PCD PC&TC 2011-05-10 to 13 F2F

PCD Home

This is merely a sketch to start the process -- please enter suggested topics in PCD 2011 Spring Face-to-Face Topic Suggestions

Meeting Objectives

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

• Planning Committee: Review, plan and initiate overall PCD activities
• Technical Committee: Review all materials slated for publication in 2011 and resolve any issues so that final editing and publication may proceed.

Some suggested topics for PCD Spring Face to Face

Planning Committee

Suggested topics may be added to PCD 2011 Spring Face-to-Face Topic Suggestions

The Roadmap - is there a disconnect between the roadmap and what participants are really prepared to do?

How much of the way we are organized serves our long-term goals and what can we do about it?

What the heck are our long-term goals, anyway?

Wednesday afternoon(?) we reserve time for Christel Anderson (and maybe me - Jon) to introduce someone from Christel’s patient informatics group and see how her/his HIMSS connections in this area might best be put to use in IHE PCD.

Publicizing PCD to users, vendors.

Recruiting users, vendors.

Setting the date for the Fall 2011 F2F

Technical Committee

Event driven processing: are EMR vendors really interested, what are the generic requirements and the infusion management requirements, should we treat Alarm Communications Management as a special case of event processing?

Asynchronous Data Query - where is it needed, when will clinical information systems be ready to play, what are the real requirements, do we need a phased approach?

Content Profiles and the mythical "volume 3"

Implementation Guides - what should be in them, how should they be organized (and who wants to work on them)

What about OIDs and use of identifying different versions of things (focus on conformance profile used in a cycle, and how subsequent cycles change [e.g., "x" --> "o" at the HL7 component level of a field]and what this means if there are not enough vendors participating as a particular actor for a later version versus an earlier version)?

Point-of-care Identity Management: what are the problems? What can (and should) we say about the solutions?

How much of Medical Equipment Management can we accomplish using existing PCD-01? How much nomenclature do we already have? What do we need to add?

Traceability in PCD-01: MDSes, VMDs, Channels, Device identifiers and metrics, and what can we and EMR vendors do to associate data with sources? Who cares now? Who will care in the future?

Modeling approaches: Clinical Workflows, ICE-PAC and HL7 Detailed Clinical Models for Medical Devices

Are manufacturers going to sign up for system -> device and device <-> device interactions?

Change Proposal Process (Ioana Singureanu)

Participants

Tuesday:

Dominick Anggara, Christel Anderson, Sam Carrillo, Anupriyo Chakravarti, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Chad Hays, Jack Hoffman, Khalil Maalouf, Sandra Martinez, Steve Merritt, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Erin Sparnon, Richard Swim, Rob Wilder, Manny Furst

Wednesday:

Dominick Anggara, Christel Anderson, Sam Carrillo, Anupriyo Chakravarti, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Chad Hays, Jack Hoffman, Brad Lunde, Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Erin Sparnon, Richard Swim, Rob Wilder, Kristina Wilson, Manny Furst

Thursday:

Dominick Anggara, Anupriyo Chakravarti, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Brad Lunde, Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Richard Swim, Rob Wilder, Kristina Wilson, Manny Furst

Friday: Placeholder

Dominick Anggara, Anupriyo Chakravarti, Bikram Day, Ken Fuchs, John Garguilo, Brad Lunde, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Rob Wilder, Kristina Wilson, Manny Furst

Schedule & Agenda

Daily Schedule

08:00 - 08:30 Meet at Philips Emergin

Meeting will start promptly at 08:30 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

NOTE: Friday the meetings will end by 15:00.

Date	Hours	Committees	Topics
Tuesday 2011.05.10	08:30 - 17:00	PCD Planning Committee	Greeting & Introductions (20 minutes) Review & Approve Agenda (20 minutes) IHE IP Management Process (5 minutes) Review Current PCD Program: - Roadmap Review (30 minutes) - Schedule / Milestones Review (30 minutes) - Break (15 minutes) - Current Workitems (15 minutes) - New Workitems - Profile Supplements (30 minutes) - White Papers (15 minutes) Cycle 7 Work Item Ideas (30 minutes) Lunch IHE PCD User Handbook (30 minutes) PCD Marketing & Funding (30 minutes) - PCD 101 - Education opportunities - What information are we missing to educate providers? Interop Showcase 2012 planning (30 minutes) Break (15 minutes) VA Update (Ioana/Greg) Overflow discussions (90 minutes)
Wednesday Morning 2011-05-11	08:30 - 12:00	PCD Planning and Technical Committees	IHE IP Management Process Web / wiki / FTP Review Review and discuss "time" issues Review and discuss ADQ requirements 11:00 AM - MEM Networked Medical Device proposal (Axel and Steve to webex in) Other business
Wednesday Afternoon 2011-05-11	13:00 - 17:00	PCD Technical Committee (TC)	IHE IP Management Process TC Welcome and Agenda Review (Garguilo/Rhoads)(10 mins) Location, Dates of the Fall F2F Are manufacturers going to sign up for system -> device and device <-> device interactions? (Rhoads) (30 mins) Asynchronous Data Query (Khalil - WebEx - John Z.) (45 mins) - Where is it needed, when will clinical information systems be ready to play, what are the real requirements, do we need a phased approach? Afternoon Break How much of Medical Equipment Management can we accomplish using existing PCD-01? (Scheduled for 3:30 PM - Merritt/Rhoads)(30+ mins) - How much nomenclature do we already have? What do we need to add?
Thursday Morning 2011-05-12	08:30 - 12:00	PCD Technical Committee (TC)	IHE IP Management Process NIST Test Tooling (45 mins) - Cycle 6 Pre-Connectathon & Beyond... (Garguilo) - Supporting Tool Update (Garguilo/Sandra Martinez) - (Note Connectathon 2012 Dates @ Chicago Hyatt Grand Regency January 9th - 14th) What about OIDs and use of identifying different versions of things (Garguilo/PIV WG) (15 mins) - Focus on conformance profile used in a cycle, and - How subsequent cycles change [e.g., "x" --> "o" at the HL7 component level of a field]and what this means if there are not enough vendors participating as a particular actor for a later version versus an earlier version)? RTM Update (Schluter)(30 mins) - How to handle restructure in TF (from Integration Profile to Appendix) - Pointer to dynamic/living file Morning Break Format for expressing event Containment and content model (Schluter) (45 mins) Modeling approaches (Ioana Singureanu)(60 mins) - Clinical Workflows / example from VA - HL7 Detailed Clinical Models for Medical Devices (HL7 Ballot Item) - ICE-PAC Change Proposal Process (Ioana)(30 mins) Technical Framework Status and Review (Rhoads)(30 mins) Content Profiles and the mythical "volume 3" (Garguilo/Rhoads)(15 mins) - What is this and what would such a volume contain? - Is now the right time? Move to the 'Parking Lot'? Lunch
Thursday Afternoon 2011-05-12	13:00 - 17:00	PCD TC WG Meetings	IHE IP Management Process Point-of-care Identity Management (Flanders via WebEx) (45 mins) - What are the problems? What can (and should) we say about the solutions? PIV Update and CP Review/Discussion (Rinda [via WebEx]/Engelbert/Lunde)(45 mins) Afternoon Break ACM Update (Patillo)(30 mins) - Should we treat Alarm Communications Management as a special case of event processing (next Topic)? - Move from Alarms to Event Communication? Event driven processing: (45 mins)(Patillo/PIV/Others) - Are EMR vendors really interested, what are the generic requirements and the infusion management requirements, should we treat Alarm Communications Management as a special case of event processing?
Friday Morning 2011-05-13	08:30 - 12:00	PCD TC WG Meetings	IHE IP Management Process Recap and :30 min overflow from Thursday WCM Attributes (Fuchs) (45 mins) - Action Item TC 110. Test cases (development and definition) for Cycle 6 (Furst) Tech Committee Overflow (First Day and half) ?? Others ?? Morning Break IDCO Update (Nick Steblay and Tom Schultz via WebEx at 11 AM, Eastern)(60 mins) - Recap and Report out from HRS Conference/Meetings (week of May 2 - 6) - What's new or planned for cycle 6 Lunch
Friday Afternoon 2011-05-13	13:00 - 15:30	PCD Technical Committee	IHE IP Management Process Traceability in PCD-01: (Rhoads / Schluter) - MDSes, VMDs, Channels, Device identifiers and metrics, and what can we and EMR vendors do to associate data with sources? - Who cares now? Who will care in the future? Implementation Guides (Garguilo) (15 mins) - What should be in them, how should they be organized (and who wants to work on them) ~ Relationship to other artificts (Use Cases, Message Profiles, Message Templates, Static/Dynamic Definitions) - Proposed Table of Contents? Action Items Review (Rhoads/Garguilo) Meeting Recap and Summary (Rhoads/Garguilo/Furst) - Record To Dos / New Action Items

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

Location Information

Philips Emergin

6400 Congress Avenue

Boca Raton, Florida 33487

(561) 361-6990

• IMPORTANT REGISTRATION INFORMATION

Please reserve a place at the table as early as possible so that logistical planning can accommodate your attendance. Send your anticipated arrival and departure dates/times, cell phone number and hotel to Manny Furst. If you would like more information contact Manny.

Attachments / Materials

Documents related to the meeting are found at ftp://ftp.ihe.net/Patient_Care_Devices/Minutes-and-Meeting-Summaries-Yr6-2011-12/F2F-2011May/ unless otherwise noted. Documents are available without a password.

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. 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: Webex meetings have been scheduled and the schedule and access codes have been distributed by email. IP Patent and Disclosure Ken 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. PCD Roadmap: Ken led discussion with reference to the PCD Roadmap Wiki page. The Roadmap was updated at the Fall 2010 F2F. He reviewed the work accomplished to date and the projections for the future. See the Roadmap for details. The original is at ftp://ftp.ihe.net/Patient_Care_Devices/Roadmap_and_Calendar/ and the updated version will be posted in that folder. Architecture: PCD-02: the question was raised about the number of implementations required to move a supplement to TF FT. John Rhoads indicated that the requirement for three vendors on each side can be met cumulatively in multiple Connectathons. Also, WS was tested in the 2010 Korean Connectathon and thus was added to the updated Roadmap. Security was added to Cycle 7. Device Cybersecurity will be added to Device Management. Device Enterprise Communications: Ken noted that ADQ might also be applied to the ACM AA. Monroe suggested a later discussion about removing the AA to permit ACM becoming FT since there has been insufficient interest in implementing and testing. A CP is required to remove the AA and another would be required later if it is to be added back. HL7 is considering order alarm (e.g., critical priority lab) results notification, and these are site specific. Christel noted that alarm fatigue and other issues should be a high priority for PCD and that the Smart Alarm project may address this. Manny asked how to involve other domains so that ACM meets the clinicians’ and the domains’ needs. Monroe responded that ITI was not interested in the past. Radiology has responded that they address this within DICOM, but that ACM is for system to people rather than system to system. - Discussion of smart alarms (decision support for alarms) followed (cycle 8). This is currently out of scope due to complexity and FDA regulation. Monroe indicated that there is a demand for this. Ken noted that ADQ will accommodate these and that this project will address the requirements to support smart alarms while not specifying what the alarms will be – they will be vendor specific. Dominick asked about the application and Monroe responded by saying that this will assure the data is appropriately available, but not define the algorithms for decision making. - AAMI will initiate an alarm safety committee and PCD should be represented. Erin will share the announcement with the PCD PC, TC. - Data Mining (Cycle 7) was incorporated into ADQ. Device Context Management: Device Patient Association is renamed Point of Care Identity Management (PCIM) which is about to begin work. Where and how this is accomplished has yet to be defined. Device Order Management: CPs will be offered to PIV. With regard to PCA pumps, this will be renamed PIV for PCA pumps, Jeff noted that HL7 does not yet provide necessary elements. Medical Equipment Management: Changes were made, moving timetables and adding a Security “Profile” to Cycle 7. Point of Care: - Christel encouraged PCD to make DPI a high priority and that the WP, even short of a comprehensive document, is needed now. PCD has been resource limited in completing the WP. John Garguilo noted that the FDA is struggling with this issue. Ken noted that DPI and ICE-PAC are addressing this and are addressing technical issues. Content Management: - WCM is available for testing and demonstration. Snippets should be tested and demonstrated in Cycle 6, Continuous in Cycle 7 and in FT in Cycle 8. - LOINC mapping was removed; adding SNOMED or LOINC are an optional responsibility. Paul noted that others, such as the National Library of Medicine are more appropriate responsible parties. - Extensive discussion ensued regarding RTM marketing – making its tables known to, and available for other domains and potentially expanded for terms that PCD would not use. Paul noted that RTM for PCD is a rapid way to add new terms, evaluate them and then submit to IEEE for adoption. This should be distributed as “best practice” through IHE as a level of rigor rather than required implementation since other domains use LOINC, SNOMED. Ioana endorsed this as a value set required of all IHE domains. o ACTION ITEM: Iona will document this. PCD with Christel’s assistance will need to find a way to promulgate the message. Coordination Efforts: - Changes were made to the schedule. PCD Schedule: Steve led discussion of the schedule, noting the deadline for new supplements and CPs to be published in time to be tested in the 2012 Connectathon Cycle. Event Communication and CPs have the following deadlines: Submit new supplements due May 29, publish for public comment June 5, submit for TI July 24, publish for TI Aug. 7. CPs will be due about a month before Aug. 7. The registration window for the Connectathon and Showcase will be added to the Wiki page. Steve will update the page. There are two portions: development and deployment. Decisions/Issues: Action(s): Iona will document the PCD RTM as a "best practice" exemplifying the use of tight structure and rigorous definitions which produce specific coding for each element of the data. PCD with Christel’s assistance will need to find a way to promulgate the message.

Tuesday Afternoon May 10

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: PCD User Handbook: Steve led discussion of the document and comments received. Questions were resolved. PCD Marketing and Funding: Discussion about the need for, and the engagement of users indicated that much of what PCD does in meetings would not be of interest. Ioana commented on how users can contribute, e.g., by identifying needs and requirements rather than active participation on a schedule. Steve added that users can help identify workflow requirements. Steve identified needs for users to identify needs and priorities, what has already been accomplished, how to participate. - PCD 101 was conceived to help the marketing effort by describing PCD to HIMSS’ clinical informatics membership. Christel noted that she holds monthly meetings with clinical informatics professionals and invited PCD to provide a presentation. She recommended that Erin and Ioana conduct the presentation. Erin noted the introductory portion and Ken added that he would like to add some “to do” items. - HIMSS and Alliance for Nursing Informatics (ANI) with 20 some odd member organizations that holds periodic meetings and PCD can be represented. - Christel encouraged PCD members to submit proposals for presentations at HIMSS12. The HIMSS12 Call for Proposals is open until May 23: http://www.himss.org/ASP/education_annualConf_callProposal.asp - Christel described the clinical informatics survey she recently conducted. - Christel suggested PCD take advantage of the many HIMSS publications, from formal peer reviewed JHIMSS to informal. - Anupriyo raised the question of the disparate communications required – clinicians’ different from technologists’. Christel noted the clinicians’ desire for workflow information. Ken noted that PCD develops use cases for the profiles and are not well communicated. Christel said that clinicians won’t ask for the information from PCD, so PCD needs to be proactive. - Christel described her survey and her focus on integration into the EMR. Comments received on’the draft were described. Richard suggesting adding supply chain. Discussion addressed varying the survey for use with other audiences. Changes were suggested and the survey will be sent consistent with Erin and Ioana’s timetable. AAMI11: Manny provided an update. Christel will provide the handouts and will need the final version the end of the month. HIMSS12: Manny summarized recent discussions which indicated PCD should increase emphasis on workflow and connectivity and reduce the focus on clinical story, messages and transactions. The Showcase will have limited floor and ceiling space. One concept is to have portions similar to the PIV wall at HIMSS11 and the fourth wall which permitted in depth discussion of technical and other issues. IDCO may participate again. Christel invited PCD members to submit proposals for presentations. Sessions include roundtables. Proposals should emphasize what participants will learn. Board Report: - Ken reviewed the BoD report. The latest draft is available on the PCD ftp site and will be submitted shortly. VA Update: - Ioana led the discussion. Attending at various times via Webex: Greg Staudenmaier, Holly Miller, Chatherine Hoang. - IOANA’s slides (DCM for Medical Devices Project)are on the PCD site: ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2011-May-BocaRaton/ This will be discussed next week at the Health Care Devices group of IEEE. - Ioana described the use and importance of the Domain Analysis Model (slide 2). She went on to describe each of the slides. In slide 18, Choice 3 is continuation of Choice 2. - Device to patient association is most effective in addressing patient safety occurs when accomplished at the point of care. Each step removed from there appears to be less effective. (Slide 18). - Patient safety and data validity issues were discussed in detail, identifying real issues that may lead to errors in associating legacy devices with patient identifiers. Paul noted that at least one demographic item must be required. - Ioana noted that accuracy and precision were raised for the first time by clinicians, specifically for alarms, but is more general. Decisions/Issues: Action(s): Action(s):

Wednesday Morning May 11

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary - Chair	Status/Discussion: ADQ: Khalil summarized the five recent meetings. ADQ are patient specific, user activated queries for data from stored or streamed clinical data aligned under one time frame with appropriate resolution supporting clinical decisions [paraphrased]. Scope is (1) one dimensional waveforms, (2) medical device settings, (3) discrete clinical parameters, (4) events and alarms. Storage requirements are not enforced so discovery is required to learn what is available. Khalil’s presentation is available at ________________ . Actors are ADQ Requester and ADQ Responder Interface. ADQ starts with new actors with the idea that these may be replaced by existing actors. Debate ensued about the name (asynchronous vs. synchronous), whether this implies the ability to initiate a second query before the system responds to the first as well as other considerations. For this profile, at this time, it does not imply that all data is time correlated. Many questions were raised so attention turned to the use cases deferring many of the questions until later this day. The availability of data requires storage at least at a simple level such as FIFO, acknowledging that this may still not yield sufficient time synchronization. Another question: is a subscription option needed? It would be needed for asynchronous data or device control (future). The availability, accuracy of the time stamp would be reported if available (R2). MEM: Networked Medical Device Proposal: IT Integration and Management of Medical Devices available at ftp://ftp.ihe.net/Patient_Care_Devices/Profiles/MEM/Proposal-CE-IT_Device_Network_Mgmt/ Axel Wirth, Michelle Johnston, Donald Morge, Steve Merritt joined on Webex Axel led the discussion. This new proposal continues the work of the WP recently completed public comment period and subsequent editing. Please see the document for the details. Paul noted that Continua has addressed security and asked that coordination with Continua and any others who may employ PCD profiles. Steve agreed and added that other IHE domains should be informed and coordinated where possible. Paul added that PCD will not need to address issues not required when communication is between two trusted endpoints. Ken asked if specific profiles are required. Paul noted that it is difficult to provide certification on small devices, and asked how the network will know the device is a legitimate device. Axel will add this use case. He also noted that certain data streams will be burdened by a heavy layer of security, and suggested that those that do not have patient identifiers (e.g., waveform) can be without or only lightly protected. Richard added that encryption has caused devices to shut down during cases. Steve noted that a balance needs to be found so that devices that leave the facility won’t be vulnerable. Richard said they now provide physical security as the solution. Paul suggested that solutions may be able to contribute to discovery. Paul and Ken raised the question of how well this document addresses the users’ requirements. Ken asked if the document should clearly note that the title and IT Management circle replace IT with CE-IT. John Garguilo added that we need to look at the message wrappers that ITI profiles that may impact or contribute to the solution and to testing. The next step: Axel will update the document then to recruit a WG from the vendor and CE-IT community to prioritize and disseminate aspects as they are addressed. Ken suggested that ITI expertise, collaboration is desired, and that ITI may want to take the lead. John Garguilo noted that NIST has done some work in this area that may be helpful. He will investigate and bring the information to this WG. John Rhoads, Dominick, Richard, Ken, and Khalil volunteered and Brad offered to seek a Carefusion representative. Fall F2F: Potential Weeks are Sept. 19, October 10 or 17. Preference was expressed to meet in San Diego at Carefusion the week of Sept.19, and October 17 is the second choice at Cerner. October 10 is the third choice. Decisions/Issues: Action(s):
3	Agenda Items - As Noted	Status/Discussion: Decisions/Issues: Action(s):
4	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):

Wednesday Afternoon May 11

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda reviewed by John Garguilo 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: John Garguilo reminded participants about the IHE IP policy and procedures. The group indicated that they were familiar with the P&P. John Rhoads summarized the constraints, legal considerations, patents and licensing. In response to requests Manny distributed the survey of commercially available systems to the TC for updating. Roadmap, Use Cases and Other Considerations for TC Effort: Anupriyo summarized why surgical IS systems are in the forefront of adoption. Richard indicated that “positive patient identification” is a high priority. This includes two forms of ID and some type of display. Bar codes are well suitable. Monroe noted that bar code readers are being incorporated in phones and therefore the reader is not tethered to the device, complicating the association of the patient demographics with the device. Dominick asked is patient identification is required for PCD data. Currently it is, but exceptions take place in emergencies, when patient data may be location or otherwise identified and exceptions requested by the Pump WG – those companies find a workaround. ADQ: Discussion of the patient identifier led Paul to indicate that the identifier for matching the device to data requires only: assigning authority, data type and value and may include multiple data types as well as include more than this minimum of one identification value. The type can be name, MRN, SSN, location, etc. Khalil asked if the PCD-02 portion of the ADQ profile should be processed in time to test at the Connectathon or wait until the entire document has been addressed. Khalil will update the document dated May 5, which is posted at ftp://ftp.ihe.net/Patient_Care_Devices/Profiles/ADQ/ and the revised version will be posted in the same folder. MEM: What Can Be Implemented Within Existing Nomenclature, Rosetta? John Rhoads prepared the brainstorming discussion by identifying Not available in 11073: Manufacturer model and serial number (identifiers in 20601) Traceability Patch levels Condition Location Other items Steve defined in the poster he developed for HIMSS10 Referring to Steve’s poster available at ftp://ftp.ihe.net/Patient_Care_Devices/Showcases/HIMSS2010March/PCD_Posters_2010/ titled 2009Showcase_MEM_Poster_r5_3_JPEG[1].jpg, the following can be communicated with appropriate nomenclature added to RTM. Patch management Battery and other component management Many exist as MDC codes now, others can be added to RTM tables Paul showed examples of existing hardware and software data Paul indicated additions will be easy to add Operational Status and Monitoring Device Configuration Management (the FDA will not settle on a single solution) Conventions will be required to specify coding Steve observed that this appears to be a “content profile”. Paul indicated that PCD-01 can handle much of this. Some categories might be Power Management (including battery condition, life, charge), Component Management, Consumables, Location (e.g., Access Point or other location where last used), Patch Management, Library Management (e.g., drug formulary on a pump), Settings Management. Paul offered samples, noting that many may already exist, and offered to bring this to the IEEE meeting in Orlando next week. He requested Steve to add to the list. John Garguilo’s notes showing examples are provided below. Paul suggested that the hospital spaces be linked to geodetic position system WGS84 is the existing system used by GPS providing coordinates and that the location system map from there. This would provide a vendor neutral system. This provides an exchange format and can be accompanied by uncertainty data. Manny suggested addressing these parameters would permit an impressive demonstration at HIMSS12 and can be used to recruit CMMS and RTLS vendors. Examples based upon 20601: Production-Specification MDC_ATTR_ID_PROD_SPECN All valued subcomponents shall be sent as a series of attributes using MDC_ID_PROD_SPEC_UNSPECIFIED, MDC_ID_PROD_SPEC_SERIAL, MDC_ID_PROD_SPEC_PART, MDC_ID_PROD_SPEC_HW, MDC_ID_PROD_SPEC_SW, MDC_ID_PROD_SPEC_FW, MDC_ID_PROD_SPEC_PROTOCOL_REV, and MDC_ID_PROD_SPEC_GMDN Group Names: MEM_DEV_IDENTITY (include MAC address, vendor, model, sn, fw, sw, …) MEM_DEV_STATUS_OPER (operating, admitted, off) MEM_DEV_STATUS_PWR (on-ac-mains, off, on-battery) MEM_DEV_STATUS_CONSUMABLES (paper on a roll, toner, limited lifespan items) MEM_DEV_LOC_CURRENT MEM_DEV_LOC_LAST Add value set/library management Add "RTM" patch (update) - would reflect ISO/IEEE x73 updates Decisions/Issues: Action(s): Steve will provide a list of MEM data to Paul next week for discussion.
4	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):

Thursday May 12

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: John Garguilo reviewed the updated agenda and reminded the group about the IP policy and procedures (those attending had been present yesterday). NIST Test Tool Update: - John Garguilo described the NIST tools, including a review of materials provided at an earlier date. The slides are available at __________. John noted that there are four levels of validation: HL7, TF, RTM, test cases. Error types (10-15) “break” the standard or specifications (HL7, TF, hRTM, test cases) and alerts and warnings are also provided. - Julien Deshayes and Robert Flanders joined the meeting on Webex. - Julien led discussion of the detailed tool used by PCD for Pre-Connectathon testing. John noted that the tool permits testing “bad” messages as well as “good” ones for more thorough evaluation of the system under test (SUT). o Iona suggested that NIST not restrict the vocabularies and validation types not be overly constrained, since it will be of use in more general testing. John responded by indicating that there are options for the levels of testing. o John noted that they have added a “test management” process that includes developers establishing an account and their ability to review test results. Test developers can also access the reports and use them for Pre-Connectathon system test evaluation. o John indicated that test agents for DOC, DOR have been implemented and PIV actor test agents are in development. o John was asked how the developer can test interruption of communication. It isn’t obvious how that can be done over the Internet. Bikram suggested an applet. The test is provided for developer benefit, and is not required by the TF or Supplement. o John was asked about plans for use of the tool as the partner test system, and if messages stored by the tool can be used for that type of testing. John indicated this is planned for future development. o Al asked if AE evaluation can also evaluate the ERR segment. Julien responded this is optional and will be considered in the future. o John indicated that static testing will be used at the Connectathon as well. As the NIST tool increases test rigor it will require developers to address details not evaluated in Pre-Connectathon or Connectathon testing. - Sandra then led discussion of the RTMMS and described updates (see slides). This will be publically available in the future. o Users can view the tables, vendors can modify the tables, suggesting new terms, and the reviewer can participate in discussions through the tool. The administrator manages user accounts. o There are some legal issues due to use of IEEE standards. Access may require IEEE membership. This will be discussed next week. o Paul noted that errors are addressed through a complicated set of rules. These have not yet been incorporated in the tool and is essential when new terms are added. He requested that a baseline version be established and new terms be identified and quarantined until evaluated. o New terms from the IEEE PHD have been added to the 11073 data base. o Discussion followed about the PHD terms, Continua’s use of IEEE codes for RTM. - Sandra discussed future plans for the RTMMS database (see slides). Sandra and John then led discussion of the NIST Implementation Conformance Generator (ICSGenerator). - This will become more important when the tool is used to define device profiles in XML (see slides). o Private terms will also be supported. Clarification of limitations on the availability of these private terms to other vendors (e.g., EMRs) will be discussed at next week’s meeting. Paul asked how private terms from multiple devices on a single patient will be accommodated. Ken suggested that private terms should not be permitted. - ICSGenerator is useful as a way to define the device information model for a device. John noted that this is an “upstream” tool to help achieve profile as well as RTM conformance. - John Garguilo summarized the issues and benefits of using OIDs to identify PCD documentation. A significance issue is versioning. E.g., if a field was optional and becomes required; what happens when backward compatibility is not assured. He referred to work by John Rhoads and several slides. o Correspondence with Steve Moore indicate that this has not been addressed in the Connectathon, but portions of this are imperfectly addressed when documents go to final text (see slide titled Steve Moore’s Thoughts on the Issue). Rosetta Issues: - RTM will be referred to as a Constrained Value Set. - RTM versioning will be defined within Rosetta rather than within the TF. This Rosetta Infusion Pump Event Containment Hierarchy: - Paul described the table, noting that he sent the WP last week. He described the structure of the coding for events, noting that the events may have transitions such as start and end, providing interval data. The table identifies required and optional data. Enumerations may be required to address exceptions as vendors find exceptions. Vendors have defined the content models. Status flags may be used to indicate which data has a priority or is important for display. Questions include (a) where does the event identifier go in the message, (b) where will transitions be located (not presently in MDC). Paul noted analogies with ECG data (e.g., start and end of an episode of VFib). He noted and recommended that Timepoint: tpoint Interval Event: start, end, continue, stop, where stop differs from end (e.g., stop of infusion while fluid to be delivered remains) and continue is an update or data (e.g., waveform in another profile) within a continuing event (flow or arrhythmia). o Monroe asked how users or developers in the receiving/consumer end will be able to recognize that this content in a message is conformant , in addition to whether the upper level of the message is conformant as is currently done in the MSH. Paul noted that event identifier can include the pump VMD. Agreement is required to determine how events will be associated with the device or parameter type. John Rhoads suggested design goals that would provide a measure of harmony with how IEEE addresses events, how ACM addresses alarms, etc. Monroe noted that adding R40 distinguished events from observations. Al suggested an OBX be used to identify the message as an event. Paul noted that providing the identifier in the HL7 message can be seen as Top Level Event/Alarm Types with flavors of Event (embedded in PCD-01) Alarm (ACM) Annotation (embedded in PCD-01) Episodic Command (goes the other way) Decisions/Issues: Action(s):
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Friday May 13

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: Informal review of yesterday's summaries. placeholder Decisions/Issues: Action(s):
3	Agenda Items - As Noted	Status/Discussion: Decisions/Issues: Action(s):
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5	yyy -	Status/Discussion: Decisions/Issues: Action(s):