PCD Device Infusion Pump Action Items Archive 2010-12-31

Notes

• Items in the table below are not in priority order - they are in the order of the discussion during the F2F meetings.

• Priority of HIGH indicates items that require completion in order to be included in change proposals for the current cycle.

• Updates to individual items are included in the Comments section.

Last Updates Posted: 2009.07.08 WebEx Discussion (updates in bold italics)

Number	Action	Owner	Participants	Due Date	Priority	Status	Comments
1	Enterprise PnP Discussion Topic	Cooper	PCD TC & IHE DCC	2009.07.15	.	OPEN	During Garguilo's NIST update , the topic of expanded "lower layer" coordination (beyond the HL7 MLLP * ) was brought up as a key area in which to engage. This is similar to the "enterprise plug-and-play" or discovery capability that Jan Wittenber presented during the recent F2F meetings at NIST (Friday, 2009.05.08). Todd will (a) add the discussion topic to the IHE domain coordination committee's list; and (b) add it to the PCD discussion topics list. Note: this may result in additional profile proposals for consideration in the fall. * "MLLP" = Minimal Lower Layer Protocol; a "minimalistic OSI-session layer framing protocol"; see HL7 documentation, including [1] [2009.07.01] Todd will ensure item is on the DCC meeting for 2009.07.14 (if possible at this date; otherwise the next meeting)
2	PCD MWB Message Profiling Methodology	Ioana	Garguilo	2009.07.15	.	OPEN	Given the number of PCD transaction messages targeted for registration and how that will be used in the PCD profile testing framework, a common methodology, set of principles, or template should be established to ensure consistency between the message formalizations and to ensure that they will be fit for purpose.
3	FDA Engagement Strategy	Cooper	Sparnon	2009.07.15	.	OPEN	During Erin's ECRI presentation, she stressed education including the FDA. It was clear, though, that their contacts and entry points are different from those of the PCD group. This action is to compare notes and make sure that we are inviting and engaging the right set of participants and to see if there is additional information that can be provided or events that can be hosted. Todd mentioned that the FDA has also reached out regarding medical device informatics standards and understanding how they may be incorporated into the regulatory framework. Also there is the deferred "regulatory considerations" white paper that may be considered as well. [2009.07.01] Todd will coordinate with Erin.
4	HIMSS 2010 Education Session Proposal	Sparnon	Meyer, et al.	2009.09.01	.	OPEN	Erin is developing an educatitonal session proposal for HIMSS '10 and solicited support from group members to help complete the proposal. Status Update: Info provided to Erin; submission made to HIMSS (deadline 2009.05.29); pending acceptance of proposal, the WG will provide additional support as needed / requested. [2009.06.17] Erin still waiting to hear back for confirmation from HIMSS.
5	Extend Call for Participation	Cooper	Sparnon	2009.07.15	.	OPEN	Erin will provide additional infusion pump companies that Todd can contact and encourage to participate. [2009.06.17] Todd will follow-up on information provided by Erin. [2009.07.01] Todd will coordinate Calls with Manny.
6	Work flow-Based Scenario Document Discussion	Rinda	PCD PC	2009.07.15	.	OPEN	There is a need for better coupling of workflow usage (profile) for a given set of PCD & IHE profiles (possibly, a workflow-based use case scenario document (e.g., if you want the infusion start time, look at this OBX field XYZ...)). It could be a document that is organized according to clinical workflow/use cases. This should be added to the IHE PCD Planning Committee discussion agenda. May be implemented as a registry of ICE-PAC-esque clinical workflow analyses. NOTE: Information provided by Rinda to Sparnon re. HIMSS presentation proposal is an example of the potential document content.
7	CP for ORC-2	Berge / Meyer	PCD TC	2009.07.15	HIGH	OPEN	Ruth & Gary will draft a Change Proposal for ORC-2 (PCD Technical Framework vol 2. p. 48, lines 8-20) that will address: Update the text to reflect that ORC's are now used (e.g., in the PIV profile). PIV does have a Placer Order that can be associated with the PCD-O1 stream. Ensure that the "standing order" scenario is addressed (e.g., for a gateway implementing the DOR/DOF actors). [2009.06.17] Will discuss CP proposal at the next WebEx discussion [2009.06.24] Reviewed the CP file on the ftp directory (PIV_ORC_2_20090609.DOC). Gary & Ruth are currently updating this file. Ruth will post an updated file in a few days. [2009.07.01] New file will be posted by Ruth / Gary by the end of this week; Todd will post to the web.
8	Multiple OBR Support	Cooper	Berge, Rhoads, PCD TC	2009.07.15	HIGH	OPEN	A single infusor can accommodate multiple orders (one per OBR) at the same time. Need to choose: 1. Multiple OBRs per PCD-01 update 2. Add an Order # semantic in the Source Channel data set, that can then be reported explicitly as an OBX segment. Determine issues & conventions (e.g., within IHE) around the use of OBRs and multiple OBRs per message. For example, to report operational status snapshots across all infusion channels. [2009.06.17] Rhoads indicated that multiple OBR's are not an issue within the current Technical Framework. Will coordinate with Ruth Berge (GE) on this item. [2009.06.24] Todd to coordinate with Ruth on the Source Channel Order # parameter.
9	CP for Required RXG Fields	Rinda	PCD TC	2009.07.15	HIGH	OPEN	Draft a Change Proposal for PIV that RXG-17, -18, -23 & -24 are required for a specified class of medications. Note that the "Give Code" refers to the medication ID for the infusion pump - many pharmacy systems only pass medication ID (i.e., what is scanned from a infusate bag). A key issue is that "RE" implies there is a condition when it can / cannot be valued. Problem is that the value typically has to be retrieved by the BCMA system - and is usually not automatically provided. [2009.06.17] Reviewed the CP document. Group should review it off-line in detail and post comments back to Jeff for review during the next WebEx. Note: PIV 1.1 published, a next CP-version (units) was published, but was never incorporated into the 1.1 version + never submitted for public comment. This will be addressed during the current CP processing. [2009.06.24] Jeff will re-issue the document with changes per the group review / discussion. [2009.07.01] Document has been completed but needs to be reviewed by the group; comments should be provided by next week.
10	EUI-64 Compliance for 2010 Connectathon	Rhoads	PCD	2009.07.15	.	OPEN	The IHE PCD Technical Committee has to determine ASAP the level of required compliance for usage of the EUI-64 identifier by profile implementations going forward (e.g., for testing in the 2010 Connectathon). This should be added to the TC (and PC?) agenda, open issues / TF clarifications identified and CP's - if needed - submitted and balloted. NOTE: Schedule WebEx discussion 2nd half of June. [2009.06.24] Rhoads will schedule an initial discussion the first 1/2 of July. Invitations will be sent out to the Planning and Technical Committees. This session will identify the issues around rigorous use of EUI-64s, propose how to address these issues, and provide a forum for discussion. [2009.07.01] Rhoads will get discussion added to 2009.07.15 IHE PCD PC Agenda; issue needs to be discussed both in the broad IHE PCD PC & TC groups as well as within the Infusion Pump WG with particular focus on PIV. There are two main issues: How should EUI-64 usage be addressed within the PIV profile? What will be required for the 2010 Connectathon? (In otherwords, "ultimate goal & transition plan")}
11	Infusion Pump Model MindMap	Cooper	Rhoads, I/P WG	2009.07.22	.	OPEN	Develop an updated version of the infusion pump device specialization information model, based on the ISO/IEEE 11073-10201 domain information model, that can provide a template for application to: Specific infusion pump configurations ICS Generator "template" file and device-specific versions PCD-01 OBX-4 valuation & sequences Event support (incl. pump state transitions + alert/alarm events, both for archival (DEC processing) & annunciation (ACM processing) & PoC annunciation (DPI processing). NOTE: Schedule a review in July.
12	Syringe Pump Semantics	Cooper / Khalid	Schluter, I/P WG	2009.07.15	.	OPEN	Establish a set of syringe pump semantics. Coordinate with infusion pump model (see above) Coordinate with the Rosetta tables Identify additional syringe pump events Determine whether syringe type & size is needed (e.g., by EHR systems) and whether it is provided by any syringe pumps and / or from pump servers. [2009.06.17] May move this discussion to the October F2F. [2009.07.01] Question: Is there a clear user need identified for this information? Decision: Provide the semantics in the Rosetta for reporting IF a vendor has; consumers can use IF they want the information. Gary posted a document proposing a new HL7 segment to carry this information. Once the group has more experience with syringe pump profiles, a more "normative" profile could be developed with stronger implementation requirements.
13	CP for RXR-3	Rinda	I/P WG	2009.07.15	HIGH	OPEN	Update PIV specification for RXR-3 to: Support "RE" instead of "R" Support "syringe" [2009.06.24] In process...
15	PCA Semantics	Khalid/Rinda	I/P WG	2009.07.22	.	OPEN	Add support for PCD-01 reporting of PCA-related semantics: settings, status & events. [2009.06.17] Jeff will publish a document on the GG file page + FTP folder. http://groups.google.com/group/ihe-pcd-infusion-pump/files ftp://ftp.ihe.net/Patient_Care_Devices/Devices/InfusionPumps/2009_CP_Documents [2009.06.24] Jeff posted a document to the GG folder. Khalid will update that document, and will coordinate with Gary to incorporate information from mthe ICE-PAC workflow diagrams. [2009.07.01] Merge with Action Item #18 Gary has made proposals to the HIMSS Pharmacy group; however, given the current focus on the U.S. ARRA/HITECH legislation, there has been little response. Ruth has determined that there is little use (at the presence) in pursuing this with the HL7 O&O group, which is currently focused on ballot resolution. Khalid has reviewed and agrees with the PCA semantics document posted by Jeff Rinda. Regarding the Events List at the end of that document: - (a) Extend the list for addition to the Rosetta - though not require immediate (e.g., 2010) implementation. - (b) Coordinate with workflow "events" resulting from the ICE-PAC clinical workflow analysis. - (c) Communication of these events using PCD-01 or PCD-04 or PCD-xy is TBD Using ACM (lowest non-alert priority) is prefered for general event communication where the consumer may need to respond to the events. ACTION: (Todd) Add ICE-PAC joint discussion prep. agenda item to the 2009.07.22 Agenda.
16	Infusion Therapy Recipe Model Review	Cooper	I/P WG	2009.09.01	.	OPEN	Provide a review to the Infusion Pump WG regarding the potential application of the draft Infusion Therapy Recipe Model (from the 11073-10301 draft infusion pump specialization standard) for future standardization of infusion pump standardization. NOTE: This initial discussion should occur before the 2009.09 standards meetings in Atlanta.
19	HL7 v2 ID Binding Options	Rhoads	PCD TC	2009.07.29	.	OPEN	Identify the options and IHE conventions for using HL7 v2 to bind orders to patient IDs to device IDs. (Todd) Post a query to the IHE HL7 Review Task Force. Standing orders worked for general DEC reporting; however, they do not work for transactions that are the direct result of an order, such as PIV. The resulting PCD-01 updates need to reflect the triggering order. Need to accommodate switches from Channel A to Channel B Develop a CP or Brief Profile Proposal to add this to DEC. NOTE: See #27 Below for a related action item. [2009.06.17] Decision that a Brief Profile Proposal should be developed for this.
21	Examples of PCD-01 event/alarm support	Cooper/Rhoads	...	2009.07.15	.	OPEN	Provide examples of how PCD-01 may be used to communicate device event and alarm information - for archival purposes. This will be based on content from the PCD TF vol 2, section D.2.
22	Infusion Therapy Info to EHR Discussion	Colin FX	I/P WG	2009.07.15	.	OPEN	Identify what infusion therapy information is of interest to EHR vendors, especially state transition events. For example, infusion start/stop times. NOTE: This information should then be updated to the infusion pump model (see above). [2009.07.01] Todd will follow-up with Colin.
24	ORU vs. RAS Evaluation	Berge / Meyer	Engelbert, Rhoads, Rinda	2009.10.05	.	OPEN	Evaluate the PRO's & CON's associated with using ORU or RAS messages for communicating medication semantics. AFTER feedback from PCA Semantics & HL7 support discussion (see above) Confer with HL7 ver 2.6 Chapter 4, section 4.6: Pharmacy/Treatment Transaction Flow Diagram
25	Resolve Original vs. Enhanced HL7 v2 Msg ACK	Berge / Cooper / Rinda	Rhoads, I/P WG	2009.07.15	HIGH	OPEN	The PIV group prefers to use HL7 ver 2 Enhanced Message Acknowledge rules; however, the draft ITI Annex on IHE-wide HL7 profiling guidelines (as well as the IHE PCD TF w/ proposed updates) limits transactions to Original ACK rules only. (Todd & Ruth) Confer with the HL7 Review Task Force to see whether Enhanced ACK could be used. (Ruth) Generate a CP to the PCD TF, if the change is allowed (Jeff) Develop an initial list of possible error messages that might be associated with PIV transactions and returned in message ACK responses. [2009.06.17] Todd & Ruth to coordinate with IHE groups re. "permission" to use the enhanced ack rules. Jeff reviewed his draft "error messages" document. The group will review & extend this document. [2009.06.24] Ruth submitted a CP to the ITI group to change the HL7 conventions to say the Working Group that is developing a given IHE profile should be able to decide the best ACK mode to use (Original or Enhanced). She will provide a copy of this CP to the group. Ruth & Gary will develop a CP for PIV to capture the proposed ACK approach. [2009.07.01] CP's have been submitted (by Ruth & Gary); group should review the file and e-mail feedback to the group. Add the erorr messages "gap" to the term gap wiki page table.
26	CP for DEC OBR-4	Berge / Colin FX	Gary	2009.07.15	HIGH	OPEN	Develop a CP for DEC vol 2 (B.7) to recommend use of Give Code information (supplied in the PCD-03 RXG-4) in the PCD-01 OBR-4 when used to feed back information resulting from a PIV transaction. [2009.06.17] Group reviewed file provided by Ruth. There were questions about the meaning of various proposed wording changes. Review with Ruth during the next discussion. [2009.06.24] Todd will upload the most recent (reformatted) file; Gary & Ruth will coordinate on an updated version of this file, esp. to include comments from other companies such as Epic/Colin FX. [2009.07.01] Files posted (Todd should fix the file name); group should review and posted feedback to the group via e-mail.
27	Profile Proposal for PoC ID Binding Profile	Khalid	PCD PC	2009.09.01	.	OPEN	The group reaffirmed an action item that was taken at the PCD F2F @ NIST 2009.05.04 - 08 (Action Item #10) to develop a profile proposal around the point-of-care binding of IDs (transaction(s) + data sets). This would be the PoC compliment to the DEC-PIB combination.
28	CP Process & Schedule Coordination	Rhoads	Cooper	2009.07.22	HIGH	OPEN	John & Todd will review the CP process & current IHE PCD schedule to ensure that CP authors & the Infusion Pump WG understand what has to be completed and when. NOTE: CP drop dead date is 2009.07.15! [2009.06.24] Rhoads will investigage the CP Process when a set of related changes apply to different profiles. For example, is this a single CP file or multiple files that are submitted in parallel, and if the latter is the case, then what happens if / when one CP is approved but others are not? How is this coordinated? Etc.

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