Quality Assurance in Bacteriology

8/13/2019 Quality Assurance in Bacteriology

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Quality Assurance inBacteriologyAssessment of quality


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Monitoring

Assessment of qualityOrganization of EQAS

Scoring system in EQA

Internal quality assessment


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A. Monitoring

Objectives

to confirm consistency

to alert to changeto assess the impact of changes to

processes or procedures

to identify opportunities forimprovement

to provide objective measurements


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Essential differences betweenmonitoring and evaluation


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B. ASSESSMENT OF QUALITY

External or internal

Types of assessment of quality

- External or internal


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Essential differences betweenmonitoring and EQA


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External Quality AssessmentScheme

Assessment of quality= externalagency

Challenges internal QC

Assessed Quality of results

Compares performance of different

testing sites

Proficiency testing


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Objectives of external qualityassessment scheme

Monitor laboratory performance andevaluation of quality control measures

Establish inter-laboratory comparability Influence reliability of future testing

Ensure credibility of laboratory

Stimulate performance improvements

Promote high standards of goodlaboratory practices


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Encourage use of standardreagents/ methodology and trainedpersonnel

Identify common errors

Provide mechanisms to remedyidentified deficiencies

Facilitate information exchange

Support accreditation

Education through exercises, reportsand meetings


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Benefits of EQAS

Helps laboratories in comparing theirresults with other laboratories

Acts as an educational stimulus tolaboratory staff

Participation provides credibility to thelaboratory

Helps the health administrators andregulatory agencies to have an insight intothe status of quality across the country


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Process of EQAS

Steps involved in EQAS


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Basis of success of EQAS

Voluntary participation

Confidentiality of individual reports

Avoiding provocative statements about theperformance

Identifying unsatisfactory performers ingroups or individuals

Providing educational opportunitiesOrganizer acting as adviser rather than

enforcer


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Comparison of performance andresults

Minimization of errorsSelf appraisal

Objective evidence of

quality/accreditation

Identification of training needs


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Desirable features of EQAS

Clinical relevance Comprehensiveness

Versatility

Frequency of distributionMaterial distributed -clinical source

Availability of repeat specimens

Timeliness of feedback

Availability of individual performance data

Number of participants -large enough

Independence of the scheme


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Requirements of EQAS

The Material Supplied

Documentation of AccompanyingMaterial

Manner of Performing the Test

Number of Participating Laboratories

Statistical Analysis of Results

Turn-Around Time and Frequency

Anonymity of ParticipatingLaboratories


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The Material Supplied

- Homogenous

- One source

- Stability- stated

Documentation of AccompanyingMaterial

- Documentation + specimen

- Provision= type of units- Return address, manner of returning and

last date


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Manner of Performing the Test

- Routine testing

Number of Participating Laboratories

- greater the number of participatinglaboratories, the greater is the usefulness

Statistical Analysis of Results

- Easily understood- Results=disclosed


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Turn-Around Time and Frequency

- As Short as possible

- Frequency = depends on resources andfeasibility

Anonymity of ParticipatingLaboratories


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C. ORGANIZATION OF EQAS

Organizers

Principles

Selection of Laboratories and Number

of Participants

Identification of the Laboratories

Frequency of Distribution

Criteria for Assessment of Results

Selection of Investigations and Helpto Laboratories


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Organizers

- Scientist or experts

PrinciplesSchemes:

- specimens are sent out every month to theparticipants

- every three or six months

- check the precision only

- others check for precision and accuracy.

- send two specimens


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Selection of Laboratories and Number

of Participants

- All laboratories

Identification of the Laboratories

- code system

Frequency of Distribution

- matter of policy


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Criteria for Assessment of Results

- Clear definitions

- Limits of acceptable results= percentagedeviation or standard deviation

- Time to analyze sample: one week

- Presentation of analysis of results: clear andprecise

Selection of Investigations and Help toLaboratories


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D. SCORING SYSTEM IN EQA

Semi-Quantitative ScoringSystems

Scoring as a Stimulus toLaboratory Improvement

Assessment of Progress -

Comparison Over TimeEQAS process


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Semi-Quantitative Scoring Systems

- semi-quantitative scale

- 3 point rating system

ID of unknown

2 points- correct

1 point- partially correct

0- totally wrong/failure to answer

antibiotic susceptibility testing

Minor error- R or S organism reported asintermediate or vice versa

Major error- R to S or vice versa


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Scoring as a Stimulus to LaboratoryImprovement

- Scoring system=Assess performance

Assessment of Progress - Comparison OverTime

- A well designed scoring system should be able todelineate changes in the performance of an

individual laboratory over a period of time.


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EQAS process

- Forwarding an initial questionnaire

- Seeking potential participants

- Panel preparation

- Panel distribution

- Collection of results

Forwarding of preliminary report

- Collation and analyses of results- Communication of final report to the participant

- Recommendations

- Award of EQAS certificates


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E. Internal quality assessment

Similar to EQAS

Materials- prepared, distributed, evaluated

and results assessed internally

QA specimen= split in 2

Discrepancies = observed recorded and

analyzed Suggestion of possible solutions


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Applications of IQA

Assessment of variability

Statistical analysis and confidencelimits on repeat testing

Assessment of effect on changes inprocedures or introduction of a newtechnique

Quality Assurance in Bacteriology

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