PCD PC&TC 2011-10-18 to 21 F2F

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Meeting Objectives

Placeholder

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.

Suggested Agenda Items/Topics

The agenda is available at ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2011-KansasCity/. Documents are available without a password.

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Agenda Suggestions Received in Advance:

• How do we handle WCM? Profile, Required, Option? (Ken Fuchs)
• Integration Statements - Is the current content adequate? (Ken Fuchs)
• Discussion concerning Volume 3 content and Content Profiles (Todd)
• Final discussions and ballot concerning Cycle 7 proposals (Ken Fuchs)
• Close Brief Profile Proposals ballot at 5 pm Tuesday; analyze and discuss Wed. am

- Organize work for Detailed Profile Proposals (TC) (follow up to the PC ballot)

- ITI/PCD joint efforts (e.g., cybersecurity, alarms, events)

• Pharmacy/PCD pump joint efforts

(see work item proposal for joint white paper)

• Change Proposals

- to discuss, ballot (Todd):

o Security Harmonization

o ACM Sync w/ v2.8 Proposal

o (TBD) Add "RAS" to Infusion Administration Reporting (from Rx)

- Change proposals to post as required for the Connectathon (Manny)

• High Level Architecture (Cochairs)
• NIST Test Tools
• RTMMS
• Detailed Clinical Models for Medical Devices (Ioana)
• Roadmaps, with reference to roadmaps in IHE, HIMSS; add new workitems in appropriate locations
• Address specific Action Items (both PC, TC)
• Connectathon
• Showcase

• Technical Committee - some suggested topics

Coordination updates

IEEE 11073 / TC 215

HL7 Health Care Devices

HL7 "Fresh look" activity

Ongoing project updates

ADQ

Event Comm

WCM

Point of Care Identity Management: use case review, technical approach discussion

Detailed review of technical approach and resource needs for this cycle's proposals, and leftover resource needs from present ongoing work

MEM Device content to CMMS

Pulse Oximetry Integration with Clinical Applications

Enterprise ACM

Cross Enterprise TeleHomeMonitoring Workflow Definition (XTHM-WD)- Valentina Ferrarini (Consorzio Arsenàl.IT)

Device Cybersecurity - Axel Wirth (Symantec)

Device Specializations - General Content Profile - Todd

Device Specialization - Infusion Pump - Todd

Medication Administration Clinical Integration White Paper - Todd

Long term: Technical philiosophy and strategy for realizing road map

Logistics

Meeting Location:Cerner, in Kansas City

10234 Marion Park Drive, Kansas City, MO 64137

• IMPORTANT REGISTRATION INFORMATION

- You must sign up in advance in order to gain access through Cerner's security office. Manny is compiling the registration list and will send you the spreadsheet for the required information. Please provide this information at least a week before the meeting.

- Cerner will make hotel reservations at the Marriott Courtyard ($92/day) at least through Sept. 7. If you provide registration information Sarah will use that to make your hotel reservation at the Cerner group rate. The hotel is at 500 E 105th St, Kansas City, MO 64131; (816) 941-3333

Please reserve your place at the table as early as possible so that planning will accommodate your attendance (room layout, food, security, etc.). If you would like more information contact Manny.

Travel

Airport Code MCI; approx 45 min travel time from the airport to Cerner’s Innovation Campus. Car rental is off site so plan accordingly. (As an FYI when booking travel, Cerner has 2 main locations in KC. The Innovation Campus in South KC (Grandview Triangle) and the main or World Headquarters campus in North Kansas City off Armour/Hwy 291.) We will be at the Innovation Center.

From the airport (a map is available):

- I-43 South to MO W Exit 70 (Bannister Rd.)

- Stay right at the fork to remain on Bannister

- Left on Marion Park Dr.

- Pass Hickman Mills Dr. and enter the Cerner security gate

Attachments / Materials

Documents related to the meeting are found at ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2011-KansasCity/ unless otherwise noted. Documents are available without a password. Links to references are provided in the summary and may be added here:

Participants

Those attending via Webex are identified. PLACEHOLDER ONLY

Tuesday:

Cochairs: Ken Fuchs, Steve Merritt

_________________

Webex participants: ____________

Wednesday:

Cochairs: Ken Fuchs (PC), John Garguilo (TC), John Rhoads (TC)

_________________

Webex participants: ____________

Thursday:

Cochairs: John Garguilo (TC), John Rhoads (TC)

_________________

Webex participants: ____________\

Friday:

Cochairs: John Garguilo (TC), John Rhoads (TC)

_________________

Webex participants: ____________

Schedule & Agenda

Detailed Agenda

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

Discussion

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

Tuesday Morning May 10

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Participants introduced themselves. The IP Management Process was discussed. Slides were provided. The agenda was reviewed. Todd suggested adding strategic planning and marketing PCD (publications, membership, deployments, success stories). ONC was also added. Steve noted that the Brief Profile Proposal Ballot closes tonight and participants were encouraged to vote. Decisions on priorities will be made tomorrow. Steve indicated the work to date on Integration Statements laying the ground for discussion this afternoon. Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: Decisions/Issues: Discussion Summary of previous meeting was deferred Action(s):
3	Agenda Items - As Noted	Status/Discussion: Roadmap Ken led discussion as we transition from Cycle 6 to Cycle 7. There are requirements that won’t be met until HL7 v.2.9 is available in Cycle 8 (assuming 2.9 will be available in this time frame). Todd noted that 2.7 has been published and 2.8 which will be available for Cycle 7 will not have significant changes for PCD. - It was noted that Cybersecurity is related to web services as well. - The DOF should be available for Final Text in Cycle 7. ACM PCD-05 and subsequent were delayed one cycle (Alarm Archiver to Cycle 8 (however it may just be a specialized archiver conforming to ADQ), smart alarms to Cycle 9) and Coordination with HL7 2.8 was accomplished in Cycle 6. ITI-PCD may address Enterprise ACM in Cycle 7. - ADQ will be continued in Cycle 7 and Data Mining is delayed to Cycle 8 – and Erin later asked if ADQ the only venue for data mining; will it be sufficient, in relation to pumps? Multi-component admixtures was added in Cycle 9. Collaboration with the Pharmacy Domain was added in Cycle 7 – a joint PCD/Pharmacy WP addressing workflow. - PCIM will also be continued in Cycle 7. - RFID was added to Cycle 8. Todd noted that barcode and RFID will be considered within PCIM. - Event Communication was added to Enterprise Communications to assure that events beyond pump applications are addressed in Cycle 8, with IPEC leading the way. - The Pump WG will address PCA pumps in Cycle 7. - MEM will address Operation Status/Monitoring, Device Communication Management in Cycle 7, Device Configuration Programming and RTLS in Cycle 8 rather than Cycle 7. - DPI was delayed until Cycle 8 (needs further discussion concerning mission and strategy). Other Point of Care workitems were delayed until Cycles 9, 10. Todd suggested adding AAMI/FDA/MDPNP interoperability coordination to the agenda to further discuss device control workitems. - RTM Vent Terminology and IDC terms should be ready in Cycle 7. The full set of PHD terms will be folded in within Cycle 7. Paul summarized current and planned status of RTM. Events and Alarms were added to the roadmap. RTM migration to RTMMS was accomplished in Cycle 6. - Coordination Effort: REST-ful style architecture (to suit cell phones) and PHD Alarms were added to Cycle 8 with Continua. Paul described the effort related to exploring REST-ful, with Continua and ITI. Items in Cycle 6 were moved to Cycle 9 and modified slightly (Smart Home, LTC, Physician Office, Sub-Acute Care). ICE-PAC was moved to this section of the roadmap and is a component of SHARP (type of grant). - Regulation: Alarm 60601-1-8 appendix was added and IEC80001 was modified for Cycle 7. Connectathon More companies, more systems, more profiles: Accent on Integration, Fresenius, iMDsoft, Nihon Kohden, Philips (more systems), ScottCare, Vocera. We have three AC actor systems (Nuvon, Vocera added to SIS). We will test IPEC. We will test WCM if any are interested, but this will be unofficial, off the record. We lost three companies from last year, including Polycom. Testing the PIV profile is in doubt. - Pre-Connectathon: NIST has done a great job, adding Isolated System Testing, available for most tests. Tests will be available 24 x 7; will not be posted separately. NIST is hoping to provide sample messages based upon experience after the testing is over. Gazelle will indicate which type of test – Instance or Isolated for each test. Steve Moore will announce the availability of Pre-Connectathon testing, possibly today. There is a Wiki page that points to tests. Showcase Largely unchanged from the last update. There are four Use Cases, Jack Hoffman and perhaps others have offered suggestions to John Donnelly. The HIMSS12 site is presenting issues for the structure(s). Defining them will now be done after the Use Case systems are allocated next week in Chicago. AAMI Alarm Summit Todd summarized the meeting, noting that John Garguilo, Erin, , Monroe, John Zaleski and he were among the participants. It was an open forum, with about 300 people and well organized. He described the agenda and discussions. Erin noted that alarms are generally designed for the person in the room, rather than the clinician who is not present. Todd noted John Zaleski’s suggestion that “remote alarm” would be preferred over “secondary alarm”. However, on the second day there was a focus on the primary alarm and not much good material on the secondary alarm. On the second day there was good discussion of best practices. Todd’s observations are available at _____________ . He noted that nothing related to PCD was reflected in the balloted final list. Todd described the next steps. Decisions/Issues: Action(s): - Ask Elliot for an update on ONC and CONNECT. - Todd to draft a communication to Mary Logan/AAMI to help understand the priorities coming out of the Alarm Summit and the various PCD activities that relate.:- Monroe to draft an article for publication in AAMI outlets to help educate the marketplace on ACM and how standards exist and contribute to interoperability.

Tuesday Afternoon October 18

Item	Topic	Discussion
1	Agenda Items - Chair	Status/Discussion: IHE International – Update Todd presented a summary of the work and organization of IHE International. Todd is a Board member, representing PCD. His report is available at ________ . Among the notable items: - The DCC is intended to provide opportunities to make coordination/collaboration between domains a higher priority. - Steve described the strategic planning initiative. The second item in the required PCD plan is cross-domain opportunities. The PCD plan will be based upon a shorter version of the roadmap and include the collaborative efforts discussed this morning. John Garguilo noted the customers’ needs to have complete array of profiles. Among the priorities are the cross-domain work with Pharmacy and Alarm Management. Todd suggested that clinical integration profiles, meaningful use and _________ should be included. Reference was made to the Joint Initiative Council – Joint Initiative on SDO Global Health Informatics Standardization, with a meeting in Chicago. IHE is increasingly focusing on deployment – and an interest in utilization. - John Garguilo provided an update on the Testing and Tools Committee that is primarily focused on Gazelle and related items. He noted that Steve Moore is open and working with NIST. He anticipates integrating NIST tool results directly into Gazelle at some time. - The DCC also focuses on ONC. HIMSS - Opportunities - Steve extended HIMSS’ invitation to submit papers for the HIMSS journal’s issue on interoperability. Abstracts are due the end of October. - Survey: Steve reviewed the survey that will go to HIMSS members regarding each individual’s/ organization’s interest in PCD and PCD’s work to help PCD set its priorities. Surveys will go to clinicians, IT and other users, and to vendors. Suggestions were offered and the survey was edited. - Crystal will post a PCD Webex for the clinical informatics members. Review ITI-PCD Joint Work: See morning notes. Marketing: Publications, membership, deployments, success stories: discussion stressed the importance of developing a strategy which can include: publicizing the commercially available systems, identifying devices/systems commercially available in the Showcase, finding and publicizing implementations, the Nashville demonstration site, a demonstration by successful hospitals in the Showcase with some PCD devices/systems, expanded use of the AAMI venue, video. Telehealth/Home Monitoring: John Donnelly informed Todd that PCC is interested if PCD will work with them. Todd suggested that the initial effort be a WP. Todd asked how the group wants to respond. Steve suggested that the recent PCD/ITI meeting might be a model for this collaboration. Todd suggested that a WP include a “grouped actor”, identify the requirements and where the actor would reside. ITI/PCD Joint Meeting Sept. 23: Ken summarized the discussion and outcomes. A detailed list of potential areas of collaboration was shared afterward. The meeting focused primarily on cybersecurity. The groups agreed to meet 4 times per year. A list of joint tasks was developed and prioritized. The Cybersecurity whitepaper will be the first joint work effort developed with the intention of creating supplements in year 2. IEEE 1073 Copyrights: John Garguilo led this discussion with the goal of an MOU permitting use of various elements of the standard. There are important elements of 11073 that are used by PCD in RTM. A meeting was held Friday with several IEEE staff. PCD representatives provided PCD’s point of view within the context of what PCD is trying to accomplish. A follow up meeting will be held early in Dec. An element is the coordination between ISO and IEEE on this standard. John then described how NIST and IEEE might work together in the future when NIST’s efforts are ready to be turned over to another organization – NIST’s role is to do the research that establishes the solution, not to continue indefinitely. WCM - What is it?: Ken described the issue as WCM evolved from a profile to something else. The issues are primarily: it is not a profile because it doesn’t have actors in its present form, cannot stand alone because it is an object, not a complete message. Alternatives include making it a profile (adding actors) and making it an option (it has issues including the lack of reporting results by Gazelle and assuring that DOCs don’t crash). Another option is to make WCM required like RTM and submit to HL7 as a replacement for the deprecated waveform data type. Vendors are able to market an option, include it in the Integration Statement even without Gazelle reporting the results. The consensus is to proceed with making WCM an option, addressing the issue of assuring that receiving systems don’t fail when these messages are received, and taking the issue of non-reporting of results to the Testing and Tools Committee. WCM may be one of many similar PCD efforts, e.g., event communications. Ken’s slides are available at ____ . Integration Statements Ken displayed product-registry.ihe.net/ and follow on pages. Discussion followed to determine if PCD should provide additional information on the ISs. Additional information, such as profile version (maturity), if/when last tested, and other details were suggested. Decisions/Issues: Action(s): Manny to ask Erin how to coordinate on deployment marketing effort by DCC. Develop a strategy for publicizing IHE PCD. - Find some sites which would be willing to prototype PCD compliant integration use cases.. - Manny to explore with Sandy: videotaping, identifying commercially available systems. - Erin to explore commercially available testing opportunities with Mario @ Kaiser, Ted Cohen at UC-Davis and other large facilities that may already have test-beds. - Erin to find out how to get onto the IHE “news blasts” - Manny to explore opportunities for a “COMMERCIALLY AVAILABLE TODAY” sticker at the Showcase. - Cochairs to explore opportunities with Elliot and Joyce on how to encourage reference implementation sites of PCD profiles, grants/awards/etc - Todd to respond to John Donnelly regarding collaboration with PCC on telehealth. - John G to take the issue of non-reporting of results in Gazelle to the Testing and Tools Committee. This needs to be a priority for Gazelle. - John Rhoads to explore how to (or if) volume 2 needs to explicitly reflect that consumers need to gracefully process unknown (but properly formed) data. In other words if a DOC receives WCM OBX’s and doesn’t know how to process them it should continue on and not bomb out. Integration Statement improvement - add to integration statements: - Version of profile (John Gargiulo to dig up the Profile maturity index to see if it applies) - Was the product tested at Connectathon and a link to connectathon results page

Wednesday Morning October 19

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary - Chair	Status/Discussion: Decisions/Issues: Action(s):

Wednesday Afternoon October 19

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda reviewed by John __ and approved Action(s):
2	Discussion Summary Past Meeting (TC) - Chair	Status/Discussion: Deferred Decisions/Issues: Action(s):
3	Agenda Items - As Noted	Status/Discussion: Alarm Management Continued: John Zaleski added to yesterday’s discussion, emphasizing the need to consider context, focus on the clinician and not technology, and the need for alarms to provide the right alarm to the right person at the right time. He noted that there is no good regulatory framework to address alarms. AAMI/FDA/MDPnP Interoperability Coordination: Todd observed that interoperability has not achieved the goal of improving patient care. Roadmap Continued: Ken asked if ADQ was sufficient to address data mining. Discussion elicited the belief that ADQ was the first step possibly followed by a WP. Device Point of Care Integration (DPI): Ken asked what the role of DPI is when implemented within a device? Is DEC sufficient? Todd suggested that DPI has applications, such as with ICE. Progress with DPI depends upon a number of standards, some of which are being more or less actively pursued, and regulations. These include control, format, plug and play, _________ . He suggested asking PCD’s sponsors to help address the issues, and including the FDA. He suggested that reference to DPI in the roadmap include a WP. Ken suggested that we need a better understanding of how DPI and DEC differ in terms of requirements and whether DEC can be used in certain DPI Use Cases or can it be modified to meet the needs of certain DPI Use Cases. Brief Profile Proposal Ballot: For the two that failed to pass, these will be led by other domains and PCD will provide support. All that passed may proceed if leadership is available. The next steps are development of the Detailed Profile Proposal and then ballot by the TC. Decisions/Issues: Action(s): Erin to discuss with Christal to see how to build Clinical Advisory Board (primarily non-physician) John Zaleski to explore recruiting physicians to a Clinical Advisory Board.

Thursday October 20

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved as updated. Action(s):
2	Discussion Summary of Yesterday's Meeting - Chair	Status/Discussion: Deferred Decisions/Issues: Action(s):
3	Agenda Items - As Noted	Status/Discussion:

Friday October 21

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved. All present have been present and there was no need to review the IP policy. Action(s):
2	Discussion Summary - Chair	Status/Discussion: Summaries have been distributed daily and participants have been asked review them while memories are fresh. Traceability in PCD-01: - ACTION: John Rhoads will ______________. _______ ACTION: John Garguilo will provide _______. Review of Action Items: Decisions/Issues: Action(s): -

Next Meetings

Planning Committee:

Technical Committee: