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

Data Element
Specimen Condition Acceptability
Description (*Please confirm or update this field for the new USCDI version*)

Information regarding a specimen, including the container, that does not meet a laboratory’s criteria for acceptability.

Examples include but are not limited to hemolyzed, clotted, container leaking, and missing patient name.

Usage note: This may include information about the contents of the container, the container, and the label.

Applicable Vocabulary Standard(s)

Applicable Standards (*Please confirm or update this field for the new USCDI version*)
  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, March 2023 Release
  • Health Level 7® (HL7) Code System SpecimenCondition
Submitted By: Han Tran / College of American Pathologists (CAP)
Data Element Information
Use Case Description(s)
Use Case Description Reference Range:
This data element aligns with CLIA’s Reference Range reporting requirement. The CLIA requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The primary use cases for this data element in the USCDI are routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation. These use cases are similar to existing use cases for OBX-7 that are described in detail in the following documentation.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Name and Address of Laboratory Location:
This data element aligns with CLIA’s requirement to report the name and address of the laboratory location where the test was performed. The CLIA-defined requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The main use case is routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation.

Condition and Disposition of Specimens:
This data element aligns align with CLIA’s requirement to report any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. The CLIA-defined requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The main use case is routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation.

Test Result Harmonization Status:
The primary use case for harmonization status is in sharing data for clinical interpretation and use. If a test result from an external site has a harmonization status matching local tests, the harmonized results could be displayed in the same line of a flow sheet, and trended and processed with local results. A non-harmonized result would not be clinically compatible with local results and should be displayed and processed separately. In a public health setting, harmonized results could be grouped for surveillance processing, statistical analysis, and machine learning applications. Non-harmonized results should be kept separate.
Estimate the breadth of applicability of the use case(s) for this data element Reference Range:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.

Name and Address of Laboratory Location:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.

Condition and Disposition of Specimens:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States, there is a usage floor of approximately 660,000 organizations assuming each laboratory sends data to at least one other organization.

Test Result Harmonization Status:
Because the data element would be needed to meet any current or future clinical interoperability requirements, the CAP anticipates that it would become a routine component of laboratory result reporting. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) These proposed elements are a work in progress and the CAP urges that the vocabulary standards listed be considered for a future version of USCDI:

Reference Range:
The CAP proposes that the content of this data element follow the OBX-7 field from the HL7 2.5.1 standard. The CAP supports the use of the HL7 2.5.1 standard because the standard was designed to help laboratories comply with CLIA requirements. For numerical values, the CAP also proposes the Unified Code for Units of Measure (UCUM) standard. The CAP supports the use of the UCUM standard because it is well-established and because a common standard for units of measure will reduce errors related to translation of units of measure from one system to another.

Name and Address of Laboratory Location:
In lieu of a non-standard and inefficient textual description of a name and address, the CAP is proposing the use of the CLIA identification number as the data element content. All laboratories performing clinical testing have a CLIA identification number and are required to be able to report it, so the use of this number is not burdensome. The name and location of a laboratory can be determined quickly from the CLIA number using available online resources (for example, https://www.cdc.gov/clia/LabSearch.html).

Condition & Disposition of Specimens:
The CAP proposes the use of SNOMED CT for data element content. SNOMED CT is a relatively complete, well-curated, and actively-managed medical ontology that has excellent coverage of concepts appropriate for description of laboratory specimens, specimen sources, and conditions, and supports a rich array of hierarchical and other concept relationships.

Test Result Harmonization Status:
This is the first proposal of a harmonization status data element, and examples do not exist in other health data standards. Recently the ISO defined standard methods for harmonizing laboratory tests (see ISO 17511:2020 and 21151:2020). The CAP proposes development of a standard representation of these methods as content for this data element.
Additional Specifications Reference Range:
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Name and Address of Laboratory Location:
 Data elements representing laboratory identity are included in the following HL7 2.5.1 Implementation Guides.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Condition & Disposition of Specimens:
 Analogous data elements are discussed in the HL7 v. 2.5.1 documentation, see below. HL7 uses two fields to carry this information, SPM-21 and SPM-24. The contents of these fields are HL7 code sets, with extensions allowed. The CAP is proposing similar concepts but using SNOMED CT for data representation.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Test Result Harmonization Status:
To our knowledge, this is the first proposal of a data element to represent result harmonization.
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts Reference Range:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Name and Address of Laboratory Location:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Condition & Disposition of Specimens:
Note that the usage has been with the two HL7 fields and the HL7 value sets, which are strongly analogous to but not identical with what is proposed here.
 Supporting Artifact: HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279), see SPM-21 and SPM-24.

Test Result Harmonization Status:
Not currently captured or accessed.
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279
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 Reference Range:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Name and Address of Laboratory Location:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Condition & Disposition of Specimens:
The data elements have been tested at scale (“5 or more…”) but not in exactly the form proposed. For analogous HL7 data elements, see HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279).

Test Result Harmonization Status:
No.
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None per se. There could be a dependence on ISO standards, which are proprietary, depending on how that information is used.
Restrictions on Use (e.g. licensing, user fees) Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None
Privacy and Security Concerns Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None
Estimate of Overall Burden Reference Range:
No burden. Laboratories are already required to report this information as part of CLIA.

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
Laboratories would need to define the content of an additional data field when building result messages. The content of the field is likely to be selected a limited number of alternatives and therefore should be of limited additional burden.
ONC 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 2 - Use cases apply to most care settings or specialties.
Evaluation Comment This data element aligns with CLIA requirements to report any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.

It has been tested at scale and is supported in HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm.

Comment

Submitted by AndreaP on

Specimen Condition…

  1. Specimen Condition Acceptability. 
    1. This element should be split into 2 separate items:  Specimen Reject Reason and Specimen Condition, to be better aligned with CLIA requirements and usage of these distinct items.
    2. Specimen Reject Reason 
      1. See https://www.ecfr.gov/current/title-42/section-493.1242 “(7) Specimen acceptability and rejection.”
      2. Also https://www.ecfr.gov/current/title-42/section-493.1283  and https://www.ecfr.gov/current/title-42/part-493#p-493.1251(b)(1)
      3. This item is commonly utilized for a rejected specimen (e.g. clotted) and may be used for a Laboratory Order cancellation reason. 
      4. Specimen Condition 
        1.  Often noted for specimens that can be used for some testing, but may not be acceptable for others.
        2. It can be reported as a lab result and value as part of a lab order panel, especially when generated by an IVD analyzer as a result and its value.  These would be considered laboratory results in the Laboratory Class and thus mapped to LOINC codes.  It might be good to have the laboratory results for these items aligned with the LOINC mapping requirement and functionality EHRs are already certified against.  The laboratory result values indicating hemolysis, lipemia, or icteric specimens can be result values which can be mapped to SNOMED CT codes to maintain the LOINC as the question and SNOMED CT as the response encoding approaches
        3. It can be also reported as a chartable footnote on a laboratory result, which often doesn’t support encoding to codesystems.
        4. Clinical Laboratory Standards Institute (CLSI) has a standard for Hemolysis, Icteric, and Lipemia (HIL) Indices and terminologies and reporting that would be considered laboratory best practice:  https://community.clsi.org/media/1350/c56a_sample.pdf  IT also further details IVD reporting of these indices.
        5. See https://www.ecfr.gov/current/title-42/part-493#p-493.1283(a)(3)  and https://www.ecfr.gov/current/title-42/part-493#p-493.1291(c)(7)

Submitted by Riki Merrick on

APHL suggests to update the data element to reduce ambiguity

As previously commented in April 2024 "Rename element and update definition" (https://www.healthit.gov/isp/comment/13837) and in September 2023 "APHL Comment on Speicimen Condition Acceptability" (https://www.healthit.gov/isp/comment/13519) APHL requests the renaming of this element to "Specimen Condition" and requests the resolution in  https://jira.hl7.org/browse/FHIR-43567 be followed. APHL has been supporting HL7 Orders & Observations WG in improving the available valuesets to reference for specimen condition and expects to have those updated in time for V6 to properly represent conditions (current mapping for specimen condition (and also reject reason, which is related, but not used the same) is here: https://confluence.hl7.org/display/OO/Specimen+Condition+and+Specimen+Reject+Reason+Vocabulary).

Submitted by Riki Merrick on

APHL Comment on Speicimen Condition Acceptability

This field combines several aspects about the specimen and why it can or cannot be used in testing and should be split up into more data elements:

Specimen condition (SPM-24 in V2, specimen.condition in FHIR): attribute of the specimen - hemolyzed, frozen etc - should be represented using either SNOMED CT from the clincial finding hierarcy (or more specifically descendants of 441742003 | Evaluation finding) or HL70439 (https://terminology.hl7.org/5.1.0/ValueSet-v2-0493.html) used in both V2 and FHIR - this is usually not reported when the specimen is in the expected conditon and the test is performed, but it must be reported per CLIA as part of the result, when testing was performed on a specimen that was not ideal, but tested anyway to alert the provider to interpret the results with caution.

Specimen appropriatemess (SPM-23 in V2 using HL70492 ( https://terminology.hl7.org/5.2.0/ValueSet-v2-0492.html), sort of captured in FHIR in specimen.status using (https://hl7.org/fhir/valueset-specimen-status.html) this is really an attribute of the test - a specimen in a specific condition may be unacceptable for one test, but totally fine for another - vocabulary for this element is not worked out well.

Specimen reject reason (SPM-21 in V2 using HL70490 (https://terminology.hl7.org/5.2.0/ValueSet-v2-0490.html) and not in FHIR) - This is used when the testing is not performed to convey the reason why.

 

Submitted by jkegerize on

ACLA Comment on Specimen Condition Acceptability for USCDI v5

The American Clinical Laboratory Association (ACLA) comments pertain to the burden of using the Unified Code for Units of Measure (UCUM).

ACLA believes the vocabulary standard, UCUM, should be recommended, but not required. Laboratories should be allowed to use units of measure other than UCUM. The unit of measure provided by the instrument manufacturers, including FDA authorized, cleared, or approved method, is the standard that laboratories need to adhere to for result reporting. We recommend conversations and adoption from instrument manufacturers is incumbent for the adoption of UCUM to be viable. We would also recommend the ONC solicit feedback from CAP and CLIA on their stance on the need for conversion to UCUM.

The UCUM can be a preferred standard, but it should not be required for all tests. Currently, there is a large base of units of measure that are in use across trading partners. To convert these units to UCUM would be problematic, difficult to achieve and time consuming.

While ACLA acknowledges UCUM as an option for standardized vocabulary for units of measure it is crucial to recognize and understand the limitations of the UCUM coding system and the impact of key issues identified by ACLA prior to universal adoption.

  • UCUM has codes for ALL US customary units (e.g., UCUM guide §35 U.S. survey lengths, and §37 U.S. volumes). However, these will not necessarily have the same string representation that a given laboratory uses (see UCUM GUIDE http://unitsofmeasure.org/ucum.html). It also includes codes for all non-arbitrary unit of measure (UoM), includes many arbitrary UoM such as Somogyi units, and has a way to include strings (which will not be computable for any arbitrary units -- but arbitrary units are never computable in the sense that they can be interconverted).
  • There are issues with transmission of unusual or unrecognizable characters (e.g. ‘*’ or ‘^’, and descriptions sometimes use ‘#’ and ‘&’) which cause errors in some sending and receiving systems. These are restricted characters that cause issues in data exchanges including HL7.
  • Some recommended UCUM units exceed the HL7 prescribed field lengths for the coded element of 20 characters (e.g. nmol{BCE}/mmol{creat}, %{normal_pooled_plasma}). For example, some state public health systems are unable to accept more than 20 characters in the unit of measure HL7 field.
  • The mandate to report all units of measure in a UCUM format could impact patient safety. 
    • There may be a potential for discrepancies between the units of measure directed by instrument and/or reagent vendors in their package insert/operator’s manual for result reporting of a particular test vs. the UCUM units identified for that test. 
    • The instruments that process the specimens may or may not use UCUM standard units. There is a risk in converting results into a unit of measure that is different than the original unit of measure. 
      • Conversions cannot always be achieved to equivalency.
      • Even if it is accurately converted, it does not ensure that providers will always interpret it correctly.
      • It is common for conversion algorithms to encounter errors. While the problem with that is self-explanatory, a second issue may not be.  The value and the units of message occupy two separate HL7 fields.  Should a numeric value encounter an error, and the translation process choses to handle the issue by leaving the value as it was received but incorrectly modifies the units of measure (assuming the value algorithm performed correctly), there could be a disconnect between the value and units of measure that could greatly impact the interpretation of the results, and by extension, the health of the patient.
    • At present, units can be very confusing and unpredictable and almost impossible to use for computer purposes like decision support and quality assessment. We have seen more than 30 different representations of units for the number RBCs e.g.  10^12/Lit  bill/liter,  10*12/liter., etc.

Submitted by jkegerize on

ACLA Comment on Laboratory: Specimen Condition and Disposition

The American Clinical Laboratory Association (ACLA) pertains to the Applicable Standard(s):  SNOMED CT and Estimate of Overall Burden: Very low burden. This element should already be part of the EHR due to its laboratory regulatory requirement (CLIA).

ACLA Comments:

These comments pertain to the burdens using SNOMED CT.

Using only SNOMED CT for specimen condition data element content is problematic as this data element has not been tested at scale. The burden would be very high using SNOMED CT values lieu of HL7 table values. We propose the use of either HL7 table or SNOMED CT as acceptable values.

 

Submitted by hantran on

CAP Comment on Specimen Condition and Disposition

  • Data Class: Laboratory
  • Data Element: Specimen Condition and Disposition
  • CAP Comment: The CAP applauds the ONC’s decision to add this data element to USCDI v4, as this data element includes any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability relevant to the performance or non-performance of a test as required by CLIA. The CAP recommends that SNOMED CT—which was in the original submission for this data element—be added as the vocabulary standard for this data element.

Submitted by hswmin on

THIA Comment on Laboratory: Specimen Condition and Disposition

The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for specimen condition and disposition. Many institutions already have a process in practice, but there is value in standardization of this practice. Standardization means there would be data on prevalence and occurrence, which is important for quality assurance purposes.

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