CLIA Frequently Asked Questions

Does Virginia have any state regulations for laboratories or laboratory personnel?
No, Virginia does not license laboratories or laboratory personnel nor have any state regulations for labs. Labs in Virginia follow all federal CLIA regulations.

How do I renew my CLIA Certificate?
Billing coupons for CoW, PPM, and CoA labs are mailed out six months prior to your current certificate expiration date. After full payment is received, your next two year certificate cycle is considered renewed.

Compliance fee coupons for CLIA Certificate of Compliance renewals are mailed out twelve months prior to your current certificate expiration date. Full payment must be received before a compliance survey will be scheduled. Once CLIA performs the survey and determines that your laboratory is compliant with applicable CLIA regulations, a certificate fee coupon will be mailed to you. After full payment of the certificate fee is received, your next two year certificate cycle is considered renewed.

Where do I send my payment for my CLIA Certificate?

Make check payable to and Mail check to:
CLIA Laboratory Program,
P.O. Box 3056
Portland, OR 97208-3056

Write your CLIA number on the check, and include the billing coupon with your payment.

Where do I submit application for a CLIA Certificate?
Submit the completed, signed CMS 116 to our office via snail mail with an original director signature. Applications will be processed within 30 days of receipt. You may send applications to:

Acute Care Division – CLIA
Office of Licensure and Certification
9960 Mayland Drive, Suite 401
Henrico, Virginia 23233

 

How can I make a change on my CLIA Certificate?
Send a letter or the CMS 116 via fax, email or snail mail to our office within 30 days of the change. Changes are processed within 45 days of receipt. For facilities holding a Certificate of Accreditation (CoA), changes in director, specialty and volume need to be submitted directly to the Accrediting organization.

How do I make a payment?
Mail to Portland, OR using your fee Coupon (see question #3) or go to www.pay.gov. To pay on-line, you will need your CLIA # and the amount due.

I have made my payment but not received my certificate?
Certificates are mailed 30 days before the current one expires if the payment has been made. Requests to terminate your CLIA certificate must be submitted in writing and should include laboratory name, CLIA number, name of the laboratory director and/or owner, the reason your certificate should be terminated, the effective date of termination, your laboratory contact information and the signature of the laboratory director or his/her designee.

How do I terminate my CLIA certificate?
Requests to terminate your CLIA certificate must be submitted in writing and should include laboratory name, CLIA number, name of the laboratory director and/or owner, the reason your certificate should be terminated, the effective date of termination, your laboratory contact information and the signature of the laboratory director or his/her designee.

What is the cost for a CLIA certificate?
Certificate of Waiver: $180 for 2 year certificate
Certificate of Provider Performed Microscopy Procedures: $240 for 2 year certificate
Certificate of Compliance or Certificate of Accreditation: Fees depend on the annual test volume and number of laboratory specialties/subspecialties.

Can patients order their own tests in Virginia?
Yes, this practice is known as Direct Access Testing (DAT) and currently Virginia law does not prohibit patients from ordering their own tests. However, Medicare and Medicaid will not pay for any laboratory testing not ordered by an authorized person.

Can I have more than 1 location under the same CLIA number?

CLIA certificates are location specific. If you perform testing at more than one location then you will have more than one CLIA certificate unless you qualify for a multi-site site exception by meeting one of the following criteria:

  • Temporary Testing such as a health fair
  • A not-for-profit or Federal, State, or local government laboratory engaged in limited public health testing (no more than 15 total tests for all sites, waived or moderately complex)
  • Laboratories within a hospital that are located in contiguous buildings on the same campus and that are under common direction may file a single application. (Hospital satellites or auxiliary laboratories located outside a hospital must each make a separate application.)

Can I get a replacement CLIA certificate?
Yes, along as you are not within your renewal period and all fees have been paid. There is no cost for replacements at this time. Certificates are printed once a week and mailed from Atlanta.

When can a new facility begin testing?
As soon as you receive verification payment was received by CMS. You do not need to wait until you receive the certificate, as long as you have verification from CLIA that CMS received your payment.

 Can the results of lab tests order by physicians be released directly to test subject?
Yes, provided the lab receives written authorization from the physician ordering the test. Section 54.1-2409.4 of the Code of Virginia authorizes the release of test results to the test subject at the same time the results are provided to the physician.

When submitting an application for CLIA certification, is it necessary to include the required continuing education courses taken by the director?  Yes, the application should include a listing of the continuing education units (CEUs) taken by the lab director.

Who can qualify for a Provider Performed Microscopy (PPM) laboratory certificate?
Under this certificate, select laboratory tests must be performed in an office setting, and be performed by a provider.  A provider is a physician, dentist, or mid-level practitioner (nurse practitioner, physician’s assistant, or nurse midwife).  Mid-level practitioners must be authorized by the state to practice independently where the lab is located.  The test specimens to be examined are limited to the microscopic examination of the following body fluids: urine, wet mounts including the presence/absence of bacteria, fungi, parasites; and human cellular elements in vaginal, cervical, and skin preparations.  Nasal smears for granulocytes, fecal exams for leukocytes, and sperm qualitative analysis limited to the presence or absence of sperm and the detection of sperm motility are also performed under this certificate.

Sometimes my inspection is conducted several months before the certificates’ expiration date. Why?
The inspector may schedule your lab inspection up to 13 months before the expiration date of your certificate.  The CLIA state inspectors schedule inspections according to location and expiration date in order for the inspections to be done in the most efficient manner.

Will the early inspection move my expiration date up and cost the lab more money?
No.  If your lab is inspected several months before its expiration date, your expiration date or fees will not change.  The expiration date and the survey date are two separate fields in the computer database and are tracked separately.  Although the inspection is completed months before the expiration date, the laboratory’s new certificate will not be mailed until two weeks prior to the expiration date.

Can I reschedule my inspection? How much prior notification is given?
A survey date can be rescheduled only if there is a serious illness, a death in the family or if the lab is forced to be closed on the day of the survey.  CQHCCCP has recommended the inspector give the laboratory two weeks notice before an inspection.  The laboratory should be prepared for an inspection at all times.  If there is a complaint lodged against your laboratory, an unannounced inspection will occur.  Your laboratory should maintain compliance with the regulations on an ongoing basis.

What should I do with the pre-inspection packet the laboratory received in the mail?
Please review the accompanying correspondence and directions.  All required documentation should be completed prior to the onsite inspection.  The personnel form must be signed by the laboratory director.  The lab will provide documentation of the highest level of education and of appropriate laboratory training for all new employees.  This documentation must be reviewed by the CLIA inspector before the employee may perform any patient testing.