Orders & Observations s1

Orders & Observations

September Working Group Meeting

September 12-16, 2011

Meeting Minutes Table of Contents

ATTENDEES...... 3 MONDAY...... 4 Q1 – OO...... 4 Co-Chair Elections...... 4 Agenda Review...... 4 V2.8 Proposals...... 4 Q2 - OO...... 4 Dietary DAM...... 4 Q3 – OO...... 5 Lab Microbiology Template/Lab Order Template...... 5 Q4 – OO / Patient Care / CDS...... 6 Hands on Model of the Patient Care...... 6 TUESDAY...... 7 Q1 – OO/Rx...... 7 Q2 – OO/Rx/RCRIM/Pt Safety/PHER...... 7 CPM / Substance DSTU Status...... 7 CPM CMET Development roadmap...... 7 Clinical Statement...... 7 Clinical Trial Lab Statement...... 8 Next WGM...... 8 Q3 - OO...... 8 Blood Bank Donation Services Ballot Reconciliation...... 8 Test Compendium Framework e-DOS IG...... 8 Q4 – OO...... 9 V2.8 Proposals...... 9 WEDNESDAY...... 10 Q1 – OO/II...... 10 Q2-4 – OO...... 10 Composite Order Review...... 10 Use Case /Requirements Documentation...... 10 Project Statements...... 11 V2.8 Proposals...... 11 THURSDAY...... 13 Q2 – OO/CDS...... 13 V2.8 Proposal - Order Document Payload...... 13 FRIDAY...... 14 Q1 - OO...... 14 Attendees Please contact Hans Buitendijk (OO co-chair) in case your name or e-mail is misspelled, or the attendance is not checked appropriately.

Name Company/E-Mail Monday Tuesday Wednesday Thursday Friday Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 Gustav Alufeldt [email protected] √ Bill Braithwaite [email protected] √ Debbie Bogert [email protected] √ Victor Brodsky [email protected] √ Louise Brown [email protected] √ √ Hans Buitendijk [email protected] √ √ √ √ Tim Buxton [email protected] √ Stephen Chu [email protected] √ √ Lorraine Constable [email protected] √ √ √ √ √ √ √ Todd Cooper [email protected] √ Christel Daniel [email protected] √ Margaret Dittloff [email protected] √ √ √ √ √ Jean Duteau [email protected] √ √ Derrick Evans [email protected] √ √ Christof Gessner [email protected] √ √ √ Adel Ghlamallah [email protected] √ Hugh Glover [email protected] √ √ William Goossen [email protected] √ Corinne Gover [email protected] √ Grahame Grieve [email protected] √ Freida Hall [email protected] √ √ √ √ √ Dave Hamil √ John Hatem [email protected] √ √ Rob Hausam [email protected] √ √ √ √ Lori Havener [email protected] √ Christian Hay [email protected] √ Erin Holt [email protected] √ Wendy Huang [email protected] √ Stan Huff [email protected] √ Julie James [email protected] √ √ Tom de Jong [email protected] √ J Karp [email protected] √ Andrzej Knafel [email protected] √ √ √ Helmut Koenig [email protected] √ Funika Kubota [email protected] √ Patrick Loyd [email protected] √ √ √ √ √ √ √ Francois Macary [email protected] √ √ √ Ken McCaslin [email protected] √ √ √ √ √ √ √ Lloyd McKenzie [email protected] √ Tim McNeil [email protected] √ √ Michael Meissner [email protected] √ Mark Roche [email protected] √ Melva Peters [email protected] √ √ Vincent Phury [email protected] √ Jeff Rinda [email protected] √ John Rhoads [email protected] √ John Roberts [email protected] √ Scott Robertson [email protected] √ √ Rob Savage [email protected] √ Gunther Schadow [email protected] √ Line Sele [email protected] √ John Snyder [email protected] √ √ Harry Solomon [email protected] √ √ Panagiotis Telonis [email protected] √ √ Marti Velezis [email protected] √ Perry Vonk [email protected] √ Name Company/E-Mail Monday Tuesday Wednesday Thursday Friday Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 Taku Watanabe [email protected] √ Mikael Wintell [email protected] √ √ √ √

Communication with declared O&O participants can be done through [email protected]. You can sign up through the HL7 website, www.hl7.org. List servers for focused aspects of the O&O domain are: [email protected], [email protected], [email protected], [email protected], and [email protected]. Monday

Q3 - OO Agenda Review

Nutrition Motion to let the editor address all A-T topics. Against: 0; Abstain: 1; In Favor: 7

See spreadsheet for reconciliation comments.

D:\data\SROs\HL7\ V300\2011-09\ballotcomments_Nutrition_Consolidated_2011SEP.xls Agreed to go one more round Informative to wrap-up and start a new project statement for the next phase. Motion to submit NIB for next round. Patrick, Jean Against: 0; Abstain: 1; In Favor: 7

Q4 – OO / Pt Care  DCM o Brief history by William. o JIC approved project statement, so expect ISO specs to come to HL7 . Part I – Process definition . Part II – Content specification, metadata (ownership of the model, etc.), and model specification (Data Element specification, data type, relationship in UML) o Got pushback from TSC and MnM on roll-out of conceptual and logical level in parallel. Wanted the conceptual level to be more mature before starting with logical level. Problem was immaturity of guidance documents, processes, etc. o Part I is ISO for committee draft. o Preparing Part II for ISO by November. Distribution to create awareness occurred last year. o Will stay with conceptual level. Vocabulary binding is flexible. o Composite expression of concepts not yet defined. o Procedure, evaluation, supply, etc. categorization not clear yet. o 5 models in ballot. Scales ~40,000 (wag), and other ~60,000 (wag)  Care Statement – Clinical Statement – Composite Order o Patrick, Kai, William trying to get together to harmonize models o Walk-through of Care Statement o Walk-through of Composite Order o Care Statement will be removed and Clinical Statement will be the reference model o When Composite Order needs reference observations, the A_SupportingClinicalStatement will be sufficient to ensure we stay in sync. o When ordering, e.g., a blood pressure, need to make sure that code and classCode are consistent between ObservationRequest and the DCM concept definition. o Could we make the order data collection requirement definition part of the DCM template definition process so we can identify new data requirements that Composite Order may not have covered yet? o Working on how to do composites. o Consider that as order attributes are defined as part of DCMs, we could define a map to where in the Composite Order this attribute is actually to be collected. o Question to the methodology of defining DCM. To be reviewed in May 2012. o Jan 2012 will focus on Care Statement – Clinical Statement harmonization. Tuesday

Q1 – OO + Rx Co-Chair: Ken McCaslin

Agenda  CPM Governance – want to move this to Q2 Tuesday

Nutrition Ballot – Reconcillation  See Monday for reconciliation spreadsheet.  Found typo’s and some issues with terminology. Needed to be consistent with the use of terminology – example Food Services as department or group.  Brought up the model – Split out the Tube Feeding or Formula feeding as two separate pieces – Intend to put them together since they are consistently the same.  Will consider to tie back tolerance and Allergies back to Nutrition requirements  Had to drive some detail out of complex issues once they are able to uncover what needs to be discrete messaged as they begin to gather more information, specifically around the Administration detail. Responded with not yet at this time. Intend to bring back the more detail solution in January 2012.

Project Scope Statement – Logistics Messaged for Material Flows and Inventory Management  Started from work at IHE sent out a request for information regarding how delivered products should be messaged for pharmacy products, it is believed this is not a pharmacy issue, but a Logistics issue. Since this is a logistics issue.  Believe chapter 17 is owned by OO.  Jose Costa Texiseria and Jane Daus (project leaders for the project) joined us by - skype – Modified the Project need to suggest it is a set of messages. It is it the intent to build a messages that are domain specific, or can they live side by side? Common set of messages that can be used across domains and it is expected the domains will need to review to see if they can use the messages. Medicines are not normal items for distribution, we will need to aware of the issues around the distribution of items considered medicines based on realm laws, therefore need to be careful to handle business requirements consistent with realm legal issues.  Motion: Accept the project scope statement – Added name, moved OO to sponsor and minor adjustments to – Tom de Jong moved, Seconded by Scott Robertson. Against:0 Abstain: 2 Favor: 16

Managing workflow IHE/XDW  Two issues with Work Flow –  There is a need to have payload for actual contain inside a CDA document, as an architecture, it stops at the payload but does not include the wrapper. Need to have a conversation around wrappers. This struggle has gone on for sometime and it has been a difficulty between OO and IHE and it is a need to have Structured Documents to engage in this discussion to help put workflow in/around the document. Currently Structured Documents have a separate concept for workflow that describes what a CDA message previously messaged therefore there is a disconnect between the message and the workflow that created that document. The workflow document would only have the work effort that produced the document. What IHE has problems with, each time a XDS document is created, they need to have a wrapper to explain how the document was created including how a preliminary document sent previously was created. It might be handled by a workflow would be documented through the wrapper and multiple payload. The semantic content has a tendency to change as one steps through the workflow and therefore it needs to be dynamic. The conversation between HL7 and IHE has not been constructive; it needs to have a better flow that allows for a give and take. Does the XDW does it have a concept to help document the workflow – we think so, it has an identifier provides for the relationship across multiple documents in the workflow and to learn the status. SAIF needs to address this based on the dynamic model. XDW is this web based, XDS is. Below is the concept of the issue and how it exists today. Work Flow CDA Message – V3 Wrapper Service - Soap  Action item: Tom de Jong – Work with to put on tomorrow’s agenda with Structured Documents: How to handle workflow in the message so that there is a consistent relation between the document and the workflow.

Change of Pharm/admin message - Every event that an infusion creates, it is a message, and it should be more than just an observation. It is RAS message needs to drive this. This will better capture the semantics of what is happening. Tom de Jong will take back the information that OO supports this concept.

Composite Order – Originally developing it as a super model, it was very difficult and it did not work.  Moved instead to develop the concept of high-level requirements and therefore the edges are not managed, and then the domains need to be invoked to support the issues that need to be addressed at the edge or the domain (or department). This allows the common pieces to be driven by the Composite Order. This becomes a template, but not a fully formed template and it clearly has edges.  Should the edges be left off or just add bunches of CMETS? Not sure where we are going moving forward, this will require additional discussion to help develop the concepts.  Have not resolved the issues around context conduction, still have more things to learn about this issue. Still using the old concepts and intend to resolve the concepts to the new concepts within the next 30-60 days.  Outstanding issues: o Cardinality of 0..* missing sequence numbers. o R_AssignEntity is it too large for implementers – still working through that issue.

Q2 – OO/ + Rx Co-chair: Ken McCaslin

CPM Governance

Current statement at: http://wiki.hl7.org/index.php?title=CPM_Governance Guther Shadow joined via Skype.

Principles

The Common Product Model is freely available for any HL7 to modeller to use for representation of clinical products, devices, substances or any other material that has to be identified, named and have its manufacturing, packaging, licensing or composition specified.

Modellers are encouraged to use the existing CMETs or if they are inappropriate to derive new CMETs from the core model. Alternatively CPM structures may be used as a pattern to follow. CMETs are much the preferred route since this makes change management easier and makes all CPM modelling visible from one source.

Where a modeller wishes to create a new CMET they should follow the procedure below to ensure that the CMET generated is not already covered by existing CMETs and that the concepts involved have been correctly used.

Procedure

1) Notify the OO list that a new CMET is required.

2) Time will be allocated on conference calls or at working meetings to ensure the requirements for the new CMET are discussed and understood. 3) The outcome of the discussion will be either agreement that a new CMET is required or agreement that an existing CMET is adequate.

4) Where a new CMET is required it should be developed and balloted as normal.

5) When a number for the new CMET is required the keeper of CMET numbering (Dave Hamill-PMO, Currently responsible for CMET Numbers, but may change in the future) will only issue one with the confirmation of OO that the above procedure has been followed and a new CMET has been approved.

 We have an agreed procedure and process to follow. Do want a motion to support this process.  Publishing mechanism may need to be modified – CPM is different from all other domains, because it does not have a specific domain model and is not used as other domain models.  This keeps the process to a single source of truth of the DMIN for the CPM.  Hugh makes a motion to suggest the wiki proposal be adopted, seconded by Guther. Against: 0 Abstain: 3; Favor: 20  Action item: Recreate a DMIM for the CPM – Hugh will make do this.

Questions on the CPM List

 Question about national authority – Effectively the authorization at two levels, national authorization that drives local authorization.  Item 4 A Contact Party role and an SDLOC role on the Agency entity, to support the description of any contact parties within the MRA and any alternative locations (for offices of) the MRA. This would be re- used for the Approval information that is associated with the various manufacturing operations that need describing as well (see below). o Action item: Julie will model two business requirements to validate the business case. Julie will bring examples back in three weeks to OO conf call.

We feel we no longer need Q1 as joint, we still want Q2 as joint for January 2012. It will be used for more than CPM discussion.

Q3 – OO Co-Chair: Hans Buitendijk

V2.8 Reconciliation

D:\data\SROs\HL7\ V280\ballotcoments_V28_OO_N1_2011SEP_Consolidated.xls Motion that all A-Ts will be addressed by the editors appropriately. Patrick Loyd, Rob Savage Against: 0; Abstain: 0; In Favor: 5 Wednesday

Q1 – OO Chair Lorraine Scribe Lorraine

Microbiology

-Patrick summarized the background as to how and why we kicked off the project Infoway has a concern that process not moving fast enough and was not working for them In a meeting between OO co-chairs and Vocabulary co-chairs yesterday, it was noted that the Harmonization process has matured since this project was created and it has been clarified that the Canadian harmonization requirements can move forward independently of the UV model. A recommendation was put forward that InfoWay re-craft the harmonization proposals to support the Canadian models.

Recent attempts to align the model with our normative meta model has driven some questions about the structure, and given resourcing and time constraints, including the fact that we are trying to call on the same set of resources to address the composite model, lab model, behavioral framework, etc, and the fact that Infoway is resource constrained, and the other realms have stepped back, does it still make sense to continue? Wendy thinks we need to itemize requirements – do the requirements reflected by the normative meta model still apply?

Ken’s questions: - Who are the key sponsors

- What scope of PSS

- What is the focus re realms/UV

- Concern if realms disengage that we will not have business experts to validate modles

PSS – goal was to create constrained model from the normative Result Event model, with participation from UK (who since step back, so their requirements were inferred from the normative edition, and Canada Louise – Impetus for the original project was that Canada needed to get their vocabulary harmonized, and the UV model work was seen as required to support that goal. . Freida – Recommends putting the project on hold rather than canceling it so the work is visible when it is picked again Motion: that we put the micro project on indefinite hold, and re-evaluate status in January. Moved by Patrick Loyd, Seconded by Rob. Against 0, abstention 1, in favor 7 Action item: prepare and bring back the required harmonization proposals - Wendy Action item – check the PBS metrics so we assign the correct hold status to micro so as to not affect the project health metrics – co chairs

Project Insight Walked through Project Insight – updating status of current projects Dave Hamil joined the meeting to assist us with Project Insight field updates, and he indicated the correct approach to setting milestone dates and status values when putting a project on hold Dave indicated they are putting together a short FAQ of best practices to give co-chairs guidance in the updates. The work group suggested that a customized screen with the most important fields for updating projects would be useful. Q3 – OO + MnM

Lloyd review SAIF wiki: http://wiki.hl7.org/index.php?title=Category:SAIF_Artifact_Definition to step through artifacts available.

 Some of our definitions may need to move from concept to logical level.  DAM to DMIM to RMIM mapped to RIM  Templates live as Serializable Information Models or Loose Information Models  Template to be applied at run-time  Pattern to be applied at development time  Patterns live as Loose Information Models  Intended use could be provided, but would not be restrictive  Content behind hyperlinks can range from initial sections, to almost complete.

Lorraine reviewed what we have

 Executive Summary reflects the scope.  Why is Information viewpoint  Express the business piece.  Focus on things we now, but recognize we need to address extensibility at some point since we won’t capture everything.  Adopt snapshots from MnM.

Joint OO MnM next time.

Q4 – OO No quorum Thursday

Q1 – OO / II / AP

Introductions

AP Project Statements

D:\Data\SROs\HL7\  Orders-Observations\PSS-II_AP_OO-RadSurgPathOrderWF.doc  Move to accept the RadSurgPath project statement as documented. Harry Solomon, Christoff Gershner (check spelling) o Who will orchestrate the project? Image Integration is the main sponsor. o Against: 0; Abstain: 0; In favor: 12

Agreed to meet Wednesday Q1 OO/II/AP in January See notes project statement.

Composite – DCM – Clinical Statement Brief summary

II/Pt Safety meeting identified DICOM has the ability to include contrast agents into medication administration record. May yield need for further clarification in DICOM on use of RAS^O17. Not likely to yield updates in base standard, but could.

Q2 – OO

Administrative Topics  Blood Bank Ballot Reconciliation o The Ballot passed. One affirmative suggestion will be addressed in the next release. We will update the spreadsheet and post it on the ballot site. o With that, the document is ready for publishing without any further need for motions to accept as it does not contain negatives that could not be addressed. o Co-chairs will file the necessary paperwork.  Project Insight Updates o Friday

V2.8 Ballot Reconciliation See earlier spreadsheet.

Agreed to put proposal 715 on the agenda for Sept 29 and make sure that HD and Rx are invited to review.

Before going into the details, first review what the intent and flow, including Rosetta terminology mapping.

Plan to submit new waveform sections.