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

Data Element
Specimen Received Date/time
Description

Date (and optionally time) when specimen was received by the testing laboratory
Submitted By: Riki Merrick / APHL
Data Element Information
Data Element Description Date (and optionally time) when specimen was received by the testing laboratory
Use Case Description(s)
Use Case Description It is needed in USCDI because it is required in a Test Result Report by CLIA in 42 CFR 493.1242(b) = "The laboratory must document the date and time it receives a specimen." (https://www.ecfr.gov/current/title-42/part-493/section-493.1242#p-493.1242(b)).
Estimate the breadth of applicability of the use case(s) for this data element This element is recorded in EVERY laboratory and has been included in HL7 messages for a long time. It is used to determine turn around time for lab testing. It is also used by PH as a proxy for the clinical temporal context when specimen collection date/time is not providedfor example as a proxy for symptom onset.
This element maps to in V2 = SPM-18 (Specimen Received Date/Time) https://www.hl7.eu/refactored/segSPM#248 and also in OBR-14 (Specimen Received Date/Time) = https://www.hl7.eu/refactored/segOBR.html#248 in versions before SPM segment was added, in FHIR = https://build.fhir.org/specimen-definitions.html#Specimen.receivedTime
It is a "Must Support " (usage RE) in NAACR (https://www.naaccr.org/pathology-laboratory-electronic-reporting/) for SPM-18 and OBR-14, it is required for SPM-18 in the LRI base profile (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279) and ELR R1 IGs (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98). ELR R1 has been part of certification requirements for lab result reporting to public health since MU1 as called out "Implementation specifications. HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (incorporated by reference in § 170.299) with Errata and Clarifications, (incorporated by reference in § 170.299) and ELR 2.5.1 Clarification Document for EHR Technology Certification, (incorporated by reference in § 170.299)." in https://www.ecfr.gov/current/title-45/part-170/section-170.205#p-170.205(g)
These 3 criteria account for at least being level 2: Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) V2 = SPM-18 (Specimen Received Date/Time) https://www.hl7.eu/refactored/segSPM#248 and also in OBR-14 (Specimen Received Date/Time) = https://www.hl7.eu/refactored/segOBR.html#248 in versions before SPM segment was added, in FHIR = https://build.fhir.org/specimen-definitions.html#Specimen.receivedTime
Additional Specifications It is a "Must Support " (usage RE) in NAACR (https://www.naaccr.org/pathology-laboratory-electronic-reporting/) for SPM-18 and OBR-14, it is required for SPM-18 in the LRI base profile (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279) and ELR R1 IGs (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98).
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 2) Between more than two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts ELR R1 has been part of certification requirements for lab result reporting to public health since MU1 as called out "Implementation specifications. HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (incorporated by reference in § 170.299) with Errata and Clarifications, (incorporated by reference in § 170.299) and ELR 2.5.1 Clarification Document for EHR Technology Certification, (incorporated by reference in § 170.299)." in https://www.ecfr.gov/current/title-45/part-170/section-170.205#p-170.205(g)
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden Minimal, since already in use for all lab tests
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is does not meet the criteria for breadth of applicability.

Comment

Submitted by melanie.kourba… on

Add to USCDI with updated definition

APHL suggests elevating the level 0 data element "Specimen Received Date/Time" to USCDI with the definition: "The date/time when the testing laboratory received the specimen.”

APHL can offer multiple examples of use cases in which this data element would play a critical role, such as: 

This information enables notification that a specimen is in the lab, which supports both patient treatment and laboratory workflows (e.g., labs know that an urgent test can now be worked on, physicians can avoid re-ordering a test or order an add-on test)

The time a specimen is received affects the evaluation of specimen acceptability and is also important for medicolegal chronology

This information is a CLIA required element (most important for the lab): Corresponds to CLIA element in §493.1242(b) in CLIA 42 CFR 493.1242 -- Standard: Specimen submission, handling, and referral (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR5f8f0b6639946fd/section-493.1242)

This element is used to determine turnaround time for lab testing. It is also used by public health as a proxy for the clinical temporal context when specimen collection date/time is not provided; it is collected in the LIS, not in the EHR.

APHL made similar comments in 2024 as part of the USCDI+ Laboratory Data Exchange Use Case, but ONC has not made these comments public yet.

Submitted by melanie.kourba… on

Do not rely on Performance time for laboratory date fields

ASTP’s current approach is to use a single procedure performance date/time element in USCDI to cover all lab relevant date/time, which include: Specimen collection date/time; Specimen received date time; Test performed date/time; Report released date/time. APHL raises the concern that most systems don’t model specimen receipt as a procedure. APHL recommends at a minimum adding data elements to capture Specimen receipt at the lab date/time, Laboratory Test performed data/time, and Report released date/time.

Many of these dates are clinically relevant and important for CLIA accreditation, and having data elements within the EHR and LIMS with the appropriate specificity will enable a laboratory to meet these criteria more easily. Performance time can be broad, as in a surgery that can last multiple hours. In contrast, a specimen collection occurs at a specific moment in time, when the specimen physically leaves the body. To add complexity, the observation takes place at a later time, after the collection and when the specimen is in the laboratory. Nevertheless, it is necessary for CLIA for the laboratory to be able to map this information to what is contained in the EHR source system.

APHL is confident that most EHRs already track and have the capability to send Specimen Collection date/time, and so including it in USCDI V6 should not impose a burden on vendors.

An alternative name for this data element could be Performance time of the specimen collection.

Submitted by melanie.kourba… on

Do not rely on Performance time for laboratory date fields

ASTP’s current approach is to use a single procedure performance date/time element in USCDI to cover all lab relevant date/time, which include: Specimen collection date/time; Specimen received date time; Test performed date/time; Report released date/time. APHL raises the concern that most systems don’t model specimen receipt as a procedure. APHL recommends at a minimum adding data elements to capture Specimen receipt at the lab date/time, Laboratory Test performed data/time, and Report released date/time.

Many of these dates are clinically relevant and important for CLIA accreditation, and having data elements within the EHR and LIMS with the appropriate specificity will enable a laboratory to meet these criteria more easily. Performance time can be broad, as in a surgery that can last multiple hours. In contrast, a specimen collection occurs at a specific moment in time, when the specimen physically leaves the body. To add complexity, the observation takes place at a later time, after the collection and when the specimen is in the laboratory. Nevertheless, it is necessary for CLIA for the laboratory to be able to map this information to what is contained in the EHR source system.

APHL is confident that most EHRs already track and have the capability to send Specimen Collection date/time, and so including it in USCDI V6 should not impose a burden on vendors.

An alternative name for this data element could be Performance time of the specimen collection.

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