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LABORATORY ERRORS & CAPA 2 KEMRI-Wellcome Trust Research Programme

3 Learning Objectives At the end of this presentation, you will be able to:  Describe Laboratory errors and occurrences  Identify causes of Laboratory errors  Define the term “corrective action preventive action”.  Differentiate preventive actions, remedial actions, and corrective actions.  Describe the relationships between preventive action and risk management practices.  Define and describe root cause analysis.

4 What is Laboratory Error?  Laboratory error is an occurrence or an event that has a negative impact on Laboratory, which includes personnel, product, equipment, or the environment.

5 Some common laboratory errors  patient ID error  lost sample  sample delayed in transit  contaminated samples  wrong test performed  test performed inconsistent with the written procedure  proficiency testing error  no action on out of range controls  false negative result  late reports  missing reports  Complaints  laboratory accident  “near miss”

6 individual responsibilities unclear no written procedures written procedures not followed training not done or not completed transcription errors checks not done test kits not stored properly QC, EQA not performed equipment not properly maintained Common causes of error

7 Errors occurrence in Testing Process THE PATIENT Test selection Sample Collection Sample Transport Laboratory Analysis Examination Phase Report Creation Report Transport Pre-examination Phase Result Interpretation Post-examination Phase

8 THE PATIENT Test selectionSample Collection Sample Transport Pre-examination Phase Pre-examination Errors Examples include: wrong sample collected sample mislabeled or unlabeled sample stored inappropriately before testing sample transported inappropriately reagents or test kits damaged by improper storage

9 Examination Errors Laboratory Analysis Examination Phase Examples:  established algorithm not followed  incorrect timing of test  results reported when control results out of range  improper dilution and pipetting of sample or reagents  reagents stored inappropriately or used after expiration date

10 Post-examination Errors Report Transport Report Creation Postexamination Phase Result Interpretation Examples :  transcription error in reporting  report illegible  report sent to the wrong location  report not sent

11 Risks of Laboratory Errors Inadequate or inappropriate patient care Death Inappropriate public health action Undetected communicable disease outbreaks Wasteful of resources ERROR

12 Detection of Laboratory Errors Accreditation Certification QMS COMMITTEE Quality indicators External audits PT / EQA Internal audits Monitoring complaints Customer satisfaction Management Review

13 Lab Errors Management Process Communicate ACTION Awareness Investigate

14 Corrective Action Preventive Action (CAPA) EVENT See the potential event and plan to avoid it Preventive actions Address the event and its consequences Remedial actions Corrective actions Learn from the event and avoid its recurrence

15 CAPA Process 3. Investigate causes, analyze information 1. Establish a CAPA Process. 2. Log findings and actions 4. Take appropriate action 5. Monitor for recurring problems 6. Provide information to all needing it

16 Laboratory Error Investigation steps information gathering  thorough investigation root cause analysis

17 Root Cause Analysis Structured investigations that focus on identifying the underlying true causes of occurrences  every cause has a deeper reason  for each occurrence seek 5 levels of explanation, asking WHY, before being satisfied as to the true (root) cause

18 Root cause analysis example WHY?

19 Summary employ an active process for occurrence management and take a positive approach. try to detect problems early, and take immediate remedial and corrective action. seek opportunities to identify potential error, thus preventing its occurrence. keep good records of all problems, investigations, and actions taken. The laboratory should:

20 Key Messages The difference between a GCLP compliant laboratory and those non- GCLP compliance is that the compliant laboratory detects the problem, investigates, and takes actions.

THANK YOU COMMENTS SUGGESTIONS COMMENTS 21

22 What about your laboratory? List the 5 most common errors occurring in your laboratory.  Why do they occur?  What remedial actions did you take to address the immediate consequences?  What measures could you put in place to correct the problem and prevent recurrence?  How did you document the problem and action?  Can you look at some of your common procedures to seek improvement and problem prevention?