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If you need a copy of an existing CIA certificate then you may contact our office to request a copy. Reprinted certificates are generated and mailed from our Central Office in Maryland and may take up to 3 weeks to arrive.
How do I apply for a CIA certificate? The CIA application (Form CMS-116) is available online. Send your completed application to the address of the local State Agency for the State in which your laboratory is located. Additionally, check with your State Agency for any other state- specific requirements.
How long will it take to receive our CIA certificate of waiver? Depending on your state health department, it can take between 4-12 weeks to receive your CIA certificate.
The Clinical Laboratory Improvement Amendments (CIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
However, a CIA certificate is needed for all other testing conducted by a SAMHSA-certified laboratory. ... Testing that is used to gather evidence for legal purposes, and is not performed for purposes of clinical treatment, medical diagnosis, health assessment or disease prevention is not subject to CIA.
A. Yes, the testing you perform qualifies as waived laboratory testing, and you need a CIA Certificate of Waiver. This testing requires a CIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.
The Clinical Laboratory Improvement Amendments (CIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
In general terms, the CIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
CIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CIA certification.
We only draw blood samples that are sent to a lab for testing. Do we need a CIA certificate? If laboratory tests are NOT performed, a CIA certificate is not required.
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