Dr.M.MalathiFinal year postgraduate

M.D., Microbiology

Introduction

• Importance of Microbiological investigations• High cost of culture media, reagents• Lack of rational approach regarding laboratory

investigations• Test report – Reliable and timely

Laboratory assessment

• Quality assurance (QA)• Quality control (QC)• Standard operating procedures (SOP)

Quality assurance

Definition by WHO:The total process whereby the quality of laboratory reports can be guaranteed.

• Right result, at the right time, on the right specimen, from the right patient, with result interpretation based on correct reference data and at the right price.

Quality control

• QA = QC + IQA + EQA• Quality control : The term QC covers that part

of QA , which primarily concerns the control of errors in the performance of tests and verification of test results.

• QC – covers all aspects of every procedure • Practical, achievable and affordable

External quality assessment

• Laboratories must take part in the EQAS programme.

Internal quality assessment

• Regular distribution of simulated specimens for all sections and benches

• Can assess the following:1. Changes in media, equipment and

procedures2. Efficacy of communications and training3. New tests, new procedures and equipment

can be checked

A guide for quality control

Standard Operating Procedures (SOPs):• Quality of lab service• Identify problems• Written instructions• Avoid short cuts• Promote safe practices

QC at multiple stages of analysis

Pre analytical stage

Collection and transport of specimens :• Quality of specimen• Nature and timing of specimen• Suitability of sampling method• Transportation • Transit time• Information about patient

Analytical stage

• Standard procedure for methodologies as per SOP

• QC of stains • QC of reagents• QC of culture media• Preservation of stock cultures• QC of antimicrobial susceptibility testing• QC of antibiotic disks

• QC of equipment • QC of antigen and antibody reagents for

immunological techniques• Sterility check of laboratory

Post analytical stage

• Reporting and interpretation of results• Computerization• Confidentiality• Communication

Organization of quality control

QC officer1. Set up QC in department2. SOP3. Regular monitoring4. IQAS issue and result analysis5. EQAS process and result analysis6. Rectification of problems

7. Reporting to HOD about QC 8. Communication and training to all staffs of

department9. Analysis of all QC data annually for

performance analysis

SUMMARY

• QC• EQAS• IQAS• QA• SOP• Stage of analysis ?

References1. Practice of quality assurance in laboratory medicine in developing

countries. In Health laboratory services in support of primary health care in developing countries. World Health Organization, New Delhi, 1994:77-137.

2. Cheesbrough, M. District laboratory practice in tropical countries. Part 1. (Cambridge University Press, New York). 1st edition, 1998:3-37.

3. Specific guidelines for accreditation of clinical laboratories. National Accreditation Board for Testing and Calibration Laboratories 112,1998:8.

4. Koneman EW, Allen SD, Janda WM, Schreckenberger PC, Winn Jr. WC. Color atlas and textbook of diagnostic microbiology. Lippincott-Raven Publishers, 5th edition, 1997:133-120.

5. Cheesbrough, M. District laboratory practice in tropical countries. Part 2. (Cambridge University Press, New York). 1st edition, 2000:1-9.