1 - Quality Control. pdf

qc

1. QUALITY CONTROL IN
MICROBIOLOGY.
Group One Presentation:
• Maureen Achieng’
• Fredrick Okello
• Collins Adera
• Everlyne Kagendo


30.01.2017

2. 1)To define terms related to quality.
2)To appreciate the advantages of quality control in
the laboratory.
3)To identify factors that may affect quality in a
microbiology lab.
4)To discuss the criteria for specimen rejection.
5)To outline the roles of a quality control officer in
the lab.

3. Key terms;
q Quality; meeting of pre-determined requirements of users for a particular
substance or service. Covers aspects of quality assurance and quality
control.
q Quality Assurance; total processes whereby the quality of lab reports can
be guaranteed to be the right result, at the right time, for the right
specimen, for the right patient, with the right interpretation based on the
right reference data and at the right place.

IQA EQA QA

4. Continued…
q Quality control; control of errors in performance of tests and verification of results.
Should be practical, achievable and affordable.
set of procedures undertaken by lab staff for continuously
and concurrently assessing lab work and emergent results.
Assesses: i) changes in media, equipment and procedures
ii) Efficacy of communication and training among staff
iii) New tests and procedures.
Ø External Quality Assessment; system of objectively assessing the performance of a
lab by an outside agency to ensure inter-laboratory compatibility.

5. oReduced cost.
oReduced turn around time for diagnosis.
oCustomer and physician satisfaction.
oEnsures objective and effective correction
action.
oInfluences planning for training and
management.

7. 1. PRE-ANALYTIC PHASE.
vQuality and nature of specimen – collect from actual site; avoid minimum
contamination from adjacent tissues,
organs or secretions.
vTiming of specimen – pathophysiology of disease should be known for optimal
collection of the organism of interest.
vSuitability of sampling method – sterile containers should be used. Tightly
fitted caps prevent leakage and
contamination.

8. vSpecimen labeling – ensure proper labeling with the patient’s name,
identification number, age, sex, gender, source of
specimen, clinician requesting, investigation
required and any antibiotics given.
The information should correspond with that in
the requesting form.
vQuantity of specimen – must be sufficient. Guidelines should be
established to define a sufficient volume.

9. Continued…
vTransportation and transit time – its necessary to place the sample in an
appropriate transport media when in transit to
preserve it in its original state as much as
possible under adverse conditions.
NB: Prolonged storage in the transport media beyond the optimum
may lead to bacteria dying off or overgrowth.
vSpecimen receipt and preliminary observation – there should be designated
areas for specimen receipt. Essential data should be
entered into a log book or computer data base.
Visual examination and determination whether all criteria
for acceptance are met.

10. a. Leaking container.
b. Unlabeled/ wrongly labeled sample.
c. Insufficient quantity.
d. Prolonged transport.
e. Dried specimen.
f. Hemolysed blood.
g. Wrong collection tube.
h. Lipemic serum

11. Microscopic Examination Processing Specimen
Preliminary Identification of
Bacterial Isolates.
Culture and Interpretation
Antimicrobial Susceptibility Testing.

12. Factors continued…
2. ANALYTICAL PHASE.
ü Standard Operating Procedures – function:
a. Improve and maintain quality of lab services to patients.
b. Identify problems associated with poor work performance.
c. Provide lab staff with written instructions.
d. Help avoid short-cuts in test performance.
e. Promote safety in the lab.

13. Continued…
ü QC of stains – all stains and reagents should be properly labeled, dated
and stored. Control smears should be prepared for
each batch. They should not be used beyond the
expiry date.
ü QC of culture media – appropriate culture media, temperatures,
inoculation techniques and incubation
conditions should be used.
E.g; Nichrome has oxidizing properties. Tests where the oxidizing
property of bacteria is to be studied, platinum wire should
be used.
ü Sterility check – disinfect workbench at the start and close of work. Wash
hands with soap and water before and after specimen
handling.

14. ü QC of antimicrobial susceptibility testing:
• Use correct content of antimicrobial agent per disc.
• Stock the supply of antimicrobial agents at -20 degrees Celsius.
• Use appropriate control cultures e.g coded strains from time to time.
• Space antibiotic discs appropriately to avoid overlapping of inhibition zones.
• Use inoculum size that produces near confluent growth.
• Ensure an even contact of the antibiotic disc with inoculated media.
• Measure zones properly.
• Interpret zones by referring to standard charts.
• Keep antibiotic discs at room temperature 1 hour before use.
• Incubate the sensitivity discs for 16-18 hours at 35 degrees Celsius before
reporting.

15. ü QC of equipment – all should undergo;
1. Verification: a QC process used to evaluate whether the apparatus or system complies
with the regulations, specifications or condition implied by the
supplier.
2. Validation: a QA process of establishing evidence that provides a high degree of assurance
that the product meets intended standards.
3. Calibration: set of operations that establishes the relationship between values indicated
by an instrument or system and the corresponding known values of
reference standard.
4. Qualification: action of proving that any equipment works properly and actually gives
accurate and reliable results.
5. Others; - troubleshooting
- service and repair
- maintenance.

18. 3.POST-ANALYTIC PHASE.
a) Reporting – should be done based on the right reference
data. Ensure right result for right patient.
b) Information management – results should be confidential.
c) Record keeping – a copy of the results should be retained for future
reference. Accessibility should be limited.
d) Occurrence management – root cause analysis.

19. Roles: - set up quality control in departments.
- establish standard operating procedures.
- regular monitoring.
- IQA and EQA issue and result analysis.
- rectification of problems.
- reporting to head of department about quality control.
-communication and training to all staff.
- analysis of QC data annually for performance analysis.

20. As we finish….