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LABORATORY ERRORS
&
CAPA
KEMRI-Wellcome Trust Research Programme
2
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.
3
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.
4
Some common laboratory errors
patient ID error

proficiency testing error

lost sample


sample delayed in transit
no action on out of range
controls

false negative result

contaminated samples

late reports

wrong test performed

missing reports

test performed

Complaints
inconsistent with the

laboratory accident
written procedure

“near miss”

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equipment
not properly
maintained
QC, EQA
not
performed
test kits
not stored
properly
individual
responsibilities
unclear
Common
causes of
error
transcription
errors
checks
not done
no written
procedures
written
procedures
not followed
training
not done
or
not completed
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Errors occurrence in Testing Process
THE PATIENT
Test selection
Sample Collection
Pre-examination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
Report Creation
Post-examination Phase
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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
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Examination Errors
Examples:
Laboratory Analysis
Examination Phase
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
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Post-examination Errors
Examples :
transcription error in reporting
report illegible
report sent to the wrong location
report not sent
Report
Creation
Report Transport
Result
Interpretation
Postexamination Phase
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Risks of Laboratory Errors
ERROR
Inadequate or
inappropriate
patient care
Inappropriate
public health
action
Death
Undetected
communicable
disease outbreaks
Wasteful of
resources
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Detection of Laboratory Errors
Customer
satisfaction
Accreditation
Certification
QMS
COMMITTEE
Monitoring
complaints
Management
Review
Quality
indicators
Internal
audits
External
audits
PT / EQA
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Lab Errors Management Process
Awareness
Investigate
Communicate
ACTION
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Corrective Action Preventive Action (CAPA)
Learn from the event
and avoid its recurrence
Preventive
actions
See the
potential
event and
plan to
avoid it
EVENT
Remedial
actions
Corrective
actions
Address the event
and its consequences
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CAPA Process
1. Establish a CAPA Process.
2. Log findings
and actions
3. Investigate
causes,
analyze
information
4. Take
appropriate
action
6. Provide
information
to all
needing it
5. Monitor for
recurring
problems
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Laboratory Error Investigation steps

information gathering
 thorough investigation
 root cause analysis
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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
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Root cause analysis example
WHY?
WHY? WHY?
WHY?
WHY?
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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.
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Key Messages
The difference between a GCLP
compliant laboratory and those nonGCLP compliance is that the
compliant laboratory detects the
problem, investigates, and takes
actions.
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COMMENTS SUGGESTIONS
COMMENTS
THANK YOU
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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?
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