The recommendations provide a framework for interpreting results affected by hormone therapy and improving electronic health record practices.
The Association for Diagnostics & Laboratory Medicine (ADLM) has released US guidance to help laboratory medicine professionals navigate challenges when caring for gender-diverse patients.
The recommendations provide a framework for interpreting laboratory results affected by gender-affirming hormone therapy, improving electronic health record (EHR) practices, and supporting patient-centered care.
As gender-affirming care becomes more common, laboratory professionals face questions about how to accurately interpret test results, ADLM notes. Gender-affirming hormone therapy can alter the results of several common laboratory tests used for cardiac, kidney, and liver health. This can make it difficult for clinicians to determine whether a test result indicates a medical issue.
Addressing Electronic Health Record Limitations
EHR systems often lack the flexibility to capture information relevant to gender-diverse patients, such as gender identity, sex assigned at birth, and organ inventories. According to the ADLM, this can affect screening reminders, causing patients to miss screenings that remain relevant based on the organs they have, such as cervical cancer screenings for transgender men.
Limitations with other laboratory and pathology systems and practices can also lead to gaps in care in areas ranging from transfusion medicine to autopsy reporting.
Filling a Clinical Gap
While several US medical societies have published recommendations for the care of gender-diverse patients over the past 15 years, the ADLM says none have broadly covered the specific challenges facing laboratory medicine and pathology. To fill this gap, the ADLM convened a group of clinical chemists, pathologists, endocrinologists, and clinicians who directly care for transgender patients to develop the guidance.
The document primarily focuses on adults who have been receiving gender-affirming hormone therapy for at least 6 months, as this is the area where the strongest evidence currently exists. Major recommendations from the document include the following:
- Clinicians should move beyond a one-size-fits-all approach to reference intervals—which are critical for interpreting lab test results—and instead take a holistic approach to patient care, looking at physiology, hormones, and how the patient feels. For example, although societies have recommended 100–200 pg/mL as the target concentration for estradiol for transgender women, published data support a wider range, assessed in the context of patient-personalized goals and other factors.
- An organ inventory should be included in a patient’s electronic health record. It would take the form of a table or checklist that documents the presence or absence of specific organs and dates of surgical procedures and allow for more precise interpretation of lab results and preventive screening decisions.
- Transfusion medicine practices involving transgender and nonbinary donors and recipients would benefit from standardized, evidence-based approaches to maintain safety and equity.
- Autopsy reports should document both legal sex and affirmed gender identity, use the decedent’s chosen name and correct pronouns, describe anatomical findings in gender-neutral terms, and note evidence of gender-affirming care without speculation.
“The interpretation of laboratory and pathology tests for gender-diverse patients remains an evolving area of medicine,” says document authors Tiffany A Thomas, Gabrielle N Winston-McPherson, Ina Amarillo, Alisha D Berry, Caroline J Davidge-Pitts, Sridevi Devaraj, Zil Goldstein, Brad S Karon, Brooke M Katzman, Mahmoud A Khalifa, Hung S Luu, James H Nichols, Tracy L Stockley, Michelle R Stoffel, Dina N Greene, and Matthew D Krasowski, in a release. “As the evidence base continues to grow, laboratories, healthcare organizations, and researchers must work together to develop patient-centered approaches that support accurate test interpretation, respectful documentation, and equitable care.”
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