Laboratory Use Case variations for transgender woman presenting to provider for laboratory test; patient is not seen by the laboratory

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.

• Use Case 1A test results are not impacted by patient’s biological/chromosomal clinical gender.

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.

• Use Case 1B test results are impacted by patient’s biological/chromosomal clinical gender.

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.

• Use Case 1C test results may be impacted by patient’s biological/chromosomal clinical gender related to hormone therapy drug regimen

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.

• Use Case 1D COVID test results are not impacted by patient’s biological/chromosomal clinical gender, however the State requires SOGI data to be reported.

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[1]. Since the lab never saw the patient and is focused on reporting laboratory data based on laboratory design that is “fit for purpose[2]”, 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.

[1] The state’s PHA may not be able to support legislated data; the laboratory must collaborate/confirm with the state PHA.

[2] “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 Provider

• Provider orders laboratory test(s) via their EHR system and sends specimen(s) to the laboratory
• Provider complies with laboratory’s test requirements re: specimen collection and ask at order entry (AOE) questions (if applicable)
  • Note: Every AOE requires a modification to the EHR system to present the AOE question to the provider during the order process.  Additionally, the laboratory must be able to process the AOE ‘answer’ messaged as an observation.

Pending and will be submitted by the American Clinical Laboratory Association (ACLA)