Current Practice & Recommendations for Managing Transgender Patient Data (UK & Ireland) 2023 PDF

Research Article Annals of Clinical Biochemistry 2023, Vol. 0(0) 1–9 © The Author(s) 2023 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/00045632231195484 journals.sagepub.com/home/acb Current practice and recommendations for managing transgender patient data in clinical la...

Research Article Annals of Clinical Biochemistry 2023, Vol. 0(0) 1–9 © The Author(s) 2023 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/00045632231195484 journals.sagepub.com/home/acb Current practice and recommendations for managing transgender patient data in clinical laboratories in the United Kingdom and Republic of Ireland Sophie Hepburn1,2 , Devon Buchanan2  and Seán J Costelloe3,4  Abstract Background: Transgender people may avoid seeking medical care due to previous negative experiences and fear of discrimination. Clinical laboratories can contribute to a poor patient experience and clinical outcome when the design and functionality of laboratory information management systems (LIMS) do not consider the needs of transgender patients. This survey aimed to capture current practices in United Kingdom and Republic of Ireland clinical laboratories concerning how transgender patient data and test requests are managed throughout the total testing process. Methods: An anonymous survey was distributed to clinical laboratory professionals in November 2021. Thirty-three questions covered how gender variables are recorded for transgender patients and used to inform gender-specific calculations, test access, and reference intervals (RIs). Results: Of the 66 respondents, 70% were based in laboratories in England, with a majority of laboratories having ISO 15189 accreditation and processing 1000–10,000 blood samples daily. Eighty-five percent stated that their LIMS had a single field recording sex or gender information. Forty-three percent did not limit test access based on gender, but 68% did not append RIs for patients with unknown or indeterminate gender. Conclusions: This survey was the first to quantify how clinical laboratories manage sex and gender information and report results for transgender and non-binary patients, and details several key recommendations based on the survey responses. Keywords Transgender, pre-analytical, post-analytical, laboratory information management systems Accepted: 1st August 2023 Introduction Transgender people have a felt sense of gender (gender identity) that is different from the gender that was assumed when they were born based on the appearance of their genitals (sex assigned at birth).1 Most of the population have a gender identity consistent with their sex assigned at birth and may be described as cisgender. The terms ‘transgender’ and ‘cisgender’ are usually shortened to ‘trans’ and ‘cis’. Since the 20th century, social movements advocating for the rights of transgender people have made it more socially acceptable for people to be openly trans and brought 1 Department of Blood Sciences, Raigmore Hospital, Inverness, UK Association for Clinical Biochemistry and Laboratory Medicine, PreAnalytical Phase Special Interest Group, London, UK 3 Department of Clinical Biochemistry, Synnovis, King’s College Hospital, Denmark Hill, London, UK 4 Department of Clinical Biochemistry, Cork University Hospital, Wilton, Co. Cork, Republic of Ireland 2 Corresponding author: Sophie Hepburn, Department of Blood Sciences, Raigmore Hospital, Inverness IV2 3UJ, UK. Email: [email protected] 2 attention to prejudice and discrimination against trans people in all areas of life. Health care is one area in which trans people face discrimination. In the United Kingdom (UK) and Republic of Ireland (ROI), trans people report that when accessing health care, they encounter a lack of understanding of their specific needs, inappropriate curiosity, pressure to undergo medical and psychological investigations, and an inability to access transition-related health care.2–3 Trans people may suppress their gender identity or avoid seeking medical care due to fear of discrimination.3–4 Laboratory information management systems (LIMS) may contribute to trans people’s negative healthcare experiences since they have not, historically, been designed with gender diversity and the needs of transgender patients in mind. Where a LIMS cannot record a patient’s gender identity and sex assigned at birth, laboratories may not be able to help clinicians interpret results appropriately.5 Where changes to name or sex are made in most LIMS, this can cause previous medical records to become disconnected from current records.6 Depending on how a LIMS is configured, clinicians may find that access to certain test requests is limited by sex or gender, such as when ordering Cancer Antigen 125 (CA-125) in a man.6 When different reference intervals (RIs) are reported for cis men and women, laboratories may not have considered which of these, if any, are most appropriate for trans people,7 and there may be no RI available at all for some sexes, such as prostate-specific antigen (PSA) measured in women.8 When laboratories perform calculations that include sex or gender variables, such as estimated glomerular filtration rate (eGFR), clinicians might not realise that it will not accurately reflect true GFR in trans people due to changes in muscle mass.9 These issues were somewhat evaluated when Martha Lyon sent a survey about transinclusive features to LIMS companies in 2019.10 However, previous literature has not quantified how many clinical laboratories are affected by these issues or how many have implemented best practices to avoid or manage them. This survey aimed to capture current practices in UK and ROI clinical laboratories concerning how transgender patient data and results are managed throughout the total testing process. The authors make recommendations for areas of improvement and LIMS requirements moving forward. Annals of Clinical Biochemistry 0(0) encountered with blood tests and what would improve their experience of having blood tests. The author made contemporaneous notes and used them to identify themes. Some of the themes were addressed in the survey: staff that are knowledgeable about trans health, laboratories reliably performing the investigations requested, and trustworthy interpretation of results. Unfortunately, the other themes could not be addressed because they were outside of the control of medical laboratories: patient facing staff who are not prejudiced and address service users correctly, knowing which investigations trans and non-binary service users need, and the difficulties of forwarding results to private medical providers. The survey was hosted on the SurveyMonkey® platform, then emailed to all members of the Association of Clinical Biochemistry and Laboratory Medicine (ACB), the Association of Clinical Biochemists in Ireland (ACBI), the Academy of Clinical Science and Laboratory Medicine (ACSLM) and was advertised by the authors via the JISCMAIL ACB-CLINCHEM-GEN mailing list (jiscmail.ac.uk). The survey was open for responses from 1 November to 4 December 2021. Due to the anonymous nature of the survey, it was not possible to identify multiple responses that may have been received from the same institution. Response data were manipulated in Microsoft Excel and multiple-choice questions were summarised using simple descriptive statistics. Free text responses were recoded if they matched one of the multiple-choice responses, then additional information was analysed qualitatively for anything judged to add value to the survey response. R was used to generate Figure 1 (R Core Team [2023]. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www. R-project.org/). Subgroup analysis was not possible due to the low response rate. Percentage response is calculated in relation to the total number of survey respondents (n = 66), unless indicated. Responses accounting for <10% of the total response are discussed in the context of number of individuals (n) responding. No research ethics committee review was required for the survey, nor for the patient involvement during its design. Results Laboratory and LIMS characteristics Methods A survey totalling 33 multiple-choice or open-ended questions was designed (Supplemental File 1). Patient engagement was used to inform the questions posed in the survey. This involved one of the authors interviewing five service users at the trans and non-binary health clinic run by CliniQ and King’s College Hospital in London. Service users were asked to describe any problems they had Sixty-six individuals responded to the survey and 28 of the 33 questions were answered by at least 95% of respondents. The characteristics of the laboratories that respondents were based in are shown in Table 1. Most were based in England, had ISO 15189 accreditation, and received 1000–10,000 blood samples per day from primary and secondary care. Fifty-five percent were based in a teaching or university hospital, and 42% were from district general hospitals. Fifteen different Hepburn et al. 3 Figure 1. Responses to a survey about best practices managing transgender patient data and results in clinical laboratories in the United Kingdom and Republic of Ireland. Total response (n = 66). Trans-inclusive data fields refer to fields for gender identity, sex assigned at birth, or an inventory of current organs. A missing reference interval is when a test is reported with a reference interval for one sex, but none for another sex. CA-125, Cancer Antigen 125; eGFR, estimated glomerular filtration rate; LIMS, laboratory information management system; PSA, prostate-specific antigen. LIMS were in use amongst respondents, the most common being APEX and WinPath, while Wales and Northern Ireland had national LIMS (TrakCare and NIPIMS, respectively). All respondents used their LIMS to select RIs and automated comments, and 92% used their LIMS to calculate eGFR. Some respondents also used their middleware to select RIs (21%), add automated comments (12%) and calculate eGFR (17%). Recording sex and gender The survey included 18 questions about LIMS best practices that could improve care for trans people, and the responses are shown in Figure 1. Figure 1 includes four questions about how sex and gender are recorded. Fifteen percent of respondents had two or more fields available to record sex and gender information, and of those who did, 12% labelled them ‘sex’ and ‘gender’, n = 1 used ‘sex’ and ‘gender identity’, and n = 1 used ‘sex’ and ‘current gender’. A majority (68%) of respondents had a single field labelled ‘sex’, 15% had a single field labelled ‘gender’, and n = 1 had a single field labelled ‘sex assigned at birth’. None of the respondents could record an inventory of the patient’s current anatomy in their LIMS. Survey participants were asked if they had requested data fields for gender identity, sex assigned at birth, or an 4 Annals of Clinical Biochemistry 0(0) Table 1. Laboratory characteristics reported by individuals that responded to the survey. Question and response No. of respondents from total n = 66 (%) Country England 46 (70) Republic of Ireland 9 (14) Wales 5 (8) Northern Ireland 3 (5) Scotland 3 (5) Accredited to ISO 15189 Yes 61 (92) No 4 (6) No response 1 (2) Type of institution (multiple responses allowed) Teaching or university hospital 37 (56) District general hospital 28 (42) Children’s hospital 6 (9) Maternity hospital 5 (8) Other 3 (5) Community hospital 1 (2) Daily sample throughput 501–1000 8 (12) 1001–5000 39 (59) 5,001–10,000 13 (20) >10,000 5 (8) No response 1 (2) Sample source (multiple responses allowed) Primary care 65 (98) Secondary care 66 (100) LIMS (multiple responses allowed) Dedalus, APEX 17 (26) Clinisys, WinPath 14 (21) Dedalus, Telepath 9 (14) InterSystems, TrakCare 6 (9) Cirdan, Ultra 3 (5) Clinisys, LabCentre 3 (5) HSC, NIPIMS 3 (5) Sunquest, Sunquest Laboratory 2 (3) Waters, OMNI-Lab 2 (3) Other 6 (9) Insufficient detail given 2 (3) inventory of current organs (abbreviated to ‘trans-inclusive data fields’ in Figure 1) during LIMS procurement. Only a small number had asked for these features in a previous procurement, although 30% were unsure. Some free text responses indicated that laboratories have LIMS that were 10–20 years old. Around one-third of respondents had asked for some of the aforementioned data fields in a planned LIMS update, while 36% did not know if the fields had been requested for future updates. When asked whether information was recorded anywhere to indicate when a patient was transgender in order to aid the interpretation of laboratory results, 45% of respondents stated that it was recorded somewhere. Free text responses indicated that when information was not in a dedicated LIMS field: it might be recorded in the electronic patient record, clinical details field, clinical notepad, scanned paper request form, non-reportable patient flags, or recorded as a comment. Changing sex and gender Participants were asked whether historical records would become unlinked or change following changes to a patient’s recorded name, sex or gender. Sixty-two percent responded that historical records would remain linked and would not change (Figure 1). The remainder were unsure or reported that historical records could become unlinked or change in some circumstances. Free text responses indicated historical records were likely to become unlinked if the patient’s National Health Service (NHS) number changed (a unique number allocated to patients in England and Wales) or if laboratory staff were not asked to merge the new and old record manually. Free text responses about changing historical records stated that some LIMS would change every historical record to match the current sex, were unsure, or would only change results if edited or re-authorised after a change in sex or gender. Sex-specific tests Most respondents reported that PSA could be requested in female patients, and CA-125 could be requested in male patients (Figure 1). Respondents were asked what special procedures clinicians must follow to order these tests. Some laboratories had minor barriers in these situations, including alerts when clinical staff requested them electronically, alerts when laboratory staff requested them or queueing the results for manual authorisation after analysis. Some had more significant barriers, including requiring paper request forms because the electronic requesting system does not allow the tests to be ordered, requiring the requester to call the laboratory in advance, or running samples ‘offline’ (without using the LIMS) because the LIMS would not allow the tests to be booked in. Respondents were asked which other tests could only be requested for a specific sex or gender. Forty-three percent of respondents wrote a free text response saying every test could be ordered in the LIMS regardless of gender. Human chorionic gonadotrophin (hCG) was the only other measurement restricted by some respondents. Some calculations were also restricted based on gender, including free testosterone and free androgen index; and one respondent did not calculate eGFR or the fibrosis-4 index in patients where the sex was recorded as ‘unknown’. Hepburn et al. 5 Reference intervals Only two respondents reported that they could select RIs using a combination of gender identity, sex assigned at birth and current organs (Figure 1). However, while thinking this functionality exists, they do not currently use it, instead employing a single ‘sex’ field. Of the respondents who said they had two or more fields for sex and gender information, none reported that they could combine this information to select RIs. Participants were asked about missing RIs; when a test is reported with a RI for one sex but no RI for another sex (Figure 1). They were specifically asked whether they reported a RI alongside PSA when measured in female patients and CA-125 when measured in male patients. When a PSA was reported for females or trans females, 50% said that the result was reported with no RI, and 38% said it was reported with the cisgender male RI. Two respondents reported using a RI specific for trans females, with one identifying this as <0.1 µg/L. When CA-125 was reported for male or trans male patients, 30% said the result was reported with no RI, and 62% said it was reported with the cis female RI. When asked which other tests had missing RIs, more than half reported there were no missing RIs on test reports for males or females, but only 32% had no missing RIs for patients with unknown or indeterminate gender. Participants were asked to list the tests with missing RIs, and their responses are summarised in Table 2. Notably, in patients with unknown or indeterminate sex, many respondents reported appending no RI for any tests or that they were not appended for those tests with sex-specific RIs. Some of the free text responses also describe how respondents dealt with unknown sex: some will contact the requester to ask for the binary sex, n = 1 reported both male and female RIs, and n = 1 reported a RI that encompassed both male and female RIs. Sex-based calculations Only n = 2 respondents stated that clinicians were warned that eGFR might be under-estimated in trans females and over-estimated in trans males (Figure 1). One respondent did this via commenting on patient reports, and one did it through general education. Participants were also asked which sex or gender field was used to calculate eGFR. Participants who only had one field to record sex and gender used that field, but amongst the n = 10 participants who had two fields available, n = 9 used the ‘sex’ field, and n = 1 used ‘gender’. One participant did not know, and one did not calculate eGFR because they served a children’s hospital. Clinical liaison A majority (62%) responded that there was no clinical liaison concerning the management of transgender patients, including hormone therapy, result interpretation and testing panels (Figure 1). However, 33% stated that clinical liaison was in place or planned, which included: discussion with GP practices, scheduled hospital meetings, a national approach being adopted, engagement with national transgender services and meetings with equality, diversity and inclusion staff at the hospital. One respondent explained that a specialist nurse was available to arrange telephone discussions between patients and the laboratory to explain Table 2. Investigations with missing reference intervals that were reported by respondents, arranged by frequency. Missing in male patients Missing in female patients Missing when sex is unknown or indeterminate CA-125 Free androgen index CA 15-3 sFlt-1 and PlGF Progesterone hCG Anti-Mullerian hormone Total bile acids FSH PSA Calculated free testosterone Every test Every test with sex-specific RIs Testosterone Oestradiol Prolactin SHBG FSH LH DHEAS GGT Progesterone Ferritin Urate ALP Creatinine (42 others omitted) ALP, alkaline phosphatase; CA-125, Cancer Antigen 125; CA 15-3, Cancer Antigen 15-3; DHEAS, dehydroepiandrosterone sulphate; FSH, folliclestimulating hormone; GGT, gamma-glutamyl transferase; hCG, human chorionic gonadotrophin; LH, luteinising hormone; PlGF, placental growth factor; PSA, prostate-specific antigen; sFlt-1, soluble fms-like tyrosine kinase-1; SHBG, sex hormone binding globulin; RI, reference interval. 6 Figure 2. Key recommendations for clinical laboratories about managing data and results for transgender patients. LIMS reporting so that consent could be obtained to record their transgender status in the LIMS. Most (70%) respondents did not have a coordinated approach to managing transgender patients in their LIMS with other pathology departments within their institution, for example, blood sciences, microbiology and histopathology (Figure 1). However, n = 4 respondents identified that a coordinated approach was planned for newly procured LIMS, and a further two reported ongoing discussions between departments. Regarding pathology networks, 65% of respondents did not have a standardised approach for managing results from transgender patients across their shared or various LIMS (Figure 1). Discussion and recommendations The survey results suggest that LIMS in use in UK and ROI clinical laboratories do not have the functionality required to handle pathology results appropriately for transgender patients. Recording sex and gender This survey has shown that very few LIMS in the UK and ROI have two fields to record information about patient sex and gender and that, in the past, laboratories rarely asked for this feature during infrequent procurement or upgrade of LIMS. However, many laboratories plan to introduce them in a future LIMS update. These findings are consistent with a survey of LIMS companies in 2019, where 38% did not produce a product that could collect gender identity and sex assigned at birth, only 25% had been asked for them by their customers, but all of the remaining respondents planned to introduce the feature within 1–2 years.10 The findings can also be compared to existing recommendations for how to record sex and gender. The authors Annals of Clinical Biochemistry 0(0) recommend that LIMS have two fields to collect sex and gender information: ‘gender identity’ and ‘sex assigned at birth’. These terms are used at the Center of Excellence for Transgender Health at the University of California, San Francisco6 and at CliniQ, a well-being and sexual health service for trans and non-binary people in London. However, none of the respondents who did have two fields labelled them using these preferred terms, and instead, most used ‘gender’ and ‘sex’. These labels have the drawback of being ambiguous. In everyday usage, ‘sex’ and ‘gender’ are used interchangeably to refer to a broad range of biological, psychological, social, cultural and legal phenomena,1 making it difficult for the laboratory to provide reliable interpretative advice based on them. Since, in practice, there are often technical barriers and institutional resistance to removing the ‘sex’ field in electronic systems, the World Professional Association for Transgender Health (WPATH) guidelines recommend a pragmatic compromise.6 They recommend that computer systems continue their current practice of having a mandatory ‘sex’ field but should also include the fields ‘gender identity’ and ‘sex assigned at birth’. It is recommended that these fields should be optional demographic fields, like ethnicity or sexual orientation. The authors recommend against creating policies that require the ‘sex’ field to match the sex assigned at birth or government-issued documents. This is because they may lead to discrimination due to the broad everyday meaning of ‘sex’. If, for example, a trans woman has her sex recorded as ‘male’, health-care staff may be inclined to treat her as a man, perhaps failing to meet her social, psychological and medical needs.1 In England, patients may request a change in their recorded sex or gender at any time, and they do not need to undergo medical interventions or change government-issued documents to do so.11 The WPATH guidelines also recommend that computer systems provide a way to maintain an inventory of a patient’s medical transition and current anatomy.6 None of the respondents had this functionality in their LIMS. This feature would be helpful for laboratories because interventions such as gender-affirming hormone therapy alter the interpretation of many results. The sex assigned at birth and the gender identity of a patient can give a clue about whether they have had those interventions, but not every trans person has them. For example, a person who was assigned female at birth but has a non-binary gender identity may or may not be taking testosterone. If they are on testosterone therapy then parameters such as haemoglobin will change.12 Recording this information in an inventory would allow laboratories to provide more appropriate RIs. Recommendation. When laboratories upgrade or replace their LIMS, they should ask for functionality to store sex and gender information fields labelled ‘gender identity’ and Hepburn et al. ‘sex assigned at birth’. If there are barriers to removing or renaming the ‘sex’ field, a pragmatic alternative is keeping this alongside the above two fields. Laboratories could also ask that the LIMS is able to record an inventory of the patient’s current anatomy. Changing sex and gender This survey found that in around two-thirds of laboratories, when patients change sex or gender, their historical records remain linked to their current ones, and historical results are not altered (Figure 1). The former was included in the survey because the WPATH guidelines highlighted access to historical records as an important feature of ongoing care in trans patients.6 The latter was included because many computer systems assume the patient’s sex will not change and might apply the RIs to historical records or perform calculations based on the current sex and not the sex at the time of specimen collection. Recommendation. When laboratories upgrade or replace their LIMS, they should ask for it to base RI selection, automatic comment selection, flagging of abnormal results, and sex-related calculations on the sex or gender information at the time of specimen collection, not the current demographics. Laboratories should also test this when installing a new LIMS. Sex-specific tests The survey results identified that in most laboratories, sexspecific tests like PSA and CA-125 can be ordered for patients of any sex. Judging by the free text responses, this is because clinicians demand it. These questions were included because, through the authors’ own experiences and previously published accounts, certain LIMS are configured to block or cancel requests for sex-specific tests in patients who are not of the expected sex.6,8 For example, a PSA request for a female patient may be cancelled based on a lack of understanding that trans women may have a prostate and that the test is clinically indicated. CA-125 and hCG are sometimes treated the same way when ordered in males because it is not considered that trans men may have ovaries and become pregnant.8,13 Considerate provision of these tests can make a significant difference to the clinical management and experience of trans patients. For example, in a study by Gooren and Morgentaler (2013), prostate cancer was found at a prevalence of 0.04% in a cohort of trans females,14 and without screening, these cases might have been missed. Recommendation. Laboratories should remove all laboratory test restrictions based on sex or gender. In particular, they should check PSA, CA-125 and hCG. 7 Reference intervals This survey found that even when a laboratory has a LIMS with multiple fields for sex and gender, they could not use this extra information to select RIs automatically. It is unlikely they would be able to use the information to automate other post-analytical activities either, such as appending comments, populating authorisation queues, flagging abnormal results, or reflex testing. The survey asked about this because RIs and decision limits are important for correctly interpreting blood test results. Highthroughput laboratories rely on LIMS to automatically select the RIs most appropriate for a sample, and many of these are sex-specific and derived from cisgender populations. For example, tests that have sex-specific RIs include creatine kinase, haemoglobin, testosterone, prolactin and creatinine. Trans people often have medical interventions that change laboratory results, sometimes shifting them outside the RI associated with their sex assigned at birth. Gender-affirming hormone therapy is the most common of these interventions and affects many commonly requested laboratory blood test results. This therapy leads to some test values falling within RIs associated with a patient’s affirmed gender. For example, Greene et al. found that trans people on testosterone hormone therapy have a haemoglobin RI identical to cis men.12 However, RIs for other tests may remain more similar to the sex assigned at birth. For example, Humble et al. found that trans females on oestrogen hormone therapy had a creatinine RI similar to the cisgender male RI.15 Therefore, it is important that LIMS can select RIs based on multiple sex and gender fields. LIMS, with this feature, could use current and future evidence about RIs and clinical decision limits in trans people. The survey also identified a widespread issue with laboratories not reporting RIs for some sexes, especially when the sex was unknown or indeterminate. Questions about this were included because of a case report by Dina Greene.8 In this case, no RIs were reported for PSA measurements in a female patient, so that two results of 11 and 15 µg/L were not flagged as abnormal and were not noted by the clinician. The raised PSA went unnoticed until it was 100 µg/L, and prostate cancer was stage III.8 Clinicians can rely on computerised flagging of abnormal results, so results reported with no RI create a risk that they will not be noticed. Recommendation. Laboratories should report RIs, with appropriate comments, for every gender, even if some are estimates, to ensure that abnormal results are flagged to the requester. This is imperative when the sex or gender is unknown or not specified. When laboratories upgrade their LIMS, in addition to asking for ‘gender identity’ and ‘sex assigned at birth’ fields, they should ask for the ability to use 8 the information in those fields for actions such as automatic RI selection, automatic comment selection and other postanalytical automation. Sex-based calculations The final key finding in this survey was that laboratories only rarely warn clinicians that eGFR results might not reflect the true GFR in trans people. This was included in the survey because eGFR uses sex as one of its input variables, but the calculation has only been validated in cisgender populations. Whitley and Greene published a case study of a trans man being evaluated for a kidney transplant.9 They reported a lack of understanding about how being transgender led to his eGFR being over-estimated, which led to a delay in being offered a transplant. Clinicians should be mindful of this effect, and the potential impact on patient management. Recommendation. Laboratories should warn clinicians that eGFR may be an under-estimate in trans females and an over-estimate in trans males. This message could be communicated via comments on eGFR results in trans people, or if this is not possible, via general communication. Study limitations The survey response rate was 17% if each individual had responded from a different UK/ROI laboratory (detail of the respondent’s institution was not recorded due to the anonymous nature of the survey). The number of total diagnostic blood science laboratories in the UK and ROI was estimated to be 395 based on two previous surveys.16–17 The response rate was not as high as expected, given the need for laboratory engagement in this area; however, it was similar to other UK clinical laboratory-based surveys.16,18 Although the survery response rate was low, results could be used to inform recommendations and provide an indication of areas that require further research and laboratory adaptation. A more targeted approach may have improved the response rate, such as sending the survey directly to the head of department of laboratories. Such a direct approach would have allowed a detailed account of response rate, and prevented multiple responses from a single institution. However, links to surveys in emails can easily be missed, and in the medical laboratory profession, the frequency of surveys can lead to survey fatigue. A majority of responses were returned by scientists working in UKAS-accredited medical laboratories in England, which may have somewhat biased results. However, there was good representation from teaching and district hospitals. In addition, responses came from predominantly medium to high-throughput laboratories, receiving both primary and secondary care samples. Annals of Clinical Biochemistry 0(0) Further research could include evaluation of how other European countries manage pathology results and reporting for transgender patients. Conclusions This survey was the first to quantify how clinical laboratories manage sex and gender information and safely report results for transgender and non-binary patients. Figure 2 contains the key recommendations arising from the results. Barriers can be overcome with education and clinical and patient liaison. The medical laboratory community can also achieve change by highlighting patient safety risks and liaising with LIMS providers and other medical professionals to work together to improve patient management. Acknowledgements We would like to thank all individuals that responded to the survey. Declaration of conflicting interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) received no financial support for the research, authorship, and/or publication of this article. Ethical approval None required. Guarantor SH. Contributorship SC formulated and developed the concept of the study. SC, SH and DB designed the survey, and SH and SC organised distribution of the survey. SH wrote the first draft of the report. DB oversaw data analysis and interpretation. All authors contributed to and approved the final version. ORCID iDs Sophie Hepburn  https://orcid.org/0000-0002-9012-0932 Devon Buchanan  https://orcid.org/0000-0003-1175-7212 Seán J Costelloe  https://orcid.org/0000-0002-2464-3735 Supplemental material Supplemental material for this article is available online. Hepburn et al. References 1. Vincent B. Transgender health: a practitioner’s guide to binary and non-binary trans patient care. Philadelphia: Jessica Kingsley Publishers, 2018. 2. Government Equalities Office. National LGBT survey: research report. https://www.gov.uk/government/publications/nationallgbt-survey-summary-report (2018, accessed 10 February 2023). 3. LGBT Foundation. Hidden figures: LGBT health inequalities in the UK. Manchester: LGBT Foundation, https://web. archive.org/web/20221005173026/http://www.lgbt. foundation/hiddenfigures (2020, accessed 10 February 2023). 4. Bauer GR, Scheim AI, Deutsch MB, et al. Reported emergency department avoidance, use, and experiences of transgender persons in Ontario, Canada: results from a respondent-driven sampling survey. Ann Emerg Med 2014; 63: 713–720. 5. Costelloe SJ and Hepburn S. Management of transgender patients in laboratory information management systems – moving on from binary and ternary logic. Ann Clin Biochem 2021; 58: 264–266. 6. Deutsch MB, Green J, Keatley J, et al. Electronic medical records and the transgender patient: recommendations from the World Professional Association for Transgender Health EMR Working Group. J Am Med Inform Assoc 2013; 20: 700–703. 7. Roberts TK, Kraft CS, French D, et al. Interpreting laboratory results in transgender patients on hormone therapy. Am J Med 2014; 127: 159–162. 8. Goldstein Z, Corneil TA and Greene DN. 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: 1342–1352. 9 9. Whitley CT and Greene DN. Transgender man being evaluated for a kidney transplant. Clin Chem 2017; 63: 1680–1683. 10. Patel K, Lyon M and Luu H. Providing inclusive care for transgender patients: capturing sex and gender in the electronic medical record. J Appl Lab Med 2020; 6: 210–218 11. Primary Care Support England. Adoption and gender reassignment processes - primary care support England, https:// pcse.england.nhs.uk/help/patient-registrations/adoption-andgender-re-assignment-processes/ (2022, accessed 10 February 2023). 12. Greene DN, McPherson GW, Rongitsch J, et al. Hematology reference intervals for transgender adults on stable hormone therapy. Clin Chim Acta 2019; 492: 84–90. 13. Sterling J and Garcia M. Cancer screening in the transgender population: a review of current guidelines, best practise and a proposed care model. Transl Androl Urol 2020; 9: 2771–2785. 14. Gooren L and Morgentaler A. Prostate cancer incidence in orchidectomised male-to-female transsexual persons treated with oestrogens. Andrologia 2014; 46: 1156–1160. 15. Humble RM, Imborek KL, Nisly N, et al. Common hormone therapies used to care for transgender patients influence laboratory results. J Appl Lab Med 2019; 3: 799–814. 16. Boot C, Toole B, Harris S, et al. A UK national audit of the laboratory investigation of phaeochromocytoma and paraganglioma. Ann Clin Biochem 2022; 59: 65–75. 17. Leonard A, Murray B, Prior AR, et al. Survey of laboratory medicine’s national response to Covid-19 pandemic in the Republic of Ireland. Ir J Med Sci 2022; 191: 65–69. 18. Hand M, Crampton A, Thomas A, et al. A survey of clinical laboratory instrument verification in the UK and New Zealand. Ann Clin Biochem 2019; 56: 275–282.