Clinical Laboratory - Fundamentals

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Point-of-Care (POC) Testing

Testing Outside the Laboratory

"Bedside" or "point-of-care" (POC) testing occurs in close proximity to the patient both in time and distance. For example, a finger-stick procedure can be done to obtain a drop of blood for use in a hand-held glucometer instrument to obtain a blood glucose test result for monitoring of control of diabetes mellitus. The patient may learn to perform this test (and likely performs it better than health care providers).

The specimens obtained and the instrumentation and the training of persons performing the POC test may not be as rigorously controlled as in a certified laboratory employing technicians who are professionals. However, the test results for POC situations may not require the degree of accuracy and precision of test results as specimens sent to the laboratory.

Governmental regulation of POC testing in the U.S. is based upon "CLIA" (Clinical Laboratory Improvement Amendments). In general, a proper laboratory (clinical laboratory) has obtained certification of its conformance to standards that help insure proper performance and reporting of tests. In general, "CLIA waived" tests are those that "(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) "the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly." (CFR§263a)

The most common POC testing errors include:

  • Operator incompetence
  • Nonadherence to test procedures
  • Use of uncontrolled reagents and equipment

Problems that amplify POC testing error for the patient include: incoherent regulation, rapid availability of results, and immediate therapeutic implications.

A quality control methodology appropriate to the POC technology must be employed.

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