Practical Application of a Failure Modes and Effects Analysis (FMEA) in the Healthcare Setting

Transcription

1 Practical Application of a Failure Modes and Effects Analysis (FMEA) in the Healthcare Setting Paul Henkel, Director Quality Improvement Consulting, Cincinnati Children s Hospital Medical Center Mary Jo Giaccone Director, Patient Safety, Cincinnati Children s Hospital Medical Center 1

2 Learning Objects Understand the structure and components of a Failure Modes and Effects Analysis (FMEA) Identify when the use of an FMEA might be appropriate in your healthcare setting This document is part of the quality assessment, peer review and risk management activities of CCHMC and, as such, is a confidential document not subject to discovery pursuant to Ohio Revised Code Sections , and All committees involved in the review of this document, as well as those individuals preparing and submitting information to such committees, claim all privileges and protection afforded by ORC Sections , , , and and any subsequent legislation. The information contained is solely for the use of the individual or entity intended. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of the contents of this information are prohibited. 2

3 Agenda Who is Cincinnati Children s Failure Modes and Effects Analysis (FMEA) Basics The FMEA and Safety Practical Examples Summary 3

4 Who is Cincinnati Children s? Established in 1883 PATIENTS Admissions (includes short stay) 33,017 Emergency & Urgent Care Visits 179,857 Patient Encounters 1,307,479 Served pts from all 50 states & 61 countries OUTPATIENT VISITS Primary 85,161 Specialty 884,860 SURGICAL PROCEDURES Inpatient 6,436 Outpatient 28,566 Surgical Hours 45,424 SPONSORED FUNDING >$200 million Third best children s hospital in the country in U.S. News & World Report ranking PEOPLE Active Medical Staff 1,904 Total Employees 15,750 TOTAL OPERATING REVENUES $2,310, registered beds * FY17 data 4

5 Who is Cincinnati Children s? 10 Neighborhood Locations Urgent care Radiology Lab Physical and Occupational Therapies Ophthalmology Dentistry and more Main Campus Located in the center of the city: Full service, not-for-profit pediatric academic medical center Liberty Township August /7 ED Pediatric Medical & Surgical Clinics Imaging & Lab Services Surgical Services 42 inpatient beds Proton therapy and cancer research center College Hill Campus Psychiatric hospital for children and adolescents 5

6 Who is Cincinnati Children s? Our Vision: To be the leader in improving child health Our Mission: Cincinnati Children s will improve child health & transform delivery of care through fully integrated, globally recognized research, education & innovation. For patients from the community, the nation & the world, the care we provide will achieve the best: medical & quality of life outcomes patient & family experiences & Value today & in the future. 6

7 Introduction to the Failure Modes and Effects Analysis 7

8 What is a Failure Modes and Effects Analysis (FMEA)? Definition: Failure Modes and Effects Analysis (FMEA) is a tool for conducting a systematic, proactive analysis of a process in which harm may occur. In an FMEA, a team representing all areas of the process under review convenes to predict and record where, how, and to what extent the system might fail. The FMEA tool prompts teams to review, evaluate, and record the following: Steps in the process Failure modes (What could go wrong?) Failure causes (Why would the failure happen?) Failure effects (What would be the consequences of each failure?) Source: FMEA tool at 8

9 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of Source: FMEA tool at 9

10 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Add water to Add water to Insert filter Press brew button Wrong amount of water Spill water Wrong filter type Didn t start brew cycle Measuring cup not used Water container doesn t have spout Multiple filter types in cupboard Distracted by insistent pet Likelihood of Detection Severity Complete the FMEA from left to right Risk Priority Number Actions to Reduce Occurrence Coffee too weak Use measuring cup Mess on counter and floor; slip risk; electrical risk Coffee overflowed; burn risk Coffee was not made FMEA Use measuring cup with spout Only store most commonly used filters in cupboard Use automatic start feature on Source: FMEA tool at 10

11 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Wrong amount of water Measuring cup not used Coffee too weak Use measuring cup Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 11

12 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Wrong amount of water Measuring cup not used Coffee too weak Use measuring cup Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 12

13 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 13

14 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Use rating scales Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 14

15 Rating Scales Example Rating for Occurrence of Failure Our Example Best Case Worst Case Rating Approximate Probability of Failure Approximate Probability of Failure Description of Occurrence 1 1 x 10-5 <=1/100,000 Extremely remote 2 1 x /100,000 Remote, very unlikely 3 1 x /100,000 Very slight chance of occurrence 4 4 x /10,000 Slight chance of occurrence 5 2 x /1,000 Occasional occurrence 6 1 x /100 Moderate occurrence 7 4 x /100 Frequent occurrence /10 High occurrence /3 Very high occurrence >=1/2 Extremely high occurrence Source: 15

16 Rating Scales Example Rating for Detection of Failure Our Example Best Case Worst Case Rating Description of Detection 1 Almost certain to detect 2 Very high chance of detection 3 High chance of detection 4 Moderately high chance of detection 5 Medium chance of detection 6 Low chance of detection 7 Slight chance of detection 8 Remote chance of detection 9 Very remote chance of detection 10 No chance of detection; no inspection Source: 16

17 Rating Scales Example Rating for Severity of Failure Our Example Best Case Worst Case Rating Severity Description 1 The effect is not noticed by customer 2 Very slight effect noticed by customer, does not annoy or inconvenience customer 3 Slight effect that causes customer annoyance, but they do not seek service 4 Slight effect, customer may return product for service 5 Moderate effect, customer requires immediate service 6 Significant effect, causes customer dissatisfaction; may violate regulation or design code 7 Major effect, system may not be operable; elicits customer complaint; may cause injury 8 Extreme effect, system is inoperable and a safety problem. May cause severe injury. 9 Critical effect, complete system shutdown; safety risk 10 Hazardous; failure occurs without warning; life threatening Source: 17

18 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Press brew button Wrong filter type Didn t start brew cycle Multiple filter types in cupboard Distracted by insistent pet Coffee overflowed; burn risk Coffee was not made Only store most commonly used filters in cupboard Multiply the ratings to determine RPN Use automatic start feature on Source: FMEA tool at 18

19 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 19

20 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 20

21 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of FMEA Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Add water to Spill water Water container doesn t have spout Mess on counter and floor; slip risk; electrical risk Use measuring cup with spout Insert filter Wrong filter type Multiple filter types in cupboard Coffee overflowed; burn risk Only store most commonly used filters in cupboard Press brew button Didn t start brew cycle Distracted by insistent pet Coffee was not made Use automatic start feature on Source: FMEA tool at 21

22 Brewing Coffee a Familiar Example Turn on Add water to Insert filter Add grounds Press brew button Pour cup of Process Steps Failure Mode Failure Causes Failure Effects Likelihood of Occurrence Add water to Insert filter Press brew button Spill water Wrong filter type Didn t start brew cycle Water container doesn t have spout Multiple filter types in cupboard Distracted by insistent pet Mess on counter and floor; slip risk; electrical risk Coffee overflowed; burn risk Coffee was not made FMEA Likelihood of Detection Severity Risk Priority Number Actions to Reduce Occurrence Use measuring cup with spout Only store most commonly used filters in cupboard Use automatic start feature on Use the RPNs to rank the risk and prioritize for mitigation Source: FMEA tool at 22

23 Rating Scales Example 5 point scale Severity 1 Very Low No effect to the patient's health or the reputation of CCHMC (not reported) 2 Low Little effect to the patients health and mild reputation issue with CCHMC (not reported) 3 Moderate Minor effect to patients health and minor reputation damage to CCHMC 4 High Effect to the patients health and impact to reputational damage to CCHMC (Reported) 5 Very High Death to patient, significant impact on hospital reputation, legal and regulatory risk Likely to Occur 1 Hardly Ever less than 10 occurrences in 1 million encounters 2 Occasionally less than 100 occurrences in 1 million encounters 3 Sometimes Less than 1000 occurrences in 1 million encounters 4 Frequently less than 10,0000 occurrences in 1 million encounters 5 Almost Always Greater than 10,000 occurrences in 1 million encounters Ability to Detect 1 Almost Always 100% reliability in ability to detect 2 Frequently 95-99% reliability in ability to detect 3 Sometimes 90-94% reliability in ability to detect 4 Occasionally 50-89% reliability in ability to detect 5 Hardly Ever No reliable ability to detect Source: 23

24 The FMEA and Safety 24

25 FMEA & Safety RCA Hospital Acquired Conditions FMEA 25

26 FMEA & Safety RCA or FMEA RCA Adapted from 2007 Healthcare Performance Improvement, LLC ALL RIGHTS RESERVED 26

27 FMEA & Regulatory Centers for Medicare and Medicaid Services Standard: Executive Responsibilities The hospital s governing body are responsible and accountable for ensuring the following: That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained. That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated Condition of Participation: Quality assessment and performance improvement program The Joint Commission Leadership Proactive Risk Assessment RCA required for Serious Safety Events and Sentinel Events 27

28 The FMEA in the Healthcare Setting 28

29 Practical Examples Proactive Risk Assessment (TJC) Refrigerator temperature monitoring Employee Safety Event Bodily Fluid Exposure, post-mortem care Patient Safety Event Trach Safety at Home 29

30 Example #1 Refrigerator Temperature Monitoring Monitoring Clinical Refrigerator/Freezer temperatures: The reliability of monitoring temperature alarms was identified as an area of risk for the institution. When a monitored device goes out of limits, the contents (pharmaceuticals, vaccines, food and lab specimens) can create risk for patients or at a minimum create financial waste if they have to be destroyed. Process Map: Device Alarms Appropriate personnel are notified of alarm Alarm is investigated Contents are destroyed or moved as necessary Device is adjusted, repaired or replaced Resolution is documented in RMMS 30

31 Example #1 Refrigerator Temperature Monitoring Current Process Assessment Process Function Potential Failure Mode Potential Effect(s) of Failure Severity (1-5) Potential Cause(s)/ Mechanism(s) of Failure Likely to Occur (1-5) Current Process Controls Ability to Detect (1-5) R P N Device alarms - Device fails Death of patient, reputational, legal and reg risk 5 Device alarms - Sensor fails Death of patient, reputational, legal and reg risk 5 Device alarms - RMMS range or set point is improperly set Death of patient, reputational, legal and reg risk 5 Device alarms - RMMS malfunction Death of patient, reputational, legal and reg risk 5 Device alarms - Power failure Death of patient, reputational, legal and reg risk 5 Device alarms - Network failure Death of patient, reputational, legal and reg risk 5 Device alarms - Wrong pager number Death of patient, reputational, legal and reg risk 5 Device alarms - Pager alert not heard Death of patient, reputational, legal and reg risk 5 Device alarms - Pager system not functioning Death of patient, reputational, legal and reg risk 5 Device alarms - Device not RMMS Death of patient, reputational, legal and reg risk 5 Device alarms - Temp range/limits were too narrow and not standard across types Death of patient, reputational, legal and reg risk 5 Local equipment failure Local equipment failure Individual personnel Systematic failure Systematic failure Systematic failure Individual personnel Individual personnel Systematic failure Process failure Process failure 3 RMMS RMMS No process No process RMMS RMMS No process No process RMMS No process No process 5 25 Appropriate personnel are notified of alarm - Incorrect contact number listed Death of patient, reputational, legal and reg risk 5 Appropriate personnel are notified of alarm - Personnel change Death of patient, reputational, legal and reg risk 5 Appropriate personnel are notified of alarm - Personnel can t access space after hours Operational issue no risk to patient 1 Appropriate personnel are notified of alarm - New personnel that don t know how to respond Problem will be resolved before patients are impacted 1 Appropriate personnel are notified of alarm - No backup listed or backup is off Death of patient, reputational, legal and reg risk 5 Appropriate personnel are notified of alarm - Secondary people being contacted (first responder and onsite personnel) Nuisance 1 Individual personnel failure Process failure Process failure Process failure Process failure Process failure 5 no process no process no process no process no process no process 5 25 Alarm is investigated - Nobody onsite to investigate Operational issue; will be resolved without risk 1 Alarm is investigated - Onsite personnel is contacted but fails to investigate No response, high risk 5 Alarm is investigated - Incorrect determination of issue/non-issue Will alarm again 3 Alarm is investigated - Invalid alarm Human capacity drain 1 Alarm is investigated - Investigation of incorrect unit Delay in appropriate investigation 3 Will keep trying; won't use med; financial risk of Alarm is investigated - Pharmacy unavailable for consultation 1 unnecessary waste Alarm is investigated - Staff not trained to access RMMS to check device history Secondary research into device failure 1 Alarm is investigated - First responder does not go to site No response, high risk 5 Will keep trying; won't use med; financial risk of Alarm is investigated - Clinical staff not available to accompany Hospital Operations/PE first responders into med rooms 1 unnecessary waste Alarm is investigated - Didn t document resolution in RMMS Audit risk 3 Process failure Individual personnel failure Individual personnel failure Local equipment failure Individual personnel failure Process failure Process failure Individual personnel failure Process failure Individual personnel failure 5 no process no process rmms rmms rmms no process no process rmms rmms no process 5 75 Contents are destroyed or moved as applicable - Contents destroyed unnecessarily Financial risk or unavailable medicine 3 Contents are destroyed or moved as applicable - Contents not destroyed when they should be Death of patient, reputational, legal and reg risk 5 Contents are destroyed or moved as applicable - Contents not moved from malfunctioning device Death of patient, reputational, legal and reg risk 5 Contents are destroyed or moved as applicable - Contents moved to inappropriate storage Death of patient, reputational, legal and reg risk 5 Contents are destroyed or moved as applicable - No suitable alternate storage is available Risk to unnecessary disposal 3 Contents are destroyed or moved as applicable - Contents not replaced as required so unavailable to meet operational/clinical needs Patient risk 3 Contents are destroyed or moved as applicable - Appropriate transportation/courier not available to move contents. Risk to unnecessary disposal 3 Individual or process failure Individual or process failure Individual or process failure Individual or process failure Process failure Individual or process failure Process failure 1 no process no process no process no process no process no process no process 5 15 Device is adjusted, repaired or replaced as applicable - Device comes back into limits just for the time that maintenance is onsite but fails again Inconvenience to PE 1 Device is adjusted, repaired or replaced as applicable - Purchase wrong brand/model of device Inconvenience to PE 1 Device is adjusted, repaired or replaced as applicable - Device not taken out of service when it has a history of failure Inconvenience to PE 1 Device is adjusted, repaired or replaced as applicable - Improper installation of device (not in accordance with instructions) Death of patient, reputational, legal and reg risk 5 Device is adjusted, repaired or replaced as applicable - Device was adjusted incorrectly Problem wasn't resolved, will continue to alarm 1 Device is adjusted, repaired or replaced as applicable - Device adjusted by non-maintenance or untrained staff Problem wasn't resolved, will continue to alarm 1 Device is adjusted, repaired or replaced as applicable - Not enough space to place the appropriate sized device Issue will have to be resolved; device will alarm 1 Process failure Individual or process failure Process failure Individual or process failure Individual personnel failure Individual or process failure Process failure 5 rmms no process no process rmms rmms rmms no process 5 5 Resolution is documented in RMMS - Failure to document Regulatory risk 3 Resolution is documented in RMMS - Insufficient information provided in RMMS Regulatory risk 3 Resolution is documented in RMMS - Documentation not provided by appropriate staff (done by inappropriate staff) Regulatory risk 3 Resolution is documented in RMMS - Resolution is documented on wrong alarm Regulatory risk 3 Resolution is documented in RMMS - Resolution not completely communicated to individual completing documentation in RMMS Regulatory risk 3 Individual or process failure Individual or process failure Individual or process failure Individual personnel failure Individual personnel failure 5 no process no process no process no process no process

32 Example #1 Refrigerator Temperature Monitoring 32

33 Example #1 Refrigerator Temperature Monitoring Actions taken and mitigating controls: Updated pager listing Developed and implemented ongoing review of contact numbers Implemented systematic audit of alarm responses to ensure contacts are being reliably made. Impact: Acknowledgement process for temperature alarms increased in reliability from 10% to 95%. 33

34 Example #2 Employee Safety Employee Safety Leaking Body Bag: One of our chaplain staff was assisting with the transport of an expired patient. She was unsure about where to find PPE once at the morgue. She exposed herself to bodily fluids (due to a leaking body bag) from a patient who had been diagnosed with meningitis. Process Map: Patient Expires on the Unit Patient placed in body bag shroud RN calls for Protective Services, Chaplain and Transport to take patient to the morgue Patient moved from bed to discreet cart. Once at the morgue, the RN scans the patient and checks patient into the system Patient moved from discreet cart to the cooler. Patient is placed in the cooler. For funeral home pick up, Security and Chaplain come with funeral director. Chaplain signs in to remove body from cooler. Notification goes to Pathology staff when body retrieved. Body moved from cooler cart to funeral home gurney Body is transported out by funeral director, chaplain and Security. 34

35 Example #2 Employee Safety Rating Scales Used Frequency 1 rare 2 uncommon 3 common Severity 3 No harm 6 Slips/Strains 9 Hazardous Exposure 35

36 Example #2 Employee Safety Process Step Failure Mode Failure Cause Failure Effects Patient placed in body bag shroud -Do not have right size body bag -Bag not liquid tight -No infectious flag -Not stocked -Poor quality bag -Not standard procedure -Bag too tight on body -Bag leaks -No awareness of need for PPE Likelihood of Occurrence Severity RPN Actions for Mitigation Purchase more bag sizes of higher quality -Apply chucks underneath body -Treat all bodies as biohazard 36

37 Example #2 Employee Safety Actions taken and mitigating controls: Larger sized body bag is now available through the storeroom Investigating new body bags that have additional zipper protection EVS has a process to follow in order to assure that they are prepared to clean bodily fluids Refresher information provided to clinical staff from infection control for the handling of deceased patients 37

38 A Cincinnati Twist - Simplified FMEA (sfmea) 3 Interventions 1 Current process from High Level Process Map 2 Failure Modes 38

39 Example #3 Trach Safety at Home Trach Safety: Higher incidence of trach events at home than expected 5 patients with ventilator support 2 patients with only tracheostomy tube Process Map: Initiate trach care Arranging for equipment and supplies Arranging for home care services Parents meet unit training requirements Care at home Follow up visits 39

40 Example #3 Trach Safety at Home 40

41 Example #3 Trach Safety at Home Standardize training across unit and trainers Identify designated trainers More frequent and stringent competency assessments Conduct simulation Initiate trach care training for parents Variation between units on who does the training Standards can be different between what trainers Annual trach competency training may fall short of what is needed to make staff comfortable Staff need to carve out time to conduct family training EMS training 41

42 Example #3 Trach Safety at Home Actions taken and mitigating controls: Standardize Caregiver Education Optimize 24 Hour Stay Simulation Head of the Bed Airway Sheet Home Organization HEROES Program Training home care nursing prior to patient discharge Build Trach Registry Improve standard for follow up care 42

43 Summary 43

44 Lessons Learned RCA FMEA Consistent process important Communication to Sr. Leaders & area leaders Executive Sponsor Team Leaders Team Members Event Manager Safety Support Report out to Safety Oversight Group House wide presentation 44

45 Challenges Sustain - Ongoing monitoring of action plan 6mo, 12mo, 24mo Spread Leadership driven clear the deck/reprioritize Included in FY priority planning 45

46 Questions? 46