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: 2009.06.17 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	2009.07.01		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]
2	PCD MWB Message Profiling Methodology	Ioana	Garguilo	2009.07.01		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	2009.07.01		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.
4	HIMSS 2010 Education Session Proposal	Sparnon	Meyer, et al.	2009.05.29		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	2009.07.01		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.
6	Work flow-Based Scenario Document Discussion	Rinda	PCD PC	2009.07.01		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	2009.06.24	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
8	Multiple OBR Support	Rhoads	Berge, PCD TC	2009.06.15	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.
9	CP for Required RXG Fields	Rinda	PCD TC	2009.06.24	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.
10	EUI-64 Compliance for 2010 Connectathon	Rhoads	PCD TC	2009.07.01		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.
11	Infusion Pump Model MindMap	Cooper	Rhoads, I/P WG	2009.07.01		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	2009.06.15		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.
13	CP for RXR-3	Rinda	I/P WG	2009.06.15	HIGH	OPEN	Update PIV specification for RXR-3 to: Support "RE" instead of "R" Support "syringe"
14	I/P CP Wiki	Rinda	CP Owners	2009.06.15		OPEN	Create a wiki page to capture and discuss PIV-related Change Proposals. [2009.06.17] Rinda/Cooper/Rhoads will coordinate on best way to manage and track these CPs during development. During CP development, Jeff will maintain the working documents on the Google Groups page and Infusion Pump CP working folder. Ultimately the CPs will be posted to the IHE PCD FTP CP folder, per the process detailed on the IHE PCD CP Process wiki page.
15	PCA Semantics	Khalid/Rinda	I/P WG	2009.06.15		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. <Jeff - add links here?>
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.
17	Review of ICE-PAC Infusion Pump Clinical Work Flow Analysis	Cooper	ICE-PAC & I/P WGs	2009.07.01		OPEN	The IHE PCD ICE-PAC joint working group has completed a significant amount of analysis on PCA clinical workflow, starting with clinical scenarios and working to detailed connectivity & informatics requirements. A general overview of the analysis work should be provided to the infusion pump working group, especially since it would provide strong motivation for future infusion pump activities. The overview will provide: Review of the analysis process and work products that were developed during the ICE-PAC work Specific analysis for infusion pump modalities and infusion therapies. Note: Please respond to the Doodle poll to schedule this review session during the last week of 2009.06
18	PCA Discussion Engagement	Meyer	I/P WG	2009.10.05		OPEN	Engage additional clinicians & vendors to discuss needs and requirements around PCA therapies. NOTE: This should be completed after the ICE-PAC analysis overview identified above.
19	HL7 v2 ID Binding Options	Rhoads	PCD TC	2009.06.15		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.
20	Identify HL7 v2 Options for PCA Order Support	Berge	Rhoads, I/P WG	2009.10.05		OPEN	Identify the options for using HL7 v2 to communicate PCA-related order information. For example, investigate the use of Parent/child orders Composite order sets ... Note: Ruth will post a query to the HL7 O&O group for input.
21	Examples of PCD-01 event/alarm support	Cooper/Rhoads	...	2009.07.01		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	2009.07.01		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).
23	Pump Semantics Wiki Pages	Cooper / Rinda	...	2009.07.01		OPEN	Set up wiki pages to enable tracking & discussions for: Infusion Pump Term Gaps Infusion Pump Specialization (model) Infusion Pump Therapy "Recipe" Model Discussion NOTE: There should be a top-level wiki page for Device Specializations pointing to pages for specific modalities such as Infusion Pumps.
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	2009.06.15	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.
26	CP for DEC OBR-4	Berge / FX	...	2009.06.15	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.
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	2009.06.24	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!