Central Service Association Of Ontario Fahrenheit 270

1. Central Service Association Of OntarioFahrenheit 270 Failure Modes and Effects Analysis

4. ISMP CANADA Vision • Independent nonprofit Canadian organization • Established for: • the collection and analysis of medication error reports and • the development of recommendations for the enhancement of patient safety. • Serves as a national resource for promoting safe medication practices throughout the health care community in Canada.

5. ISMP Canada Mission: • Committed to the safe use of medication through improvement in drug distribution and drug delivery system design. • Collaborate with healthcare practitioners and institutions, schools, professional organizations, pharmaceutical industry and regulatory & government agencies to provide education about adverse drug events and their prevention

6. Objectives • To introduce the principle and application of FMEA tool/process • To discuss its application in healthcare facilities • To briefly review the FMEA process

7. Failure Mode and Effects Analysis • ISMP Canada one day workshop • 4 exercises of 45 – 60 minutes • Practce on your own issues

8. Human Factors Engineering 101 HFE: a discipline concerned with design of systems, tools, processes, machines that take into account human capabilities, limitations, and characteristics

9. Human Factors Engineering • Research and practical applications designed to improve the interface of humans with systems • Develops practical design principles that account for the psychological and physical characteristics of people

10. Human Factors Engineering Principles • Simplify key processes • Standardize work processes • Anticipate that human make errors • Use checklists • Improve label design • Promote effective team functioning

11. Constraint: Hydromorphone 10 mg was removed

12. Engineering Begin with premise that anything can and will go wrong Don’t expect humans to perform perfectly or without variation Design systems accordingly and are proactive Health Care Errors are the result of human failures Humans generally perform flawlessly Perfect performance is the expectation Use re-training, and punishment to root out bad apples The “Brain Flip” Needed in HealthCare

13. Human Factors – Guiding Principle Fit the task or tool to the human, not the other way around.

14. High Reliability Organizations (HRO) Characteristics • Collective preoccupation with the possibility of failure” • Expect to make errors and train their workforce to recognize and recover from them • Continual rehearsal of familiar scenarios of failure

16. FMEA Definition • FMEA is a team-basedsystematic and proactive approach for identifying the ways that a process or design can fail, why it might fail, the effects of that failure and how it can be made safer. • FMEA focuses on how and when a system will fail, not IF it will fail.

17. Why FMEA? • Brings analysis logic into the hospital • Is a proactive approach for quality and safety • Initiates system fixes before a patient dies or is injured • Makes systems more “robust” and enhances performance • Makes systems more “fault tolerant” • Focuses on systems, not individuals

18. Everyday FMEA

19. FMEA versus RCA(when to use) FMEA = Future (preventative) RCA = Retrospective (after the event or close call)

20. FMEA Origins • FMEA in use more than 40 years beginning in aerospace in the 1960s • 1970s and 1980s used in other fields such as nuclear power, aviation, chemical, electronics and food processing fields ( High Reliability Organizations) • Automotive industry requires it from suppliers, reducing the after-the-fact corrective actions

21. FMEA is a tool to: • Analyze a process to see where it is likely to fail. • See how changes you are considering might affect the safety of the process.

22. CCHSA Patient Safety Goals 2005 • Create a culture of safety within the organization • The organization has in place a formal team/committee whose sole focus is patient safety, and that does one proactive RCA or FMEA a year.

23. FMEA Steps

24. FMEA Steps (cont)

25. Step 1 Step 2 Step 3 Select a high risk process and assemble the team FMEA Process Steps

26. Select a high-risk process • Internal data – aggregate data, significant individual events • Sentinel Events • CCHSA Patient Safety Goals • ISMP Canada • Executive buy-in Select processes with high potential for having an adverse impact on the safety of individuals served.

27. High Risk Processes - Definition • Those processes in which a failure of some type is most likely to jeopardize the safety of the individuals served by the health care organization. Such process failures may result in a sentinel event.

28. High Risk Processes - Examples • Medication Use • Operative and other procedures • Blood use and blood components • Restraints • Infection control • Care provided to high-risk population • Emergency or resuscitation care

29. Assemble a team • Leader • Facilitator • Scribe / Recorder • Process experts • Include all areas involved in the process • “Outsider” /Naïve person • 6-10 optimal number

30. Step 1 Step 2 Step 3 Select a high risk process Diagram the and assemble Process the team FMEA Process Steps

31. Diagram (flow chart) the process • Define beginning and end of process under analysis • Chart the process as it is normally done • Using the collective process knowledge of the team, a flow chart is sketched.

32. Why diagram the process? • Diagrams clarify things between members • Narrows the topic – goes from broad topic e.g. narcotic use process to narrow topic e.g. morphine removed from narcotic drawer

33. Narcotic Drug Use Process Number Basic Steps 1 2 3 Receive drugs from Check drugs into Dispense to patient Pharmacy vendor pharmacy care area 4 5 6 Remove from stock Document drug one dose at a time Administer drug to administration and as patients request patient record waste medication

34. Narcotic Drug Use Process Select One Portion of Process at a Time to Diagram 1 2 3 Receive drugs from Check drugs into Dispense to patient Pharmacy vendor pharmacy care area 4 5 6 Remove from stock Document drug one dose at a time Administer drug to administration and as patients request patient record waste medication

35. Narcotic Drug Use Process Diagram the Sub - Process Steps Receive request Technician pulls Narcotic and from Patient Care drug from Narcotic request set out to Area vault / cabinet be checked Pharmacist checks Technician hand Technician drug against carries to the assembles drug ( s ) request Patient Care Area

36. Step 1 Step 2 Diagram the Process FMEA Process Steps Step 3 Select a high Brainstorm risk process potential and assemble failure modes the team

37. Brainstorm potential failure modes • People • Materials • Equipment • Methods • Environment Failure modes answer the WHAT could go wrong question

38. Handy Hints • Failure Modes are the WHATs that could go wrong • Failure Mode Causes are the “WHY”s • May be more than one cause for each failure

39. Narcotic Drug Use Process Potential Failure Modes 3 A 3 B 3 C 3 D 3 E 3 F Technician pulls Technician hand Receive request Narcotic and Pharmacist Technician drug from carries to the from Patient request set out to checks drug assembles Narcotic vault / Patient Care Care Area be checked against request drug ( s ) cabinet Area 1 1 1 1 1 1 Technician pulls wrong Technician forgets to set Technician drops drug or Request never received Pharmacist doesn’t check Technician grabs partial drug out on counter request 2 2 2 2 2 2 Technician doesn’t pull Drug diverted while sitting Pharmacist checks only Technician grabs order Technician hijacked on Pharmacy is closed drug out on counter part of request for closed unit way to patient care area 3 3 3 3 3 3 Technician pulls wrong Drug slips off the counter Pharmacist checks Technician mixes up Technician mixes up Request is blank quantity or falls through crack inaccurately drugs and requests drugs and requests Potential Failure Process Steps Modes

40. FMEA Process Steps Step 4 Step 1 Step 2 Step 3 Select a high risk process Diagram the and assemble Failure Process Modes the team Identify Identify Effects And Causes

41. Effects of the Failure Modes • Review each failure mode and identify the effects of the failure should it occur • May be 1 effect or > 1 • Must be thorough because it feeds into the risk rating • If failure occurs, then what are the consequences

42. Identify root causes of failure modes • Focus on systems & processes, not individuals • Asks why?, not who? • Prospective application of RCA • Critical to identify all root causes and their interactions

43. Single Point Weakness • A step so critical that its failure will result in a system failure or adverse event • Single point weaknesses and existing control measures “modify” the scoring • Single point weaknesses should all be acted upon • IF effective control measures are in place, it would cancel the need to take further action (risk is mitigated)

44. Step 4 Step 1 Step 2 Step 3 Select a Identify high risk Diagram causes of process and the failure assemble Process modes the team Step 5 FMEA Process Steps Brainstorm potential failure modes and determine their effects Prioritize Failure Modes

45. Prioritize failure modes • Score severity of effect of failure mode • Score frequency of occurrence of failure mode • Score likelihood of detection (detectability) of failure prior to the impact of the effect being realized

46. Severity The seriousness and severity of the effect (to the process or system or patient) of a failure if it should occur. Score based upon a “reasonable worst case scenario”

47. Frequency • Also known as occurrence – it is the likelihood or number of times a specific failure (mode) could occur

48. Detectability The likelihood of detecting a failure or the effect of a failure BEFORE it occurs Many events are detectable or obvious after they occur but that is not a FMEA detectable event by definition.

49. Examples of Detectability • Break away locks • Emergency drug boxes with pop up pin • Ampoules • Low battery alarm

50. Calculate the Risk Priority Number • Determine the impact of the failure on the patient or the system using the severity, frequency and detectability parameters • Multiply three scores to obtain a Risk Priority Number (RPN) or Criticality Index (CI) • Also assign priority to those with a high severity score even though the RPN may be relatively low RPN = Severity x Occurrence x Detection