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  • WV AIDS-Related Testing Facilities: Waived

  • You are not required to obtain WV HIV/AIDS-Related Testing Certification. If you continue the application process, you acknowledge that any payments made are nonrefundable. 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    If the information on your certificate is outdated or incorrect, please do not proceed with this application until the information has been updated! 

    • If your laboratory has a Certificate of 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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  • You may access the QCOR lookup tool at https://qcor.cms.gov/index_new.jsp.

    Instructions for accessing QCOR can be found at https://tinyurl.com/Access-QCOR. 

  • 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 this topic, click HERE to view CMS clarification and examples.

  • Testing Information

    The questions in this section only apply to HIV/AIDS-related testing performed in your laboratory.
  • This section is gathering information about the AIDS-related 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. 

  • FDA approval for waived HIV tests by sample type

    Please review this chart to determine if you are using sample type(s) that are FDA-approved for waived testing. 

    If the type of specimen you use is not checkmarked, you are not permitted to perform the test. 

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  • FDA approval for waived HIV tests by sample type

    Please review this chart to understand what sample type(s) are FDA-approved for waived testing. 

    You are only permitted to perform tests on the sample types that are checkmarked in the chart. Please refer back to the chart to ensure compliance when you are ready to begin testing patient samples.

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  • Personnel, Procedures, and Testing Materials

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

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

  • Reporting

  • All AIDS-related test results must be reported to the WV Office of Epidemiology and Prevention Services (OEPS) per the WV Reportable Disease Rule. Please visit the OEPS website for more information. 

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  • Payment

  • The link to the online payment system will be displayed on the submission confirmation page; it will also be included in your submission email if you need to return at a later time. 

  • An invoice will be sent in a separate email. Please return this form with your check. 

    In order to prevent processing delays, please be sure to include your CLIA number on the check!

    EFFECTIVE 1/1/2024, CHECKS MUST BE MADE PAYABLE TO "DEPARTMENT OF HEALTH"

  • Review and Submit

  • 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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