| Interoperability Standards Platform (ISP)

Data Element

Submitted By: Robert McClure, MD / HL7 International
Data Element Information
Rationale for Separate Consideration	While we strongly suggest this is incorrect, many systems dangerously operate assuming that the category known as “Sex Assigned At Birth” can be assumed to be a sex categorization for the patient in all situations.
Use Case Description(s)
Use Case Description	The Sex For Clinical Use categorization is intended to communicate the sex category (Male or Female) that would best align with the expected observations based upon the identified observation context used to determine the value. When male or female is not a proper categorization, then “Specified” is to be used as a flag to indicate that the SFCU value for the intended use must be based upon the specific clinical observations that pertain. In short, the SFCU is a sex category, specific to an intended use, with a value based upon specified observations. When no observations are specified then the user must assume that the sender has properly determined the SFCU for the intended use. Per the HL7 Gender Harmony specification : SFCU is a sex categorization that can provide context specificity, derived from observable information (e.g., Clinical Observation, Radiology report, Lab report, genetic testing) that is preferably directly linked to the information this data element summarizes (such as a comment or a linked data observation) in order to clarify the context and resulting value. This element is intended to characterize observations that align with or vary from female or male when the observation(s) are intended for use in a clinical activity. Examples of clinical observation that may be used to determine a value are: karyotype, phenotype, sex from imaging, hormonal values, organ inventory, certain surgical procedures, genetic observations, external genital morphology and internal organ morphology. In some systems the SFCU value may be automatically determined based on the medical record so that they match the recipient system’s needs. The Gender Harmony specification identies a set of intended data attributes to best clarify the SFCU use. Additional information is also found in the JAMIA article discussing the project . International H. HL7® Informative Document: Gender Harmony - Modeling Sex and Gender Representation, Release 1. 2021.http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564 (accessed 21 Nov 2021). McClure RC, Macumber CL, Kronk C, et al. Gender harmony: improved standards to support affirmative care of gender-marginalized people through inclusive gender and sex representation. J Am Med Inform Assn 2022;29:354–63. doi:10.1093/jamia/ocab196
Estimate the breadth of applicability of the use case(s) for this data element	This data element has not been widely implemented but is central to many use cases in clinical care and is expected to be necessaary in any system that requires information on the clinical sex characteristics of a patient.
Link to use case project page	https://confluence.hl7.org/display/VOC/Cross+Paradigm+Use+Cases
Use Case Description	1. We recommend that a form of “Sex For Clinical Use” (SFCU) be included within “Clinical Tests”. It could be called “Sex for Clinical Test” and is recommended for Level 1. Please see B2, below. 2. We recommend that a form of “Sex For Clinical Use” (SFCU) be included within “Diagnostic Imaging”. It could be called “Sex for Diagnostic Imaging” and is recommended for Level 1. Please see B3, below. 3. We recommend that a form of “Sex For Clinical Use” (SFCU) be included within “Laboratory”. It could be called “Sex for Laboratory Use” and is recommended for Level 1. Please see B4, below. 4. We recommend that a form of “Sex For Clinical Use” (SFCU) be included within “Procedures”. It could be called “Sex for Procedure” and is recommended for Level 1. Please see B5, below. The "See below" items are included in the attached pdf.
Estimate the breadth of applicability of the use case(s) for this data element	We expect most clinical systems doing tests or procedures on patients will need to use this element. In addition most clinical care systems may need to be able to represent SfCU
Supporting Attachments	SFCU use case examples.pdf
Healthcare Aims	Improving patient experience of care (quality and/or satisfaction) Improving the health of populations Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	LOINC “Sex for clinical use” 99501-9 https://loinc.org/99501-9/
Additional Specifications	HL7 Gender Harmony informative publication http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564
Current Use	In limited use in production environments
Supporting Artifacts	There are systems, such as Epic, and other locally configured systems, such as at the Fenway Institute in Boston, that support an approach similar to SFCU.
Extent of exchange	N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	No restrictions other than changing the perceived approach to this common element.
Restrictions on Use (e.g. licensing, user fees)	None
Privacy and Security Concerns	Some SfCU data items may represent PHI
Estimate of Overall Burden	Most systems will require updates to implement the SfCU element, differentiating it by context and previously recorded Sex information.
Other Implementation Challenges	None

ASTP Evaluation Details Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1 Maturity - Current Standards	Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2 Maturity - Current Use	Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3 Maturity - Current Exchange	Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4 Use Case(s) - Breadth of Applicability	Level 2 - Use cases apply to most care settings or specialties.
Evaluation Comment	This submission is for 4 separate data elements in a new data class. Possible 5th element for patient context.

Comment

Submitted by Kristic333 on 2024-04-15

Cornell Health Comments on Draft USCDI v5

Collecting SOGI data, including a sex parameter for clinical use and a two-question process to determine sex assigned at birth and gender identity, can be crucial in ensuring that the correct reference ranges and settings are applied to patients. Failure to collect this information could lead to poor or unsafe clinical outcomes, such as misinterpretation of lab results.

Submitted by BLampkins_CSTE on 2024-04-15

CSTE Comment - v5

CSTE is supportive of the Gender Harmony project work in this area linked below and recommends following their implementation guidance.

Submitted by cooper.thompson on 2024-01-19

Gender Harmony Guidance on SPCU

I believe the Gender Harmony project guidance on context independent vs. contextual SPCU has evolved a bit. The current guidance is documented in this section of the Gender Harmony IG.

Submitted by rmcclure on 2022-11-04

remove this generic SFCU data element

Per our last request for improvements in SFCU, we suggest removing this generic context independent SFCU from USCDI. We encourage the use of context-specified SFCU data elements only.