The Clinical Laboratory Improvement Amendments of 1988

All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing.

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A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease.

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Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials.

The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are:

  1. Knowledge
  2. Materials used in proficiency, quality control, and calibration of materials
  3. Features of operational steps
  4. Experience and training
  5. Troubleshooting of test system troubleshooting and maintenance of equipment
  6. Preparation of reagents and other materials
  7. Interpreting and judging the results of the tests
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Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments

Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include:

Procedure manual

A basic part of the Clinical Laboratory Improvement Amendments; procedure manuals are a guide to a lab's quality assurance system and program.

Testing

Clinical Laboratory Improvement Amendments make testing a part of their provisions on meeting accuracy and quality requirements.

Classification of the lab

Clinical Laboratory Improvement Amendments classify labs according to their size and the types of tests they carry out.

Personnel

The personnel working in the laboratory and carrying out their tests are required to have prescribed qualifications and experience as set out by the Clinical Laboratory Improvement Amendments of 1988.

Duties of chief personnel

The Clinical Laboratory Improvement Amendments clearly prescribe the roles and responsibilities of the Director of the Physician Office Laboratory

Recordkeeping

Another of the requirements prescribed by The Clinical Laboratory Improvement Amendments relate to recordkeeping. It has clear guidelines on the nature of records to be preserved, the duration and extent to which they need to be, ways of storing and accessing them, and so on.