Submitted by erjones on 2023-04-17
Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ) | |
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Data Element Information | |
Rationale for Separate Consideration | The current concept of laboratory tests, including results are included in USCDI v1. To add clinical context to those results, recommending requiring the associated date and timestamps (meta data). |
Use Case Description(s) | |
Use Case Description | Laboratory 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 lab 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 labs. |
Estimate the breadth of applicability of the use case(s) for this data element | 4,000+ hospitals and 1 million providers currently capture, access and exchange laboratory 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 laboratory tests 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. |
Estimate the breadth of applicability of the use case(s) for this data element | All healthcare providers and laboratories who are collecting labs are also collecting associated date and timestamps for when tests are taken, when results are returned, and often when results are entered in EHR systems. |
Healthcare Aims |
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Maturity of Use and Technical Specifications for Data Element | |
Applicable Standard(s) | LOINC codes for labs—date and timestamps collected in standard format |
Additional Specifications | Many technical specifications include laboratory test specifications—all require an associated date and timestamp as part of the information: HL7 FHIR US Core Implementation Guide STU3 based on FHIR R4, Observation Laboratory Test Profile, collection date and timestamp (effective date time) must be supported by the profile (https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-observation-lab.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 laboratory test 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 |
Extent of exchange | 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 |
Laboratory 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 laboratory 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 |
Submitted by nedragarrett_CDC on 2023-09-19
CDC's comment on behalf of CSTE for USCDI v5