Patient Care Working Group Meeting Minutes – May 2012 Vancouver

Monday 14th May 2012 - Patient Care Q1Attendance: Stehpen Chu, David Rowed, Susan Matney, Elaine Aryes, Rajan Rai, Adel Allah, Kai Heitmann, Michael Tan, William Goosen, Hugh Leslie, Kevin Coonan

WG went through ballot results for the Care Provision DMIM.

Discussion of agenda for the week. Organisation of Chair and scribe for the week.

GG to come to Q2 to discuss FHIR and PC contribution.

Discussion about Thursday Q2 – need an agenda. Discuss pressure

Tuesday Q4 – still sorting out if SD have joint meeting with us.

New agenda sent out to list.

Continued review of work program:

Allergy DSTU dropped and now we are going for a DAM. Discussed dropping the Adverse reaction topic and including it in the allergy, intolerance and adverse reaction topic.

DCM discussion – TSC want to reduce the scope of the DCM ballot or withdraw it. Published as informative only for the 2 models.

Motion: Patient care committee agrees to reduce the scope of the current DCM project 320 from the current five models to two models (Body Length and Body Weight) and publish as informative.

Further discussion – none

Stephen Chu proposed, Kai Heitman second, Against - 0, Abstain - 0, For – 9

This motion will be communicated to TSC by William Goosen.

Remove DCM for medical devices project

Motion: Approve new work plan which will be published in the Patient Care Document space.

Proposed: Susan Matney, Second Michael Tan Against 0 Abstain 0 For 9 Passed

Monday 14th May 2012 - Patient Care Q2Attendance: Stehpen Chu, David Rowed, Susan Matney, Elaine Aryes, Rajan Rai, Adel Allah, Kai Heitmann, Michael Tan, William Goosen, Hugh Leslie, Kevin Coonan, Graham Grieve, Charlie McKay, Ken Rubin

Grahame Grieve presented on the FHIR project (see presentation) and asked PC to contribute resources to test the approach for PC materials.

Grahame will work with William to handle Assessment Scales as a resource to have a small scoped example.

Motion: Patient care to agree to review the outputs of a FHIR activity to be delivered by Grahame and William for a FHIR project with a limited scope with the PC Assessment Scale R-MIM example.

Moved: William

Seconded: David

Discussion:

Against: 0

Abstain: 1

In Favor: 10

Actions

Grahame creates a FHIR example resource for Assessment Scales < week

Charlie will provide a list of candidate resources for Patient Care < this week.

William will assist Grahame in reviewing the Assessment Scale FHIR resources < 24 hrs after Grahame provides the resource draft.

Next topic: Ken Rubin / Kevin Coonan.

What can we do with SOA?

Consultation

PC does want a SOA project. However, we also agreed in the past that to take it up on our workload, we need to have a PSS to identify goals, approaches and results.

SOA has Hot topics quarters, PC can go to these meetings to consult, e.g. Wed Q1 Wed Q4.

Monday 14th May – Patient Care Q3Attendance: Kai Heitmann, Michael Tan, William Goosen, Hugh Leslie, Kevin Coonan, Zabrina Gonzaga

Ballot reconciliation Care Provision D-MIM

Tuesday 15th May – Patient Care Q1Attendance: William Goossen, Michael Tan, Barry Guinn, Iryna Roy, Irma Jongeneel, Gavin Tong, Rajan ra, Adel Ghlamallah, Stephen Chu, Hugh Leslie

After discussing the ballot comments, the group moved to discuss the different participations and act relationships.

1. Missing entry point to Encounter Act

Motion to accept.

William moves

Irma 2nds

Abstain 0

Against 0

In favor 11

2. Reason Participation to include priority number

Discussion on the definition of priority number and use case(s) for it.

Kevin asked to table the motion below, but did not get a 2nd, so we moved to the next

Use Case: Needs the model to support the prioritizing or ranking of diagnoses against each other, such as primary and secondary diagnosis for admission and discharge diagnoses and to ask further expert advice on the proper modeling approach for this.

Motion to accept the use case

Irma moves

Susan 2nds

Against 0

Abstain 0

In Favor 11

3. Missing Account Guarantor.

CMET to be included in the model.

Irma moves

William 2nds

Against 0

Abstain 0

In favor 10

4. Sequel to recursive relationship to the encounter => that is explicit in the model to the choice box where encounter is in. However, apparently has the wrong value set attached. Will check with modeler.

Mail this morning:

On 2012-05-15, at 9:46 AM, William Goossen wrote:

Jean, we’re are currently discussing the PC D-MIM with PA. One requirement we have and PA has is that the Act Care Provision should have a sequel.

Currently we only have source of target off. Can these be specialized into the Sequel?

Answer: I think so.  Down in the bottom right hand is the sourceOf2/targetOf2 relationship.  That can be constrained to be SEQL.

Jean

Tuesday 15th May – Patient Care Q2Ballot D-MIM R-MIM Care RecordR-MIM TransferR-MIM Queries

Tuesday 15th May – Patient Care Q3Do the work on the reconciliations of the ballot D-MIM R-MIM Care RecordR-MIM TransferR-MIM Queries

Wednesday 16th May – Patient Care Q1 – Joint CIC, PHER, CBCCAttendance: Hugh Leslie, John Roberts, Lura Daussat, Rebecca Wilgus, Ed Hammond, Susan Matney, Dianne Reeves, Anita Waldon, Margaret Ditloff, William Goossen, Laura Heerrmann Langford

V3 Nutrition Order Clinical Messages – co-sponsor/work group – pharmacy and patient care

Use Diet and Nutrition DAM – balloted May 2012 used to derive messages.

Need to develop vocab which doesn’t yet exist. Vocab just uses user defined list everywhere currently. Also references the current allergies and intolerances work within HL7.

V3 messages and CDA.

Motion: Approve a motion to accept this project statement and be involved in the development.

Ken Poole, Susan

Against, 0, Abstain, 0, Approve 9

CIC update –

Cardiology data model expanding to cardiology imaging. 30 prof. societies. Divided up into different cardiology domains. Include data elements into DAM and RIM where possible. 350 data elements.

Planned to ballot jan 2013

Schizophrenia – new project. Involving clinical stakeholders from around the world. Working with NCI

TB domain – expanding to include paediatrics. 75+ areas. CDISC. FDA looking for standardised data submission.

Discussion re DAMS Q3

Susan – making DAMs real. Chair nursing loinc subcommittee, chair snomed nursing sub. Pressure ulcer model – risk assessment, word assessment. HL7 dam for risk and models for wound.

Valuesets submitted to snomed. Also submitted to LOINC.

Where to publish the model with the bindings as well. HL7 couldn’t publish the terminology bindings, NLM said that they would publish BUT need someone to maintain the terminology.

DAMs – don’t help the implementors. Terminology bindings have no way for governance at the moment.

Care provision ballot – William Goosen gave an update on the ballot to the meeting

Wednesday 16th May – Patient Care Q3Discussed DCM ballot.

Lunch discussion initiated by Kevin Coonan

Focus of discussions to identify what DCM and DAM are and are not

No conclusion established

CIMI update

Derived from fresh look taskforce

Clinical modelling path that has international support

About 18 months

Stakeholder: national programs: UK, Australia, Canada, Singapore

Others: KP, Ocean/openEHR, GE, VA/DoD, Intermountain, ONC, Netherlands

Objective: try to arrive at agreed formalism to represent clinical

models that are implementable and can be transformed into other

isosemantic models including HL7 models

Progress to-date: archetype-based models (openEHR, ISO/CEN13606); UML

Reference model task force: produced and presented a reference model at

San Francisco meeting - a slim version of openEHR reference model

OMG working on developing extended UML profiles to support heath

modelling and use-case based constraints. Current UML stereotyping,

profiling and tooling are incapable of support complex constraint

requirements

OMG is working with stakeholders/Australia to enhance UML and tooling to

support the more complex requirements

CIMI has identified a list of complex, detail clinical concepts for

modelling

Concern of disparity between the CIMI detailed model and the FHIR 80%

requirement modelling approach.

Glossary versus data table (as spreadsheet)

HDF recommends the creation of glossary of terms/concepts

Experiences appear to validate that in modelling, the common practice is

to create a table of data, then define the data after that

Glossary is the starting point - for collection of concepts and

definitions and evolving toward data element table

For ballot - use data element table instead of glossary

DAM Ballot comments update (Anita)

Presented comments on 5 DAMs that are balloted

(refer to ballot comment list from Anita)

Discussions on whether DAM should be informative and normative

To answer question - needs to answer the question of what is/are the

purpose(s) of DAM

If DAM is to inform the domain models to be developed - it should be

informative and not normative

If DAM is normative, all modelling should be conforming to the DAM

instead of using it as informative resource

TSC already made decision - DAM is informative

Question on whether DCM should be in DAM. Agreement: DCM should not be

in DAM

DAM Session update (Anita)

Meeting Tuesday Q5: session on DAM and EA

Discussions and suggestion on Common modelling patterns to be developed

uploaded to gforge repository

William motion:

Joint group creates a project scope statement to revise HDF so that the

DAM development can be more consistent and easier

Laura: second

Abstain: 0

Against: 0

Favour: 8

Agree to repeat this meeting in next WGM

Wednesday 16th May – Patient Care Q4 – Allergy and Intolerance meetingCo-Chairs: Stephen Chu, Hugh Leslie, Elaine Ayres Scribe: Hugh Leslie

Name Organization E-mail Present on 5/16/2012

Elaine Ayres Academy of Nutrition and Dietetics/NIH

eayres@nih.gov X

Andre Boudreau

Boroan, Canada a.boudreau@boroan.ca

Stephen Chu NEHTA Stephen.Chu@nehta.gov.au XKevin Coonan kevin.coonan@gmail.com X

Margaret Dittloff

Academy of Nutrition and

Dietetics/CBORD

mkd@cbord.com X

Jean Duteau Gordon Point Informatics

jean.duteau@gpinformatics.com X

Adel Ghlamallah

Canada Health Infoway

aghlamallah@infoway.ca

Maggie Gilligan

Academy of Nutrition and

Dietetics

mmgilligan@gmail.com

Bill Gregory Patient SafetyNick Halsey European

Medicines AgencyNick.halsey@ema.europa.eu X

Peter Harrison McKessonKai Heitmann HL7 Germany HL7@kheitmann.deWilliam Hess FDA X – by phoneWendy Huang Canada Infoway whuang@infoway.ca

Steve Hufnagel

US DOD Stephen.Hufnage.ctrl@tma.osd.mil

Gaby Jewell Cerner gjewell@cerner.com XTom de Jong HL7 Netherlands tom@nova-pro.nlHugh Leslie Ocean Informatics,

AustraliaHugh.leslie@oceaninformatics.com X

Russell Leftwich

Office of eHealth Initiatives, Tennessee

[Russell.Leftwich@tn.gov] X – by phone

Ben LoyMasaharu Obayashi

HL7 Japan obayashi@metacube.jp

Richard Sakakura

'richard.sakakura@stjoe.org'

Carolyn Silzle Academy of Nutrition and

DieteticsJohn Snyder Academy of

Nutrition and jwsnyder@nutrioffice.biz

DieteticsLise Stevens FDA XMichael Tan Nictiz tan@nictiz.nl XCathy Welsh St. Judes

Agenda for WGM Vancouver, Wednesday Q4 May 17, 20121. Review agenda for meeting and add other issues as needed2. Review and approve the minutes for April 26, 2012 meeting 1. Review status of Project Scope Statement - Elaine2. Review status of DSTU Extension Withdrawal Request - Elaine3. Review of current functional model - Jean4. Review of allergy use case list5. Review assigned use cases6. Confirm ongoing meeting day and time for conference calls (currently every other

Thursday at 5 PM EDT). Next call would be on May 31th.7. Plan the agenda for the next conference call

Minutes –

Minutes of the April 26, 2012 conference call – deferred until the next conference call

Project Scope Statement – approved by the TSC. Elaine will post on the wiki. Encouraged by the TSC to submit another scope statement after the completion of the DAM that will address the outstanding RMIM issues.

DSTU Extension Withdrawal - Approved by the TSC.

Project Update: - Relationship to other projects:

Care plans Nutrition orders (through O & O) EHR FM (through EHR WG) Composite orders (through O & O)

Presentations on the project made to the O & O WG (Monday Q4) and the EHR WG (Wednesday, Q2). The O & O WG received a status update and a request for input. The group requested collaboration with the O & O project on nutrition orders. The EHR WG had an active discussion of the use cases, particularly the concept of an allergy vs. intolerance. Continued cross-mapping to the EHR-S FIM for Allergy and Intolerance was requested. The notion of failed therapy was discussed – this term has specific meaning for the US FDA – e.g. a drug is not effective, vs. the notion of a preference. A suggestion was made re preferences to note the preference but classify as “no reaction”. The group had not considered the issue of devices and will now consider for the EHR FIM for allergies.

Review of Concept Model – Jean Duteau –

Presentation Objectives:• Present the last version of the conceptual information model and associated

definitions developed in Canada, and enhanced with HL7 Patient care Work Group

• Collect feedbackAddition Notes to the Concept Model:

• The terms used in the concept model are the ‘right’ terms and not necessarily the terms ‘preferred’ by specific clinical groups

‘Preferred’ terms can be the ones displayed to clinicians in a given setting as synonyms to the ‘right’ term

• All discussions notes behind the model and definitions can be found in meeting minutes of the HL7 PC WG on allergies and in the Canadian Standards Partnership Minutes

• A few definitions are to be completedJean then reviewed the model as previously discussed by the Patient Care Workgroup:

Jean then presented a series of definitions related to the concept model:• Health Condition (ISO 13940)

one or more observed aspects of the health state of a subject of care at a given timeo NOTE 1 In the perspective of health care, the term 'health condition' is often

used to label a bad condition (diseases, disorders, injuries, etc.), because it may motivate certain health care activities

• Adverse sensitivity to substance or agent A susceptibility to an agent or substance or category of substances, such that

exposure to it is likely to result in a harmful physiological response rather than the expected (non-harmful, normal) physiological response AND where it has not been possible to determine whether the sensitivity is of the allergic type or not. Allergy

• Allergy - An immunological hypersensitivity to one or several defined antigens, called allergens, resulting in a marked increase in adverse reactivity to that antigen upon subsequent exposure, sometimes resulting in harmful immunologic consequences

• Intolerance - Adverse sensitivity caused by a mechanism other than an immunologic over-response

• Adverse Event (CDISC, NCI/NIH) - Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship

• Adverse Reaction (New) - Noxious (harmful or injurious to health or physical well-being) and unintended response to a substance or agent

• Adverse Effect (MedicineNet.com) - A harmful or abnormal result. An adverse effect may be caused by administration of a medication or by exposure to a chemical and be indicated by an untoward result such as by illness or death

• Adverse Drug Reaction - Use Adverse Drug Reaction to Health Product• Adverse Drug Reaction to Health Product (Health Canada, adjusted)

Noxious (harmful or injurious to health or physical well-being) and unintended response to health products

Health products include both prescription and non-prescription medications; natural health products; biologically derived products such as therapeutic or diagnostic vaccines and fractionated blood products; cells, tissues and organs; radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims.

• Allergen (The Free Dictionary by Fairfax∕ Medical Dictionary) An antigenic substance capable of producing hypersensitivity (allergy)

• Contraindication (Stedman's Medical Dictionary) A factor that renders the administration of a drug or the carrying out of a medical

procedure inadvisable• Relative contraindication (MedicineNet.com)

A contraindication may be absolute or relative A relative contraindication is a condition which makes a particular treatment or

procedure somewhat inadvisable but does not rule it out• Hypersensitivity (also called hypersensitivity reaction) refers to undesirable reactions

produced by the normal immune system, including allergies and autoimmunity. These reactions may be damaging, uncomfortable, or occasionally fatal. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.

Wikipedia: http://en.wikipedia.org/wiki/Hypersensitivity Includes ref to Gell PGH, Coombs RRA, eds. Clinical Aspects of Immunology. 1st

ed. Oxford, England: Blackwell; 1963• Anaphylaxis (severe allergic reaction)

Hypersensitivity (as to foreign proteins or drugs) resulting from sensitization following prior contact with the causative agent

o Merriam-Webster's Medical Dictionary, © 2007 Merriam-Webster, Inc. Anaphylaxis refers to a rapidly developing and serious allergic reaction that affects a

number of different body systems at one timeo MedicineNet.com: http://www.medicinenet.com/anaphylaxis/article.htm

Discussion

Recommended changes to the model – it was noted that in the Agent/Substance area, that the arrow from allergen to agent/substance should be reversed. The Agent/Substance is an allergen. Jean will make this change.

In the area entitle Adverse Sensitivity - Kevin Coonan had the view that allergy and intolerance are the incorrect categories - a very long discussion followed about the theoretical view that allergy and intolerance were not the only categories that were necessary. Kevin suggested that it was better to have a more abstract view of the model so that a more fine grained approach could be constructed. This discussion also ranged around the need to actually not include reported allergies in the allergy

list until they were confirmed – there was general disagreement with this idea. Kevin was asked by Stephen Chu to write up his proposal and review it with Stephen prior to the next conference all.

Michael Tan noted that in the Netherlands, allergy is a subtype of intolerance and that a note on the mechanism of the reaction is used to differentiate. However, he also noted that in terms of documentation there is no differentiation – only the concept of certainty is added as known.

The definitions were then reviewed by the group. • Under adverse sensitivity, the suggestion was made to change the word harmful to

undesirable. • Comments were also made about adverse reaction and adverse effect related to the word

harmful.

The group then reviewed the practicality of how allergies and intolerances are documented. They are often reported, not observed and noted as “unconfirmed”. Another use case was suggested – that of the patient recording their own allergies such as in a PHR/patient portal which would then become of the EHR.

It was noted that the model should also reflect a reaction history (reported vs. documented) and an evaluation of certainty based on signs and symptoms.

A use case related to failed therapy should be removed – it is a specific term for the US FDA related to drugs that are not effective (vs. a preference). A use case on preference can be retained. The provenance of the reported reaction or condition should also be included.

Use Cases as of 5/16/12 Owner1. Observed reaction/condition (allergy or

intolerance) [no distinction of allergy/intolerance from informatics perspective]

a. Medications Stephen/Hughb. Food Carolyn/Elaine

c. Environmental Stephen/Hughd. Devices (different than known immunological mechanisms)(breast

implants, drug-coated stents)

Contact devicegroup

e. Immunization Andre2. Reaction without clear attribution to a substance (e.g. patient on multiple antibiotics)

Stephen

3. Mis-attribution of causality to a substance4. A reported reaction or reaction history Carolyn/Elaine

5. A reported condition and reaction history Carolyn/Elaine6. A reported condition with an observed

adverse reaction Stephen/Hugh

7. Creating and maintaining a list of reactions/conditions (including updating and

modifying)

Russ

8. Sharing a list within one provider organisation Russ9. Sharing a list between provider organisations Russ

10. Active vs inactive items on the list Russ11. Query of EHR for conditions/reactions

12. Include use cases to identify severity (related to the symptoms) and criticality (related to the

condition) 13. Include a use case for preferences (e.g. no

reaction)14. No known allergy Stephen/Hugh

15. Allergies “not asked” Stephen/Hugh16. Unable to determine if allergy/intolerance Stephen/Hugh17. Allergy/Intolerance Information to a Patient

18. Allergy rechallenge based on additional exposure

Agenda for Thursday, May 31 at 5 PM EDT

1. Review agenda for meeting 2. Review and approve the minutes for April 26, 2012 and for the Vancouver WG

meeting minutes from May 16, 2012. 3. Review update to concept model - Jean4. Review of allergy use cases 5. Plan the agenda for the next conference call on Thursday, June 14 at 5 PM EDT.

Thursday May 17th - Patient Care Q1 – Care plan meeting*** KC Minutes? ***

Thursday May 17th – Patient Care Q2 – Joint SD, Templates and PCAttendance: Stephen Chu, Hugh Leslie, John Roberts, Elaine Ayres, Zabina Gonzaga, Amando Oliva, Michael Tan, Kai Heitmann, William Goossen, Kevin Coonan, Keith Boone

John – Templates up.

Templates just completed project to define the requirements for a templates registry.

Project to establish an interchange format on hold – smaller scope. Now for CDA templates only.

Keith Boone – CDA R3

CDA has document header, narrative content and structured entry.

New document header – now is MUCH more complicated. Late summer producing a draft for comment as its not ready for ballot.

New document header will allow for recording CDA about animals, groups, or things which was a limitation of R2. Now able to be generated by a device.

Narrative section:

Models have a lot of structure but don’t work well when you break them up into sections. Able to point from entry to narrative section.

Structure can be anything in the RIM. This means that models currently available can be represented here now rather than having to use a fixed model.

HTML5 can possibly be used in the narrative – being considered.

Discussion about complexity vs the success of CDA. Is the new version of CDA going to affect implementers and therefore affect the success of CDA. Discussion was around profiling. Maybe the whole CDA would be a DMIM and there would be various RMIMs for different purposes.

No workflow in CDA still but is now a V3 message.

Templates and template interchange formats.

Registry requirements are done but no resources for an actual HL7 registry. Registry requirements are going through ballot. Work being done on registry repository.

Discussion going on about an interchange format.

Trifolia has XML based format of the CDA specifications.