Vital Signs

Date and timestamps associated with the completion of vital signs, that are meta data associated with the vital sign results

Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)
Data Element Information
Rationale for Separate Consideration	The current concept of vital signs, including results are included in USCDI v1. To add clinical context to those results, recommending requiring the associated date and timestamps for the required vital signs.
Use Case Description(s)
Use Case Description	Vital sign tests with associated results and metadata are used extensively in CMS quality measures across programs including IQR, QPP, and Promoting Interoperability to define measurement populations and numerator events. The date and timestamps associated with vital sign tests are critical for defining which tests occur within the measurement period, and help associate tests to specific encounters or visits and are standard metadata for vitals.
Estimated number of stakeholders capturing, accessing using or exchanging	4,000+ hospitals and 1 million providers currently capture, access and exchange vital sign results with associated metadata (date and timestamps) eCQI resource center, includes measure specifications for CMS program eCQMs (i.e. CMS 349, CMS 529): https://ecqi.healthit.gov/ecqms
Link to use case project page	https://ecqi.healthit.gov/ecqms
Use Case Description	Date and timestamps for vital signs are also critical pieces of information exchanged with test results for clinical care and care decision support. A result itself is not useful unless the context of the timing of that result is also available.
Estimated number of stakeholders capturing, accessing using or exchanging	All healthcare providers and laboratories who are collecting vital signs are also collecting associated date and timestamps for when tests are taken.
Healthcare Aims	Improving patient experience of care (quality and/or satisfaction) Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	LOINC codes for vitals—date and timestamps collected in standard format
Additional Specifications	Many technical specifications include vital sign specifications—all require an associated date and timestamp as part of the information: Vital Sign Profiles, including a time the measurement was taken: http://hl7.org/fhir/R4/observation-vitalsigns.html CMS Quality Data Model (QDM) version 5.5 Guidance, relevant authored and resulted date/times (https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf) HL7 C-CDA Release 2.0 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492)
Current Use	This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts	Date/time stamps associated with vital sign results are used at scale by hospitals, providers, and laboratories. Widely available within EHR systems: https://fhir.cerner.com/millennium/r4/diagnostic/observation/ https://fhir.epic.com/Specifications?api=998 https://mydata.athenahealth.com/fhirapidoc https://ecqi.healthit.gov/ecqms
Number of organizations/individuals with which this data element has been electronically exchanged	5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts	Vital sign date/time metadata is electronically exchanged for quality measurement used across CMS programs via QRDA files and other architectures. This metadata is also exchanged for virtually all instances a vital sign result is being exchanged, as it is important for clinical context and interpretation of results. https://ecqi.healthit.gov/qrda http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 https://ecqi.healthit.gov/qrda
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	No challenges anticipated
Restrictions on Use (e.g. licensing, user fees)	None
Privacy and Security Concerns	This data, like any patient data, should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.
Estimate of Overall Burden	No burden estimated—metadata already in use across the entire stakeholder community.
Other Implementation Challenges	N/A