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  • Syphilis Testing Certification

  • You are not required to obtain Syphilis certification. If you have any questions about this message, please email us at DHOLSHIV@wv.gov before proceeding.

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  • Laboratory and CLIA Information

  • Except for capitalization, enter the data in this section EXACTLY as it appears on your CLIA certificate (example below). Please do not use CAPS unless it is appropriate (e.g. LLC). 

    If your laboratory is waived, PPMP, or compliance, contact WV CLIA to make any necessary changes. 

    If your laboratory is accredited and you are changing the laboratory director, please notify your accrediting organization. For all other changes, contact WV CLIA. 

    WV CLIA can be reached at DHOLSCLIA@wv.gov. 

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  • Contact Information

  • The email address for Contact 1 must be verified before this application can be submitted to ensure your documents are delivered successfully. Enter the address and click the "verify email address" button. A validation code will be emailed. Copy the code from the email, paste it into the box, and select "confirm code." If the email address was initially entered incorrectly, select "reset email" and start over.  

    Note that documents will be sent to both contacts, but Contact 2's email is not being verified. Please ensure that it is entered correctly before submitting the application.

    Please do not use CAPS when entering contact information.

  • Multiple Site Exceptions

  • We will verify whether your CLIA certificate has a multiple site exception to perform testing in other locations and will contact you if further attention is required. 

  • For more information on multiple sites, click HERE to view CMS clarification and examples.

  • Testing Information

    The questions in this section apply only to Syphilis testing performed in your laboratory.

  • If you are not currently testing, answer the questions based on the testing you will be performing.

  • Waived Testing

  • This section is gathering information about the Syphilis testing your facility physically performs.

    If you are not currently testing, answer the questions based on the testing you will be performing.

    Please DO NOT document tests that you are only sending to another laboratory for testing.

  • These three rapid tests are only FDA approved for fingerstick whole blood. Using other specimen types constitutes noncompliance with federal CLIA regulations and may result in sanctions. 

  • You are reporting the use of expired materials. If this was an error, please edit your previous response.

  • Nonwaived Testing: Personnel, Procedures, and Testing Materials

  • The Office of Laboratory Services will check the CMS database to determine if your laboratory is certified to perform syphilis serology testing. We will let you know via email and provide further instructions, if necessary.

  • You are reporting the use of expired materials. If this was an error, please edit your previous response.

  • Quality Control, Calibration, and Quality Assessment


  • Test Specialties/Proficiency Testing/Accuracy Verification

  • All nonwaived, FDA-approved syphilis tests, with the exception of darkfield microscopy, are classified as syphilis serology and accuracy is required to be verified via commercial proficiency testing. 

    Darkfield microscopy is classified as bacteriology and direct visualization of a bacterial structure is not subject to commercial PT requirements.

    A list of analytes with required commercial PT can be found on pages 11 and 12 of this document.  


  • The following questions will capture information regarding the PT testing/accuracy verification studies you perform for Syphilis tests only. 

    Be sure to use the test/instrument name, not the PT event name (example: Siemens Atellica Syphilis assay). 

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  • Reporting

  • All syphilis test results must be reported to the WV Office of Epidemiology and Prevention Services (OEPS) per the WV Reportable Disease Rule.

    • Positive darkfield microscopic exam: report within 24 hours
    • Positive syphilis serology: report within 1 week

    Please visit the OEPS website for more information.

  • Reference Laboratory


  • Completion

  • Reminder: all follow-up emails and documents will be sent from noreply@jotform.com. 

    Please add this address to your contacts or safe senders list to ensure you receive further communications. 

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