Quality control in the medical laboratory

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  • Proficiency Testing is the equivalent of External Quality Assessment (EQA).
  • Quality control in the medical laboratory

    1. 1. Quality Control in the Medical laboratory Introduction and Overview FD lecture Adnan S Jaran PhD. 1
    2. 2. How do we achieve QUALITY performance in the laboratory? Adnan S Jaran PhD. 2
    3. 3. QUALITY is ACHIEVED BY:  Determining the customer’s precise requirements  Ensuring that all resources, facilities and skills required to meet the customer’s requirements are available  Planning, documenting and implementing management procedures to ensure that the customer’s requirements are met consistently  Ensuring that staff are trained and provided with the resources to do the job right the first time Adnan S Jaran PhD. 3
    4. 4. QUALITY is ACHIEVED BY:[cont]  Ensuring that all activities are undertaken correctly  Ensuring that when things go wrong, effective corrective action is taken to avoid repetition of errors  Undertaking regular reviews and audits of all processes  Total and organised commitment from management Adnan S Jaran PhD. 4
    5. 5. The Quality Assurance Cycle Patient/Client Prep Sample Collection Reporting •Data and Lab Management •Safety •Customer Service Personnel Competency Test Evaluations Sample Receipt and Accessioning Record Keeping Quality Control Testing Adnan S Jaran PhD. Sample Transport 5
    6. 6. What is Quality? Adnan S Jaran PhD. 6
    7. 7. Achieving a 99% level of quality means accepting a 1% error rate 1% Adnan S Jaran PhD. 7 7
    8. 8. In France a 1% error rate would mean everyday  14 minutes without water or electricity  50,000 parcels lost by postal services  22 newborns falling from midwives’ hands  600,000 lunches contaminated by bacteria  3 bad landings at Orly Paris airport Adnan S Jaran PhD. 8
    9. 9. Result: Adnan S Jaran PhD. 1% failure 9 9
    10. 10. Laboratory errors cost in time personnel effort patient outcomes Adnan S Jaran PhD. 10
    11. 11. Organization How do we achieve excellent performance in the laboratory? Adnan S Jaran PhD. Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety 11
    12. 12. Quality Management System Definition Coordinated activities to direct and control an organization with regard to quality (ISO,CLSI). All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system. Adnan S Jaran PhD. 12
    13. 13. QUALITY CONTROL     Every analysis in the lab. generates a result The validity of that result cannot be taken for granted, however, without some body of supporting evidence. The most convincing evidence is the establishment of a rigorous comprehensive Quality control program that is faithfully followed This is the only way to guard against the possible deterioration of an analytic system, to become altered to imprecision of results when they occur, and have confidence in test result when everything is in control 16/11/13 13 Dr. Adnan S. Jaran
    14. 14. QUALITY CONTROL A comprehensive quality control (QC) program consist of all the means used by a laboratory to ensure the reliability of every assay performed on specimens arriving in the lab.  The program includes much more than the analysis of a control serum with every run, and it involves: (1) lab. Director, (2) Technologists, (3) all other personnel who are an integral part of the specimen collecting, and (4) The analytical system.  16/11/13 14 Dr. Adnan S. Jaran
    15. 15. Essential to all aspects of health care are laboratory results that are  accurate,  reliable, and  timely Adnan S Jaran PhD. 15
    16. 16. Complexity of a Laboratory System Reporting Patient/Client Prep Sample Collection Personnel Competency Test Evaluations •Data & Laboratory Management •Safety •Customer Service Sample Receipt and Accessioning Record Keeping Quality Control Testing Adnan S Jaran PhD. Sample Transport 16
    17. 17. Path of Workflow THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Analysis Examination Phase Report Transport Result Interpretation Adnan S Jaran PhD. Report Creation Postexamination Phase 17
    18. 18. Laboratory tests are influenced by  laboratory environment  knowledgeable staff  competent staff  reagents and equipment  quality control  communications  process management  occurrence management  record keeping Adnan S Jaran PhD. 18
    19. 19. Organization Responsibilities, Authorities Quality Policy Provision of resources Adnan S Jaran PhD. Communication 19
    20. 20. Personnel human resources job qualifications job descriptions orientation training competency assessment professional development continuing education Adnan S Jaran PhD. 20
    21. 21. Equipment  acquisition  installation  validation  maintenance  calibration  troubleshooting  service and repair  records Adnan S Jaran PhD. 21
    22. 22. Process Control quality control sample management method validation method verification Adnan S Jaran PhD. 22
    23. 23. Information Management fidentiality uisitions and records orts mputerized laboratory rmation systems (LIS) Adnan S Jaran PhD. 23
    24. 24. Documents creation revisions and review control and distribution Adnan S Jaran PhD. Records collection review storage retention 24
    25. 25. Occurrence Management complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions Adnan S Jaran PhD. 25
    26. 26. Laboratory Assessment External Internal Internal Proficiency testing (EQA) Inspections Accreditations Adnan S Jaran PhD. 26
    27. 27. Process Improvement opportunities for improvement (OFIs) takeholder feedback problem resolution isk assessment preventive actions orrective actions Adnan S Jaran PhD. 27
    28. 28. Facilities and Safety safe working environment ransport management security containment waste management aboratory safety ergonomics Adnan S Jaran PhD. 28
    29. 29. Implementing Quality Management does not guarantee an ERROR-FREE Laboratory Adnan S Jaran PhD. But it detects errors that may occur and prevents them from recurring 29
    30. 30. Organizatio n Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Manageme nt Assessmen t Process Improvement Customer Service Adnan S Jaran PhD. Facilities & Safety Laboratories not implementing a quality management system guarantees UNDETECTED ERRORS 30
    31. 31. Laboratory Quality Management System Coordinated activities to direct and control an organization with regard to quality. ISO 9000:2000 Adnan S Jaran PhD. 31
    32. 32. Key Messages     A laboratory is a complex system and all aspects must function properly to achieve quality. Approaches to implementation will vary with local situation. Start with the easiest, implement in stepwise process. Ultimately, all quality management system elements must be addressed. Adnan S Jaran PhD. 32
    33. 33. Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Adnan S Jaran PhD. Questions? Comments? Facilities & Safety 33
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