4.10 to 4.12 NABL Training Class-SMH CL-Dr Raksha.pptx
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This document discusses corrective and preventive actions (CAPA) and continuous quality improvement as required by clauses 4.10, 4.11, and 4.12 of NABL standards. It defines diagnostic errors and nonconformities that can occur in pre-analytical, analytical, and post-analytical phases. CAPA is a structured process to identify root causes of issues and eliminate them to prevent recurrence, while continual improvement focuses on risk-based improvements. The roles of corrective action to address existing problems, preventive action to anticipate risks, and root cause analysis are explained.
4.10 to 4.12 NABL Training Class-SMH CL-Dr Raksha.pptx
- 1. CA, PA& CQI Corrective and Preventive Actions & Continuous Quality Improvement Clause 4.10, 4.11 & 4.12 Dr Raksha K HOD, Consultant Microbiologist & Infection Control Officer Central Laboratory St. Marthas Hospital 1
- 2. Presentation Outline Diagnostic errors & Nonconfirmities NABL Clauses- 4.10, 4,11 & 4.12 Defining corrective and preventive actions. CAPA Tools CAPA Process. Summarize Role in Quality Improvement and Patient Safety. 7 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions
- 3. Diagnostic Errors Delayed In spite of available resources Wrong Different from correct one Missed No diagnosis Diagnostic errors result in death or disability almost 2xmore often than other medical errors (Including medication errors, surgical errors, and others associated with treatment.) 2 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions
- 4. Diagnostic Errors 3 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions The Patient Pre-Pre- Analytical Pre- Analytical Analytical Post- Analytical Post-Post Analytical Outside the Laboratory Pre-Pre-Analytical Failure to order test Order wrong test Post-Post-Analytical Misinterpreted results Failure to inform patients Failure to take timely action Inappropriate follow-up Inside the Laboratory Pre-Analytical Patient misidentification Specimen collection Order entry Handling/Transport/Storage Analytical Equipment Malfunction Sample issues Undetected QC failure Post-Analytical Data entry/validation Excessive TAT Delayed Critical Results Diagnostic errors and errors in lab medicine are interconnected
- 5. Nonconformities 4 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Nonconformities are accidents, errors, events, incidents, occurrences, and accidents CLSI and ISO 15189:2012 define nonconformities as Nonfulfillment of a requirement ISO 15189:2012 (section 4.9) holds clinical labs accountable to have: a documented procedure to identify and manage nonconformities in any aspect of the quality management system, including pre- examination, examination or post-examination processes.
- 6. Why is addressing nonconformities important? 5 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions 55 year old male with type II DM with chest discomfort of 1 hr duration. Several previous visits, all with normal ECG and mild troponin elevations.
- 7. Why is addressing nonconformities important? 6 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Nonconformities are weaknesses in procedures that may lead to significant patient harm in certain circumstances. Event severity
- 9. 4.10 Corrective action The laboratory shall take corrective action to eliminate the cause(s) of nonconformities. Corrective actions shall be appropriate to the effects of the nonconformities encountered. The laboratory shall have a documented procedure for: a) reviewing nonconformities; b) determining the root causes of nonconformities; c) evaluating the need for corrective action to ensure that nonconformities do not recur; d) determining and implementing corrective action needed;
- 10. 4.10 Corrective action e) recording the results of corrective action taken (see 4.13); f) reviewing the effectiveness of the corrective action taken (see 4.14.5). NOTE Action taken at the time of the nonconformity to mitigate its immediate effects is considered immediate action. Only action taken to remove the root cause of the problem that is causing the nonconformities is considered corrective action.
- 11. WHAT IS TO BE CHECKED DURING AUDIT WITH REGARD TO CORRECTIVE ACTION Reviewing of Nonconformity. Determination of root cause. Evaluating the need for corrective action. Actual corrective action implemented. Review of corrective action take.
- 13. 4.11 Preventive action The laboratory shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. The laboratory shall have a documented procedure for: a) reviewing laboratory data and information to determine where potential nonconformities exist; b) determining the root cause(s) of potential nonconformities; c) evaluating the need for preventive action to prevent the occurrence of nonconformities; d) determining and implementing preventive action needed;
- 14. 4.11 Preventive action e) recording the results of preventive action taken (see 4.13); f) reviewing the effectiveness of the preventive action taken. NOTE Preventive action is a proactive process for identifying opportunities for improvement rather than a reaction to the identification of problems or complaints (i.e. nonconformities). In addition to review of the operational procedures, preventive action might involve analysis of data, including trend and risk analyses and external quality assessment (proficiency testing).
- 15. WHAT IS TO BE CHECKED DURING AUDIT WITH REGARD TO PREVENTIVE ACTION Reviewing of the Possible Nonconformity. Determination and reviewing laboratory data. Determining the root cause for potential non conformity. Effectiveness of the preventive action. Outcome preventive action implemented. Review of preventive action taken.
- 17. 4.12 Continual improvement The laboratory shall continually improve the effectiveness of the quality management system, including the pre-examination, examination and post-examination processes, through the use of management reviews to compare the laboratorys actual performance in its evaluation activities, corrective actions and preventive actions with its intentions, as stated in the quality policy and quality objectives. Improvement activities shall be directed at areas of highest priority based on risk assessments. Action plans for improvement shall be developed, documented and implemented, as appropriate. The effectiveness of the actions taken shall be determined through a focused review or audit of the area concerned (see also 4.14.5).
- 18. 4.12 Continual improvement Laboratory management shall ensure that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care. When the continual improvement programme identifies opportunities for improvement, laboratory management shall address them regardless of where they occur. Laboratory management shall communicate to staff improvement plans and related goals.
- 19. WHAT IS TO BE CHECKED DURING AUDIT WITH REGARD TO CONTINUAL IMPROVEMENT Action plans. Laboratory participation in continual improvement activities. The opportunity for the improvement. Outcome of continual improvement.
- 20. Passive and Active Nonconformities 8 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Passive Active Complaints Incidents Adverse Events Safety audits Review of internal QC Review of external QA Review of QC failures Quality Indicator Monitoring Staff comments Incident reporting Near misses Investigating instrument problems
- 22. Corrective Action 9 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions ISO 15189:2012 (section 4.9): When it is determined that nonconformities in pre-examination, examination and post-examination processes could recur the laboratory shall take action to identify, document and eliminate the cause(s).
- 23. Corrective Action: Two types 10 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Remedial- immediate resolution Corrective- prevent repeat occurrence. Damage Control Quick Action Involves: Stop How much/howbad Contain effects Notify affected Document Organized Process Requires: Identifying true cause Action plan to eliminate it
- 24. Corrective Actions 11 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Nonconformity Quality Indicator Analytical problem Incident Report QC or PT Failure Complaint Reactive processes that address problems that have occurred. Focus: Correcting an existing problem.
- 25. Preventive Actions 12 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Risk EQA Trend Management Review Audits & Surveys OFI Policy& Procedure Review Proactive processes to prevent a problem from occurring or reduce potential severity. Focus: Risks associated with trends or patterns.
- 26. CAPA 13 How do we arrive at corrective and preventive actions? Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Corrective Action Remedial Action Root cause analysis Preventive Action FMEA Prospective Risk Management
- 29. Root Causes Analysis 14 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions Root Causes Equipment& Materials Human Organization & System Proactive: Forecasts probable events. Identifies gaps between desired & actual. Determines whatto change and how. Reactive: Determines why. Eliminates the problem. Minimizes probabilityfor recurrence. Symptoms Underlying Causes
- 30. Root Cause Analysis 15 Edward Randell/ Control of laboratory error through Corrective and Preventive Actions RCA Understand the Problem Identify causes Collect data on cause(s) Analyze data on cause(s) Determine Root Cause Determine CAPA(s) Implement and verify Flow Charts Incident Reports