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Training Workshop on “Laboratory Risk Management”2-4 Oct, 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) define 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
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• 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.
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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 04/13/23 7
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Transporting SpecimensRemember:1. Follow proper collection procedures and use correct
device.2. Tightly close container ,Label the specimen & complete
requisite form3. Maintain the samples in a state close to their original as
possible.4. Protect anyone who handles the specimen 5. Protect container from exposure to potentially infectious material.1. 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
Analytical factors
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• 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 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 blueP.aeruginosa
Each use ColorlessNo growth
Serology rotator
Count of revolutions/min
Each use 180 +10rpm
Autoclave Sterilization dick stripsSpore strips
Each runmonthly
Color changeNo 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
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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 (-)
Post analytical factors
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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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Laboratory results
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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