Laboratory Errors: Within The Laboratory & Their Causes

LABORATORY ERRORS
within the laboratory & their causes.
1
Suhair.A.A./ Quality Assurance / 3rd year
What is Laboratory Error?
What are ❑ Laboratory error is an
Errors: Laboratory occurrence or an event that has
errors are described a negative impact on
as defects occurring
at any part of the
Laboratory, which includes
Laboratory systems, personnel, product, equipment,
from ordering tests or the environment.
to reporting results
and appropriate
interpretation and
reaction to these
errors. Errors in
Laboratory may
occur as a result of
the failure on the
Laboratory systems
and processes.
2
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
Suhair.A.A./ Quality Assurance / 3rd year 3

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

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

Phases of Errors in Testing Process:
▪ Total testing process is typically divided

into three main phases:
( Pre-analytical: Analytical: Post-analytical).
▪ Studies have demonstrated that a large
percentage of Laboratory errors occur in
pre- and post-analytical phases, with fewer
errors occurring during the analytical
phase.

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

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

◼ Analytical errors rates has decreased
significantly as a result of standardization,
automation and technological advancement thus
improving the analytical reliability of Laboratory
tests.
◼ Possible causes of analytical errors includes:
incorrect measuring of the sample or reagents;
usually these are dilution or pipetting errors;
using reagents that have been improperly
stored, or after their expiration date.

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

◼ Post-Analytical performed in the Laboratory
includes verifying Laboratory results to the
clinicians, logging laboratory results into the
LIMS and communicating results to the
clinicians.
◼ The common errors in this phase are wrong
validation, delayed results, results not reported
or reported to wrong providers, incorrect results
reported because of post analytical data entry
errors and transcription errors.

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

◼ Risk of Laboratory Errors:
The laboratory errors may results to the risk
of inadequate or inappropriate patient care,
repetition of Laboratory results, more
invasive testing, inappropriate public health
action; undetected communicable disease
outbreaks; wasting of resources; increased
cost to patients and healthcare systems and
death of an individual.
◼

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

Errors Management: Laboratory errors should
be monitored regularly. Monitoring Laboratory
errors requires that a detailed documentation
process be maintained.
Any error, however small should be recorded,
causes investigated and corrective action taken
to avoid future occurrences.

Lab Errors Management Process
Awareness
Investigate
Communicate
ACTION

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

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

CAPA Process: Implementing an effective corrective or
preventive action capable of satisfying quality assurance
and regulatory documentation requirements is
accomplished in seven basic steps:
1.Identification:Define the problem
2.Impact / Risk Assessment: Initial assessment of the
impact and the magnitude of the problem.
3.Immediate Action: Protect the customer from the
problem.
4.Root Cause Investigation: Identify the root cause of the
problem by using a systematic approach.
5.Conclusion and Quality Decision: Final thorough
conclusion on the impact and magnitude of the
problem,decision regarding the use of the product, etc.
6.Action Plan: Define corrective and preventive actions.
7.Implementation and Follow-up: Implement corrective
and preventive actions and verify their effectiveness.of the
19
actions taken .
Laboratory Error Investigation steps
◼ information gathering
▪ thorough investigation
◼ root cause analysis

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

Identify the source of error: The initial step
in the process is to clearly define the problem.
It is important to accurately and completely
describe the situation as it exists now.
This should include the source of the
information, a detailed explanation of the
problem, the available evidence that a
problem exists.

Root cause analysis example
WHY? WHY? WHY?
WHY?
WHY?

Any Questions
THANK YOU

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LABORATORY ERRORS

within the laboratory & their causes.

❑ test performed ❑ Complaints

inconsistent with the ❑ laboratory accident

Suhair.A.A./ Quality Assurance / 3rd year 3

QC, EQA Common written

Suhair.A.A./ Quality Assurance / 3rd year 4

Report Transport Report Creation

Result Interpretation Post-examination Phase

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▪ Total testing process is typically divided

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▪ every cause has a deeper reason

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