Under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), the Office of Licensure and Certification evaluates laboratories--including physicians offices, hospitals, and nursing homes--that perform diagnostic testing on human specimens. CLIA requirements also apply to laboratories seeking payment under the Medicare and Medicaid programs. There are over 6,850 federally certified CLIA laboratories in Virginia.
CLIA applications must be submitted by postal mail with an original director signature:
Office of Licensure and Certification
Division of Acute Care Services
ATTN: CLIA Program
9960 Mayland Drive, Suite 401
Henrico, VA 23233
CLIA inquiries and questions may be sent to clialab@vdh.virginia.gov.
| Lab Schedule | # of Specialties | Annual Test Volume | Certificate Fee | Avg. Compliance Fees |
|---|---|---|---|---|
| Waived | N/A | N/A | $180 | |
| PPM | N/A | N/A | $240 | |
| Low Vol A | N/A | Less than 2,000 | $180 | $360 |
| Sched A | 3 or Less | 2,000-10,000 | $180 | $1,192 |
| Sched B | 4 or More | 2,000-10,000 | $180 | $1,591 |
| Sched C | 3 or Less | 10,001-25,000 | $516 | $1,988 |
| Sched D | 4 or More | 10,001-25,000 | $528 | $2,336 |
| Sched E | N/A | 25,001-50,000 | $780 | $2,684 |
| Sched F | N/A | 50,001-75,000 | $1,320 | $3,032 |
| Sched G | N/A | 75,001-100,000 | $1,860 | $3,380 |
| Sched H | N/A | 100,001-500,000 | $2,448 | $3,728 |
| Sched I | N/A | 500,001-1,000,000 | $7,464 | $4,076 |
| Sched J | N/A | Greater than 1,000,000 | $9,528 | $4,408 |
Effective March 6, 2019, the new vendor (US Bank) and mailing address for CLIA Coupon Payments:
CLIA Laboratory Program
PO.Box 3056
Portland, OR 97208-3056
- The Certificate of Registration (CoR) fee is set at $100.00 for all laboratory types, regardless of number of tests performed. Please note anytime a change in type of certificate is requested (i.e., downgrading from a certificate of compliance or certificate of accreditation to a certificate of waiver or certificate of provider performed microscopy), the laboratory is billed the $100.00 registration certificate and issued a new registration certificate even if it is an already established laboratory. The same is true for any laboratory wishing to upgrade its certificate status from waived or PPM to the compliance or accreditation level.
- For facilities requesting a certificate of waiver (CoW), the laboratory pays a $180.00 fee for the certificate of waiver. The laboratory is then billed $180.00 every two years for the CoW.
- For facilities requesting a provider-performed microscopy certificate (PPM), the laboratory pays $240.00 for the PPM certificate fee. The laboratory will be billed $240.00 every two years as long as it maintains its PPM status.
- For facilities requesting a certificate of compliance (CoC), the laboratory pays the initial $100.00 registration certificate fee. The laboratory will then be billed a compliance fee based on the total annual volume of tests performed in the moderate and high complexity level categories. Note from Table "CLIA USER FEES AS OF JANUARY 8, 2019" that CMS has established eleven different schedules, Low Volume A through Schedule J, based on total volume of laboratory testing. After the facility has paid the compliance fee, the laboratory will be scheduled by Virginia Department of Health's Office of Licensure and Certification for an inspection. After the inspection has occurred and a completed final package has been entered into the computer system, the laboratory will be billed the corresponding certificate fee, also based on total annual testing volume, and this figure can be found under column 1 "Certificate Fee." Please note CMS bills the compliance fees a year in advance of when the inspection is due and then bills the certificate fee upon completion of the inspection. The CLIA certificate is good for a two-year cycle, however the laboratory will receive a bill from CMS on an annual basis (compliance fee, then certificate fee).
- For facilities requesting a certificate of accreditation (CoA), the laboratory pays the initial $100.00 registration certificate fee. The laboratory will be billed a fee by whatever accrediting agency the facility has selected. After the accrediting agency has completed its inspection and submitted its data to CMS, the laboratory will receive a bill from CMS for its certificate of accreditation. The certificate of accreditation fee is based on the annual testing volume reported by the laboratory to the accrediting agency at the time of the inspection. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.
Frequently Asked Questions
Yes. In an effort to provide support to workplaces who may be doing COVID-19 testing, the U.S. Centers for Medicare and Medicaid Services (CMS) has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.
Yes, you are required to obtain a CLIA certificate if you are conducting diagnostic testing for COVID-19. If you are only collecting specimens and not conducting any diagnostic test, a CLIA certificate is not required. Please be advised that if you are conducting COVID-19 diagnostic testing, you must comply with all current federal and state disease reporting requirements. Failure to report may result in enforcement action.
No, Virginia does not license laboratories or laboratory personnel nor have any state regulations for labs. Labs in Virginia follow all federal CLIA regulations. However, laboratories reporting the results of a test for Lyme disease should review Va. Code § 32.1-137.06 regarding minimum notice requirements that the laboratory must provide.
Billing coupons for Certificate of Waiver (CoW), Certificate of Provider-Performed Microscopy Procedures (PPM), and Certificate of Accreditation (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 Certificate of Compliance (CoC) 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.
Make check payable to and mail check to:
CLIA Laboratory Program
P.O. Box 3056
Portland, OR 97208-3056
Write your CLIA number in the memo section of the check, and include the billing coupon with your payment.
Submit the completed, signed Form CMS-116 to our office via postal mail with an original director signature. Applications will be processed within 30 days of receipt. Send applications to:
Office of Licensure and Certification
Division of Acute Care Services
ATTN: CLIA Program
9960 Mayland Drive, Suite 401
Henrico, VA 23233
Send a letter or the Form CMS-116 via postal mail to our office within 30 days of the change:
Office of Licensure and Certification
Division of Acute Care Services
ATTN: CLIA Program
9960 Mayland Drive, Suite 401
Henrico, VA 23233
Changes are processed within 45 days of receipt. For facilities holding a Certificate of Accreditation (CoA), changes in director, specialty, or volume need to be submitted directly to the Accrediting Organization.
You may pay by postal mail, as directed in Question No. 3 above, or you may pay online at www.pay.gov. To pay online, you will need your CLIA certificate number and the amount due.
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.
Certificate of Waiver (CoW): $180 for 2 year certificate
Certificate of Provider-Performed Microscopy Procedures (PPM): $240 for 2 year certificate
Certificate of Compliance (CoC) or Certificate of Accreditation (CoA): Fees depend on the annual test volume and number of laboratory specialties/subspecialties. Please see the chart of CLIA user fees above.
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.
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.
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.
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.
Yes, provided the lab receives written authorization from the physician ordering the test. Va. Code § 54.1-2409.4 authorizes the release of test results to the test subject at the same time the results are provided to the physician.
Yes, the application should include a listing of the continuing education units (CEUs) taken by the lab director.
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.
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.
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.
A inspection 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 inspection. It is recommended that 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.
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.