QUALITY

CONTROL
LEARNING OBJECTIVES
 Upon the completion of this chapter, students will be able to: -
Define quality control
Explain the types of quality control
Know how to calculate and interpret specificity, sensitivity, PPV,
NPV
DEFINITION
 The term quality control covers that part of quality assurance, which primarily concerns the
control of errors in the performance of tests and verification of test results.
 QC must be practical, achievable, affordable, and above all continuous.
 It refers to operational procedures and the activities needed to maintain the quality of results.
 Quality control involves the use of a variety of methods or techniques to reduce variance in
analytical procedures.
QUALITY CONTROL SYSTEM
 Quality control system ensures that results fall within certain limits.
 Use of either of the limits is dependent on:
– Lab facility- instrument, infrastructure
– Training /experience of lab personnel
– Quality of reagents and other materials
PURPOSE
1. Monitoring analytical process
2. Monitoring analytical errors, and
3. Correct results of analysis
TYPES OF QC
 Quality control is one of the elements of QA.
 It is of two types:

1. Internal quality control - intra-laboratory QC.

 This is a quality control program which is carried out in the lab. It encompasses all measures
taken and technical performances within an individual laboratory.
 It is mainly based on the use of control samples like pooled serum prepared for such purpose.

Purpose: To ensure tests are performed reliably and reported correctly.

 Effective QC system detects error at an early stage before they lead to incorrect test results.
 Laboratory personnel need to be aware of the errors that can occur when collecting and
processing specimens, testing specimens, and reporting test results.
TYPES OF QC
2. External QC (inter laboratory QC)
 This has very similar application with external quality assessment scheme and is commonly
abbreviated EQA.
 This involves observation of variance in results when the same material is analyzed in
different laboratories.
 Two principal forms are available:

I) Survey program (proficiency survey)- is very identical with EQA and involves very large
number of laboratories (international, continental, national, regional).
II) Regional QC- involves laboratories in a specific locality or specific geographic area.
CONTROLS
 Controls are used for different purposes:

1. Expected values are known by the analyst: this helps to know whether analytical system is
reliable or not.
2. Expected value is unknown by the analyst: this is important to obtain independent
assessment of all the procedures performed in the lab and also to assess the quality of the
analyst.
 Example of this type of control is commercial controls (value is intentionally hidden for
quality control purpose), specimens diluted with certain known additives.
EXTERNAL QUALITY
ASSESSMENT (EQA)
 Although steps are taken in a laboratory to ensure test results are reliable, a system of
assessing a laboratory’s ability to do this to a satisfactory standard is recommended, i.e. an
external quality assessment (EQA) scheme.
 EQA must never be a substitute for internal QC because it can only assess past performance
when test results have already been reported and acted on.
 It is a system of evaluating a lab ability to produce reliable results to a satisfactory standard
from an outside laboratory.
AIMS OF EQA
 The aims of EQA is to:
– Identify problems
– Eliminate (minimize) errors
– Identify best practice
– Maintain and rise standards of lab practices.
 And not to: -
– Make laboratories compete with each other
– Punish poor laboratories
THANK YOU
PREPARED BY
ABDULHALIM MOHAMED
ZANZIBAR UNIVERSITY