IHE Lab Meeting Minutes Face to Face Meeting

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Attendees

(*) participating online

Name Organization
Filip Migom MIPS
Anna Orlova PHDSC
Jean Benech (editor for LAW vol 1) Bio Mérieux
Ed Heierman (project lead for LAW) Abbott Diagnostics
Ron Ranauro (LAB secretary for the meeting) CAP
Shigeo Hasegawa Beckman Coulter
Hiroyoshi Okada (chair of IHE LAB Japan) ITEC Hankyu-Hanshin
Nobuyuki Chiba A&T Corporation
Tsuyashi Kawata ITEC Hankyu-Hanshin
Shinishi Watanabe A&T Corporation
Francesca Frexia (editor for LBL extension) CRS4
Alessandro Sulis (editor for LBL extension) CRS4
Naomi Ishi (Host) Hitachi High-Tec
Ken Iguchi Osaka Medical College
Jim Harrison(*) (project lead for LCC) CAP
Mayu Nagao A&T Corporation
Osamu Yamada (LAB planning cochair) Okazaki City Hospital
François Macary (LAB planning cochair) ASIP Santé
Yoshimi Hirasawa (LAB technical cochair) Techno Medica
Sondra Renly(*) (LAB technical cochair) IBM




Meeting Organization

  • Host: Naomi Ishii - Hitachi High-Tech (Monday), JAHIS (Tuesday & Wednesday)
  • Chair: François Macary
  • Secretary: Ron Ranauro
  • Daily organization & adjustments:
  • Monday 19: 9 am to 5 pm, room: Hitachi coffee breaks: 10:30, 3 pm lunch: 12pm
  • Tuesday 20: 9 am to 5 pm room: JAHIS coffee breaks: 10:30, 3 pm lunch: 12pm
  • Wednesday 21: 9 am to 1pm room: JAHIS coffee break: 10:30 lunch: 12pm
  • Meeting documents and materials are available on: ftp://ftp.ihe.net/Laboratory/Face%20to%20face%20meetings/Tokyo_2011/

Minutes

1. Review of the objectives of this meeting

A. Check LAB governance: Domain sponsors, Secretariat, LAB Representative to IHE Board
B. LAW supplement: content review, calendar for PC release, check implementers & CAT
C. LBL options: Discussion, content review, planning, check implementers & CAT
D. LCC proposal: standards availability, editorial team, check implementers & CAT, planning
E. LAB TF: Status of last ballot of Change Proposals. Planning of Release 4.0
F. Domain Coordination Committee: procedures & docs templates, update LAB timeline
G. Participation to connectathons: Guidance

2. Agenda Review & Adjustments: http://wiki.ihe.net/index.php?title=Lab_Domain_Agenda_19September2011

3. LAB Domain current sponsors: http://wiki.ihe.net/index.php?title=Laboratory

Sponsors’ duties:
  • Organization of face to face meetings: CAP, JAHIS, ASIP Santé - per rotation
  • Organization of conference calls: CAP
  • Promotion of the IHE LAB profiles
  • Secretariat: CAP. John Ritter is the official secretary of IHE LAB. Ron Ranauro is taking the role for this meeting only.

4. Domain news (implementations, connectathons, showcases, success stories, perspectives …):

A. See presentations in the meeting folder.
B. Report from North America (Anna Orlova, Sondra Renly)
C. Report from Japan (Yoshimi Hirasawa)
D. Report from Europe (François Macary, Filip Migom, Alessandro Sulis, Francesca Frexia)
E. Connectathons testing LAB profiles:
  • North-America: January
  • Europe: April/May
  • Japan:October/November

5. IHE International &Domains Coordination:

A. John Ritter, from CAP, is unanimously confirmed by the participants as the representative of the LAB domain to the Board of IHE International
B. Two wiki pages to be updated from the output of this meeting:
C. Review templates for TF & supplements produced by the Domain Coordination Committee (deadline for review is September 30): http://wiki.ihe.net/index.php?title=Domain_Coordination_Committee#Coordination_Documents

6. Laboratory Barcode Labeling (LBL) supplement: A new optional transaction added to this profile

A. Editorial team: Alessandro Sulis, Francesca Frexia
B. Potential implementers: IMPECO, ISAZA, DIANOEMA, SYSTELAB, DEDALUS, … at European CAT 2012
C. Planning: see portfolio of projects at the end of these minutes.
D. Attention: Ensure conformance with the last DCC template for IHE supplements (vol 1, vol 2)
Discussions:
  • The event “Specimens collected” should not be part of this profile. This event exists in LTW between Order Placer and Order Filler. However it is not described explicitly enough.
  • Moreover, given the flexibility of organizations that can support the 3 major use cases of LTW (1 = “specimens collected by placer”, 2 = “specimens collected by lab”, 3 = “specimens collected by 3rd party”), it appears necessary to track the “specimen collected” event with two new actors in an independent profile. Considered in a more general scope, this new profile could carry the notifications of specimen related events, such as (“collected”, “sent to lab”, “received in lab”, “broken”, “lost”, “rejected”, “arrived on station X”, “stored in bio repository”…), in any part of the workflows of lab testing (including intra-hospital, community lab testing, and inter-lab testing). The specification of the appropriate actor groupings between the two actors of this new profile and existing actors from the other profiles LTW, LBL, ILW, LDA, LAW, would enable to accommodate the various use cases and organizations for specimen workflow (collection in ward, in dedicated phlebotomy facility, at patient home, in lab, sending to another lab …). The new profile could be named Specimen Event Tracking (SET), and define two new actors: “Specimen Event Informer” and “Specimen Event Tracker”. This is a new project to add to the portfolio of IHE LAB, in wait for someone to take it and write a supplement proposal for it.
  • The event “Specimens collected” is therefore not in scope of the LBL profile itself. The new option for the LBL profile must support only the trigger event “labels & containers delivered”, clearly under the responsibility of the actor “Label Broker”.
  • For this event, the HL7 trigger event shall be ORC-1 = “SC” : Status change of the order to deliver the containers and attached labels, which are needed for the collection of specimens required to fulfill a lab test order group.
  • The resulting status of the order shall be ORC-5 = “CM”: The order (to deliver the labels) is completed.
  • Specimen centric OML^033, fits the need of this interaction.

7. Laboratory Analytical Workflow (LAW) supplement

A. Editorial team: IICC led by IICC CTO Ed Heirman, Jean Benech from Bio Mérieux for Vol 1
B. Potential implementers: Abbott, Roche, Orchard?, Systelab? Bio Mérieux? Siemens … at Europe CAT 2012
C. Planning: see portfolio of projects at the end of these minutes.
D. Attention: Ensure conformance with the last DCC template for IHE supplements (vol 1, vol 2)
E. Technical discussions:
  • Usage code “Allowed”. Need to provide a clear mapping with HL7 usage codes. To avoid the “allowed”, it is suggested to split the “usage column” in two columns, one for each sending actor: Analyzer or Analyzer Manager.
  • A possible set of “Allowed” fields could be associated with an option in volume 1, which would turn them to “RE” for the Analyzer in vol 2 in case the Analyzer claims to support this option.
  • The options in Vol I, section X.4 Vol I of the supplement will be modified to identify the bidirectional support for the AWOS. Broadcast and Query for AWOS are optional transactions for the Analyzer.
  • The “Mandatory” code is fine provided an intial statement in Vol 2 explains its constraint, which is stronger than the HL7 usage code “R”, since it adds a receiver’s responsibility.
  • 2 part “AWOS Query” transaction. The second part of the query (OML/ORL) should take place within the “AWOS Broadcast” transaction. The query transaction must specify the first part (QBP/RSP), and stress how the second part is taking place in the “AWOS Broadcast” transaction.
  • Identification of equipment, model, vendor: Pre-adoption of HL7 v2.7 PRT segment linked to the OBX (resulting from discussion of Andrzej, Ed and François with HL7 OO in Cambridge Oct. 2010).
  • Decision to try to build a LOINC® subset for all IVD analyzers. Project carried by Rob Bush from Orchard, and strongly supported by the Regenstrief Institute, owner of LOINC®. The decision on whether to make this subset mandatory will be taken after assessment of this subset post sufficient successful testing of the LAW profiles at connectathons in Europe, Japan and North-America.
  • Units (OBX-6) will rely on UCUM terminology. Some gaps have been identified. The team will have to close them before releasing the draft for public comment. OBX-6 is conditional, the condition being that there is a result and that result is resulting from the measurement, estimate or calculation of a physical quantity.
  • Order control codes: “New order”, “cancel”, “cancel as requested”, “cannot cancel”, “OK”: A subset from the common list selected by the LAB Technical Framework , Vol. 2 section 3.5
  • The LAW supplement removes effectively the transaction LAB-23 and the actor “Analyzer” from the LDA profile. This must be explicitly stated as editing instructions in the LAW supplement.
  • “UNICODE UTF-8” will be used as the character set for LAW message transmissions. This value will be set in MSH-18.
  • Enhanced acknowledgment mode, as discussed during the Sept 2010 face-to-face meeting, will be implemented for the LAW messaging. Only one acknowledgement will be sent (either application or accept). To support this decision, MSH-15 will be set to “ER” and MSH-16 will be set to “AL”.
  • Identification of the material: The LAW messaging team had chosen container ID (SAC-3) rather than specimen ID (SPM-2), to carry the barcode identifier. Conversely, the LAB Technical Framework Vol. 2 has chosen SPM-2 for this purpose in all its profiles, although this is not enough emphasized in the current release. Hence the decision below.

Decision: We shall write a Change Proposal to the LAB TF Vol 2, inserting the statement highlighted yellow below, after the common descriptions of the SPM and SAC segments at the end of section 3.8. The LAW transactions are expected to conform to this statement:

  • The LAB Technical Framework considers in all its profiles that the specimen identifier is identical to the identifier appearing (e.g.; in bar code) on the container that holds this specimen. The proper field to carry this identifier is in all cases SPM-2 “Specimen identifier”.
  • The usage of the SAC segment in the LAB TF is dedicated to carrying additional properties regarding the container (e.g.; the container location on a device).
  • The condition predicates for SPM-2 and SPM-3 will be the same as SAC-3 and SAC-4 in HL7 2.5.1 chapter 13, that is:
- For a primary specimen, only SPM-2 is populated.
- For an aliquot specimen identified with a bar code, SPM-2 is the bar code of the aliquot, SPM-3 is the id of the parent specimen.
- For an aliquot specimen without bar code, SPM-2 is empty, SPM-3 shall be populated with the id of the primary specimen, and a SAC segment shall carry the specimen location as defined by HL7 2.5.1 chapter 13.
  • The transactions of profiles LAW and LBL use only the 1st component of datatype EIP in fields SPM-2 and SPM-3.
  • Whenever field SAC-3 is populated in a message, it shall have the same value as field SPM-2.
  • Whenever field SAC-4 is populated in a message, it shall have the same value as field SPM-3.

8. LCC proposal

A. Project presented by Jim Harrison and Ron Ranauro. See the slides in the meeting folder.
B. Detailed proposal: http://wiki.ihe.net/index.php?title=LCC_Long_Proposal_-_wiki
C. Editorial team: Jim Harrison (lead), + team of individuals from the potential implementers
D. Potential implementers: Cerner, Epic, Elekta, Sunquest, …
E. Planning: see portfolio of projects at the end of these minutes.
F. Attention: Follow the last DCC template for IHE supplements
G. Unanimous decision by the LAB committees to launch this LCC supplement project.
H. Discussion:
- Recommendation from the committees to consolidate the storyboard scenarios candidates for this profile, and to clearly sort in each scenario, which part is carried by LCC and which part is carried by another profile (LTW, ILW, …)


9. Last ballot of Change Proposals on LAB TF 3.0 in July 2011

A. CP 168: SPM-8, SPM-9, SPM-10 populated if known also in results messages of LAB-3 CP 169: usage of ORU^R01 conformant to the standard: OBX related to the order must be in the OBSERVATION segment group, below the ORC/OBR. The OBX below an SPM are only observation qualifying the specimen, not responding directly to the order above.
B. CP 170: More than one report fac-simile responding to an Order Group (e.g., one report per specialty)
C. Result: All 3 CPs approved. All votes received were “yes to all”. More than half of the non-voters should no longer be in the roster, since they have not participated to at least 2 of the last 3 meetings or conf calls. These 3 CPs are to be published on ihe.net, in wait for their integration into LAB TF 4.0 next summer
- Comments from Jim Harrison discussed: CP 170 is about the option “report facsimile”. This option has been defined 2 years ago to provide the facsimile of the paper lab report as a pdf file. The lab results message carrying the structured results provides a link to this pdf report. Pdf was selected as the best fit for such a facsimile carried by a results message. The purpose of CP 170 is just to allow more than one report for an Order Group. On the other hand the XD-LAB profile enables to share the report as an electronic CDA document containing both the human-readable results with a defined layout, and the machine-processable equivalent data (level 3 of CDA).
- Comments from Nobuyuki Chiba discussed: CP 169 fixed an incorrect interpretation of the ORU^R01 message structure by transaction LAB-3 in the LTW profile: All observations related to an order shall appear below the ORC/OBR, not below the SPM segments. The issue was about multi-specimens orders like dynamic function tests, and how to link the results of such panels to the specimen they were tested on. This is solved either by using the OUL message structure available in LAB-3, or by the LOINC test codes, which differ for each specimen of the dynamic study.

Wrapup

1. Assignments:

  • François + Sondra: Review of DCC TF & Supplements templates Sept 30
  • Sondra: Get CP 168, 169, 170 published on ihe.net -> October
  • François: Check the removal of transaction LAB-23 in both Vol 1 and Vol 2 instructed by the LAW supplement in the current LAW draft.
  • François: Update “domains milestones” and “LAB timeline” wiki pages -> Sept 30
  • François: Write CP on specimen ID/container ID -> Sept 26
  • Anna + Sondra: Collect a set of examples of XD-LAB reports responding to explicit use cases, in the fields of patient care coordination and of public health and biosurveillance. -> May 2012. Once reviewed and approved, this set will be published for implementers’ guidance.

2. Next face to face meeting:

  • At the end of the Europe connectathon: May 26, 2012, Place: Bern or Paris or Lyon
  • Topics of work:
1. Address 1st feedback of LAW testing at connectathon, as well as other CPs for LAB TF
2. Building of LCC profile
3. 1st assessment of LOINC subset for analyzers
4. Preparation of LAB TF Release 4.0, in conformance with the new DCC templates.
5. Preparation of the publication of a set of examples of XD-LAB reports.

Publication of LAB TF 4.0 conformant to new DCC templates: June 2012

Portfolio of LAB projects and timeline:

Project Type Left to Do Committee review of the draft Public Comment Release Public Comment period TI Release 1st Connect-athon
Laboratory Barcode Labeling (LBL) Optional extension to an existing profile Remove LAB-64 Align / Supplt. Template Static definitions Oct 14-31 Nov 4 Nov 4 to Dec 4 Jan 30, 2012 Europe 2012
Laboratory Analytical Workflow (LAW) New profile superseding a part of the former LDA profile Align / supplt. Template Vol 1: Adjust options (“bidirectional”, “clinically validated results”) Vol 2: Final update Oct 14-31 Nov 4 Nov 4 to Dec 4 Jan 30, 2012 Europe 2012
Laboratory Clinical Communication (LCC) New integration profile Use case completion, specifying for each, how LCC is articulated with LTW, LBL, ILW …Check standard availability Write the supplement May 20, 2012(assuming standards availability) June 10, 2012 June 10 to July 10, 2012 August 2012 North America January 2013
Specimen Event Tracking (SET) Idea for a future profile Proposal to introduce in the 2012-2013 cycle N-A N-A N-A N-A N-A