Results Reporting for Orthopoxvirus, Non-Variola Orthopoxvirus, and Monkeypox Virus Diagnostic Testing

Reporting process

Any laboratory that performs diagnostic testing for monkeypox should report test results to state, tribal, local, or territorial (STLT) health departments. This includes real-time polymerase chain reaction (PCR) testing for orthopoxvirus, non-variola orthopoxvirus (NVO), or monkeypox virus (MPXV).

• Report all qualitative results unless otherwise specified by the appropriate health department.
• Report positive results via 1CDP within 24 hours of testing, or immediately by telephone to the appropriate health department per the regulations in the applicable jurisdiction.
• The applicable jurisdiction is typically 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.
• Do not reject specimens if data elements are missing but there is enough other information to perform testing.

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
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 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 de-identified and will not include patient-level information.

Information to inform surveillance and contact tracing efforts

• Laboratories are strongly encouraged to obtain the following information from electronic health records, ordering physicians, or both for reporting reasons.
• Educate physicians (and those who place test orders on their behalf) about data needs at the time the test order is placed.
• To collect this information efficiently, you may need to update electronic laboratory order interfaces to ensure necessary information from the electronic health record, the ordering physician, or both is fully populated.

1. Patient information: name, date of birth, street address, phone number
2. Demographic data (i.e., sex) to support epidemiologic priorities
3. Specimen information, including the type, the source site (with topography, e.g., right, left, distal) and collection method
4. Clinical history, if known, including symptoms, onset dates, travel history, epidemiological links to other cases, treatment with any medical countermeasures, and co-morbidities (International Classification of Diseases (ICD) diagnoses) that accompany the lab order

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 policy or state or local law.
• Send reports via 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 their specific implementation guides if available in your jurisdiction.
• Coordinate with your STLT health department to review data feeds before you submit results.

Standard terminology

Laboratories should use standardized LOINC and SNOMED-CT codes. This improves the accuracy of reporting results for orthopoxvirus, NVO, and MPXV and helps ensure that test types are uniformly represented across the United States.

LOINC codes represent the "question" a test asks of a specimen (for example, does this specimen have monkeypox?), 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).

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 "Monkeypox Technical Assistance Request" as the subject line.