integrate into PCD messages (John R/Monroe)
- Took evolved version of UPC to make global trade identifier with 14 more symbols. Called GS1. Medical equipment is a small part of the whole device world. Displayed sample image. FDA has 'Good ID' which lets them look up manufacturer. Some fields don't have fixed digit lenths, though some do. Since century isn't provided, is 2000's implied – yes). Took out OBX18. Group reviewed fields that may have medical device impact. There are other health care barcode standards. Interested in providing more fields in human readable form – Lot numbers, donor source, etc. Sender can provide all the code or portions, the receiver must be ready to take either. Does HL7 make the scope clear? Not really.
> PCIM white paper (John R/Doug P.)
- John - Quick intro. Trying to deal with right patient/right device issue. White paper out, need feedback. Provide for someone to report an association; a patient with device(s). Patient registration not new, will use ITI patient mechanisms. John explained how the process would work. Association Manager could have UI. You need to know the current association and keep eye on beginning and end.
- Doug – Reviewed use cases. DOR-DOC isn't a use case fulfilled by this, but this is the result of this activity. Messaging review – Device reporting observation. OBX-9, 11. Very important to have the fields correct, can affect who is accepts changes.
- Stan – Glossary. First approach, datamined to use what was available and worked. Can't confirm all are accurate, need feedback. Each member of the group sponsored a definition, the group challenged.
- Chris – Effects on the system section: Association Manager or other entititiy evaluates association integrity. No details associated yet. Recommend – Embed capability for a small JPEG photo for identification.
- Discussion – How does this integrate with IHE PCD ecosystem? How to mitigate chances of things going wrong. Discussed where PRT segment goes; can go many places, depending upon content. A collaboration with other groups. If you find an error, you can fix it, but need to fix it with the enterprise system – they do this quite well.


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Thursday

Item Topic Discussion
1 Introductions & Agenda Review
- Chair
Status/Discussion:

Decisions/Issues:

Agenda approved

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2 ____________
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3 Agenda Items
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Status/Discussion:
Jeff reviewed IHE IP Management Process
Review of On-going work
- ACM update (Monroe)-
Alerts and Alerms inventory; Specific inventories challenging, will likely go into next cycle. First time a nurse call will be ACM participant at CN. Which field will be hosting information – In ACM for at least 5 years, just not used.
- CP107 –
Adding web services to Vol 1, section 4.2. Web service not listed, so not a valid CN option. Adding this will enable it. Same actors, option name WS*Reporter, WS*Consumer. Vol 2 Appendix J. Paul Sh will prepare and send for ballot. Similar to WTCP.
- Possible CP to add language to Vol 2 regarding pulling future HL7 version items into PCD work. Profiling section may be a better fit. Some disussion regarding where to best fit this statement. Add superscript number with the referred statement outside the table. 2.2 (Profiling Conventions) seems to be the best place for this. So far, applies to ACM, MEMLS, IPEC; jeff Mc will search for usage.
- WCM – progress on integer/second issue. Chris and Paul Sc will update documentation
- OMS – dormant
- RTMMS –
Goal – Get new terms out to ballot in 3 weeks.
Working on vent terminology. Include Infusion pump terms, should be ready in 3 weeks, infusion technology should drop in without changes. Need to review background/introductory text.
- IEEE 11073 -10101a update – Almost there (Paul Sc -slides).
Updated VMD list. Next big item – camera ready pump terms. Waveform attributes – most defined. Sent earlier draft to RTM group, let him know of any changes. If we take a device specialization process, the work goes faster. Discussion of vent progress and terms.
- MEM DMC (Monroe P) and MEM LS (Monroe P)
New profiles for new actors. Discussion of how LS info is conveyed. MEMLS profile also provides ability to send to LS concentrator. Example – Awarepoint is sender and consumer. Listed a number of MEMDMC items they can send, but vendors using a limited number of them. Will likely end up in 10101b. MDCx – not sanctioned in RTM, MDC0 – awaiting approval. One nurse call vendor interested in tying LS into response to patient calls.
  • 10:00 > Joint PCD PCC meeting (via Webex)
- Remote Patient Monitoring Profile
Intro by Paul Schluter highlighting end to end connectivity plan. This proposal creates the implementation of this plan. Just need a profile to tie this together. New platforms can implement as well. Could migrate some of Continua's work as this moves forward. Many options for getting the message in.
PCC – not entirely clear on technical detail. Don't need high detail to go forward. Home health to EHR.
- Device Observation Semantic Bridge Proposal (Alex Lippitt and PCC via Webex)
Alex – overview with slides. While home care devices has clear mapping, there's no such path for info into LOINC. One struggle is what this falls under. It's broken into 3 sections.

NOTE – ask Alex for slides

- Has IEEE11073 codes been mapped to LOINC? No
- No one to one term mapping. What will be lost in mapping? Different 11073 code depending upon device providing the measurement. LOINC has measurement and device codes. Potential safety issues exist – vent example. Working on submitting 11073-10101a to ISO.

NOTE: USE RECORDING TO FILL IN THE BLANKS (MANY OF THEM)

- Connectathon and Showcase Update (Sandy via Webex)
Showcase – using vignettes again, averaging six vendors per vignette. Sign up ASAP for biggest discount. Reviewed levels of participation. Vignettes worked well – more visibility, easier for attendees. Enhancements – storyboards will have more info. Have graphics match storyline; will need help ahead of time. Looking for a way to have presenters face the audience and still see displays. Good positioning in McCormick Place. Dates April 12-16, planning start in Jan, and work on Feb – March.
Next demo at mHealth Summit in DC. About 8000 attendees. Brings in Continua and home health. In December. Work with Manny and Sandy to participate.
AAMI – AAMI approached IHE to make this an anchor, more like HIMSS demo.
Questions?
- Pricing: Blanket % off for level of participation (International/domestic). She will send prospectus.

Showcase registration deadline extended until Oct 31.

Remote Command Control/Continua (Barry Reinhold)
- Overview of process and capabilities (with slides).
- To be standardized: AHD models, config and interrogation operations, Comms protocol with WAN, security to restrict to authorized users
- Options
1. Use 11073 Object model and protocol.
2. Use 1. and mapping it to lwm2m model – focused on cell environment, can use sms, mapping may be difficult.
3. Use 1 and OMA DM 2x or 1x objects and protocol.
- Questions
PCD doesn't have all those challenges – what do we want to move between 'here and there'.
Challenge will be ensuring accurate delivery/fallback if it fails. Use other protocols.
Tooling update (John G)
- Tools updated for Cycle 9, Pre-Conn starts Nov 4
- IEEE agreement for royalty free use
- Implementation Guide Authoring Tool
- Domain Information Model Editor (DIM) – Automatically producing containment tree, IEEE formatted standard document. Enables building device specilization documents/profiles.
- IHE Japan used Connectathon static tool for CN
- Overview of Pre-Conn tools. MEM tools added.
Medical device cybersecurity project (Axel, via Webex)
- Started with Steve Merrit's white paper. Talked about how to generally mitigate risks. Two years ago started on technical white paper. Ongoing, but closing in, some challenges with day job activities. Now; the team has a deadline of Oct 24. Complex topic, 50 pages, comprehensive; descriptions and solutions. Team core about 6-7 people, new people joined and contributed.
- Axel proposed NDIS and IHE to work together on a consistent message. NDIS wrote patching white paper. Would be good for IHE to supply editing/formatting guidelines ASAP (they are editing tomorrow). John R can provide some info.
- Nat'l Academy of Sciences workshop. FDA released cybersecurity document Oct 1. Workshop last week – very hands on. Many gov't agencies working together, hospitals and vendors sitting at table discussing the issue and solving it. He will publish info soon, will send us a copy.
- Use cases
(Missed 1st)
Infusion pump use case; medical device security problems. Most providers – clinician and user authentication a big problem. Too tight – unable to treat. Too loose – anyone can adjust. John G will forward document to pump members for review/comment. Intent – Guideline documents Groups; local/state government drive this (CRADA), are looking for members. So far a paper exercise.
Encryption of devices at rest and at motion, how to manage and still make devices manageable.
Review of a couple of articles sent by Manny, will send to group
Wiki page Maintenance
- What is most used page in our wiki?
- Priorities for wiki pages?
- Archive all but last 4 meeting pages on meeting wiki. (Paul Sh)
- Profile wikis are not up to date – IHE seems more interested in format than content.
- Moving some items to Google Docs from wikis (Google is phasing it out), existing items may not migrate. Also doesn't work well from in some companies' firewalls.
- Need to have WG leads update Profile pages. (Cochairs)
- OIDs and Transaction numbers page needs updated
- PCD main page needs updated
- Add Wiki page review to cochair agenda items. (Paul Sh)
- CP grid – add a column for current status
TC action items and F2F action items covered next Wednesday
- 3 CPs – Alert list, HL7 v2.6, Brian's remote monitoring
Assemble DCC calendar
Enforce system identifiers.

Technical Committee Adjourned


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Decisions/Issues:

Action(s):


Action Items - PC

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

Submit updated Milestones to IHE (Mary Junger)
Update PCD's long term visionary roadmap calendar

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.

CP 107 - Update TF-1 to include Web Services delivery
Provide instructions reconciling MSH-3 and MSH-5 messages.

Next Meetings

Joint Planning and Technical Committee: PC and TC __ PCD PC&TC 2014-10-29 Webex

TC PCD TC 2014-11-05 Webex

PC PCD PC 2014-11-12 Webex