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CLIA Compliance
- 1. CLIA COMPLIANCE BY NANCY FADLING, MBA, HCM
- 26. CLIA Labs by Certificate Type
Editor's Notes
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- Clinical Laboratory Improvement Amendments. In addition to CLIA laws, your laboratory must be in compliance with all other federal, state, and local laws. We have a moderately complex lab requiring a Certificate of Compliance which is renewed every two years after a survey is conducted by your state program. The Certificate of Compliance clearly states that the survey is completed through random sampling and that they may not find every instance of non-compliance (reasonable assurance). It remains the responsibility of the laboratory and its director to ensure that the lab is at all times following all CLIA requirements, to identify any problems in the laboratory and take corrective action specific to the problems, and to institute appropriate quality assessment measures to ensure that the deficient practices do not recur. Monitor process ongoing.
- Before you report patient results you must verify that the test’s performance in your laboratory is similar to the manufacturer’s claims for accuracy, precision and reportable range. This verification (called a correlation study) requires you to test your equipment against a similar using patient samples. Your equipment also undergoes manufacturing precision testing. These records must be retained and become a permanent laboratory record.
- CLIA has a relatively new format and the regulations are now arranged to match the path a patient specimen takes as it moves through the laboratory; I.e. specimen received (preanalytic), testing (analytic), and result reporting (postanalytic). CLIA also has incorporated new terms: Quality Assessment has replaced the term “quality assurance.” Quality System refers to all of the laboratory’s policies, processes, procedures, and resources needed to achieve quality testing. NonWaived testing replaces the terms “moderate” and “high complexity” testing when referring to requirements that pertain to both levels of testing.
- Proficiency testing (PT) programs are shipped three times a year. PT is run with patient samples and submitted timely to be included within the nationwide results. You must review and evaluate all of the PT scores and should receive 100%. Your proficiency testing service then forwards your results to CMS who then will issue the Certificate of Compliance. AAB is designed with the flexibility to satisfy the needs of all laboratories ranging from one person specialty labs to an automated full service lab. AAB is the least expensive of the services. PT service provides two challenges per testing event. One usually falls within the reportable range.
- This fact is stated in the CLIA application along with educational requirements of lab directors and testing personnel. Once the completed Form CMS-116 has been returned to your state agency and it is processed, a fee remittance coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate. If you are applying for a Certificate of Compliance or a Certificate of Accreditation, you will initially pay for and receive a Registration Certificate. A Registration Certificate permits a facility requesting a Certificate of Compliance to perform testing until an onsite inspection is conducted to determine program compliance.
- Once
- Calibration is the process of testing and adjusting the instrument or test system readout to establish a correlation between the instrument’s measurement of the substance being tested and the actual concentration of the substance. Some equipment doesn’t allow you to run samples until you have a calibrated reagent on board. CLIA will want to see this data. QC or quality control consists of the procedures used to detect errors that occur due to test system failure, adverse environmental conditions and variance in operator performance, as well as the monitoring of the accuracy and precision of the test performance over time.