HL7 Gender Harmony Project Sex-for-Clinical-Use (SFCU) Issues

Hi everyone,
I have had a chance to review the original SFCU and new SPCU with clinical reps at Trans Care BC. If the SFCU/SPCU concept must be used, we are supportive of the alternative language and options proposed in the context of reference ranges and settings. We recognize this is not a final solution, but a forward step in a longer journey. We are keen to continue developing use cases and client centred implementation guidance related to this topic and look forward to rapid development of an anatomical inventory.

Thanks!
Lindsay

Hello everyone,

I think that everyone has outlined a lot of problems, positives, and considerations about Sex Parameters for Clinical Use (SPCU).
I have read them all, have attended the HL7 meetings, been on the UVic team for 3 years, and have some lived experience in this realm as a patient.
This posting is my personal perspective and thoughts based on my personal and professional experience and knowledge.


From my perspective, I think of SPCU as a small step towards making a healthcare system that is more equitable with better patients experiences.
It is by no means a perfect solution. It has many faults.
There are a lot of complexities that will need to be addressed in the implementation and use of SPCU within real clinical settings.
However, I think that SPCU will reduce harm and help to create a more affirming and equitable healthcare system.

I wish we could take a large leap, which anatomic inventories and CCDATS would be.
However, I see SPCU as a compromise between many stakeholders that will lead slowly into a more ideal future for healthcare.

I would also like to emphasize that there is a very real cost to not voting or voting in the negative.
Harm is occurring within healthcare currently, especially for trans people. The status quo is violent
If SPCU is not accepted nor implemented, this harm will continue to occur.
And with how slowly standards move, this harm could continue for years before another solution is accepted.

Some systems, such as AHS's CIS, can readily serve patients in an affirming, equitable manner.
And I really applaud that and think it is a great example of that more ideal future that I spoke about above.
However, from my perspective and knowledge, AHS is an exception in a healthcare world that is non-affirming and non-equitable.

Those are my thoughts and perspectives on this complex and nuisance topic.
I hope what I said was clear and concise.

Regarding the request for comment on Sex Parameter for Clinical Use (SPCU)
I am perplexed as to how trying to make a choice based on these criteria creates a more usable system for a patient who has breasts, typical estrogen levels, a neo vagina, a prostate and a penis but no testes. Or someone who has ovaries, but no uterus, and is on very low dose Testosterone. Or someone who is currently on Testosterone, but planning a pregnancy or is unexpectedly pregnant. Or someone who is intersex. How do these SPCU reference ranges etc even work for these folks? What would SPCU tell the clinician and how would the parameters be applied to these individuals and how would the questions be asked? To me, this creates much more confusion and has the potential to lead the clinician down the wrong path than simply stating the currently true clinically relevant characteristics for the patient. And if I come in with a broken leg, most if not all of the above, is irrelevant.
It's time to move away from male and female 'typical'; those are binary concepts and neither gender, nor even sex (eg. for intersex folks) are binary.
And the last option: 'Unknown clinical parameter setting or reference range/ No pertinent data available.' Is equally problematic. It seems a fancy way of saying we're not sure which box this person fits into. What, who determines which 'data' is 'pertinent'. Doesn't it depend on the reason the person came into contact with the health system? Like I said, if my leg is broken, that's what's relevant. SPCU seems to make this so much more complicated than it needs to be based on a prima facie assumption of the binary male/female typical. It really is time to let that go.
Karen

I appreciate and respect there are many people on this forum with many years of academic, research and lived experience. I wish to offer the perspective of someone, also with lived experience, but also many years real life professional experience of sitting at bedside, in clinics, working with lab services and diagnostic imaging, supporting the implementation and use of a CIS for millions of people that addresses and resolves many of the issues being discussed here. It hasn't been easy, it is certainly not perfect, but has already had an incredible, positive impact on many SOGIE patients.

Consider:

1. A trans woman is given a requisition for regular bloodwork including a PSA screening (to test for "typical male range") and estrogen levels (to test for "typical female range" and thyroid, CBC, etc.. There is only one requisition, what "clinical sex" would be entered on it? M? F? U? based on what? How would seeing M impact this patient? Would the downstream system in the lab even allow a PSA screaning for a woman? (This was the case in Alberta about 8 years ago but has since been addressed, now women can get PSA screenings, STI, HRT tests and mammograms all at once).

2. Even if we were able to put a clinical sex on a requisition in addition to their administrative gender and/or gender identity, there are thousands of public and private downstream labs and D&I clinics that would only have one sex/gender field in their system. In most cases, this field will have been populated by previous visits, information from their healthcare card, etc. They would not be able to change that one marker for different tests.

3. Since these downstream systems would not be able to accept additional sex markers like clinical sex (without inadvertently and incorrectly changing the sex/gender they have on file for the patient) the alternative would mean assigning that marker to the patient and not the individual tests. This raises all kinds of concerns for that patient that have been discussed extensively in this forum.

4. The suggested process of determining when to apply a "clinical sex" to a patient or the test they will be having are based on "observable characteristics". Firstly, many of the characteristics that would influence how those tests should be read are not observable. Secondly, this still opens up the patient to be identified based on a number of assumptions. Our goal is to remove as many assumptions from the system as we can and treat the patient based on the parts they have.

I understand the purpose of having some lab test that require "typical sex" ranges. I really do. However, the use of clinical sex does not solve the issues in the labs and D&I clinics but does increase the likelihood the patient will be misclassified and misgendered.

I am going to share personal medical information here so I trust you with it.

A few weeks ago, I found myself in the ER with significant lower back and abdominal pain. Fortunately, I was at one of our sites who had recently installed our new clinical information system. I had all my bloodwork done, urine samples, and had to be sent for abdominal and pelvic x-rays. At no time was a "clinical sex" or "sex at birth" entered or needed. All the tests were set using the administrative gender of F that is on my Alberta Health Care Card and in the CIS at the ER. After the tests, my physician was able to look at my history, see that I was on Estradiol, she asked why. I felt safe to say it was because of my gender affirming care. She then asked what surgeries I had. I replied I had GRS. She then asked if I had both testicles removed. She went on to explain she wanted to rule out the pain being caused by a testicle that was undescended but not removed during surgery. (That wasn't the cause). This is a GREAT example of treating a patient with the parts they have. She was then able to go into the CIS to update my organ inventory so that question doesn't need to be asked the next time I should find myself in the hospital or clinic. We were able to find the source of the pain, I received the care I needed, when I needed it. It is the very experience I would hope for every trans person. At no time would "clinical sex" been needed or relevant. In fact, including it anywhere, and having it been "male" to test my PSA, would have done much more harm than good. The issue comes down to the relationship between HCP and the patient. Treating the patient, not the machine. An HCP with any amount of skill would be able to take whatever results were provided in a test and apply it to the specific needs of their patient. (e.g. There are many cis women who have higher testosterone. Many cis men who have higher estrogen.) If 'clinical sex" was offered to the physician, they might have felt they needed to enter something there. Based on what?

BTW, in Alberta, if a patient has F in their Admin Sex/Gender field on their health care / cis, "typical female" ranges will be used. If they have "M" then typical "male" ranges will be used. If they have X (or in rare cases, U), (so either they have not disclosed, we do not know for sure or they are non-binary) the range will be set for the lower range of one sex and the upper range of the other sex.

Most of what we have been discussing has been theoretical and in the abstract. It's important we understand it from a practical application at bedside and examination room and how this information comes from upstream systems (like government registration) and feeds thousands of downstream systems that will only be able to have one field and it's a field that is already pre-populated based on registration data.

Having been one of the "very vocal and passionate" voices here, I must admit it that has not been easy. I may need to step away from this specific work for a bit for my own well-being. While I come to this work with significant professional expertise, this also requires I dig deep into my own lived experiences as well. And that part has been draining. I sincerely wish you all the best in this very important work. As I step back a bit, I must remind you that the experiences of trans men, trans women and non-binary people in healthcare are vastly different from each other. I do hope you actively seek out the experiences and perspectives of other trans women.

Hope this helps.

Marni

Hi Folks,
My name is Aaron Devor. I’m part of the SGWG community and part of the UVic GSSO team. I’ve been following the discussions here but have remained pretty quiet on this forum. I now feel that it is time to speak up.

To give some context to my comments, I’d like you to know a little bit about where I am coming from. I first came out into the gender and sexual minority community in the mid-1960s. I was an activist for many years and turned to academe in the mid-1980s. I have been working with gender-diverse people ever since, with strong ties with both activists and researchers. In the early 2000’s I came out as trans and transitioned. In 2011, I started the Transgender Archives at UVic. In 2014, I started the Moving Trans History Forward conferences . In 2016, I started the Chair in Transgender Studies . I’ve been one of the authors of versions 6, 7, and 8 of the WPATH Standards of Care. You can find out more about my career at my website .

People all over the world have been working very hard for several years to try to come up with a way to ensure that Trans+ people can get the clinical care that they require while being treated respectfully by service providers, and in their electronic health records. I respect and applaud all of the people who have been working hard on improving clinical record keeping for gender-diverse people and I am eager to see progress become implemented in the not-too-distant future.

As I understand the situation, we are rapidly coming to a decision point on whether or not to endorse the use of “sex parameters for clinical use” (SPCU). The proposal coming up for a vote describes SPCU as “A summary parameter that provides guidance on how a receiver should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc.” SPCU allows the choices of “female-typical,” “male-typical,” “specific,” and “unknown” and provides definitions for each. As such, SPCU would be quite specific to each person, and to each specific situation relevant to that person. For upwards of 99% of the population, SPCU would be simple to use.

I’ve heard two very vocal and passionate voices on this forum that feel that we should not endorse SPCU because (1) there is too much room for SPCU being used in ways that some Trans+ people would find insensitive and (2) we should not use sex at all in such applications. While, as a trans person myself, I am entirely sensitive to the offensiveness of labeling a Trans+ person as a sex with which they do not identify, SPCU does not label a person as male or female. It merely says that there is a situation wherein a known reference range, etc., should be used. I imagine that in a great many situations Trans+ people would fall into the “specific” category.

I’ve seen an argument that we should reject SPCU and wait for the implementation of systematic anatomical inventories to use to serve the functions proposed for SPCU. I’ve also seen a cogent discussion about how anatomical inventories as currently conceptualized could prohibitively complicate clinical practice. I am a big fan of anatomical inventories and I very much want to see work proceed in that direction. However, I see the role of anatomical inventories as being an invaluable source of information as noted in the above-quoted definition of SPCU, not as a replacement for SPCU.

I believe that we should do what we can to see progress now. We should not let our pursuit of perfection prevent us from making meaningful progress at this time. I would like to see Canada vote in favour of SPCU, and to commit to continuing working on anatomical inventories as a priority going forward.

There are 110 people on the SGWG. This statement has been endorsed by members of the UVic GSSO Team Aaron Devor, Francis Lau, Karen Courtney, and Kelly Davison. We’ve heard from two opposing voices, and a small handful of people pondering what to do. What do the rest of you think?

Aaron Devor, PhD, FSSSS, FSTLHE
Founder and Inaugural Chair in Transgender Studies
Founder and Subject Matter Expert, The Transgender Archives
Founder and Host, Moving Trans History Forward conferences
University of Victoria

Hello Folks,

I am attending the HL7 Working Group Meeting this week and the proposal for the alternative to SFCU has been discussed extensively. The updated version of the proposal is as follows:

Sex Parameter for Clinical Use (SPCU) (Required binding, select one)
A summary parameter that provides guidance on how a receiver should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc.

•Display: Apply female-typical setting or reference range; Code: Female-typical
•Synonym: Female sex for clinical use
•Definition: Available data indicates that diagnostics, analytics, and treatments should consider best practices associated with female reference populations.

•Display: Apply male-typical setting or reference range; Code: Male-typical
•Synonym: Male sex for clinical use
•Definition: Available data indicates that diagnostics, analytics, and treatments should consider best practices associated with male reference populations.

•Display: Apply specified setting or reference range; Code: Specified
•Definition: Available data indicates that diagnostics, analytics, and treatment best practices may be undefined or not aligned with sex-derived reference populations. Additional information (usually, but not always, in the form of comments and/or observations) may be available.

•Display: Unknown clinical parameter setting or reference range; Code: Unknown
•Definition: No pertinent data available.

The proposal coming out of the WGM will be discussed on the main Gender Harmony call which will occur on Jan 23 from 4-5:30pm EST. The proposal will then be voted on during the main call at the same time on January 30th. The zoom link for both of these meetings is: zoom.us/j/7183806281?pwd=WHVnUUlkWWhhcnRaYk9sWWQyOEkvUT09

The proposal will likely also be discussed on the SFCU and Gender Identity subgroup call on Jan 26 at 2:30pm EST. The zoom link for that call is us02web.zoom.us/j/82612447163

Best Regards,
Joanie Harper
Standards Specialist
Canada Health Infoway