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CFA StudiesWaived Laboratories & Moderate Complexity StandardsMyths & Facts Judith A. Most, M.A., M.T. (ASAP) FDA PAC Meeting June 14, 2001Background !CIA Law waived tests are simple and have an insignificant
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What is hcfa studies-waived?
hcfa studies-waived refers to a form that indicates which laboratory tests are exempt from the requirements of the Clinical Laboratory Improvement Amendments (CLIA) and can be performed without seeking certification from the Centers for Medicare & Medicaid Services (CMS).
Who is required to file hcfa studies-waived?
Healthcare facilities and laboratories that conduct waived tests, which are tests that have been approved by the FDA as simple and low-risk, are required to file hcfa studies-waived.
How to fill out hcfa studies-waived?
To fill out hcfa studies-waived, healthcare facilities and laboratories need to provide information on the specific waived tests they are performing, including the test's name, purpose, and any pertinent information.
What is the purpose of hcfa studies-waived?
The purpose of hcfa studies-waived is to document and verify which tests conducted by healthcare facilities and laboratories are exempt from CLIA certification requirements.
What information must be reported on hcfa studies-waived?
On hcfa studies-waived, healthcare facilities and laboratories must report the name of the waived test, the test system used, and any applicable manufacturer information.
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