Frequently Asked Questions

1 Frequently Asked Questions1. How do I know if I need clia certification? clia certification is required for facilities thattest clinical specimens for the purpose ofdiagnosis, treatment, or prevention of disease. Ifyour facility only collects specimens tobe sent out for testing at another facility, thenCLIA certification is not required for yourfacility. Laboratories performing research only testing,laboratories operated directly bythe Federal Government (for example VA, DOD), or laboratorytesting for the hiring ortermination of employees are clia -exempt and do notrequire clia certification. Thereare four certification types, depending on the typeof testing performed: Certificate ofWaiver, Certificate of PPM, Certificate of Complianceor Certificate of Accreditation.

2 Allcertifications are valid for a 2 year Where do I get the clia application?TheCMS-116applicationisavail ableontheCLIA website, HowtoApplyforaCLIA certificate ontheleftsideofthescreen,thentheCMS-116a pplication is found under Related Links at thebottom of the How does the application process work?Once the application is completed, the applicationmust be sent to the state send the payment with the mayfax or email the application to:Fax (602)364-0759 or application is processed bythe State Agency and, once processed, the facilitywill receive an invoice ( clia user feecoupon) from CMS in Maryland. Once the invoice ispaid, CMS will mail the facility theirCLIA certificate. The entire application processusually takes 4-6 weeks.

3 Fee schedulescan be found on the clia website, Which types of payment methods are available?Once the laboratory receives the invoice from CMS,there are 2 ways to make apayment. The facility may mail a check to the PO Boxaddress listed on the fee coupon: clia Laboratory Box 530882 Atlanta, GA30353-0882or pay online (enter clia in thesearch area).Do not send paymentto the State How do I make general changes to an existing CLIAC ertification?Facilities are required to notify our office of any changes to your clia certification within30 days of the change the address, mailing address, phone or fax,email, facility name and/or tax IDthat does not include a change of ownership, you mustuse the facility status changeform found change the director of a Certificate of Waiveror a Certificate of PPM, use the facilitystatus change form found change the director of a Certificate of Complianceor a Certificate of Accreditation,use a CMS-116 form found our purposes, a change in ownership occurs whenthe facility undergoes a change infacility name and tax ID.

4 If you have a change inownership, you must submit a facilitystatus change form and a Disclosure of Ownership formfound your existing certificate type,use the CMS-116 application Why haven t I received my certificate since mypayment was already processed?The certificaterenewal process is automatic for any existing will mail out the renewalinvoice approximately 6 months prior to the currentexpiration date. There will be atotal of 3 invoices mailed out, every two months,until the payment is made. Once thepayment is processed, CMS will not mail the new certificateuntil approximately 3weeks prior to the current expiration date, regardlessof when the payment Why does my facility address not appear on theinvoice?

5 , separate mailing address listed, then the facilityaddress will appear on the How do I get a copy of my clia certificate?If you need a copy of an existing clia certificatethen you may contact our office torequest a copy. Reprinted certificates are generatedand mailed from our Central Officein Maryland and may take up to 3 weeks to , reprinted certificates arenot available if the request is made within 6 monthsof the current expiration Is there State licensure or phlebotomy licensurein Arizona?Arizona does not have State Licensure for laboratories in Arizonaare only required to be clia certified. There areno additional requirements forspecimens that are collected in Arizona and sent toanother state for testing, other thanthe testing laboratory must be clia certified in theirown state, at the appropriate levelfor the testing performed.

6 Each state has differentregulations, so make sure to checkwith each state prior to collecting and testing clinical specimens. Arizona does not havephlebotomy licensure or How do I terminate an existing clia certification?If you no longer test clinical specimens and do notrequire clia certification any longer,then you must submit a letter of termination to theState Agency. The terminationletter must include: the clia number, facility nameand address, effective date of thetermination and reason for termination. Please submitthe termination letter on thefacility s letterhead, if possible. The request mustbe signed be the laboratory directoror authorized personnel. You may submit the terminationrequest by fax to602-364-0759 or by email