CLINICAL LAB SCIENEC

232
ESSENTIALS OF CLINICAL LABORATORY SCIENCE
Introduction
Many components and departments of a modern health care facility are
required to have programs to provide continuous monitoring of all facility
processes and systems. The laboratory in particular is involved with providing
documentation of effective and accurate functioning in the provision of
diagnostic testing. The common term quality control (QC) and the activities
involved in quality control programs were thought for many years to be sufficient
for providing for accuracy in the laboratory. Eventually it was realized
that QC provides for precision, or reproducibility, whereas proficiency testing
(PT) is now used for monitoring accuracy, although the two go hand in hand.
Quality assurance (QA) became the new buzzword, and the Clinical Laboratory
Improvement Amendments (CLIA) required programs to ensure quality
results through systematic procedures to improve the quality of laboratory
services. Operational changes were called for. Although larger organizations
already had a version of QA as mandated by their accreditation agencies,
smaller laboratories and physicians’ office laboratories (POLs) began to
scramble to initiate a QA program or to improve on what they had and to
document their activities for accreditation site visitors to review.
Quality Assurance in the Medical Laboratory
Quality assurance is a general term that includes many components. While QC
is of the utmost importance in the medical laboratory, it is by no means the only
aspect of quality assurance. Quality assurance may be thought of as the global
aspect of an institution, and QC for the laboratory is a vital piece of the institution’s
quality assurance program. Quality assurance is a focus of The Joint
Commission (TJC; formerly, Joint Commission on Accreditation of Healthcare
Organizations [JCAHO]) and federal requirements under the CLIA 88 regulations.
Quality assurance, also sometimes known as quality assessment, among
other terms, includes QC and PT programs.
Personnel Qualifications and Proficiency Testing
Some personnel, depending on the state in which they work or the facility in
which they are employed, are required to meet certain standards, although
there is a great disparity between requirements for education and training
in various institutions. Continuing and inservice education are a must, with
facilities often required to provide for both types of education and training.
To further ensure accuracy other than by having only qualified, trained personnel,
PT may also be required to ensure accuracy. Certain agencies provide
programs where blind samples of assayed specimens that have been tested
multiple times by more than one method to establish ranges for acceptable
performance are prepared for periodic testing. The blind samples are then
sent to subscribing laboratories. Results submitted from participating clinical
laboratories must fall within the established ranges to document accuracy
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