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practice of assessing performance in all steps of the process to promote excellent outcome in medical care
Quality control aggregate of processes and techniques to detect, reduce, and correct deficiencies in an analytical process.
Processes
Quality Assurance
With thanks to Derek Brown @ EUCAST Educational Workshop: 31 March 2012
Quality
Evaluation Internal Quality Assurance
Prepares sample and sends to participants Receives and analyses results Prepares report
Validation
EQA
Examples of EQA organizations College of American Pathologists Royal College of Pathologists (Australasia) UKNEQAS Local reference laboratories
EQA: benefits
Independent assessment of performance Assessment of performance over time Comparison with other laboratories Highlights problem areas Performance related to guidelines and methods
EQA: benefits
International differences highlighted Gives practical experience of difficult tests (especially if resistance is uncommon) Provides background information and guidance on appropriate methods Performance indicator for accreditation
EQA: limitations
Number of specimens distributed is small May be considered inappropriate to send some organisms Specimens do not reflect routine isolates Laboratories may not treat specimens as routine
Performance assessment
results
reported
Sample
blinded routine testing results
Routine testing
results
IQA: Benefits
Check of laboratory processes Identifies: typographical errors Inconsistencies between different technologists process errors
Audit
Processes Documentation Skills Knowledge
Documentation
Standard operating procedures
user-friendly, not reference text! updated regularly document control
Documentation
Standard operating procedures
user-friendly, not reference text! updated regularly document control
Examples from:
WHO SOP (SE Asia) http://apps.searo.who.int/PDS_DOCS/B0217.pdf HPA (UK) SOP repository http://www.hpa.org.uk/SMI Mount Sinai SOP http://microbiology.mtsinai.on.ca/manual/anti/ind ex.shtml
Examples from:
http://apps.searo.who.int/PDS_DOCS/B0217.pd f http://www.hpa.org.uk/SMI
Readily accessible
Readily accessible
Documentation
Standard operating procedures
user-friendly, not reference text! updated regularly document control
Readily accessible
hard copy soft copy
www.hpa.org.uk/webc/hpawebfile/h paweb_c/1317131674973
Analytic accuracy
Precision
Training topics Importance of proper technique for AST Observation of resistance mechanisms expression in Proteuses Antimicrobials and the beta lactam family drug family Extended spectrum beta lactamases Staph lugdunensis: significance, identification, and susceptibility ampC beta lactamases Lab reports vs clinical impact of Staphylococcal AST Interpretation and reporting of test results for Enterococcal AST Interpretation and reporting of test results for Enterobacteriaceae AST Interpretation and reporting of test results for non-Enterobacteriaceae ASTcs Identification, susceptibility testing and result interpretation of Strep pneumoniae MIC determination by macrobroth and microbroth methods Microscan testing Drug options, result interpretation and reporting for Staphylococcal AST
Penicillin binding proteins in relation to staphylococcal growth and drug resistance Antimicrobial testing and reading of test findings
Training Category
Talk Practical
Topic
Importance of proper technique for AST
Trainer
LNG LNG HJ / LNG HJ / LNG LNG HJ / LNG LNG
HYX
AL
HJ
p
SMF LHZ
p p
TSY
OFF
Observation of resistance machanisms expression in Proteuses Antimicrobials and the beta lactam family Powerpoint drug family Powerpoint Extended spectrum beta lactamases Talk Staph lugdunensis: significance, identification, and susceptibility
Trainer
Trainer
Trainer
Trainer
AL
Trainer
Trainer
Powerpoint ampC beta lactamases Talk Penicillin binding proteins in relation to staphylococcal growth and drug resistance
Trainer
Trainer
OFF
Trainer
AL
HJ / LNG
0.5
Trainer
AL
Trainer
LNG
0.5
Speaker
AL
11/06/2013
LNG
0.5
Speaker
AL
Quality Control
Antibiotic testing
Temperature Atmosphere
QC Disc: testing
Westgard rules
multiple rules used to monitor a charted process determines if the process is within acceptable limits
Westgard relevant
10x reject when 10 consecutive control measurements fall on one side of the mean.
QC Disc: monitoring
QC Disc: failures
Cause found: repeat x 01 ID cause No obvious cause 5 consecutive days Re-examine 1 out of range Repeat out of range Repeat ok = case close All within range = case close repeat
QC strains
Wrong strains Inocula Storage Contamination Age
QC strains
Wrong strains Inocula Storage Contamination Age
Antibiotics
Storage Wrong disc
Procedures
Incubation conditions Disc placement transcription
Antibiotics
Storage Wrong disc
Procedures
Incubation conditions Disc placement transcription
QC strains
Age Storage Inocula Contamination Wrong strains
QC strains
Wrong strains Inocula Storage Contamination Age
Antibiotics
Storage Wrong disc
Procedures
Incubation conditions Disc placement transcription
Antibiotics
Storage Wrong disc
Procedures
Disc placement Incubation condition transcription
QC Disc: Troubleshooting
QC of Automated Systems
Use the recommended quality control strains Follow manufacturers instructions Purity check of used inocula
Restricted range of test concentrations means that the available range may not include the MIC of the control strain.
Quality Assurance
Quality measure Clinically relevant testing strategies Testing of reference QC strains Technical competency Organism antibiogram verification Supervisor review of results Procedure manual Cumulative antibiogram Proficiency surveys Other
Effort (%) 15 15 15 15 15 10 5 5 5
Conclusion
Rankin I. D. (2005). Quality Assurance/Quality Control (QA/QC) In: Coyle M. B. (ed.) Manual of Antimicrobial Susceptibility Testing. 1st ed, Washington, D.C.: American Society for Microbiology; 63-89.
Resources
WHO Laboratory Quality Management System Handbook 2011
http://whqlibdoc.who.int/publications/2011/9789241548274_eng.pdf
General Review
http://www.intechopen.com/books/latest-research-into-qualitycontrol/quality-assurance-in-antimicrobial-susceptibility-testing#B23