Laboratory

Laboratory Data Class

NACHC supports the following comments on laboratory data types it developed in partnership with HL7:

Laboratory: Specimen Condition Acceptability

https://www.healthit.gov/isa/taxonomy/term/7691/draft-uscdi-v5

HL7 notes that with the introduction of Specimen Condition Acceptability in USCDI v4 there has been confusion about what exactly is intended to be included: either the condition of the specimen as-is, or the reason why a test was not performed given the acceptability of the specimen, also known as Criteria for CLIA Specimen Acceptability and Rejection.   HL7 notes that various conditions of a specimen (e.g. lipemia) may not prevent a test from being performed, while other conditions make the specimen unacceptable for any test (e.g., compromised/broken tube).  HL7 recommends that ONC update the name of Specimen Condition Acceptability to Specimen Condition and update the definition to reflect the focus on the actual specimen condition.  This would align with the actual implementation of this concept in both HL7 FHIR US Core 7.0.0, HL7 Clinical Document Architecture (CDA) and HL7 Consolidated Clinical Document Architecture (C-CDA).  We also ask that ONC applies this to USCDI v4 as an errata, clarifying intent, to ensure that those reviewing and interpreting USCDI v4 without reviewing the supporting FHIR US Core and implementation guides for CDA and C-CDA do not yield different expectations, than those implementing the FHIR US Core and implementation guides for CDA and C-CDA.

Laboratory: Tests [General]

https://www.healthit.gov/isa/taxonomy/term/676/draft-uscdi-v5

HL7 notes that the name does not differentiate between the test that was ordered versus the test that was performed.  HL7 recommends updating the name to "Laboratory Performed Test Code" and clarifying the binding to be to “LOINC: Lab class (Obs only or Both).”  

Laboratory: Tests [Panel Code]

https://www.healthit.gov/isa/taxonomy/term/676/draft-uscdi-v5

HL7 recommends that that Laboratory Test/Panel Code in Level 2 could be elevated to USCDI v5, but only if the name and definition are updated as listed below. Update the name to "Ordered Laboratory Test / Panel Code"

• Update the definition to "A code that identifies the test or group of tests (panel or profile), including reflexive tests being ordered for the analysis on a specimen derived from humans, which provide information for the diagnosis, prevention, treatment of disease, or assessment of health."

This will correspond to the coded version of the CLIA element in §493.1291(c)(4).

This change will also provide better clarity since the current name is misleading and given there are no results for any orders such as a panel.  The change also provides improved distinction with the element "Tests" when that is updated as proposed in our Tests comments.

Laboratory: Test Kit Unique Device Identifier (UDI) [New Data Element]

https://www.healthit.gov/isa/taxonomy/term/3731/draft-uscdi-v5

HL7 notes that the definition is referencing UDI and the name includes "unique".  Relevant standards and guidance such as HL7 Version 2 (HL7 v2), Integrating the Healthcare Enterprise Laboratory Analytical Workflow (IHE LAW), HL7 FHIR US Core, HL7 Clinical Document Architecture (CDA) and HL7 Consolidated Clinical Document Architecture (C-CDA) can use the full UDI as defined by the FDA for certain, limited use cases. However, the necessary guidance to support it -- from the source instrument all the way to systems such as electronic health records (EHRs) and those in public health -- are not yet attainable in practice.  The full UDI of the test kit or the instrument (where applicable) is not a reality.  The following are challenges that must be addressed:

• The laboratory may have some of the UDI components on paper but not necessarily all, and typically not electronically within their laboratory information systems (LIS). 
• The relevant HL7 v2 standards and IHE LAW profiles support some of the requirements, but not all requirements to fully enable instruments and LIS to communicate the necessary UDI components. Even just the name and model of the instrument with a manufacturer name and/or the name of the test kit/reagent and manufacturer is a challenge.  Specifically: 
  • IHE Law profiles are not widely adopted by instrument manufacturers and LIS vendors.
  • While those using IHE LAW include an instrument name and/or model, the formal Device Identifier is typically not included.
  • Guidance on correctly including UDI components into the appropriate IHE LAW profile fields is insufficient.
  • Guidance on correctly including multiple UDIs (instrument plus test kit/reagents) for an individual test is insufficient within standards frameworks such as HL7 v2, IHE LAW, and profiles and Implementation Guides relating to Laboratory Results Information (LRI) and Electronic Lab Reporting (ELR). If only one can be communicated, which one should be included?
• It is unclear how the test kit / reagent UDI components can be electronically obtained in the LIS for a specific test, as an instrument can use different test kits/reagents from different manufacturers.  Inherent challenges are: either the instrument cannot communicate which test kit/reagent is in use for a given test, and/or the LIS cannot assert which combination is being used for the test result received.
• Even if current standards are adopted for new instruments, older instruments would not support them.
• LIS does not typically store these elements nor make it available and usable for further reporting, thus it would not be possible to include these on the results report to the EHR or in Public Health.

Until the UDI components can be consistently populated in the LIS with the results and communicated to the ordering provider, public health, and/or other recipients, inclusion of the UDI or related components is premature.

However, recognizing the timeline by which USCDI v5 would start to be implemented, it is appropriate to consider inclusion of a minimum set of UDI components, followed by additional components in subsequent USCDI versions. ONC should also consider using USCDI+ Public Health (PH) Laboratory Reporting to include additional components as this would facilitate a more focused audience and could be used to incent laboratories and LIS in particular to support the necessary documentation and communication of the full UDI for test kit and instrument used.

Short term, HL7 therefore suggests that a focus on the name and model of the main instrument and its manufacturer (when an instrument is used) is applied.  This can be followed over time with the name of the test kit/reagent and its manufacturer and progress towards the full UDI for both the test kit/reagent(s) and instrument used.  Furthermore, HL7 suggests that ONC work with FDA, the Centers for Medicare and Medicaid Services staff responsible for implementing the Clinical Laboratory Improvement Amendments (CLIA), public health agencies, laboratories, and instrument manufacturers to establish a practical roadmap for adoption and the necessary incentives to achieve that.  Having the source systems, e.g., instrument, test kit, and LIS, be able to share this information will enable receiving HIT (e.g., EHRs, Public Health) to provide support where needed.  Additionally, an approach should be established for tests where UDI are not present, to understand what was used to perform the test.

Lastly, HL7 observes this related gathering UDI on test kits, whether the exchange would be captured across all healthcare entities (i.e., electronic medical records, Payer's State or Federal Agencies) should be examined. Ensuring this cohesion is critical. Entities responsible for tracking and reporting this data should also be considered.

Laboratory: Values/Results [General]

HL7 notes that the definition and vocabulary of Values/Results focuses on qualitative values and results.  The variances in vocabulary are notable particularly given the nominal scale uses SNOMED CT in organism hierarchy with example value set: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=64089FFA-B015-4DC7-B470-F20DF5B13BFA, while the ordinal scale uses SNOMED CT from a qualifier hierarchy: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=815C6DD4-C5A6-DF11-9BDD-0015173D1785).  Additionally, the structure of quantitative results (e.g., relationship with the Result Unit of Measure) of interest should be further clarified.  

Laboratory: Values/Results [Date and Timestamps]

https://www.healthit.gov/isa/taxonomy/term/681/draft-uscdi-v5

HL7 recommends that rather than listing a general date and timestamps, that the specific dates and timestamps of interest should be enumerated. HL7 specifically suggests elevating the following Level 2 data elements into USCDI v5:

• Specimen Collection Date/Time: The clinically relevant time - provides clinical temporal context about the state of the patient as it relates to the performed lab test.  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 specimens obtained from the patient, it is the date and time, the specimen was collected in accord with CLIA. 
• Laboratory Test Performed Date: 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 should represent the date and time the specimen was analyzed and results obtained.  This is often the LIS verification date/time, whether by an automated process or via a human.
  • HL7 recommends adjust the definition to state: "Date (and optionally time) when testing was conducted by the laboratory performing the testing".  This date is not necessarily the clinically relevant data/time as that would be the specimen collection date/time for lab tests. This date may be important when multiple tests are part of a report and is also helpful in identifying updated results, when only some results are updated in a report.

HL7 notes these dates are widely supported and available.  We therefore support inclusion in USCDI v5. Additionally, HL7 recommends that Report Date/Time (similar to Date of Report in Case Reporting in USCDI+) is defined as “The date and time at which the LIS system releases the results to the provider and other recipients” which meets CLIA test report date  as well, as a critical date and timestamp. This applies to any report, whether preliminary, final or corrected and is widely communicated already.

SHIELD Community Comment

I am submitting this comment on behlaf of the SHIELD Community:

• #1 - Suggest to elevate this element into V5 as it supports the use of Test Kit Identifier
• #2 - Using the same applicable vocabulary as for Test Kit Identifier, i.e. at minimum instrument name and manufacturer, DI of UDI, full UDI

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.