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PRINTED: 03/06/2023
FORM APPROVEDDivision of Health Service Regulation
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION(X1) PROVIDER/SUPPLIER/CIA
IDENTIFICATION NUMBER:SHU LER HEATH CARE/Story VILLA
(X4)
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How to fill out clinical laboratory improvement amendments
How to fill out clinical laboratory improvement amendments
01
Obtain a CLIA application form from the Centers for Medicare & Medicaid Services (CMS) website.
02
Complete the application form with accurate information about the laboratory location, services offered, and testing methods.
03
Submit the completed application form along with any required documentation and fees to the appropriate CMS regional office.
04
Await approval from CMS and receive a CLIA certificate if all requirements are met.
05
Adhere to the regulations and guidelines outlined in the CLIA program to maintain compliance.
Who needs clinical laboratory improvement amendments?
01
Any entity or individual that operates a clinical laboratory in the United States and performs testing on human specimens for the purpose of diagnosis, prevention, or treatment.
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What is clinical laboratory improvement amendments?
Clinical Laboratory Improvement Amendments (CLIA) are federal regulatory standards that apply to all clinical laboratories that test human specimens for diagnosis, treatment, and prevention of disease.
Who is required to file clinical laboratory improvement amendments?
All clinical laboratories that perform testing on human specimens are required to comply with CLIA regulations, including filing amendments as necessary.
How to fill out clinical laboratory improvement amendments?
Clinical laboratory improvement amendments can be filled out online through the official CLIA website or by submitting the necessary forms by mail.
What is the purpose of clinical laboratory improvement amendments?
The purpose of CLIA is to ensure the accuracy, reliability, and timeliness of laboratory test results, thus helping to protect patients and improve healthcare outcomes.
What information must be reported on clinical laboratory improvement amendments?
CLIA amendments typically require information such as changes in laboratory personnel, testing methods, or equipment, as well as updates to quality control procedures.
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