Transitioning the Clinical Lab

Increasingly, legislative and regulatory spotlights worldwide are shining on healthcare provision for transgender and nonbinary patients. In many regions, greater restrictions are being imposed on gender-affirming care—often for minors, but in some cases for adult patients as well.¹ Healthcare providers who assist with such care can be held liable and face professional, civil, and even criminal penalties. As a result, increasing numbers of scientific and medical professionals, including laboratorians, are factoring these concerns into decisions about where they feel able to live and work—and what services they deliver.

What role does the clinical laboratory play in providing care for transgender and nonbinary patients? And what should laboratory professionals know about the medical, legal, and ethical considerations involved in serving those patients?

Testing challenges for transgender patients

When providing testing services for transgender patients, it’s vital to ensure that results are interpreted appropriately based on the patient’s physiology. This is particularly relevant when it comes to gendered reference ranges; patients who are undergoing feminizing or masculinizing hormone therapy or who have completed gender-affirming surgical procedures may not fall within the ranges of their assigned or affirmed genders, raising questions about how to interpret their results. Some experts recommend universally applying the reference range of the patient’s affirmed gender,² whereas others suggest including both male and female reference intervals with all tests.³ A more nuanced approach is to selectively apply the reference interval for the patient’s assigned or affirmed gender depending on the test performed.⁴

Some laboratory information systems double down on the challenge by restricting providers’ ability to record the details of a patient’s gender (for instance, by limiting users to binary options) or linking test menus to a patient’s recorded gender.⁵ This can create issues when, for instance, a transgender man requires a cervical smear or a transgender woman is referred for prostate-specific antigen testing. Providers of laboratory information systems and electronic medical records (LIS/EMR) are aware of the need to better serve these patient populations—but many report that their lab clients haven’t requested such changes.⁶ This doesn’t mean that expanded gender and reference range options aren’t necessary or relevant; rather, the findings demonstrate the need to raise awareness of their importance in providing high-quality care for transgender and nonbinary patients.

The legislative lay of the land

“Pathologists and laboratorians need not be medical or legal experts on transgender healthcare to have a strong impact on our trans patients’ healthcare experiences,” says Timothy Craig Allen, chair of pathology at Oakland University William Beaumont School of Medicine and chief of the pathology service line at Corewell Health East. “There is good information on the Internet that provides an understanding of transgender healthcare. A transgender glossary of terms is a good place to start.” Allen, who has also practiced health law, is aware of the complexities of current legislation surrounding gender and sexual minorities’ access to care—and stresses that, although laboratory professionals should know the basics, they should also be prepared to defer to experts when needed.

An example Allen gives is the importance of identifying patients—and patient samples—correctly throughout the process of a name or gender change. “Laboratorians should understand the laws and regulations pertaining to patient identification of laboratory tests and tissue specimens. It is also necessary for them to understand the legal and regulatory implications [of changes to patient documentation] so that they can appropriately bill and receive payment for laboratory services and pathology diagnoses.”

Finally, Allen cautions all members of the clinical laboratory to be aware of their local legislative landscape with respect to transgender healthcare. “There is currently a lot of legislative activity within the statehouses regarding trans healthcare,” he says, referring to numerous states in which laws ban or restrict the provision of gender-affirming care.⁷ Although this may seem more relevant to patient-facing providers, the lab is involved in many aspects of such care, from monitoring hormone levels to ensuring that reference ranges reflect each patient’s physiology.⁸ “Lab professionals need to understand the legal risk, which varies among the states, of providing trans healthcare.”

Might these risks affect laboratory care for patients in more restrictive states—or encourage clinical lab professionals to practice elsewhere? Allen believes it’s a possibility with worrying implications for health equity. “People are attracted to or repelled by states based on, among other things, their state laws. As such, we can expect laboratorians and pathologists who feel strongly one way or another about trans healthcare laws to migrate to states that support their views. Further, we can expect trans patients who have the ability and desire to do so to move to states with attractive trans healthcare laws and policies. Because many trans patients are financially under-resourced, restrictive state laws will change their geographic access and result in longer travel times to supportive clinics and hospitals.”

The importance of forward-thinking leadership

“During this dynamic time, people will look to their leaders for understanding and guidance,” says Allen. “These leaders can serve their staff well by understanding the evolving legal and regulatory landscape and sharing that knowledge with their teams, as well as working with those teams to develop policies and practices that meet the legal requirements.”

He emphasizes that this kind of knowledge-sharing and collaboration is not a one-time event; with our understanding of transgender health advancing rapidly and laws and guidelines changing equally fast, it’s important for teams to update their knowledge and protocols regularly. Organizations such as the American Medical Association publish guidance on ethical, responsible, and inclusive care for transgender and gender-diverse patients;⁹ the Institute for Quality Management in Healthcare has even published a document outlining considerations specific to the clinical lab.¹⁰

“Leaders also have an opportunity to influence their teams by speaking of—and exhibiting the value of—providing excellent healthcare to all our patients, including our trans patients, within legal and regulatory boundaries,” Allen concludes. “Most importantly, leaders can also emphasize the equity underpinnings related to the provision of trans healthcare.” By doing so, lab leaders create an ethical, equitable, and inclusive environment for every patient and provider who crosses their threshold.

 

References:

1. 1. The Associated Press. Efforts to restrict transgender health care endure in 2024, with more adults targeted. NBC News. January 11, 2024. https://www.nbcnews.com/nbc-out/out-politics-and-policy/efforts-restrict-transgender-health-care-endure-2024-adults-targeted-rcna133432.

1. 1. Cheung AS et al. Approach to interpreting common laboratory pathology tests in transgender individuals. J Clin Endocrinol Metab. 2021;106(3):893–901. doi:10.1210/clinem/dgaa546.

1. 1. Cheung AS et al. Sex specific reference ranges and transgender care. BMJ. 2022;376:e069874. doi:10.1136/bmj-2021-069874.

1. 1. Davis D. The importance of accurate laboratory reference intervals for transgender patients. ASCLS Today. December 2022. https://ascls.org/the-importance-of-accurate-laboratory-reference-intervals-for-transgender-patients.

1. 1. Hepburn S et al. Current practice and recommendations for managing transgender patient data in clinical laboratories in the United Kingdom and Republic of Ireland. Ann Clin Biochem. 2024;61(2):98–106. doi:10.1177/00045632231195484.

1. 1. Aquino AC. Transgender adult reference intervals taking shape. CAP Today. November 2019. https://www.captodayonline.com/transgender-adult-reference-intervals-taking-shape.

1. 1. The HRC Foundation. Map: Attacks on Gender Affirming Care by State. November 13, 2023. https://www.hrc.org/resources/attacks-on-gender-affirming-care-by-state-map.

1. 1. Goldstein Z et al. When gender identity doesn’t equal sex recorded at birth: the role of the laboratory in providing effective healthcare to the transgender community. Clin Chem. 2017;63(8):1342–1352. doi:10.1373/clinchem.2016.258780.

1. 1. Eckstrand K et al. Affirmative and responsible health care for people with nonconforming gender identities and expressions. AMA J Ethics. 2016;18(11):1107–1118. doi:10.1001/journalofethics.2016.18.11.pfor1-1611.

1. 1. Institute for Quality Management in Healthcare. Care Considerations for Inclusion of Gender Diversity within Medical Laboratory Services. July 8, 2019. https://iqmh.org/Portals/1/Docs/Resources/Education/White%20Paper%20-%20Care%20Considerations%20for%20Inclusion%20of%20Gender%20Diversity%20Within%20Medical%20Laboratory%20Services.pdf.