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Line 905: Line 905:
: - Clinical workflow status – clinical verification status
: - Clinical workflow status – clinical verification status
For PC / FHIR – differential, provisional, working, confirmed, refuted  etc.
:: ~For PC / FHIR – differential, provisional, working, confirmed, refuted  etc.
: - Use case: in slides
: - Use case: a simple use case to illustrate how clinical status and clinical workflow status is included in Stephen Chu's  slide deck
: - Recommendations: Review use of deprecated templates, review clinical status value sets to include active, inactive, resolved, remission status, and relapse status.
: - Recommendations: Review use of deprecated templates, review clinical status value sets to include active, inactive, resolved, remission status, and relapse status.

Revision as of 18:44, 10 October 2015

Atlanta, WGM - October 2015 Patient Care WG Meeting Approved agenda:

Atlanta WGM - October 2015. Patient Care WG Meeting Meeting Minutes

  • Sunday, October 4 - International Council Meeting
- No PCWG meeting

Patient Care WGM, Monday, October 5, 2015

Monday Q1

  • Plenary Session
- No PCWG meeting

Monday Q2

  • Plenary Session
- No PCWG meeting

Patient Care Monday Q3

Joint meetings

Track (a) EHRWG
Track (b) FHIR/OO (this track extended into Q4 session)


  • Track A - See EHRWG attendance list - Elaine Ayre and Laura Heermann representing PCWG
  • Track B - See OO attendance list - Stephen Chu and Michael Tan representing PCWG


  • Track A - PCWG update slide deck:
WGM October 2015 Atlanta - Patient Care Update October 5, 2015

  • Track B - Meeting Note:
Topic: FHIR workflow issues
- There are inconsistencies in the current way that FHIR resources handle workflows.
~ FHIR resources that requires workflow management and related issues are captured in this document:
WGM October 2015 Atlanta - FHIR Workflow Issues and Workplan October 5, 2015
- Need to identify set of coherent, common patterns for handling workflows more consistently
- Look into leveraging existing industry workflow patterns
- Identify what infrastructure required to support workflow management in FHIR

- FHIR approach:
~ What kind of connectathon use cases need to be satisfied to deal with the workflow requirements
~ Develop the FHIR workflow solution to address the use cases, test in the connectathon until it is right (or close to right)
~ First to get something that is useful to be tested in connectathon
~ Once tested and improved to close to right, take to ballot
~ OO will coordinate the discussion – invite stakeholders to discuss, may spin off teams to work on domain specific problems and bring back proposals, solutions to the group
- This conversation needs to be carried forward after Monday Q4
~ FHIR to request a list to be set up and start a wiki page for this topic
~ Include interested WG to participate
~ Schedule call in 2 weeks to move things forward
~ To split off some taskforce to investigate the use of BPMN in workflow modelling
~ Get domain experts to contribute
~ Will work on designing RESTful patterns first to get understanding of what can be done in RESTful space (and the limitations) then take to services and asynchronous (messaging) spaces
~ After a set of patterns are identified, then work out which resource may be associated with a particular pattern, and which resources may need to be associated with more than one pattern
- Deliverables for next meeting:
~ Spreadsheet that compares resource contents in each category
~ Identify candidate connetathon use cases (interesting from “how will this work” as well as interesting to implementers), e.g. radiology image remote read; cross departmental use cases (admission, eligibility, orders, observations), medication order lifecycle, referral lifecycle, visit appointment; charge capture; protocol (dicision support, order set, composite order)
~ Primer on BPMN and related methodologies as they might apply to this problem space
~List of resource scopes

Patient Care Monday Q4

Elaine Ayres
Emma Jones
Bryan Schellar
David Pyke
George Cole
Larry McKnight
Iona Thraen

  • Minutes: Paris meeting approved
    • Move: Emma/David
    • Abstain: 1
    • Negative: 0
    • Approved: 5

Review of Agenda - Move: Emma/Larry; Abstain: 0; Negative: 0; Approved: 5

  • Tuesday
    • Health concern - Tues Q1
    • Meetings with FHIR
  • Wednesday
    • SOA on CCS
    • Child Care
    • Negation topic
    • Allergy and intolerance
  • Thursday
    • Care Plan
    • Clinical status with SDWG
    • Health Concern ballot Reconciliation
  • Friday
    • Clinician on FHIR

New Projects?

  • Maternal Health Proposal - Stephen Hasley wants to build a registry which may be beyond patient care scope for now.
  • Question about patient preferences/Patient goals - Lisa Nelson will discuss Wed Q1

Ongoing Projects

  • Care team domain analysis model
  • Care Plan EHR Functional Model
  • HSI RECON profile is in trial implementation

Patient Care Monday Q5 & Q6

  • Q5 - Co-chairs meeting
  • Q6 - DESD meeting

Elaine Ayre
Michael Tan
Russ Leftwich
Stephen Chu
Laura Heermann


  • Co-chairs meeting - See TSC and other presentations

  • DESD meeting - see DESD meeting minutes

Patient Care WGM, Tuesday, October 6, 2015

Patient Care Tuesday Q1

Present: Stephen Chu - chair, Jay Lyle - scribe
Michael Tan, David Pike, Iona Threan, Jason Goldwater, Tom Oniki, Christina Knotts, Margaret Dittloff, Laura Heermann, Nathan Davis, Emma Jones, David Tao, Larry McKnight, Danielle Friend, david Hay, Ewout Kramer, Michelle Miller, Susan Matney, Russell Leftwich.


  • DSTU FHIR2.1 has been published. Some of the PC resources are to be frozen. They have to have maturity level 5. The proposed resources from PCWG are allergies, condition., procedure. We have to decide on this list as PCWG.
  • PCWG will test some of these resources on the FHIR clinician connectathon ( care plan, condition, allergies and medication). It is suggested to decide either on Friday or on a call after the PCWG.
  • Our estimation now is that condition should be taken out of the proposed list.
  • The publication of DSTU 2.1 will focus on the workflow, messages.
  • FHIR Discussion Condition. Issue 5546 Input from Larry McKnight.
  • It is not really clear what is being represented:
  1. The actual physical process.
  2. A person can observe at a certain time. : I see X. This is a snapshot.
  3. Action on the concern.
  • Timing aspect is not clear. Lloyd's claim is that this could either be used to state a condition and follow action on the concern. Larry's view is that it is not sufficient, because 2 care providers could have different views leading to different resources. Example 2 different concerns on 1 intervention.
  • We suggest to create a seperate resource for concern.
  • How are concerns stored in EHR's. Most of care providers misuse problem lists while they are actually are concerns. In Larry's view you can select issues depending on the role for your concern list and discard issues.
  • Jay's questions Jim view on how to keep track on the evolution of the issue.
  • Why is the word "problem" not used in the discussion. This is historical. The naming has evolved from problem, condition to concern.
  • Emma: do we capture concerns? This is not clear in her implementation how to do that. According to Larry this is not done explicitly. A care provider put's it on a problem list and therefore define it as a concern. Emma confirms that the care provider can select or discard the conditions from the problem list.
  • David Pyke put forward Motion 1 :We identify a need for a seperate resource for health concern. We will sort out the different attributes between condition and concern.
  • The motion is amended: Need an anlysis of the distintion of data attributes in condition vs concern.
  • second Russ: Vote : 1 abstain , 1 oppose, 21 favor.
  • Iona add's that in the beginning of health concerns we were approaching concerns from the family point of view. Michael's view that input from the family was brought into the scope later on. Larry add's that it is actually the same.
  • Larry's Motion 2: clarify in the FHIR specification that this current resource of condition is to be used as a point in time observation of a condition.
  • David second: Vote : 8 abstained, 3 oppose, 11 in favor.

Patient Care Tuesday Q2

Larry McKnight, Stephen Chu, Michael Tan, Jay Lyle, Dominick Brannon, Emma Jones, Yokinoh Konishi, Solomon Tabasaba, Masaake Hirai, David Tao, David Pyke, Larry McKnight, Susan Matney, Peter Park


Overview of Health concern project by Stephen

  • Concepts of health concern from clinical and technical perspective.
  • 3rd cycle of informative ballot

Overview of the Health concern DAM document by Michael Tan

Ballot Reconciliation

Textual and Grammatical changes

  • Move that Michael resolve all textual and grammatical changes and these will be handled by block vote
    • Moved: David; Second: Larry; Abstain: 0; Opposed: 0; Approved: 11

Negative Major Items

  • Comment from Jay Lyle - Chapter 3, section 4,5,6. Jay has proposed a change to this area.
    • Discussion around the room.
    • Stephen Chu contributed these section because of the confusion of the differentiation between the clinical and technical perspective. The goal was for the DAM to provide a view point of "what" it means without saying "how" this should be implemented. The intent of these sections were to provide clarity on the different perspective.
    • Proposal to circulate Jay's proposed change, group will review the proposed change and the group decide if the change will be adopted and the comment disposition.
    • Larry moved we table this for now and circulate the jay's proposed change for review then do a conference call discussion of the proposed change. Will treat as a block change.

Moved: Larry Second: David P. Abstain: 0 Opposed: 0 Approved: 11

  • Comment #42, 52: concernIdenfifier

Moved: Larry Second: David T. Abstain: 0 Opposed: 0 Approved: 11

  • Comment #46:reference to health concern section changed to health concern Act

Moved: Jay Second: David T. Abstain: 0 Opposed: 0 Approved: 11

  • Comment #53:replace "identifies" with "expresses"

Moved: Jay Second: David Abstain: 0 Opposed: 0 Approved: 11

  • Comment #54: subject of the health concern
  • Discussion about the use of "patient" in the model. Suggestion from David P to leave as 'patient' and allow others to use the model to extend this entity.
    • Move to Change to "The individual who is the subject of the care provision". Currently multiple individuals are out of scope

Moved: Jay Second: Peter Abstain: 0 Opposed: 0 Approved: 11

  • Comment #56: - Change to concernMonitor

Moved: Jay Second: David P Abstain: 0 Opposed: 0 Approved: 11

Patient Care Tuesday Q-Lunch

Present: Stephen Chu - chair, Elaine Ayres -- scribe
Russ Leftwich, Michael Tan, Michelle Miller, Jay Lyle, Lloyd McKenzie, Reuben Daniels, Linda Bird, Christina Knotts, Emma Jones, Grahame Grieve, David Hay, david Pyke, Dennis Patterson, Larry McKnight, Lise Stevens, Kevin Shekleton

Topic: Adverse Event vs Adverse Reaction
Minutes: Representatives from multiple WG's present. A clinical trial vs. a medical event. An event may or may not be related to a clinical trial. May be an adverse medical event on Non medical adverse event. Adverse medical event may be workflow or procedue related, clinical trial related or physiological (allergy/intolerance).

Can be related to patient safety or a clinical trial. Use cases -- reporting or decision support purposes. Create a Venn diagram of various states (completed - see powerpoint slides):

Reporting may be an internal institutional activity or may be a regulatory report.

What could we use now -- questionnaire? Is there enougHL7 2015-10-WGM-PCWG_AdverseEvent-vs-AdverseReactions-v2h consistency? Should this be packaged in a document?

Use cases - unanticipated reaction -- record, but don't report, known reaction risk and occurs - internal reporting, if on clinical trial, this would also be a regulatory report.

Do we treat this like another document -- with a specialized use case (profiles).

The questionnaire can be used for anything, but more difficult to query. Need to move data into a more specific resource. For queries, is there sufficient commonality to be useful. Could then take questionnaire from a variety of resources and then view and query collectively.

May want to look at diagnostic report vs. use for adverse event reporting.

Distinct resource need -- is this something that is distinct in most implementation systems? Is there a core set of information that is used across implementation? Is there a desire to have this in the FHIR environment?

Questionnaires may be driven by national reporting systems, vs. something more specific.

Currently there is a large degree of variability of current adverse event reporting data elements.

We are discussing both a resource and a package of data elements.

This will be much like clinical impression -- some core elements with additional information from many other resources.

Look at ISO for adverse event reporting. What about public health reporting -- that is different than adverse event reporting.

ISO 27953 Part I is for multiple use cases -- animal, food. Part II is more constrained for for regulatory reporting. FHIM also has a model. See EHR profile for public health.

Add to next PC/FHIR call.

Patient Care Tuesday Q3

Present: Stephen Chu - chair, Elaine Ayres -- scribe
Laura Heermann, Toni Sholemis, Floyd Eisenberg, Eric Larson, KP Sethi, Stuart Myerburg, Kimberly Smuk, Patty Craig, Thomson Kuhn, Keith Boone, Yan Heras, Larry McKnight, Bruce Bray, David Tao, Margaret Dittloff, Ian Wermhardt, Marck Hadley, Castan Quinlan, Justin Schirle, Daivd Sundaram-Stukel, Julia Skapik, Miariam Markhlent, Martin Rosner, Michael Tan, Emma Jones, David Pyke.

Minutes: This is a combined meeting of Patient Care, CDS and CQI

Agenda items: 1. Discussion of Problem Status vs. Clinical Status, 2. Care planning and CDS and 3. CDS and FHIR adverse event profile.

Semantics of clinical status is different from machine/object states:
Active, inactive, resolve
Remission states: in remission, partial remission, full/complete remission, early full/partial remission, sustained full/partial remission.
Also, relapse status - relapse, suspected relapse, relapse after partial remission, relapse after full remission.
Question: Can they be mapped up to active or inactive??

Are there phases of remission?

In V3 there are 8 status codes -- include active, inactive or resolved.
Is remission a type of inactive state?? Can't say a concern is inactive or resolved if there is an active clinical status.

Remission and relapses clinically apply to conditions such as cancer and behavioural problems
These status are semantically different from "active" and "inactive"

Remission - a relatively free period during which the individual is asymptomatic. It should be noted that asymptomatic is not defined as a complete absence of symptoms, but instead was defined as no more than minimal symptoms
National Cancer Institute defintion:
A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body. (Reference:

Inactive - is a point in time status in which there is absence of signs and symptoms characteristic of a specific condition

  • Inactive Infection (Hepatitis B) Example:
- The inactive HBsAg carrier state is diagnosed by absence of HBeAg and presence of anti-HBe, undetectable or low levels of HBV DNA in PCR-based assays, repeatedly normal ALT levels, and minimal or no necroinflammation, slight fibrosis, or even normal histology on biopsy
  • JIA (juvenile idiopathic arthritis) Example:
- Definition of 'clinical inactive disease' for JIA (all six conditions must be met)
~ No joints with active arthritis*
~ No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributed to JIA
~ No active uveitis‡
~ ESR or CRP level (or both if both tested) within normal limits for the laboratory where tested or, if elevated, not attributable to JIA
~ Physician's global assessment of disease activity score as lowest possible on whichever scale is used
~ Duration of morning stiffness ≤15 min
- Definition of 'clinical remission on medication'
~ Satisfaction of the definition of clinical inactive disease for at least 6 continuous months while on therapy for JIA
- Definition of 'clinical remission off medication'
~ Satisfaction of the definition of clinical inactive disease for at least 12 continuous months while off all therapy for JIA

Do we need a domain analysis model for clinical status?

- Clinical status is a well known and accepted clinical concepts
- C-CDA acknowledged the need to communicate clinical status information. Two templates existed in C-CDA R1.1
~ Allergy Status Observation
~ Problem Status
- These two templates were deprecated in C-CDA R2.0
- These two templates should be reinstated
- The status value (HITSP Status Value Set values - active, inactive resolved) reviewed
~ Consider inclusion of new values such as "remission" and "relapses", and possibly others
- PCWG will provide use cases to support these recommendations

What are the principles for developing the value set?

- PCWG will consider working with terminology/vocab groups to develop the principles

With severity -- want gradations. Look at computability (active/inactive) as well as the communication with other providers.

Many of the proposed clinical status terms may not be commputable, but are necessary for clinical care.

A set of use cases would be helpful in supporting the use of clinical status.

CQI Discussions:
PCWG has concern on the removal of clinical status in QDM. There had been a few email exchanges

QDM v. 4 -- presume active at the time you are doing the measure. These were removed in the revision -- because the problem list was not being updated. May use prior history -- e.g. prior history of hepatitis. Only report on what you know is available.

CDS and CQI wish to harmonize with point of care.

F/U with CQI -- with NQF -- can you rely on a problem list to get to a level of granularity for clinical status. For a domain analysis model -- would apply across all standards. What is the workflow that is needed to process status information. Need the definitions to support.

CQI - QI core - profiles of existing resources with constraints CDS -- also has profiles.

Next steps with discussions -- create shared DAM. Invite CQI and CDS and SDWG. Have conference calls q2 weeks to investigate. This is a clinical care issue -- CQI will an interested party.

There is an need for analysis but does it merit an entire DAM? IHTSDO has a hierarchy of status conditions. Does CIMI need to be included?

Start from the point of a goal -- what is needed. PC needs to be the driver. The clinical community does need to express clinical status beyond the machine state status. CQI will be an interested party.

Patient Care Tuesday Q4

Present:Stephen Chu - chair, Elaine Ayres - scribe
David Pyke, Emma Jones, Michael Tan, Margaret Dittloff, Christina Knotts, Larry McKnight, Jim McClay, Michelle Miller, Lloyd McKenzie, Laura Heermann, Iona Thraen, Danielle Friend, Dominik Brammen

Agenda - Condition vs. Concern, Family Member History, Work on existing resources - including clinical impression and GFORGE work.

Minutes: PC/FHIR meeting. Continued discussion of condition vs. concern and the outcome of the discussion on GFORGE #5546. It is possible to have one condition that is shared variably based on role. What about evolution of the name of the condition? What about if different providers have different opinions on the status of the condition.

All resources can be looked at over time. Can point to current references or historical references. However the condition with history may be more difficult to represent. Hard to tell if conditions are current or historic.

Lloyd has suggested looking at a new resource that link resources together "linkage resource".

Next steps -- look at linking resource. Lloyd will put together a resource proposal -- will most likely be handled by PC.

Near term work -- look at three key frozen resources (condition, Allergy/Intolerane and procedure), look at new linkage resource, clinical impression, and referral request and family member history.

Substance (catch-all), medication and device -- all in common product model.

GFORGE -- condition -- no known problems -- to use SNOMED codes?

Can have an allergy list, a drug allergy list, a drug allergy list for specific meds. Can put no known drug allergies on the drug allergy list. But you do not query the list, rather the resource itself. If passing a list that is empty, add a flag re not determined. Note SNOMED terms in Allergy and Intolerance resource.

NOTE -- clinical genomics not available. Schedule participation on a phone call.

Patient Care WGM, Wednesday, October 7, 2015

Patient Care Wednesday Q1

Present: Stephen Chu, Emma Jones, Lisa Nelson, Iona Thraen, Gay Dolin, Ken Rubin, Russ Leftwich, Scott Brown, Dominia Brammon, Swampa Bhatia, Lindsey Hoggle, M'Lynda Owens, Gunther Meyer, JoAnna Johnson, Pete Yu, Michael Padula, Susan Matney, Davis Pika,

Minutes: OMG presentation on implementation of Care Coordination - Ken Rubin Children with special healthcare needs - Michael Padula, Gay Dolan Childhood functions - Peter Yu

OMG RFP A call was extended to participants for implementing Care Coordination standards (Allscripts leading, Careflow, and possibly VA) Goal is to get broad engagement and cluster interest into teams. Contact Ken Rubin for more information Timeline is

 *LOI - December 2015
 *Revisions - February 2016
 *Finalization - September 2016

OMG Overview

  • affiliation with ISO
  • Large standards group
  • Don't write standards/they 'acquire' standards
  • Request for RFP - submitters respond to the RFP
  • Submissions are then selected
  • Careflow solutions, Allscripts - in talks with the VA and large vendor groups. Ken is talking to the VA
  • FHIR - issue for discussion (can't ignore it - will have to explain what they did with FHIR
  • CCS is normative, the OMG spec will be added to the HL7 specifications

Children with special needs

Children with special healthcare needs presented on the need for providing pertinent and relevant information for children with special healthcare needs for emergent care and new providers during transitions. Examples were given where there may be procedures or medication not to be used and determining how to bring that to the attention of the new provider. Lisa Nelson offered consultation on an ad hoc level, Narrowing the scope was recommended along with tying into the pertinent and relevant group.

  • Goal: Develop CDA document for children with development needs. provide a snapshot of the snapshot
  • Special alerts are like advance directive but doesn't have anything to do with end-of-life
  • No age boundary- the same things that are important with other age groups
  • Will get involved in the relevant and pertinent project
  • Need to collaborate with the Care Team Domain Analysis

Childhood functions group is working on identifying the screening tools underlying the functional status.

See wiki page [1]

Goal is to document in advance and share a person't goals, preferences, and priorities for care and treatment

  • Shift thinking from a legal point of view to a clinical point of view

Purpose - develop a CDA implementation Guide specifying how to represent a person's advance care plan information to share between systems.


  • Backward capability
    • CCDA R2.1
      • Advance Directive section
      • Care Plan document templates
  • Leverage prior c-cda work
  • Existing best practices for content - review wide range of industry current best pieces (have a list of questions that are answered by the directives)
  • Collaboration & input

Use Cases

  • Create and share it
  • Update and share it
  • Revoke it
  • Request and access the current version
  • Not addressing orders (POLST and MOSLT) - physician order for life sustaining treatment, Medical coder for life sustaining treatment


  • Health care agents
  • Living will
  • Upon death
  • "Me Data"
  • Administrative - when HCA might take effect; how to revoke or revise

See Wiki off SDWG page

  • Need implementer Feedback - who is currently using the AD section?

Scott Brown from Advance Directive Vault - discussed the work they have done for the past 10 years.

  • Digital platform - not paper based
  • History of Advance Directive
    • paper based legal documents
    • static document that address life sustaining treatment
  • MU Objective 6, measure 3 - Advance Directive is called out.
  • Preferences and values -for example "I don't want to be dependent", "I want to be at peace with my God", "I don't want to be in pain".
  • 40% of adults is incapable of making medical decisions.
  • HL7 doesn't make policy but going with a broader name will support the policies that are set
  • Consumer generated
  • Not only for terminal ill
  • Use for critical and emergency care as well

Patient Care Wednesday Q2



Patient Care Wednesday Q-Lunch

Clinician-on-FHIR Preparatory Session
Stephen Chu
Laura Heermann Langford
Elaine Ayre
Russ Leftwich
Emma Jones
Jim McCay
Grahame Grieve
Lloyd McKenzie
David Hay
Yu-Ting Yeh
Others ...

Introduction by Stephen and Russ
FHIR resources to be tested by three groups of clinicians:
Care plan + procedure
Family member history + condition
Medication + AllergyIntolerance

David Hay demonstrated ClinFHIR tool for use on Firday:

Patient Care Wednesday Q3

Present: Stephen Chu - Chair, Michael Tan - scribe Michelle Miller, Craig Parker, Susan Matney, Emma Jones, Elaine Ayres, Laura Heermann, Iona Threan, Daivd Pyke, Rob Hausam, Danielle Friend, David Tao, Scott Bolte, Grant Wood, Yue-Ting Yeh, Viet Nguyen, Keith Campbell, Russ Leftwich, Lorraine Constable, Kevan Riley, Praveen Ekkaah, Nathan Davis, Margaret Dittloff, Senteil Nachimuthu, Tom Oniki


  • Topic is to discuss the negation structure: How to express a negation: Options are negation-indicator or value set.
  • Other topic : Negation of the action versus negation of the value.
  • Keith Campbell from VA: inconsistencies in FHIR how to express values. You can represent the same thing in different ways in FHIR. The preference is to capture the negation in a value.
  • SNOMED does not allow negation values. Rob Haussam disputes that, there are a few exceptions that allows negation.
  • Michelle requires terms such as : "No known problems" or "no known allergies".
  • Stephen is not in favor of mixed concepts in FHIR. We should be consistent in the architecture.
  • Do we attach the value to an observation or to a condition?
  • In a observation with numeric output, if would be difficult to negate this topic.
  • If you want to include the negation in the value, it will lead much more into a precoordinated structure.
  • Example Keith prefers: ¨Iris colour green " ¨yes¨.
  • The reason why findings are stored differently is mostly because of the retrieval of the information. This is being disputed. Often it is how people look at the finding.
  • In Loinc the value is the result of a test. This is not always the case.
  • In a condition there is not always a value required.
  • We should recognize the different patterns: So far there are 3 Patterns of asking questions:
  • Lloyd does not agree that consistency is not always required.
  • The discussion is going back and forth. We will not come to a conclusion if we do not write down the different patterns with the preferences for each pattern.
  • The conversation will be continued in the conference call.

Patient Care Wednesday Q4

Present:Elaine Ayers, Iona Thraen, Rob McClure, Margaret Dittloff, Christina Knotts, Melva Peters, Marla Albitz, John Hatem, Rob Hausam, Russ Leftwich, Larry McKnight, Julia Skopik, Gay Dolin, Lisa Nelson, Daniel Zhang, Christof Gessner, Bad Wall, Lise Stevens, Vada Perkins, Michael Tan, Stephen Chu

Minutes: Discussion of use of drug standards for C Cda Heuristic

CVX NDFRT - National Drug File for Reference Terminology RxNORM UNII - Unique Identifier SNOMED CT

Each system offers differing information in its code sets. Need a better model to determine how to meet need of source code developer, drug ordering, adverse reactions and supplier.

Canada is required to use RxNORM but does not - uses knowledge services instead

FDA is working with International community for ISO standard. Discussion of UNII as it relates to the substance. If 3 companies uses same substance for different uses there is different identifiers. It is published on SPL site and given to RxNORM so that the relationships are known.

Does the UNII include classification at group 4 level is where they can be put into - first role out Q1 2016. Providing to Dutch

FDA will role out UNII system to identify ingredients will have association with a combined drug and with class.

FDA is willing to consider use cases to determine if the UNII can work for those use cases What the expected set of processes. Would be very important work.

Should be identifying events we want to avoid. Can not fit adverse reactions into this conversation.

How do we fit coding system into order, might search by classes, the UNII codes might be used across all uses. Have to be linked in order master list which is important.

Dutch pharmacy systems - registering an adverse event do not know ingredients only as trade produce. Can only determine multiple levels.

UNII is a FDA regulation system. How does it relate to the code systems I use as a pharmacists. Pharmacy deals with products not substances.

Alerting level can be at the ingredient level not just the product.

Event avoidance substance is recorded in the patient's ;eve;

Drug allergy rates have 90% override rate.

This group needs to assess the Heuristic set be used as a base for adverse reactions. Otherwise if using FDA UNII then we need additional work.

Another approach is to determine a smaller list for adverse actions and then determine right code system to support, could be FDA UNII - may not meet all needs may need other options in order to support other use cases. How is it represented in outside in other cases.

Patient Care Allergy and Intolerance meets regularly - is developing a more succinct list a worthwhile effort? Do pharmacy have data sources, there is literature,

Pharmacy does not define terminology value sets but rather product ordering. Give exemplar but do not demand a particular value set.

Use the subset as a test case with FDA to detmine how well the UNII codes may work or not work as a use case. REcommend - list of common issues, identify value sets, and structure it

Patient Care WGM, Thursday, October 8, 2015

Patient Care Thursday Q1

Present: Susan Matney, Stephen Chu, George Cole, Laura Heerman-Langston, Toni Skikovic, David Pyke, Michael Tan, Larry McKnight, Russell Leftwich, Lisa Nelson, Ron Shiparo, Lindsey Hoggle, Emma: scribe Stephen: chair



Russ working with learning health starting DAM on care team. He is co-chair Emma and Michelle are new co-chairs - welcome to them Elaine and Russ retired from PC co-chair position - many thanks to them for all their hard work for patient care. Congratulations to them both, they got volunteer of the year.

learning health systems workgroup

Episode of care and Care team FHIR Resourses. Both of these resources are used in care plan. Have the need to link the care plan back to the episodes of care and also to link the Care team.

Steven: Episode of care resource is used for tracking administration and financial Health concern is used for linking to differentiate the difference between the administrative and the clinical. FHIR has consider there is a need for creating a 'linkage' resource to link clinical context to other contexts. A new 'Linkage' resource to link encounters. There is blurring of the lines between episodes of care so will be used to get a clear definition of what you're linking.

Larry: Currently, the condition resource represents much of the concern history of the condition. Problem is when doing 'something' e.g. billing, etc, may not need the most current thing. May need a static reference. May not be representing the current but the static how it was at that point in time. Need to be able to represent the condition at a certain point in time but at the present time, the condition is resolving.

Lisa - QM struggles with this. QDM just made changes in version 4. It is like the problem list is at the top, encounter is at the bottom with the diagnosis associated with the encounter links the two. At that point in time, the diagnosis stays put. The problem is the problem list changes over time. Do not know what FHIR is doing to represent this.

Michael - this has been brought up for consideration by Lloyd. He need to start from the functionality and then do the modeling and the design. Shouldn't start from the availability of resources and ant they go to the functionality.

Stephen: Need to start at the condition to get to the episode of care. Care team concept on the PA side is not what we have in the care plan. There is no concept of the patient in their care team resource. If we use this in the care plan as it is today, it would need to be rigid. We may need to use extensions. We need to harmonize the care plan resource then come to PA with what the care team should look like.

Lisa - there is a value set (personal and legal relationship role type) that I worked on as part of the Patient centered work in SDWG - May want to take a look at that valueset.

David: There was work to use a larger value set for this. Over 900 values in the valueset.

Stephen: Care team resource currently only references practitioner and organization.

Larry: suggests expanding practitioner to person.

Stephen: they have not considered this.

Larry - There needs to be an agreed upon definition of episode of care. The focus see to be that there is a single practitioner over an episode which is not correct. There need to be consensus of what an episode of care is.

Learning health systems workgroup

Russ: Patient centered care team DAM. Goal is to define the attribute of everyone who touches the patient. Everybody that not just care providers but also anyone who helps the individual. Proposes that patient care is a co-sponsor this project. Will come back with the PSS before PC vote on being co-sponsor. Will need to include on one of our future conference calls.

Larry: Is this a valueset definition?

Russ: It's not a valueset definition. It's a DAM.

Laura - A kind of 'white paper' may be needed. There would be value in having a sort of explanation of a patient centered care team is.

Lisa - Currently we understand roles - family and practitioner roles. It tends to be what your licensure is.

Russ: need to define the role as it relates to the patient and what they do for the patient (in part of the health care of the patient)

Lisa - structurally today in CCDA we have 2 spots, not 3 - role code and function code. For example resident vs intern is a 3rd level. We need to be aware if there is a 3rd spot.

Russ: The patient centered care team is targeted to be balloted in the May cycle.

Storyboard 8

Lenel sent out an updated version of story board 8 this morning.


Stephen: The Care Plan DAM has gone thru 2 cycles. Few outstanding things. 1. Number of logical model changes done by Enrique - need the diagrams from him to include in the Dam 2. Storyboard 8 has gone thru a lengthy process of review. 80% of the content is okay but we needed to clean up the clinical content. What is remaining is encounter F and G which had degree of inefficiency in the CM/DM

Lenel provided an overview and review of the updates to the story board. Diagram presented.

Larry - confused with how this is different from how the feeds are coming from multiple places and how the PCP or a medical home is managing the patient. How is this different? Is it a collection of care plans.? The diagram shows static care plans. If dynamic, the same care plan will be updated in varying places.

Steven: We will need to follow-up on the updates in the next call in 2 weeks.

Lisa: Will it be just on going forward changes to episodes F, G?

Laura: Lenel updated document describes the difference between CM and DM and addition of other new texts.

Lenel: Do not want to cross the line between CM and DM because can be very different based on jurisdiction. So need to keep the definition of CM and DM simple.

Laura: The storyboard till have complexity because of wording such as "static" and "dynamic" types of care plans

George: 2 questions. First, does providers today collect in their system other folks care plans? Second, seems to be a lot of "how" in this story board for a DAM.

Russ: DAM can have workflows

Larry explained how the various care plans in the diagram will be used by a provider.

Emma: Based on Larry's explanation, there is a lot of implementation details that would drive requirements of how this will be developed. Is that the purpose of the DAM? there is still a lot of implementation details. This reads as an IG in the middle of the DAM. Which is different from other DAMs such as Health concerns.

Lenel: Disagrees this is implementation details. A payor DM/CM will need a lot more details for implementing this than what is presented here.

Emma: agree. Which is why this will be used as the beginning of an implementation requirements process.

Stephen: Will leave Emma to sort it out the degree of details with Lenel; Fix episodes F&G clinically and will meet on Tues - Oct 20

Forward planning

Harmonization work for the Care plan Dam - need the latest version of the EA file Once gone thru the harmonization need to start harmonizing with FHR, CCDA, episodes of care, Care team and the PA folks. Need to map out a process on which to start with first and a time line. Next 2 calls will be dedicated to the finalization of the care plan DAM. Third call will be on an action plan for care plan harmonization work.

Patient Care Thursday Q2

(PCWG, SDWG, Template Joint meeting)

Present:Stephen Chu – chair, Elaine Ayres – scribe, Susan Matney, Sarah Gaunt, Gay Dolin, Matthew Rahn, Benjamin Flessner, Lawrence McKnight, Rick Geimer, Emma Jones, Keith Boone, Margaret Dittloff, Michael Tan, Kai Heitmann, Mark Shartfman, Lisa Nelson, BrianScheller, david Pyke, Michael Goldcamp, Toni Skokovic

Minutes: **Templates update:**

- DSTU phase of ITS release 1. There are 25 comments related to the status machine of templates. Will have a revised DSTU document by the end of the year (without a new release). DSTU ends in November 2016.
- Looking at group specific templates – for example Pharmacy that are more universal. Supports versioning of various specialized templates.

**Patient Care/SDWG topics**

  • Problem/Allergy Problem Status Observation Templates and Clinical Status
- Stephen Chu’s slides:
WGM October 2015 Atlanta - PCWG-SDWG Updates on Allergy/Intolerance and Clinical Status October 8, 2015
- Discussed with CQI re how QDM handles clinical status. However, now would like to ensure the C-CDA addresses correctly. Deprecating does not mean that templates cannot be used, however, will this status impact use?
- Deprecated templates – allergy status observation and problem status observation.
- Act status vs. problem status represent two sets of codes.
- These templates were replaced by the problem concern act and the problem observation classes.
- What was lost by deprecating the allergy status observation template – can’t express the semantics of clinical status.
- Status code is a mechanical representation of state machine but it is not the same thing as a clinical property.
- C-CDA on FHIR – will need to revisit deprecated templates because FHIR has a clinical status element. The LOINC code 33999-4 in the deprecated template represents clinical status well.
- There is a DSTU comment pending to “undeprecate” these templates. These should be posted against 2.1.
- In quality measure – see precoordinated value sets on clinical condition. Make sure that secondary use products can use C-CDA products. For examples Diagnosis A in remission. Therefore be sure that secondary use is clear in use.
- Also need to make sure that FHIR has a verification status.
- Semantics of clinical status – discussion of remission and relapse status issues
- How is remission different from an inactive state…
~ details on differences between inactive and remission states are captured in PCWG Atlanta WGM minutes -
- Clinical workflow status – clinical verification status
~For PC / FHIR – differential, provisional, working, confirmed, refuted etc.
- Use case: a simple use case to illustrate how clinical status and clinical workflow status is included in Stephen Chu's slide deck
- Recommendations: Review use of deprecated templates, review clinical status value sets to include active, inactive, resolved, remission status, and relapse status.
- Next steps - use cases, analysis, review and develop value sets, develop guidelines for use. SDWG asks that there are use cases and suggested value sets to fully explain the clinical status.
- SDWG willing to work with PC – first place will be C-CDA on FHIR. SDWG will work through owners of FHIR resource to map. We do need modeling assistance for Patient Care work. PC can produce mind maps.

  • **Allergy and Intolerance** - updated group on C-CDA – harmonization work. All remaining comments will be posted against 2.1 as DSTU comments.

  • **Care Plan** – finishing up with the DAM and expect to publish soon. Will then move onto C-CDA harmonization. By end of November will have a plan of work. Harmonization will need to include FHIR in the discussion. In 2.1 have the Care Plan template and the Plan of Care document. In January – schedule a joint – SDWG/PC/FHIR session.

  • **Health Concern** – issues between health concern and problem concern.
- In process with DAM ballot comments. In FHIR noted that condition is not adequate for managing the health concern. The issue of representation in FHIR will continue. May use a “linkage” resource vs. the use of a new resource. Need to make clear how health concerns relate to existing EMR’s. If the use of problem concerns are not clear, the notion of health concern is more broad and therefore more difficult to use. The C-CDA health concern template can have multiple problem concern templates. Is the problem section designed to gather health concerns – the problem concern act can only contain a problem observation. The health concern act is more broad. There does need to be an alignment. The physical things stored in an EMR are problems. In V3 the word condition was used already so that the concept of health concern was developed. This allows for lack of clarity in a particular condition over time. Need to have for discrete instances as well as tracking over time.
- In C-CDA – wanted to represent the problem concern and the allergy concern through one mechanism. Some concerns are not problems. Health concern does not create another list, rather a mechanism of conveying the notion of status at a specific point in time.
- The use of a story helps developers understand the use of the health concern. The Domain Analysis Model helps but if more is needed, can add to the DAM. Examples are helpful. Stories from the patient perspective would also be helpful.

  • C-CDA on FHIR – joint between SDWG/FHIR and involved groups. Will send out alerts for specific topics. Goal is to be part of DSTU 2.1 release.

  • Relevant and Pertinent Project – now in engagement phase. Engaging professional societies in terms of receipt of information to use. AMA, ACP, AAFP – engaged for survey. Will send out to members to respond to surveys. Will now have a significant response. There is a second engagement with HIMSS health story, UPMC, AMIA and other consensus groups in professional societies in a focus group webinar. Will look at all of the collective results of feedback. Would also like to do this

Patient Care Thursday Q-Lunch

PCWG Co-Chairs meeting

Stephen Chu
Elaine Ayre
Russ Leftwich
Laura Heermann Langford
Michael Tan
Emma Jones (new co-chair)
Michelle Miller (new co-chair)

Out going co-chairs - Elaine and Russ - were thanked cordially for their tireless contributions to PCWG
Draft PCWG agenda for January 2016 Orlando WGM was reviewed and updated
Stephen is tasked to email joint meeting WGs with updated draft agenda and confirm joint sessions (completed)
Stephen is also responsible for room booking for Orlando meeting
Stephen will email Elaine for a list of her co-chair responsibility for reassignment to Emma and Michelle (completed)
Next co-chair meeting (conference call) first Monday of November 2015

Patient Care Thursday Q3


  • Lisa Nelson
  • Susan Matney
  • Larry McKnight
  • Michael Tan


Health Concern Ballot reconciliation. The resolutions of the ballot comments can be found in the ballot spreadsheet. We dealt with the comments from Iona Singureanu. We did not vote because we did not have quorum. For the spreadsheet see the uploaded file under Q4.

Patient Care Thursday Q4


  • Lisa Nelson
  • David Pyke
  • Larry McKnight
  • Michael Tan


  • Continued to resolve ballot comments from Lisa Nelson. We compared the health concern act and problem concern acts were modeled in the CCDA and explained the differences between the health concern and the problem concerns. Problem concerns were created in CCDA v1. The problem concerns can only link problem observations and nothing else. In v2 Health Concerns were designed to be able to attach different kinds of acts to the health concern act. See picture.
  • The dispositions are captured in the total ballot comment spreadsheet, that can be found here:

Patient Care WGM, Friday, October 9, 2015

Patient Care Friday Q1

(1) Template WG meeting

- PCWG representative(s) to attend
  • Joint meeting with Templates, SD, ITS.
  • Templates DSTU.
    • Status of a template. The outcome will be reflected in a intermediate publication. Explanation about the status: deprecated, retired.
    • Maybe 2 layers of status codes.
    • Additional corrections; distinguish between containment. (A section within a section.)
    • Another is inclusion. Real life examples from Austria ( ELGA)
    • The labels are human readable including OID links.
    • Are multiple labels allowed? Suggestion from Alexander is to concatenate it to the label with a slash.
  • Update on ART-DECOR:
    • Share datasets, scenario's. Now currently release 1.6 with major updates. Changes in the XML database and the XFORMS. Performances are much better.
    • IHE Europe uses ART-DECOR for tooling. They have asked some extra features. This will be in version 2.0 in beginning 2016. The new features contain editors.
    • The CCDA 2.1 has been put into ART-DECOR.
    • Now Ewout is looking at ART-DECOR to FHIR specifications into this tool.
    • Trifolia is also a template repository. It is implementation guide focussed. Implementation guides can be copied into Trifolia. It does handle some versioning, but it is not so robust. Lantena is now also looking into FHIR.
    • Pharmacy has a PSS to internationalize pharmacy templates, because it is used Internationalised. Kai is helping them out.

(2) Agenda:

- Clinician-on-FHIR

Stephen Chu, Russ Leftwich, Laura Heermann Langford, Jim McClay, Emma Jones, Rob Hausam, John Hatem, Melva Peters, Kavi Wagholikar, Riki Merick, Scott Bolte, Yu-Ting Yeh ...
FHIR Facilitators: David Hay, Lloyd McKenzie, Grahame Grieve, Ewout, Kramer


  • Three streams:
Stream 1: Care Plan + Procedure - Facilitators: Laura and Emma
Stream 2: Family member History + Condition - Facilitators: Stephen and Scott
Stream 3: Medication + Allergy/Intolerance - Facilitators: Russ and John
  • Q1
- Introduction
- Quick demon of ClinFHIR
- start testing of the 6 resources by clinicians organised into the 3 streams

Patient Care Friday Q2




  • See attendance list in Q1 notes


  • Testing of resources continued

Patient Care Friday Q3



See participant list in Q1


  • Post-FHIR clinical resources testing feedback from each stream
- Facilitators from each steam provided feedback on using ClinFHIR and interactions with the 6 clinical resources to input data
~ experiences with clinFHIR were very positive
~ there are some issues with the 6 tested clinical resources
~ improves were suggested
~ participants request to enter comments and improvement suggestions directly into google doc:
  • Post Atlanta PCWG-FHIR conference call arrangements:
- Clinician-on-FHIR: Tuesdays 5:00pm US Eastern
~ Week 1 Clinician on FHIR planning for Orlando
Laura to set up call and webex
~ week 2 and 4: drilling down on clinical resources for next Clinician on FHIR (Orlando)
- PCWG-FHIR on DSTU 2.1 and DSTU 3.0:
~ Emma to set up webex and conference call
  • Discussions on "negation" representation (Note - "negation" will be changed to some term more appropriate to avoid confusion with HL7 v3 implementation of negation)
- vigorous discussions on how negation should be represented in FHIR clinical resources including condition, procedure,, observation, medication, allergy/intolerance
- general agreement was reached to represent negation by a flag with a set of values:
~ yes
~ no
~ unknown
Example: representing patient did not have concussion
~ Condition = concussion
~ "flag" = no
- also agreement on restricting double negatives causing confusion
~ Condition = no concussion
~ "flag" = yes ("no" value should not be used)
- In case of precoordinated values, they should be represented as two clinical statements
Example: concussion with no loss of consciousness
~ this should be two clinical statements

Patient Care Friday Q4

No Clinician on FHIR event in this Quarter




The Clinician on FHIR event completed in Q3
It was decided that future Clinician on FHIR event will run for three sessions: Q1-Q3