4-2
Operator’s Manual – OPTI CCA-TS2
4 CALIBRATION AND QUALITY CONTROL
4.2 QC Overview
The intent of a Quality Control program is to assure reliable patient values over the clinically
significant ranges for all the measured parameters. The program should involve the total process
of specimen collection, preparation and results analysis, reporting and interpretation, and the
training of personnel involved in all of these processes.
A Quality Control program for blood gas analysis includes the analysis of materials with known
values or ranges of expected values and the comparisons of the results from the analyzer with
these values. This program allows the analytic performance of a laboratory to be evaluated and
documented.
An effective Quality Control program should include:
•
evaluation of precision over the entire analytical range
•
an assessment of failure modes and their effects and means of management, throughout the
process
•
simple statistical calculations which provide a means of assessing precision
•
control charts or graphs which contain warning limits to assist the technical staff in the
evaluation of results
•
a clear set of guidelines to assist the staff in determining if patient results are acceptable
•
a clear set of corrective actions to be taken in “out-of-control” situations
4.3 Proficiency Testing
Proficiency testing complements the above Quality Control program and has become an integral
part of a complete laboratory Quality Assurance program. The analysis of unknown samples
demonstrates that your results are unbiased by previous experience and these samples more
closely reflect the testing of patient samples. Proficiency testing may also serve to expand
your Quality Control testing by providing samples with different levels of analytes than those
measured in the daily testing program.
The relative testing performance of each laboratory participating in the proficiency survey is
determined by comparing test results obtained from a significantly large group of laboratories
using the same or similar instrumentation.
CAUTION:
Use proficiency material that is clear.
Do not use material that contains dyes or emulsions.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has published a
protocol for establishing a quality assurance program. The Health Care Financing Administration
(HCFA) and the Clinical and Laboratory Standards Institute (CLSI formerly NCCLS) have
published standards for quality assurance in medical laboratories.