Cardinal Health, Inc. · NYSE:CAH
Cardinal Health — Investor Presentation (2008)
34 slides from Cardinal Health's investor presentation, 2008
Slide 1: Guidelines for Conducting Failure Mode and Effects Analysis of Healthcare Processes
Guidelines for Conducting Failure Mode and Effects Analysis of Healthcare Processes Copyright 2008 Cardinal Health Inc. or one of its subsidiaries. All rights reserved.
Slide 2: Joint Commission Patient Safety Standards
Joint Commission Patient Safety Standards • Ongoing, proactive program for identifying risks and reducing unanticipated adverse events and safety risks to patients is defined and implemented (PI.3.20) – At least one high-risk process assessed annually – A failure mode and effects analysis is perfor
Slide 3: Failure Mode & Effects Analysis (FMEA)
Failure Mode & Effects Analysis (FMEA) • Engineering process • Used extensively in the airline and automobile industries • Main applications: – Quality & safety of goods/services – Safety of processes • Application to healthcare is recent PROPRIETARY 3
Slide 4: Definition of FMEA
Definition of FMEA • Systematic analysis of a process • Identifies – ways process might fail (failure modes) – effects or results of failures – possible causes of failures • Actions are taken to reduce potential for failure – prevent or minimize possibility of occurrence – minimize consequences of f
Slide 5: FMEA vs. Root Cause Analysis
FMEA vs. Root Cause Analysis • FMEA – Proactive technique – Identifies and addresses problems before they occur – Incorporates some features of RCA • Root Cause Analysis (RCA) – Retrospective technique – Used to address problems after they occur – FMEA may be used during RCA to identify actions for
Slide 6: Objectives of FMEA in Healthcare
Objectives of FMEA in Healthcare To proactively identify and reduce risk points in healthcare processes that may negatively impact outcomes for patients, caregivers, and healthcare organizations. • Additional benefits: – Increase effectiveness – Increase efficiency – Cost avoidance PROPRIETARY 6
Slide 7: Obstacles
Obstacles • Resistance to change • Lack of personnel time to participate in FMEA • Lack of resources to implement improvement strategies • Reluctance to replace immediate, convenient systems with safer, but more time-consuming ones • Lack of support from leadership PROPRIETARY 7
Slide 8: FMEA Process
FMEA Process • Choose a process • Form a team • Analyze the process • Identify strategies for improvement • Implement strategies • Evaluate effectiveness of actions taken PROPRIETARY 8
Slide 9: Choose a Process
Choose a Process • High-risk or error-prone processes • New processes/procedures – In planning stage – After implementation • Use of equipment • New or renovated facility design • Other aspects of healthcare system – including non-clinical processes PROPRIETARY 9
Slide 10: What to Analyze: High-Risk Medications
What to Analyze High-Risk Medications • Anticoagulants • Parenteral magnesium • Chemotherapy agents • Parenteral narcotics • Insulin • Parenteral potassium • Lidocaine • Parenteral NaCl>0.9% • Midazolam • Vasoactive agents • Parenteral calcium • Neuromuscular blockers PROPRIETARY 10
Slide 11: What to Analyze: Error-prone Procedures
What to Analyze Error-prone Procedures • Examples – Dose calculations and measurements – Telephone/oral transmission of orders – Handwritten and pre-printed orders – Choosing proper items from storage locations – Use of infusion control devices PROPRIETARY 11
Slide 12: What to Analyze: Changes in Processes/Procedures
What to Analyze Changes in Processes/Procedures • Examples – New or changed medication use processes – New diagnostic procedures – New or changed treatment protocols – Formulary drug reviews – Policy and procedure development PROPRIETARY 12
Slide 13: What to Analyze: Incidents Reported in the Literature
What to Analyze Incidents/High-risk processes reported in the literature • Examples – ISMP Medication Safety Alert! – Hospital Pharmacy – American Journal of Health-System Pharmacy – American Journal of Nursing – Journal of Healthcare Risk Management PROPRIETARY 13
Slide 14: What to Analyze: Incidents Reported by Organizations and Agencies
What to Analyze Incidents/High-risk processes reported by healthcare organizations and regulatory agencies • Such as – JC (Sentinel Event Alerts. www.jointcommission.org) – FDA (www.fda.gov/cder/drug/MedErrors) – USP (www.usp.org) – ASHP (www.ashp.org) – NCCMERP (www.nccmerp.org) – NAHQ (www.nahq.or
Slide 15: What to Analyze: Incidents Identified at Your Facility
What to Analyze Incidents/High-risk processes identified at your facility • Through – voluntary reporting of incidents – observation of high-risk processes – review of patient medical records – surveys of practitioners and patients – performance improvement data – evaluation of missing/unadministere
Slide 16: Form a Team
Form a Team • Most effective when conducted by a multidisciplinary team • Include all disciplines involved in the process being analyzed Helpful Tip: – A team of ten or fewer members is generally the most effective and efficient PROPRIETARY 16
Slide 17: Form a Team
Form a Team • Team composition – Pharmacists – Nurses – Physicians – Risk Managers – Others such as • Pharmacy technicians Unit secretaries • Materials management Dieticians • Information systems Laboratory • Radiology Respiratory therapy PROPRIETARY 17
Slide 18: Analyze the Process
Analyze the Process • Understand the process – Track process from beginning to end – A process flow diagram is a helpful tool • Identify potential failure modes at each step in process • Identify the effects of each potential failure • Identify any checks/controls that increase likelihood of detecti
Slide 19: Analyze the Process
Analyze the Process Helpful Tips: – Ensure that the project is manageable – For complex processes focus on an area in the process – Develop flow diagrams of sub processes in the chosen area – Use a system of numbering or lettering for process and sub process steps PROPRIETARY 19
Slide 20: Analyze the Process
Analyze the Process Helpful Tips: – Process flow diagrams can be prepared in advance – The team then reviews the diagram and makes necessary revisions – A time saver for complex processes PROPRIETARY 20
Slide 21: Analyze the Process
Analyze the Process • Prioritize failure modes by estimating – Probability of each failure occurring – Severity of effects of each failure – Probability of each failure being detected • Estimates made – Using ranking scales – Considering documented reports from the literature and from the hospital’s
Slide 22: Analyze the Process
Analyze the Process Helpful Tips: – Ranking scales should be meaningful to the team and to the process under analysis – Keep the scales simple – Develop definitive criteria for each ranking score – Ranking scales are a qualitative assessment tool used to prioritize areas of focus PROPRIETARY 22
Slide 23: Example Severity Ranking Scale
Example Severity Ranking Scale Ranking Category Criteria 1 No Harm No harm to patient 2 Minor Temporary harm to patient; monitoring or minor intervention required 3 Moderate Temporary harm to patient; initial or prolonged hospitalization 4 Major Permanent harm to patient 5 Severe Terminal injury or
Slide 24: Analyze the Process
Analyze the Process • Calculate Criticality Index (CI) for each failure mode CI= O X S X D where: O = frequency of occurrence ranking score S = severity of effects ranking score D = probability of detection ranking score Criticality Index is sometimes referred to as the Risk Priority Number (RPN) PR
Slide 25: Analyze the Process
Analyze the Process • Assign priority ranking for each failure mode in decreasing order of CI – Also may want to assign priority to those with high severity scores even though CI is low Helpful Tips: – Keep clear, detailed documentation – Worksheets or forms can be helpful in recording and compili
Slide 26: Analyze the Process
Analyze the Process • Identify root causes of potential failure modes – Critical to identify all root causes Helpful Tips: – Begin with failure modes with highest CI values – Address remaining failure modes later in descending order – Solutions to failures with highest CI values may be solutions t
Slide 27: Identify Strategies for Improvement
Identify Strategies for Improvement • Identify actions that could reduce the CI • Include actions that: – decrease likelihood of occurrence – decrease the severity of effects – increase probability of detection Helpful Tip: – Don’t reinvent the wheel! Look at strategies implemented or recommended
Slide 28: Identify Strategies for Improvement
Identify Strategies for Improvement • Decide which strategies can be implemented Factors to consider: – Likelihood that failure will be prevented – Likelihood of a long-term vs. short-term solution – Reliability of strategy/action (i.e., will it always work) – Impact on other processes, resources, s
Slide 29: Types of Strategies for Improvement
Types of Strategies for Improvement • Redundancies • Technology • Fail-Safes • Audible alarms • Eliminate item or • Protocols, procedures procedure • Documentation • Limit use or access • Education • Location • Minimize/eliminate • Appearance possibility of error • Tactile clues, special • Minimize
Slide 30: Implement Strategies for Improvement
Implement Strategies for Improvement • Develop an action plan • Develop process and outcome measures, as appropriate • Complete baseline measures of key processes as necessary • Implement action plan Helpful Tip: – Conduct a pilot test in a selected area before facility- wide implementation PROPRI
Slide 31: Evaluate Effectiveness of Actions
Evaluate Effectiveness of Actions • Recalculate CIs of failure modes • Conduct process/outcome measures and reassess key processes and compare to baselines • Improvement shown if reduction in CI values, favorable process/outcomes measures, and improvement over baseline measures • If improvement not
Slide 32: Resources
Resources • JC Failure Mode and Effects Analysis in Healthcare: Proactive Risk Reduction, 2007 • VA National Center for Patient Safety (NCPS) – www.patientsafety.gov/HFMEA.html • JC Perspectives on Patient Safety • Cohen MR, ed. Medication Errors. APhA, 2007 PROPRIETARY 32
Slide 33: Resources
Resources • Hospital Pharmacy, April 1994 – 3 articles • McNally, Page, Sutherland. Am J Health-Syst Pharm. 1997; 54:171-7 • Fletcher CE. J Nur Admin. 1997; 27(12):19-26 • Barker D, et al. J Healthc Risk Manage. 2002; 22:9-12. PROPRIETARY 33
Slide 34: Question and Answer Session
CardinalHealth Question and Answer Session