|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
|Estimated number of stakeholders capturing, accessing using or exchanging||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.
|Estimated number of stakeholders capturing, accessing using or exchanging||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|
SFCU use case examples.pdf
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||LOINC “Sex for clinical use” 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|
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.
|Number of organizations/individuals with which this data element has been electronically exchanged||N/A|
|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|
|ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following 4 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
|Maturity – Standards/Technical Specifications||Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification|
|Maturity - Current Use||Level 2 - Used at scale in more than 2 different production environments|
|Maturity - Current Exchange||Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems|
|Breadth of Applicability - # Stakeholders Impacted||Level 2 - Used by a majority of patients, providers or events requiring its use|
|Evaluation Comment||This submission is for 4 separate data elements in a new data class. Possible 5th element for patient context.|