QUALITY CONTROL

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Quality control in clinical microbiology:

Quality control in clinical microbiology Dr. Md.Khaleel

Goal of Microbiologists:

Goal of Microbiologists Important - diagnosis, treatment and surveillance of infectious diseases Results - relevant,reliable and on time

QUALITY( QC – 1965):

QUALITY ( QC – 1965) QUALITY is doing the right things and doing those things right. ---Philip crosby (1970) The degree of congruence between expectation and realization Meeting the pre-determined requirements of the users for a service i.e expectations versus fulfillment .

Objectives of quality in lab:

Objectives of quality in lab Support provision of high quality health care reduce morbidity mortality economic loss Ensure credibility of lab Generate confidence in lab results

Quality assurance:

Quality assurance The sum of all the activities(process) in which the laboratory is engaged to ensure that test results are of good quality & guaranteed. Right result Right time Right specimen Right patient Right price Quality concept

QA – Comprehensive, Rational, Periodic, Frequency :

QA – Comprehensive, Rational, Periodic, Frequency

Quality assurance – IQC + EQA:

Quality assurance – IQC + EQA Internal quality control : ABSOLUTELY ESSENTIAL FOR GOOD OPERATING PROCEDURE Continuous monitoring of lab work Recognize errors and minimize them Ensure that test results are reliable/ reproducible

IQC…Why do we need:

IQC…Why do we need Designed to give confidence in the methods. Ensure DAY to DAY consistency PROFICIENCY TESTING : Internal /External Focus is on the process , not the individual

External quality assessment - Why do we need:

External quality assessment - Why do we need Detect hidden problems To receive help and support from Reference/licensed lab. To establish inter-laboratory comparability on performance & improve quality

External quality assurance … :

External quality assurance … Should operate monthly OR at least 4 times / yr Minimum of 3 specimens Reporting period – short Instruction & report forms should be included with each survey

IQC - EQA:

IQC - EQA FEATURE IQC EQA Nature Concurrent ,continuous Retrospective,periodic Performed by Lab staff Independent agency Objective Release of reliable results on day to day basis Ensure interlaboratory comparability

Rewards of quality assurance programme:

Rewards of quality assurance programme Help physician - proper diagnosis,start app treatment Good reputation for the laboratory Motivation factor for staff Mandatory requirement for accreditation Prevention of legal suits

Quality criteria in Microbiology :

Quality criteria in Microbiology

Standard operating procedure:

Standard operating procedure Title (name of procedure) Priniciple (reason for performing the test) Preferred specimen patient preparation Transport container (need for anticoagulant, preservative, or holding medium) Transportation conditions (wet ice, room temperature). Specimen storage in Laboratory (room temperature, 4°C, -20°C,- 10°C) Criteria for unacceptable specimen (delay in transport, leaking container, presence of barium) Special safety precautions (tape plates for AFB or brucellae) Reagents or media required and incubation conditions Examination of cultures Guidelines for identification and susceptibility testing by culture type (respiratory, urine, blood, stool) Required quality control methods for reporting positive, negative, and unsatisfactory results Technical notes, including possible sources of error and helpful hints References

SOPs…:

SOPs… USES: To improve and maintain the quality of lab services to patients To provide lab staff with written instructions on how to perform tests To help to avoid shortcuts in performing tests. To promote safe laboratory practice

Slide 16:

The Quality Assurance Cycle Pre-Analytic Analytic Post-Analytic Data and Lab Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing

Who is responsible for the Specimen collection?:

Who is responsible for the Specimen collection? Specimens is the source of strength to Microbiology Department Scientific specimen collection makes difference Good Microbiology begins with Good specimen collection Resolve the issues with Clinicians with Ethics Communication is a never ending process

Lab – staff & qualifications/Space CLIA,1988:

Lab – staff & qualifications/Space CLIA,1988 Qualified Microbiologist Technical personnel Lab tech/assistant/Attendant Cleaner Clerk cum storekeeper Continuing education programme and training Source:QA in Bact and Immun,WHO

Accredation agencies Performance Improvement:

Accredation agencies Performance Improvement Emphasize Vision and mission statements Problem/action form

QC surveillance - Equipments:

QC surveillance - Equipments Equipment(name,date,serial no,manufacturer) Procedure and periodicity for routine function check Calibration and validation Corrective action – Failures/Servicing/Maintainence Autoclave, Incubators,Refrigerators, BSC,Hot air oven Microscopes, Centrifuge,Freezers ,Balance,Waterbath

QC Surveillance procedures - Equipments:

QC Surveillance procedures - Equipments Equipment Procedures Schedule Tolerance limits Refrigerators Record temp Daily 2-8oC Freezers Record temp Daily -8 to -20oC -60oC to -75oC Incubators Record temp Daily 35 oC +/- 1oC Waterbath Record temp Daily 36oC to 38oC 55oC to 57oC Autoclave Spore strips Atleast weekly No growth of spores Anaerobic jars Methylene blue strip With each use Blue – white low O2 tension Serology rotator Count revolutions /min With each use 180rpm +/- 10rpm Centrifuges Check revolutions with tachometer Monthly Within 5% of dial indicator setting Safety hoods Measure air velocity across face opening Semi annually / Quaterly 50feet airflow/min +/- 5 ft/min

CHARTS:

CHARTS

QC -stains and reagents:

QC -stains and reagents American Chemical Society Committee Established specifications to qualify- analytical reagent grade Store - aqueous solutions in plastic organic solutions in ambercolored glass bottles Keep all reagents and standards in the refrigerator All reagents & standards freshly prepared and used with controls

Performance standards for stains:

Performance standards for stains STAIN CONTROL ORGANISM ATCC No EXPECTED RESULT Ziehl Neelsen Mycobacterium sp E.Coli 25177 25922 Pink red bacilli Blue bacilli Acridine orange E.Coli S.Aureus 25922 25923 Fluorescent bacilli/ cocci Giemsa Thin blood smear Distinct staining of WBC and RBC Gram E.Coli S.aureus 25922 25923 Gram neg Bacilli Gram pos cocci Iodine solution Formalin treated stool specimen with cysts Cyst nuclei Spores Bacillus sp Spore stain one colour and bacilli stain with countersatin

QC – Biochemical tests:

QC – Biochemical tests Isolates obtained from clinical specimens are subjected Identification of the organism QC - to assess the authenticity of results of biochemical reactions

Performance standards – Biochemical test:

Performance standards – Biochemical test PROCEDURE TEST CONTROL ORGANISM EXPECTRESULT EXP REACTION Catalase S.Aureus Strep sp + _ Effervescence No eff Coagulase S.Aureus S.Epidermidis + _ Clot in 4hrs No clot Indole E.coli E.aerogenes + _ Red ring Colorless ring Methyl red E.coli E.aerogenes + _ Instant red color No color change Oxidase P.Aeruginosa E.Coli + _ Purple color in 10 sec No color VP E.aerogenes E.Coli + _ Red color No color Christensen urea agar E.coli p. mirabilis - + Colorless Pink Simmon’s citrate agar k.Pneumoniae E.coli + - Blue green

Quality control of culture media(CLSI) :

Quality control of culture media(CLSI) Nature of reporting – Quality of culture media Raw material parameters Sterilization parameters Physical parameters Ecometric parameter- Checks growth & inhibition characteristics of media Contamination parameters Gel strength parameter Ref : Quality control of culture media in microbiologylab,S.Basu,A.Pal,IJMM;(2005)23(3);159-163.

QC of commonly used media:

QC of commonly used media MEDIUM CONTROL ORGANISM EXPECTED REACTIONS Blood agar Gp A Streptococci S.pneumoniae β hemolytic,growth α hemolytic, growth Chocolate agar H.influenzae N.gonorrhoeae good growth No growth Motility P.Mirabilis K.pneumoniae Media cloudy No feather edge on streak Mac Conkey Agar E.coli p. mirabilis LF NLF Phenylalanine deaminase E.coli p. mirabilis Negative Positive(Green color) Sucrose E. coli N. gonorrhoeae Yellow + No colour change- Maltose Salmonella sp N. gonorrhoeae Yellow + No colour change- Lactose N. lactamicus N. gonorrhoeae Yellow + No colour change-

QC - Antibiotic susceptibility tests:

QC - Antibiotic susceptibility tests Discs – 6mm Stock supply –stored frozen ( -20 0 c ) Working supply – refrigerate for 1 month (2-8 0 c) Media - Muller Hinton agar Inoculum –standardized with turbidity standards Keep AB discs at room temp for 1 hr before use Incubate sens plates for overnight at 37 ° C. Spacing of AB discs Zone sizes – measured exactly,interpret - chart

Standard procedure for QC Antibiotic susceptibility test:

PPTC, Wellington, NZ Standard procedure for QC Antibiotic susceptibility test Standard control strains S.aureus (ATCC 25923/NCTC 6571/29213) E.coli (ATCC 25922/NCTC 10418) P.aeruginosa (ATCC 27853/NCTC 10622) If you encounter an unusual pattern rule out error by checking identification of organisms repeat antimicrobial susceptibility test Report if repeat testing yields same result, or refer the isolate to a reference laboratory for confirmation

Maintainence of Reference QC stocks:

Maintainence of Reference QC stocks ATCC/ Commercial vendors PT Programmes Well defined clinical isolates BACTERIOLOGY : 1yr in trypticase soy agar/Schaedler broth with glycerol/skim milk/cysteine trytic agar without CHO. Long term storage – Lyophilization/Freeze at -70o C. Non fastidious – 5yrs Fastidious – 3 yrs

QC-M.tuberculosis strain H37Rv :

QC-M.tuberculosis strain H37Rv QA similar to those in other sections Laboratory personnel/Space/Equipment Specimen/stains/Reagents/Biochemical tests Antimicrobial susceptibility tests Mycobacteria lab has unique features 1. long incubation period/growth requirements Need for decontamination of specimen Preservation of cultures :LJ Slants short term37 0 c long term 4 0 c 1 yr frozen at - 70 0 c in 7H9 broth with glycerol Contamination rates : 3 - 5% acceptable

QC OF MYCOLOGY LAB :

Specimen collection/Culture media /Stains Checked for performance using + ve & - ve control slides India Ink + ve – cryptococcus neoformans Gram stain candida Germ tube + ve – candida albicans - ve - candida tropicalis Rapid urease test + ve cryptococcus - ve C.albicans Corn meal agar – chlamydospores of C.albicans Storage at room temp – Potato dextrose slant overlaid with sterile mineral oil Long term storage - 4 0 c , 6 months to 1 yr QC OF MYCOLOGY LAB

QC IN VIROLOGY LAB:

QC IN VIROLOGY LAB Procedure manual Media/Reagents & kits/Instruments Tissue culture cells Transport media – gelatin, serum albumin Specimen storage short period-refrigeration long period -20 0 c to -70 0 c System for the propagation of viruses

QC IN SEROLOGY LAB:

QC IN SEROLOGY LAB Rapid identification Procedure manual QC of the kits,Reagents & equipment Performance of tests – monitored with controls Interpretation & reporting of results High specificity of detection of antigen/antibody Epidemiological tools Retrospective confirmation of diagnosis

QC OF PARASITOLOGY LAB:

QC OF PARASITOLOGY LAB QA similar to those in other sections Records of calibration done for ocular micrometer, centrifuge, refrigerator ,Incubator Instruction manual – texts and atlases for identification of parasites, including permanently stained smears Slides/digital images of common parasites A set of clinical reference specimens, Control for staining procedures

Quality Control: Molecular Diagnostics:

37 Quality Control: Molecular Diagnostics

Overview:

Molecular Diagnostics Quality Control - Module 8 38 38 Overview Sample Collection, Transport, and Processing maintain Nucleic acid integrity through these processes Contamination Control establish a unidirectional work flow from a DNA-free area for reagent preparation, to a sample processing area, to area where amplification and detection occur Positive and Negative Controls Reference: CLSI MM3-A (Molecular Diagnostic Methods for Infectious Diseases)

Risks with PCR:

Molecular Diagnostics Quality Control - Module 8 39 39 Risks with PCR most RT-PCR is still done as “in-house” or “home-brew” primers are not necessarily optimized to test positive controls are “in-house” negative controls are “in-house” interpretation of tests need to be done with caution

Impress with your organization for more funding to the Laboratory:

Impress with your organization for more funding to the Laboratory

Documentation :

Documentation “If you cannot measure it, you cannot improve it” Lord Kelvin, 1824-1907

Documentation:

Documentation If you don’t document it, it didn’t happen Keep data in a central location and back it up

Accreditation :

Accreditation Helps in ensuring good quality laboratories College of American pathologists(CAP) Joint commission on the accreditation of health care organizations(JCAHO) Commission of laboratory accreditations(COLA) American Assay of Bioanalysts Source : Manual of Clinical Microbiology,A.Balows,W.Hausler,5 th Ed ASM.

Q PROBES – BENCH MARKING :

Q PROBES – BENCH MARKING WHONET: is A Microbiology Data Management Tool WHONET is used to support surveillance activities in the countries

Merri’s Rules:

Merri’s Rules Quality control programme is a journey, not a destination Keep it SIMPLE and practical Involve lots of people and ideas Adapt what you’ve learnt Be methodical Document it Share what you’ve found EVERYONE!

Slide 46:

REFERENCES Text book of Diagnostic Microbiology by Bailey and Scott (10th Ed) Quality assurance in Bacteriology & Immunology,WHO Regional publication Textbook of Diagnostic Microbiology by Mahon.C,Lehman.D Textbook of District laboratory practice in tropical countries,Part 1& 2.Monica Cheesebrough. Manual of Clinical Microbiology,A.Balows,W.Hausler,5th Ed ASM. Quality control of culture media in Microbiology lab,S.Basu,A.Pal,IJMM;(2005)23(3);159-163. Quality assurance in Microbiology ,Dr Arora,IJMM(2004)22(2);81-86.

Slide 47:

Thank You

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