Lab Tech Minutes 08.06.23-25

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Topics: LAB TF 2.1 Final Text, harmonization with ITI & PCC, Inter-lab workflow supplement

Attendees

  • Nobuyuki Chiba, A&T Corporation (Japan) - LAB co-chair
  • Shigeo Hasegawa, OLYMPUS CORPORATION (Japan)
  • Kazuo Suzuki, FUJITSU YAMAGUCHI Information (Japan)
  • Sondra R Renly, IBM (USA) - Organizer of the meeting
  • Sarah Knoop, IBM (USA)
  • Karen Witting, IBM (USA) – ITI Tech co-chair - Mon. morning
  • Vassil Peytchev, Epic Systems (USA)
  • Kenneth McCaslin, Quest Diagnostics (USA)
  • Eileen Koski, Quest Diagnostics (USA) - Tue., Wed.
  • Israel Samples, Greenway (USA) - Mon., Tue.
  • Andries Hamster, Forcare B.V. (NL) - Wed. morning: phone presentation
  • Charles Rica, GIP DMP (France)
  • Ana Estelrich, GIP DMP (France) - QRPH Plan co-chair
  • Eric Poiseau, INRIA (France) - Technical Manager IHE Europe
  • François Macary, GMSIH (France) - LAB co-chair

Support

All presentations used during the meeting are available on ihe ftp server

Working documents for release 2.1 also available on ihe ftp server

Minutes

Monday June 23rd

Introduction

Sondra Renly welcomes everyone. François Macary opens the meeting. Round table and self-introduction of each participant. Agenda Review.

Review of Lab TF Vol 1

Starting with XD-LAB. Sondra presents the Public Health Lab report profile.

Discussion on the various national bodies for public health and epidemiologic surveillance: US: County  State  Federal with Centers for Disease Control (CDC) France: Réseau Sentinelles, Institut National de Veille Sanitaire (INVS ) Japan: Organization comparable to CDC

Review of Lab TF Vol 3 (Content modules for XD-LAB)

Harmonization with PCC Review of the CP for XD-LAB from Release 2 to 2.1

Template for comments defined by PCC. Two CPs from LAB to PCC, dated from december 2007, regarding this template, still pending for processing. visible on the wiki: http://wiki.ihe.net/index.php?title=PCC_Change_Proposals CP-0015: “Broaden Annotation comment Template” CP-0016: “Annotation comment in Organizer” XD-LAB adopts this comment template, anticipating the integration of these CPs by PCC. TBD : Example for a comment below a battery organizer showing the human readable part.

Decision to have a “cross domain comment” period on Volume 3 (Content module XD-LAB), to have the text reviewed by other IHE domains, in particular PCC and ITI.

Compress the section describing the binding with XDS: References to PCC for all common metadata. Keep only the constraints specific to XD-LAB. Choice of XDSDocumentEntry:format Code: urn:ihe:xd-lab:2008 Discussion on additional event codes for XDSDocumentEntry.eventCodeList (usage R2), usable as criteria in queries for documents to the Registry. documented on the wiki: Reportable condition, Type (species) of non-human subject Removal of references to SNOMED for ClinicalDocument/code. Decision to set SHALL and MAY statements upfront of each element specified. Remove MUST and SHOULD.

TBD: Add some null Flavor field in some of the examples.

Clarification of vocabulary (glossary to be updated):

Validator = Authenticator = a person who performs clinical validation of the global set of results, taking into account the clinical status of the patient.

Verifier = A person who performs technical validation of a set of observation produced by an analyzer, with regard to local QC and procedure control. Discussion on the extension to CDA R2 “serviceEvent/statusCode”. Pending decision. Sarah to add a statement related to metadata to restrict about replacement.

Tuesday June 24th

Presentation of the test tools for connectathon by Eric Poiseau

see presentation on ftp server

MESA Tools for the in-house testing for vendors: C++ and Perl Script Developed by Steve Moore in 1998 initially for Radiology

KUDU came in parallel to manage the Connectathon testing. The tool provides many functionalities (starting from registration). PHP, Postgresql DB (database management system)

Gazelle: Covers KUDU + MESA + new features. Open Source. Uses Apache 2. Targeted to vendors, users and sponsors. Systems under test are encouraged to connect via a proxy. Missing Actors can be simulated. The simulator is also useful for testing in a hospital. External validation services (EVS) are web services that are used to validate the content of the message that is captured. There are already a lot of tools that create simulators. Developed in cooperation with NIST, and potentially other parties. Test engine to manage the tests. EVS does not only check syntax and format. They can also check semantic: values defined for a scenario. PROXY : Captures the msg between test participants without interfering on the message flow. Transmits captured messages to the Test Engine for further processing - EVS Provides information about the sender and the receiver when available Each message identified with an OID.

The Japanese are organizing a Connectathon in October 2008.

Work on CPs for Volume 2

  • CP 61 (Nobuyuki Chiba, Japan): Need for a priority field at the OBX level. (OBX-13 ?)
  • An order message always orders through (ORC, OBR, TQ1), not OBX, even if it is a single test. So the need is not confirmed for that category of messages.
  • A result message may need to indicate a priority of delivery of the result, assigned by the fulfiller. A new field should be needed.
  • Action Item: IHE LAB shall post a request to HL7 OO, to add a field “result priority” in the OBX segment in a future version.
  • IHE Japan will deal with this need in a national extension in the meantime.
  • CP 79 (Nobuyuki, Japan): OBX-14 physiologically relevant date/time?
  • Keep the semantic of OBX-14 as it is in the HL7 standard: date&time the specimen was collected.
  • Use OBX-19 to record the date-time the analysis was performed.
  • Set OBX-19 usage to RE, cardinalities [0..1] in LAB-3, LAB-5, LAB-23 and LAB-32 result messages.
  • CP 80 (Nobuyuki, Japan): SAC segment forbidden in LAB-3. This segment is needed in some cases:
  • When profile LTW is leveraged by LBL profile, there are situations in Japan in which a LAB-3 message must provide specimen/container id, using the SAC segment.
  • Usage of SAC in OUL imessage moves from X to O, with cardinality [0..*].
  • CP 64 (Nick Radov, US): Field OBR-7 is forbidden in LAB TF. For conformance with the HL7 standard (which makes this field required in results messages) It should be conditional in results messages of LAB-3, LAB-5, LAB-23, LAB-32, the condition being: If the order is related to one single specimen, then OBR-7 is a copy of SPM-17.1. In all other situations in these messages OBR-17 = “” (null value).
  • Ken McCaslin says the statement on OBR-7 HL7 definition is incorrect. The original intent, which has been lost in the current versions of the standard is: If there is only one specimen related to the observation, populate OBR-7 with time of specimen collection, and leave OBX-14 empty. If there is more than one, leave OBR-7 empty, and populate these date/times in the appropriate OBX-14.
  • CP78 (François, France): Copy of the paper report in a pdf file referenced by the result message, using a reference pointer.
  • Improvement proposed by Ken and adopted: The universal service code corresponding to “provide laboratory report” (LOINC code “11502-2”) shall be ordered by the Order Placer whenever it wants such a report to come back with the results messages. This saves an extra flow of reflex order management: The order numbers of this particular service are assigned from the start.
  • Action item: François updates the CP accordingly and integrates it in Vol 2.
  • CP41,&42 (Joost van Averbeke) Enhance microbiology result messages.
  • Integrated as new section 3.11 “microbiology reporting rules”
  • This new method for structuring micro results messages is aligned with the HL7 Implementation Guide: “Ambulatory Care Laboratory Result Implementation Guide”
  • This new method is based on Observation Sub-id, classification of the OBX per specimen/isolate and Parent/Child mechanism.
  • These new rules are approved by the committee.
  • Sample snippets illustrate this section 3.11. In addition the microbio example of section 19.5 has been reshaped in accordance with these new rules.
  • The microbiology workflow will be tested in October at the Japan Connectathon.

Draft supplement “Inter-laboratory workflow (ILW)”

The draft is available on ihe ftp server

Confrontation of use cases in the countries represented. If V2.5.1 messages are chosen: In case the subcontractor lab should be able to handle the invoicing of its own acts, Ken suggests to add segments GT1 (Guarantor) and DG1 (diagnosis) to the order message. Adopted. François will update the supplement in this sense. Otherwise, collect more use cases (including those from NL that might rely on CDA R2, see presentation from Andries Hamster) before selecting the most appropriate established standard.

Global cleanup of all 4 volumes of LAB TF

All title pages, document titles, headers, footers, copyrights updated to reflect the recent rules edicted by IHE International, and discussed in the domains coordination committee.

Volume 1 will drop the descriptions of deprecated profiles LSWF and LIR and will rather refer the reader to the LAB TF 2.0 which contains the full description of these profiles.

Volumes 1 & 3 description of XD-LAB aligned in terms of section numbering scheme with PCC domain. (Done by Sarah).

To avoid text duplication, any statement already defined in PCC or ITI and reused by LAB appears as a cross domain reference in LAB TF.

XD-LAB Vol 3: Suppression of two extensions to CDA Handsome templates for Specimen Collection D/T and Specimen Reception D/T including specimen target site proposed by Sondra and adopted.

Wednesday June 25th

Work of Volume 3 / harmonization with PCC

Comments on update prepared by Sarah.

  • Capitalize SHALL and MAY
  • Numbering for figures
  • Ken comment – Acronyms to add to the glossary (CLIA, GBEA)
  • R2 vs RE discussion: Keep R2, and add a footnote that R2 is used in content profiles across all of IHE.
  • Discussion on table of template Ids
  • Add a list of templates available for the header
  • Lab report is not a type of a medical summary, so remove the template ID and text about medical summary.
  • Fix typos
  • The Chicago manual of style was brought up as a good reference for writing the specification: http://www.chicagomanualofstyle.org/home.html
  • Validator template – there is a difference in the structure of the validator role in the header and in the entries. Needs to be split in two separate templates, with the current one being the structure for the entry.
  • service/Event/statusCode suppressed and potentially replaced by the metadata classCode in XDSDocumentEntry, which can provide one code for “Final Laboratory Report” and another for “Preliminary Laboratory Report”, based on business rules and associated vocabulary defined by the Affinity Domain.
  • Hence, one single extension to CDA R2 stays in XD-LAB: The criteria associated with the reference range of an observation (same extension as in CCD).
  • Add open issue to volume 3 about how to show lab certification (from Harry Solomon): “It's not clear to me from the comments why an Assigned Entity and Scoping Organization cannot list certifications at those levels. The laboratory pathologist (legal authenticator) has a certification ID. The organization (lab/hospital) has one or more certification IDs, such as through JCAHO. In lab reports that I have seen with documentation of lab credentials - those credential IDs are alongside the lab pathologist and lab organization (ie the legal authenticator for the report).”

Sondra: presented 7 use cases of replacement of an existing lab report by a newer version.

Correction of results – not only needs the document to be replaced, but the new document needs to contain indication about the correction... Seven use cases showing the need for handling corrected reports (See Sondra's e-mail). How to show the corrected observation: use an organizer to replicate the original observation as a sibling to the current observation, and put OBSOLETE status on the original observation. and active or complete ton the current observation... How do you know what the original observation is? There is no observation ID, so we need to find a mechanism. One option is to require a generated observation ID, based on document ID and a sequence number (similar to OBX-1). This seems to be actually irrelevant, as the discussion returned to use cases. Some labs do not track the history in a discrete manner, just keep a comment. Still, there are definitely use cases where the full history of the corrected value is necessary...

Decision: In Volume 1, put a use case as an outstanding issue with a note that this is currently out of scope, and the work is continuing on providing a solution.

Update on national IHE projects related to the LAB domain

Presentations available on ihe ftp server

  • IHE-J presentation by Nobuyuki Chiba
  • IHE Lab - Netherlands presentation b Andries Hamster
  • Eric offered to give Andries contact info for IHE Australia.
  • IHE Netherlands was interested if anyone else is confronting the external ordering issues presented.
  • In France the patient can also choose the laboratory. and the national PHR project (DMP) chose XDS.b and is likely to move forward to prescription of lab orders based on this infrastructure.
  • IHE Europe web site pages to manage connectathon participation presented by Eric Poiseau.

IHE LAB domain docs, tools, organization, meetings, future work

  • Overview of what is on the IHE wiki pages with regards to the Lab domain.
  • Review of membership status. New attendees officially invited to join the IHE Lab committee.
  • The LAB domain needs an official sponsor. One candidate is “Societe Française d’Informatique de Laboratoires”, and should register to IHE International on July.
  • Reminder about the Google groups mailing list of the committee: ihe-laboratory-committee@googlegroups.com
  • The Lab committee is a single committee, and has two meetings per year. Francois proposed that each meeting changes continents: [dec 2007 Japan, June 2008 US, Winter 2008 Europe, Summer 2009 Japan]. Thus, next one would be in the winter in Paris. Next news about next meeting will come in July, when IHE-J will know if they can come to Paris in December or January...
  • At the next meeting (December or January) there will be elections for co-chairs (both current co-chairs' mandate is expiring).
  • Future work includes:
  • images in lab workflow messages
  • finalize lab-to-lab supplement
  • possible orders document (see IHE LAB NL project), also a forms-type request for voluntary reports... It may need to be presented in QRPH as well.
  • Other subjects may pop-up in the mailing list...
  • Webinar NA. Lab domain profiles will be presented by François on July 8.
  • Request for spreading the word about IHE Lab in the US (and Canada too)... Also Siemens, GE, JEOL - device vendors... CIC in the US, CLSI as well...

Wrapup

IHE LAB TF 2.1 Final Text to be published on July 4th. Volume 3 (CDA content module for lab report) will have an cross domain comment period to enable other IHE Committees to review its content, for cross-domain consistency checking. The remaining work on vol 2 is done by François The remaining work on vol 1 and 3 is shared as follows:

  • reformatting/template documentation pages 30 -> end - Sarah
  • officially assign OIDs for templates and example document id – François
  • reduce CDA R2 extensions - François
  • appendix/ftp of other examples/snippets - François
  • move any remaining open/closed issues to wiki - François
  • review all example xml in document - Sondra
  • review of conformance (SHALL, MAY), grammar, spelling by Ana and Ken
  • Schedule of last steps
  • July 4: publish vol 1, 2 of LAB TF v2.1 Final Text (François)
  • July 8: publish vol 3 for cross-domain comment/notification to PCC,ITI, QRPH - (François)
  • July 21: Due date of cross-domain comment: (ITI, PCC, QRPH)
  • Meeting to discuss comment: during PCC/ITI/QRPH meeting on July 23/24 as a conf 23/24 (François to coordinate with PCC/ITI/QRPH on exact time)
  • Aug 8: publish vol 3 final text - (Lab Committee)

François adjourned the meeting a 4 pm.

Date of next face to face winter meeting in Paris will be fixed in July.