FMEA Failure Risk Scoring Schemes

FMEA Failure Risk Scoring Schemes 1-10 Scoring for Severity, Occurrence and Detection CATEGORY Severity 10 9 8 7 6 5 3 2 1 Hazardous, without warning Hazardous, with warning Very High High Moderate Low Very Low Minor Very Minor Occurrence < = 1 in 2 1 in 3 1 in 8 1 in 20 1 in 80 1 in 00 1 in 2000 1 in 15000 Detection Absolute Very Remote Very Low Moderate Moderately High Uncertainty Remote Low High Severity x Occurrence x Detection = Risk Priority Number (RPN) 1 in 150000 Very High None > = 1 in 150K Almost Certain National Patient Safety Agency (UK) Risk Assessment Scoring Matrix 1 More than once a day 6 High High High High Likelihood Once a day to once a week Once a week or once a month Once a month to once a year Once a year to once every 10 years Less than once every 10 years 5 Medium High High High Medium Medium High High 3 Low Medium Medium High 2 Low Low Low Medium 1 Low Low Low Low A Low (Minimal harm) B Moderate (Short-term harm) Consequence C Severe (Permanent or longterm harm) D Fatality (Death of one or more people) 1-5 Scoring for Consequence and Likelihood Consequence scores Score Likelihood scores No injury/adverse outcome 1 Rare Short term injury or damage 2 Unlikely Semi permanent injury/damage 3 Possible Permanent injury/damage Likely Death 5 Almost certain Consequence x Likelihood = Risk Ranking 1 http://www.npsa.nhs.uk 1

1-5 Rating scale developed by the Department of Clinical Effectiveness and Quality Improvement, University of Pennsylvania Health System Likelihood rating scale Rating Description Definition 5 Very high: failure is most 1 in 5 inevitable High: repeated failures 1 in 50 3 Moderate: occasional failures 1 in 500 2 Low: relatively few failures 1 in 5000 1 Remote: failure is unlikely <1 in 500,000 Severity rating scale Rating Description Definition 5 Catastrophic event Death or serious physical or psychological injury or the risk thereof. Serious injury specifically includes loss of limb or function. Must meet two of the three criteria: 1. Results in unanticipated death or major permanent loss of function 2. Associated with a significant deviation from the usual process 3. It has the potential for undermining the public confidence Major event Injury or permanent loss of bodily function (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased LOS, increased level of care. 3 Moderate event An event, occurrence, or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not cause an unanticipated injury or require the delivery of additional healthcare services 2 Minor event Failure is not noticeable to the patient and would not affect delivery of care. Failure can be overcome with modifications to the process; failure may cause minor injury. 1 Near miss A process variation that does not affect the outcome but for which a recurrence carries a significant chance of a serious outcome. No injury, no increased LOS or level of care. Ability to detect rating scale Rating Description Definition 5 Absolute uncertainty Potential failure mode and subsequent effect cannot be detected in time for adequate intervention Remote Remote chance that the potential failure mode and subsequent effect will be detected in time for adequate intervention 3 Low Low chance that the potential failure mode and subsequent effect will be detected in time for adequate intervention 2 Moderately high Moderately high chance that the potential failure mode and subsequent effect will be detected in time for adequate intervention 1 Almost certain The potential failure mode and subsequent effect will be detected in time for adequate intervention 2

1- Scoring for Severity and Probability 2 (based on the VA HFMEA rating scale) Key for Severity Rating Severity Score Patient Outcome Description 1 Minor No injury, increased length of stay, or increased level of care 2 Moderate Increased length of stay or increased level of care for 1 to 2 days 3 Major Permanent lessening of bodily function (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more days, increased level of care for 3 or more days Catastrophic Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, surgical/procedure on the wrong patient or wrong body part, infant abduction or discharge to wrong family Key for Probability Rating Probability Description Score 1 Remote Unlikely to occur (may happen sometime in 5 to 30 years) 2 Uncommon Possible to occur (may happen sometime in 2 to 5 years) 3 Occasional Probably will occur (may happen several time in 1 to 2 years) Frequent Likely to occur immediately or within a short period (may happen several times in one year) Hazard Scoring Matrix (Hazard score = Severity Score x Probability Score) (Failure modes with scores that fall in the gray area (8 or greater) should be given highest priority Probability Severity of Effect Catastrophic Major Moderate Minor Frequent 16 12 8 Occasional 12 9 6 3 Uncommon 8 6 2 Remote 3 2 1 Comment from people involved in the HFMEA on IV Medication Administration Pump Programming 3 In the problem prone, high risk IV medication administration process, the HFMEA scoring method did not allow for minute differentiation of probability, severity and detectability scores and therefore made prioritization of failure modes difficult. 2 Day, S., Dalto, J., Fox, J., & Turpin, M. (2006). Failure mode and effects analysis as a performance improvement tool in trauma. Journal of Trauma Nursing, 13(3), 111-117. 3 Challenges With The Performance Of Failure Mode And Effects Analysis In Healthcare Organizations: An IV Medication Administration HFMEA. Presentation at the Annual Conference of the Human Factors and Ergonomics Society September 20-2, 200 3

Prevention of Patient Falls Improvement Priority (1 = highest priority; 10 = lowest priority)* Process Step Potential Failure Mode Effect Conduct initial assessment using Morse Fall Risk Assessment tool Record total score on the patient s interdisciplinary care plan Implement High Risk Fall Prevention plan of care if Morse Fall Risk score is 50 or higher or nurse judges patient to be at higher-than-normal risk for fall Communicate patient s fall risk to other disciplines Monitor patient Patient s fall history not available at time of initial assessment Patient s report of his/her fall history is not reliable Nurse does not accurately calculate fall risk using Morse Assessment tool Score not recorded Not enough equipment (chairs, bed alarms, signage) All shifts and disciplines do not implement interventions consistently Fall Prevention plan not implemented as required by policy/procedure Inadequate communication among disciplines Patient not monitored as required by policy/ procedure Fall risk re-assessments not documented in patient record Incomplete assessment Inaccurate Morse score Inaccurate Morse score Caregivers not made aware of patient s fall risk; proper fall prevention precautions not instituted Delay in implementing fall precautions Increased risk for patient fall Increased risk for patient fall Other disciplines not made aware of patient s fall risk; proper fall prevention precautions not used Increased risk for patient fall All caregivers/disciplines not made aware of patient s current fall risk; increased risk for patient fall My Opinion Group Average** When scoring your improvement priorities consider how often you think the failure mode actually occurs (or the risk of it occurring) and the consequences or effect failure occurrence would have on the incidence of patient falls * Give each failure a different number; starting with what you feel is the highest priority failure mode that needs to be prevented (#1) down to the lowest priority failure mode that needs to be prevented (#10) ** Group average = sum of each person s score divided by total number of people voting

Examples of Actions Based on Human Factors Science Reduce Errors Involving Administration of IV Solutions & IV Medications 1. Reduce the variety of IV solutions available as floor stock to the most frequently used IV solutions Identify the solutions used 80% of the time and gain consensus on which should be kept as floor stock. Inform physicians of those solutions that are most readily available (laminated card or notice in computer system) Establish a rapid turnaround delivery process for all other IVs 2. Standard concentrations of IV solutions will be used 3. Tag large volume IV solutions before hanging Nurse will tag all IV solutions that do not come from pharmacy with a tag before she hangs them Make the label large enough to include: name, date, solution and rate. Independent double checks of IV medications, pump settings and IV tubing All IV meds, pump settings, and IV tubing will be double-checked before administration All IV meds, pump settings, and IV tubing will be double-checked before patient transfer For all potentially hazardous IVs: medication, pump settings, and IV tubing will be doublechecked at change of shift 5. Drug specific labels containing flow rate calculations will be placed on each IV 6. Only one kind of pump in each class will be available in the hospital. 7. No free flow devices will be used and all devices have forcing functions to prevent misprogramming 8. Standard IV orders will be programmed into the computerized order entry system. 9. IV flush procedures and solutions will be standardized 10. Change the arrangement of the medication access control device (Sure-med and Pyxis) so that only one injection is available per drawer Agency for Healthcare Research and Quality resource on Mistake Proofing: http://www.ahrq.gov/qual/mistakeproof/ 5

FMEA on the process of administering a 2 nd IV Predicted Scores After Actions Implemented Process Steps or Activity Failure Modes Probability/ Frequency Effects of Failure Severity Score Hazard Score Recommended Actions Probability/ Frequency Severity Score Hazard Score Hang secondary IV bag and open clamp on secondary bag Infuse secondary bag Failure to open clamp on secondary bag. Clamp opened but secondary bag does not infuse. Failure to verify secondary bag is dripping. IV pump defaults to primary bag at secondary bag rate without alarming. Patient receives a bolus from the primary bag based on the rate change for secondary bag. Does not receive the medication in the secondary bag. Nurse unrolls clamp, but IV pump may not recognize that secondary bag has been hung secondary possibly due to incompatibility issue. IV pump automatically draws from the primary bag. IV pump defaults to primary bag at secondary bag rate without alarming. Patient receives a bolus from the primary bag and does not receive the medication in the secondary bag. 3 12 2 8 3 12 Take issue to Clinical Education Team to develop plan to heighten awareness of the trend and the need to ensure opening the clamp on the secondary bag is occurring. Clinical Education Team may consider the following: - Heighten awareness: Utilize safety checklist hung on laminated x6 cards on rings attached to the infusion pump for quick reference to open clamp. - Heighten awareness on need to complete occurrence report on IVPB omissions. - Evaluate if interruptions, distractions, etc. can be reduced. Department managers or designee will intermittently walk around unit and observe IVPB administration process to confirm heightened awareness. Nurses that participated in FMEA to talk with their peers about the FMEA process and what they learned (trend of omissions related to clamp not open and goal of heightening awareness of problem). Biomed contacted representative. Secondary to conversation it was determined that there was not a software fix. However, the representative informed hospital of an incompatibility issue with the secondary tubing (not a hospital alert). Biomedical engineering dept trends all infusion device problems/incidents to identify problems as either hard failures (device malfunction is confirmed) or potential user error/confusion and will communicate problems to the pump manufacturer, ECRI and the FDA as appropriate. More than five similar pump problems without determination of cause will trigger Safety Committee involvement. Purchase/utilize flow sensors on Primary bag. If the pump detects drops from the primary bag while in secondary mode, the pump will alarm. Purchase and use pen lights for use when hanging medications in dark room. Re-educate staff on the goal and importance of walking rounds. Probability/Frequency: (1 = low/unlikely; 5 = high/very likely) Severity: (1 = no significant effect; 5 = very significant effect/death) Hazard Score: Probability x Severity 6

FMEA Scoring Grid (based in part on Joint Commission requirements) 1. Was a high-risk process selected for the project? 2. Was the process (as it now functions) described? 3. Did the team identify ways in which the steps in the process could break down (the failure modes)? Criteria YES PERHAPS NO. Did the team identify the possible effects of the failure modes on patients and the seriousness of the effects? 5. Did the team prioritize failure modes for analysis and action? 6. Did the team analyze high priority failure modes to determine why they could occur? 7. Were actions proposed/taken to minimize/reduce the risk of failure or to protect patients from the effects? 8. Will the risk of failures be eliminated or reduced by the actions taken? Or the effects mitigated? 7