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CAPULE, RMT
MARJORIE CINCO, RMT
Quality and safety are of the
utmost importance in a clinical
laboratory.
The Clinical Laboratory
Improvement Amendments
(CLIA 1988) was enacted in
response to concerns about
laboratory testing errors.
Included in the CLIA 1988
provisions are requirements for
quality control and quality
assessment and for the use of
proficiency testing.
The accuracy of laboratory
testing begins with the quality of
the specimen received.
QUALITY CONTROL
• Set of laboratory procedures designed to ensure that a test method is working properly and
that the results meet the diagnostic needs of a physician. Includes testing control samples,
charting the results, and analyzing them statistically.
Failing to identify a patient Equipment malfunctions
before phlebotomy Work environment( e.g.,
disconnect between lab and
Missing blood vessel during patients)
phlebotomy Staffing problems (e.g., chronic
Errors with collection tubes shortages)
Teamwork factors ( e.g., poor
Errors with transportation communication between shifts,
system departmental silos)
Errors with data entry Deemphasis on incident reports
Active error occurs at the interface Latent error are related to the design
between a healthcare worker and patient of a laboratory
Formal patient safety training, including discussion of
disconnect between lab personnel and patient
Non-
analytical Quality control
factors
Established Lab policies- lab policies should
be included in a reference manual
Lab procedure manual-should be updated
Proper procedures for specimen collection
and storage-correct storage of specimen is
critical to obtaining accurate results
Preventive maintenance equipment- failure to
monitor equipment regularly can lead to
expensive repairs
Appropriate methodology-when new
methods are introduced, it is important to
check its accuracy and variability
Established quality control and quality
assessment techniques-
Accuracy in reporting results
System of ensuring accuracy and precision in
the laboratory
Routine technical activities that must be
included during each assay run to verify that
the test is working properly
Sensitivity
◦ ability of the test to determine the
lowest concentration of the analyte.
Specificity
◦ ability of the test to determine only
the analyte of interest
Accuracy
◦ Closeness with which measured values
agree with the true value.
◦ Aka reliability
Precision
◦ Closeness of results with each other.
◦ Aka reproducibility
Practicability
◦ Degree by which a method is easily
repeated
Reliability
◦ Ability of analytical method to
maintain accuracy and precision.
Diagnostic Sensitivity
◦ ability of a test to detect a given disease
or condition
Diagnostic Specificity
◦ ability of a test to correctly identify the
absence of a given disease or
condition
Intralab Quality Control
(Internal QC)
◦ Involves the analyses of control
samples together with the patient
specimens.