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

Data Element
Laboratory results: date and timestamps
Description

Date and timestamps associated with the completion of laboratory results, that are meta data associated with laboratory results
Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)
Data Element Information
Data Element Description Date and timestamps associated with the completion of laboratory results, that are meta data associated with laboratory results
Rationale for Separate Consideration The current concept of laboratory tests, including results are included in USCDI v1. To add clinical context to those results, recommending requiring the associated date and timestamps (meta data).
Use Case Description(s)
Use Case Description Laboratory tests with associated results and metadata are used extensively in CMS quality measures across programs including IQR, QPP, and Promoting Interoperability to define measurement populations and numerator events. The date and timestamps associated with lab tests are critical for defining which tests occur within the measurement period, and help associate tests to specific encounters or visits and are standard metadata for labs.
Estimate the breadth of applicability of the use case(s) for this data element 4,000+ hospitals and 1 million providers currently capture, access and exchange laboratory results with associated metadata (date and timestamps)
eCQI resource center, includes measure specifications for CMS program eCQMs (i.e. CMS 349, CMS 529): https://ecqi.healthit.gov/ecqms
Link to use case project page https://ecqi.healthit.gov/ecqms
Use Case Description Date and timestamps for laboratory tests are also critical pieces of information exchanged with test results for clinical care and care decision support. A result itself is not useful unless the context of the timing of that result is also available.
Estimate the breadth of applicability of the use case(s) for this data element All healthcare providers and laboratories who are collecting labs are also collecting associated date and timestamps for when tests are taken, when results are returned, and often when results are entered in EHR systems.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC codes for labs—date and timestamps collected in standard format
Additional Specifications Many technical specifications include laboratory test specifications—all require an associated date and timestamp as part of the information:
HL7 FHIR US Core Implementation Guide STU3 based on FHIR R4, Observation Laboratory Test Profile, collection date and timestamp (effective date time) must be supported by the profile (https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-observation-lab.html )
CMS Quality Data Model (QDM) version 5.5 Guidance, relevant authored and resulted date/times (https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf)
HL7 C-CDA Release 2.0 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492)
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts Date/time stamps associated with laboratory test results are used at scale by hospitals, providers, and laboratories. Widely available within EHR systems:
https://fhir.cerner.com/millennium/r4/diagnostic/observation/ https://fhir.epic.com/Specifications?api=998
https://mydata.athenahealth.com/fhirapidoc

https://ecqi.healthit.gov/ecqms
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 Laboratory date/time metadata is electronically exchanged for quality measurement used across CMS programs via QRDA files and other architectures.
This metadata is also exchanged for virtually all instances a laboratory result is being exchanged, as it is important for clinical context and interpretation of results.
https://ecqi.healthit.gov/qrda
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7

https://ecqi.healthit.gov/qrda
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) No challenges anticipated
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns This data, like any patient data, should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.
Estimate of Overall Burden No burden estimated—metadata already in use across the entire stakeholder community.
Other Implementation Challenges N/A
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 represents a specific type of existing USCDI data element Author Time Stamp in the Provenance data class.

Comment

Submitted by BLampkins_CSTE on

Laboratory results: date and timestamps - CSTE Comment

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 v7 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 BLampkins_CSTE on

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

Submitted by Riki Merrick on

APHL supports leaving at this level or removing this data elemen

APHL supports this data element being left at level 0, or removed entirely unless USCDI design has created a mechanism to further define domain specific constraints on generic data elements that provide guidance on which workflow steps should be date/time stamped.

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), 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 CDC_DSMH_WG on

CDC's Comment for draft USCDI v5

This is used to calculate turnaround time or to determine timeliness of reporting for quality metrics.

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 erjones on

Please Include Laboratory Results to USCDI v5

Vizient recommends adding the Laboratory Results data element to USCDI v5. Date and timestamps would allow for trending of labs over time. This could be especially helpful when initially adding patient data into Fast Healthcare Interoperability (FHIR) databases since the upload date would be similar for all results.

Submitted by CDC_DSMH_WG 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 erjones on

Please add Laboratory Results to USCDI v4

Vizient recommends adding the Laboratory Results data element to USCDI v4. Date and timestamps would allow for trending of labs over time. This could be especially helpful when initially adding patient data into Fast Healthcare Interoperability (FHIR) databases since the upload date would be similar for all results.

Submitted by hantran on

CAP Comments on Laboratory results: date and timestamps

  • Data Class: Laboratory
  • Data Element: Laboratory results: date and timestamps
  • 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 results: date and timestamps data element, which is required in regulation and is intended to represent the most recent timestamp associated with completion of all components.
    • This data element should be renamed to Laboratory Results Issued Date/Time and should be included as a data element in USCDI v4. This data element should accommodate time zone differences.
    • This data element aligns with CLIA’s required “Test Report Date” and also with FHIR’s observation.issued data element.
  • Vocabulary Standard: The College of American Pathologists (CAP) recommends replacing the listed standards for 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. HL7 2.5.1 OBX-19 is aligned with the ISO 8601 international standard for communicating date and time information.

Submitted by CDC_DSMH_WG on

CDC's Consolidated Comment for USCDI v4

  • This element continues to be needed to represent the date and time the pathologist rendered a diagnosis into a signed report for release. The Result Status can be used in conjunction with the date/time to identify when a report is Final and if there is a correction or amendment to the Report. This information has been captured by central cancer registries for over a decade with no issue. These dates are critical to have with the results.
  •  Comments from NACCHO: NACCHO supports including this data element laboratory results: date and timestamps.
  •  Comments from CSTE: CSTE strongly recommends that the following data elements should be included in USCDI v4 as proposed. 
  1. Type of specimen - this is critical for triggering electronic case reports and for making decisions on which cases are invasive (e.g., for S. pneumoniae, MRSA, Group A strep). 
  2. Result status - knowing that a result is preliminary, or final is critical for determining the certainty of the existence of a critical public health condition
  •  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 v4 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)  Laboratory test value  Specimen source site (HIGH PRIORITY)  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.

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