Quality Control Management

CHAPTER IX
Quality control
– is the sum of all those activities in which the laboratory is
engaged to ensure that the information generated is correct.
- It includes all aspects of lab activities that affect results such
as the choice of methods, education or personnel, handling of
specimen and reporting of results
- Quality control programs vary with the product, available
expertise, and the limitation of resources. In he case of
hospital laboratories, the product is test data; standards of
quality include timeliness of performance, accuracy of results,
and effectiveness of communication.
- Establishing and maintaining of good program may sound
expensive, but it pays off in terms of efficiency, higher staff
morale and productivity and greater patient acceptance
 Division of lab practices on quality control

Lab practices on quality control can be divided into 3 major divisions:

1. Preventive – are those activities done prior to the examination of
specimen or sample and are intended to establish systems
conducive to accuracy in analytic systems such as preventive
maintenance and calibration of instruments, testing of media,
orientation and training of personnel.
2. Assessment – are those activities done during the testing to
determine whether the test systems are performing correctly such
as the use of standards and controls and maintenance of control
charts.
3. Corrective – are those activities done when error or possible error
is detected to correct the system such as equipment trouble
shooting, recalibration of instruments, etc.

* Numbers 1 & 2 are more emphasized because the information must

be timely to be useful
 Control of tests

Selection of tests should be based on four factors:

1. The result produced should be useful in a time-
reference frame.
2. The procedure should be feasible for the particular
laboratory.
3. The value produced should be accepted to
clinicians
4. The reports forwarded to clinicians should be
uniform. A good report should be compact,
consistent in terminology and format.
 The assessment factors for method evaluation
and selection

1. Precision – maybe defined as the extent to which measurements are

repeated. The assessment is made by replicate analysis of a biological
control containing stable and measurable amounts of the appropriate
constituents(s) and expressed as the magnitude of error in the method.
2. Accuracy – maybe defined as the extent to which measurement approach
the “true” quantity of the constituent being analyzed. Measurement must
be conducted on a reference material having a known composition and
concentration.
3. Sensitivity – maybe defined as either
- the extent to which the minimum amount of constituent can be
measured of
- the reliability of a test to be positive in the presence of the disease it was
design to detect
4. Specificity - maybe defined as either
- the extent to which measurements are those of single constituent or
- the reliability of a test to be negative in the absence of a disease it was
design to detect.
 Control of specimen

Collection of proper specimens is extremely important.

Those involved in blood collection know the proper
way to collect a specimen and the correct details
concerning name of tests, containers and labels, time
delivery, preparation of patients, preservation or
anticoagulant, handling or storage of specimen
before delivery to lab and special instruction.

A good way to assure proper specimen is the

distribution of specimen collection manual to those
involved in collection.
 Control of reagents and supplies

Reagent should be purchased only from reliable suppliers.

But only the quantity you use in a reasonable time, date it
upon receipt and again when opened for use.

Guidelines in the use of reagent kits:

1. It should give consistent results form day to day and in
patient samples with low, normal and elevated values.
2. The manufacturer’s data must be complete: statement
of principle, description or test performance and
calculation, data on precision, accuracy and stability of
reagents.
3. Cheaper than manual methods
4. Every employee should be competent to use the kit.
The reliability of reagents and materials can never be taken
for granted, and they must periodically verified to be
without contamination or deterioration.
In the microbiology laboratory and blood bank where
testing is largely the identification of unknowns
(qualitative), frequent assessment of reagents and
material quality provide the only means of assuring
reliable test results.
In the clinical chemistry and hematology laboratories,
where testing is largely quantitative of specifically
requested constituents, biological controls containing the
same constituents provide an alternative one step-
method for assuring total integrity of test performance.
 Control of equipments

There is usually some variation in the performance of equipment. The

error can be exaggerated if the equipment is improperly calibrated
of malfunctioning.

Suggestions in the control of equipment:

1. Use National Bureau of Standard equivalent thermometers for
monitoring water baths, heating blocks, incubators, refrigerators
and similar equipment.
2. Verify the reliability of analytical balances and weights by
inspection using National Bureau of Standards class S weights.
3. Verify the speed of centrifuges regularly using quality tachometer.
4. Check all water used in testing for its pH, purity and any foreign
substance that could affect test results.
 Control of staff

The work of any laboratory can be as good as the quality of

its workers. Therefore, the laboratory should seek to
attract and keep only the best employees. Three
important ingredients are:
1. Maintaining an atmosphere of professional challenge
2. Offering fair wages
3. Providing a means for obtaining continuing education

* To be sure the staff is working at maximum efficiency-

neither underutilized nor overworked – a system of
workload reporting is necessary
 Non-analytical quality control functions

1. Physician request – all requests made by the attending physician should be stated
clearly.
2. Request specification
a. time specifications:
- routine – response for test requests within 24 hours, but may take longer for
some procedures as culture
- today – response and test results within 8 hours
- stat – response within 10 min, no delay in test performance
- specific time – specimen collection within +/-5 min time designated, no
delay in test performance
b. condition specifications: pre-op, pre-admissions, etc.
c. patient category specifications: “in-patient”, “out-patient” etc.

3. Worksheets – they are used most commonly for recording test results and other
informative data not usually reported. The are particularly well suited to most
hospital chemistry and hematology laboratories.
4. Patient identification – the customary practice is to attach
identification band to all patients. The exact matching of all
patient information appearing on the request with that on the
bracelet should be done.
5. Distribution of test results – in most instances, the recipients
of the laboratory data include:
a. nursing station personnel (patient chart attachment)
b. hospital business office (patient bills)
c. attending physician (personnel use)
d. laboratory clerical section (department record)
6. Specimen reassignments – reassigning specimens to a
reference laboratory is considered only after the capabilities
and cost of in-house performance are determined. Factors
to be considered in the selection of reference laboratories:
6.a. range of available services (brochure listing)
b. quality (staff, facilities, etc)
c. location (transportation mode)
d. turn-around-time (periodic review)
e. fee schedule (comparison with laboratories of
comparable structure)
 Quality control charts

Control charts assist in monitoring avoidable and

unavoidable error. The usual format includes an
ordinate for entering the range of values over which
the control results are most likely to occur and
abscissa for recording the time intervals at which the
control results are obtained. A pair of horizontal
lines are included to correspond with the permitted
limits (values) of unavoidable error
 Quality control charts are used in:

1. Identifying the sporadic errors that are generally

caused by the analyst – control values falling out of
acceptable range are rejected as avoidable errors that
must be identified and corrected. All unknown tests
belonging to this batch are repeated. In the absence of
avoidable error, 95% of analysis should be within
control values.
2. Determining subtle problems manifested by trends and
shifts – a trend occurs when control values continue to
increase or decrease over consecutive days, suggesting
reagent or equipment alterations. A shift is formed by
control values that maintain a constant level on one
side of the mean line, suggesting an incorrectly
prepared reagent.
 Proficiency testing

The major thrust or proficiency testing is to improve the quality

of laboratory services by setting forth standards of
performance that must be met or exceeded.

A reference laboratory is one of the recognized competence,

which examines in detail proficiency testing samples or other
materials to authenticate identification, content or titer.
The laboratory is specially qualified by experience, interest and
accepted expertise.
The analysis are done carefully and are performed in replicate.
The mean test results values are considered to approach “true
values” and serve as a measurement of the accuracy of test
results obtained by the participating laboratories.
A referee laboratory is one recognized competence and
a general participant in the proficiency program.
It uses the same time schedule and performs the
examination under the same condition as all other
general participants.
The identity of these laboratories is not revealed.
Their test results are used as a measure of quality of
the proficiency testing specimen and with the
reference laboratories’ results, are influencing factors
in deciding the acceptable range of results.
A participating laboratory is enrolled in a proficiency
program and adheres to testing all proficiency
specimens in the identical manner employed for
patient testing.
Replicate analysis are avoided and duplicate assays are
performed only when duplicate testing is a
laboratory routine.
Requirements for participation, frequency of specimen
shipments, time allotted for returning results and
methods of grading are determined by the
organization conducting the program.
the end