Reporting Results from Orthopoxvirus, Non-Variola Orthopoxvirus, and Mpox Virus Diagnostic Testing

Who should report

• Any laboratory that performs diagnostic testing for mpox should report test results to state, tribal, local, or territorial (STLT) health departments. This includes real-time polymerase chain reaction or PCR testing for orthopoxvirus, non-variola orthopoxvirus, or Monkeypox virus.
• Report all results (positive, negative, equivocal) unless otherwise specified by the applicable health department.
  • Report positive results within 24 hours of testing, or immediately by telephone to the appropriate STLT health department per the regulations in the appropriate jurisdiction.
• Report test results to the health department in the patient's state or territory of residence.

What to report

Laboratories should make every reasonable effort to provide the following data elements when reporting results to state and jurisdictional health departments.

1. Test order—use appropriate Logical Observation Identifiers, Names and Codes (LOINC) terms (see table below)
2. Test order date (date format)
3. Test result
   1. Performed Test—use appropriate LOINC terms (see table below)
   2. Test result value – For quantitative results include units of measure, if applicable—coded in Unified Codes for Units of Measure (UCUM). For qualitative results use appropriate Systematized Nomenclature of Medicine- Clinical Terms (SNOMED-CT) code (see table below).
4. Test result date (date format)
5. Patient ID** (unique identifier assigned to an individual)
6. Patient name (Last name, First name, Middle Initial)
7. Patient street address
8. Patient phone number with area code
9. Patient date of birth
10. Patient age
11. Patient race
12. Patient ethnicity
13. Patient sex/gender
14. Patient residence zip code
15. Ordering provider name
16. Ordering provider zip code
17. Ordering provider address
18. Ordering provider phone number
19. Performing facility name and Clinical Laboratory Improvement Amendments, or CLIA number
20. Performing facility zip code
21. Accession # / Specimen ID** (unique identifier assigned to a specimen)
22. Specimen Source
    1. Specimen Type—use appropriate SNOMED-CT codes from the specimen hierarchy (see table below for some examples), or HL70487 codes
    2. Source site—when the specimen type is a crust or a swab, it may be necessary to indicate where on the body this was taken from—use appropriate SNOMED-CT codes from the anatomic body site hierarchy (see table below for examples); in addition, more detailed topography like laterality may be needed. Include this in the code for the source site, or send in as an additional element—properly coded using SNOMED-CT codes from the qualifier hierarchy
23. Specimen collection date (date format)

**Patient ID and Accession #/Specimen ID are necessary to identify multiple specimens from an individual once the data is deidentified.

To protect patient privacy, any data CDC receives from state and jurisdictional health departments will be deidentified and will not include patient-level information.

Note: Laboratories are strongly encouraged to obtain complete information, including:

1. Information about the patient to facilitate a rapid public health response; this includes complete patient contact information (name, date of birth, street address, phone number) so that public health may quickly contact the patient, provide treatment if necessary, and limit transmission
2. Demographic data (gender, race, and ethnicity) data to support critical health equity priorities
3. Information about the specimen, including the type, the source site (with topography, for example, right, left, distal) and collection method to support clear differentiation of the multiple submitted specimens, as well as better understanding of the clinical relevance
   1. Clinical history, if known, including symptoms, onset dates, travel history, epidemiological links to other cases, and treatment with any medical countermeasures (Medical Countermeasures Available for the Treatment of Mpox); also co-morbidities (International Classification of Diseases, or ICD diagnoses) that accompany the lab order

This may require updates to the laboratory test order process, including:

• Updating electronic laboratory order interfaces to ensure necessary information (from the electronic health record, or the ordering physician, or both) is fully populated
• Educating physicians (and those who place test orders on their behalf) about data needs at the time of test order

Laboratories should not reject specimens if data elements are missing and there is enough information to perform testing.

How to report

Laboratories should follow these best practices when reporting test results:

• Submit laboratory diagnostic test results directly to STLT health departments according to state or local law, or policy
• Send reports using existing electronic laboratory reporting (ELR) channels to ensure rapid initiation of case investigations
  • Share results concurrently with the ordering provider
• Send compliant HL7 messages, if possible, and prioritize the data elements described in the "How to Use Standard Terminology" section (see below)
• Engage with your STLT health department to ensure compliance with STLT-specific implementation guides, if available in your jurisdiction
• Coordinate with your STLT health department to review data feeds before you submit results

How to use standard terminology

Laboratories should use standardized LOINC and SNOMED-CT codes. This improves the accuracy of reporting results for Orthopoxvirus, non-variola Orthopoxvirus, and Mpox virus and helps ensure that test types are represented uniformly across the United States.

LOINC codes represent the "question" a test asks of a specimen (for example, does this specimen have mpox?), and SNOMED-CT codes represent the diagnostic "answer" (for example, what was detected?). Find more background on these terminology standards here:

• LOINC Term
• SNOMED CT
• UCUM

Whenever possible, laboratories should use standard codes that already exist.

* These are the preferred terms to use, when reporting results from PCR testing; other presence/absence terms like positive/negative are possible and should be mapped to these terms.

*** These could also be included in the Source Site values above; for example: Left hand (85151006) or Right thigh (11207009).

How to get assistance with electronic reporting

CDC can provide technical assistance to laboratories that are not currently reporting electronically to their STLT health department and would like to establish electronic reporting. Contact the CDC Electronic Data Exchange inbox at edx@cdc.gov and use "Mpox Technical Assistance Request" as the subject line.