Laboratory

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

Cerner Corporation USCDI Draft V2 Comments - Laboratory

Provided below are Cerner's comments on the USCDI draft V2 proposals for the Laboratory data class. Cerner's full public comments on the USCDI draft V2 have been posted on the USCDI general comments section.   Cerner supports the proposal to re-classify the Laboratory Report Narrative and Pathology Report Narrative data elements from the Clinical Notes data class to the Laboratory data class. As with the Diagnostic Imaging Narrative data elements (for which we provide recommendations in the Diagnostic Imaging data class section of this comment letter), the data elements do not fit within the intended scope of Clinical Notes and are better classified in a more distinctive data class. That said, there is still significant ambiguity as to the intended definition of those data elements, even with their reclassification. Additionally, we note that if these re-classifications are finalized in USCDI V2, ONC should include the same changes in USCDI V1 via an errata adoption. This is important for consistency as HIT developers and healthcare providers are currently working to align with USCDI V1. If changes other than additions are made for USCDI V2 it may create inconsistencies for exchange of the same data between those versions.   Our first recommendation is to remove “narrative” from the data elements’ naming and adopt them simply as “Pathology Report” and “Laboratory Report.” Including “narrative” in the naming is misleading because it implies the whole of the content is narrative. However, freetext narrative content would be only one component of a full report, which consists of both coded and freetext/narrative data, as well as quantitative and/or qualitative observations. In the case of Laboratory Report, a narrative component may not even be relevant as even textual results are generally encoded as a discrete observation with a specific result “type” classification (e.g., “string”). We recommend accounting for this in adopting the formal definition of the data elements and ensuring that the scope of data to be contained within each is clear so that health IT developers and healthcare providers have a consistent understanding of precisely what is required or expected to be exchanged for the data class.   Additionally, regarding the Laboratory Report data element, we note that there are already well-defined standards established by the regulations of the Clinical Laboratory Improvement Amendments (CLIA) that define what constitutes a laboratory report. This is explicitly the data elements listed below, which are adopted in the CFR at 42 CFR 493.1291(c)(1) through (7).  CLIA laboratory report elements:

• For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number.
• The name and address of the laboratory location where the test was performed.
• The test report date.
• The test performed.
• Specimen source, when appropriate.
• The test result and, if applicable, the units of measurement or interpretation, or both.
• Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.

Furthermore, supporting the ability to represent a laboratory report is already a requirement as part of the ONC’s Health IT Certification Program under the 170.315(e)(1) View, Download, and Transmit to 3rd Party criterion. Guidance in the 170.315(e)(1) Certification Companion Guide states that the laboratory report should be represented with a HL7 CDA C-CDA Result Observation entry template, which HL7 has published examples of (see here). This has similarly been a requirement of past certification of laboratory results reporting in prior editions of ONC’s certification criteria.   Given the precedence for both the established definition of what constitutes a laboratory report and how it should be represented for purposes of ONC Health IT Certification (at least in HL7 CDA C-CDA), the most sensible approach would be to adopt the Laboratory Report data element with a definition aligned with that of CLIA regulations defined above, inclusive of any relevant narrative notes. Following this recommended approach will maintain consistency with long-held industry principles and ensure a common understanding of the scope of the data element.   As a final note, the Laboratory data class is a fitting example for our recommendation under the General Comments section of this comment letter that ONC seek to stratify the USCDI to specify the actors for whom various data classes and/or elements are intended (or required). This is because specific interoperability use-cases for laboratory data may not call for all elements of a CLIA laboratory report to be present.