<style>.markdown-body { max-width: 1500px; }</style> Category based upon clinical observations typically associated with the designation of male and female. ## :new: Observation Data Class <!-- image of summary of changes--> Draft ![image](https://hackmd.io/_uploads/B1-EmUDYa.png) Final ![image](https://hackmd.io/_uploads/H1swdNSK0.png) ... ![image](https://hackmd.io/_uploads/BJvd_VBY0.png) <!-- markdown table summary of proposal use adobe to convert to excel and then script to markdown or just copy/paste --> DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)<br/>Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. Where an applicable vocabulary standard has not been identified, this field will remain empty.|US Core V8 Proposal ---|---|--- | **Sex Parameter for Clinical Use** <br/> Category based upon clinical observations typically associated with the designation of male and female.<br/><br/>Usage note: There may be multiple instances of this data element for a single person, based on how the clinical observations (e.g., anatomic characteristics, recent hormone levels, or genetic testing) relate to or effect the clinical uses such as laboratory tests and results, diagnostic imaging, or preventive screening measures. Context specific values should be associated with these clinical uses. | Logical Observation Identifiers Names and Codes (LOINC) version 2.77  |<!-- here is hoping we can get rid of this with next administration ;-)--> See options below based upon the [Sex Parameter for Clinical Use Extension](http://hl7.org/fhir/extensions/StructureDefinition-patient-sexParameterForClinicalUse.html) <!-- ### USCDI5-Sandbox Mockup source: https://github.com/Healthedata1/USCDI5-Sandbox #### US Core Patient Profile <iframe width="100%" height="500" src="https://healthedata1.github.io/USCDI5-Sandbox/StructureDefinition-us-core-patient.html" frameborder="10"></iframe> source: https://healthedata1.github.io/USCDI5-Sandbox/StructureDefinition-us-core-patient.html #### Example <iframe width="100%" height="500" src="https://healthedata1.github.io/USCDI5-Sandbox//Patient-example.html" frameborder="10"></iframe> source: https://healthedata1.github.io/USCDI5-Sandbox//Patient-example.html --> ### Known issues Limit the cert requirement to just patient context or other US Core profile contexts (e.g., Observation). There was no consensus in Gender Harmony discussions regarding this issue. See [Background section](#Background) below. 1. **Option 1:** (1) Add *Sex Parameter for Clinical Use Extension* as *Add'l USCDI Requirement* to US Core Patient and (2) add general guidance that it may be used on any other US Core Profile for specific clinical context (e.g., Observation). :point_down: US Core Patient Profile Mock up source: https://healthedata1.github.io/USCDI5-Sandbox/StructureDefinition-us-core-patient.html <iframe width="100%" height="500" src="https://healthedata1.github.io/USCDI5-Sandbox/StructureDefinition-us-core-patient.html" frameborder="10"></iframe> 1. **Option 2:** (1) Add SPCU Extension as *Add'l USCDI Requirement* to: 1. US Core Patient 1. US Core Simple Observation Profile 2. US Core Observation Clinical Result Profile 3. US Core Laboratory Result Observation Profile 4. US Core ServiceRequest 5. US Core Procedure Profile 6. Other (e.g., DiagnosticReport)? and (2) add guidance that may be used on any other US Core Profile for specific clinical context. 1. **Option 3:** No changes to US Core profiles, but add a section with guidance and conformance rules that servers SHALL be capable of using the SPCU extension on any appropiate US Core Profile to meet the USCDI requirement. :point_down: US Core SPCU Guidance Page Mock up source: https://healthedata1.github.io/USCDI5-Sandbox/spcu.html <iframe width="100%" height="500" src="https://healthedata1.github.io/USCDI5-Sandbox/spcu.html" frameborder="10"></iframe> ### Decisions <!-- 1. Only add extension to US Core Patient --> 1. Option 1 - Only requires support for extension to US Core Patient - general guidance that it MAY be used on any other US Core Profile for specific clinical context (e.g., Observation). - Guidance on AOE's being an Observation not using the extension 4. Add'l USCDI Requirement 5. No new search parameter ### IG Updates - [ ] USCDI Mapping Table - [ ] Implementation Specific Guidance - [ ] New Example(s) --- ### Background (from) #### Sex Parameter for Clinical Use (SPCU) >Sex Parameter for Clinical Use is provided for use in orders, observations, and other clinical uses. SPCU can be highly contextual and allows specific considerations to be provided for potential automated uses and records. ##### Patient Level SPCU > A Sex Parameter for Clinical Use (SPCU) may be used in specific clinical contexts, for example, when placing an order or when interpreting a result. However, there are cases where having a context-free categorization of a patient can be useful...When using SPCU at a patient level, consider if any information is available suggesting that the patient is NOT male-typical or female-typical across all clinical contexts, then using specified as the patient-level SPCU is most appropriate. ##### Contextual Sex Parameter for Clinical Use (e.g., Observations) >A Sex Parameter for Clinical Use (SPCU) may be used in specific clinical contexts, for example, when placing an order or when interpreting a result. In these contexts, consider whether using a categorization such as Sex Parameter for Clinical Use is sufficient, or if using a more specific clinical observation such as an Observation about the presence or absence of an organ is most appropriate. If a categorization is sufficient, then the patient-sexParameterForClinicalUse extension may be added to the resource that best represents the context. For example, if the context is a referral order or lab order, then the extension could be added to the ServiceRequest. ##### CCDA Implementation ###### [HL7 CDA® R2 Implementation Guide: Gender Harmony - Sex and Gender Representation](http://www.hl7.org/permalink/?GenderHarmonyCDAIG) - Entry template - No document or section templates - >The Sex Parameter for Clinical Use template has its own rules for where it should be used...Given that CDA supports multiple approaches for asserting relationships among entries, putting the SPCU observation in a section with the entries it constrains would not imply the required information. Document section boundaries do not carry or imply semantics...The SPCU template defined here describes an approach using entryRelationship to establish context specific to an entry, to an encounter, or to the patient generally. This approach leverages context conduction appropriately, and it is a tactic with which many implementers are familiar. It also requires the use of the Entry Reference template where the SPCU applies to multiple entries. ###### [V2 Implementation](https://hl7.org/xprod/ig/uv/gender-harmony/hl7v2genderharmony.html) - >three (3) new segments that can be added to any message structure, where appropriate, which allows support to convey ... the concept of Sex Parameter for Clinical Use for the patient. - In V2 the context of segments is often derived from the placement in the message structure – the following chapters in the HL7 Standard: Version 2.9.1 - An application Protocol for Electronic Data Exchange in Healthcare Environments - [list of trigger events](https://hl7.org/xprod/ig/uv/gender-harmony/hl7v2genderharmony.html#using-the-gender-harmony-artifacts-for-specific-use-cases) - >In order to use these new segments in earlier versions of HL7 (before V2.9.1) the data exchange partners have to agree to support this functionality by pre-adopting this profile component as part of their data exchange agreement and specifications...The 3 Gender Harmony segments are related and will be inserted in patient specific messages as needed at the end of the patient identification (after the PD1 segment if it exists, otherwise after the PID segment), indicating that these concepts belong to the patient. ###### [FHIR](https://hl7.org/xprod/ig/uv/gender-harmony/fhirgenderharmony.html) - The [patient-sexParameterForClinicalUse](http://hl7.org/fhir/extensions/StructureDefinition-patient-sexParameterForClinicalUse.html) extension - same guidance as above for exchanging Sex Parameters for Clinical Use - [Patient Level SPCU](#Patient-Level-SPCU) - [Contextual Sex Parameter for Clinical Use (e.g., Observations)](#Contextual-Sex-Parameter-for-Clinical-Use-eg-Observations) #### Federal Policy Regarding SCPU Capture by EHR ##### HTI-1 >We have finalized the addition of Sex Parameter for Clinical Use as a new data element in § 170.315(a)(5)(i)(F) ["a(5)"]. >We have finalized as proposed (88 FR 23820) that the Health IT Module must be able to record at least one value for Sex Parameter for Clinical Use for each patient and note that there may also be multiple values tied to different events, such as requesting a laboratory test or imaging study, allowing for and encouraging more than one. We recognize that the Sex Parameter for Clinical Use data element may be a new concept to some. However, we note that developers of certified health IT have the flexibility to configure their user interface and to capture and display these data in clinical workflows consistent with their own design decisions. - >[§ 170.207(n)(3)] Standard. Sex Parameter for Clinical Use must be coded in accordance with, at a minimum, the version of LOINC® codes specified in § 170.207\(c)(1). - >[§ 170.315(a)(5)] Patient demographics and observations. (i) Enable a user to record, change, and access patient demographic and observations data including...sex parameter for clinical use, sexual.... - > [§ 170.315(a)(5)(i)(F)] Sex Parameter for Clinical Use. Enable at least one sex parameter for clinical use to be recorded in accordance with, at a minimum, the version of the standard specified in § 170.207(n)(3)[LOINC]. Conformance with this paragraph is required by January 1, 2026. ##### HTI-2 - § 170.315 ONC Certification Criteria for Health IT. ("a(5)") > [170.315(a)(5)(i)] Enable a user to record, change, and access patient demographic and observations data including ... sex parameter for clinical use,.... > [170.315(a)(5)(i)(F)] Sex Parameter for Clinical Use. Enable at least one sex parameter for clinical use to be recorded in accordance with, at a minimum, the version of the standard specified in § 170.207(n)(3) [LOINC]. Conformance with this paragraph is required by January 1, 2026. ##### LRI/LOI Implementation LOI >This guide does not formally address communication of SOGI data. However, guidance on conveying SOGI data in v2 messages can be found in the [HL7 Cross Paradigm Implementation Guide: Gender Harmony – Sex and Gender Representation](https://hl7.org/xprod/ig/uv/gender-harmony/). Additional guidance on the use of OBX – Observation/Result Segment to convey SOGI data is also available in the [SOGI Observation-Based Data Exchange Profile](http://www.hl7.org/permalink/?SOGIGuidance)[*]. *SOGI Observation-Based Data Exchange Profile: >This profile does not address the sending of either Recorded Sex or Gender values or Sex Parameter for Clinical Use.