HL7 Gender Harmony SFCU Issues - Proposing an Alternative - updated

Hello Folks,

On the SFCU call on Thursday, we (the Canadian folks) were asked to come up with an alternative to SFCU that would be acceptable, and document that alternative.

Craig Parker, who is leading the SFCU subgroup, and I met today to discuss this and came up with a proposal that we would like the SGWG to review.:
We incorporated some of the concepts that were suggested by SGWG and changed some descriptions to bring the other concepts in at the description level.

Apparently there was another call that we were not on and a proposed alternative name that was floated was Clinical Characteristics. In our conversation, Craig and I landed on Clinical Characteristics for Diagnostics, Analytics, Testing and Settings which we abbreviated as CCDATS. We felt that this name sufficiently conveyed the context of the Clinical Characteristics being recorded, while not being specific to sex.

We added concepts to the proposed value set for internal/external organs, and fe/male hormone profiles. Specified was changed to: ‘Apply specified reference ranges or settings (see comment)’. We didn’t include separate concepts for anatomical inventory or surgical history, however, we would anticipate that anatomical inventory and/or surgical history would be part of the comment anytime that ‘Apply specified reference ranges or settings (see comment)’ is selected. We changed the ‘Apply specified reference ranges or settings (see comment)’ concept and definition to both reference the comment, which is a separate element in the extension. We also excluded free text comment as anything free text should be entered into to comment element of the extension.

Proposed Value Set: Clinical Characteristics for Diagnostics, Analytics, Testing and Settings
Apply female reference ranges or settings
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with female reference populations.
Apply male reference ranges or settings
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with male reference populations.
Apply specified reference ranges or setting (see comment)
Available data (see comment) indicates that diagnostics, analytics, treatment, and settings best practices may be undefined or not aligned with existing sex-derived reference populations. Individuals or systems providing care should review the comment data and then either use default behavior that is safe for both male and female populations, individually review treatment options with the patient, or carefully inspect relevant observations (ie. reproductive organs, anatomical inventory, hormonal inventory, surgical history) before proceeding with treatment.
Apply reference range or settings applicable to internal reproductive organs
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with populations having internal reproductive organs.
Apply reference range or settings applicable external reproductive organs
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with populations having external reproductive organs.
Apply reference range or settings applicable to a female hormone profile
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with populations having a female hormone profile.
Apply reference range or settings applicable to a male hormone profile
Available data indicates that diagnostics, analytics, treatments, and settings should consider best practices associated with populations having a male hormone profile.
Unknown
The clinical characteristics cannot be determined because there are no relevant evidence or documentation, or the evidence or documentation are not sufficient to determine a value. Individuals or systems providing care should either use default behavior that is safe for all populations, individually review treatment options with the patient, or carefully inspect relevant observations (ie. reproductive organs, anatomical inventory, hormonal inventory, surgical history) before proceeding with treatment.

Some use case for the ‘Apply specified reference ranges or settings’ that are not necessarily served well by the binary male/female paradigm were discussed last Thursday – a male patient with a removed prostrate, a female who has had a hysterectomy, a female patient who is pregnant, a female patient who is menopausal.

Please review the above value set. I’m hopeful that the SGWG is in agreement with these suggestions so that we can put them forth in the SFCU meeting on Thursday at 2:30pm ET (us02web.zoom.us/j/82612447163). I’m also hopeful that we have participation from SGWG members as last weeks discussion was a very good one..

Best regards,
Joanie Harper

Specialist, Standards,
Canada Health Infoway