Version Published Changed By Comment
CURRENT (v. 13) Jul 20, 2022 18:45
v. 12 Jul 18, 2022 15:34
v. 11 Jul 12, 2022 21:04

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Use Case Description:

ACLA originated use case, with revisions discussed 2022-03-21 GHP call and subsequent edits by others:

Current State:

A genetic male transgender patient, presenting as female, presents to the laboratory for a blood draw for a Creatinine without Glomerular Filtration Rate, Estimated (eGFR) test, which has different test reference ranges results based on the patient’s age and genetic clinical gender.  The laboratory test may be electronically ordered by the patient’s provider or ordered via a paper requisition.  Since HL7 V2 is used for electronically ordering lab tests, the values supported are typically limited to male, female, unknown, other, ambiguous, or not applicable, or the field may be blank in an electronic order. Paper requisitions may have similar choices.

Note: other common tests that may have different results based on genetic male or female are HDL Cholesterol, Estrogen Total Serum, and Testosterone Total MS,

Future State (Clair Kronk Edit):

A 46,XY,SRY+ transgender woman presents to the laboratory for a blood draw for a Creatinine test, which has different test reference ranges results based on the patient’s age and sex for clinical use, based on karyotype.

Male
(mg/dL)
Female
(mg/dL)
<20 Years>45  >45
≥20 Years≥40≥50

Actors:

Trans Woman Patient

Ordering Provider

Laboratory Personnel

Scope Statement:

This use case originated from the American Clinical Laboratory Association (ACLA)

Out of scope:

Patient ‘sex’ has historically been used for patient matching and EHR functionality may be impacted by Gender Harmony Use cases in future, but patient matching issues is out of scope for this laboratory use case.

Precondition(s):

Provider orders laboratory test(s) via their EHR system, or a paper requisition, and refers patient to a laboratory facility

Postcondition(s):


Workflow/Storyboard:

Before Gender Harmony

  1. The laboratory’s legacy system only captures a single legacy value messaged in PID-8, or sent via a paper requisition.

V2.3 and V2.3.1 PID-8 Sex: F-Female; M-Male; O-Other; U-Unknown

V2.5.1 PID-8 Administrative Sex: F-Female; M-Male; O-Other; U-Unknown; A-Ambiguous, N-Not applicable


  • If provider indicates M-Male the reference range result for the male will be reported
  • If provider indicates F-Female the reference range result for the female will be reported
  • If the provider does not indicate M or F the laboratory may be able to report both male and female or a general reference range to the patient/provider. This permits both to appropriately interpret the results.

If left blank, this may impact claims and billing.


After Gender Harmony

  1. The Provider will select the Sex For Clinical Use value that is clinically indicated when submitting the electronic order to the lab, or via a paper requisition. For example as the result of a prior genetic test, e.g. 46,XY,SRY+ based on karyotype, or other clinical observation determining the genetic value that impacts the laboratory reference ranges in the laboratory test result.


V2 mapping to SFCU (includes definitions from HL7 Informative Document: Gender Harmony - Modeling Sex and Gender Representation, Release 1):


F-Female – Female (The “female” values apply to this patient, in the case of a given procedure or process in a given context, for instance for a procedure, algorithm, hormone level, organ inventory, etc.)


M-Male – Male (The “male” values apply to this patient, in the case of a given procedure or process in a given context, for instance for a procedure, algorithm, hormone level, organ inventory, etc.)


O-Other – Unknown (The SFCU can not be determined because there are no observations or the observations are not sufficient to determine a value. For example, an emergency trauma case may require treatment before SFCU can be established.)


U-Unknown – Unknown (The SFCU can not be determined because there are no observations or the observations are not sufficient to determine a value. For example, an emergency trauma case may require treatment before SFCU can be established.)


A- Ambiguous - Unknown (The SFCU can not be determined because there are no observations or the observations are not sufficient to determine a value. For example, an emergency trauma case may require treatment before SFCU can be established.)


N-Not Applicable - Unknown (The SFCU can not be determined because there are no observations or the observations are not sufficient to determine a value. For example, an emergency trauma case may require treatment before SFCU can be established.)


Open Issue:

Should Specified be used instead of Unknown in any of the mappings above? (This patient has specific documented characteristics that do not fully match either male or female in a given context, for instance for a procedure, algorithm, hormone level, organ inventory, etc.) 


Alternative and/or related Workflow(s):


Alignment and/or Misalignment with Gender Harmony Model:


Current Standard Support:

  • HL7 V2.x   

V2.x Resource:

New segment proposal pending for review and potential ballot September 2022

  • HL7 V3
V3 Resource:
  • HL7 FHIR
FHIR Resource:
  • DICOM
DICOM Resource:
  • NCPDP
NCPDP Resource:
  • X12
X12 Resource:
  • Other (please specify standard and resource below)

Other:

Required Additional Standard Support:


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