11/7/2017

Control of laboratory error through

“Corrective and Preventive Actions”
Edward Randell
IFCC Committee on Clinical Laboratory Management -
http://www.ifcc.org/ifcc-education-division/e md-committees/c-clm/

Satellite Educational Workshop on Intelligent Clinical Laboratory

Management: Impacts on Quality System Improvement
Hilton Durban - October 22, 2017
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Diagnostic Errors

Delayed Wrong Missed

• In spite of • Different • No
available from diagnosis
resources correct one

Diagnostic errors result in death or disability almost 2x more often than other medical errors
(Including medication errors, surgical errors, and others associated with treatment.)
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Diagnostic Errors
Outside the Laboratory Inside the Laboratory
The
Pre-Pre-Analytical Patient Pre-Analytical
• Failure to order test • Patient misidentification
• Order wrong test Post-Post Pre-Pre- • Specimen collection
Analytical Analytical • Order entry
• Handling/Transport/Storage
Post-Post-Analytical
• Misinterpreted results
• Failure to inform patients Analytical
• Failure to take timely action • Equipment Malfunction
• Inappropriate follow-up Post- Pre- • Sample issues
Analytical Analytical • Undetected QC failure
Diagnostic errors and
errors in lab medicine Analytical Post-Analytical
• Data entry/validation
are interconnected • Excessive TAT
• Delayed Critical Results
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Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”

Nonconformities

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.”
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Why is addressing
nonconformities important?
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.

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Why is addressing
nonconformities important?
Nonconformities are
weaknesses in
procedures that may
Event severity

lead to significant patient

harm in certain
circumstances.

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Presentation Outline
• Defining corrective and preventive actions.
• CAPA Tools
• CAPA Process.
• Summarize Role in Quality Improvement and
Patient Safety.

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Passive and Active

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

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Corrective Action

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). ”

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Corrective Action: Two types

Damage Control
Quick Action
Involves: Organized Process
Remedial- Corrective-
• Stop immediate prevent repeat Requires:
• How much/how bad resolution occurrence. • Identifying true cause
• Contain effects • Action plan to eliminate it
• Notify affected
• Document

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Corrective Actions
Complaint

Reactive processes that address

Analytical
problems that have occurred. problem
Quality
Indicator
Nonconformity

Focus: Correcting an existing

problem. Incident
Report

QC or
PT
Failure 11
Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”

Preventive Actions
Policy &
Procedure
Review

Proactive processes to prevent

Management
a problem from occurring or Review

reduce potential severity. EQA

Trend
Risk
Focus: Risks associated with
trends or patterns. Audits &
Surveys

OFI
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CAPA
Root
Prospective cause
Risk
Management analysis

Remedial
FMEA Action

Preventive Corrective
Action Action

How do we arrive at corrective and preventive actions?

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Root Causes Analysis

Symptoms
Human

Equipment & Organization

Materials & System
Underlying Causes

Root
Reactive: Causes Proactive:
• Determines why. • Forecasts probable events.
• Eliminates the problem. • Identifies gaps between desired & actual.
• Minimizes probability for recurrence. • Determines what to change and how.

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Root Cause Analysis

Understand the Problem Flow Charts

Identify causes

Collect data on cause(s)

RCA

Analyze data on cause(s)

Determine Root Cause

Determine CAPA(s)

Implement and verify Incident Reports

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Root Cause Analysis

Understand the Problem Brainstorming

Identify causes

Collect data on cause(s)

RCA

Analyze data on cause(s)

Determine Root Cause

Determine CAPA(s)

Implement and verify

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Root Cause Analysis

Understand the Problem Sampling/Surveys/Check sheets

Identify causes

Collect data on cause(s)

RCA

Analyze data on cause(s)

Determine Root Cause

Determine CAPA(s)

Implement and verify

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Root Cause Analysis

Understand the Problem Pareto Charts

Identify causes

Collect data on cause(s)

RCA

Analyze data on cause(s)

Determine Root Cause

Determine CAPA(s) Affinity Diagrams

Implement and verify Histograms/Scattergrams

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Root Cause Analysis

Understand the Problem 5 Whys

Identify causes Fishbone analysis

Collect data on cause(s)

RCA

Analyze data on cause(s)

Fault tree analysis
Determine Root Cause

Determine CAPA(s)

Implement and verify

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Root Cause Analysis

Understand the Problem 6 Thinking Hats

Identify causes

Collect data on cause(s)

RCA

Process Cautions
Analyze data on cause(s)
Emotions
Determine Root Cause
Creativity
Determine CAPA(s)

Implement and verify

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Root Cause Analysis

Understand the Problem Tree Diagram

Identify causes

Collect data on cause(s)

RCA

Analyze data on cause(s)

Determine Root Cause

Determine CAPA(s) Force-Field Analysis

Implement and verify

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FMEA

Describe Identify potential Describe Effects Determine

Process Failure modes of Failure Response

How can What are What is What

failure root impact of needs to
occur? causes? failure? be done?

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FMEA
A risk analysis process involving: Preventive Actions focus on higher RPN scores
1. Assembling at Team (Greater effect on patient outcome/lab process/safety)
2. Identify Threats
3. Estimate the Impact Likelihood of occurrence Severity of Failure
4. Identifying Actions to address risk. (Scale: 1 to #) (Scale: 1 to #)
5. Assign accountability for corrective actions

Step Failure Mode Failure Causes Failure Effects O D S R Actions to

C E E P reduce
C C V N Occurrence
Specimen Hemolysis Traumatic Draw Erroneous Educate
analyzed Result 4 2 4 32 collectors
Uncentrifuged Improper Erroneous None
processing Results 1 2 3 6
Clot Improper mixing Erroneous None
result 1 4 1 4 Risk Priority Number =
Likelihood of detecting OCC x DET x SEV
(Scale: 1 to #) 23
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Continuous
Improvement Models
Surveys and
Complaints

Other systematic Personnel

(Competency Internal

strategies for CAPA:

assessments/ Audits of
Annual QMS
Review)

• TQM
• RCA Continual
• PDCA Equipment &
Improvement
Internal Audit

• LEAN
diagnostic of testing
systems processes

• Six Sigma (DMIAC)

Health &
Safety PT and EQA

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The big and small

Opportunities
for Nonconformities
Improvement

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CAPA as a process
Potential or True
nonconformity

Corrective or Preventive
Major Action Report (CAR or CAPA process to
Major or minor? PAR) resolve CAR or PAR

Minor

Proceed with nonconformity/OFI Investigating Corrective Action Reports and

report and review.
Preventive Action Reports take time.
CAPA to resolve
nonconformity/OFI Minor nonconformities and Opportunities
For Improvement can be addressed quickly.

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Addressing the Minor

Generally require lower
level review and sign off.

Sign of f
Record completion
Inv estigate & on log.
decide actions
Begin report

Record event

Assign OFI#

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Assign
CAR/PAR #

Addressing List items

needing
correction

the Major Document the

issue
Root Cause Analysis

Document
Actions

Describe
outcome of
CAPA

FMEA or other risk

Designated management tools
person
reviews and
Generally require high level signs off.

review and sign off.

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Summary
Monitor
QI/Occurrences
The CAPA Process /Audits

The
Patient Document & Nonconformity
or
Implement OFI
Post-Post Pre-Pre-
Analytical Analytical

Post- Pre-
Analytical Analytical RCA/FMEA or
CAPA
Other
Analytical
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