QUALITY CONTROL

MANAGEMENT
IX. Quality Control Management
 Definition
 Types of Control
 Laboratory Practices of Quality
Control
 Non-Analytical Quality
Control functions
 Quality monitoring and
assessment tools
 Proficiency testing
 - is designed to detect, reduce, and correct
deficiencies in a laboratory’s internal analytical process
prior to the release of patient’s results.
- to provide accurate and reliable result in the
minimum possible time. With minimum error.
As name suggest assurance meaning, we ensure to patient
and clinician that this test result done in a laboratory is
GRANTED 100% correct.

Quality control is just a branch of QA. Quality control,

require when we performing test while in quality assurance,
we are concerning with all the step from collecting of
sample up to dispatch of report.
Internal Quality Control External Quality Control
 Internal Quality Control
 We check, quality of work
internally in lab with
known sample.
Which is divided into :
1. Pre-analytical
2. Analytical
3. Post-analytical
 External Quality Control

 In this external agency

send us artificial sample,
we have to done proper
test in lab. Then we send
report to that
agency/organization for
giving assurance to our
lab.
 Pre-Analytic Analytic
 Patient identification  Right technique
 Labelling error  Right Control
 Correct vial  Instruments
 Correct volume  Exact Time
 Specimen transportation

Post-Analytic

 Right Reporting
 Right Record
 Right TAT
 Report give to right patient
 Accuracy – How much  Precision – How much
test results is close test result is closeness
towards the to each other same
original/actual value patient same test
several time.
ACCURACY PRECISION
 Control of test – There shall be written procedures for testing materials and
products at different stages of manufacture, describing the methods and
equipment to be used. The tests performed shall be recorded.
 Control of specimen – Ensure quality specimen management for accurate test
results.
 Control of reagent – Reagents shall be used and controlled according to
manufacturer’s recommendations.
- Reagents should be purchased from reputable, approved
suppliers and should be accompanied by the certificate of analysis, and the
material safety data sheet.
 Control of equipment – A written record of periodic function checks and
maintenance on each piece of equipment should be mandatory.
 Control of staff – Rational managerial function for effective production
process which ensures that set standards that reflect organization structure
constitute the terms for measuring performance to expedite the correction of
negative deviations.
 Important Consideration Factors :
 Patient preparation
 Patient identification
 Specimen acquisition
 Specimen handling
 Documentary system ( specimen recording and
result reporting)
 Monitoring – is essential to ensure that the intended project objective
can be achieved within the given time frame following the activities
as planned to be carried out by project personnel.
 Assessment – is a tool for examining laboratory performance and
comparing it to known standards or to performance of other
laboratories. Assessment may be internal, performed by the
laboratory’s own staff, or may be external, conducted by an external
group or agency outside the laboratory.
There are three commonly used EQA methods or processes;
1. Proficiency testing (PT) through a panel of unknown
specimens sent regularly to the laboratory by an
organizer. The laboratory reports the results back to the
organizer who will compare the test results with known
results and record a pass (all results concordant) or fail
(any discrepant results) for the PT.
2. Confirmation by sending a subset of isolates to a
reference laboratory for re-identification and
characterization.
3. Site visits conducted by inspection, certification, or
accreditation bodies.
 Proficiency testing - determines the performance of
individual laboratories for specific tests or measurements
and is used to monitor laboratories continuing
performance.
- is also called inter laboratory
comparison. As this term implies, proficiency testing
compares the measuring results obtained by different
laboratories.
 https://www.hn-proficiency.com/profi.htm
 https://m.youtube.com/watch?v=xYaMO3k1F9I
 https://www.ncbi.nlm.nih.gov/m/pubmed/10926
259
 https://www.slideshare.net/mobile/drgomibasar/
quality-control-in-clinical-laboratory
 https://www.clinlabnavigator.com/quality-
control.html
 https://www.slideshare.net/mobile/heli992/quali
ty-control-laboratory