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CHALLENGES WITH THE PERFORMANCE OF FAILURE MODE ANDEFFECTS ANALYSIS IN HEALTHCARE ORGANIZATIONS:An IV Medication Administration HFMEATMTosha B. Wetternecka, Kathleen Skibinskib, Mark Schroederc, Tanita L. Robertsdand Pascale CarayoneaDepartment of Medicine, University of Wisconsin Medical SchoolbSchool of Pharmacy, University of Wisconsin, MadisoncDepartment of Anesthesia, University of Wisconsin Medical SchooldUniversity of Wisconsin Hospital and ClinicseCenter for Quality and Productivity Improvement and the Department of Industrial Engineering,University of Wisconsin, Madison, WIThe value of performing prospective analysis before technology implementation is well known tothe chemical, nuclear and aviation industries. The performance of a failure mode and effectsanalysis (FMEA) is now required by healthcare organizations accredited by JCAHO as part oftheir patient safety standards. However, most healthcare organizations have little experience withapplying human factors engineering techniques to process or technology evaluation and theprocedure of how and when healthcare organizations should perform FMEA is not welldescribed. This paper describes the method and challenges of performing a process and designFMEA to prepare for the implementation of a new intravenous infusion pump at a UniversityHospital. Recommendations are made for the performance of a process and design FMEA fornew technology implementation in healthcare organizations.INTRODUCTIONFailure mode and effects analysis (FMEA) is ahuman factors engineering technique used to define,identify, and eliminate known and/or potential failures,problems, and sources of error from the system, design,process, and/or service before they reach the customer.Both the IOM report, To Err is Human: Building a SaferHealth System and the AHRQ EvidenceReport/Technology Assessment Number 43, MakingHealth Care Safer: A Critical Analysis of Patient SafetyPractices, recommend using human factors techniquesto evaluate medical devices before purchase and on anongoing basis after implementation because technologycan introduce new errors, even when its purpose is toprevent them (Kohn, 2000; Wachter, 2001). The JointCommission on Accreditation of HealthcareOrganizations (JCAHO) also required the performanceof a yearly proactive risk assessment (e.g., FMEA) of aprocess or technology in 2001, to encourage patientsafety efforts in healthcare organizations. Typicalapplications for FMEA in healthcare organizationsinclude preventing technology or device defects,improving patient care processes for high riskprocedures (blood transfusion, MRI scanning) andidentifying potential safety issues both to patients andcare providers (Stamatis, 1995). Recently, the VeteransAdministration National Center for Patient Safetydeveloped a Health Care FMEA (HFMEA ), intendedto be easier to apply to healthcare situations. This modelincludes concepts from the industry FMEA model, thehazard analysis and critical control point model fromfood safety, and a modified hazard matrix scoringsystem based on health care outcomes (DeRosier, 2002).The widespread use of FMEA by healthcareorganizations and its effectiveness to improve quality ofcare and safety has not been well studied or discussed.However, there are reports about the considerable timeand resource commitment required by organizations toperform the task (Burgmeier, 2002; ECRI, 2002) andwith problems applying the FMEA model to health caresettings (Capunzo, 2004). This paper describes ourorganization’s undertaking of a process and designFMEA for the implementation of a new technology, anintravenous infusion pump or “Smart pump” which has apreprogrammed drug library with dosing limits.Challenges identified by the team during and after theFMEA are discussed and recommendations are made forhealthcare organizations to guide their planning andexecution process for using FMEA.BACKGROUNDThe decision to consider the purchase of newintravenous (IV) infusion pumps with a preprogrammeddrug library designed to decrease pump programmingerrors was made in late 2002 by Hospital leadership as aTo be presented at the Annual Conference of the Human Factors and Ergonomics Society – September 20-24, 2004
fail-safe solution for IV medication administrationerrors, specifically pump programming errors leading topatient harm. A multidisciplinary team evaluated theexisting IV infusion pump technologies based on desiredand ideal function criteria developed by the team. TheAlaris Medley Medication System with Guardrails pump technology was chosen for purchase and a Returnon Investment (ROI) proposal was developed based oncost of implementation versus cost avoidance fromreduction in medication errors. At the time of thepurchase agreement, the organization’s Patient SafetyCommittee chose the introduction of the new technologyas the next FMEA to be performed by the organization.The organization had performed one previous FMEAthat evaluated the existing safety of MRI use. The IVPump FMEA team started its work 3 ½ months beforeimplementation of the new technology was planned. Thetiming of implementation was delayed to allow the teamto complete its work and operationalize solutions forhigh priority failure modes to improve safety duringimplementation. The team’s final report was ready oneweek before technology implementation, during whichtime end-users were undergoing training on the newtechnology. Overall, the team felt the FMEA processwas useful and identified appropriate solutions forprioritized failure modes.METHODSTo understand the process and challengesencountered by the FMEA team, information wascollected through a variety of mechanisms including:open forum discussion by team members at the end ofthe FMEA, recording of the personal experiences of theFMEA facilitator and team leader, review of meetingminutes, and post-FMEA structured interviews withFMEA team members.RESULTSChallenges and recommendations wereidentified and grouped into the following areas:personnel, team leadership, definition of team charge,FMEA execution and organizational factors.PersonnelA multidisciplinary team including Pharmacy,Nursing administration and end-users, Anesthesia,Medicine, Biomedical Engineering, AnesthesiaEngineering, Safety, and Quality Improvement wasassembled with an anesthesiologist as team leader and aPharmacy graduate student and Quality Improvementanalyst chosen to co-facilitate the group. Themultidisciplinary nature of the FMEA team wasidentified as a key strength by 9 of the 14 FMEA teammembers interviewed upon completion of the FMEAprocess. However, the substantial time commitment forindividual team members and the significant personnelinvestment for the organization were not recognized atthe start of the FMEA. In total, twelve to fifteen hospitalpersonnel attended over 46 hours of meetings over thefour and a half month time period to complete theFMEA. Most members were familiar with aspects of themedication use process involving the pump, however,only half of the FMEA team members were end-users ofthe pump, and therefore significant time was spentfamiliarizing the team with the process of programmingboth the current and new pumps. There were problemswith end-user attendance at the meetings due to patientcare responsibilities. Nurses on disability leave werethen utilized as team members to overcome difficultieswith finding staff nurses from varied care areas to attendthe meetings. In addition, to supplement gaps in enduser participation, team members performed directobservations of the IV medication administration processand interviewed end-users.Team LeadershipThe team realized at the first meeting that anexperienced facilitator was necessary to guide themthrough the FMEA exercise. The organization did nothave such an expert on staff and a human factors-trainedpharmacist with FMEA experience from an affiliatedSchool of Pharmacy was asked to join the team in thisrole. In response to an open-ended question on strengthsof the FMEA process, 7 of the 14 interviewees indicatedthat the facilitator was a strength of the process.Defined Team ChargeThe team’s charge from the Patient SafetyCommittee did not include a specific process to analyzenor did it define the scope of the team and whichprocesses the team should or should not analyze;therefore, the first meeting was spent for this purpose.The team chose to analyze the medication use process.Also, the team made the decision to perform both aprocess FMEA of the current system and a designFMEA of the new process with the new technology.This added considerable time to the entire FMEAprocess, but was necessary to understand the changes inthe process that needed to occur and the processvulnerabilities that would not be fixed with the additionof new technology.FMEA ExecutionTo be presented at the Annual Conference of the Human Factors and Ergonomics Society – September 20-24, 2004
Training for the FMEA team members wasprovided through a half-day seminar on FMEA andhuman factors engineering concepts and an hour-longlecture on HFMEA . Only one team member had priorexperience with a process and design FMEA. In theinterviews conducted upon completion of the FMEAprocess, 6 of the 14 members interviewed indicated thatthey did not have a good understanding of FMEA at theinception of the team. The team determined that themedication use process had six overall process steps:patient assessment, prescription, transcription,preparation/dispensing, administration, and monitoring.Five of the process steps (excluding administration) hada total of 22 sub processes identified. Theadministration process was much more complex with 3major sub process steps (prepare medication forinfusion, program pump, run infusion) that required thedevelopment of 5 further processes for primary,secondary and continuous infusions due to variation inIV medications and pump programming possibilities.The team repeated the administration process mappingfor the new IV pump. Significant variations of practicewere noted in many of the process steps based on themany different patient care areas (e.g., general care,ICU, pediatrics) and the team mapped only the mostcommon variations due to time considerations.The identification of failure modes was alsotime-consuming and challenging. One of the challengeswas the availability of data to objectively evaluate thenew IV pump and pump process. Data reviewed by theteam to assist in completing the failure modedetermination included internal information: pilot studydata and medication error incident reports, as well asexternal information: ECRI data, list serve discussions(which needed to be verified), biomedical engineeringquality assurance data and the product specificationdocument. The level of detail in the failure modes andnumber of failure modes to consider was debated. Teammembers had concerns with listing failure modes thatwere not thought to have occurred, and considerabletime was spent discussing solutions during the failuremode process, due to the action oriented health careteam. Areas in the new process that were highlighted ashigh priority, problem areas included the appropriateplacement of and correct use of the IV tubing, theinfusion description display, pump usage during codesituations and reprogramming the pump whentransferring patients from the operating room orintensive care unit to the general floor.The HFMEA hazard scoring system was usedto assess failure modes (Table 1). Severity andprobability were assessed to arrive at a hazard score.Each failure mode then proceeded thru the HFMEATMdecision tree to review criticality, control measures anddetectability to decide which failure modes neededfurther action. Probability and severity were scored on a4-point scale based on HFMEATM definitions for thecurrent process. A low-medium-high scoring system wasused for the new process steps involving the newtechnology, as there was little to no informationavailable to guide the team. In HFMEATM, detectabilityis scored differently than traditional FMEA; rather, it isanswered yes/no as part of the decision tree analysis.The large number of medication administrations per dayin the organization (about 10,000 per day) led to highscores for probability. The scoring of probability, withthe top score of 4 representing failures that occur severaltimes in one year, did not allow the team to differentiatescoring for failures that occur multiple times daily, daily,weekly, or monthly. Likewise, the dangerous nature ofIV medications delivered incorrectly to a patient led tohigh severity scores. Therefore, most failure modes hadhigh hazard scores (8, 9, 12, and 16) and most were noteliminated by the decision tree. All failure modes andcauses that were not eliminated by the decision tree weremoved to action and outcomes, the last step inHFMEATM. Identical process step failure modes thatappeared in both process and design FMEAs wereevaluated together.Approximately 200 failure modes and relatedcauses were evaluated. The team used the subgroups oftraining, policy and procedure, technology, environmentand people to further categorize causes of the failuremodes, which guided the team to solution building, eg.Causes of improper insertion of the tubing into the newpump were identified as lack of knowledge of properinsertion because of a different technique for insertion inthe new technology (training), which led to a short-termtraining solution focused on exact insertion of the tubingtop fitment (Table 2). The team also noted with thisfailure mode that the new technology ‘allowed’ forimproper insertion of the tubing, something that thecurrent pump did not allow, and identified a technologychange solution as a long-term solution. Wheneverpossible, the team sought technology redesign solutionsas a long-term solution with better reproducibility andduration of outcomes as well as recommending shortterm systems change and end-user training.Recommendations for systems change were summarizedand presented to Hospital leadership. Technologyredesign solutions were shared with the vendor. Theteam was empowered to begin short-term solutions assoon as possible and also took advantage of hospitalcommittees already in place to help with systems changeand education (Nursing Practice Committee, Bar CodeTechnology committee, etc).To be presented at the Annual Conference of the Human Factors and Ergonomics Society – September 20-24, 2004
Organizational FactorsMany of the challenges described above relate tothe newness of the FMEA process to healthcareorganizations. The Patient Safety Committee chose theimplementation of new technology for prospective riskanalysis based on expert opinion that technology couldlead to new errors in the system. However, it was notrealized that the FMEA process would be so timeconsuming and the original planned technologyimplementation date did not allow our team time tomake process changes before technology trainingoccurred. Also, even though the decision to purchasethe new technology was made based on desiredfunctioning, it was done before the FMEA which meantthat the team could not consider a variety oftechnologies available on the market as solutions toparticular failure modes and weigh which technologywould be best suited for our processes in place topromote patient safety.DISCUSSIONDue to the substantial time commitment andsignificant investment of time and resources needed,FMEA should be considered only on the healthcareorganization’s highest priority processes. Based on ourexperience performing a complex process and designFMEA involving technology, the followingrecommendations are made to guide other healthcareorganizations as they perform these FMEAs.The people and time resources committed to theFMEA process should be considered as important as theinvestment in the technology. Therefore, a complexFMEA should only be performed with experienced teammembers and a defined scope. Organizations shoulddevelop FMEA experts and an expert team facilitator.Super-users should be dedicated to the FMEA process.Ideally, the implementation schedule of the newtechnology should not be determined until the entireFMEA process is completed or near completion and theteam should have authority to halt or delay theimplementation based on their findings. Thus, the teamshould have a direct link for feedback to organizationalleadership.The VA HFMEATM process defined criteria toevaluate potential failure modes, however, these criteriamay be viewed as a disadvantage because of theirrigidity. In the problem prone, high risk IV medicationadministration process, the HFMEATM scoring methoddid not allow for minute differentiation of probability,severity and detectability scores and therefore madeprioritization of failure modes and ability to follow thehazard score over time for improvement difficult.However, the goal of FMEA is to err on the side ofsafety and prevent or eliminate risk potential. Thereality of healthcare processes remains. We have looselycoupled system designs with substantial variation inprocesses that contribute to numerous failure modes.Before the team scores failure modes, the scales used forthe hazard score (HFMEATM) or risk priority number(traditional FMEA) should be reviewed and evaluationcriteria should be established by team consensus.Many authors recommend limiting the numberof process steps in the FMEA, hence, limiting thenumber of failure modes and eventual action items(DeRosier, 2002; ECRI, 2002), however, theimplementation of new technology in a process did notlend well to such limitations in the medication useprocess and despite the limiting of our FMEA to mostlythe IV administration process, hundreds of causes weregenerated for over 50 failure modes.Potential solutions to failure modes shouldexplore alternative technology or technology redesign.In this case, it is essential to have biomedical and humanfactors engineers as an active part of the FMEA team tobe involved with product design as well as to performquality assurance and user interface and product safetytesting on the technology.ACKNOWLEDGMENTSThis research is funded by AHRQ Grant # 1 UC1HS014253-01 (PI: Pascale Carayon, co-PI: ToshaWetterneck). Tanita Roberts is currently affiliated withBen Taub General Hospital, Houston, Texas.REFERENCESBurgmeier J. Failure mode and effect analysis: an applicationin reducing the risk of blood transfusion. JointCommission Journal on Quality Improvement.2002;28:331-339.Capunzo M, Cavallo P, Boccia G, Brunetti L, Pizzuti S. AFMEA clinical laboratory case study: how to makeproblems and improvements measurable. ClinicalLeadership and Management Review. 2004;37-41.DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using healthcare failure mode and effect analysis : the VAnational center for patient safety’s prospective riskanalysis system. Joint Commission Journal onQuality Improvement. 2002;28:248-267.ECRI. An introduction to FMEA. Using failure mode andeffects analysis to meet JCAHO’s proactive riskassessment requirement. Health Devices.2002;31:223-226.Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human:building a safer heath system. Committee on QualityTo be presented at the Annual Conference of the Human Factors and Ergonomics Society – September 20-24, 2004
of Health Care in America. Institute of Medicine.Washington, D.C.:National Academy Press;2000.Stamatis DH. Failure mode and effects analysis – FMEAfrom theory to execution. Milwaukee, WI:ASQCQuality Press, 1995.Wachter RM, Shojania DG, Duncan BW, McDonald KM(Eds.), Making health care safer: a critical analysis ofpatient safety practices. Washington, DC: Agencyfor Healthcare Research and Quality, 2001. AHRQPublication 01-E0Table 1. HFMEATM Step 4 – Hazard Analysis of IV Medication Administration, Programming PumpaProbabilitybHazard ScoreSingle PointWeaknessControlMeasureDetectableProceed?Turn pump on – E2b(1)Battery deadNo powerPump self-checks – E2b(2)Electrical mechanical failurePush
document. The level of detail in the failure modes and number of failure modes to consider was debated. Team members had concerns with listing failure modes that were not thought to have occurred, and considerable time was spent discussing solutions during the failure mode process, due to the action oriented health care team.
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