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

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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: 2010.03.17


Number Action Owner Participants Due Date Priority Status Comments
1 HL7 (v2/v3) Infusion Med Admin Extension Proposal Meyer Al, Jeff, Khalid, Ruth, Todd 2010.08.31 . OPEN Develop a proposal to HL7 to extend both v2 messaging & v3 to support a more extended set of infusion pump medication administration orders. Initial proposal review shall be during the first infusion pump WG meeting after HIMSS '10 on Wednesday 2010.03.10. Target is to submit a proposal in time for consideration at the 2010 May HL7 meetings in Rio.
2 FDA Interop Workshop Link Cooper ... 2010.02.22 . CLOSED Post a web link for the presentations at the FDA Interoperability Workshop 2010.01.25-27 when it has been made public.
3 PCD Users Guide Comments Sparnon Jeff, Todd 2010.03.24 . OPEN Post the Users Guide public comments based on the Pump Summit discussions to the RSNA site (www.IHE.net Handbooks page has link). Key considerations include:
  • Organization to make it easier for care providers to quickly get the information they need to make evaluation and purchasing decisions. (e.g., a "capability" (per HITSP/TN905) or "device modality" focus)
  • Create a map for locating clinical requirements within the IHE handbook, possibly as a separate appendix titled "Clinical Considerations".
  • Extend the RFP templating language - perhaps coordinate with ECRI in drafting & publication of statements
4 FDA "de novo submission" Support Cooper / Sparnon Gary, Jeff, Khalid, Pat 2010.04.07 . OPEN Investigate the possibility of participating in the proposed FDA "Thing" Trial Submission, based on IHE (PCD) interoperability profiles supporting enterprise integration. This may be based on the medication administration diagram (see presentation at the Summit).
5 Update Infusion Terms in the Rosetta Lunde Al, Fred, Kristina, Pat, Todd 2010.04.14 . OPEN Update the infusion pump terms in the Rosetta tables, including:
  • Assignment of term codes for the MDC_ATTR_AL_COND enumerations
  • Units (incl. proposed from Al)
  • <alarm proposals>
  • <event proposals>
  • <parameter proposals>
NOTE: Lunde - check which other term codes are missing ...
NOTE 2: There is a follow-on task of formalizing the semantic content in the Rosetta once the content has been specified.
6 Clarify TF vol 2 re. 11073/Rosetta Usage Cooper / Rhoads ... 2010.04.07 . CLOSED Clarify in the PCD technical framework volume 2 appendix D the requirement to use 11073 semantics + those contained in the harmonized Rosetta tables.
7 IOP/IOC "Source of Truth" Sync Meyer Al, Colin, Erin, Khalid, Rinda, Todd 2010.05.01 . OPEN Update the PIV supplement to address synchronization issues when parameters in a PCD-03 are not actioned by the IOC. Updates include:
  • Develop use case scenarios to better define the problem space.
  • Add text describing the "source of truth" problem and need to address both in system interface design + clinical workflow / policy definition. For example, the clinician may need to be alerted on both systems
  • IF PCD-03 parameter(s) are not acted upon in the IOC, an application error should be returned indicating the error condition. This response may (optionally) include the actual value that was used on the pump.
  • HL7 Table 0533 (in the supplement, section 3.3.5.3) needs to be extended to include these conditions, including rate mismatch ("dose rate differs from drug library starting dose")

Additional Issues:

  • (Meyer) to determine ability to signal the issue in the application ack w/o signaling an error.
  • Mechanism for the IOP to override a parameter based on clinician input. Determine need / approach.
  • Determine whether a set of events (vs. PCD-01 parameter updates) could be used for critical sync issues or parameter change notifications.
  • Evaluate benefits of an IOC always issuing an enhanced ack, regardless of error condition presence.
8 Clarify Reporting of Parameters based on device operational mode Cooper / Rhoads Brad 2010.03.24 . OPEN Clarify the Technical Framework vol 2 wording around the reporting of parameters that are either out-of-scope (based on the device's operational mode & state) or questionable status. Approach should be:
  • If the value is displayed, it should be reported
  • If it is out of scope, the DOR may choose not to report it and omit the OBX
  • If it does include the OBX, appropriate status should be included (e.g., based on special values such as NaN, MetricStatus or MeasurementStatus ... from the 11073-20101 & 11073-10201 standards).

For example, if the device has a Patient Weight but it is not used based on current operational programming, should it be reported?


9 NIST HL7 Validation Tool Feedback Lunde Todd 2010.03.10 . CLOSED Provide feedback to NIST regarding experience using the HL7 validation tool during the 2010 Connectathon cycle. Feedback should include:
  • Copy & paste into tool window is ... painful and time consuming. A more automated approach would be very useful.
  • Dynamically updating tables (e.g., patient names) or turning off / reducing alert level of certain conditions would facilitate tool usage.
  • ...
10 IHE PCD 2010 May F2F Agenda Cooper Al, Gary, Jeff, Khalid 2010.05 . CLOSED Include on the IHE PCD 2010 May F2F agenda:
  • Review infusion pump model definitions as formalized in the NIST ICSGenerator tool.
  • Concurrent delivery (multiple simultaneous channels) pump discussion
  • ...
11 Update enhanced ACK handling PCD TF vol 2 FX Al, Brad, John R., Kristina, Ruth, Todd 2010.06.18 . OPEN Update the IHE PCD Technical Framework volume 2 to:
  • Reference HL7 v2.6 2.9.3 in the TF's discussion of acknowledgement handling.
  • HL7 standard practice is that the enhanced ack is returned on a separate channel / pipe.
  • Provide an example of the workflow around an IOP-IOC-Pump interaction.
12 Coordinate PIV Supplement Updates w/ TF ver 2.0 Drafting Rinda John R., Ken, Todd 2010.06.01 . OPEN Ensure that supplement updates to PIV are coordinated in the version that is being rolled into the updated technical framework (for trial implementation).

NOTE: This item is contingent on completion of #7 above.

13 PCD-02 "one shot" Specification Lunde Al, Gary, Kristina, Paul 2010.06.18 . OPEN The current PCD-02 specification does not detail how a "one shot" function should be implemented. The spec should be updated to:
  • Specify the approach for "one shot" usage. Note: a current practice is to utilize subscription start and end times, where the effective window is shorter than the update period.
  • Clarify what happens if no filter specification is active.

Note: Review filter predicate proposals from the IHE PCD F2F meetings 2008 October for possible inclusion in this update activity.

2010.03.17 See notes from the group's weekly discussion.

2010.06.09 CP currently out for ballot

14 Develop Event Comm Transaction Proposal Cooper Al, Brad, Colin, John R., Khalid, Kristina, Paul 2010.06.30 . OPEN Based on the Summit discussion, further investigate event reporting options and propose a direction at the 2010.03.10 Pump WG WebEx meeting. Options include:
  • As part of DEC using existing actors
  • As part of DEC w/ Event Reporter actor
  • As an option of DEC: Event Communication

The proposed transaction (PCD-99) is tailored for for episodic event communication using ORU^RO1, possibly using MSH message type OID to identify event message (vs. yet another trigger), to support CDSS & workflow automation types of applications

Additionally,

  • Update DEC language for usage of PCD-01 to report events for data logging / archival purposes vs. -99
  • Use the same data formatting (i.e., OBX sequence) for both PCD-01 & -99 transactions
See Summit notes for additional information.
15 Develop Infusion Pump Event Content Proposal Cooper Al, Anna, Brad, Colin, Erin, John R., Kristina, Pat, Paul 2010.06.30 . OPEN Develop a proposal for the infusion pump event set + content, factoring in...
  • Event model developed by the Infusion Pump WG during the 2009.10 F2F meetings in Dallas
  • Additional event content discussions during the 2010.02 Summit
  • Early set of proposed events from consumer applications (e.g., from Epic & GE)
  • General event comm. modeled approaches based on 11073-10201 Information Model
  • Coordination / input from the ICE-PAC group & extended set of "consumer" application vendors (e.g., VA, Meditech, etc.)
16 Develop Basic Program/Mode-based Reporting Proposal Cooper Al, Brad, Colin, Erin, Fred, Kristina, Pat 2010.06.30 . OPEN Based on the discussions to date, develop a proposal for reporting basic infusion therapy / mode-based data model & messaging. Initial focus is on primary, piggyback & bolus. Additional therapies factored in subsequently.
17 <tbd> <dude> <group> <2010.02.16> . OPEN ...
18 <tbd> <dude> <group> <2010.02.16> . OPEN ...
19 <tbd> <dude> <group> <2010.02.16> . OPEN ...
20 <tbd> <dude> <group> <2010.02.16> . OPEN ...
21 <tbd> <dude> <group> <2010.02.16> . OPEN ...
22 <tbd> <dude> <group> <2010.02.16> . OPEN ...
23 <tbd> <dude> <group> <2010.02.16> . OPEN ...
24 <tbd> <dude> <group> <2010.02.16> . OPEN ...
25 <tbd> <dude> <group> <2010.02.16> . OPEN ...
26 <tbd> <dude> <group> <2010.02.16> . OPEN ...
27 <tbd> <dude> <group> <2010.02.16> . OPEN ...



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