Patient Safety Tools: RCA & FMEA Bob Feroli, PharmD, FASHP Medication Safety Officer Johns Hopkins HospitalObjectives  Define Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA)  Describe what each methodology is used for  Compare and contrast the two methodologies  Provide a detailed review of an RCAPatient Safety Tools  Root Cause Analysis (RCA) is a retrospective analysis of an actual event.  Failure Modes and Effects Analysis (FMEA) is a prospective analysis of a new system, process, or device.Root Cause Analysis A systematic process designed for investigating what, how, and why something happened and to figure out how to prevent the same thing from happening again. Journal of Health Care Compliance 2005;7(2):1-10.Failure Mode and Effects Analysis (FMEA) “A systematic method of examining a process prospectively for possible ways in which failure can occur and then redesigning the process to eliminate the possibility of the failure, stop the failure before it harms an individual, or minimize the consequences of failure.” (The Joint Commission - TJC)FMEA vs. RCA  FMEA  What if . . .?  How can harm be prevented  Prospective  Proactive  Needs frank and open discussions (safe environment)  RCA  Why did it happen  How can harm be avoided in the future  Retrospective  Reactive  Needs frank and open discussions (safe environment)Why do we use these processes?  Goal of FMEA  Analyze a system to identify potential “failure modes” and to prospectively “engineer” them out of the system before the failure occurs  Goal of RCA  Analyze errors to identify the root causes and fix underlying system problems to prevent recurrence of a similar eventFMEA General Steps  What process do you want to examine?  What are the steps of the process? (flow chart)  What can go wrong? (“FM” - failure modes)  What happens? (“E” - effect of failure)  Action based on above. (“A” – analysis)  Make failure impossible  Make failure less likely  Decrease harm caused by failure (mitigate harm)  Make failure quickly visible so that harm can be prevented or minimizedWhen do you conduct an FMEA?  High risk, high volume, high cost, problem prone processes  Regulatory requirements  The Joint Commission (TJC) requires that an acute care setting performs at least one FMEA every 18 monthsWhen do you conduct an RCA?  When a sentinel event occurs or a potential sentinel event occurs (close call)  Sentinel event  Any unexpected occurrence involving death or serious physical or psychological injury, or risk thereof (TJC)  Eg. Pt commits suicide  For medications, its permanent harm (something that lasts for more than a week)TJC Sentinel Events  Event that resulted in an unanticipated death or major permanent loss of function, not related to the patient’s illness or underlying condition  Any of the following:  Suicide of a patient in a setting where the patient receives around-the-clock care or within 72 hours of discharge  Unanticipated death of a full term infant  Infant abduction or discharge to wrong parents  Rape  Hemolytic transfusion reaction involving administration of incompatible blood products  Surgery on wrong patient or body part  Unintended retention of a foreign object after surgeryRCA - Patient Case 25-year-old woman was admitted for reconstruction of her nose with rib graft  PMH significant for a total blindness Event TimelineEvent Timeline  Intraoperative course was uneventful  Immediate post operative course was uneventful with the exception of a mild ADR (itching) from oxycodone  On discharge patient informed prescriber that Demerol worked for her in past  Prescription was written for Demerol with dose looked up in Tarascon (2003 edition) Prescription for Demerol was filled from an outpatient pharmacy  Two days after discharge unplanned clinic visit due to complaints of shakes, headaches, lightheadedness and occasional nausea  Clinic assessment: alert, oriented, vital signs stable, no signs or symptoms of infection, no apparent distress  Patient reported taking her antibiotics and pain medication faithfully. Instructed to take more fluid and continue with her medications as prescribed. Event Timeline The next morning, patient seized, arrested and could not be resuscitated  Cause of death reported by medical examiner: “meperidine intoxication.” Event TimelineRCA - Characteristics  Analysis that digs deep to the ‘root’ of the problem by repeatedly asking “why?” questions  Often more than one root cause  Focuses on systems and processes, not on individual performance  Identifies changes that can be made in the systems and processesMaryland Hospital Regulations  Adverse events – don’t memorize  Level 1: results in death or serious disability  Level 2: requires a medical intervention to prevent death or serious disability  Level 3: does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability  RCA must be conducted for all level 1 or level 2 adverse events or near-misses COMAR 10.07.06 Hospital Patient Safety ProgramRequired Reporting  Maryland Office of Healthcare Quality  All level 1 adverse events within 5 days of hospital’s knowledge that event occurred  Submit RCA and action plan within 60 daysRoot Cause Analysis Steps  Gather the facts  Assemble the investigation team  Understand what happened  Determine the root causes  Design and implement risk reduction strategies Brown-Spath & Associates 1998; Journal of Health Care Compliance 2005;7(2):1-10Step One: Gather the Facts  Gather the facts  Start immediately – the trail gets cold fast  Identify and interview the people directly involved in the event  Collect physical evidence (e.g. equipment, materials, safety devices)  Collect documentary evidence (e.g. patient chart)Step Two: Assemble RCA Team  Select people for the RCA team  Interdisciplinary root cause analysis team must be developed  Specially trained standing committee (?)  Include those personally involved in the event (?)  Core group:  Team leader  Facilitator  Individuals with expertise in area – frontline staff  Hospital leadershipStep Three: Understand What Happened  Use