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

Data Element
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.
Submitted By: Maria Michaels / CDC
Data Element Information
Use Case Description(s)
Use Case Description Actively monitoring diseases, making decisions about public health threats, identifying trends in healthcare services utilization and other public health matters depend on accessible and accurate data. EHRs are a data source that can provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to more rapid disease detection, tracking, and treatment and innovation in healthcare delivery.

Laboratory information, including the test code, test performed date, result status, result value and the result date, are important to multiple public health reporting and research use cases to track and analyze information about treatment for various health conditions.

The Making EHR Data More Available for Research and Public Health (MedMorph) project's goal is to create a reliable, scalable, and interoperable method to get electronic health record data for multiple public health and research scenarios (use cases). MedMorph has identified Cancer Reporting, Healthcare Surveys, Hepatitis C Reporting, electronic Initial Case Reporting (eICR), PCORnet, and Birth Defect Reporting use cases that support the adoption of these data elements. These specific use cases are described in more depth on their respective web pages.
Estimate the breadth of applicability of the use case(s) for this data element All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.

All hospitals and physicians who diagnose or treat cancer are required to provide cancer related laboratory information to state cancer registries.

Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. 

There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here.

Supporting Links:
MedMorph Project Page: https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html

Cancer Reporting: https://www.cdc.gov/cancer/npcr/

Healthcare Surveys: https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm

Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf

eICR: https://www.cdc.gov/ecr/index.html

PCORnet: https://pcornet.org/

Birth Defect Reporting: https://www.cdc.gov/nchs/nvss/births.htm
Link to use case project page https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html; https://www.cdc.gov/cancer/npcr/; https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm; https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf
Supporting Attachments MedMorph-ChronicHepatitisCSurveillanceUseCase-DRAFT.pdf
MedMorph-CancerReportingUseCase-DRAFT.pdf
MedMorph-HealthCareSurveyReportingUseCase-DRAFT.pdf
Use Case Description A foundational goal of MedMorph is generalizability beyond the 10 use cases that are actively informing the MedMorph project, in order to support many more public health and research use cases. Therefore, other public health and research use cases that use the MedMorph architecture will also benefit from the adoption of these data elements.
Estimate the breadth of applicability of the use case(s) for this data element All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.

All hospitals and physicians who diagnose or treat cancer are required to provide cancer related laboratory information to state cancer registries.

Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. 

There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here.
Healthcare Aims
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Laboratory Test/Panel Code: LOINC Codes: http://loinc.org

Laboratory Test Performed Date: FHIR dateTime, Period, Timing, Instant: http://hl7.org/fhir/observation-definitions.html#Observation.effective_x_

Laboratory Result Status: FHIR Observation Status: http://hl7.org/fhir/valueset-observation-status.html

Laboratory Result Value: FHIR Quantity|CodeableConcept|string|boolean|integer|Range|Ratio|SampledData|time|dateTime|Period: http://hl7.org/fhir/observation-definitions.html#Observation.value_x_
http://loinc.org
Additional Specifications HL7 FHIR US Core Implementation Guide v3.1.1 (https://www.hl7.org/fhir/us/core/index.html)

HL7 FHIR US Core Laboratory Result Observation (http://hl7.org/fhir/us/core/StructureDefinition-us-core-observation-lab.html). MustSupport for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Status, Laboratory Result Value

HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492). SHALL for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Value

HL7 CDA ® Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398). SHALL for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Value

HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385)

HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm (http://hl7.org/fhir/us/ecr/STU1/)

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436)

HL7 FHIR® Implementation Guide: Common Data Models Harmonization FHIR Implementation Guide (Release 0.1.0) (http://hl7.org/fhir/us/cdmh/2019May/)

HL7 CDA® R2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries Release 1, STU 2 -US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=428)

HL7 FHIR® Implementation Guide: Birth Defect Reporting Implementation Guide 0.1.0 (https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html)
Current Use Extensively used in production environments
Supporting Artifacts Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems.

Widely available in EHR systems.

These data elements exist in FHIR with a FHIR Maturity level of Normative for the Observation Resource. FHIR Observation Resource: http://hl7.org/fhir/observation.html

LOINC is included in the ISA with an adoption level of 3 in production implementations for representing laboratory tests. SNOMED CT is included in the ISA with an adoption level of 1 in production implementations for representing laboratory tests. Laboratory in ISA: https://www.healthit.gov/isa/section/laboratory

Part of Core EHR Certification since at least 2014
Specified in Meaningful Use/Promoting Interoperability since Stage 1
Part of EHR Certification for Transmission to Cancer Registries (2015 and 2014 Editions)

Promoting Interoperability Programs Eligible Hospitals and Critical Access Hospitals are required to, and Merit-based Incentive Payment System (MIPS) participants may optionally, report on any two measures under the Public Health and Clinical Data Exchange objective of these programs. The § 170.315(f)(5) – Transmission to public health agencies – electronic case reporting certification criteria in the 2015 Edition Final Rule and the ONC Cures Act Final Rule, the § 170.315(f)(7) – Transmission to public health agencies – health care surveys, and the § 170.315 (f)(4) – Transmission to Cancer Registries are three such options to meet these measures.

The current standard for § 170.315(f)(5), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: Public Health Case Report, Release 2: the Electronic Initial Case Report (eICR), Release 1, STU Release 1.1. ONC’s Certified Health IT Product List (CHPL) lists 73 EHR or HIT Module products certified to (f)(5) using this standard. eCR IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436

The current standard for § 170.315(f)(7), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 116 EHR or HIT Module products certified to (f)(5) using this standard. NHCS IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385

The current standard for § 170.315 (f)(4), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7 CDA® R2 IG: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, R1, DSTU Release 1.1 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 288 EHR or HIT Module products certified to (f)(4) using this standard. Cancer Reporting IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398

These three widely adopted CDA standards have many of the Laboratory data elements contained on this form as Shall (required) or Should (best practice to include if available) conformance criteria, which demonstrates the maturity of these commonly exchanged data elements.                

Supporting Links:
§170.315(f)(4) Transmission to cancer registries: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure

2014 Edition Test Methods: https://www.healthit.gov/sites/default/files/2014_test_methods/2014_edition_test_methods_archived.zip

Observation API: https://fhir.epic.com/Specifications?api=998

Certified Health IT Product List: https://chpl.healthit.gov/#/search

Certified Health IT Product List for Cancer: https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries
Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information
Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries)
http://hl7.org/fhir/observation.html; https://www.healthit.gov/isa/section/laboratory; §170.315(f)(4) Transmission to cancer registries: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure
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 Level 2 – exchanged between 4 or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to the next draft version.

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) - the Electronic Initial Case Report (eICR) is currently implemented in 5,400+ reporting sites nationally and exchanges Laboratory information including: Laboratory Test Code, Performed Date, Test Result Status, Result Value.

As part of Cancer Reporting CDA IGs:
IHE Connectathons 2010-2020
HIMSS Interoperability Showcase 2010-19
Public Health Informatics Conference Interoperability Showcase 2014, 2016, 2018
NACCHO 360X Interoperability Demonstrations, 2020

As part of National Health Care Surveys CDA IGs:
IHE Connectathons 2019-2020

ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies. https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies

Supporting Links:
Certified Health IT Product List for Cancer: https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries
Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information
Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries)

IHE Connectathon: https://connectathon-results.ihe.net/
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
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 Low.

All providers need to capture laboratory information as a basic component of patient care.

Several existing IGs, as listed, require the exchange of this data element.

The Promoting Interoperability Programs Objective 8 - Public Health and Clinical Data Registry Reporting, Measures 1: Immunization Registry Reporting, 2: Syndromic Surveillance Reporting, 3 -: Electronic Case Reporting and 4: Public Health Registry Reporting all require these data elements.

This information is routinely communicated in HL7 CDA Documents and some FHIR API transactions.
Other Implementation Challenges None

Comment

Submitted by nedragarrett_CDC on 2023-09-19

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 2023-09-15

CDC's Consolidated Comment for USCDI v5

  • Propose to change the definition of this data element to: "This is the date and time a laboratory test was executed, and an observation made."This data element is created when the test is run at the performing lab. The LIMS will capture and store this data element in its database. It will be used by the laboratory professional when interpreting lab results. It will be exchanged as part of the results message. It may be stored by the EHR receiving the results message. Care providers may look up this date and time for decision-making. For bedside tests, it will be the time the test was performed, and an observation was made.
  • An additional use case is laboratory auditing.This element may be seen as similar to performance time. This should be considered separately as this is crucial for test interpretation irrespective of the type of test. Since this is fundamental to testing, it may not be considered a specialization or related to performance measurement. Similar to a test needing to be represented in USCDI even though it may be “performed for a patient as part of the provision of care,” observation timing also needs to be represented as it is fundamental to the test element.
  • NAACCR Comment: Agree this element is necessary for cancer reporting to public health.

Submitted by hantran on 2023-04-17

CAP Comments on Laboratory Test Performed Date

  • Data Class: Laboratory
  • Data Element: Laboratory Test Performed Date
  • 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 Test Performed Date data element, which is required in regulation and represents the most clinically relevant time point in which to interpret the result and is distinct from result reporting date (Laboratory Results Issued Date/Time). In the case of observations taken directly from a subject, this data element is the actual date and time the observation was obtained. In the case of a specimen-associated study, this data element represents the date and time the specimen was obtained from a patient and collected into a container or obtained.
    • This data element should be combined with the Specimen Collection Date/Time 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 2023-04-06

CDC's Consolidated Comment for USCDI v4

  • This element is needed to know when the laboratory performed the test on the specimen. Cancer registries have been receiving this information from laboratories for over a decade with no issue. It is a standard element that laboratories track and it is important to monitor timeliness of reporting that can impact the quality of care provided to the patient.
  • Comments from NACCHO: NACCHO supports including this data element laboratory test performed date 

Submitted by hantran on 2022-09-30

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.

Submitted by Riki Merrick on 2022-09-30

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)

Submitted by nedragarrett_CDC on 2022-04-28

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.

Submitted by Riki Merrick APHL on 2021-09-30

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)

Submitted by nedragarrett_CDC on 2021-09-29

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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