Laboratory

APHL supports elevation of Level 2 data elements

APHL supports elevation of these data elements:

#1 Test Kit Unique Identifier (https://www.healthit.gov/isa/taxonomy/term/3731/level-2): it would be necessary for the EHR-s to support collection of this data element, when it is provided; if EHR-s cannot retain this data element then it will not be available to downstream systems for use in research or by public health for emergency preparedness.

#2 Laboratory Test/Panel Code (https://www.healthit.gov/isa/taxonomy/term/2431/level-2): It is helpful to understand the clinical context for the results and one way is to understand how they were ordered - also this is a CLIA required data element (§493.1291(c)(4)). LOINC should be used to represent the order code, when an appropriate code exists (for the lab workflow the local code is the important element, as that is the test that the authorized requesting provider is asking for) - it should be codes of type 1 (Laboratory), where the Order vs. Observation is 'Order only' or 'Both'.

#3 Accession number (https://www.healthit.gov/isa/taxonomy/term/3716/level-2): This data element is also a CLIA required element (§493.1276 (a)), and it is probably especially important to have it identified as such, since what the lab uses as its accession number varies by lab,so this identifier is used as the primary key to locate all data that belongs to this specimen. To support communication between provider (EHR-s, which is patient centric) and lab (LIS, which is specimen-centric) and between lab and public health agency (Sureveillance system that receives reports from both EHR-s and LIS) this identifier is very important. It must be stressed, that this identifier should be unique within the assigning authority and not reused over time (though that may still be a practice in some labs).

For these three elements reconciliation needs to happen, but it is unclear what the USCDI definition will be, since only the link to the submission currently defines the element:

Laboratory results: date and timestamps (https://www.healthit.gov/isa/taxonomy/term/2426/level-2): For laboratory the following date/timestamps should be considered:

#1 Specimen Collection Date/time = Clinically relevant time = observation date/time, a CLIA required element (42 CFR 493.1241 (c) (6)) - this date/timestamp provides the temporal context for the result in relation to the patient's disease phase for example and is also needed for trending of result over longer periods of time; This cannot be the same as procedure date, because in most cases the specimen collection is not separately tracked as a procedure, and even if it was it's not included in the data exchange with the lab (on the order or result), so it would need to be easily identifiable in the EHR-s as the specimen collection date/time.

#2 Results/Report/Update date/time, a CLIA required element (§493.1291(c)(3)) - which can be one of several date/times tracked in the LIS: the date/time the result is produced by the analyzer (this is more often referred to as the test date/time), the date/time the result is verified by the supervisor (for each individual result) - this would be metadata on the Tests (https://www.healthit.gov/isa/taxonomy/term/676/uscdi-v4) element, the date/time the report is released, which often includes more than one result, so it might be the meta data associated with the Laboratory Test Panel Code (https://www.healthit.gov/isa/taxonomy/term/2431/level-2) or the Accession Number (https://www.healthit.gov/isa/taxonomy/term/3716/level-2).

#3 specimen received date/time = the date/time the specimen was received by the lab and is available for scessioning and processing - while this is not a CLIA element, it is the FIRST date the lab actually has control over, so could be used as proxy for the specimen collection date, should that ever not be obtainable

Laboratory Test Performed Date (https://www.healthit.gov/isa/taxonomy/term/2436/level-2) - the definition on this element is ambivalent: "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." - Since this element is called Laboratory Test only the second part of this sentence applies, which basically means it is the same element as Specimen collection date/time (https://www.healthit.gov/isa/taxonomy/term/3256/level-2)

See prior comment: https://www.healthit.gov/isa/comment/5236

Laboratory Data Class - L2 Data Elements as of 9.20.2023

• Emory Healthcare submits its support for the inclusion of all Data Elements currently listed as Level 2 under the Laboratory data class in draft USCDI v5.
• Emory Healthcare performs both clinical pathology and anatomic pathology testing to support patient care. While the Laboratory data class, with the inclusion of the Level 2 data elements, includes the information necessary to paint a comprehensive picture of clinical pathology testing, Emory Healthcare recommends ONC work to provide clarity on the appropriate documentation of anatomic pathology reports or narratives within USCDI.

CAP 2023 Comments on USCDI v4

The College of American Pathologists (CAP) appreciates the opportunity to comment on the draft of USCDI version 4. As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the CAP serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine.

Data sharing through widely accepted standards is critical to ensure that health information is available and comprehensible across care settings for use in patient care, public health, and emergency (eg, pandemic) preparedness and response. For broader sharing of electronic health information, the USCDI is critical to establishing foundational standards to support patient care. The CAP is pleased that the draft version of USCDI v4 is a dramatic improvement on previous versions and will offer comments for how to further improve USCDI v4. The CAP emphasizes that there should be alignment of data element names and meaning between USCDI and FHIR to simplify and promote the accuracy of future data element mapping.

The ONC has issued a request for information as to whether a single USCDI data element Time of Procedure satisfies the community submissions to add timing elements to a variety of USCDI data classes. The CAP does not support the use of a single Time of Procedure data element for pathology and laboratory purposes, as it cannot clearly represent the laboratory times and dates that are required by regulation to be reportable. For example, it is unclear whether a single data element named Time of Procedure is indicating the time of the sampling procedure or the time of the analytic procedure. Separate laboratory data elements are necessary to represent regulatorily mandated laboratory dates and times in the USCDI. With respect to current USCDI submissions, this single Time of Procedure data element would not be sufficient to represent the Level 2 laboratory time data elements, which are necessary for interoperability and should be added into the USCDI. The CAP provides the following recommendations in the attached comment letter.  

CAP USCDI v4 Final Comments 2023_1.pdf

CAP Comments on USCDI v4

The College of American Pathologists (CAP) appreciates the opportunity to comment on USCDI version 4. As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the CAP serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine.

Data sharing through widely accepted standards is critical to ensure that health information is available and comprehensible across care settings for use in patient care, public health, and emergency (eg, pandemic) preparedness and response. For broader sharing of electronic health information, the USCDI is critical to establishing foundational standards to support patient care. In that spirit, the CAP recommends that USCDI align with the CLIA Test Report requirements1 in the Clinical Laboratory Improvement Amendments (CLIA) of 1988. CLIA requirements are required for clinical laboratories, and those elements should consequently be the basis for developing a foundation for the standardized sharing and reporting of laboratory information to support patient care. Aligning the USCDI with CLIA requirements will support interoperability by building on existing standards and patterns of use while avoiding contradictory or duplicative reporting requirements.

Therefore, the CAP provides the following recommendations for USCDI v4 in the attached comments. 

CAP USCDI v4 Comments_0.pdf

APHL Comments on ISA 2022

APHL suggests to include ALL CLIA required elements in the USCDI; a mapping between CLIA elements to those in an HL7 order message are provided in Section 12.1 of LOI and for result reporting in Section 14.1 of LRI. A mapping of CLIA element to USCDI elements has been created and is accessible here: https://docs.google.com/spreadsheets/d/1SQe58YXc-GJ18Mdk_taxpZowP1Aw1hKcpvMnGAQB0Ns/edit?usp=sharing

Date and time - Testing and Results

The date and time of testing and when the results are observed and recorded in the system denotes the timeliness of reporting. The element reflects one of the major indicators for performance of Public Health Surveillance Systems and timeliness of reporting is critical for Public Health action.

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. Therefore, it is recommended that the following elements are added as part of the core data set.

The elements recommended are:

• Date/Time of Testing
• Date/Time of Results

Data Class: Laboratory

IMO supports the inclusion of the Laboratory Data Class in USCDI V3 to include the Draft data elements for Tests and Values/Results. We would propose additional data elements for UCUM units, normal ranges or flags for abnormality, and data elements to indicate if the lab test was ordered, and/or performed.

Laboratory

The Regenstrief Institute applauds the addition of Specimen type as a data element in USCDI.

We recognize that specimen that specimen is embedded in the text name (and conveyed in the tests codes delivered as LOINC or local codes) in most use cases. However, in those instances where specimen type is not embedded in the LOINC name or where a more specific specimen is required, LOINC has a way to send specimen information as a separate variable in messages via HL7 or FHIR.

As such, we recommend including LOINC as a standard to capture Specimen Type   when indicated.  

CDC Unified Comment: California Department of Public Health

The California Department of Public Health recommends adding the following data elements for the Patient Profile in exchange between EHRs:
 

• Laboratory Class

• Date Specimen Collected 

• Last lab consistent with COVID infection 

• Last lab consistent with latent TB infection 

• Last lab consistent with active TB infection 

• Interferon-gamma release assay result 

• Tuberculin skin test: Date placed (may be in Laboratory or Immunization section) 

• Tuberculin skin test: Date read 

• Tuberculin skin test result 

• Last lab consistent with Chlamydia trachomatis, Gonorrhea, or Syphilis infection 

• Last serology/viral load for Hepatitis B, Hepatitis C, and HIV infection 

• Last reported Hemoglobin A1c 

• Last reported total cholesterol 

APHL comment to expand elements included for laboratory

• We suggest to include the following data elements from level 2 into USCDI as this data is already widely supported and included in laboratory results:
  • test result status
  • test result date timestamp
  • test performed date/time – which should be renamed to clinically relevant time (which for laboratory tests is the same as the specimen collection date time)
  • specimen collection date/time (same as what USCDI defines as the test performed date/time)
  • specimen type