{"id":21,"date":"2016-07-20T17:58:01","date_gmt":"2016-07-20T17:58:01","guid":{"rendered":"https:\/\/www.vdh.virginia.gov\/licensure-and-certification\/?page_id=21"},"modified":"2025-12-31T14:29:21","modified_gmt":"2025-12-31T19:29:21","slug":"laboratories","status":"publish","type":"page","link":"https:\/\/www.vdh.virginia.gov\/licensure-and-certification\/division-of-acute-care-services\/laboratories\/","title":{"rendered":"Diagnostic Testing & Laboratories"},"content":{"rendered":"
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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.<\/p>\n

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Laboratories and providers that perform laboratory testing have until March 1, 2026, to switch to CMS email<\/em><\/strong><\/h3>\n

notifications and <\/em><\/strong>begin receiving electronic CLIA fee coupons and certificates. After this date, paper fee coupons and<\/em><\/strong><\/h3>\n

paper CLIA certificates will no longer be available.<\/em><\/strong><\/h3>\n

To switch, you can provide written notification by email to<\/em>\u00a0CLIALAB@vdh.virginia.gov<\/span><\/strong><\/h3>\n<\/div>\n

 <\/p>\n

CLIA applications must<\/span> be submitted by postal mail with an original director signature:<\/strong><\/p>\n

Office of Licensure and Certification
\nDivision of Acute Care Services
\nATTN: CLIA Program
\n9960 Mayland Drive, Suite 401
\nHenrico, VA 23233<\/p>\n

CLIA inquiries and questions may be sent to clialab@vdh.virginia.gov<\/a>.<\/strong><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div>

Quick Links<\/h3>\n
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Laws, Regulations, and Interpretative Guidance for Certified Labs<\/a><\/p>\n

CMS Resources for CLIA<\/a><\/p>\n

Examination Process Evaluation<\/a><\/p>\n

Laboratory Quick Start Guide to CLIA Certification<\/a><\/p>\n

Form CMS-116 CLIA Application<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

Fee Schedule<\/h3>
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tCLIA Fees as of January 27, 2024 (click to expand)\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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Certificate type<\/th>\n# of Specialties<\/th>\nAnnual Test Volume<\/th>\nCertificate Fee<\/th>\nReplacement Certificate Fee<\/th>\nRevised Certificate Fee<\/th>\nFollow-up Surveys (to include addition of Specialties)<\/th>\nUnsuccessful Proficiency Testing (PT) Desk Reviews<\/th>\nSubstantiated Complaint Surveys<\/th>\n<\/tr>\n
Certificate of Waiver (CoW)<\/td>\nN\/A<\/td>\nN\/A<\/td>\n$248<\/td>\n$75<\/td>\n$95<\/td>\nN\/A<\/td>\nN\/A<\/td>\n$2,059<\/td>\n<\/tr>\n
Certificate of Provider-performed Microscopy (PPM)<\/td>\nN\/A<\/td>\nN\/A<\/td>\n$297<\/td>\n$75<\/td>\n$150<\/td>\nN\/A<\/td>\nN\/A<\/td>\n$3,858<\/td>\n<\/tr>\n
Certificate of Registration (CoR)<\/td>\nN\/A<\/td>\nN\/A<\/td>\n$184<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$4,230<\/td>\n<\/tr>\n
Certificate of Compliance (CoC) - Laboratory Schedule V<\/td>\nN\/A<\/td>\n2,000 or fewer<\/td>\n$223<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
Certificate of Accreditation (CoA) - Laboratory Schedule V<\/td>\nN\/A<\/td>\n2,000 or fewer<\/td>\n$223<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule A<\/td>\n3 or fewer<\/td>\n2,001 to 10,000<\/td>\n$223<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule A<\/td>\n3 or fewer<\/td>\n2,001 to 10,000<\/td>\n$223<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule B<\/td>\n4 or more<\/td>\n2,001 to 10,000<\/td>\n$223<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule B<\/td>\n4 or more<\/td>\n2,001 to 10,000<\/td>\n$223<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule C<\/td>\n3 or fewer<\/td>\n10,001 to 25,000<\/td>\n$639<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule C<\/td>\n4 or more<\/td>\n10,001 to 25,000<\/td>\n$639<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule D<\/td>\n4 or more<\/td>\n10,001 to 25,000<\/td>\n$654<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule D<\/td>\n4 or more<\/td>\n10,001 to 25,000<\/td>\n$654<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule E<\/td>\nN\/A<\/td>\n25,001 to 50,000<\/td>\n$966<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule E<\/td>\nN\/A<\/td>\n25,001 to 50,000<\/td>\n$966<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule F<\/td>\nN\/A<\/td>\n50,001 to 75,000<\/td>\n$1,635<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule F<\/td>\nN\/A<\/td>\n50,001 to 75,000<\/td>\n$1,635<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule G<\/td>\nN\/A<\/td>\n75,001 to 100,000<\/td>\n$2,304<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule G<\/td>\nN\/A<\/td>\n75,001 to 100,000<\/td>\n$2,304<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule H<\/td>\nN\/A<\/td>\n100,001 to 500,000<\/td>\n$3,032<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule H<\/td>\nN\/A<\/td>\n100,001 to 500,000<\/td>\n$3,032<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule I<\/td>\nN\/A<\/td>\n500,001 to 1,000,000<\/td>\n$9,244<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule I<\/td>\nN\/A<\/td>\n500,001 to 1,000,000<\/td>\n$9,244<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n
CoC - Laboratory Schedule J<\/td>\nN\/A<\/td>\n1,000,000 or more<\/td>\n$11,801<\/td>\n$75<\/td>\n$150<\/td>\n$497<\/td>\n$780<\/td>\n$2,836<\/td>\n<\/tr>\n
CoA - Laboratory Schedule J<\/td>\nN\/A<\/td>\n1,000,001 or more<\/td>\n$11,801<\/td>\n$75<\/td>\n$95<\/td>\n$497<\/td>\n$780<\/td>\n$7,564<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Effective March 6, 2019, the new vendor (US Bank) and mailing address for CLIA Coupon Payments:<\/strong><\/em><\/span><\/p>\n

CLIA Laboratory Program<\/strong>
\nPO.Box 3056<\/strong>
\nPortland, OR 97208-3056<\/strong><\/p>\n

 <\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n<\/div>\n<\/div><\/div>

Frequently Asked Questions<\/h3>
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tNEW: Does my workplace need a CLIA certificate to test employees for COVID-19?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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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.\u00a0 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<\/a>\u00a0and the\u00a0Workplace COVID-19 Testing Fact Sheet<\/a>.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tNEW: Do I need a CLIA certificate if I am conducting diagnostic testing for COVID-19?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\n\t\t\t\t
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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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n<\/div>\n<\/div><\/div>

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t1. Does Virginia have any state regulations for laboratories or laboratory personnel?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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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 \u00a7 32.1-137.06<\/a> regarding minimum notice requirements that the laboratory must provide.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t2. How do I renew my CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\n\t\t\t\t
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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.<\/p>\n

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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t3. Where do I send my payment for my CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\n\t\t\t\t
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Make check payable to and mail check to:<\/p>\n

CLIA Laboratory Program<\/strong>
\nP.O. Box 3056<\/strong>
\nPortland, OR 97208-3056<\/strong><\/p>\n

Write your CLIA number in the memo section of the check, and include the billing coupon with your payment.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t4. Where do I submit application for a CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\n\t\t\t\t
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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:<\/p>\n

Office of Licensure and Certification<\/strong>
\nDivision of Acute Care Services<\/strong>
\nATTN: CLIA Program<\/strong>
\n9960 Mayland Drive, Suite 401<\/strong>
\nHenrico, VA 23233<\/strong><\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t5. How can I make a change on my CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Send a letter or the Form CMS-116 via postal mail to our office within 30 days of the change:<\/p>\n

Office of Licensure and Certification<\/strong>
\nDivision of Acute Care Services<\/strong>
\nATTN: CLIA Program<\/strong>
\n9960 Mayland Drive, Suite 401<\/strong>
\nHenrico, VA 23233<\/strong><\/p>\n

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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t6. How do I make a payment?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t7. I have made my payment but not received my CLIA certificate. When will it arrive?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Certificates are mailed 30 days before the current one expires if the payment has been made. You may find a URL link to the electronic certificate listed under your CLIA number at CMS's CLIA Laboratories look-up on S&C's Quality, Certification and Oversight Reports (QCOR) located at:\u00a0https:\/\/qcor.cms.gov\/main.jsp<\/a><\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t8. How do I terminate my CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t9. What is the cost for a CLIA certificate?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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Certificate of Waiver (CoW): $248 for 2 year certificate
Certificate of Provider-Performed Microscopy Procedures (PPM): $297 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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t10. Can patients order their own tests in Virginia?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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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.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t11. Can I have more than one location under the same CLIA number?\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t<\/span>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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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:<\/p>\n