Out of State WV HIV/AIDS-Related Testing Certification

  • Out of State AIDS-Related Testing Facilities

  • Is this an initial or renewal application?*
  • Are you currently performing AIDS-related testing on specimens obtained from patients residing in WV?*
  • Do you anticipate performing AIDS-related testing on WV residents 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 on WV residents.*
     / /

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    If the information on your certificate is outdated or incorrect, please do not proceed with this application until the information has been updated!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

    State CLIA contact information can be found at https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/contacts.  

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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.

  • Which type of CLIA certificate does your laboratory have?*

  • 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. 

  • What types of nonwaived HIV/AIDS-related assays does your laboratory perform? Select all that apply.*

  • Personnel, Procedures, and Testing Materials

  • Do all personnel meet minimum CLIA requirements for the nonwaived testing being performed? Hover over this question to access the qualifications for each complexity (moderate and high).*
  • Does the laboratory have a personnel training policy?*
  • Does the laboratory have a competency assessment policy?*
  • Are all training and competency assessment activities documented?*
  • Does the laboratory have a current step-by-step procedure, approved by the laboratory director, for each AIDS-related test performed?*
  • Do personnel follow all laboratory standard operating procedures?*
  • Is preventive maintenance performed at the interval determined by the manufacturer and/or laboratory?*
  • Are all reagents, test kits, and testing materials dated when opened?*
  • Does the reagent/test kit/instrument instructions for use (package insert) require specific environmental conditions (temperature, humidity) for use or storage?*
  • Are you monitoring environmental conditions with NIST-traceable or calibrated thermometers?*
  • 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 your laboratory have an approved policy for using EXPIRED materials?*
  • Does the laboratory have an AIDS-related testing confidentiality policy?*

  • Quality Control, Calibration, and Quality Assessment

  • Does the laboratory have a written QC plan that includes expected and acceptable ranges?*
  • How often is external QC performed? Select all that apply.*

  • Are calibration/calibration verification procedures performed at the interval determined by the manufacturer and/or laboratory?*
  • Are QC and calibration procedures, when applicable, documented?*
  • Does the laboratory have written Quality Assessment (QA) policies that cover all phases of laboratory testing (preanalytic, analytic, postanalytic, and general laboratory systems)?*
  • Are all laboratory records retained for at least two years?*

  • Proficiency Testing/Accuracy Verification

  • How does your laboratory verify the accuracy of AIDS-related testing? Select all that apply.*
  • Which PT provider(s) do you use for AIDS-related tests? Select all that apply.*

  • Have at least 2 PT events or alternate accuracy verification studies been performed for all AIDS-related tests on an annual basis?*

  • The following questions will capture information regarding the PT testing you perform for HIV-related tests only. 

    Be sure to use the test/instrument name, not the PT event name (example: Siemens Vista HIV 1/2 antibody). 

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  • Why was proficiency testing not completed? Select all that apply.*

  • 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.

    HIV is a Category V disease and must be reported within 1 week. 

    Please visit the OEPS website for more information. 

  • Reference Laboratory

  • Do you refer samples for AIDS-related testing to another laboratory?*
  • 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.*

  • Creative Testing Solutions locations; if marking "other," please enter the city, state, and CLIA number.*

  • Eurofins locations; if marking "other," please enter the city, state, and CLIA number.*

  • Quest Diagnostics locations; if marking "other," please enter the city, state, and CLIA number.*

  • Is there a 3rd party who should also receive the invoice?*

  • Payment

  • How will your laboratory pay the certification fee?*

  • 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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