PaLM F2F Minutes 2016-Nov 09-11

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Recording

The recordings for this meeting can be downloaded here:

• Wednesday, 09 November 2016:
• Thursday, 10 November 2016:
• Friday, 11 November 2016:

Attendees

Name	Company	09-Nov	10-Nov	11-Nov
Raj Dash	CAP, planning co-chair	X	X	X
Gunter Haroske	IHE Germany	X(tc)	X(tc)	X(tc)
Ed Heierman	Abbott	X	X
Naomi Ishii	JAHIS / Hitachi High-Tech	X(tc)
John Hopson	Abbott	X	X	X
Mary Kennedy	CAP, board representative	X	X	X
Carolyn Knapik	CAP, secretary	X	X	X
Megumi Kondo	Sakura Finetek Japan	X	X	X
Laurent Lardin	bioMerieux	X	X	X
Alessandro Sulis	CRS4	X(tc)	X(tc)	X(tc)
Francois Macary	Phast, technical co-chair	X	X	X
Juho Yamamoto	IHE-J (NIHON KOHDEN)	X	X	X
Riki Merrick	APHL, planning co-chair	X	X	X
Filip Migom	MIPS	X	X	X
Dmytro Rud	Roche	X(tc)	X(tc)	X(tc)
Kenichi Takahashi	JAHIS (Hitachi High-Technologies)	X	X	X
Francesca Frexia	CRS4	X(tc)
Francesca Vanzo	Arsenal IT	X(tc)	X(tc)	X(tc)
Sabrina Krejci	CAP	X	X	X
John David Nolen	Cerner	X	X	X(tc)
Andrea Pitkus	IMO	X	X	X
Dan Rutz	Epic	X	X	X
Doug DeShazo		X(tc)
James Wulkan	Beckman Coulter	X(tc)		X(tc)
Victor Feria		X(tc)
Ross Simpson	CAP		X(tc)
Rich Moldwin	CAP		X
Sam Spencer	CAP	X(tc)	X
(tc) = Teleconference

Action Items/Wrap-Up

Action Items/ Wrap - Up

SET:

• Have defined all use cases, will add on the derived specimen – complete Vol 1 by Dec 2016 and review on that call
• create first draft of Vol 2 data model for Jan 2017
• publication for public review in Fall 2017 – aim for end of Sept beginning of Oct 2017 to have 1 month to collect comments and review at F2F meeting

LSH:

• Write Vol 1 and Vol 2, make it coincide with the SET publication
• Update profile document on wiki
• Contact Gazelle team regarding simulator testing

LCC:

• Aim for April 2017 for group review
• Timeline dependent on HL7

APSR 2.0:

• Aim for summer, but Call for Proposals comes out 11/15/2016
• Proposals due by 12/31/2016

Blood bank

• Review at January meeting
• Selection Feb 8, 2017

PaLM Milestones updates

• # of supplements = 4
• publish 9/18; give longer review period, so close date of 10/23
• publish supplements Jan 8, 2018 with no republication requests
• 1 TF, publish June 2017
• white paper – remove from 2016 table and plan on publishing Dec, 15, 2017

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Minutes

Minutes November 09:

Welcome

Introductions All Around

Election Update: New Co-Chairs are Francois for Technical and Riki for Planning

 

International meeting Update - please pay dues for 2016/17 if not yet done

 

IHTSDO Update  

• There has not been anything new
• Any “observable entity” we want to add to SNOMED CT for lab needs to go to Regenstrief. LOINC is the terminology for observables.
  • This will need follow up – not sure if this applies to specimen type and related terms
• The question was more about the development license that IHTSDO has with HL7 and use of the SCT codes in guides
• Discussion about LOINC, SCT, or data element registry use

 

SET profile review (attach SET_F2F_Chicago_NOV2016.pptx)

• Example of macro activities = in vitro diagnostic testing of the specimen: need to process specimen prior to testing
• Whose scope is it to define the specimen collection event? We will need to identify the information to be tracked about the specimen collection – need to do that for all events – important use cases would be referral between labs or specimen collection from a patient
  • The scope of IHE profiles is the interaction between 2 systems, but not how that information is used in the systems
• Pathology workflow should be generic = derivation of specimen, as it also applies to micro
• Keep “aliquots” separate from “derived”
• Should be valid for both Anatomic Pathology (AP) and Clinical Pathology (CP)
• Specimen retrieved – (query initiated and when specimen is shipped)-  need to decide if the use case starts with the retrieval part or should it include the query
• How do we deal with the unexpected event? Do we need to cover when specimen was dropped but not rejected?
• Other specimen event - design to allow collection of unexpected events/ exception handling
• Regarding LSH – need to support  every potential scenario
• Specimen collection use case #1
  • Part of the LBL profile is the creation of the specimen container, but pretty specified for just the labeling part, so created this profile
  • In the specimen collection event could include comment on exception (for example the collection volume is not what is expected and a reason for that) – would need patient, order, collection specific elements (those can depend on the type of specimen collected), exception reason; EXCLUDE optimization of collection process (multiple orders combined for collection is not part of that).
• Use case #2 has 3 flows = with or without (not sure this would happen very often) re-identification by receiver and then specimen rejection
  • Not sure the sender will do much with the receivers’ ID, except as part of the result in order to support follow up
  • We decided to track the events both within and across the organizations – but we wanted to support, if wanted – can decide which of these transaction MUST be supported, while others are optional
  • May need to include a note, that some of the data elements shared with this use case may depend at what state the specimen was exchanged between organizations
  • Need to consider the provenance change as part of this profile
  • Issue with single specimen vs multiple specimen in this use case? Handling with the packaging list – individual items are grouped; HL7 has a shipping message, but not sure it handles the individual specimen – should we just adopt FedEX process for this
  • What about digital specimen where one lab does upstream work and then another lab will do downstream work (for next generation sequencing information will need complex results attached with the specimen) -> deal with that in the digital pathology workflow
• Homework: review if use cases #2 and #3 can be merged

 

AUTO16 update

• Draft of AUTO16 (aka LAW) has been submitted to Clinical and Laboratory Standards Institute (CLSI) for vote initiating in December. Workflow as follows: open for 60 days, then address comments, and after that will have 30 day final vote to get it published (hopefully) in time for AACC 2017 announcement.
• Currently running about 5 months behind schedule. Hope to have AUTO16 ready by July 2017.
• Sections 1 and 2 are added by IICC – from technical framework and historical information
• Section 3 is verbatim LAW, but slightly different organization
• Added a few guidance elements that would be useful for users – example additional segments and fields may be added per HL7 rules, etc. – may consider CPs to add to TF in future
• Some grammar fixes that will result in CPs for TF in the future
• Section 4: Security considerations of the interface
• Section 5: Conclusions
• Supplemental information: several examples were checked (from James Wulkan, Dmytro Rud,  Gazelle)
• Appendix information added as required by CLSI
• The use of TCD to handle dilutions in re-run. – Ed and Francois to draft a CP to add a usage note for LAW  (not a substantial change, just clarification)
• Suggestion to revise the title, since in the laboratory world “Next Generation” has a different meaning  (Next Generation Sequencing (NGS))
• Question from Bill Williams – how did we establish the usage of some optional fields – example PV1 patient location (RE) vs OBR-2 (RE.AN), some information sent by the AM, but is not echoed back by analyzer
• Should echo back to the sender, if it was used as part of the result interpretation it should be echoed back -> may result in CPs for Usage Note

 

FDA/CDC/NLM/ONC meeting on 11/8/2016 (attach 2 documents: IICC Proposal for LOINC Publication.pdf + Digital Format for Publication of LOINC for Vendor IVD Tests (Draft) 2016-11-03.pdf)

• LOINC use in OBX-3 is what we need to capture. It does NOT cover ordering from LIS to the instrument  as OBR-4 coding is Out of Scope. Need to discuss if LOINC could be used for that in the future, or what other code system might be used
• Round 1: Table description for excel PLUS the electronic format for exchange between LIS and the instrument (which may or may not need ALL the information that the human readable version needs)
• Currently result values and coded units of measure are out of scope
• ALL the information that affects selection of LOINC parts should be in the vendor comment  (i.e. detection limits)
• Need to update the diagram to show more than one LOINC can be used
• For JSON format, need to be sure we establish the grouping and recurrence based on JSON rules
• Need to nest the localization of analyte name in a group in the schema
• LOINC covers too many parts in the pre-coordinated codes:
  • Use case of creating a list of clinically comparable results is currently not being addressed
  • Currently have an extensional list of codes that are applicable for that
  • What do I send to the instrument, what do I get from the instrument, what do I send to the doc – this covers the last part
  • Parts needed by the instrument: method, property, scale and component (though there are subcomponents that the instrument may not know).
  • Automating the mapping requires additional elements such as transmission code, specimen description (not from the instrument)