Quality Assurance in

Microbiology Lab
Dr Sadia Hassaan
Junior Resident
JNMC, AMU
 Introduction
Microbiological investigations are important in the
1. Diagnosis
2. Treatment
3. For surveillance of infectious disease and
4. For policies regarding the selection and use of antimicrobial drugs.
It is therefore essential that test reports are relevant, reliable, timely and
interpreted correctly.
 QUALITY
• Quality is derived from latin word ‘QUALIS’ meaning what is like/ what
kind
• Quality is defined as degree to which a set of inherent characteristics
fulfils requirements.
• Quality in simple terms mean how good or bad is something.
• A diagnostic test in clinical microbiology to be of good quality must be
clinically relevant that is must help in prevention or treatment of disease
 FACTORS INFLUENCING QUALITY OF
TEST
• There are 3 stages which influence the quality of a test
1. pre analytical stage
2. Analytical stage
3. Post analytical stage
 FACTORS INFLUENCING QUALITY OF
TEST
1. PRE ANALYTICAL STAGE
• Patient preparation
• Proper sample collection and transport
• Details of the patient and specimen identification
• Knowledge of the normal range of results and abnormalities
• Selection of right test method
2. ANALYTICAL STAGE
• Detailed procedure for examining different specimens. (SOP)
• Investigating techniques and quality control of investigating technique
• Universal precaution should be followed (STRICTLY).
• Aseptic techniques and safe handling of infectious material
• Preparation and quality control of culture media and preservation of stock strains.
• Regular reading and interpretation of cultures
• Antimicrobial sensitivity testing and quality control of procedure and
antibiotic disc.
• Cleaning , quality control and log of equipments used.
• Proper disposal of biomedical waste and also maintain log of biomedical
waste.
• Sterilization procedure and their control
3. POST ANALYTICAL STAGE
• Final report writing.
1. The report should be legible with all the details filled properly.
2. It should have legible signature of the consultant along with stamp
• It should be delivered timely.
• Interpretation of reports by clinician
• Suggestion of appropriate therapy ( if possible)
Phases of Lab Testing

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 QUALITY CONTROL
• Quality control in simple terms means to ensure that information
generated by a lab is accurate, reliable, reproducible.
• Quality control is examining control materials of known substances along
with patient samples to monitor the accuracy and precision of the
complete examination process.
 QUALITY ASSURANCE
• Quality assurance is the sum of all those activities in which the laboratory
is engaged to ensure that test results are of good quality.
• Summarised as right result at the
• Right time on the
• Right specimen from the
• Right patient with result interpretation
• Based on right reference data and at the right place
 INTERNAL EXTERNAL
Quality QUALITY QUALITY QUALITY
CONTROL ASSESSMEN ASSESSMENT
Assurance T
 TYPES OF QUALITY ASSURANCE
• INTERNAL QUALITY ASSESSMENT
Each lab has programme to check the quality of its own test.

• EXTERNAL QUALITY ASSESSMENT

Lab performance is assessed by external professional agency.
In some places participation is mandatory and required for licensure.
 External Quality Assessment
Organizing Lab Participants

Prepare quality Examine specimen

assurance specimen

Analysed results Report/results

Send to organizing lab Evaluation by

Prepare report organizing lab
 QUALITY CONTROL FOR STAINS
• Check with known organism or cells
• Examine for contamination
• Store appropriately
• Label content, concentration, date prepared, date of expiry etc
QUALITY CONTROL OF GROWTH MEDIA
• Keep record of media prepared in house
• Do not use outdated, dried out, contaminated media
• pH , sterility, ability to support growth using stock culture, biochemical
response of stock culture.
STANDARD OPERATING PROCEDURES

• Each lab must have its own SOP

1. To provide lab staff with written instruction on how to perform tests
consistently to an acceptable standard in the lab.
2. To provide written standardized technique for use in the training of lab
personel.
Relationship between QC, QA & QMS

 QC : Activities used to monitor the testing

process and ensure that the test run is valid
 QA : Process whereby the overall quality of
the laboratory test report is assured
 QMS: A management system of
coordinated activities to direct and control
an organization with regard to quality

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Ref: National guidelines on QMS in HIV labs; NACO-2015
 QUALITY MANAGEMENT SYSTEM
• Quality management system is to direct and control an organisation with
regards to quality.
• Therefore quality management system comprise of all the manuals,
procedures and reference standards focussed on implementing the quality
and quality objectives to meet consumer/ user requirement.
 Quality System Essentials (QSE)

 Quality System Essentials (QSE) are the building blocks QMS

 QSE is a set of 12 coordinated activities that support
laboratories to perform and implement QMS.

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Quality System Essentials
Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Documents Occurrence Assessment

& Management
Records

Process Customer Facilities

Improvement Service &
Safety
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 1.Organization

 It is a model to indicate
the management and the
supporting organizational
structure of the laboratory

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 2. Personnel

Most valuable laboratory resource

 qualifications
 job descriptions
 orientations and trainings
 professional development
 staff meetings

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Note: Document these in Personal File

 3. Equipment

Service specific equipment must be in place

 Calibration of pipettes, thermometer, centrifuge
 Maintenance
 Service and repair
 Equipment files and records

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 4. Purchasing and Inventory

 Forecast needs - Uninterrupted

availability of reagents, kits,
supplies, and services
 Minimum stock Management
 Inventory management- storage of
kits
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 5.Process control

Concerns all operations in the laboratories

work flow.
 Environment Checks
 Quality control for laboratory tests
 Determines sample traceability
 SOP / work instructions specific testing
present & easily accessible at work bench
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 6.Information Management

 Are test results recorded in hard

format
 Storage of Archived documents.
 Availability of monthly / yearly
statistics

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 7.Documents and Records

 Documents provide written information about policies and

procedures
 Policy : Overall intentions and direction. eg: Strategies of testing
 Tells you “What to do”
 Procedures: the specific activities. E.g. SOPs
 Tells you “How to do it ”
 Records: any information that produces evidence e.g. requisition
forms, instrument print outs, EQA records etc. 30
 8.Occurrence Management

 Collection of information about errors/ problems

 Establishing a process to detect and document these problems
 Corrective actions taken /documented / reported to appropriate
individuals

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 9. Assessments

 Internal and External Assessment

 It is the means to determine effectiveness of the quality management
system
 External: Participation in retesting and Panel testing labs
 Internal: Self assessment (Checklist)
 Is QC data reviewed & appropriate actions taken

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 10. Process improvement

 Deficiencies/ Non conformities noted

 Root Cause analysis (RCA) done
 Is a corrective action developed with clear
timelines

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 11. Customer Service
Service to customers is a measurable quality
 Identify who the customers are
 Provide information to the customer –Tests available, working
hours, sample collection instructions
 Mechanism for obtaining Feedback (complaint box)
 Record and resolve complaints and other feed back

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 12. Facilities and Safety

Health care services need to establish and maintain safe

environment

Space & Facility:

 Confidential environment
 Separate space for LT and Counselor
 All staff vaccination for Hepatitis-B.

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WHY QUALITY MANAGEMENT SYSTEM
IS REQUIRED
• Medical lab services are essential to patient care and therefore should
meet the needs of all patients and clinical personnel responsible for human
health care.
 Quality control of Medium
Medium Incubation Control organism Expected result
Blood agar 24 hours S. aureus Growth and beta hemolysis
S. pneumoniae Growth and alpha hemolysis
Chocolate agar 24 hours H. influenzae Growth
Mac conkey agar 24 hours E. coli Pink colonies
E. faecalis No Growth
P. mirabilis Colourless colonies (no
swarming)
Methyl red/Voges 48 hours E. coli Positive /Negative
Proskauer broth K. pneumoniae Negative/Positive
 Quality control of Medium
Medium Incubation Control organism Expected result
Peptone water 24 hours E. coli Positive
(Indole) K. pneuomoniae Negative
Simmona’s citrate 48 hours E. coli No growth
agar K. pneuomoniae Growth (Blue color)
TCBS agar 24 hours Vibrio species Yellow colonies

Thayer martin agar 24 hours N. meningitides Growth

Staphylococcus No Growth
E. coli No Growth
 Quality control of Reagents
REAGENT CONTROL EXPECTED RESULT
ORGANISM
Catalase S .aureus Positive- bubbling
Streptococcus sp Negative- no bubbling
Coagulase S. aureus Positive- clot formation
CONS Negative- no clot formation
Oxidase P. aeruginosa Positive- purple colour in 20sec
E.coli Negative- no purple colour
Bacitracin disc Group A Positive- Zone of inhibition
Streptococcus Negative- No zone of inhibition
E. faecalis
Optochin disc S. pneumoniae Positive- Zone of inhibition
S. Viridans Negative- No zone of inhibition
 Quality control in serology

• Most appropriate test must be chosen

• Quality control manual should be available all the time.
• Sera to be used as controls should be kept sterile to avoid
deterioration
• Each procedure should have -ve /+ve/borderline +ve controls
• False positive errors by Over-centrifugation, Dirty glasswares, hemolysed serum
etc should be avoided
• False negative errors by omitting serum or reagents from test mixtures, under-
centrifugation etc should also be avoided.
• Incorrect labelling, expired reagents, inaccurate recording of results should also be
checked.
 IF QUALITY CONTROL IS OUT OF
CONTROL
• The good practice is to :
1. Stop testing
2. Identify and correct problem
3. Repeat testing on patient sample and controls after correction
 AUDIT
• The quality of different aspects of the laboratory services should be
assessed regularly.
• The term audit implies that after the results of a survey have been
assessed, ways of making improvements are identified and implemented.
 Audit cycle
1. Observe practice
2. Choose specific area for
audit

7. Re-assess 3. Set standard

5. Decide changes in 4. Compare

structure/process practice with
6. Implement changes standard
 Duties of the QC manager
• Setting up and organizing QC measures throughout the department.
• Preparation, implementation, update and review of all methods and procedures.
• Regular monitoring of all quality control records to ensure compliance and
satisfactory maintenance of standards.
• Preparation and issue of internal quality assessment specimens.
• Issue and return of all external quality assessment specimens.
• Analysis of all relevant QC data to ensure satisfactory performance.
• Investigation and rectification of any problems.
• Reporting on a regular basis to the Head Medical Laboratory Scientific
Officer(MLSO) and the Head of Department on all matters relating to
quality.
• Communication on a regular basis to all staff in the department about all
pertinent quality matters.
• Recommendations regarding changes or proposed changes to materials,
equipment or procedures.
Thank you