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

Data Element

Information from the submission form

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

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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