1. Sandra Thompson Administrator, Quality Resources/Compliance Laurens County Health Care System Clinton, SC Thursday, May 31, 2012

2.  Discuss establishing a “Culture of Safety”  Describe the linkage between and importance of FMEA to RM  Identify the TJC FMEA requirements  Discuss the basics of failure mode and effects analysis  Identify tools and resources for further information & study

3.  1995: “The year that medicine went to Hell in a handbasket” - Dennis O’Leary, JCAHO President, 9/01  Tampa: Wrong site surgery  Dana Farber: Chemo event  Martin Memorial: Anesthesia event  These events helped drive a consensus for change

4.  Imperative driven by IOM reports  “To Err is Human” – 1999  “Crossing the Quality Chasm” – 2000  Culture of Safety is owned by ALL  Not physicians, Administration, or a single department  Requires new tools, new thinking, new information not traditionally utilized in healthcare  FMEA, RCA, Six Sigma, Lean, Systems Engineering, ????

5.  Root cause analysis  Lean  Forcing functions (poke yoke)  Standardization (5S)  Customer focus (value stream mapping)  Front-line staff involvement (observation – “going to the gemba”, spaghetti diagrams)  Push/pull systems (patient flow)  High-reliability organizations  “Going for Zero”  Electronic health record  Proactive risk assessment  Healthcare FMEA!

6. Least Effective Most Effective Forcing Functions Automation, Computerization Protocols, Pre- Printed Orders Standardization Checklists Information Education Rules & Double- Checking Effectiveness Scale Inspection Auditing Proactive Reactive HFMEA is a proactive means of assessing & decreasing risk in your organization! Proactive Risk Assessment (FMEA, HFMEA)

7.  FMEA  Failure Mode & Effect Analysis  Traditionally used in industry  Looks at a device or a component  HFMEA  Healthcare Failure Mode & Effect Analysis  Looks at a process

8.  Process developed by VA Pt. Safety Center  Online tutorial at:  http://www.patientsafety.gov/CogAids/HFMEA/inde x.html#page=page-1 http://www.patientsafety.gov/CogAids/HFMEA/inde x.html#page=page-1

9.  Do you take actions to prevent yourself from being late to work? Yes or No  Do you “take the shortcut” when you see traffic building up in a familiar place? Yes or No  Do you try to distinguish “big problems” from “little problems”? Yes or No  Do you see the possibility of eliminating some problems, but need a better way to show that to people? Yes or No

10.  Failure  When process begins to produce undesired results/effects  Failure Mode  Weakness/vulnerability in any part of process  Chain of events that has potential to cause safety problem

11.  Assists RMs to favorably impact the patient care environment  Another tool in the box of RM strategies to understand and reduce medical error  Assists RMs & others in driving change before it can do harm  Proactively forecasts potential failures  Applies risk /loss control techniq ues to those potential failures

12.  What philosophy ?  “Blame free” vs. “Just Culture”  Do we see systems or individuals?  Are the right tools & resources available for the job?  What is an incident to be reported at your facility?  Close call/near miss/”good catches”?  Only adverse events (e.g., “harm”)?  Sentinel events?  Where do willfully unsafe acts fit in? Disruptive behavior?

13.  Design/redesign incident reporting systems to capture near misses  Predictive – show patterns around a process – 100:10:1  Rich source of information  Reward/encourage near miss reporting  Follow up on near misses and trend  Don’t forget the narrative! Important details found here  Close the loop – report back to staff on trends, patterns noted, solicit suggestions for improvement

14. Must filter the tidal wave!

15. Assign Severity Catastrophic Failure could cause death or serious injury (Sentinel Events) Major Permanent lessening of bodily functioning, disfigurement, surgical intervention required, additional treatment required (3 or more patients) Moderate Increased LOS, increased level of care (1-2 patients) Minor No injury, no increased LOS, no increased level of care For each reported incident:

16. Assign Frequency: Frequent: Likely to occur immediately or within a short period (may happen several times in one year) Occasional: Probably will occur (may happen several times in 1-2 years) Uncommon: Possible to occur (may happen sometime in 2-5 years) Remote: Unlikely to occur (may happen sometime in 5-30 years)

17.  Apply the risk management equation  Severity x Frequency = RISK  What resources per level of risk?  Examine trends/patterns Probability Severity CatastrophicMajorModerateMinor Frequent3321 Occasional3211 Uncommon3211 Remote3211

18.  Sources:  Your incident report data  Loss runs/claims data  Brainstorm list of HR processes for your organization  Consider physical resources, environment, staffing, etc.  Worker’s Compensation reports  Literature  Sentinel Event Alerts  Infection Control data  IHI  Joint Commission  Organizational strategic quality goals/objectives

19.  Multidisciplinary group who have hands-on experience with the selected process/procedure  Include physicians!  RM role  May be multifaceted  CAUTION: Leader/Facilitator

20.  ABSOLUTE MUST:  Direct observation of process (Lean)  Tools:  “Process Mapping” vs. Flowcharting  Fishbone (Cause & Effect Diagram)  Current State Stream Maps (Lean)  Differentiate - need TWO maps!  “The way things were intended to work”  “The way things are actually working”

21. Medication ordered Auto electronic transfer to Pharmacy system Pharmacy fills scipt; sends to floor Nurse administers Process Step Sub-Processes A.Dummy terminal B. PCs A.Check drug allergies B.Check drug interactions C.Check proper dosages D.Orders labs E.Order sent to auto dispensing A.Automatically fills orders checked B.Drugs pulled and script filled C.Med cart filled D.Cart sent to floor A.Log on to laptop B.Medcart C.Medications scanned D.Patient band scanned E.Medication given to pt. F.Pt. record updated 1234 Sub-Processes A.Dummy terminal B. PCs

22.  Compare “ideal” vs. “reality”  May be multiple failure modes – list all  Each failure mode can have multiple possible effects  Tool: Brainstorming  Ask:  What could fail with this step? (i.e., failure modes)  Why would this failure occur? (i.d., causes)  What could happen if this failure occurred? (i.e., effects)

23.  Assess risk – severity/probability  Tools:  Fishbone (C&E) Diagram  Hazard Scoring Matrix (HFMEA) Probability Severity CatastrophicMajorModerateMinor Frequent161284 Occasional12963 Uncommon8642 Remote4321

24.  Decision (proceed or stop)  If score 8 or higher & decision to stop, document rationale  Tools:  Decision Tree (HFMEA)  HFMEA Worksheet  Develop action plan for change  Include outcome measures, management concurrence

25.  Concerns re: discoverability  Could provide potent evidence for plaintiff if all potential failures not addressed & mishap occurs involving that failure point  Follow current procedures under state law relative to peer review protection  Must be produced under guidance of medical staff & reviewed in “medical staff committee”  Include “disclaimer” on document  Seek guidance from legal counsel

26.  Seek support from senior leadership  Executive/Administrative Sponsor?  Include physicians  Physician Champion  Seek out trained facilitator OR get training in facilitation  Important to open communication  Involve front-line staff; give them ownership  Look for best practices already identified for the process being assessed

28.  VA Center for Patient Safety  HFMEA Toolkit  http://www.patientsafety.gov/CogAids/HFMEA/index.ht ml#page=page-1 http://www.patientsafety.gov/CogAids/HFMEA/index.ht ml#page=page-1  Institute for Healthcare Improvement  Online tool for conducting FMEA; can be shared  Tutorials, journal articles  Completed examples  http://www.ihi.org/knowledge/Pages/Tools/FailureMod esandEffectsAnalysisTool.aspx http://www.ihi.org/knowledge/Pages/Tools/FailureMod esandEffectsAnalysisTool.aspx

29.  http://www.patientsafety.gov/SafetyTopics/HFMEA /FMEA2.pdf http://www.patientsafety.gov/SafetyTopics/HFMEA /FMEA2.pdf  http://psnet.ahrq.gov/resource.aspx?resourceID= 1531 http://www.patientsafety.gov/SafetyTopics/HFMEA /HFMEAIntro.pdf http://psnet.ahrq.gov/resource.aspx?resourceID= 1531 http://www.patientsafety.gov/SafetyTopics/HFMEA /HFMEAIntro.pdf  http://intranet.uchicago.edu/quality/FailureMode sandEffectsAnalysis_FMEA_1.pdf http://intranet.uchicago.edu/quality/FailureMode sandEffectsAnalysis_FMEA_1.pdf  http://www.patientsafety.gov/SafetyTopics/HFMEA /HFMEA_JQI.pdf http://www.patientsafety.gov/SafetyTopics/HFMEA /HFMEA_JQI.pdf