Laboratory errors and caba

1. 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
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distributed freely under the same conditions.
www.GlobalHealthLaboratories.org

2. LABORATORY ERRORS
&
CAPA
2
KEMRI-Wellcome Trust Research Programme

3. 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. 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. 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. 6
equipment
not properly
maintained
QC, EQA
not
performed
test kits
not stored
properly
transcription
errors
checks
not done
training
not done
or
not completed
written
procedures
not followed
no written
procedures
individual
responsibilities
unclear
Common
causes of
error

7. 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. 8
THE PATIENT Test selection Sample 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. 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. 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. 11
Risks of Laboratory Errors
Inadequate or
inappropriate
patient care
Inappropriate
public health
action
Wasteful of
resources
Death
Undetected
communicable
disease outbreaks
ERROR

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

13. 13
Lab Errors Management Process
Communicate
ACTION
Awareness
Investigate

14. 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. 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. 16
Laboratory Error Investigation steps
 information gathering
 thorough investigation
 root cause analysis

17. 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. 18
Root cause analysis example
WHY?
WHY? WHY? WHY?
WHY?

19. 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. 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. THANK YOU
COMMENTS SUGGESTIONS COMMENTS
21

22. 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?