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

Data Element
Specimen collection date/time
Description

Date/time when clinical specimen was collected from subject patient.
Submitted By: Nedra Garrett / Centers for Disease Control and Prevention
Data Element Information
Use Case Description(s)
Use Case Description 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. Specimen type and specimen site provides information useful in interpreting laboratory findings to determine severity and transmissibility.
Estimate the breadth of applicability of the use case(s) for this data element Over 3000 public health agencies in the US would use these data elements for disease surveillance and control activities.
Link to use case project page https://www.cdc.gov/elr/index.html
Healthcare Aims
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC
https://phinvads.cdc.gov/vads/SearchVocab.action
Additional Specifications N/A
Current Use Extensively used in production environments
Supporting Artifacts These are standard elements in HL7 laboratory messaging
https://www.cdc.gov/elr/index.html
Extent of exchange 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 These data elements are standard components of HL7 electronic test order and reporting (ETOR) messages between clinical setting and clinical laboratorories and of HL7 electronic laboratory reporting (ELR) messages sent from clinical laboratories to public health.
https://www.cdc.gov/elr/index.html
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 N/A
Other Implementation Challenges N/A

Comment

Submitted by BLampkins_CSTE on

CSTE Comment - 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:


Name of testing/performing laboratory and associated identifiers (CLIA) (HIGH PRIORITY)
Name of ordering provider and submitter
Address of testing/performing laboratory 
Accession number at testing laboratory (HIGH PRIORITY for matching purposes)
Date the test was ordered
Date the test was performed (needs to be reconciled with results date/timestamp)
Specimen collection date and time (HIGH PRIORITY) (Needs to be reconciled with Test Date=Clinically relevant time)
Test result value (needs to be reconciled with values/results in USCDI V1 and V2), units, reference range and interpretation (HIGH PRIORITY)
Abnormal flag (HIGH PRIORITY)
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
 

Submitted by nedragarrett_CDC on

CDC's comment for USCDI Draft v5

CDC supports the inclusion of this data element in USCDI v5 as it is an element that may be necessary for calculation of our digital quality metrics from FHIR data. 

Conceptualizing Laboratory Specimen collection date/time as a procedure time may not be clinically correct. In certain situations, such as during a surgery, the procedure time, i.e., Surgery start time, could be different from the time the specimen is obtained.

Laboratory specimen collection date/time is used for laboratory situational awareness and surveillance needs. This date/time is used as a proxy for infectious/contagious period. It is different from order date, as sometimes the order is placed well before the specimen was collected.

This is used in public health to determine onset of a case (for some conditions and if onset date is not available) and also, as with other dates, is used to assess timeliness of data and lab processes. 

Additional Resources for 4):

CLIA Requirement (https://www.ecfr.gov/current/title-42/part-493/subject-group-ECFR5f8f0b6639946fd#p-493.1241(c)(6)). 

In this study, look at Table 1 where they indicate time delay as a reason for specimen rejection. Specimen collection time is needed to calculate the time delay. 

“The request form must document unique study-participant identifiers, specimen collection date and time, study participant demographics, specimen type, and the collector’s (phlebotomist’s) identity” from this study. 

For this study, see the relationship between temperature and time. Collection time is crucial to know if the specimen is viable. 

In this Mayo Clinic’s document time delay is again a reason for rejection. 

Overarching Comment: 

There are extensive comments that have been submitted in support of the specific, granular date/timestamps for laboratory data, including a very granular one submitted by CMS. We agree with these, and CSTE explained it best in their existing comment: “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.” 

These are required data elements in the many laboratory data-public health exchange standards (including the dominant one used for laboratory data exchange currently, ELR 251 r1).

Submitted by Steven.Lane on

Clinical value of Specimen collection date/time

As a practicing physician I cannot fully understand or utilize exchanged laboratory data without knowing the date and time that the specimen was collected.  This information is critical to be able to interpret results that change over time, especially in an intensive care setting, such as the Emergency Department, Labor & Delivery, operating room, ICU, etc..  As noted in the numerous comments received from laboratory and public health organizations supporting the inclusion of this data element, this data is routinely collected and exchanged and should therefore be added to USCDI as a CORE data element for exchange.

Submitted by nedragarrett_CDC on

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.

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment for USCDI v5

  • Specimen collection date/time is created at the provider side when a specimen is collected for laboratory testing. EHRs capture it during test order creation and exchange it with the laboratory as part of the order message. A proper test interpretation can only be given for most test types with knowing the specimen collection date/time. Laboratories are required to receive this as per CLIA requirement §493.1291(c)(6). Additionally, Disease reporting to public health relies on data from the EHR for the identification of reportable events and to provide critical information used in confirming a diagnosis, understanding the 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 particularly important for public health in understanding when laboratory-confirmable evidence of a disease process was present in the patient. This data element can provide important time trends and surge capacity information during public health response.
  • This may seem represented by the “Performance time” element applicable to a procedure. The specimen collection method is different from a procedure. It is currently not considered a procedure in EHR data collection methods, and considering so will be a major deviation from current practice. Specimen collection date/time is considered a test's “clinically relevant time” and not a procedure.
  • NAACCR Comment: Agreed, important for cancer (and other public health) reporting.
  • NACCHO Comment: Supports CDC's comment.

Submitted by hantran on

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.

Submitted by nedragarrett_CDC on

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.

Submitted by hantran on

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.

Submitted by Riki Merrick on

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.

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