Introduction to Quality

Assurance (QA) In
Medical Laboratory

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 Learning Objectives
Upon completion of course, the student will be able to:
oDesign and implement quality enhancement plan to ensure the
delivery of quality laboratory services.
oSetup specification for laboratory equipment and other logistics
o Evaluate test results and methods; develop and update standard
operating procedures to ensure the accuracy of tests.
oPromote and apply laboratory safety practices and standard
operating procedures.
oApply international Medical laboratory quality standards.
o Confirm and verify laboratory test results through in-depth
knowledge of scientific methods, principles and instrumentation
theory.
o Monitor and maintain proper functioning of medical laboratory
equipment and reagents.

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Learning Outcomes:
To meet the above module objective, the student will be
expected to:
 Apply laboratory quality assurance system
 Identify different types of quality controls
 Evaluate and select different laboratory methods
 Maintain specimen integrity in the laboratory
 Perform quality control test
 Apply standard operating procedure
 Update SOPs regularly
 Understand safety need of laboratory

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Learning Outcomes:
√ Identify laboratory physical arrangement obstacles that
affects working environment
√ Apply universal safety precaution in medical laboratory
√ Understand medical laboratory quality standards
√ Apply quality control to monitor and maintain proper
functioning of medical laboratory equipment and reagents
√ Describe material resource and financial management
√ Prepare specification of equipment and materials
inventory

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 Assessment method
Formative assessment
- Quizzes 20 %
- Assignment/ presentation 20 %
- Attendance and class activity ------ 10%

Mid exam-----------------------------------30%
• Summative Assessment
- Final exam 30%

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References
1. Greg Cooper, CLS, MHA , Basic Lessons in Laboratory Quality Control, Bio-Rad Laboratories, 2008.
2. The Handbook for Quality Management:A Complete Guide to Operational Excellence:Second Edition
3. Murali Dharan, Total quality control in clinical laboratory, 1977Lawrence A. Kaplan, Clinical Chemistry, theory,
analysis, correlation, Fourth edition, Mosby Inc, 2003.
4. Lawrence Kaplan, Clinical Chemistry, theory, analysis, correlation, Fourth edition, Mosby Inc. 2003.
5. CLSI. (2011). Laboratory quality control based on risk management; approved guideline (Vol. 31, No. 18). CLSI
document EP23-A. Wayne: Clinical and Laboratory Standards Institute.
6. Westgard, James O. (2010). Basic QC practices (3nd ed.). Madison: Westgard QC, Inc.
7. Current Laboratory Practice Series (2009) Laboratory Quality Management System Training Toolkit [CD-ROM]. World Health
Organization
8. Westgard QC. www.westgard.com [Website]
9. Cheesbrough Monica, Medical Laboratory manual for Tropical countries, Cambridge university, 2000 (Vol. 1).
10. Endris Mokonnen, Health Laboratory Management and quality assurance lecture note, carter centre, the Ethiopian public
heath initiative, 2004.

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 Definitions of Terms
•Quality assurance (QA) is the development and
implementation of measures to assure reliable lab service
•Quality assurance includes the process of planning for
quality, and setting & communicating of standards. (ISO)
• QA:- The formal and systematic exercise of identifying
problems in the care delivery, designing activities to
overcome these problems and carrying out follow up steps to
ensure that no new problems have been introduced and that
corrective actions have been effective
•Includes IQC , EQA
•QA is designed to detect, control, and hopefully prevent
the occurrence of errors.

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Definitions of Terms…
Assurance: The act of giving confidence, the
state of being certain or the act of making
certain.
•Quality Assurance(QA):- is a planned and
systematic activities to assure quality lab
results

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 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/ value
• Precision : closeness of replicated results of the same
sample to each other
- The amount of variation in the measurements

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PRINCIPLES OF QUALITY ASSURANCE
Focus on the needs of the users (Customer focused)- both
internal and external
Focus on processes to increase the productivity of work
Use data to improve services
Use teams to improve quality
Improve communication
Benchmark for process improvement
Re-engineer where needed

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 Objectives of QA
•To provide assurance for both the lab staff and
clinician that the data provided are relevant and
reliable.
•To improve trust in the laboratory result.
•To solve problems that limit the improvement of
laboratory performance
•To ensure the reliability of instrument and equipment
performance

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 Total Quality Management

Is Creating an organizational culture committed to the

continuous improvement of skills, teamwork, processes,
product and services quality and customer satisfaction
 Describes a management approach to long-term success
through customer satisfaction.
 Is a method by which management and employees can
become involved in the continuous improvement of the
production of goods and services.
 It is a combination of quality and management tools aimed
at increasing business and reducing losses due to wasteful
practices.

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 Seven Basic TQM Tools

Source: Tenner/DeToro, TOTAL QUALITY MANAGEMENT (figure 9.2 from page 113). © 1992 by Addison-Wesley
Publishing Company, Inc. Reprinted by permission of Pearson Education, Inc.
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 Seven Basic TQM or
Statistical Process Control (SPC) Tools:
• Flowchart
• A graphic display of a sequence of activities and decisions.
• Cause-and-Effect Analysis
• The fishbone diagram helps visualize important cause-and-effect
relationships
• Pareto Analysis (80/20 Analysis)
• A bar chart indicating which problem needs the most
attention. 20% of the sources cause 80% of the problem
• used to display categories of problems graphically so they
can be properly prioritized

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• Histogram
• A bar chart indicating deviations from a standard bell-
shaped curve.

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• Control Chart

• Visual aid showing acceptable and unacceptable variations

from the norm for repetitive operations
• Control chart is the best tool for monitoring the
performance of a process. These types of charts can
be used for monitoring any processes related to
function of the organization.

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Fish Bone/Honeycomb
Systematically analyzes cause and effect relationships

Harmening. Laboratory management; principles and processes.

2007
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Seven Basic TQM Tools…
• Scatter Diagram
• A diagram that plots relationships between two
variables.
• It detects correlations between two variables. Ex,
maternal cigarette smoking during pregnancy versus
birth weight
• Preventive maintenance vs Equipment downtime

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• Run Chart
• The run chart displays an average line taken from the
data and will have data points and lines connecting
them
• A trend chart for tracking a variable over time.
EX. Trend malaria infection over time in line graph.

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What Is “Quality?”
oThe ability of a product or service to satisfy stated
or implied needs of a specific customer
o “Exceeding or Conformance to requirements”.
o“According to ISO 9001:2008, quality is defined as
“the degree to which a set of inherent
characteristics fulfills requirements”.

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What Is “Quality?”…
Definition: conformance to the specifications
 means "degree of excellence" implies "comparison" is not
absolute
The quality is thus checked by comparison between the
output and the specifications.
methods: -
- Standardization;
- Statistical quality control;
- Inspection.

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Quality….
Quality of healthcare is about
• Achieving positive health outcomes
• Limiting the negative consequences of health care
• Complying with scientific recommendations
• Addressing beneficiaries’ needs and expectations

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Quality …Achieved by:
•Determining the customer precise requirements
•Ensuring that all resources, facilities and skills required to
meet the customer requirements are available.
•Planning, documenting and implementing management
procedures to ensure that the customer’s requirements are
met consistently.
•Ensuring that staff are trained & provided the resources to do
the job Ensuring that all activities are taken correctly.
•Ensuring that effective corrective action is taken
•Undertaking regular reviews and audits of all process
•Total and organized commitment from management.

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Quality Assurance (QA)vs Quality
Control(QC)…
•Quality Control(QC) : is a procedure, samples of control
material and rules
- Designed to assess/detect for analytic errors
- Part of QA in the Analytic Stage
-QC in the medical laboratory is a statistical process used to
monitor and evaluate the analytical process that produces
patient results.
-QC: The observation techniques and activities used to fulfill
requirements for quality.
-QC samples are “known” while patient samples are
“unknown

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Definition of a Lab Quality
System(LQS)
oThe organizational structure, responsibilities,
processes, procedures, and resources for
implementing quality management of the laboratory
o In other words… all activities which contribute to
quality of tests, directly or indirectly
What is it? QS
o All operations of the lab e.g. Method selection ,SOPs
development ,Specimen Mgt ,QC ,EQA , Use of an up-to-date information,
Technical procedure manuals, maintenance schedules, calibrations
oLab quality system has 12 essential components

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 Essential of a Quality System

Organization Personnel Equipment

Process
Purchasing
Control Information
Quality
& Inventory Control &
Management
Specimen
Management

Documents Occurrence
Management Assessment
& Records

Process Customer Facilities &

Improvement Service Safety

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 To ensure total laboratory
quality, organization needs

Quality Policy Sufficient

& Standards Resources

Clearly Defined A Culture

Roles Committed
& Accountability to Quality

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 Quality System
Personnel
-Develop job descriptions (duties & responsibilities)
-Provide orientation, training & continuing education programs.
-Assess employee competence & performance
-Then, - identify retaining needs - Record all activities

Human Resource Hiring Retention

Planning

Performance
Training Supervision Management

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Quality System
Documents and Records

Standardized Document Document

Forms Approval Distribution

Document Document
Storage/Retrieval Destruction

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 Quality System Essential:
Assessment--Also called as "self-
evaluation“---GAP Analysis

External
Quality
Assessment

Internal Audit
Improvement
or Self
Measures
Evaluation

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Characteristics and Aspects of
QA
Characteristics Of QA

• It is comprehensive

• It is regular activity (Frequent action to detect and correct errors)

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Characteristics and Aspects
of QA …
Aspects of QA: has three aspects

A. Preventive aspect : to prevent errors :. How? proper method

selection, careful laboratory design, competent human power, well
designed SOPs and effective maintenance program.

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 Characteristics and Aspects of QA…
B. Assessment aspect :

- To monitor the analytical process; i.e type and amount of errors.

- This is achieved by, running of QC materials, performing instrument

function checks and participating in proficiency testing program.

C. Corrective aspect :
- To correct errors after discovery.
- To attain this communication with users, reviews of work and
troubleshooting program

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 The Quality Assurance Cycle

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

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 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

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Basic Components of QA…
External QA : objectively checking the laboratory’s results
and performance in general by means of an external agency
or personnel.
EQA is accomplished by implementing the following, either
alone or usually combined: through proficiency testing,
onsite evaluation of all processes and rechecking or
retesting samples.
A well functioning internal assurance scheme results in
good performance in external Quality Assessment.

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 Benefits of QA

• Early detection of errors.

• Meeting the requirements for accreditation
agencies.
• Improvement of precision and accuracy to best
possible reach.
• Helps physicians, patients and clients
• Creates good reputation
• Motivates staff-to work better
• Builds trust

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Errors in the clinical laboratories
Pre-Analytic Errors
Process Potential Errors

Test Ordering Wrong test for patient, not legible, wrong

patient, delay
Specimen Requirements not met including patient
Collection ID, wrong tube, volume, poor sample or
wrong time, haemolysis/Prolonged
tourniquet application
Specimen Wrong transport conditions, /vigorous
Handling shaking
Delay sample
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 Preventing and Detecting Pre-
Analytic /Before Testing Errors
• Check storage and room temperature

• Select an appropriate testing workspace

• Check expiration dates

• Review testing procedures

• Record pertinent information, and label test device

• Collect appropriate specimen

• Avoid vigorous shaking of specimens-Avoid hemolysis

• -Make adequate measurement

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Analytic Errors
During testing phase errors may occur
◦ Auto-monitoring : Automated instruments provide monitoring for analytical
errors.
◦ Error codes
◦ Quality control result rejection signals: Do not forget the meaning of the
indicator
◦ Quality control samples may be analyzed along with patient samples to
determine if analytic errors have occurred.

Analytical errors are of two types

A. Indeterminate (random error)

B. Determinate (systematic error)

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 A. Indeterminate (random errors)
• Are errors that occur with out prediction or regularity
• Can not be easily determined
• It is an error which varies in un-expectable manner in
magnitude & sign
• Any positive or negative deviation away from the calculated
mean is defined as random error.
• May occur as a result of fluctuations in temp ,Pipetting,
carelessness, inattention and short cuts in procedures etc.

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A. Indeterminate (random errors)
…

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A. Indeterminate (random errors)…

Caused by uncontrollable variables, which can

not be defined/eliminated.
 Instrument errors - failure to calibrate, power
fluctuations, variation in temperature, minute
difference in the wave length of the measurements
etc. Can be corrected by calibration or proper
instrumentation maintenance.
 Causes data to be scattered more or less
symmetrically around a mean value.

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RE AND SE

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 B. Determinate Errors (systematic errors)
o Consistent change in the analytical system(high or low).
o Error in a given direction
o A shift in the observed mean value
oIt is an error which occurs in the course of a number of measurements of the
same value of a given quantity, remains constant when measurements are made
under the same conditions.
oIt may originate from incorrect operations, malfunction in the instrumentation
or poor quality of materials, modification of test methods, and change in the
incubation period etc.

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A systematic error..
 A procedure that suffers from a systematic error is always
going to give a mean value that is different from the true
value.
Interfering substance in all samples or in reagents that give
rise to a false signal
Aging of reagents , Gradual deterioration of control
materials, Deterioration of the instrument light source

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Examples of westgard rules

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Preventing and Detecting Errors During Testing
Perform and review Quality Control (QC)
Follow the SOP to prepare the reagents/QC materials
Conduct test according to written procedures

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 Post-Analytic Errors
Includes:
•Report illegible
•Report sent to the wrong location
•Wrong reference ranges
•A missing decimal place or wrong numbers listed are examples of
clerical (transcription) errors.

•Not reporting in a timely manner

•Not maintaining confidentiality

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Preventing and Detecting Errors
After testing
Re-check patient/client identifier

Write legibly

Assign result reviewer-Verify the result

Package EQA specimens for re-testing, if needed

EQA = external quality assessment

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 Types of Diagnostic Test
Results
•Qualitative: positive/ negative
• Rapid HIV,HCG,HCV,covid Ag/Ab test
• B. goup/Rh others
•Semi-quantitative: estimated
• Urinalysis biochemical results
• Others
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•Quantitative: numerical amount
with unit
•Classifies people as diseased or
disease free based on certain cutoff
value or reference value.
• Properties can be expressed by
precision, accuracy, sensitivity,
specificity, predictive value and test
efficiency etc WBC count
•Ex: - Hgb mg/dl, CD4 count
• - Glucose,chol,TG, HDL mg/dL
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