Clia Information and Courses from MediaLab, Inc.
These are the MediaLab courses that cover Clia and links to relevant pages within the course.
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| Which one of the following does not directly regulate clinical laboratories: | View Page |
| Which of the following is the main function of the ASCP Board of Registry: | View Page |
| Federal Regulations The importance of quality control is recognized by the federal government. Federal regulations, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), require successful participation in external quality control programs for clinical laboratories, regardless of size. These regulations are aimed at providing all citizens with the highest quality of health care and at the same time controlling costs. | View Page |
| External Quality Control External quality control is performed to ensure the reliability of test results between different laboratories. It is also required by CLIA for laboratory accreditation. External quality control is generally accomplished through proficiency testing (PT). In proficiency testing, simulated patient samples are sent out to laboratories for testing. The CLIA standards for handling proficiency testing specimens are as follows: PT samples must be tested with the laboratory's regular patient load. PT samples must be tested the same number of times that patients' samples are tested routinely. Laboratories participating in PT programs must not engage in interlaboratory comparison of PT sample results. Laboratories may not send PT samples to another laboratory for analysis. Laboratories must document all steps of processing for PT samples. PT is required for only the primary method used for testing of analytes in patients' samples during the period covered by the PT event.In return for their participation, the laboratory will receive the following information: results for each analyte sample mean result for each analyte standard deviation of results by the comparative method number of laboratories using the same method standard deviation index (SDI) lower and upper limits of acceptability of resultsPT results that are between the lower and upper limits of acceptability are considered satisfactory. For chemistry, 80% of samples must test within the acceptable range for the PT to be considered successful. External quality control serves several purposes, including: providing a check on internal quality control detecting errors in a lab's methods providing a comparison of testing methods, which is useful in selecting new methods | View Page |
| Which of the following statements about CLIA testing requirements are true? | View Page |
| Utilization and other regulations Laboratories must not induce physicians to order unnecessary tests through their marketing or education activities: They must monitor the use of laboratory services by their clients. They must correct any situation where something they did caused an unnecessary increase in test utilization. Cost Reports Hospitals laboratories must ensure that information used in hospital Medicare cost reports is accurate and includes only those costs which are appropriate. Laboratories must follow all CLIA and OSHA regulations: failure to do so may result in a False Claims Act violation. | View Page |
| External Quality Control (3) Participation in some sort of proficiency testing program is now required by all accrediting bodies and the Clinical Laboratory Improvement Amendment (CLIA). Because the results must be returned to a testing center for comparison, there is a delay between the time of testing and the receipt of any statistical summary. | View Page |
| What is Non-waived Testing? In 2003, the Center for Disease Control and Prevention and the Center for Medicare and Medicaid Services published the Clinical Laboratory Improvement Amendment (CLIA).Under CLIA, the term "Non-waived" replaces the terms “Moderate” and “High Complexity” testing. Before a laboratory can report patient results for a non-waived, FDA-approved test for the first time, the laboratory must verify that the test’s performance is similar to the manufacturer’s claims for accuracy, precision, and reportable range.
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