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

Data Element

Laboratory Test Performed Date
Description

The clinically relevant date/time of the observation. In the case of observations taken directly from a subject, it is the actual date and time the observation was obtained. In the case of a specimen-associated study, this field shall represent the date and time the specimen was collected or obtained.

Comment

CDC's comment on behalf of CSTE for USCDI v5

  • 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 v5 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. Specimen collection date and time (HIGH PRIORITY) (Needs to be reconciled with Test Date=Clinically relevant time)
  8. Test result value (needs to be reconciled with values/results in USCDI V1 and V2), units, reference range and interpretation (HIGH PRIORITY)
  9. Abnormal flag (HIGH PRIORITY)
  10. 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.
     

CDC's Consolidated Comment for USCDI v5

  • Propose to change the definition of this data element to: "This is the date and time a laboratory test was executed, and an observation made."This data element is created when the test is run at the performing lab. The LIMS will capture and store this data element in its database. It will be used by the laboratory professional when interpreting lab results. It will be exchanged as part of the results message. It may be stored by the EHR receiving the results message. Care providers may look up this date and time for decision-making. For bedside tests, it will be the time the test was performed, and an observation was made.
  • An additional use case is laboratory auditing.This element may be seen as similar to performance time. This should be considered separately as this is crucial for test interpretation irrespective of the type of test. Since this is fundamental to testing, it may not be considered a specialization or related to performance measurement. Similar to a test needing to be represented in USCDI even though it may be “performed for a patient as part of the provision of care,” observation timing also needs to be represented as it is fundamental to the test element.
  • NAACCR Comment: Agree this element is necessary for cancer reporting to public health.
  • NACCHO supports CDC's recommendations.

CAP Comments on Laboratory Test Performed Date

  • Data Class: Laboratory
  • Data Element: Laboratory Test Performed Date
  • CAP Comment:
    • One single Time of Procedure data element cannot clearly represent all the many times and dates associated with laboratory and pathology data, including this Laboratory Test Performed Date data element, which is required in regulation and represents the most clinically relevant time point in which to interpret the result and is distinct from result reporting date (Laboratory Results Issued Date/Time). In the case of observations taken directly from a subject, this data element is the actual date and time the observation was obtained. In the case of a specimen-associated study, this data element represents the date and time the specimen was obtained from a patient and collected into a container or obtained.
    • This data element should be combined with the Specimen Collection Date/Time Level 2 data element, titled Specimen Collection Date/Time, and included as a data element in USCDI v4. This data element should accommodate time zone differences.
    • This data element aligns with the FHIR observation.effective data element (if greater alignment with FHIR is desired, this data element could also be renamed Laboratory Results Effective). CLIA specifies the use of this data element if appropriate.
  • Vocabulary Standard: The College of American Pathologists (CAP) recommends the value format from the SPM-17 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. The CAP supports the use of the HL7 2.5.1 standard because the standard was designed to help laboratories comply with CLIA requirements. HL7 2.5.1 SPM-17 is aligned with the ISO 8601 international standard for communicating date and time information.

CDC's Consolidated Comment for USCDI v4

  • This element is needed to know when the laboratory performed the test on the specimen. Cancer registries have been receiving this information from laboratories for over a decade with no issue. It is a standard element that laboratories track and it is important to monitor timeliness of reporting that can impact the quality of care provided to the patient.
  • Comments from NACCHO: NACCHO supports including this data element laboratory test performed date 

CAP Comment on Laboratory Test Performed Date

Data Element: Laboratory Test Performed Date

  • Corresponding CLIA Reporting Requirement: The test report date
  • Description: The CAP supports the inclusion of this Level 2 data element into USCDI v4. This inclusion will align the USCDI with CLIA’s Test Report Date reporting requirement. The CLIA reporting requirements are required for clinical 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 results: date and timestamps 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 in 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. The CAP supports the use of the HL7 2.5.1 standard because the standard was designed to help laboratories comply with CLIA requirements. HL7 2.5.1 OBX-19 is aligned with the ISO 8601 international standard for communicating date and time information.

APHL Comments on ISA 2022

APHL suggests to include this data element in USCDIV4. APHL supports renaming to Performed Date/Time as suggested by WA DOH and requests a different definition for this element to match its name of: Date and time (if available) the result was created and approved the supervisor for reporting.

If the intent of this element is the clinically relevant date time of the observation (which for a lab test is the specimen collection) then it should be merged with this element Specimen collection date/time . For non- lab observations the clinically relevant time is the same as this element Observation Timing (https://www.healthit.gov/isa/taxonomy/term/1411/level-2)

CDC's comment on behalf of WA DOH

Recommend changing the element name to: 
"Laboratory test performed: date and timestamps" since timestamp is already part of the element's scope.

The data element name and definition don’t match

The clinically relevant date time of the observation for a lab test is the specimen collection, which is part of the element definition. So if that is what is desired here it should be merged with this element Specimen collection date/time (https://www.healthit.gov/isa/taxonomy/term/3256/level-2)

If the desire is to represent the actual date/time the result was obtained as the name suggests, it should be merged with Laboratory results: date and timestamps (https://www.healthit.gov/isa/taxonomy/term/2426/level-2)

For non- lab observations the clinically relevant time is the same as this element Observation Timing (https://www.healthit.gov/isa/taxonomy/term/1411/level-2)

Unified Comment from CDC

  • Citable sources: https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html   CDC has promulgated use of the terms contact precautions, droplet precautions, and airborne precautions for many years.  Additional background information and useful definitions are available at: https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf
     
  • Additional Use Case: HIV, STDs, Viral Hepatitis and Tuberculosis are nationally notifiable diseases for which diagnosis is dependent upon laboratory results. As such, laboratory test performed date, result value and result status are collected as part of CDC's routine surveilannce for these conditions. Additionally, beyond diagnostic tests, additional laboratory test information is collected to understand the health status of patients (e.g. HIV viral load, liver enzymes), and trends in drug susceptibility.
  • 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.  
     
  • All of the laboratory data collected is used both for case management purposes within state, local, territorial and tribal health jurisdictions, and public health purposes at the national level. These data are integral to understanding disease transmission and to prioritize appropriate interventions for affecting communities.
     
  • Estimate number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of HIV Prevention, Division of TB Elimination, Division of STD Prevention, and Division of Viral Hepatitis flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.
     
  • Healthcare Aims: Improving patient experience of care, Improving health of populations, Reducing cost of care, provider experience of care.
     
  • Use of data element: Extensively used in production environment
     
  • CSTE supports inclusion of this measure into USCDI v3

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