OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 73 / 271

4-2 Operator’s Manual – OPTI CCA-TS
4 CALIBRATION AND QUALITY CONTROL
• 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.
4.4 Calibration Verification
Calibration verification allows for the validation of the blood gas analyzer’s ability to recover
known values at various points within the reportable range of all parameters and may be required
by various regulatory agencies.
The OPTI CCA-TS Analyte Section, included in the back section of this manual, provides
precision and recovery data for all the measured parameters in the ranges that are usually
encountered in the diagnostic testing of patients.
A calibration verification kit is available from OPTI Medical for all parameters except tHb and
SO
2
. For calibration verification of tHb and SO
2
, OPTI Medical recommends testing whole blood
against a reference analyzer.
Should a laboratory wish to perform a calibration verification for measurement values outside
the broad range, OPTI Medical Systems suggests tonometry of whole blood for P O
2
and P CO
2
,
correlation against flame photometry for electrolytes, correlation against cyanmethemoglobin
method for tHb, and blood pH correlation with conventional blood gas analyzers.
For calibration verification of glucose, OPTI Medical Systems recommends the hexokinase