Good Example Of Research Paper On Clinical Laboratory Improvement Amendments

Type of paper: Research Paper

Topic: Medicine, Laboratory, Education, Law, Health, Testing, Business, Services

Pages: 4

Words: 1100

Published: 2021/01/06


According to FDA (2012), the CLIA are Federal government regulatory standards that ensure scientific and technical counsel to clinical laboratories in order for them to provide quality and best practices in clinical laboratory services. Clinical Laboratory Improvement Amendments is a combination of a chronology of events that have culminated to the current laws and regulations that guide the practice in clinical laboratories. The services offered by clinical laboratories are of critical importance in medicine and healthcare because they aid in monitoring diseases, including the pathophysiology of such diseases. Consequently, this contributes to the improvement of the quality of patient care, which is driven by quality clinical decisions for the patients.

The Center for Medicaid Services

The CMS, according to FDA (2012), is mandated by CLIA to control and standardize all the testing in laboratories, except research. Although laboratories must receive certification through the centers for Medicaid and Medicare services in order for them to be entitled to payments by Medicaid and Medicare, the CLIA bear no direct responsibilities to the Medicaid and Medicare programs (Gargis, et al, 1033). The CMS is responsible for issuing certificates to qualified applicant laboratories. Laboratories seeking certification must fulfill the “standards and certification: Laboratory requirements” federal regulations.
The CMS is also responsible for collecting fees from laboratories. The fees are collected during and after certification at a determined period for a laboratory to maintain its certification. These fees enable the CMS and other bodies to carry out their duties, since they do not depend on federal funding. Inspection of new and existing facilities to ensure that they adhere to regulations is also a duty if the CMS, as well as publishing the CLIA rules and regulations and ensuring that they reach the targeted organizations on time (Davey, et al, 189). In addition, the CMS monitors the performance of the various laboratories through proficiency testing, PT, and also approves the PT programs. Since the CMS cannot manage to perform inspections of all the laboratories on alone, they certify and accredit private organizations to assist in the inspections, while observing state exemptions for such accreditations (FDA, 2012).

Food and Drug Administration

The FDA is a federal organization whose main responsibility is to ensure the wellbeing of the population by establishing regulations on the safety and efficacy of foods, drugs, cosmetics, medical devices, and other services provided to the public. In addition, the FDA works to ensure that the public has access to science-based information on products that are consumed by the public. The FDA is mandated by the CLIA to categorize laboratory tests based on their complexity. This categorization aids in ensuring that only laboratory facilities with the right equipment and expertise are mandated to perform various tests. The categorization is either waived tests, moderate complexity tests, or high complexity tests. To obtain the categorization, laboratories must apply to the FDA, which in turn reviews the test instructions submitted with the application (FDA, 2012). In the case that applicants feel they have been wrongly categorized by the FDA, they can apply for a waiver back to the FDA, by following the instruction provided on their website.
The FDA also reviews the application requests from various laboratory facilities (FDA, 2012). The applications are received through the CMS, but it is the FDA which is responsible for reviewing and approving the applications. These applications describe the type of diagnostic tests that the facilities intend to be carrying, including the devices that will be used to perform the tests. This description helps the FDA to make a categorization of the tests that will be provided by the facility, ranging from waiver, moderate to high complexity tests. In addition, the FDA is also mandated to develop the rules and guidelines that govern the categorization process. Currently, the FDA utilizes the scorecard categorization method.

The Centers for Disease Control and Prevention

The CDC is a national public health organization in the United States, whose responsibility is to ensure the safety of the American citizens through research (Davey, et al, 189). The CDC ensures the safety by researching on health and security threats that face the nation, whether foreign or national. The CDC protects the public’s health by preventing the spread of disease, the possibility of injuries, and disabilities to individuals and community at large. In relation to the CLIA, the CDC performs various duties like providing technical assistance and carrying out research and analysis in various issues concerning laboratories and testing (Davey, et al, 189). The research aids in provision of evidence-based services as well as best practices. The research also aids in validating new methods of testing, hence reducing chances of harm or injury to patients. The CDC also develops standard guidelines for laboratory practice in cytology.
More importantly, apart from research to provide evidence-based practice, the CDC also conducts research intended to improve the current practices. Technological innovations are being developed every so often and the CDC seeks to utilize these innovations to improve the quality of services provided in the laboratories. In addition to the improvements, the proficiency testing practices provided by the CMS are reviewed by the CDC to ensure that they are competent enough. The research conducted by CDC would be of no help if it wasn’t distributed to the public. Therefore, apart from conducting the research, the CDC also ensures that the research findings are made public and available to the users (Davey, et al, 188). The CDC also manages the Clinical Laboratory Improvement Advisory Committee, CLIAC.


In conclusion, the Clinical Laboratory Improvement Amendments is a combination of laws and regulations that have been developed to guide the laboratory testing practices performed on human beings in the United States. CLIA ensures the safety of patients, accuracy and reliability of test results, and the timely delivery of those test results. The importance of testing cannot be undermined in the prevention and treatment of diseases. Therefore, the CLIA is developed and reviewed often to ensure that guidelines and standardization of clinical laboratory testing are maintained and improved. This paper covered the organizations mandated with ensuring that Clinical Laboratory Improvement Amendments are implemented and enforced by the laboratory facilities. The paper also discussed the role of each institution in delivering their responsibilities.

Works Cited

Clinical Laboratory Improvement Amendments (CLIA). Food and Drug Administration, FDA,
2015. Web. 30 March 2015
Davey, Diane Davis, et al. "The Impact of the Clinical Laboratory Improvement
Amendments of 1988 on Cytopathology Practice: A 25th Anniversary Review."
Gargis, Amy S., et al. "Assuring the Quality of Next-generation Sequencing in Clinical

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