GF#16038 Add interventions required in AdverseEvent
GF#16037 Add attribute to capture likelihood of recurrence
GF#16028 Add who detected the adverse event
GF#16092 Add contributing factors to AdverseEvent
GF#15573 AdverseEvent.category may need to be expanded
- GF#13698 AdverseEvent.suspectedEntity.instance should allow CodeableConcept
- GF#13302 Vocabulary issues with AdverseEvent
- GF#11021 Increase cardinality of substance and make certainty relation to substance not reaction - 2016-09 core #40
- GF#15525 AllergyIntolerance meaning of unconfirmed yet resolved
- GF#16685 The Careplan should include the time an date it was created. - 2018-May Core STU #2 2018-May Core - In Person
- GF#13903 CarePlan should allow tracking of past activities (i.e. past interventions)
- GF#13140 logical definition of care-plan-category value set may require realignment with SCT changes
- GF#11173 CarePlan needs support for reviews - 2016-09 core #327
- GF#10028 Careplan: Provide ability to specify patient and/or provider preferences
SD / SOAP Notes
- GF#12676 Guidance request for GP SOAP in FHIR
- GF#14720 Add Guidance for Exchanging Notes - 2018-Jan Core #42
- GF#16433 CommunicationRequest: PractitionerRole as recipient? 2018-May Core
- GF#13936 CommunicationRequest - intent value set
- GF#16047 incorrect status mapping
- GF#16196 Change the coding system for Condition.clinicalStatus from HL7 to SNOMED CT 2018-May Core - In Person
- GF#16195 Summary: Change terminology binding strength for Condition.clinicalStatus from "required" to "example" 2018-May Core - In Person
- GF#16193 Change data type for Condition.clinicalStatus and Condition.verificationStatus 2018-May Core - In Person
- GF#16192 Change the coding system for Condition.verificationStatus from HL7 to SNOMED CT 2018-May Core - In Person
- GF#16190 Change terminology binding strength for Condition.verificationStatus from "required" to "example" 2018-May Core - In Person
- GF#16147 Condition.category - can be used to specify granular type code? 2018-May Core - In Person
- GF#16146 FamilyMemberHistory - Why Not Represent using Condition profile? 2018-May Core - In Person
- GF#16145 Condition.bodySite - allow BodySite use - 2018-May Core - In Person
- GF#14874 Condition.clinicalStatus should not be a limited to a code from the condition-code value set - 2018-Jan Core #215-InPerson
- GF#14872 Not sufficient support for Concern - 2018-Jan Core #213
- GF#14732 How are dependent relationships represented? - 2018-Jan Core #54-InPerson
- GF#10635 QA 5a: Resource references exist in both directions for Condition and ClinicalImpression
- GF#16352 Clarify how we specify the start/end of a procedure if automatically started by a device (e.g. infusion, dialysis) 2018-May Core - In Person
- GF#16346 Explain when we should use Procedure.reasonCode vs. Procedure.reasonReference 2018-May Core - In Person
- GF#13047 Add DosageInstructions to Procedure
- GF#12993 Please Create a NonMedicationAdministration object or an Administration object
- GF#15691 Add an element to Procedure to indicate whether an individual chose to self-direct the service - discussed, but not resolved.
WGM Discussed Trackers
- GF#16678 Recommend that NDKA be a requried field as it is reportable to the patient record as a required value - 2018-May Core
- GF#15781 AllergyIntolerance.assertedDate
- GF#14643 Asserted Date on Conditon and on Condition Definition page have inconsistent definitions
- GF#16062 Clarification of PerformedRange in Procedure resource 2018-May Core
- GF#15809 Procedures cannot be searched by "reason" or "reasonCode"
- GF#15682 Add attribute to enter body site laterality in Procedure resource - discussed, but not resolved
- GF#15682 Add attribute to enter body site laterality in Procedure resource
- GF#15691 Add an element to Procedure to indicate whether an individual chose to self-direct the service - discussed, but not resolved
- GF#14334 allow careteam.participant member to reference a Practitioner role
- GF#15583 PC Missing IsModifierReason
- GF#15579 why is carepplan.activity.status an is_mod?
- GF#15644 review Careplan "completed" status
- GF#14483 Use of reference for planDefinition in carePlan need to be added back. 2018-Jan Core-InPerson
- GF#14959 Clarify difference between Requester and Sender in CommunicationRequest
Recap last WGM.
There may be differences between clinical research and allergies/clinical use case. In clinical research, the first occurrence is considered an incident or adverse event, but the first occurrence of an allergy reaction is not considered an adverse workflow.
Is the AdverseEvent the adverse workflow or the adverse manifestation? AdverseEvent is when something undesirable happens and then track anything that may help determine causality.
Regulatory use cases:
- Associate drug to AdverseEvent
- Which stage of medication process? AdverseEvent.category is 0..* because there can be multiple axes of categorization, so you could use category for "when" it was caught: ordering vs dispensing vs administrating the medication.
- To pinpoint the root cause was a barcode, a change request is recommended.
- Other root causes, which can vary by category
- Barcode or NDC issue
- Communication (illegible handwriting, unclear verbal message)
- Container labels or carton labeling confusing
- Container labels or carton labeling look alike
- Data entry error
- Device malfunction
- Human factors (e.g., knowledge deficit, product name was abbreviated on the computer listing)
- Instructions for use are confusing
- Name confusion (drug names look alike or sound alike)
- Other (text/speech to text field)
- Packaging (product for oral use was packaged in a vial typically used for injections)
- Prescribing Information is confusing or inaccurate
- Product quality issue
- Products stored next to each other
- Wrong storage temperature
- Fetus has AdverseEvent when med was administered to parent/mother
- Link fetus infant report to parent report if parent also experience the adverse event
- Is this referencing another DocumentReference (the resource allows that) or referencing an AdverseEvent or some kind of a knowledge artifact saying they are linked together (Linkage allows you to link two AdverseEvent resources)?
- Product, problem, or med error without a patient - medication didn't reach the patient
- Incorrect instructions on a medication dispense, but the patient caught it before taking the medication. The subject is still the Patient, but the AdverseEvent.actuality = potential.
- Possible change request: Do we need to document an expected vs unexpected AdverseEvent?
- For example, an expected AdverseEvent might be giving non-compatible blood in an emergent situation when compatible blood is not immediately available.
- A defective bottle of medications (or stinky tray of food) where a specific patient is not identified yet. Is this the Group of all patients (at risk) OR relax cardinality of subject to be optional OR is that not within scope of AdverseEvent?
Resolved GF#16027 Add date when AdverseEvent detected
To log new change requests:
Click "Submit a Change" on the bottom of FHIR specification, which opens gForge.
To get a gForge account, refer to http://wiki.hl7.org/index.php?title=FHIR_gForge_Tracker#Who_can_submit.3F