Use Case Description:
ACLA Original Use Case text:
A transgender (hence after, trans) woman is in the first six months of estradiol therapy. Due to EHR system limitations, the patient record still reads as "M" in the EHR messaged in PID-8.
The patient presents to her provider with symptoms prompting the provider to order a laboratory test not impacted by the patient’s biological / chromosomal clinical gender. For example, a COVID test.
The patient presents to her provider with symptoms prompting her provider to order a laboratory test contingent on the patient’s biological / chromosomal clinical gender. For example, a Creatinine test, which has different test reference ranges results based on the patient’s age and biological / chromosomal clinical gender.
The patient presents to her provider for a routine history and physical (H&P), prompting her provider to order H&P related laboratory tests; some test results may be impacted by the patient’s biological / chromosomal clinical gender related to their hormone therapy drug regimen.
The patient was exposed to COVID and presents to her provider’s office for a COVID test. The provider collects a specimen from the patient and forwards the specimen to the provider’s contractual laboratory, which may be controlled by the patient’s payer. The lab never sees the patient, only the patient’s COVID test swap specimen, accompanied by an electronic order for the test which may, or may not, contain patient demographic data. The results of the COVID test are not affected by the patient’s biological/ chromosomal gender. However, the patient’s state of residence enacted legislature requiring the SOGI data to be reported for the laboratory result. Since the lab never saw the patient and is focused on reporting laboratory data based on laboratory design that is “fit for purpose”, the laboratory does not report SOGI data to the PHA. The provider’s EHR system is the “source of truth” since the provider saw the patient; the provider should report demographic (including SOGI) data to the PHA using HL7 public health or electronic case reporting implementation guides (CDA or FHIR) based on the applicable state PHA’s capabilities.
 The state’s PHA may not be able to support legislated data; the laboratory must collaborate/confirm with the state PHA.
 “Fit for purpose” as defined by NIST: “Fit for purpose is used informally to describe a process, configuration item, IT service, etc., that is capable of meeting its objectives or service levels. Being fit for purpose requires suitable design, implementation, control, and maintenance. Source(s): NIST SP 800-161 from ITIL Service Strategy – Adapted”
Trans Woman Patient
Ordering ProviderLaboratory Personnel
This use case is from the American Clinical Laboratory Association (ACLA)
This use cases deal only with electronic orders for laboratory tests and does not address paper requisitions.
Pending and will be submitted by the American Clinical Laboratory Association (ACLA)
Alternative and/or related Workflow(s):
Alignment and/or Misalignment with Gender Harmony Model:
Current Standard Support:
- HL7 V2.x
Use OBX segment to report Gender Identity using ONC required terminology
ONC 2015 Edition Final Rule:
(2) Standard. Gender identity must be coded in accordance with, at a minimum, the version of SNOMED CT® codes specified in paragraph (a)(4) of this section for paragraphs (o)(2)(i) through (v) of this section and HL7 Version 3 Standard, Value Sets for AdministrativeGender and NullFlavor (incorporated by reference in § 170.299), for paragraphs (o)(2)(vi) and (vii) of this section, attributed as follows: (i) Male. 446151000124109 (ii) Female. 446141000124107 (iii) Female-to-Male (FTM)/ Transgender Male/Trans Man. 407377005 (iv) Male-to-Female (MTF)/ Transgender Female/Trans Woman. 407376001 (v) Genderqueer, neither exclusively male nor female. 446131000124102 (vi) Additional gender category or other, please specify. nullFlavor OTH (vii) Choose not to disclose. nullFlavor ASKU
- HL7 V3
- HL7 FHIR
Other (please specify standard and resource below)