Waived HIV/AIDS-Related Testing

  • WV AIDS-Related Testing Facilities: Waived

  • Is this an initial or renewal application?*
  • Are you currently performing HIV testing?*
  • Do you plan on performing HIV testing in the future?*

  • 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. 

  • Date you anticipate to begin performing HIV testing. *
     / /

  • 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    If the information on your certificate is outdated or incorrect, please do not proceed with this application until the information has been updated!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. 

  • Image field 295
  • Browse Files
    Cancelof

  • 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.

  • Format: (000) 000-0000.
  • Format: (000) 000-0000.

  • Multiple Site Exceptions

  • Do you currently or plan to perform HIV testing at multiple locations under this certificate? Multiple locations include temporary testing and mobile testing.*
  • Where does/will additional testing occur? Select all that apply.*

  • 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. 

  • Do you know which tests/kits you will be using for HIV testing?*
  • Do you know what type(s) of samples you will be testing (oral fluid, fingerstick whole blood, venipuncture whole blood)?*

  • 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. 

  • Rows

  • 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.

  • Rows

  • Personnel, Procedures, and Testing Materials

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

  • Are testing personnel trained to accurately perform the testing?*
  • Is training performed and documented?*
  • Do testing personnel follow all manufacturer's instructions?*
  • Does the reagent/test kit instructions for use (package insert) require specific environmental conditions (temperature, humidity) for use or storage?*
  • Are you monitoring the environmental conditions in the storage/testing areas?*
  • Are reagents, test kits, or testing materials used IF THEY ARE EXPIRED?*

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

  • Does the reagent/test kit instructions for use (package insert) require external quality controls (QC) to be performed?*
  • Are you performing QC as required?*
  • Is QC/accuracy verification testing documented?*

  • Reporting

  • Is your laboratory reporting all AIDS-related test results to the WV Bureau for Public Health Surveillance and Disease Control program?*

  • 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. 

  • Reference Laboratory

  • Do you send samples for AIDS-related testing to another laboratory? This includes sending samples to WV Office of Laboratory Services (state lab).*
  • Which reference lab(s) do you use? Select all that apply. Please only mark the location(s) that perform and report the testing; the location will be documented on the patient's report. LabCorp in Charleston does NOT perform HIV testing on-site and should not be written in as an "other" option.*

  • Payment

  • How will your laboratory pay the certification fee?*
  • Is there a 3rd party who should also receive the invoice?*

  • 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. 

  •  
  • Should be Empty: