Analysis of clinical specimens to obtain information about the health of a patient.

Data Element

Information from the submission form
Laboratory results: date and timestamps
Description
Date and timestamps associated with the completion of laboratory results, that are meta data associated with laboratory 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 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.
Estimated number of stakeholders capturing, accessing using or exchanging 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.
Estimated number of stakeholders capturing, accessing using or exchanging 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
  • 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 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
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 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

Comment

Submitted by hantran on 2022-09-30

CAP Comment on Laboratory results: date and timestamps

Data Element: Laboratory results: date and timestamps
  • Corresponding CLIA Reporting Requirement: The test report date
  • Description: The College of American Pathologists (CAP) supports the inclusion of this Level 2 data element into USCDI v4, corresponding to the time of result transmission. This inclusion will align the USCDI with CLIA’s Test Report Date reporting requirement. The CLIA requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. For future iterations of USCDI, we would suggest collapsing this data element with the Laboratory Test Performed Date data element called “Date/time of the analysis,” which is the name of the OBX-19 field of the HL7 2.5.1 standard. The CAP may submit this new data element for USCDI v5 in 2023.
  • Vocabulary Standard: The CAP recommends replacing the listed standards for this data element with the value format from the OBX-19 field in HL7 2.5.1, which is a version of the Health Level Seven (HL7) standard that defines methods for transferring and sharing data between various healthcare systems and providers. HL7 2.5.1 OBX-19 is aligned with the ISO 8601 international standard for communicating date and time information.

Submitted by Riki Merrick on 2022-09-30

APHL Comments on ISA 2022

This definition is not sufficient, there are many dates of interest to a laboratory test result, so a single “Date” is not appropriate; the date and time of analysis, which may be the same as the Laboratory Test Performed Date attribute, the date the result was released and the date of the overall report. From a clinical perspective the most important date for a laboratory test is the date/time of specimen collection, as that gives the clinician the temporal context of the observation which is the same as the Specimen collection date/time attribute #1 APHL suggests clarifying the name and the definition to a single one of the above mentioned dates so that this element does not overlap with others defined in USCDI.

Submitted by nedragarrett_CDC on 2022-09-29

CDC's comment on behalf of CSTE for USCDI v4

 
  •  CSTE strongly recommends that the following data elements should be included in USCDI v4 as proposed.
  1. Type of specimen - this is critical for triggering electronic case reports and for making decisions on which cases are invasive (e.g., for S. pneumoniae, MRSA, Group A strep).
  2. Result status - knowing that a result is preliminary, or final is critical for determining the certainty of the existence of a critical public health condition.
 
  • CSTE supports collection of more granular laboratory data to support case adjudication and reporting as well as patient deduplication and linking of data from cases to ELR, which can be critical. The variables we recommend be added to USCDI v4 include:
  1. Name of testing/performing laboratory and associated identifiers (CLIA)(HIGH PRIORITY)
  2. Name of ordering provider and submitter
  3. Address of testing/performing laboratory
  4. Accession number at testing laboratory (HIGH PRIORITY for matching purposes)
  5. Date the test was ordered
  6. Date the test was performed (needs to be reconciled with results date/timestamp)
  7. Laboratory test value
  8. Specimen source site (HIGH PRIORITY)
  9. Specimen collection date and time (HIGH PRIORITY) (Needs to be reconciled with Test Date=Clinically relevant time)
  10. Test result value (needs to be reconciled with values/results in USCDI V1 and V2), units, reference range and interpretation (HIGH PRIORITY)
  11. Abnormal flag (HIGH PRIORITY)
  12. Test kit identifier
  • Dates and times are critical to evaluating the timeliness of reporting - it is a major indicator for the performance of public health surveillance systems and without this information it is unknown how data exchange is impacting the ability for public health to respond in a timely fashion. Although the date and time data are generated by the system, in practice it has been observed that availability of this data to Public Health Departments is sparse for use in timeliness analysis. Therefore, it is recommended that the following elements are added as part of the core data set.

Submitted by nedragarrett_CDC on 2022-04-28

CDC's Consolidated Comment

Additional use case:
  • Use case background: For cardiovascular disease prevention and treatment, particularly cholesterol management, laboratory-related data elements are vitally important for quality improvement related to clinical treatment as well as public health surveillance. Patients who have LDL-C values of ≥190 mg/dL are considered to have severe hypercholesterolemia and are recommended to be on a high-intensity statin. They are at high risk for having an atherosclerotic cardiovascular disease (ASCVD) event. Having information about their LDL-C values is critically important for understanding level of risk and for monitoring the impact that statin treatment (or other lipid-lowering agents) has on their LDL levels. Moreover, both laboratory result value and the date/timestamps are important for ensuring patients have LDL-C screening done in accordance with clinical guidelines. These data elements are currently in or will be part of future proposed iterations of CMS347, Statin Therapy for the Prevention and Treatment of Cardiovascular Disease, currently used in multiple CMS quality reporting programs, HRSA’s Uniform Data System, and the CDC/NACDD Multistate EHR-based Network for Disease Surveillance (MENDS). Chronic disease surveillance for diabetes (A1c), and chronic kidney disease (estimated glomerular filtration rate [eGFR] and/or urine albumin-to creatinine ratio [uACR]) also rely on the use of laboratory result values
Link to use case:
  • https://chronicdisease.org/page/MENDSINFO/
Implementation Guide:
  1. HL7 FHIR Quality Measure STU2 for FHIR R4 Implementation Guide - Quality Measure STU2 for FHIR R4 Implementation Guide (hl7.org)
  2. HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm 2.0.0 - STU 2 - HL7.FHIR.US.ECR\Home Page - FHIR v4.0.1 (http://build.fhir.org/ig/HL7/case-reporting/)
  3. HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 2, STU Release 3.0 - HL7 Standards Product Brief - HL7 CDA® R2 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=436)
  4. HL7 FHIR Health Care Surveys Content Implementation Guide (http://hl7.org/fhir/us/health-care-surveys-reporting/2022Jan/);
  5. HL7 FHIR Central Cancer Registry Reporting Content Implementation Guide (http://hl7.org/fhir/us/central-cancer-registry-reporting/2022Jan/).
  6. 17 message mapping guides (MMGs) used for under the National Notifiable Diseases Surveillance System (NNDSS) (https://ndc.services.cdc.gov/message-mapping-guides/)
CSTE Comment:
  • CSTE strongly recommends that the following data elements should be included in USCDI v3 as proposed.
  1. Type of specimen - this is critical for triggering electronic case reports and for making decisions on which cases are invasive (e.g., for S. pneumoniae, MRSA, Group A strep).
  2. Result status - knowing that a result is preliminary, or final is critical for determining the certainty of the existence of a critical public health condition.
 
  • CSTE supports collection of more granular laboratory data to support case adjudication and reporting as well as patient deduplication and linking of data from cases to ELR, which can be critical. The variables we recommend be added to USCDI v3 include:
  1. Name of testing/performing laboratory and associated identifiers (CLIA)(HIGH PRIORITY)
  2. Name of ordering provider and submitter
  3. Address of testing/performing laboratory
  4. Accession number at testing laboratory (HIGH PRIORITY for matching purposes)
  5. Date the test was ordered
  6. Date the test was performed (needs to be reconciled with results date/timestamp)
  7. Laboratory test value
  8. Specimen source site (HIGH PRIORITY)
  9. Specimen collection date and time (HIGH PRIORITY) (Needs to be reconciled with Test Date=Clinically relevant time)
  10. Test result value (needs to be reconciled with values/results in USCDI V1 and V2), units, reference range and interpretation (HIGH PRIORITY)
  11. Abnormal flag (HIGH PRIORITY)
  12. Test kit identifier
 
  • Dates and times are critical to evaluating the timeliness of reporting - it is a major indicator for the performance of public health surveillance systems and without this information it is unknown how data exchange is impacting the ability for public health to respond in a timely fashion. Although the date and time data are generated by the system, in practice it has been observed that availability of this data to Public Health Departments is sparse for use in timeliness analysis. Therefore, it is recommended that the following elements are added as part of the core data set.
  WA DOH Comment:
  • The date and time of testing and when the results are observed and recorded in the system denotes the timeliness of reporting. The element reflects one of the major indicators for performance of Public Health Surveillance Systems and timeliness of reporting is critical for Public Health action.
  • Although the date and time data are generated by the system, in practice it has been observed that availability of this data to Public Health Departments is sparse for use in timeliness analysis. Therefore, it is recommended that the following elements are added as part of the core data set.
The elements recommended are:
  1. Date/Time of Testing
  2. Date/Time of Results
     

Submitted by nedragarrett_CDC on 2021-09-29

Unified Comment from CDC

  • Additional Use Case: This is a standard data item used by central cancer registries in all states. Data received through data exchange from pathology laboratories to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law.   
  • This element is used by CMS Quality Reporting and is marked Required or MustSupport in the FHIR QI Core IG  
  • CSTE supports inclusion of this measure into USCDI v3

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