Issues And Decisions

What does the effectiveTime element of the Allergy -  Intolerance Observation mean?

20211018-01

"The clinically or operationally relevant time of an act, exclusive of administrative activity." I.e., low = time of first reaction, whether witnessed or reported.

High is typically not recorded: the current instruction in CCDA to use high = not null => status = resolved is incorrect. Use status observation for status.

What does it mean when an entry is composed of multiple acts?

20211018-02

When a Concern Act contains multiple Observations of the root type (allergy or problem), the only safe approach is to assume each a separate phenomenon. This has not been seen and may never happen.

What resource in FHIR should be used to represent a Problem Concern, Health Concern, or Allergy Concern in CDA?

20211018-03

None. Presence in section implies concern act. ID or context may be applicable to the child object.

Is severity a property of the allergy or the reaction in CDA?  What about in FHIR?

20211018-04

What does the statusCode element mean in CDA and how should it be handled when mapping information from C-CDA to US Core FHIR?

20211018-05

In the RIM, the Act.statusCode element represents the status of the act (of observing, e.g.) and it is usually "complete" for a recorded observation. It does not describe the clinical subject.

 There are only a handful of C-CDA templates where the statusCode supports expression of a state machine model other than simply "completed".  Those templates were designed for data for which an EMRs typically maintains a state-machine for internal representation, and where including the machine state is relevant for exchanging the information with another system.

FHIR APIs follow the REST paradigm which is stateless.  If the statusCodes over than completed should be generalized to Active or Completed in the high-order act of the entry.  EffectiveTime/high SHALL be populated if Completed.  Only EffectiveTime/low SHALL be populated if Active.

Review all C-CDA templates where statusCode supports a more complex state model, and reduce the complexity of the value set to just Active or Completed.  Add guidance saying "Don't send information entered in error" in standard clinical note documents.  

Tranforming to FHIR could simply rely on the effectiveTime.

What are the definitions for various roles expressed within a resource in FHIR and how do they relate to the roles used in C-CDA for various templates?

20211018-06

Under discussion at SD: see work product here

CDA Allergy Concern & Observation both (may) have authors; FHIR only has one recorder. Which one should be used? 

20211019-01

Follow context conduction.

If Obs has author, use that; if not, use Concern, or Section, or Document, unless CC defaults have been modified.

In CDA the cardinality for authors allows multiple authors to be included. How do we handle the mapping when FHIR resources only permit 0..1 reporter?

20211019-02

Duplicate: See 20211019-01

When documenting an Allergy reaction in C-CDA the template allows multiple medications and multiple procedures to be included. These are large and deep templates, and possibly recursive. How do we manage this? 

20211019-03

Decouple maps, so references don't tangle things. Only inline maps if child is very short and not reused elsewhere.

Does ContextConduction apply inside a complex entry that has entryRelationships to nested acts?

20211025-01

How can you reduce the file size of a document by using an id to reference the author information already contained elsewhere in the document?

20211025-02

When mapping from US Core to C-CDA, can additional modeling defined in the base CDA standard be used, even if it is not mentioned in the target template?

CDA patterns support data not specified in C-CDA - e.g., Informant. Are these in scope?

20211025-03

What about language? CCDA specifies in Document only. Clinical statement Acts (& specializations) may assert language, per RIM, but there isn't an option to support that in CDA R2.0. How do we handle that?

20211026-01

Note that FtC conversions only support language assertion for resource representation at the document level.  Conversions from FtC must use resources represented all in one single language.

CtF:  all FHIR resources would be represented in the language established at the document level.

Resources have text, which seems appropriate to section.text. How to should we record section.text for the collection of multiple resources into one section?

20211026-02

CtF: Text representation and referencing should be handled in the same way.  

ACTION NEEDED:  What is the html mechanism in FHIR for doing text linking to entries? C-CDA on FHIR IG needs to provide this guidance.

FtC:  Text representation and referencing should be handled in the same way.

This is a document construction question, not a mapping question. Both document formalisms have text. - JL

A resource may refer to an encounter. This could be equivalent to a document encompassing encounter or a separate encounter (in Encounters section). How should this be handled?

20211026-03

Scenario: A patient or related person asserts a health concern, complaint, or symptom the patient has been or is experiencing.  The practitioner listens, asks questions, listens to the person's clarifications, then documents the issue that was communicated by the patient or related person.

At the moment when the practitioner is documenting the patient's or related person's expressed concerns in her EHR:

1. What resource would be used in FHIR to represent this information? (Any specific details?)
2. Who is the recorder? Who is the asserter?
3. Who is the author? Who is the informant? Who is the performer?

20211031-01

1. Condition category=healthConcern
2. practitioner, person
3. practitioner, person, person (or no performer)

ACTION NEEDED:  Condition should have an extention added for .type which would allow us to distinguish a problem from a symptom or complaint, etc.  C-CDA has a well established value set for Problem type)

This is an instance of the general question of roles, q.v. (20211031-01)

Scenario: Adding to the scenario described in 20211031-01, After examining the patient the practitioner comes to the conclusion (based on her judgement of the situation and the information she has considered) that the patient has or might have a specific "named" condition.

At the moment when the practitioner is documenting her judgement of the patient's condition (diagnosis) in her EHR:

What resource would be used in FHIR to represent this information? (Any specific details?)

Who is the recorder? Who is the asserter?

Who is the author? Who is the informant? Who is the performer?

20211031-02

1. Condition category=encounterDiagnosis, problemList
2. practitioner, practitioner
3. practitioner, person, practitioner

This is an instance of the general question of roles, q.v. (20211031-01)

Scenario: Adding to the scenario described in 20211031-01, After examining the patient the practitioner comes to the conclusion (based on her judgement of the situation and the information she has considered) that the patient has or might have a specific "named" condition. At this practice, the doctor focuses solely on interacting with the patient and family members at the visit and the physician's assistant interacts with the EHR.

At the moment when the practitioner's assistant is documenting the practitioner's judgement of the patient's condition (diagnosis) in her EHR:

What resource would be used in FHIR to represent this information? (Any specific details?)

Who is the recorder? Who is the asserter?

Who is the author? Who is the informant? Who is the performer?

20211031-03

1. Condition category=encounterDiagnosis
2. practitioner's assistant, practitioner
3. practitioner's assistant, person, practitioner

This is an instance of the general question of roles, q.v. (20211031-01)

Scenario: A patient or related person is using an app to maintain a record of personal health issues. In that system of record, the patient or a related person asserts a health concern, complaint, or symptom the patient has been or is experiencing.  The practitioner receives a document generated by that system, reads it, and uses that information to enter encounter information into her own EHR. She reads what the person or related person wrote, then documents the issue that was communicated in the document by the patient or related person.

At the moment when the practitioner is documenting the patient's or related person's expressed concerns in her EHR:

What resource would be used in FHIR to represent this information? (Any specific details?)

Who is the recorder? Who is the asserter?

Who is the author? Who is the informant? Who is the performer?

20211031-04

1. Condition category=healthConcern
2. practitioner, person (or related person)
3. practitioner, person (or related person), person (or related person) (or no performer)

This is an instance of the general question of roles, q.v. (20211031-01)

Scenario: Adding to the scenario described in 20211031-02, Before the conclusion of the visit, the practitioner decides, based on her diagnosis of the patient's condition at this visit, that the patient should get some physical therapy for to minimize the symptoms the patient's is experiencing and potentially resolve the problem.  The office staff get an appointment scheduled for the patient at a Physical Therapy practice. The staff person clicks on a button which causes the EHR to generate a referral note summarizing the patient's situation and requesting physical therapy services to be performed. She sends it to the Physical Therapy practice.

At the moment when the digital Referral Note document is generated by EHR and focusing only on the representation of the patient's main problem to be addressed:

What resource would be used in FHIR to represent this information? (Any specific details?)

Who is the recorder? Who is the asserter?

Who is the author? Who is the informant? Who is the performer?

20211031-05

1. Condition category=encounterDiagnosis, problemList
2. practitioner's assistant, practitioner
3. practitioner's assistant, person, practitioner

This is an instance of the general question of roles, q.v. (20211031-01)

Scenario: Adding to the scenario described in 20211031-05, At the practice of the Physical Therapist, the digital Referral Note document is received and ingested by the EHR used by that practice. A staff member reviews the Referral Note and imports it into the patient's chart. 

At the moment when Referral Note document is imported into the patient's chart within the Physical Therapist's EHR and focusing only on the representation of the patient's main problem to be addressed:

What resource would be used in FHIR to represent this information? (Any specific details?)

Who is the recorder? Who is the asserter?

Who is the author? Who is the informant? Who is the performer?

20211031-06

1. Condition category= problemList,encounterDiagnosis
2. staff member, practitioner from sending practice
3. staff member, practitioner from sending practice, practitioner from sending practice

Also note, the Condition would point to an Encounter Resource that help the information about the Encounter where this condition was diagnosed.

This is an instance of the general question of roles, q.v. (20211031-01)

What is the definition of Onset Time?

20211031-07

Date(/time) when allergy or intolerance first manifest itself in the patient.

Definitions are in the spec

Date(/time) when the condition was recorded in this organization's medical record for the patient.

Definitions are in the spec

Topic revisited, reaffirmed at PC 8/4 link

What is the definition of last occurrence?

20211031-09

Date(/time) of last known occurrence of a reaction

Definitions are in the spec

What is the definition of Reaction.onset?

20211031-10

The start-time Date(/time) of a particular manifestation of the allergy or intolerance.

Definitions are in the spec

What is the definition of Reaction.effectiveTime?

20211031-11

The relevant time when the reaction manifest itself in the patient.

Definitions are in the spec

What is the definition of a concern?

20211031-12

An issue that has risen to the level of concern to the point it should be documented and/or tracked as a healthConcern or a problem on the patient's problem list.

Definitions are in the spec

What is the definition of author.time?

20211031-13

The time when the information is recorded/updated in the record.

Definitions are in the spec

What is the definition of author?

20211031-14

Represents the humans and/or machines that entered the information into the medical record which now is being exchanged in the format of a [document/section/entry/act].

Definitions are in the spec

What is the definition of informant?

20211031-15

An informant (or source of information) is a person that provides relevant information.

Definitions are in the spec

What is the definition of performer?

20211031-16

A person who actually and principally carries out an action. In the case of an Observation, it is the person (or organization in the case of a laboratory test result) who makes the observation/diagnosis/assertion of a problem

Definitions are in the spec

Is the the Allergies Data Concepts sheet from 20211111 complete? accurate? anything else needed?

20211101-01

How do we handle mapping FHIR AllergyIntolerance.code values that represent 'negations' (e.g. SNOMED-CT 1003774007 | No known Hevea brasiliensis latex allergy (situation) ) and converting those to a combination of the underlying substance (e.g. Hevea brasiliensis latex) in the C-CDA value set and a C-CDA observation/@ negationInd = 'true'?

FC allergy, line 27.

https://docs.google.com/spreadsheets/d/1EhRiTh3-wOd6t0eQa2iKD4RQ-A32aqNju1R0rG-afgE/edit#gid=486894550

20211101-02

Mapping Condition verification status from CDA to FHIR: how do we populate verification status? Unconfirmed? Confirmed?

Chat:V-Status

This case tells us: SCT in root & LOINC in translation.

Are there other cases?

This will be harder going the other direction.

We are mapping ProblemObservation.code to Condition.category. They are both classifications of disorder, but there is no clear mapping between the values. We propose to not map, as both bindings are permissive.

chat: category

Translating from CDA, use context conduction as specified to infer context for resources. E.g., if author is missing on entry, get it from above & write to FHIR.

(Determine whether anyone is actually using the exception allowing mods to entryRelationship.contextConductionInd.)

Translating from FHIR, assign context to CDA entries as explicitly asserted by FHIR.

If FHIR does not assign context, specify null context values per CDA 4.4.2.

Does inclusion in the CDA Problem Section imply membership in a Problem List, or is it a collection of all known problem observations?
Companion Guide 5.2.6: "Currently the Problem Section uses the Problem Concern template to record concerns commonly identified as being “on the patient’s problem list”."
Section code: 11450-4 (Problem List - Reported)
Knowing there are cases where this guidance is not followed, should we assume it is, try to change those cases, or decline to follow it?

chat

The CCDA "no known problems" example of the problem section has an explicit observation of a "problem" with the negation indicator set to true.

The CDA on FHIR guide includes an "emptyReason" property for indicating, e.g., "no known  problems" (coded as "nilknown").

These patterns are equivalent.

Problem code map (chat)

CCDA has a SHOULD binding to the Problem value set in SCT, with a supported translation to ICD.

US Core FHIR has a CodeableConcept (set of codes + 1 text), with an extensible binding to several SNOMED axes.

Going from CCDA to FHIR, we propose
    The CD goes in a Coding
    The CD displayName goes in CodeableConcept.text
    If there are translations, include them and mark the root CD value as "user selected"

Going from FHIR to CCDA, we propose
    If there is one code, put it in CD
    If there are multiple codes, the one that goes in CD is
        the "user selected" 
        else, the most granular one in the Problem List VS (?)
        else, the first one in the FHIR list in the Problem List VS
        else, the first one in the FHIR list 
    the rest in Translation

Observation. It's more common. 

Don't use both: equating distinct objects will cause confusion

Possible future option: add extension to identifier for act identifier. Seems unnecessary and contrary to assumption that we are not designing new functionality to address gaps.  

Follow graph structure: CDA allergy participant is at level of sensitivity, so map to allergy code.

If CDA has reaction medications, those would go in FHIR reaction substance.  CDA has no equivalent to reaction substance. (14 Mar 23)

Open

Open

Target: yes

Source: if not supported

Mood should be reflected even if not mapped