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

Data Element

Information from the submission form

Specimen collection date/time
Description

Date/time when clinical specimen was collected from subject patient.

Comment

CAP Comment on Specimen collection date/time

  • Data Class: Laboratory
  • Data Element: Specimen Collection Date/Time
  • 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 Specimen collection date/time data element, which is required in regulation and represents the date/time when clinical specimen was collected from subject patient.
    • This data element should be combined with the Laboratory Test Performed Date 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

  • CDC-CMS Joint Priority  
Disease reporting to public health relies on data from the EHR for identification of reportable events and to provide critical information used in confirming a diagnosis, understanding severity and classifying a case of disease that requires public health intervention for prevention, treatment, control, and outbreak identification and response. The specimen collection date is of particular importance for public health in understanding when laboratory confirmable evidence of a disease process was present in the patient. Required by CLIA (42 CFR 493.1241 (c) (6)). Procedure time is test performed date/time.  This element has been reported to cancer registries for over a decade with no issues.
  • Comments from NACCHO: NACCHO supports including the data element specimen collection date/time
  • Comments from CSTE: CSTE agrees with CDC's recommendation for this data element.

CAP Comment on Specimen collection date/time

Data Element: Specimen collection date/time
  • Description: The College of American Pathologists (CAP) supports the inclusion of this Level 2 data element into USCDI v4. While this is not a CLIA requirement, the specimen collection time defines the clinically applicable time of the result, which is crucial for correct interpretation of the result by care providers and correct response by public health agencies in emergency (eg, pandemic) preparedness and response settings. For future iterations of USCDI, we may recommend replacing this data element with two data elements corresponding to the OBX-14 and SPM-17 fields in HL7 2.5.1. The data elements should be named “Date/time of the observation” which is the name of OBX-14, and “Date/time of specimen collection,” which is a minor variation on the name of SPM-17. Date/time of the observation refers to the clinically-relevant date/time associated with the measurement. When there is testing of a specimen, HL7 2.5.1 specifies that the content of OBX-14 and SPM-17 should be identical. Having these two data elements allows for documentation of specimen collection time in rare cases where the clinically relevant time and specimen collection time might differ. The CAP may submit these new data elements for USCDI v5 in 2023.
  • Vocabulary Standard: The 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.

APHL Comments on ISA 2022

APHL supports inclusion of this data element in the Laboratory class of USCDI V4 because it is a CLIA required element and represents the clinically relevant time of laboratory results, which means it provides the temporal context to the clinician.

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 laboratories to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law.  

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