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Title: SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment

Abstract

Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this work was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA criticalmore » failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.« less

Authors:
 [1];  [2]; ; ;  [3]
  1. Oregon State University, Corvallis, OR (United States)
  2. (United States)
  3. University of California, San Diego, La Jolla, CA (United States)
Publication Date:
OSTI Identifier:
22648862
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; HAZARDS; PUBLIC HEALTH; RADIOTHERAPY; RISK ASSESSMENT

Citation Formats

Harry, T, University of California, San Diego, La Jolla, CA, Manger, R, Cervino, L, and Pawlicki, T. SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment. United States: N. p., 2016. Web. doi:10.1118/1.4956386.
Harry, T, University of California, San Diego, La Jolla, CA, Manger, R, Cervino, L, & Pawlicki, T. SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment. United States. doi:10.1118/1.4956386.
Harry, T, University of California, San Diego, La Jolla, CA, Manger, R, Cervino, L, and Pawlicki, T. 2016. "SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment". United States. doi:10.1118/1.4956386.
@article{osti_22648862,
title = {SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment},
author = {Harry, T and University of California, San Diego, La Jolla, CA and Manger, R and Cervino, L and Pawlicki, T},
abstractNote = {Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this work was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA critical failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.},
doi = {10.1118/1.4956386},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • Purpose: The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. Methods: The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of riskmore » priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. Results: The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. Conclusions: The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.« less
  • The staff at three Washington State hospitals and Battelle Pacific Northwest Division have been collaborating to apply Failure Mode Effects and Criticality Analysis (FMECA) to assess several hospital processes. The staff from Kadlec Medical Center (KMC), located in Richland, Washington; Kennewick General Hospital (KGH), located in Kennewick, Washington; and Lourdes Medical Center (LMC), located in Pasco, Washington, along with staff from Battelle, which is located in Richland, Washington have been working together successfully for two and a half years. Tri-Cities Shared Services, a local organization which implements shared hospital services, has provided the forum for joint activity. This effort wasmore » initiated in response to the new JCAHO patient safety standards implemented in July 2001, and the hospitals’ desire to be more proactive in improving patient safety. As a result of performing FMECAs the weaknesses of six medical processes have been characterized and corresponding system improvements implemented. Based on this collective experience, insights about the benefits of applying FMECAs to healthcare processes have been identified.« less
  • Highlights: • This study is based on a real case in hospital in Taiwan. • We use Failure Mode and Effects Analysis (FMEA) as the evaluation method. • We successfully identify the evaluation factors of bio-medical waste disposal risk. - Abstract: Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposalmore » units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included “availability of freezing devices”, “availability of containers for sharp items”, “disposal frequency”, “disposal volume”, “disposal method”, “vehicles meeting the regulations”, and “declaration of three lists”. This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal.« less
  • Purpose: To optimize the clinical processes of radiotherapy and to reduce the radiotherapy risks by implementing the powerful risk management tools of failure mode and effects analysis(FMEA) and PDCA(plan-do-check-act). Methods: A multidiciplinary QA(Quality Assurance) team from our department consisting of oncologists, physicists, dosimetrists, therapists and administrator was established and an entire workflow QA process management using FMEA and PDCA tools was implemented for the whole treatment process. After the primary process tree was created, the failure modes and Risk priority numbers(RPNs) were determined by each member, and then the RPNs were averaged after team discussion. Results: 3 of 9 failuremore » modes with RPN above 100 in the practice were identified in the first PDCA cycle, which were further analyzed to investigate the RPNs: including of patient registration error, prescription error and treating wrong patient. New process controls reduced the occurrence, or detectability scores from the top 3 failure modes. Two important corrective actions reduced the highest RPNs from 300 to 50, and the error rate of radiotherapy decreased remarkably. Conclusion: FMEA and PDCA are helpful in identifying potential problems in the radiotherapy process, which was proven to improve the safety, quality and efficiency of radiation therapy in our department. The implementation of the FMEA approach may improve the understanding of the overall process of radiotherapy while may identify potential flaws in the whole process. Further more, repeating the PDCA cycle can bring us closer to the goal: higher safety and accuracy radiotherapy.« less
  • Purpose: To examine the ability of traditional Failure mode and effects analysis (FMEA) and a light version of Healthcare FMEA (HFMEA), called Scenario analysis of FMEA (SAFER) by comparing their outputs in terms of the risks identified and their severity rankings. Methods: We applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation are based on risk priority number (RPN). RPN is a product of three indices: occurrence, severity and detectability. The SAFER approach; utilized two indices-frequency and severity-which were defined by a multidisciplinarymore » team. A criticality matrix was divided into 4 categories; very low, low, high and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: Two methods were independently compared to determine if the results and rated risks were matching or not. Our results showed an agreement of 67% between FMEA and SAFER approaches for the 15 riskiest SIG-specific failure modes. The main differences between the two approaches were the distribution of the values and the failure modes (No.52, 54, 154) that have high SAFER scores do not necessarily have high FMEA RPN scores. In our results, there were additional risks identified by both methods with little correspondence. In the SAFER, when the risk score is determined, the basis of the established decision tree or the failure mode should be more investigated. Conclusion: The FMEA method takes into account the probability that an error passes without being detected. SAFER is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allow the prioritization of risks and mitigation measures, and thus is perfectly applicable to clinical parts of radiotherapy.« less