CLINICAL LAB SCIENEC

CHAPTER 10: QUALITY ASSURANCE 233
in test performance. Failure to achieve acceptable results may lead to prohibiting
the laboratory from performing certain tests or, in extreme cases
and with repeated failure, could result in closing of the laboratory. Quality
systems in some cases replaced quality assessment and are used to evaluate
policies, methods of performance, and processes necessary to provide for
quality results in tests performed.
All of these programs, by whatever moniker they are known, have a common
goal. The desired result is that all laboratories adopt sufficient policies and
systems to ensure accurate and timely laboratory results, to provide for and
protect the health of the patient.
Quality Improvement
Quality improvement is a term that some facilities use to describe their ongoing
efforts to improve the quality and level of services provided to patients
and clients. With the increasing importance of this concept not only in the
health care environment but also in industrial and business applications, the
term continuous quality improvement (CQI) now is often used to describe
ongoing measurable changes that are deemed improvements. The medical
laboratory with quality control programs makes it easy to statistically document
improvement. In the case where there is a decline in expected results,
there are problems that need addressing. Some aspects of quality assurance
include components that are not statistically measurable but that show a
qualitatively positive condition. The use of competent personnel, usually
determined by hiring only certified, registered or licensed workers, should
be a main concern of a medical facility. Risk management and utilization
reviews are other areas where hospitals may effect positive results in quality
assurance programs. A quality management system is another approach
for the laboratory to focus on providing consistently accurate cost-effective
results that positively benefit the patient. The box on the next page lists key
components in any quality assurance program for the clinical laboratory.
Effective Quality Assurance Programs
Certain common factors are involved in an effective quality assurance program.
Although all aspects of the functions of the clinical laboratory and the health
care facility as a whole should be considered, QC is the basic component of a
quality assurance program that gains the most attention in the laboratory. This
is true because no patient results can be released unless certain parameters of QC
have been achieved for each “run” of samples.
Spectrophotometry for QC
Both patient specimens and QC samples are treated in the same manner. Colorimetric
end-point determinations use a principle that measures the intensity
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