Theses, Dissertations, and Capstone Projects

Year of Award

1992

Degree

Master of Business Administration (MBA)

College

College of Business & Professional Studies

Degree Program

Business Administration

Department

Business Administration

Keywords

blood, testing, ABO typing, HIV, storage, medical, transfusion, cytology

Abstract

The Clinical Laboratory Improvement Amendments of 1988 regulates every laboratory in the United States. Congress enacted legislation after many stories surfaced about the carelessness of laboratory testing. Of major concern át the time was the false results in Pap testing that caused many deaths. At first, the new regulations met with great opposition from medical groups like the American Medical Association. With high tech advancements in testing equipment and computer science, physician office laboratories found it profitable to operate their own laboratories. The final version of CLIA '88 regulates all laboratories, including physician office laboratories.

About 12,000 laboratories were already regulated by the Clinical Laboratory Improvement Act of 1967. Congress concluded that these regulations were weak and covered only a fraction of the nations laboratories. Included in this group regulated by CLIA '67 were laboratories operated by commercial blood banks. These blood banks collect and distribute raw material that is used in research, biopharmaceutical products and testing kits. They are now faced with the increased regulation of CLIA '88 which sets standards on personnel, proficiency testing, quality control programs, documentation, and patient test results. This thesis provides a basic overview into the history of laboratory regulation, the personnel requirements and the cost consideration of implementing CLIA '88. It also provides an analysis on which personnel requirements and cost considerations will apply to the different types of commercial bloodbanks

Document Type

Restricted Thesis

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Creative Commons Attribution-No Derivative Works 4.0 License
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