Training Workshop on “Laboratory Risk Management”28-30 May, 2012, • Cairo, Egypt

Quality In Microbiological Laboratory

Dr : Dina RamadanMicrobiologist In Central Health Laboratory

Ministry of HealthQuality Manager

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Juran’s (father of the quality) two definitions of quality

1."Quality" means those features of products which meet customer needs and thereby provide customer satisfaction.

2. "Quality" means freedom from deficiencies-freedom from errors that require doing work over again (rework) or that results in field failures, customer dissatisfaction.

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“Quality is compliance with standards.” QA Project Contract, 1997

Definition of Quality

“Doing the right thing, right, the first time. Doing it better the next time.”

ODI Consulting (management training and consulting firm )

Meeting the needs and exceeding the expectations of those we serve

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Quality in laboratory

Lab quality Management

Patient/Client PrepSample Collection

Sample ReceiptTest Evaluations

Sample Transport

Record Keeping

Reporting

Testing

Pre-analytical factors• Collection and transporting systems

–Sample collection• If specimen is collected incorrectly, the

organism will not grow in culture and then cannot be identified.

• If a specimen contains contaminants that are identified as causing the infection, the patient may be treated incorrectly.

The lab must have instruction procedure

the request of analysis must have some data of the sample e.g.:

Patient’s name, age, gender ,Type & source of specimen, date & time of collectionClinical note- antibiotic history

collecting samples:The lab shall have writing instructions for

collecting sample and must be distributed to all area which samples collected from it 09/08/12 6

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Transporting SpecimensRemember:1. Follow proper collection procedures and use correct

device.

2. Tightly close container ,Label the specimen & complete requisite form

3. Maintain the samples in a state close to their original as possible.

4. Protect anyone who handles the specimen

5. container from exposure to potentially infectious material.

6. Regularly scheduled daily pickups by the lab

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Rejection of samples• Laboratory must reject the samples that can give

incorrect result of the lab e.g.:

–Missing or inadequate identification

–Insufficient quantity

–Specimen collection in an inappropriate container

–Contamination suspected

–Inappropriate transport or storage

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Analytical factors

• Equipment reliability

• Reagent stability, integrity & efficiency

• Adequate calibration

• Proficiency of personnel

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checks for equipments• Calibration: process which is applied to

quantitative measuring of equipment to assure its accurate operation throughout its measuring limits.

This done for all equipment in the lab as balance ,thermometer , autoclave , glassware , • Validation: steps taken to confirm and record the proper operation of equipment at a given point of time in the range in which tests are performed

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Quality control of equipmentsEquipment Procedure Schedule Tolerance limit

Refrigerator Temp. check Daily 2-80C

Freezers Temp. check Daily + 50C

Incubator Temp. check Daily +10C

Water bath Temp. check Daily +0.50C

Anaerobic jar Methylene blue

P.aeruginosa

Each use Colorless

No growth

Serology rotator

Count of revolutions/min

Each use 180 +10rpm

Autoclave Sterilization dick strips

Spore strips

Each run

monthly

Color change

No growth

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Equipment Procedure Schedule Tolerance limit

Hot air oven Spore strips weekly No growth

Centrifuge Revolution check by tachometer

monthly

Microscope Stage &lenses Each use

Pipettes Volume delivery check 10 times

Initially

Balances Checked against known weights

Annual

Bio-safety hood Air velocity check 6 monthly Flow 50 +5 ft/min

Quality control of equipments

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Quality control of stains and reagents

• Each lot of newly prepared stain tested with positive & negative controls

• Regular testing done:

Weekly: Gram’s

Each day of use: ZN stain & other stains• Discard stains if outdated

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Quality control of Media

Media have role in the results of the microbiological Lab ,so its quality included in lab, it act as the supplier,many parameter of media lab must be controlled to make sure of its preparation : Sterilization parameter

Autoclaving time:

Indicators, Temperature, Pressure

Physical parameter:

Bubbles/unequal filling/cracks/freezing/pH

Quality control of Media

• Microbiological parameter

Growth supporting characteristics (with both previous & new batch), productivity of media ,performance

• Contamination parameter

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Reagent testing for validationProcedure Control Expected reaction

Catalase S.aureus Bubbling(+)

Streptococcus spp. No bubbling(-)

Coagulase S.aureus Clot in 4hrs (+)

S.epidermidis No clot (-)

Oxidase P.aeruginosa Purple colour in 30 sec

E. coli No change (-)

Bacitracin S.pyogenes Zone of inhibition(+)

E.faecalis No inhibition (-)

Optochin S. Pneumoniae ZOI(+)

S. viridans No inhibition

Indole E.coli Red ring (+)

K.Pneumoniae Yellow ring (-)

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DocumentationAll laboratory equipment , procedures, personal data must be documented, also the document must

stored probablyExample of document in the lab:• Name and serial number of instrument• Elements to be checked and kind of data to be

collected• Frequency of checking• Record of data• Signature with date of the person performing these

tasks

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Post analytical factors

The results of the lab must be :

• Accurate recording

• Range of normal values must be written

• the lab must have copy of the results and stored carefully for the patient privacy

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Questions

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