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Regulatory Issues For Opening A Laboratory

1521 words - 6 pages

Ka Yui Yin (Writer), Adrienne Kischnick, Krystina Jeroue, James Casey, Efosa Asemota, Anthony TurnerUncle Buck has been working in a large metropolitan hospital for 10 years. He has Bachelor's of Science degree in Medical Technology (ASCP). He is informed that there is a physician group out in the suburbs looking for a MT (ASCP) to open their lab. In the interview for the job, the physicians indicate they have a budget for the development of their facility. There are several regulatory issues he needs to address.First of all, the physicians gave buck a list of the tests they would like to have performed. However, we found out that all tests are CLIA- waived. These tests are not highly complex and may not require specialized equipment. Waived tests are cleared by FDA for home use and there is no risk of harm. For example, a test should not require sample manipulation, such as centrifugation or complex mixing; require operator evaluation of sample; or produce results that must be communicated to a state or local health department. A test system is cleared or approved by the FDA through the premarket notification or premarket approved process for in-vitro diagnostic use. CLIA regulation recognizes that clinical laboratories can run three types of test systems with reference to FDA-clearance or approval: 1) test systems run by laboratory without modification 2) test systems run by the laboratory after modification by the laboratory and 3) test system not subject to FDA clearance or approval. Verifying test system performance varies, depending on whether the test system has FDA clearance or approval and/or is modified by the laboratory. In other words, a laboratory would not be permitted to modify an FDA-cleared or approved test system without subjecting the laboratory to FDA clearance or approval requirements.In order to perform all CLIA-waived tests in the laboratory, he needs to apply for a CLIA certificate of wavier (COW), Form CMS-116. The form collects information about the laboratory operation which is to determine the fees and the type of certificate, to establish baseline data, and to fulfill the law requirements for CLIA. Also, the form needs some basic information such as type of laboratory, hours of routine operation, volume of waived testing, and individuals involved in laboratory testing. There is a certificate fee of US $150 pay biannually, and it must follow the manufactures' test. This must follow all of the instructions in the product insert from "intended use" to 'limitations of the procedure." Once Uncle Buck has the certificate, he cannot perform any other tests. After applying for the certificate, CMS arranges to inspect laboratories and assess laboratory activities against CLIA requirements. If everything passes, CMS will mail the certificate and Uncle Buck can start his first testing.Secondly, he needs to find analyzers for these assigned tests: Prothrombin Time, Lithium, Fecal Occult Blood Test, Glycosylated Hemoglobin, Group...

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