Clinical Laboratory Improvement Act Compliance Manual
The CLIA manual outlines the Clinical Laboratory Improvement Act (CLIA) compliance requirements for clinical laboratories engaged in the practice of flow cytometry. The legislation requirements are based on the complexity of the laboratory testing. Flow cytometry is considered high complexity testing. The recommendations in this manual will apply to high complexity testing and will give instructions and forms for complying with the personnel, quality control, proficiency testing, and quality assurance requirements.
In 2008 Michael Keeney ART, FIMLS and Teri Oldaker B.A., CLS (NCA) QCYM (ASCP) revised the original CLIA Manual. The original CLIA Manual was written by A. Hurley and D. Zito. The CLIA Manual does not constitute the rendering of legal or other professional advice and is provided 'as is' with no express or implied warranty of correctness, merchantability, or fitness or suitability for any particular purpose or use. ISAC is not responsible or liable for any adverse consequences that may arise from the use of, or reliance on, this document.
The second version of the CLIA Manual is available to ISAC and CCS members online at no cost. Non-members can purchase the Clinical Laboratory Improvement Act (CLIA) manual through the ISAC Membership Department. The CLIA Manual is updated on an as needed basis by ISAC Councilors in-conjunction with ICCS and other cytometry associations.
The Flow Cytometry CLIA Compliance Manual has been written to help make sense of the CLIA requirements and give laboratories a clear format by which to monitor quality assurance and quality control.
ISAC hopes the information put forth here will help cytometry laboratories meet these regulatory requirements with greater ease, so that they may focus with more intensity on the quality of patients' results. ISAC and ICCS should review this document every five years for changes.
Click here to order a print version of the CLIA Manual. You can also download the PDF version.