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  • Syphilis Testing Certification

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

  • 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.

  • Date you anticipate to begin Syphilis 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 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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  • 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.

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  • What 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 Syphilis 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 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.

  • Which complexity of Syphilis testing does your laboratory perform? Select all that apply.*

  • 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.

  • Which waived test and sample type do you use? Select all that apply.*

  • 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. 

  • 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?*

  • Nonwaived Testing: 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).*
  • Do testing personnel performing moderate or high complexity syphilis testing have active WV laboratory licenses?*

  • 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.

  • 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 Syphilis 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?*

  • 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?*

  • Test Specialties/Proficiency Testing/Accuracy Verification

  • Which specialty of nonwaived syphilis testing does your laboratory perform? Select all that apply.*
  • Is your laboratory certified by WV CLIA or your accrediting organization for the specialty of syphilis serology? The specialties your laboratory is certified to perform are listed at the bottom of your CLIA certificate.*

  • 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.  

  • How does your facility verify the accuracy of its darkfield microscopy? Select all that apply.*
  • Which PT provider(s) do you use for Syphilis tests? Select all that apply.*

  • Have at least 2 PT events been performed for all Syphilis serology tests on an annual basis?*
  • Have at least 2 PT events or alternate accuracy verification studies been performed for all Syphilis darkfield microscopy on an annual basis?*

  • 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). 

  • Rows
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  • Why was syphilis serology proficiency testing/accuracy verification not completed? Select all that apply.*

  • Reporting

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

  • 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

  • Do you send samples for Syphilis testing to another laboratory in WV?*
  • Which WV reference lab(s) do you use? Select all that apply. Please DO NOT add labs that are not physically located in WV. If you select the "Other WV Lab" option, please type in the name of the facility. LabCorp in Charleston does not perform Syphilis testing on-site and should not be written in as an "other" option.

  • 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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