Chapter 1

Introduction to Quality
Assurance

“MeLS is the bridge to

invisible Universe!!”
Learning Objectives
Upon completion of this chapter the student will be able to:
 Define quality assurance

 List important terms in quality assurance

 Discuss the basic principles of quality assurance

 Describe the different components of quality assurance

 Describe the importance and necessity of quality assurance

 Classify types of diagnostic tests based on type of result obtained

and method of analysis

 Describe Accuracy and precision

 Cont…
 Describe indicator values of diagnostic tests including sensitivity,
specificity, test efficiency, predictive values.

 Calculate the following diagnostic values:

 Sensitivity

 Specificity

 Overall Test Efficiency

 Predictive values

 Use the diagnostic values to determine acceptability of test

methods
 Chapter Outline

 Definition of important terms in QA

 Essential components of quality system

 Aspects of QA

 Characteristics of QA

 Basic components of QA program

 Benefits of QA

 The purpose of health laboratory

Quality Assurance vs. Quality Control

Quality Assurance Quality Control

Activities to ensure process Activities to evaluate a

are adequate for a system to product or work result
Definition
achieve its objectives

• Establish standard • Analyze known QC

procedures for sample sample to determine if a

Examples collection test is valid

• Define criteria for • Decide if a sample is

acceptable samples acceptable for testing
 Errors in the clinical laboratories Cont…
 Sampling errors

 Analytical errors

 Clerical Errors

 Types of Diagnostic tests

 Accuracy and precision

 Indicators of values of diagnostic test

 Sensitivity

 Specificity

 Test Efficiency
What is Quality Assurance?
Definition

 What is “Quality?”

 The ability of a product or service to satisfy stated or

implied needs of a specific customer

 Quality Assurance (QA): development and

implementation of measures to assure reliable laboratory
service

 Achieved by conforming to established requirements and

standards.
Quality Assurance vs Quality Control
 Quality Assurance
 Planned and systematic activities to assure quality lab results

 A system that encompasses pre-analytical, analytical, and post-

analytical factors.

 Quality Control
A procedure, samples of control material and rules

 Designed to assess for analytic errors

 Part of Quality Assurance in the Analytic Stage

Definitions of Terms
 Pre-analytical: before testing

 Analytical: testing phase

 Post-analytical: after testing

 Clerical Errors: mistakes in writing results

 Sampling errors: mistakes in the specimen

 Accuracy : closeness of result to true result

 Precision : closeness of replicated results of the same

sample to each other
Definition of a Lab Quality System
 The organizational structure, responsibilities, processes,
procedures, and resources for implementing quality
management of the laboratory or testing site

 In other words… all activities which contribute to quality

of tests, directly or indirectly

 Laboratory quality system has 12 essential components

Why is the Quality System Important to Patient Sample
Testing?
 Ensures that quality is the foundation of everything we do

 Sets the standard for level of quality

 Meets/exceeds customer expectations

 Provides means to prevent, detect and correct problems

 Becomes the core of a monitoring, evaluation, & improvement

system

 Reduces costs

Even the simplest Rapid Test is not foolproof

 Essential of a Quality System

Organization Personnel Equipment

Purchasing & Process Control

Information
Quality Control & Management
Inventory
Specimen
Management

Documents & Occurrence

Management Assessment
Records

Process Customer Facilities &

Improvement Service Safety
 Quality System: Organization
To ensure total laboratory quality, organization needs to:
 Create quality policy and standards
 Secure sufficient resources
 Clearly define roles and accountability
 Cultivate a culture committed to quality
This component is closely linked to other components such
as personnel, equipment, process improvement, and
customer service.
A Culture
Clearly Defined Committed
Sufficient Roles to Quality
Quality Policy Resources & Accountability
& Standards
Quality System: Personnel
 To achieve total lab quality, we need to have the right
people on the right job.
 Develop job descriptions
 Provide orientation, training and continuing education
programs
 Assess employee competence and performance on each
procedure: initially, periodically

Human Resource Retention

Hiring
Planning

Performance
Training Supervision Management
Quality System: Equipment

Installation &
Selection Acquisition
Initial Calibration

Maintenance,
Troubleshooting Disposition
Service & Repair
Quality System: Purchasing and Inventory

Receiving and
Procurement Storage
inspection

Inventory Record
Management Keeping
Quality System: Process Control
 Directly relates to analysis in the laboratory.
 Testing requires having the correct specimen, which is
preserved properly until analysis occurs.
 Testing needs to follow the SOP for the instrument and
method
 QC specimens should be analyzed and evaluated based on
a set QC procedure.

Standard
Specimen Quality
Operating
Management Control
Procedures
 Quality System: Documents and Records
 Develop uniform format for each document type,
including standardized format
 Develop and implement a system for document revision,
approval and distribution
 Manage patient test records
 Maintain a document storage, retrieval system

Standardized Document
Forms Approval

Document Document Document

Distribution Storage/Retrieval Destruction
 Quality System: Information Management
 Managing incoming and outgoing information
 Standardization of information
 Confidentiality and privacy of patient information
 Competency in computer skill

Information
Flow

Data Collection Patient Privacy

& Computer
&
Management Confidentiality Skills
 Quality System: Occurrence Management
 An occurrence is a problem situation or error.
 A written procedure needs to be in place specifying what written
and oral information is collected to document an occurrence.
 Corrective actions and steps to take immediately to resolve a
problem or error.
The process of dealing with problems and errors as they occur
 Collect information systematically
 Establish a system to detect all problems
 Analyze the problem and take corrective action
 Keep records

Written
Procedures Corrective Occurrence Occurrence
or Addressing Actions Records Reporting
Errors
 Quality System: Assessment
 Conduct periodic assessment of the quality system and
laboratory operation
 Compare to internal and external benchmark
 Are requirements met? >>>> "Gap analysis"
 Gap analysis:
 Identify area of weakness in the lab
 Prioritize
 Develop a plan for addressing needs

External Internal Audit

Improvement
Quality or Self
Measures
Assessment Evaluation
 Quality System: Process Improvement
 A systematic and periodic approach to improving lab quality
 Design a study that results can be statistically measured if possible
 Use available information to select topic for study such as:
 Errors
 Internal audit
 External assessment
 Use a problem solving process: once a problem situation is
discovered, a plan is set in place to improve the system to prevent it
from happening again.

On-Going
Improvement
Data
Measures
Collection
 Quality System: Service and Satisfaction
 Actively seek information on both internal and external
satisfaction by doing:
 Customers surveys
 Focus group discussion

 Value and reward staff providing good service

 Rewards or recognition can be given to lab employees
who show improvement in customer service.

Monitoring
Process Rewards
Customer
Improvement
Satisfaction
Quality System: Facilities and Safety

Testing and
Storage Safety Practice
Areas

Safety
Procedures
& Records
Total Quality Management
 TQM addresses all areas of laboratory that most influence how a
laboratory service functions and

 Uses its resources to provide a quality and relevant service

 Successful TQM requires close collaboration between:

 Laboratory staff

 Those who request the laboratory tests

 Laboratory coordinator

 Medical officer

 Health Management team

 Purpose of Health Laboratory

 Laboratory services are a key component of quality health

care services

 Provide patient laboratory results

 Diagnostic

 Prognostic

 Monitor treatment

 Monitor disease outbreaks

Characteristics and Aspects of Quality Assurance
 There are 3 clear phases of the QA cycle for generating
useful patient results

Patient/Client Prep
Sample Collection
Personnel Competency
Reporting Test Evaluations
• Data and Lab
Management
• Safety
• Customer
Service Sample Receipt
and Accessioning

Record Keeping

Quality Control Sample Transport

Testing
 Basic Components of QA

 Internal quality assessment (IQA)

 External quality assessment (EQA)

 Standardization of processes and procedures (pre-analytic,

analytic and post-analytic phases)

 Management and Organization

Benefits of Quality Assurance

 Helps physicians, patients and clients

 Creates good reputation

 Motivates staff

 Is cost-effective

 Prevents complaints

 Builds trust
Three Stages Errors in clinical laboratory

 Pre-analytic

 Analytic

 Post-analytic

Errors in each stage should be prevented

 Pre-Analytic Errors

Process Potential Errors

Test Ordering Wrong test for patient, not legible, wrong

patient, delay

Specimen Requirements not met including patient ID,

Collection wrong tube, volume, poor sample or wrong
time.

Specimen Wrong transport conditions.

Handling
Pre-Analytic Error
Specimen Collection Errors
 Wrong:
 Patient ID
 Anticoagulant
 Volume
 Process
 Hemolysis

 IV contamination

 Prolonged tourniquet
Preventing and Detecting Pre-analytical Errors

 Check storage and room temperature

 Select an appropriate testing workspace

 Check inventory and expiration dates

 Review testing procedures

 Record pertinent information, and label test device

 Collect appropriate specimen

Analytic Errors
During testing phase errors may occur
Auto-monitoring
Error codes
Quality control result rejection signals
Data Error Flags: AMS Autolab
Code Causes of Error
CHECK Blank absorbance reading,
QC sample result or %CV
outside of limits

L Higher than upper linearity

limit
 Quality Control Material

 It is a process or system for monitoring the quality of

laboratory testing, and the accuracy and precision of
assay in order to provide reliable results

 Assess analytical phase

 Acceptance versus rejection of patient results

2 or 3 control materials
 Cont…

Use of QC materials:
Quality Control Tracking
 Known concentration of the
analyte
 Use 2 or more levels of
controls
 Controls are performed daily,
usually each shift of work.
 Controls performed before
patient samples are run and
released.
 Used to validate reliability of
the test system
QC Rules
 Guide acceptance or rejection of patient results based on
QC results
 95% confidence limits
 Westgard multi-rules may be used for detecting analytical
errors in automated methods
 Rules for rejection of patient results can be used to
recognize when random errors occur each day or
systematic errors occur such as a trend over time occur.
 These analytical errors decrease the accuracy of current
and future patient results unless the analytical problem is
resolved.
Preventing and Detecting Analytical Errors

 Perform and review Quality Control (QC)

 Follow safety precautions

 Conduct test according to written procedures

 Correctly interpret test results

Post-Analytic Errors
 Clerical errors

 Report illegible

 Report sent to the wrong location

 Information system not maintained

 Wrong reference ranges

 Not reporting in a timely manner

 Not maintaining confidentiality

Preventing and Detecting post-analytical Errors

 Re-check patient/client identifier

 Write legibly

 Clean up and dispose of contaminated waste

 Package EQA specimens for re-testing, if needed

Exercise: When Patient Result is Outside the Expected
Result

 A previously confirmed HIV-positive patient is being re-

tested by HIV Rapid Test and the test results are negative.
What could be the problem?
Troubleshooting: When Outside the Expected Result
 In order to troubleshoot why your patient result is outside the
expected result, it is important to take into consideration all factors
that effect the test result, from the time the test is ordered
 Let’s go through these:

Pre-analytic Analytic Post-analytic

Quality of collection Pipetting technique Timely resulting

Age of specimen Instrument problem Communication of
Specimen transport Clerical errors results to patient file
Specimen Analytical errors Record keeping
acceptability
Summary of QA
 Definitions in quality assurance

 The 12 essential components of quality system

 Aspects, characteristics and benefits of QA

 The purpose of a health laboratory

 Basic components of QA

 Types of errors in the clinical laboratory including

 Pre-analytical (sampling) errors

 Analytical errors, and

 Post-analytical (clerical) errors

Part 2:Types and indicator values of
Diagnostic tests

Chapter 1 Introduction to
Quality Assurance
Types of Diagnostic Test Results
 Qualitative: positive or negative
 Rapid HIV
 Others serological tests ( RPR, HCG)

 Semi-quantitative: give estimated results

 Urinalysis biochemical results
 ASO Titer
 Quantitative: numerical amount with unit
 WBC count
 CD4 count
 Hemoglobin (g/dl)
 Glucose (mg/dl)
 Accuracy and Precision
 Quality Control testing of samples and rules are used to
monitor both the precision and the accuracy of the assay
in order to provide reliable results.

 Accuracy: The closeness of the measured result to the

true value

 Precision: Reproducibility or closeness of results to each

other
Accuracy
Possible causes of inaccuracy:

 Lack of technologist skill

 Dirty cuvette for analysis

 Poor mixing

 Evaporation of controls

 Evaporation of standards

 Reagent deterioration

 Poor pipetting e.g. using the wrong type of pipette

Precision
Possible causes of imprecision
 Erratic (changing) temperature,
 Plugged dilutor or pipettor and
 problems with photometer or other detector

 The degree of fluctuation on repeated measurements is

indicative of the “precision” of the assay
Reliability of Measurement
Ability to maintain both precision and accuracy
Comparison of Accuracy and Precision
Precision Calculations
 Precision is determined by % coefficient of variation

 % CV = (standard deviation x 100%)/ mean

 %CV relates to % of Precision error

 Acceptable %CV < 5% (method dependent)

 Practice: calculate % CV given the following:

 Study was performed for 50 uL pipette with the following results:
Volumes obtained from gravimetric testing of distilled water.
Mean of volumes = 49.2 uL standard deviation = 3 uL.
 Accuracy Calculations
 Accuracy can be determined from bias:

 Calculating the difference between the measured and true

value

 |True value-mean| / True Value x 100%

 % Accuracy error should be < 5%

 Practice: calculate % accuracy error

 Study was performed for 50 uL pipette with the following results:
Volumes obtained from gravimetric testing of distilled water.
Mean of volumes = 49.2 uL standard deviation = 3 uL.
 Indicators of Diagnostic Tests

 Clinicians rely on the laboratory to provide accurate test

results
 Aid in diagnosis of disease

 Determine the patient’s prognosis

 Determine effectiveness of treatment

 Determine relative risk of contracting disease

 There are several statistical assessments that can be of

value in evaluating the diagnostic usefulness a test
 Cont…
 This process relates the patient’s test results with the
presence or absence of disease

 The ability of the screening test to differentiate between

those who are disease free from those who are affected is
called the test validity.

 All methods have an inherent amount of error present that

will affect test results

 No method is able to detect all persons with and without

disease accurately
Gathering Data for Diagnostic Usefulness
 How do you get results for diagnostic usefulness?

 Verify test result by reference or “gold standard” method

 ELISA method for rapid HIV antibodies

 Clinicians (physicians) may need to be involved to provide

diagnosis by alternate method.
 ECG (EKG) results for myocardial infarction

 Uterus size and imaging for pregnancy

Four Possible Outcomes to Test Results and Disease
Diagnosis
 True positive (TP)
 A positive test result for patients who have the disease

 True negative (TN)

 A negative test result for patients who do not have the disease

 False positive (FP)

 A positive test result for patients who do not have the disease

 False negative (FN)

 A negative test result for patients who do have the disease
Results of Disease Screening Testing: Possible
Outcome

A = true positive (TP) b = false-positive (FP)

C = false negative (FN) d = true negative (TN)
 Ideal situation - hypothetical
 All positive results would be true positive
 All negative results would be true negative
 Reality: false positive, false negative results
 Therefore, must utilize other statistics to evaluate tests for their
diagnostic value
Definition of Analytical Sensitivity and specificity
Sensitivity

 Ability of the test to detect small amounts of the analyte

 Test Sensitivity = Diagnostic Sensitivity
 The ability of the test to correctly identify those patients who
have the disease
 Percentage of patients who have a disease that test positive (true
positive)

 Before a test can be sensitive for disease detection it must

have analytical sensitivity

 Sensitivity = TP *100 OR A/A+C *100

TP + FN
Specificity Cont…
 Ability of the test to distinguish one analyte apart from similar
substances
 Test Specificity = Diagnostic Specificity
 The ability of a test to correctly identify those patients who do
not have the disease
 Percentage of patients who do not have disease that test
negative (true negative)
 Specificity = TN * 100 OR D/D+B*100
TN + FP
 Before a test can be specific for a disease it must have analytical
specificity
 No test is 100% sensitive and 100% specific
 Test Efficiency is the relationship between specificity and
sensitivity of a test.
 Predictive values
 Is the probability of the disease, given the result of the
test.
 Depend not only on sensitivity and specificity but also on
the prevalence of the disease.
Positive Predictive Value
 Is the probability of disease in patient with a positive
(abnormal) test result.
 Patients positive for the disease will test positive by the
test method.
 Positive Predictive Value = TP *100 OR A/A+B *100
TP + FP
 Cont…
Negative Predictive Value

 Is the probability of not having the disease when the test

result is negative (normal).

 These patients should test negative by the test method

designed to detect the disease

 NPV = TN *100 OR D/C+D *100

TN + FN

 Closer to 100%, the Better

 QUIZ

 Calculate the sensitivity, specificity and predictive values

for a rapid HIV method and diagnostic usefulness in
assessing HIV status.

 In testing 3000 patients, 1000 patients tested positive and

2000 patients tested negative for HIV. Among positives,
980 of those had a confirmed HIV antibody with ELISA
and among negatives, 30 of them actually had confirmed
HIV antibody with ELISA.
Solution
Construct 2x 2 table. Then fill in

Test Results Patients withHIV Patients without

Ab HIV Ab

PositiveHIV rapid (TP) (FP)

Negative HIV (FN) (TN)

rapid
Solution

n = 3000

Test Results Patients with HIV Patients without

Ab HIV Ab

Positive (n=1000) TP = 980 FP = 20

Negative (n= 2000) FN = 30 TN = 1970

Answer
 Sensitivity = TP X 100 = 980 X 100 = 97%
TP + FN 980 + 30
 Specificity = TN X 100= 1970 X 100 = 99%
TN + FP 1970 + 20
 PPV = TP X 100 = 980 X 100= 98%
TP + FP 980 + 20
 NPV = TN X 100 = 1970 X 100 = 98.5%
TN + FN 1970 + 30
 Does this test have good diagnostic indicator value?
Summary of QA Lecture 2

 Classification types of diagnostic tests based on type of

result obtained and method of analysis: qualitative,
semi-quantitative and quantitative

 Accuracy and precision calculated using mean, standard

deviation, %CV and % accuracy error/ bias.

 Diagnostic sensitivity, specificity, test efficiency,

predictive values defined, calculated and results
evaluated.