NABL clauses 4.10 to 4.12

1. CA, PA& CQI
Corrective and Preventive Actions
& Continuous Quality Improvement
Clause 4.10, 4.11 & 4.12
Dr Raksha K
HOD, Consultant Microbiologist & Infection Control Officer
Central Laboratory
St. Martha’s Hospital
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2. Presentation Outline
•Diagnostic errors & Nonconfirmities
•NABL Clauses- 4.10, 4,11 & 4.12
•Defining corrective and preventive actions.
•CAPA Tools
•CAPA Process.
•Summarize Role in Quality Improvement and
Patient Safety.
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”

3. Diagnostic Errors
Delayed
• In spite of
available
resources
Wrong
• Different
from
correct one
Missed
• No
diagnosis
Diagnostic errors result in death or disability almost 2xmore often than other medical errors
(Including medication errors, surgical errors, and others associated with treatment.)
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”

4. Diagnostic Errors
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
The
Patient
Pre-Pre-
Analytical
Pre-
Analytical
Analytical
Post-
Analytical
Post-Post
Analytical
Outside the Laboratory
Pre-Pre-Analytical
• Failure to order test
• Order wrong test
Post-Post-Analytical
• Misinterpreted results
• Failure to inform patients
• Failure to take timely action
• Inappropriate follow-up
Inside the Laboratory
Pre-Analytical
• Patient misidentification
• Specimen collection
• Order entry
• Handling/Transport/Storage
Analytical
• Equipment Malfunction
• Sample issues
• Undetected QC failure
Post-Analytical
• Data entry/validation
• Excessive TAT
• Delayed Critical Results
Diagnostic errors and
errors in lab medicine
are interconnected

5. Nonconformities
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
Nonconformities are accidents, errors, events, incidents,
occurrences, and accidents
CLSI and ISO 15189:2012 define nonconformities as “Nonfulfillment
of a requirement”
ISO 15189:2012 (section 4.9) holds clinical labs accountable to have:
“a documented procedure to identify and manage nonconformities in
any aspect of the quality management system, including pre-
examination, examination or post-examination processes.”

6. Why is addressing
nonconformities important?
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
55 year old male with
type II DM with chest
discomfort of 1 hr
duration.
Several previous visits,
all with normal ECG
and mild troponin
elevations.

7. Why is addressing
nonconformities important?
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
Nonconformities are
weaknesses in
procedures that may
lead to significant patient
harm in certain
circumstances.
Event
severity

8. 4.10 CORRECTIVE ACTION

9. 4.10 Corrective action
•The laboratory shall take corrective action to
eliminate the cause(s) of nonconformities.
Corrective actions shall be appropriate to the
effects of the nonconformities encountered.
•The laboratory shall have a documented
procedure for:
a) reviewing nonconformities;
b) determining the root causes of
nonconformities;
c) evaluating the need for corrective action to
ensure that nonconformities do not recur;
d) determining and implementing corrective
action needed;

10. 4.10 Corrective action
e) recording the results of corrective action
taken (see 4.13);
f) reviewing the effectiveness of the corrective
action taken (see 4.14.5).
NOTE Action taken at the time of the nonconformity to
mitigate its immediate effects is considered
“immediate” action. Only action taken to remove the
root cause of the problem that is causing the
nonconformities is considered “corrective” action.

11. WHAT IS TO BE CHECKED DURING AUDIT
WITH REGARD TO CORRECTIVE ACTION
Reviewing of Nonconformity.
Determination of root cause.
Evaluating the need for
corrective action.
Actual corrective action
implemented.
Review of corrective action
take.

12. 4.11 PREVENTIVE ACTION

13. 4.11 Preventive action
•The laboratory shall determine action to
eliminate the causes of potential
nonconformities in order to prevent their
occurrence. Preventive actions shall be
appropriate to the effects of the potential
problems.
•The laboratory shall have a documented
procedure for:
a) reviewing laboratory data and information to
determine where potential nonconformities
exist;
b) determining the root cause(s) of potential
nonconformities;
c) evaluating the need for preventive action to
prevent the occurrence of nonconformities;
d) determining and implementing preventive
action needed;

14. 4.11 Preventive action
e) recording the results of preventive action
taken (see 4.13);
f) reviewing the effectiveness of the preventive
action taken.
NOTE Preventive action is a proactive process for
identifying opportunities for improvement rather than a
reaction to the identification of problems or complaints
(i.e. nonconformities). In addition to review of the
operational procedures, preventive action might involve
analysis of data, including trend and risk analyses and
external quality assessment (proficiency testing).

15. WHAT IS TO BE CHECKED DURING AUDIT
WITH REGARD TO PREVENTIVE ACTION
Reviewing of the Possible Nonconformity.
Determination and reviewing laboratory
data.
Determining the root cause for potential
non conformity.
Effectiveness of the preventive action.
Outcome preventive action implemented.
Review of preventive action taken.

16. 4.12 CONTINUAL IMPROVEMENT

17. 4.12 Continual improvement
The laboratory shall continually improve the
effectiveness of the quality management
system, including the pre-examination,
examination and post-examination processes,
through the use of management reviews to
compare the laboratory’s actual performance in
its evaluation activities, corrective actions and
preventive actions with its intentions, as stated
in the quality policy and quality objectives.
Improvement activities shall be directed at areas
of highest priority based on risk assessments.
Action plans for improvement shall be
developed, documented and implemented, as
appropriate. The effectiveness of the actions
taken shall be determined through a focused
review or audit of the area concerned (see also
4.14.5).

18. 4.12 Continual improvement
Laboratory management shall ensure that the
laboratory participates in continual
improvement activities that encompass relevant
areas and outcomes of patient care. When the
continual improvement programme identifies
opportunities for improvement, laboratory
management shall address them regardless of
where they occur. Laboratory management shall
communicate to staff improvement plans and
related goals.

19. WHAT IS TO BE CHECKED DURING AUDIT WITH
REGARD TO CONTINUAL IMPROVEMENT
Action plans.
Laboratory participation in continual
improvement activities.
The opportunity for the improvement.
Outcome of continual improvement.

20. Passive and Active
Nonconformities
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Passive
Active
Complaints
Incidents
Adverse Events
Safety audits
Review of internal QC
Review of external QA
Review of QC failures
Quality Indicator Monitoring
Staff comments
Incident reporting
Near misses
Investigating instrument
problems

22. Corrective Action
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ISO 15189:2012 (section 4.9):
“When it is determined that nonconformities in pre-examination,
examination and post-examination processes could recur… the laboratory
shall take action to identify, document and eliminate the cause(s). ”

23. Corrective Action: Two types
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
Remedial-
immediate
resolution
Corrective-
prevent repeat
occurrence.
Damage Control
Quick Action
Involves:
• Stop
• How much/howbad
• Contain effects
• Notify affected
• Document
Organized Process
Requires:
• Identifying true cause
• Action plan to eliminate it

24. Corrective Actions
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Nonconformity
Quality
Indicator
Analytical
problem
Incident
Report
QC or
PT
Failure
Complaint
Reactive processes that address
problems that have occurred.
Focus: Correcting an existing
problem.

25. Preventive Actions
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Risk
EQA
Trend
Management
Review
Audits &
Surveys
OFI
Policy&
Procedure
Review
Proactive processes to prevent
a problem from occurring or
reduce potential severity.
Focus: Risks associated with
trends or patterns.

26. CAPA
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How do we arrive at corrective and preventive actions?
Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”
Corrective
Action
Remedial
Action
Root
cause
analysis
Preventive
Action
FMEA
Prospective
Risk
Management

29. Root Causes Analysis
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Root
Causes
Equipment&
Materials
Human
Organization
& System
Proactive:
• Forecasts probable events.
• Identifies gaps between desired & actual.
• Determines whatto change and how.
Reactive:
• Determines why.
• Eliminates the problem.
• Minimizes probabilityfor recurrence.
Symptoms
Underlying Causes

30. Root Cause Analysis
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RCA
Understand the Problem
Identify causes
Collect data on cause(s)
Analyze data on cause(s)
Determine Root Cause
Determine CAPA(s)
Implement and verify
Flow Charts
Incident Reports