Compliance, Regulatory & Quality Professionals

A "laboratory" or "clinical laboratory" refers to any facility that conducts biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or similar examinations of materials derived from the human body. These examinations provide crucial information for diagnosing, preventing, or treating diseases, impairments, or assessing overall health.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the Secretary of Health and Human Services has authorized the FDA to determine whether specific tests are classified as "simple" with "an insignificant risk of an erroneous result," making them eligible for waiver categorization (69 FR 22849, April 29, 2004). The Centers for Medicare & Medicaid Services (CMS) oversees clinical laboratories, including the issuance of waiver certificates. CLIA mandates that laboratories must obtain a certificate before performing tests on human-derived materials. Laboratories that conduct only "simple" tests with "insignificant risk of an erroneous result" may qualify for a Certificate of Waiver.

CFR Compliance LLC™ supports clients and laboratories in meeting the requirements established by Section 263a(d)(3) of CLIA and 42 U.S.C. § 263a(d)(3). Our services include:

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• CLIA Waiver Applications

• Accreditation assistance with American Society for Clinical Pathology (ASCP)

• Risk Analysis and Flex Studies

• Fail-Safe and Failure Alert Mechanisms

• External Control Procedures

• Study Design Options

• Considerations in Satisfying CLIA Waiver Requirements

• Testing sites (Operators and Patients)

• Specimen Collection and Sample Preparation

• Financial disclosures

• Clinical study reports

• Labeling for Waived Devices

• Quality Control (QC) Labeling Recommendations

• Safeguards for Waived Tests

• Training