guidelines for the use of root cause analysis (rca) to
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Guidelines for the Use of Root Cause Analysis (RCA) to Reduce Error and Improve Quality in Forensic
Science Laboratories
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The Quattrone Center
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Errors in Forensic Science Labs
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To Err Is Human
“Errors are caused by faulty systems, processes, and condi7ons that lead people to make mistakes or fail to prevent them.”
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1998
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Nat’l Commission on Forensic Science
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Procedure for NCFS Recommendations on RCA
1. 1st Draft - Interim Solutions Subcomm. – HF Subcomm. permitted review/comment – Public comments received, reviewed
2. Presentation of draft to full Commission – Add’l public comments received, reviewed
3. 2nd draft – Interim Solutions Subcomm. 4. Publication for comment by 7/27/2015
– http://www.justice.gov/ncfs/meetings 5. Presentation to full Commission for vote 8/10/2015 6. Recommendations to U.S. Atty Gen
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Corrective Action in Forensic Science
• Required by ISO 17025 – Labs shall implement corrective action for all
nonconforming work or departures from policies/procedures (4.9)
– Procedure begins with an investigation to determine the root cause(s) of the problem. (4.11.2)
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RCA: A Learning Tool • Create team to review nonconformity,
identify core causative factors – “Why?” not “who?”
• Create action plan to prevent recurrence • Identify necessary system/process
redesign, improvements to reduce risk • Conducted in a blame-free manner
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Sample RCA Process: VHA
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Adverse Event Occurs
Implement Actions and Examine Outcomes for Effectiveness
Safety Manager Notified
Safety Manager Assigns SAC Score
to Event
Safety Manager Charters
Interdisciplinary Team
Gather and Analyze Info Leading to AE
Determine Root Cause and Contributing
Factors
Determine Actions to
Address Root Cause
Determine How to Measure Outcomes
Present Analysis and Proposed Actions to Leadership
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A “Just Culture” Is Essential
“People s(ll must be vigilant and held responsible for their ac(ons. But when an error occurs, blaming an individual does liDle to . . . prevent someone else from commiEng the same error.”
1998
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When to Conduct RCA
Severity
Prob
ability
Catastrophic Systemic errors in procedure that
affect several outcomes or reported results; inten7onal misconduct or recklessness in
execu7on of role
Major Casework or proficiency test error that affects outcome or reported result.
Poten7al problems that may affect the reliability, accuracy or performance of a
test procedure or policy; serious negligence in execu7on of role
Moderate Clerical nonconformity affec7ng result but corrected during the
review process prior to repor7ng; nonconformity that does not affect
outcome or reported result
Minor Clerical nonconformity that does not affect outcome or reported
result
Frequent Likely to occur mul7ple 7mes in 1 year
3 3 2 1
Occasional May occur several 7mes in 1-‐2 years
3 3 2 1
Uncommon May happen once in 2-‐5 years
3 2 1 1
Remote May happen once in 5+ years
3 2 1 1
RCA Required for 3, Recommended for 2, Op7onal for 1
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“Near Miss” = Nonconformity • Nonconformity with potential to cause
damage; damage prevented through a fortuitous intervention
• Should be evaluated in the same way they would be if the injury had actually occurred
• Emotionally easier “teachable moment” 12
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Recurring Nonconformity
• Assess extent of nonconformity
• Re-analyze & address additional cases
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• Communicate nonconformity to affected internal/ external individuals
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Transparency and “Safe Harbor” to Incent RCA
• Anonymization – Discipline is private
• Use immunity – No punishment from
participating • Limit use in civil
discovery
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• Goals: promote both transparency and incentives that encourage RCA
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RCA: Culture of Constant Quality Improvement
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