Laboratory Errors & CAPA: Managing Occurrences in the Global Health Laboratories

1. www.GlobalHealthLaboratories.org This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions.

2. LABORATORY ERRORS & CAPA 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. Common causes of error

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

8. Pre-examination Errors THE PATIENT Test selection Sample Collection Pre-examination Phase Sample Transport 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 Examples : • transcription error in reporting • report illegible • report sent to the wrong location • report not sent Result Interpretation Report Creation Report Transport Postexamination Phase

11. Risks of Laboratory Errors ERROR

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

13. Lab Errors Management Process Awareness Communicate Investigate ACTION

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

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

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? WHY? WHY? WHY? WHY?

19. Summary The laboratory should: • 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.

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.

21. COMMENTS SUGGESTIONS COMMENTS Thank you

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 andproblem prevention?