Data Element
Submitted By: Nedra Garrett / Centers for Disease Control and Prevention
Data Element Information
Use Case Description(s)
Use Case Description Disease reporting to public health relies on data from the EHR for identification of reportable events and to provide critical information used in confirming a diagnosis, understanding severity and classifying a case of disease that requires public health intervention for prevention, treatment, control, and outbreak identification and response. The specimen collection date is of particular importance for public health in understanding when laboratory confirmable evidence of a disease process was present in the patient. Specimen type and specimen site provides information useful in interpreting laboratory findings to determine severity and transmissibility.
Estimate the breadth of applicability of the use case(s) for this data element Over 3000 public health agencies in the US would use these data elements for disease surveillance and control activities.
Link to use case project page https://www.cdc.gov/elr/index.html
Healthcare Aims
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC
https://phinvads.cdc.gov/vads/SearchVocab.action
Additional Specifications N/A
Current Use Extensively used in production environments
Supporting Artifacts These are standard elements in HL7 laboratory messaging
https://www.cdc.gov/elr/index.html
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 These data elements are standard components of HL7 electronic test order and reporting (ETOR) messages between clinical setting and clinical laboratorories and of HL7 electronic laboratory reporting (ELR) messages sent from clinical laboratories to public health.
https://www.cdc.gov/elr/index.html
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 N/A
Other Implementation Challenges N/A

Comment

Submitted by Riki Merrick on

It might be beneficail to indicate that element can repeat

APHL recommends updating the description to: The anatomical site the specimen was taken from (e.g., leg, lung, nasopharynx, etc.)

Note that this element can repeat - and as for most coded elements, if a code is not available, sending of free text should be required.

Update vocabulary to more specific value sets: Body Site Value Set (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.3.88.12.3221.8.9/expansion) and SNOMED CT Body Structures (http://hl7.org/fhir/R4/valueset-body-site.html#4.4.1.342)
 

Submitted by Riki Merrick on

Source Site vocabulary suggestion

APHL fully supports inclusion of this data element and suggests to further specify the hierarchy in SNOMED CT for this data element - concepts should be from the body structure hierarchy.

Submitted by hantran on

CAP Comment on Specimen Source Site

  • Data Class: Laboratory
  • Data Element: Specimen Source Site
  • CAP Comment: The CAP applauds the ONC’s decision to add this data element to USCDI v4, as this data element indicates the body location where a specimen was obtained and is required by CLIA.

Submitted by hswmin on

THIA Comment on Laboratory: Specimen Source Site

The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for specimen source site. We support the actions to help mine data for specimens.

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment for USCDI v4

  • CDC-CMS Joint Priority Data element

Disease reporting to public health relies on data from the EHR for identification of reportable events and to provide critical information used in confirming a diagnosis, understanding severity and classifying a case of disease that requires public health intervention for prevention, treatment, control, and outbreak identification and response. The specimen collection date is of particular importance for public health in understanding when laboratory confirmable evidence of a disease process was present in the patient. Specimen type and specimen site provides information useful in interpreting laboratory findings to determine severity and transmissibility. Required by CLIA for all laboratory reports, 493.1291 Standard: Test report. Link

  • Comments from NACCHO: NACCHO supports including the data element specimen source site but recommends using the HL7 reference standard for the specimen source site.
  • Comments from CSTE: CSTE agrees with CDC's recommendation for this data element.

Submitted by hantran on

CAP Comment on Specimen Source Site

Data Element: Specimen Source Site

  • Corresponding CLIA Reporting Requirement: Specimen source
  • Description: The College of American Pathologists (CAP) supports the inclusion of this Level 2 data element into USCDI v4 to align with CLIA’s Specimen Source reporting requirement. The CLIA requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. 
  • Vocabulary Standard: For the content of the data element, the CAP recommends replacing the LOINC standard with the SNOMED CT standard. LOINC does not adequately represent specimen types or anatomic locations and relationships necessary to represent specimens and their sources, and is not intended for that purpose. 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 and specimen sources, and supports a rich array of hierarchical and other concept relationships.

Submitted by Riki Merrick on

APHL Comments on ISA 2022

APHL continues to support inclusion of this data element in the Laboratory class of USCDI V4; it is mentioned in CLIA as a “provide as appropriate” element.

Submitted by nedragarrett_CDC on

Unified Comment from CDC

  • Additional Use Case: This is a standard data item used by central cancer registries in all states. Data received through data exchange from laboratories to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law.  
     
  •  CSTE supports inclusion of this measure into USCDI v3: very useful for laboratory related fields context.

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