Regulatory Issues for Opening a Laboratory

Essay by manymanUniversity, Bachelor'sA+, May 2009

download word file, 6 pages 3.0

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...