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.
 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
 no action on out of range
 lost sample
controls
 sample delayed in transit
 false negative result
 contaminated samples  late reports
 wrong test performed  missing reports

 test performed  Complaints

inconsistent with the  laboratory accident

written procedure  “near miss”

5
 individual
responsibilities
equipment
unclear
not properly no written
maintained procedures

QC, EQA Common written

not procedures
performed
causes of not followed
error
training
test kits
not done
not stored transcription or
properly errors not completed
checks
not done

6
 Errors occurrence in Testing Process
THE PATIENT Test selection Sample Collection

Pre-examination Phase

Sample Transport

Laboratory Analysis
Examination Phase

Report Transport Report Creation

Result Interpretation Post-examination Phase

7
 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
8
 Examination Errors
Laboratory Analysis
Examples: 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

9
 Post-examination Errors
Examples :
transcription error in reporting
report illegible
report sent to the wrong location
report not sent

Result
Report Report Transport Interpretation
Creation
Postexamination Phase

10
 Risks of Laboratory Errors

ERROR

Inadequate or Inappropriate
Wasteful of
inappropriate public health resources
patient care action

Undetected
Death communicable
disease outbreaks

11
 Detection of Laboratory Errors
Customer
satisfaction
Accreditation Monitoring
Certification complaints

Management
QMS Review Internal
COMMITTEE audits

External
Quality
audits
indicators
PT / EQA

12
Lab Errors Management Process
Awareness

Investigate

Communicate
ACTION

13
 Corrective Action Preventive Action (CAPA)
Learn from the event
and avoid its recurrence

Preventive
actions Corrective
actions
See the
potential
EVENT
event and
plan to
avoid it
Remedial
actions
Address the event
and its consequences

14
 CAPA Process
1. Establish a CAPA Process.

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

15
 Laboratory Error Investigation steps

 information gathering
 thorough investigation
 root cause analysis

16
 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

17
 Root cause analysis example
WHY? WHY? WHY?

WHY?

WHY?

18
 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.

19
 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.

20
COMMENTS SUGGESTIONS COMMENTS

THANK YOU

21
 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?

22