1. PCD Infusion Pump WG 2012 Spring Summit
Updated: Wednesday

2. Welcome to San Diego …
“America’s Finest City!”

3. IHE PCD Infusion Pump Spring Summit
Summit Objectives:
Establish the technical content and approach for the five Technical Framework Device Specialization Documents:
Device Specialization – General Content Module
DS – Infusion Pump – General Content Module
DS – Infusion Pump – LVP Profile Supplement
DS – Infusion Pump – Syringe Profile Supplement
DS – Infusion Pump – PCA Profile Supplement
Plan for document & profile development & prototyping
Review IHE PCD Technical Framework CPs
Challenges:
Time Management – Way more than a week’s worth of discussion!
Focus on technical issues – address editorial later …

4. IHE PCD Infusion Pump Spring Summit
Tuesday Agenda:
Q1:
Introductions & Agenda Review & Logistics
Review General Work Plan
Review Proposal Slide Deck (level setting)
TF Supplement Templates
Medication Administration Strategy White Paper
Call for CPs of Pump WG Interest
Q2:
Device Specialization – General Content Supplement
Device Online/Offline Status Event Reporting (in PCD-01)
Device Specialization – Infusion Pump – General Supplement
Q3 / Q4:
Device Specialization – Infusion Pump – LVP Profile Supplement
(Including IPEC Content Review)

5. IHE PCD Infusion Pump Spring Summit
Wednesday Agenda:
Q1 / Q2:
Syringe Pump Device Specialization
Review Diagram Updates
EC vs. DEC Charting Data
Q3 / Q4:
PCA Device Specialization
(Discussion agenda for each specialization)
Device Characterization & Use Cases
11073 Terminology & Model
Alarms w/ Evidentiary Data
Operational Modes & Event Semantics (w/ state/context data)
Auto-programming Support

6. IHE PCD Infusion Pump Spring Summit
Thursday Agenda:
08:00!!!
Q1:
Mixed Modality Modeling (e.g., LVP w/ PCA Module Attached)
PCIM Technical Review
Review PCIM use cases / requirements / Scope
Resolve technical direction
Establish profile elements & work plan
Q2 / Q3:
Future Development Cycle Proposals (e.g., drug library support, or intra-operative anesthesia pumps, etc.)
Review new term process, tooling & proposals
Pump-related CPs Review (2nd pass)
Review Summit Action Items & Work Plan
Adjourn by 15:00!!!

7. IHE Development Process

8. IHE PCD Profile Life Cycle
IHE Profile Cycle Stages
Open Date
Close Date
Learn More
Call for Proposals (2011)
July 2011
Sept 2011
Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr /Cycle_5_Proposals/
Profile Selection
Oct 2011
Dec 2011
Examples of Detailed Proposals:
ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr /Cycle_5_Proposals/
Profiles drafted in Committees
Feb 2012
May 2012
Public Comment on Supplement
June 2012
Call for Proposals (2012)
July 2012
Sept 2012
Trial Implementation (TI) Published
N/A
Aug 2012
ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkforTrialImplementation/
Test at Connectathon
H1 2013
N.A., EU, Korea, etc.
Update Profile TI
H2 2013
Re-Test at Connectathons
2014, 2015
Need minimum of 3 Test Cycles
Update Profile TI, Final Text
Public Comment on Final Text
Q1 2015
Q2 2015
Publish Final Text
Q3 2015
We are here!

9. IHE PCD Profiles

10. IHE Infusion Pump Device Specialization Profiles Technical Framework Considerations

11. Device Specialization – Infusion Pump
Why for a DS-IP Work Item?
Lack of consistency in how the same semantic content is reported from various vendors (terms & models)
Can’t conformance test for specific device modalities
IHE Integration Statement (IIS) language not clear per device modality
IP users have to look at a list of items for RFP language (not in their words “syringe pump profile”!)
IP users can’t easily identify what exactly has been tested (using IHE databases)
Not easily integrated into other profiles (e.g., PCC PW)
Challenges:
Consistency w/ The IHE Way
Minimize unnecessary work
Ensure extensibility to new modalities / capabilities

12. DS-IP: Anticipated Benefits
DS-IP “Success Factors”:
Stronger testing of specific device modalities
Especially semantic content testing & consistency
Devices identified clearly in testing results & IIS
Consumer (e.g., DOC) applications would be “simplified”
End users would benefit from knowing that the “widgets” that they are interested in have been validated … directly …
Easier uptake of PCD TF components, both in PCD & other domains
Extension to new device modalities (both therapeutic & diagnostic) – vents, physiological monitors, SpO2, … beds!
What will it take to define new DS-X’s?!
Value sets only?
When does it “justify” a profile?
Time lag / effort to develop specializations?

13. IHE TF Examples: PCC Perinatal Workflow (PW)
Actor Names:
DOR & AM … grouped?
Device Observation Recorder?
Device Gateway?
The Device Gateway Actor coordinates communication between the recording / viewing equipment and specialized monitoring (e.g., electronic fetal monitoring [EFM]) or treatment (e.g., Infusion Pump) devices.
Transactions:
Actor end points?
Direction? (e.g., PCD-05)
Typo
Specific devices:
Hearing Screening Device …
IHE PCC-PW (rev 1.1, ) Figure X.3-1 PW Actor Diagram

14. DS-IP: Scope & “Deliverables”
DS-IP Deliverables:
Define pump-specific semantic content modules:
Parameters (settings, observations, status)
Alarms / Alerts
Events
Bind to DS-G w/ IP guidance & constraints
Support device subtypes, including information models & value sets:
General infusion pump (incl. LVP?)
Syringe
PCA
Bind to existing transactions / foundational profiles:
DEC (periodic reporting)
ACM (alarm/alert reporting)
PIV / PCD-03 (device programming)
IPEC (event reporting)
Define new transactions (TBD)

15. IHE PCD TF Components
Note: 1st pass model – this may be broken into layers as more detail is added.

16. Flashback: PCD TF a la 2009 Very high level – “Devil in the details!”
Focus was on testing of transactions vs. semantic content
Device specializations seen as v3 content – messaging / transport a separate problem
Note: This was for discussion only – never balloted in PCD.

17. PCD Technical Framework - Today
Notes:
Read mostly top-down
Dotted ovals are TI versions
IPEC is intended to become EC
“Basic Models” includes TF-2 Appendix D
“Alarms” includes ACM alarm model + params
Narrow profile use?
DEC – Periodic updates
ACM – Episodic delivery to a clinician
EC – Episodic delivery to a system
Not shown are format specifications and content bindings …

18. PCD Technical Framework++?
Consider…
Specialized applications will focus on binding to existing general / foundational transactions
PIV left independent for historical purposes but will also be an option for DS-IP; should it remain standalone?
DS-IP content modules will include LVP, syringe and possibly PCA
IPEC => EC, with DS-IP[-xyz] including an EC binding to PCD-10 + DS-IP[-xyz] (events) content module.

19. DS-IP: Tech Framework Approach
Notes:
Agent / Manager … ?
OR … Specialize IP Actors per pump type
Profile dependencies are for required functionality
For dependent profiles, Initiating & Receiving Actors are “grouped” with IP Agent or Manager Actors
Event Communication (EC) an option or dependency?
OIDs (MSH-21) indicate content bindings + options
Content binding => New Transactions?
“PnP Connect” Option w/ DPI profile binding? How would that affect the Dependencies? Do they have DPI option?
This is still a tortured diagram …

20. DS-IP: Actors – Grouped & Fused
Notes:
Alternative to having single DS-IP-LVP Agent & Manager actors is to have a combination of grouped actors + a fused actor that combines all the functionality.
Grouped actors represent the binding between the profile transactions and the appropriate content model
This would allow for testing, for example, of the LVP specific alarm transactions separately from the DEC or EC transactions.

21. IEEE 11073 Stds. vs. IHE Elements
See draft diag. on next slide …

22. IEEE 11073 Stds. vs. IHE Elements
Slide-in-progress! (See previous slide…)

23. IHE PCD Technical Framework Supplements

24. NIST Test Tooling Support

25. NIST Test Tooling

26. NIST Test Tooling

27. NIST Test Tooling

28. NIST Test Tooling

29. NIST Test Tooling

30. IHE Medication Administration Clinical Integration Strategy White Paper

31. IHE Med Admin Strategy WP
Addressed by PIV Profile
Scope of the White Paper

32. IHE Med Admin Strategy WP

33. IHE Med Admin Strategy WP

34. IHE Med Admin Strategy WP

35. IHE Medication Administration Clinical Integration Strategy WP
White Paper Development Target: Summer ‘12

36. IHE PCD Technical Framework Change Proposal … Proposals

37. IHE PCD TF CP Discussion
Issues for Tech Framework CPs …
<see proposed TF CPs list>
<TBD> …

38. Device Specialization - General

39. Device Specialization - General
Review Volume 3 Content
Review TF-2
MSH Fields
OBX-18
Other?
Review System Objects Attribution
Coordination w/ MEM-CMMS Profile
Multi-patients per Box – Modeling Guidance
Additional information:
Device IP / MAC / AP addresses
I/F properties (BT, Ethernet … properties, state, etc.)
Switch between transports & reason
EC for DevMgmt – Clock Updated + source of change + new val.
Device online/offline status reporting in PCD-01

40. Device Specialization – Infusion Pump – General

41. DS – IP – General Device Specialization – Infusion Pump – General …
Review Volume 3 Content
General Considerations
VMD scope: per Delivery Channel?
OBX-18
Other?
Additional Content?
From PIV? …

42. Device Specialization – Infusion Pump – LVP

43. DS – IP – LVP Device Specialization – Infusion Pump – LVP …
Review Content from TF-3 Infusion Pump
Review IPEC Content
Review PIV Content
(from general DS discussions)
Device Characterization & Use Cases
11073 Terminology & Model
Alarms w/ Evidentiary Data
Operational Modes & Event Semantics (w/ state/context data)
Auto-programming Support …

44. Device Specialization – Infusion Pump – Syringe

45. DS – IP – Syringe Device Specialization – Infusion Pump – Syringe …
Device Characterization & Use Cases
11073 Terminology & Model
Alarms w/ Evidentiary Data
Operational Modes & Event Semantics (w/ state/context data)
Auto-programming Support …

46. Device Specialization – Infusion Pump – PCA

47. DS – IP – PCA Device Specialization – Infusion Pump – PCA …
Device Characterization & Use Cases
11073 Terminology & Model
Alarms w/ Evidentiary Data
Operational Modes & Event Semantics (w/ state/context data)
Auto-programming Support …

48. Additional Considerations

49. PCD TF Issues: “Fused” DOFR?
Discussion:
Should a fused DOFR actor be defined for DEC?
Companies today implement DOFR
NIST testing assumes a DOFR
Making the change would:
Reflect reality!
Simply IIS …

50. PCD TF Issues: Containment
Question: How should static containment information be sequenced in a PCD-01 message?
Message Header
MDS
Channel #1
Parameters
Channel #2
Option 1: Interleaved
Message Header
MDS
Channel #1
Parameters #2
Channel #2
Parameters #1
Option 2: Containment Block + Parameter Block
Option 3: 1 Source/Delivery Set / Message (+ #1 / #2)
Discussion:
PCD TF should make some statement
Option #1, #2, #3 or all of the above?
Pros & Cons for DOR vs. DOC?
Choosing one would simply implementations
Is it too late to choose?
Message Header
MDS
Channel #1
Parameters #1
Message Header
MDS
Channel #2
Parameters #2

51. PCD TF: OID Allocation Content:
Bring in basic table w/ architecture from wiki
Discussion
Use multiple OIDs in MSH-21 to identify specifications for message, starting with PCD-x conformance spec + options + semantic content “modules” + …
Identify other OID bindings to HL7 v2 messages + CDA documents
Identify other OID usages … ???
Does OID architecture follow IHE TF object model?
OIDs should be associated objects / classes in the preceding UML model …

52. Issues – To Be Considered
Topics for future discussion:
<see proposed TF CPs list>
<TBD> …

53. PCD Rules!

54. <heading>

55. <heading>

56. Additional Slides

57. IHE TF Examples: XDS.b “Import” existing actors & transactions
Optional grouped or “fused” actor
Profile “options” include:
“Mandatory” / conditional options
Capability extensions
Transport options

58. IHE TF Examples: RAD XDS-I.b
Grouped XDS + Imaging Actor
Basic XDS Actors
New XDS-I Actor
IHE XDS-I.b PCC-PW (rev 1.2, ) Figure Cross-Enterprise Document Sharing for Imaging Diagram

59. IHE TF Examples: XDS-MS

60. IHE TF Examples: CIRC
Cardiac Imaging Report Content (CIRC) – …

61. IHE TF Examples: CIRC
CIRC: Content Modules … Constraints … Value Sets …

62. IHE TF Examples: CIRC
CIRC: Content Modules … Constraints … Value Sets …

63. IHE TF Examples: PAM
Actor grouping required so that ITI-31 can combine both identity & demographic information.

64. Example: Draft PCD ADQ Diagram
How do Device Specializations relate to ADQ?
“Medical Device” = DS-x?
Option for DS-x?