PCD PC&TC 2012 April 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.


NOTE: Original "Suggested Agenda Items/Topics" was moved further down the wiki page.


Location & General Schedule

Location:
CareFusion
Technology Center – Bld C
6055 Lusk Blvd
San Diego, CA 92121
Meeting room TC-C1-A307/A309


Dates:
April 23 ACM only
April 24 - 25 (noon) PCD Planning Committee
April 25 - 27 (mid-afternoon) PCD Technical Committee
Wednesday morning is joint with Planning & Technical Committees


Daily Schedule
08:00 - 08:30 Meet at CareFusion, 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


Attachments / Materials

Documents related to the meeting when established will be found at ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2012-April-SanDiego/ 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.

Detailed Schedule & Agenda

Monday

Date Hours Committees Topics
Monday

2012.04.23

08:30 - 17:00 ACM Special Meeting
  • 08:30 > Meeting Starts
o Greeting & Introductions (10 minutes)
o Review & Approve Agenda (10 minutes)
o Intellectual Property Policy
o Starting state of reference document: ftp://ftp.ihe.net/Patient_Care_Devices/Profiles/ACM/IHE_PCD_Suppl_Alarm_Communication_Management_ACM_TI_Rev1.3_2012-04-19.doc
-Is an "alarm object" a Profile? (Fuchs)
-Discussion of focus of special session
o What we're here to do
o What we're not here to do
- Cleaning up ACM TI - housekeeping and corrections
o Required profiles - ITI CT
o Related profiles - PCD WCM
o Security common text
o Attribute tables cardinality corrections
o MSH-21 - OIDs or text?
o PCD-04 - ORU_R01 structure or an ORU_R40 structure?
- Getting it ready for eventual inclusion in PCD TF
o To keep PCD-05 or to eject it as was done for AA actor
o If keeping PCD-05 then…
Need to change it from ORA R42 to ORA R41
Need to submit R41 description change to HL7
IPEC WG needs to submit R42 description change to HL7
Aside from default, need to define PCD-05 content filter in PCD-04
- Reevaluation of ACM scope
o In light of EC
o In light of IPEC
- Broaden definition of location to support any location or unit in hospital
o GPS to operator recognizable text
- Make it very clear that cancel does not cancel the alarm at the source
- Multiple OBR segments as multiple alarms per PCD-04 instance
- AR actor provided, operator recognizable message text
o Nurses don't know from MDC codes and references
- Focus on WCTP protocol usage consistency
o Polling and/or push response (POST) for PCD-07
o PCD-07 is a required message, but some PCD-07 response types (PRT-3-2) are optional
Received by AC actor indication is required
One-way devices (pagers, and marquees) or not, if not then the following are required
Delivered/undeliverable to endpoint
Read receipt
Accept/Reject by endpoint
o Version Query response
Need to respond with at least 1.2 to support MCR tuples
o Multiple Choice Response
Tuples, not singlets, so as to abstract responses from response data
- Extending WCTP to support WCM
o Evidentiary data (embedding PCD-04 in PCD-06)
o Graphical snippet for non-medical device AC actors
- Formalization of PCD-06 operator presented message text
- Why is there an HL7 v3 message at the end of the ACM TI document when the ACM profile only supports v2?

Tuesday

Date Hours Committees Topics


Tuesday Morning

2012.04.24

08:30 - 12:30 PCD Planning Committee (PC)
  • 08:30 > Introduction
- Greeting & Introductions (20 minutes)
- Review & Approve PC Agenda (10 minutes)
- IHE IP Management Process (5 minutes)
  • 09:00 > Review Current PCD Program:
- ACM
- WCM
- PCIM
- SpO2 Specialization (Wednesday)
- Pump Specialization
  • 09:30 > Device Management Communication (30 minutes)
  • 10:00 > Cybersecurity Educational Session; Update on Device Management White Paper with ITI (Axel)(60 minutes)
  • 11:00 > Break (15 minutes)
  • 11:15 > Integration Statement update (15 minutes)
  • 11:30 > Brainstorm Cycle 8 Work Item Ideas (30 minutes)
- Profile Supplements
- White Papers
  • 12:00 > ADQ Requirements (30 minutes)
  • 12:30 LUNCH
Tuesday Afternoon

2012-04-25

13:30 - 17:00 PCD Planning Committee (PC)
  • 13:30 > PCD Marketing & Funding (30 minutes)
- PCD 101
- Education opportunities
- What information are we missing to educate providers?
- MDFire collaboration
  • 14:00 > Interop Showcase 2013 Planning (15 minutes)
  • 14:15 > Update on FDA MDICC activities (30 minutes)
  • 14:45 > Review current Action Items (30 minutes)
  • 15:15 > Break (15 minutes)
  • 15:30 > Continue review of current Action Items (30 minutes)
  • 16:00 > Overflow discussions (60 minutes)
  • 17:00 > Adjourn

Joint PC and TC Meeting, May 9, 2012 PCD PC&TC 2012-05-09 Webex

TC May 16, 2012 PCD TC 2012-05-16 Webex

PC May 23, 2012 PCD PC 2012-05-23 Webex

Wednesday

Date Hours Committees Topics


Wednesday Morning

2012-04-25

08:30 - 12:30 Joint PCD Planning and Technical Committees
  • 08:30 > IHE IP Management Process
  • 08:35 > Introductions and Agenda Review
  • 08:45 > Recap Tuesday highlights
  • > Report on IHE International Board
  • > Reports on National / Regional Deployment Committee Activities (esp. PCD related)
  • 09:00 > Review and update Roadmap
  • 09:45 > Review and update PCD Schedule Wiki
  • 10:15 > Break
  • 10:30 > SpO2 Specialization (VA) (30 minutes)
  • 11:00 > Wrap-up Planning/Technical Committee joint meeting
- Location, Dates of the Fall F2F
- Elections
- Other Business
- May PC, TC Meeting Schedule
  • 12:15 > Adjourn Planning Committee
  • 12:30 > LUNCH
Wednesday Afternoon

2012-04-25

13:30 - 17:00 PCD Technical Committee (TC)
  • Location, Dates of the Fall F2F
  • Elections
  • CP practices
  • Pre-set/agreed "notification list"? to external (Q posed by Rinda)
  • Timetable
  • 14:00 Review of ongoing work
  • PCIM
  • ADQ
  • Pulse Oximetry
  • WCM
  • MEM Whitepaper
  • Device Management Communications

Joint PC and TC Meeting, May 9, 2012 PCD PC&TC 2012-05-09 Webex

TC May 16, 2012 PCD TC 2012-05-16 Webex

PC May 23, 2012 PCD PC 2012-05-23 Webex

Thursday

Date Hours Committees Topics
Thursday Morning

2012-04-26

08:30 - 12:30 PCD Technical Committee (TC)
  • Technical Framework Architecture (Cooper)
  • TF Modeling - general - WORK IN PROGRESS!
  • Conformance Testing (Garguilo)
  • Modeling (incl. levels: message vs. interaction vs. transaction)
  • Transaction versioning support
  • (in process) HL7 R/RE/O conformance criteria specification (from reporter & consumer perspectives)
  • NIST Tooling Support for Device Specializations - (Cooper/Martinez)
  • Conformance and nomenclature tooling (Garguilo)
  • RTMMS Application Status and Process Overview (Garguilo) / Martinez)
  • Rosetta Update (Garguilo/Martinez)
  • RTMMS Demo and discussion (Martinez)
  • ICSGenerator Update (Sandra Martinez)
  • 10:00 Break
  • 10:15 Device Specialization Supplements Review (Cooper)
  • IPEC - CP to add note re. planned partitioning to Foundational & Specialized components
  • PIV (Cooper + Pump WG)
  • Issues with PIV in TF FT?
  • CP to add note re. planned support in pump DS profiles
  • DS - General Content Module Supplement
  • DS - Infusion Pump Content Module Supplement
  • DS - IP - LVP Profile Supplement
  • DS - IP - SYR (syringe) Profile Supplement
  • DS - IP - PCA Profile Supplement
  • Schedule & distribution channels for Public Comment Supplement publication
  • Device Specialization Profile Testing @ Connectathons (Cooper/Rinda from Pump Summit)
  • Actors + Transactions + Content: Binding it all together!
  • How are they bundled? Standalone / Grouped / Fused ...
  • Device Specialization Profiles: Options vs. Core Capabilities
  • Multi-Component Add-mixture Support (e.g., in PCD-03)
  • 12:30 Lunch
Thursday Afternoon

2011-04-26

13:30 - 17:00 PCD Technical Committee (TC)
  • 13:30 Technical Framework Change Proposals
  • General proposed CP list review
  • Prioritized discussions of specific CPs
  • 15:30 ACM (Patillo)
  • Report Out from Monday session
  • Review remaining issues + resolutions

Friday

Date Hours Committees Topics


Friday Morning

2011-04-27

08:30 - 12:30 PCD Technical Committee (TC)
  • Rosetta Status update (Schluter)
  • Rosetta for Alarms and Events - General Discussion(Schluter)
Friday Afternoon

2012-04-27

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

Webex Support

Webex was available for those who could not attend in person. The links that were below were removed because they are no longer needed. The following reminder was originally present. Reminder: the IP agreement is in force, and participation counts toward voting rights.

Suggested Agenda Items/Topics

Agenda Suggestions for the Alarm Communication Management WG F2F:

- Infusion Events and Alarms
- NIBP Complete Set (Paul)
- ECG Pattern and Numberic Limit Examples (Paul)
- Prototype hRTM with event names, properties and content models that would lead to complete list for NIST test tooling
- ACM Harmonization with IPEC
- Review the ACM TI Version in Detail
- Consider further alignment of ACM and IPEC Events
- See agenda below for the adopted agenda

Agenda Suggestions for the Planning Committee Received in Advance:

- IP Notice
- Integration Statement Maturity Index.
- Device Management Profile
- Device Management White Paper with ITI
- FDA/MDICC (Medical Device Interoperability Coordinating Council)
- Cybersecurity (education session)
- Roadmap
o Cycle 8 Brainstorming
- MD Fire
- Review of PCD documents (including guidance doc)
- ADQ Clinical Requirements
- Location, Dates of the Fall F2F
- Elections
- Action Items

Agenda Suggestions for the Technical Committee Received in Advance:

- IP Notice
- Location, Dates of the Fall F2F
- Timetable
- Volume 3 Review and Comment Resolution
- Review and clean up existing documents (1 day)
- Architecture
- Rosetta for Events
- RTMMS Overview
- Pulse Oximetry
- WCM Review and Update
- PCIM
- ADQ
- PIV/IPEC
- ACM
- Device Management Profile
- IDCO
- The Grand Unified OID scheme (Garguilo)
- Allow risk anlysis to support delayed association of patient ID to PCD-01 data?
- Administrative issues
-Make it a practice when preparing to send out a CP or publication for comment to list organizations outside of IHE who should be notified (from Jeff Rinda)
- Elections
- Action Items

Participants

Monday, April 23

On Site: Jim Beggs (West Wireless), Todd Cooper, Paul Elletson, Ken Fuchs, Manny Furst, Vivek Kamath (West Wireless), Sandra Martinez, Monroe Pattillo, Doug Pratt (Siemens), John Rhoads, Paul Schluter, Khalid Zubaidi

Remote: Jon Blasingame, Jeff Price (West Wireless), Richard Swim, John Zaleski

Tuesday, April 24

On Site: Todd Cooper, Paul Elletson, Al Engelbert, Ken Fuchs, Manny Furst, Aaron Goldmuntz (Western Wireless), Jack Hoffman, Sandra Martinez, Jeff McGeath, Gary Myers, Monroe Pattillo, Doug Pratt, Amnon Ptashek (West Wireless), John Rhoads, Jeff Rinda, Paul Schluter, Erin Sparnon, Greg Staudenmaier, Khalid Zubaidi

Remote: Steve Merritt, Larry Schwartz (Smiths Medical), Axel Wirth, John Zaleski

Wednesday, April 25

On Site: Jim Beggs, Todd Cooper, Paul Elletson, Al Engelbert, Ken Fuchs, Manny Furst, Jack Hoffman, Vivek Kamath, Sandra Martinez, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Brian Smith (Western Wireless), Erin Sparnon, Greg Staudenmaier, Khalid Zubaidi

Remote (morning, PC & TC): Jon Blasingame, Steve Merritt,

Remote (afternoon, TC): Jon Blasingame, Robert Flanders, Steve Merritt, Serafina Versaggi

Thursday, April 26

On Site: Todd Cooper, Paul Elletson, Al Engelbert, Ken Fuchs, Manny Furst, Vivek Kamath, Sandra Martinez, Jeff McGeath, Gary Mills, Gary Myers, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Brian Smith, Erin Sparnon, Khalid Zubaidi

Remote: Robert Flanders, John Garguilo, Steve Merritt

Friday, April 27

On Site: Jim Beggs, Todd Cooper, Paul Elletson, Al Engelbert, Manny Furst, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Brian Smith, Khalid Zubaidi

Remote: Robert Flanders, John Garguilo, Jeff Rinda,

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 April 23

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

Participants introduced themselves.

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

___ summarized the IP policy and displayed the Wiki page. All present represented IHE member organizations. Discussion followed about the obligations of participants who are required to notify IHE if the work in process may be impacted by a patent.

It was decided to move PCD-04, PCD-06 and PCD-07 to Final Text as quickly as possible.

- To be encapsulated as a Change Proposal to the current Final Text Technical Framework
- PCD-05 to be archived for future inclusion
- The Alarm semantics will ultimately be moved to Volume 3. In the short term the semantics will be left as is and transferred to Final Text.
- Volume 1 content will be handled by K. Fuchs. Volume 2 will be handled by J. Rhoads. M. Pattillo to provide updated text ASAP.
- Order Filler Number (OBR-3) to be used as unique alarm identification. Message Control ID (MSH-10) will not be used.
- Discussion of alarm end to end traceability
o MSH-10 is a transport instance identifier, not an alarm identifier
o OBR-3 is an instance alarm phase or status notification identifier
o Need an overall parent identifier to the alarm that is presented in a different field for clarity
o Two alternatives were identified and are to be proposed to HL7 representative:
> OBR-29 as alarm ID, and OBR-3 as the individual OBR within the alarm
> OBR-52 as alarm ID, and OBR-51 as the individual OBR within the alarm
> An alarm is same patient, same device, but left outstanding is if a second device, performing CDS, injects an alarm cancel for an active alarm from a different device
> Sequencing is an item left outstanding but is needed if it is required to confirm either
> You received everything
> You didn’t miss anything
- Decision that PCD-04 can only include a single alarm, however may have multiple OBRs of other types for future compatibility. (see next item…)
- Discussion concerning how we would include alarm display order. Initial resolution is to create a new OBR for alarm display list, and an OBX with a list of Order Filler Numbers in priority order. To be captured as an Issue in the supplement, not to be included in Final Text.
- References to WCM in the ACM profile will be removed and not included in the Final Text. Hints will be left in the document so that implementers can understand how WCM will be integrated in the future.
- Intelligence for the graphical UI resides between the AM and AC. Decision is that the AM will offer as an option the ability to pass the evidentiary to those AC vendors that have no issue with being a regulated medical device and a second option for the ability to format the evidentiary data into a graphical object to pass to the AC in support of those AC vendors that do not wish to be regulated medical devices. The FDA’s guidelines on medical device applications on mobile devices contains specific text associated with products that take ECG data and display images from it.
- Delete references to MEM since it is not a profile.
- AR will pass human readable text in CWE data type component Original Text to identify the alarm. This will be in the OBX instance that contains the MDC code for the alarm (MDC_EVT_...) The OBX data type (OBX-2) will be changed from ST to CWE and OBX-5.9 will contain the text. The text is to identify the alarming condition and not to include any parameters associated with the alarm.
o Need to capture these in examples: Infusion pump event (occlusion), high heart rate (e.g. HR 130 > 120), Bradycardia, …
- Provide guidelines but not requirements concerning how to display the information to form the message text content of the PCD-06 WCTP message and to identify the distinction between the verbose message text used in validation testing versus the more terse message text used in deployments.
- Resolved that OBR-4 will contain the type of OBX information to follow such as: ALARM, WAVEFORM, EVENT, PROCEDURE, TREND, etc.
o This is so that the package of alarm OBR + OBX array can be modularized and used in other profiles as a message content module similar to what is being done for WCM
o Need to generate MDC codes for these…
o This is a change from what AR actors do today where OBR-4 contains vendor or device ID
- Discussion about external standards groups and their impact to ACM profile
o IEC 60601-1-8 Distributed Alarm System (DAS)
o ISO 80001-2-5or6 Trusted Distributed Alarm System (TDAS)
o Trusted being defined as including safety, effectiveness, and security
- Need proper MDC codes for ACM OBX-3 values
o EVENT_PHASE
o ALARM_STATE
o Etc.
- MSH-21 is to contain OIDs
- Continua has interest in PCD-04 over WAN similar to their use of PCD-01 over WAN
- As an optional attribute to the Alarm data structure you should have an OBX for GPS Coordinates or other location description of the equipment, person other than the patient or the patient
o IntelligentInSites is an RTLS vendor that utilizes HL7 to send RTLS data

Decisions/Issues:

Action(s):


Tuesday Morning April 24

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

Participants introduced themselves.

Decisions/Issues: Agenda approved with addition of the discussion summary of previous meeting.

Action(s):

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

Decisions/Issues: Discussion Summary of previous meeting PCD PC 2012-04-11 Webex was accepted


Action(s):

3 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

- Ken reviewed the IHE IP/Patent Disclosure Policy. All present represented IHE member organizations. Discussion followed about the obligations of participants who are required to notify IHE if the work in process may be impacted by a patent.

Current Profile Status:

- ACM: Monroe summarized yesterday’s accomplishments referring to the summary of the meeting.
- WCM: Ken summarized the progress made, indicating that detailed description will be provided later this week in the TC meeting. TF volume 3 will contain most of the documentation. Several companies are interested; whether resources will be available for this cycle is a question. Recruiting AC vendors will be an obstacle. The two objectives: complete the document and request NIST to provide the Isolated Test Tool which will encourage participation. Monroe noted that obstacles to AC participation include the HIMSS costs and potential FDA regulation. Monroe suggested that providing the graphics (WCM) to the phone systems will remove that concern. Perhaps there’s a way to utilize the AC booths on the vendor floor or find another way. The solution may be to extend PCD-04 to include graphical or evidentiary data which will remove all but MDDS concerns (no alteration of the data).
- PCIM: John Rhoads indicated good progress has been made, but that meeting the deadline is challenging. The PCIM discussion will take place in the TC meeting Wed. afternoon.
- Pump Specialization: Todd summarized the accomplishments, noting that three days of work in the Pump Summit brought significant achievements. The detailed RTMMS and ICS Generator work should make it possible to meet the deadlines for CP submission and testing in this cycle. PIV will remain. With this backward compatibility and experience, this will establish the approach for other device specializations. E.g., for large volume pumps, this can be thought of as “repackaging”, and data sets for syringe and PCA pumps will be available. Jeff asked if Connectathon testing will be for the specialization or for the Profile parts. Todd explained that Connectathon registration will be for the Device Specialization Profile and for the individual profile. Jeff asked if the result will extend the testing time at the Connectathon. Reliance on NIST tools should minimize time. The other aspect is recruiting sufficient numbers of participants for testing.

Cybersecurity:

- Addressing the Challenges with Medical Device Cybersecurity – the presentation was recorded. It was originally presented at the 22nd Annual AAMI/FDA Conference on Medical Device Standards and Regulation. He delivered the presentation from his cell phone and there are portions where the graphics are unavailable.
- Axel noted the increased risk and various reasons for it.
- The recording is available at ___________

ADQ:

- John Zaleski summarized the current version of the profile.
- John described the evolution to permit query for numeric, alarm and waveform data.
- Todd asked how ADQ will handle large volumes of data. John responded that there may need to be constraints on the size – which should be reasonable given the purpose of this query. His greatest concern is the size of waveform files. He emphasized the need for this transaction to meet contextual clinical applications. Ken noted that queries are limited to a single patient, helping limit file size.
- The ADQ document, in a limited version, should be available for Cycle 7 testing in January.
- The document is available at _____________ .

MEM DMC:

- Steve Merritt indicated that there are difficulties getting vendor participation.
- The WG is developing marketing materials to obtain customer support.
- Infusion pump vendors are interested in sending device condition.
- Greg indicated his and Ioana’s interest in the effort and are desirous of having CE participation.
- A TI version will not be available in Cycle 7.
- Manny will ask Chris Dinegar for the ability to meet with exhibitors during the annual meeting.

Integration Statements:

- Ken reported that PCD cannot alter the Integration Statement form.
- Issues: you need not participate in a Connectathon, you can pass and not need to test again when the profiles have changed, and there is inadequate information. Modification will require a letter to the IHE Board, will be sent by Ken to the DCC and Marketing Committee (MARCOM).

Recruiting:

- Ken indicated another company entering the integration sandbox. Manny will invite their participation.


Decisions/Issues:

Action(s):


Tuesday Afternoon April 24

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

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

Discussed in the morning.

Brainstorming Cycle 8:

- Profiles:
o ADQ
o DPI
o DMC
o PCIM continued
o Device Specializations (e.g., ventilators, anesthesia, pulse ox)
o Really Consistent Time
o Collaboration with Pharmacy Domain depending upon outcome of the WP in Cycle 7
o Collaboration with ITI on Medical Device Cybersecurity
- Recruiting
o PCD needs additional committed participants to help move work forward
o PCD also needs those who will implement IHE profiles
o Needs: more visibility, more EHRs¸ more detail about how to implement a profile,
> the User Handbook should help, needs additional profiles/applications to be useful
> the VA is moving toward standardization and will help in this way
> companies’ marketing and sales forces can promote – and the handbook can also provide template responses that vendors can use to indicate that they conform and this can include reference to Connectathon success
> MDFire is available to help users determine their needs (version 1.7, March) has reference to IHE, PCD. There are some concerns about the reference. Steve will follow up with Dr. Goldman, including a note that PCD has included reference to MDFire in the handbook Wiki page for inclusion in the next version. Greg suggested including Sue Whitehead in the message.
> Steve recommended that we find two reference sites for each profile; Erin suggested that detail about benefits and effort/costs required to install
> Aaron requested that the Interoperability Coordinating Council seek to quantify the benefits

PCD 101:

- Erin presented the work underway and the slides indicate progress to date.

FDA MDICC:

- Ken reviewed the effort. They have several groups, including landscape (survey of what standards are available) and internal and external communications. Aaron noted that there will be additional meetings include one alongside the AAMI/FDA meeting in October.


Decisions/Issues:

Action(s):

Wednesday Morning April 25

Item Topic Discussion
1 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

___ summarized the IP policy and displayed the Wiki page. All present represented IHE member organizations. Discussion followed about the obligations of participants who are required to notify IHE if the work in process may be impacted by a patent.

Ken provided the IP Policy review. Most participants had been present yesterday. Todd very briefly noted the AAMI project has been favorably viewed by Mary Logan, AAMI to this point. Ken led discussion of the Roadmap.

- Discussion of the calendar years vs. cycles resulted in agreement that a cycle begins in one year (e.g., Cycle 7 beginning in 2011), ending in the next with publication of the TI versions.
- HL7 v3: will be left on roadmap, work is continuing within the HL7 Medical Devices WG with anesthesia; consensus in HL7 is that a CDA instance would be clearly defined and IHE will then consider how to implement in PCD. John Rhoads indicated it is likely to be ready by the October F2F where a Brief Profile Proposal would be considered. PCD will also need to determine where it will fit in the TF; Todd suggested volume 2 unless another volume devoted to persistent items is added, but it may fit in volume 3. Discussion will continue at the HL7 meeting.
- ACM: PCD-05 remains, Archiver and ITI-PCD Enterprise ACM moved out.
- Event Communication moved to Cycle 8.
- PIV for PCA now noted as Autoprogramming – changes required to PIV.
- Security WP (work item proposal) joint with ITI likely will complete in Cycle 9.
- Operation Status Monitoring – deleted (subsumed in other items).
- DPI remains in Cycle 8.
- RTM specifics: Vent, PHD, IDC, Annotated ECG near completion, Event/Alarms start in Cycle 8. SNOMED added to Rosetta is also included in Cycle 8.
- WCM postponed one year.
- Continua is moving along as expected. They are looking at a third transport mechanism, interactive questionnaires, and in the future – command and control. Paul suggested that PCD’s alarms and events work is an important factor. They are also looking at continuous waveform transmission over phones.
- PCC collaboration with Perinatal was deleted due to lack of specifics.
- Collaboration with AAMI proceeds. Manny asked if the AAMI sponsorship is leading to increased involvement in IHE by AAMI vendor members. Discussion included several suggestions including increased participation by users and the need for additional communication focused in ways that lead them to promote PCD – for the clinical, technical and vendor members who are not the developers. Erin, Ioana, Todd, Paul will consider additional approaches.
- VA interdisciplinary workgroup will meet in September and will address other efforts that will be related to PCD.
- The updated Roadmap will be posted to the ftp site ____________ .

PCD Development Calendar

- Ken noted the confusion about the Cycle number vs. year.
- John Rhoads noted the need to correct several dates. Steve will update the calendar.
-

Pulse Ox Specialization

- Ioana led discussion of the VA’s work. Her slides are available at ____ .
- The effort focuses on device to information systems, with allowance for device managers, consideration of information and work flows.
- Clinicians consider clinician verification of data to be an essential element.
- There was detailed discussion and a few suggested changes.

HIMSS Roundtable Meeting (at HIMSS13):

- PCD topics suggested:
o Pulse Ox
o Other: Ken, Ioana, Erin will address the question.

Fall Meeting:

- Cannot be Oct. 8-11 HIMSS Vendor Meeting, or 2/3 FDA/AAMI Interoperability
- Cannot be Oct. 7 – 12 Showcase Planning Meeting (Manny)

Elections:

- Ken noted that we need at least one candidate.

Decisions/Issues:

Action(s):


Wednesday Afternoon April 25

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

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure John Rhoads reviewed the IHE IP Policy.

Fall October F2F meeting – several dates were eliminated - see the PC notes.

John noted that elections will be coming. Todd nominated John Garguilo for a second term.

Collaboration with others:

- When PCD documents are issued for public comment Jeff Rinda proposed that PCD notify other domains and other organizations such as AAMI. John and Manny will look into the process and Mary Junger’s role and the PCD CP process Wiki http://wiki.ihe.net/index.php?title=PCD_Change_Proposals.

Key Dates:

- The deadlines of May 21 and July 23 were emphasized (Wiki IHE Patient_Care_Devices).
- John asked that anyone interested in editing a PCD Wiki page do so. It requires access permission that is requested on the log in window.

IHE International:

- Todd noted that IHE is looking at rebranding, including selection of a new logo. RSNA has asked their marketing people to look at IHE marketing and redoing the web site.
- Todd indicated expectations for a Hospital Operations Domain. Example: supply management.

Ongoing Work:

- PCIM: Robert described the present status, beginning with the second slide of the set (posted at ____ . )
- Three new actors are required: Patient Demographic Association Reporter, Manager, Consumer (PDAR, PDAM, PDAC).
- Jon asked how patient information source data closer to the device would be handled. Robert indicated that a bar code reader or ADT availability in the device would be considered a higher source of truth.
- Detailed discussion followed regarding
o how many transactions are required (only one is shown, but shown for multiple purposes)
o whether the PDAM is required
o the need for the device to reject an association (e.g., conflict where EMR believes it isn’t John Smith) – Ioana suggested that the application ACK may serve, and another message is not required – discussion followed
o achieving the simplest solution
o for Cycle 7 only a simple PDAR and PDAC will be documented and tested
o R43 Trigger will be used (new)
- ADQ:
o Brief discussion of portions of the Supplement took place.
o This will be reviewed by the TC.

Manny to send an email regarding the consensus review of proposed profiles / Supplements on May

- WCM (now Waveform Content Module:
o This is a module. It will be an option when integrated into a profile.
o Ken reviewed the document.
o There is no distinction between snippets and continuous (continuous would be a sequence of snippets). An additional item will be added to distinguish the two.
o Paul suggested using the zero level (metric level) to indicate that the following have common elements for each waveform. This reduces the repetitive communication of common supporting message elements.
> Alternatively, there may be a way to otherwise compress the redundant information.
- MEM:
o John Rhoads requested participation on the collaborative ITI-PCD security WP. This has a wider scope and will appeal to a wider audience.
o Erin was asked to help determine what the user audience would find beneficial. The request for participation will go to clinicians, vendors, clinical engineers, IT folk.


Decisions/Issues:

Action(s):


Thursday Morning April 26

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

Decisions/Issues: Agenda was revised to accommodate travel schedules

Action(s):

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

Decisions/Issues: Discussion Summary of previous meeting PCD TC 2012-04-18 Webex was accepted


Action(s):

3 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

- The IP policy was summarized All present represented IHE member organizations. Discussion followed about the obligations of participants who are required to notify IHE if the work in process may be impacted by a patent.

RTMMS:

- John Garguilo and Sandra Martinez led discussion.
- CPs were described (see slides at ___ ).
- RTMMS Deployment: beta version has been available to a limited number of people while IEEE copyright issues are resolved. Feedback has been mostly on the interface.
- Sandra described the benefits/features (see slides).
- Sandra will confirm that vendors cannot modify Units and Enumerations Table (will propose).
- Paul indicated that there may be issues with SNOMED licenses, but not with some other commonly used SDOs.
- Sandra described recent updates.
o Multiple Groups refers to the ability to support device specializations where a specialization has multiple terms and different specializations may have several of the same terms within the specializations.

Device Specialization – Infusion Pump

- Todd described the rationale for developing device specialization. This provides the information users and developers want and also provides actors that can be dropped into work developed by other domains.
- Other benefits are described in Todd’s slides.
- The next slide describes the scope and deliverables. Note that LVP should not be on the same line as “General infusion pump”. Note that a pump device specialization will include transactions from multiple existing profiles and may include new transactions.
- Todd described the transition from the existing TF to one that includes specializations (see slide) noting that some of the existing profiles/transactions could be viewed as specializations (e.g., PIV, IDCO).
o Discussion of events raised the question of whether episodic physiologic data (e.g., NIBP) can be sent in the event profile. It won’t be excluded but it will be preferred within DEC.
- The future TF with device specializations followed.
- When registering and testing (Connectathon), the various profiles in the device specialization will be tested and shown as dependencies.
- Todd described how the fused and grouped actors will work, describing the Agent (AGT) and Manager (MGR – the receiver). Todd noted that Jeff Rinda asked how this works when a receiver may only support one of the multiple actors (e.g., ACM system). Manny asked how this will work in Gazelle (e.g., the AM sees the AGT system as a partner and vice-versa). John Garguilo and Sandra described how NIST would handle the agent. John indicated that NIST is looking at Assertion Levels, e.g., Message Level and Interaction Level Assertions.
- John described the optionality and other constraints hat are considered in developing the test.
- Manny noted that this has implications for testing – how to efficiently test multiple infusion pump types.

Multi-Component Admixture Support (PCD-03)

- PIV does not currently support multi-drug component fluids. There are significant complications, e.g., which drug is protected. This is not a standardization issue (HL7) but a profiling effort once the problem is well defined. Paul suggested that an EMR may have the data required to lead to a work around.

The Role of NIST Test Tools in Developing the CPs:

- Todd began by describing the NIST Test Tooling (see slide).
- PCA pumps need to be distinguished from the other types.
- Paul Schluter asked that PHDs be addressed. Todd suggested this be addressed at the HL meeting. Paul suggested that there are places where the four levels are not needed, and the ability to omit unneeded OBXs is part of this. John Garguilo noted that this can be addressed within the profile definition for PHDs.

Decisions/Issues:

Action(s):


Thursday Afternoon April 26

Item Topic Discussion
1 Agenda Items
- As Noted
Status/Discussion:

Discussion Continued

Change Proposals

- John Rhoads led the discussion of CPs not yet vetted. The following will likely be sent to ballot as one CP.
- Al Engelbert: Accept Mode Enhanced ACK: was referred back to the Pump WG. John Rhoads will share it with the WG and Sandra.
- Todd: Editorial Changes to WS – Addressing. John Rhoads will take this to the next step.
- OBR start counting at 1, not 2.
- PCD-02 changes: John Rhoads will address.
- Security Considerations: Todd will provide.
- RTM: Todd will provide changes for RTM , addressing multiple items in the three volumes.
- OIDs:
- DOFR: Todd: “fused” actor for implementations where the filter is part of the DOR. The DOF is still in the Supplement TI phase. John Rhoads will draft the CP.
- Containment: Define sequencing of static containment in PCD-01. There are three ways now – is there sufficient reason to specify or recommend one? The same issue applies to MDS and VMDs – the TF should indicate a preferred sequence (the first approach) and make it clear that all are acceptable. Jeff indicated that a recommendation should be accompanied by a rationale. Paul requested that the change require that ancestral elements precede the descendants/data because it allows streaming. All three options meet this requirement, but options should all be of option 1.
- Clarify and expand treatment of time.
-
- Several CPs that did not need discussion are not included in this summary.

ACM CPs

- Monroe led the discussion. Reference the Discussion Summary of Monday’s meeting above to see the description of CPs. Some specific issues are described below.
- Alarm display order: Discussion led to a solution to the AR – AM sequence/priority order.


Decisions/Issues:

Action(s):


Friday April 27

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

Decisions/Issues: Agenda approved yesterday.

Action(s):

2 Agenda Items
- As Noted
Status/Discussion:

IP Patent and Disclosure

IP Policy was not discussed because there were no new participants.

OIDs:

- John Garguilo led discussion of the OIDs (see slides).
- Ioana suggested that there is another level to be considered: message segment; and suggested this be declared out of scope.
- Note the slide listing the reasons for using OIDs.
- The path forward issues are listed in the following slide. These address:
o Profiling – constraints on standards
o Consistency across related SDOs
o Commitment of PCD vendors – PCD must do the work, define where they will be used
- Wiki page describes current status: http://wiki.ihe.net/index.php?title=PCD_OID_Management and requested comments
o The OID was assigned by ISO
- John Garguilo noted that the “conformance profile” may differ from the “constrainable profile” (the one published) by defining specs for testing (addresses optionality within the profile) and the “implementation profile” which addresses vendor or even site specific constraints on the profile.
- The question is: what is the next step?
o Todd noted that versioning is a strong motivator.
o John documented the discussion on a new slide.
The consensus is to proceed.

Rosetta Terminology Update

- Paul led discussion.
- Development is now focused on RTMMS
o Vigileo monitor, aECG underway
o Alarms and Events
- Discussion of the scope of these indicated that more comprehensive approaches would significantly delay the availability of the terms.
- Paul cited the inconsistencies among profiles (e.g., ACM, EC) for coding the start and stop are acceptable, but not desirable. He reviewed and addressed the pump events and cardinality.
- Paul described a “containment-type” table for pumps and proposed this as the best way to present this information to vendors who can easily understand what is required.
- Paul will look at other events after the AAMI meeting to see if there are other details that distinguish these with the goal of having tables like the one shown for pumps. These would be XML from the tree, and then generate the table.
- Paul asked for suggestions on harmonizing start and stop.
- Paul reiterated the need for a Rosetta table for events.

IDCO

- John Rhoads has talked with them and they have provided good documentation.
- They’ve been working hard on terminology.


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.


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 May 9 PCD PC&TC 2012-05-09 Webex

TC May 16, 2012 PCD TC 2012-05-16 Webex

PC May 23, 2012 PCD PC 2012-05-23 Webex