Clinical Laboratory Improvement Act - Assignment Example

This information is then used to assess the patient's condition, diagnose an illness, as well as impair, prevent or treat a disease. CLIA certified laboratories work in conjunction with the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) as a means to assure that Medicare payments meet the standards and cost guidelines set by the appropriate government agency. While CLIA is a mandatory component of Medicare, it "applies to all providers rendering clinical laboratory services, whether or not Medicare claims are filed" (Centers for Medicare and Medicaid Services, 2006, p.2). In addition, CLIA has provisions for an accreditation process as well as an educational procedure.

In this way, NGOs, state, and federal agencies can participate in an ongoing review conducted by CMS, the center for all services. Numerous tests have been waived by the CMS as so "simple and accurate that there is little risk of error [even] if the test is performed incorrectly" (Centers for Medicare and Medicaid Services, 2006, p.2). Facilities that wish to perform waived tests must pay a $150 biennial fee and must apply for a Certificate of Waiver. "These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed" (CLIA waived and PPM tests defined, 2009).

In addition, the tests "pose no reasonable risk of harm to the patient if the test is performed incorrectly" and/or "are cleared by the Food and Drug Administration for home use" (CLIA waived and PPM tests defined, 2009). The original list contained eight waived tests, but recently the list has been significantly expanded. Tests that are CLIA waived include "ovulation tests that make use of visual color comparisons" (Is the Test You Need CLIA Waived, 2009). This would include home pregnancy tests.

The list also includes "blood glucose using FDA-cleared monitoring instruments", which are the automated testing devices often used by diabetics to monitor their blood sugar level (Is the Test You Need CLIA Waived, 2009). In all events, tests, and devices, the user must strictly adhere to the manufacture's instructions in regards to the use, reading, and interpretation of the results. If a test is not currently listed, "the manufacturer of the test would have to apply for a certification of waiver from CMS" (Is the Test You Need CLIA Waived, 2009).

In this way, CLIA is able to stay abreast of new technologies and medical advancements.3.) What are the other levels of laboratory services and what is the process to have your lab certifiedTest methods are categorized into three distinct levels based on the complexity of the method. There is the Waived Complexity Level, which requires no regular inspection. In addition, there is the Moderate/High Complexity level, which requires the physician or laboratory to complete an Application for Certification.

The comprehensive application includes a "description of laboratory to include name and number of tests performed annually, methodologies for each test, [and] personnel qualifications" (Moderate Complexity Testing Overview, 2004). In addition, the