Evaluation and improvement the safety of total marrow irradiation with helical tomotherapy using repeat failure mode and effects analysis.

BACKGROUND & PURPOSE: Helical tomotherapy has been applied to total marrow irradiation (HT-TMI). Our objective was to apply failure mode and effects analysis (FMEA) two times separated by 1 year to evaluate and improve the safety of HT-TMI. MATERIALS AND METHODS: A multidisciplinary team was created. FMEA consists of 4 main steps: (1) Creation of a process map; (2) Identification of all potential failure mode (FM) in the process; (3) Evaluation of the occurrence (O), detectability (D) and severity of impact (S) of each FM according to a scoring criteria (1-10), with the subsequent calculation of the risk priority number (RPN=O*D*S) and (4) Identification of the feasible and effective quality control (QC) methods for the highest risks. A second FMEA was performed for the high-risk FMs based on the same risk analysis team in 1 year later. RESULTS: A total of 39 subprocesses and 122 FMs were derived. First time RPN ranged from 3 to 264.3. Twenty-five FMs were defined as being high-risk, with the top 5 FMs (first RPN/ second RPN): (1) treatment couch movement failure (264.3/102.8); (2) section plan dose junction error in delivery (236.7/110.4); (3) setup check by megavoltage computed tomography (MVCT) failure (216.8/94.6); (4) patient immobilization error (212.5/90.2) and (5) treatment interruption (204.8/134.2). A total of 20 staff members participated in the study. The second RPN value of the top 5 high-risk FMs were all decreased. CONCLUSION: QC interventions were implemented based on the FMEA results. HT-TMI specific treatment couch tests; the arms immobilization methods and strategy of section plan dose junction in delivery were proved to be effective in the improvement of the safety.

[How to manage risk in the surgical area. A Modal Analysis of Failures and Surgical Effects]. / Cómo gestionar el riesgo en el área quirúrgica. Análisis modal de fallos y efectos quirúrgicos.

OBJECTIVE: First to identify the areas of improvement in the surgical area before and during the performance of a surgical procedure in general surgery through the application of a Modal Analysis of Failures and Effects. Second to establish preventive measures to avoid adverse events in the surgical area. METHOD: A multidisciplinary working group was created in a university hospital for risk management in the General Surgery Operating Room Unit. The Modal Analysis of Faults and Effects was used. Potential risks for the patient in the ante-surgery and within the operating room were identified. The Risk Priority Index was calculated and preventive measures were established for all of them, with special interest when the Risk Priority Index was higher than 100. Preventive measures were developed based on the detected risks as well as those responsible for them. RESULTS: We identified a greater number of risks when the patient is in the operating room than in the ante-surgery room. Those with a higher risk priority index were: anticoagulated or antiaggregated patients, urinary tract infections, osteoarticular or neuropathic problems, patients not prepared for colon surgery, errors in laterality and leaving compresses in the operative field. CONCLUSIONS: A risk map has been developed in our organization, allowing the design of strategies to improve Patient Safety in the Surgical area. Training is a key aspect to improve Patient Safety.

Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

PURPOSE: There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inputs of a well-known systems approach, failure modes and effects analysis (FMEA), in identifying patient safety risks in a real healthcare setting. DESIGN/METHODOLOGY/APPROACH: This study was conducted in a newly established adult attention deficit hyperactivity disorder service at Cambridge and Peterborough Foundation Trust in the UK. Three stakeholders of the chosen service together with the facilitators conducted an FMEA exercise along with a particular system diagram that was initially found as the most useful SMA by eight stakeholders of the service. FINDINGS: In this study, it was found that the formal structure of FMEA adds value to the risk identification process through comprehensive system coverage with the help of the system diagram. However, results also indicates that the structured brainstorming refrains FMEA participants from identifying and imagining new risks since they follow the process predefined in the given system diagram. ORIGINALITY/VALUE: While this study shows the potential contribution of FMEA inputs, it also suggests that healthcare organisations should not depend solely on FMEA results when identifying patient safety risks; and therefore prioritising their safety concerns.

A risk assessment on extraneous virus contamination in a viral vaccine production environment justifies waiving of in vivo testing.

For many years in vivo assays have been a corner stone in safety testing of vaccines for human use. However, there is now an increasing regulatory focus on replacement, reduction and refinement of methods involving animal use. Accordingly, European Pharmacopoeia (Ph.Eur.) monographs and chapters are currently being revised to reduce or discontinue the use of animals in safety and other testing, when such in vivo tests are not absolutely necessary to facilitate risk mitigation. In the current study, a risk assessment of extraneous agents in viral vaccine production has been carried out and it is concluded that only the handling procedures carried out by the technical personnel pose a risk for extraneous viral contamination. A list of named, potentially virulent contaminating viruses, which may have been introduced by these procedures, has been generated. Each of the viruses on this list has been evaluated for possible persistence during the production processes, and it has for all of these been concluded that, if at all present, they only present a negligible risk of introducing extraneous agents in the final product. The overall conclusion of the risk assessment of our vaccine production process is that it justifies the discontinuation of the current in vivo testing, and furthermore demonstrates that there is no need to substitute these in vivo assays with novel in vitro methods.

Failure Mode and Effect Analysis (FMEA) may enhance implementation of clinical practice guidelines: An experience from the Middle East.

RATIONALE, AIMS, AND OBJECTIVES: Implementation of clinical practice guidelines (CPGs) has been shown to reduce variation in practice and improve health care quality and patients' safety. There is a limited experience of CPG implementation (CPGI) in the Middle East. The CPG program in our institution was launched in 2009. The Quality Management department conducted a Failure Mode and Effect Analysis (FMEA) for further improvement of CPGI. METHODS: This is a prospective study of a qualitative/quantitative design. Our FMEA included (1) process review and recording of the steps and activities of CPGI; (2) hazard analysis by recording activity-related failure modes and their effects, identification of actions required, assigned severity, occurrence, and detection scores for each failure mode and calculated the risk priority number (RPN) by using an online interactive FMEA tool; (3) planning: RPNs were prioritized, recommendations, and further planning for new interventions were identified; and (4) monitoring: after reduction or elimination of the failure mode. The calculated RPN will be compared with subsequent analysis in post-implementation phase. RESULTS: The data were scrutinized from a feedback of quality team members using a FMEA framework to enhance the implementation of 29 adapted CPGs. The identified potential common failure modes with the highest RPN (≥ 80) included awareness/training activities, accessibility of CPGs, fewer advocates from clinical champions, and CPGs auditing. Actions included (1) organizing regular awareness activities, (2) making CPGs printed and electronic copies accessible, (3) encouraging senior practitioners to get involved in CPGI, and (4) enhancing CPGs auditing as part of the quality sustainability plan. CONCLUSION: In our experience, FMEA could be a useful tool to enhance CPGI. It helped us to identify potential barriers and prepare relevant solutions.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

BACKGROUND: Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. METHODS: A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. RESULTS: A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. CONCLUSIONS: FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system). / Estrategias para aumentar la seguridad del paciente en hemodiálisis: Aplicación del sistema de análisis modal de fallos y efectos (sistema AMFE).

BACKGROUND: Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. OBJECTIVES: To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). METHODS: Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. RESULTS: We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. CONCLUSIONS: HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures.

Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards.

BACKGROUND: Intravenous potassium chloride (IV KCl) solutions are widely used in hospitals for treatment of hypokalemia. As ampoules of concentrated KCL must be diluted before use, critical incidents have been associated with its preparation and administration. Currently, we have introduced ready-to-use diluted KCl infusion solutions to minimize the use of high-alert concentrated KCl. Since this process may be associated with considerable risks, we embraced a proactive hazard analysis as a tool to implement a change in high-alert drug usage in a hospital setting. METHODS: Failure mode and effect analysis (FMEA) is a systematic tool to analyze and identify risks in system operations. We used FMEA to examine the hazards associated with the implementation of the ready-to-use solutions. A multidisciplinary team analyzed the risks by identifying failure modes, conducting a hazard analysis and calculating the criticality index (CI) for each failure mode. A 1-day survey was performed as an evaluation step after a trial run period of approximately 4 months. RESULTS: Six major possible risks were identified. The most severe risks were prioritized and specific recommendations were formulated. Out of 28 patients receiving IV KCl on the day of the survey, 22 received the ready-to-use solutions and 6 received the concentrated solutions as instructed. Only 1 patient received inappropriate ready-to-use KCl. CONCLUSIONS: Using the FMEA tool in our study has proven once again that by creating a gradient of severity of potential vulnerable elements, we are able to proactively promote safer and more efficient processes in health care systems. This article presents a utilization of this method for implementing a change in hospital policy regarding the routine use of IV KCl.

Effectiveness and cost of failure mode and effects analysis methodology to reduce neurosurgical site infections.

Mercy Hospital Springfield is a tertiary care facility with 32 000 discharges and 15 000 inpatient surgeries in 2011. From June 2009 through January 2011, a stable inpatient elective neurosurgery infection rate of 2.15% was observed. The failure mode and effects analysis (FMEA) methodology to reduce inpatient neurosurgery infections was utilized. Following FMEA implementation, overall elective neurosurgery infection rates were reduced to 1.51% and sustained through May 2012. Compared with baseline, the post-FMEA deep-space and organ infection rate was reduced by 41% (P = .052). Overall hospital inpatient clean surgery infection rates for the same time frame did not decrease to the same extent, suggesting a specific effect of the FMEA. The study team believes that the FMEA interventions resulted in 14 fewer expected infections, $270 270 in savings, a 168-day reduction in expected length of stay, and 22 fewer readmissions. Given the serious morbidity and cost of health care-associated infections, the study team concludes that FMEA implementation was clinically cost-effective.