DIANE CAMILLE A.

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.

This quality depends on how a

specimen was collected, transported
and process.
QUALITY ASSESSMENT( previously called QUALITY ASSURANCE)
• Systemic laboratory program, encompassing preanalytical, analytical, and postanalytical
factors, that monitors excessive variation in specimen acceptability, test methodologies,
instruments, reagents and quality control.

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
before phlebotomy
 Missing blood vessel during
phlebotomy
 Errors with collection tubes
 Errors with transportation
system
 Errors with data entry
Active error occurs at the interface
between a healthcare worker and patient
 Equipment malfunctions
 Work environment( e.g.,
disconnect between lab and
patients)
 Staffing problems (e.g., chronic
shortages)
 Teamwork factors ( e.g., poor
communication between shifts,
departmental silos)
 Deemphasis on incident reports
Latent error are related to the design
of a laboratory
Formal patient safety training, including discussion of
disconnect between lab personnel and patient

Enhanced communication between patients and laboratory staff

and providers directly caring for patients

Quality improvement projects that involve patient outcomes

data and feedback of this data to laboratory staff.
 The total testing process (TPP) serves as the
primary point of reference for focusing on
quality in the clinical laboratory. TTP is
defined by activities in 3 phases:
a. preanalytical,
b. analytical
c. postanalytical.

 Currently, the majority of lab errors

preanalytical and postanalytical phases.
 PREANALYTICAL ANALYTICAL POSTANALYTICAL

• Specimen obtained • Wrong assay • Verbal reporting of

from the wrong performed results
patient • Oversight of • Laboratory
instrument flags information system
• Blood specimen incompatibility error
collected in the
wrong order
• Incorrect labeling
 To reduce and
potentially eliminate Quality
laboratory errors a assessment
quality assessment system
program is mandated
into 2 parts

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.

Interlab Quality Control

(External QC)
◦ Proficiency testing programs