|Year : 2015 | Volume
| Issue : 1 | Page : 15-22
Healthcare risk evaluation with failure mode and effect analysis in established of new dialysis unit
U Albert Anand1, Ali Syed Asif1, S Muhil2, Linta Thomas1
1 Quality and Patient Safety Department, Tertiary Healthcare Hospital, Al Ain, United Arab Emirates
2 Quality and Patient Safety Department, Dammam University, Dammam, Kingdom of Saudi Arabia
|Date of Web Publication||8-Jul-2015|
Dr. U Albert Anand
Clinical Auditor, Quality and Patient Safety Department, Tertiary Healthcare Hospital, Al Ain
United Arab Emirates
Source of Support: None, Conflict of Interest: None
Introduction: Proactive prevention of medical errors is critical in medical practice. Root causes analysis is a conventional method used to deal with errors that result in an adverse event.
Aim: The aim of this paper was the application of the failure mode and effects analysis (FMEA) tool used to evaluate the risks to prevent the infections and adverse treatment effect in dialysis for patients and it leads to improving the quality of care provided by Healthcare Organizations and to assure patients' safety.
Materials and Methods: FMEA to hemodialysis unit and sequential steps in the FMEA process are explained. Assigned severity, occurrence, and detection scores for each failure mode and calculated the Risk Priority Numbers (RPNs). The RPN was calculated as the product of the three attributes: RPN = occurrence rating × severity rating × detectability rating.
Statistical Analysis: Statistical evaluation of plan results was performed with a two-tailed Chi-square test. Results were considered statistically significant at P < 0.05.
Results: The Technical Expert Panel analyzed failure modes causes, made recommendations and planned new control measures. After failure mode elimination or reduction, we find out the association of resulting RPN with severity scores, occurrence scores, and detection scores.
Conclusions: FMEA has helped in the prospective evaluation of dialysis processes, determination of risks associated with dialysis care and development of solutions and preventive actions. Thus reduce the risk and improving the patient safety of the Dialysis Department.
Keywords: Dialysis, failure mode and effects analysis, healthcare risk
|How to cite this article:|
Anand U A, Asif AS, Muhil S, Thomas L. Healthcare risk evaluation with failure mode and effect analysis in established of new dialysis unit. J Nat Accred Board Hosp Healthcare Providers 2015;2:15-22
|How to cite this URL:|
Anand U A, Asif AS, Muhil S, Thomas L. Healthcare risk evaluation with failure mode and effect analysis in established of new dialysis unit. J Nat Accred Board Hosp Healthcare Providers [serial online] 2015 [cited 2019 Mar 26];2:15-22. Available from: http://www.nabh.ind.in/text.asp?2015/2/1/15/160238
| Introduction|| |
Hemodialysis is one option for renal replacement therapy in people with renal disease. It is required when a person's kidneys are unable to complete their normal function, that of maintaining the normal intracellular and extracellular fluid environment within the body.  Clinical risk management consists of complex actions were done to improve the quality of care provided by Healthcare Organizations and to assure patients' safety. It takes into account all of the healthcare process fields. Failure modes are operationally defined as the different ways that a particular process or sub-process step can fail to accomplish its intended purpose. ,,
Medical errors have long been an important issue in healthcare delivery. However, they have been receiving even more attention ever since the Institute of Medicine published To Err is Human: Building a Safer Healthcare System in 1999.  Errors in healthcare delivery can occur in any step or process, but they may or may not result in harm to the patient. When an error is detected and corrected before a patient is harmed, the event is termed a near miss event or a close call. Some errors go undetected and result in adverse outcomes to the patients; these are termed adverse events.  In the past, a responsible individual was typically identified as the cause of an adverse event.  Now, we recognize that adverse events in the healthcare system are the result of multiple inherent system errors that predispose individuals to commit specific errors. 
Basically, most errors are initiated by system or process failure.  Root cause analysis (RCA) has been widely used to study and identify the causes of an adverse event. It is a process mandated by state agencies and the Joint Commission on Accreditation of Healthcare Organization to evaluate sentinel events that have occurred in an institution. On the basis of a conventional RCA, the cause of an adverse event is identified, corrective actions are implemented, and outcome measures are formulated. 
Failure mode and effects analysis (FMEA) is a comprehensive, collaborative team effort which proactively evaluates a healthcare process. The end points may be performing only analysis, making recommendations or implementing new strategies developed from FMEA. Some retrospective studies of adverse events; in 2001 the United States Joint Commission on Accreditation of Healthcare Organizations involved healthcare organizations in providing annual proactive analysis as risk prevention.  One of these tools is FMEA, which has been used.
Since the 1970s in industrial fields (cars, aerospace, and nuclear energy).  International models for technical and organizational applications such as ISO 9004:2000 use FMEA too. 
In an attempt to adopt FMEA into the healthcare community, the USA Veterans Administration National Centre for patient safety combined processes in FMEA with the Hazard Analysis and Critical Control Point system and RCA, thereby creating the healthcare FMEA. ,, Three indexes were assigned for each failure mode: The occurrence rating (O), the severity rating (S), and the detectability rating (D). A 5-point scale was used to score each category, five being the number indicating the most severe, most frequent, and least detectable failure mode, respectively.
The aim of this paper was the application of the FMEA tool used to evaluate the risks to prevent the infections and adverse treatment effect in dialysis unit patients and it leads to improving the quality of care provided by Healthcare Organizations and to assure patients' safety. The applied procedure included the definition of the processes, fault trees, and RCA; the identification and scoring of each potential failure mode, and finally the suggestion of additional safety measures for process improvement and risk mitigation.
| Materials and Methods|| |
Healthcare FMEA is a qualitative method used to detect proactively risks to the patient in a particular healthcare process and correct potential error before adverse events occur. 
In this study, FMEA was applied to identify all the processes involved in the stages of:
- Preplanning hemodialysis and volume determination, and of
- Treatment planning and execution performed by using an hemodialysis unit.
Afterward, the potential failure modes (i.e., what could go wrong), together with their causes and effects, were identified and ranked in order of importance. Three indexes were assigned for each failure mode: O, S, and D. A 5-point scale was used to score each category, five being the number indicating the most severe, most frequent, and least detectable failure mode, respectively.
Finally, the Risk Priority Number (RPN) was calculated as the product of the three attributes: RPN = O × S × D. The RPN calculated by the Expert Panel and compared to the previous literature studies. The value RPN = 52 or below was considered the risk can be acceptable. The analysis was carried out by a Technical Expert Panel (TEP) composed by six people working at the Tertiary Healthcare Hospital (one intensive care physician and one Black Belt in Six Sigma, one dialysis unit nursing in charge and three other units nursing in charge).
The elaborations of the process trees and the identification of the potential failure modes, causes, and effects were initially carried out through TEP meetings. Afterward, various quarantine and preshipment panel discussions were organized to revise the results the groups, and to identify and examine the additional safety measures for the risk mitigation. The risk attributes associated to each failure mode were initially conceived by each TEP of the team in "blind mode," then collectively revised during a dedicated plenary session to reach a general consensus. The O, S, and D indexes for each failure mode were assigned by taking into account the current quality assurance program and protocols developed at Tertiary Healthcare Hospital and the safety measures already implemented. FMEA follow these steps , to find out the risk in established of the new dialysis unit [Figure 1].
- Step-1: Process study: Team member selection, process examination and brainstorming, and phases and activities recording on FMEA worksheet.
- Step-2: Risk analysis: Listing activity-related failure modes and their potential effects. Many failure modes may have more than one effect. This step must be developed very exhaustively because the information will be used to determine risk ratings. This step also includes describing control measures that eliminate or significantly reduce the likelihood of failure occurring, as well as assigning a S for each effect, which shows the seriousness of failure effects eventually happening, O for each failure mode (i.e., how often it may occur) and D (i.e., detecting failures or their effects likelihood before their occurrence). Effects severity and failure modes occurrence scores increase, while detection scores decrease (the more difficult the error detection, the higher the value): That is, the ability of detecting events before they occur reduces the degree of risk. , The coupling of scores with S, O, and D levels has to be established before risk analysis. To calculate the RPNs, the three scores were multiplied. Total process RPN was calculated by adding single failure mode RPN.
- Step-3: Planning: Prioritization is completed by plotting RPN [Table 1]. The team decides which items to focus on and work on, analyses failure modes causes, makes recommendations and plans new control measures to eliminate or reduce risk. The RPN value, we employed to define failure mode intervention priority.
- Step-4: Monitoring: After failure modes elimination or reduction, a resulting RPN is calculated and compared with the previous one [Table 1] and [Table 2].
This worksheet was used to record information during the FMEA sessions, for writing and allocating a number to each process phase, activity and possible failure modes, their effects, and safeguards in place to avoid failure (control measures). S was assigned to failure effects, whereas, O and D scores were given to failure modes. The RPN was calculated by multiplying the three scores [Table 3].
The Healthcare FMEA is well suited to be useful in a wide variety of clinical situations. Some investigators described their success in the use of FMEA to prepare parenteral nutrition formula and to reduce blood transfusion risks  and errors related to intravenous infusion pumps. 
The healthcare FMEA approach was promoted by the American Society for Healthcare Risk Management in their white paper published in July 2002.  It is an easy-to-use analytic tool, as determined by several investigators because it provides a straightforward approach to solving complicated processes [Figure 2]. 
The newer articles have described the incorporation of healthcare FMEA in the evaluation of the sterilization and use of surgical instruments,  the reduction of tubing misconnections,  the setup of outpatient parenteral antibiotics therapy,  and the ordering of potassium chloride and potassium phosphate in dialysates. 
Statistical evaluation of plan results was performed with a 2-tailed Chi-square test. Results were considered statistically significant at P < 0.05.
The results we obtained applying FMEA to hemodialysis unit. Activities, failure modes, and control measure numbers are reported for each phase. Lowest and highest RPN values and total RPN are shown too. In failure mode with control measures showed the significant relationship between S (P: 0.038 < 0.05), D (P: 0.033 < 0.05), and RPN values at 95% significance level. There is no significant relationship between the O (P: 0.067 > 0.05), and RPN values at 95% significance level.
In failure mode without control measures showed the significant relationship between S (P: 0.022 < 0.05). There is no significant relationship between the O (P: 0.06 > 0.05), D (P: 0.069 > 0.05) [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]. 
| Discussion|| |
The Heath care FMEA topics may be useful approach for a number of common sources of error in a Dialysis Department including proper patient identification, preparation, informed consent, prevention of misadministration of pharmaceuticals, reduction or avoidance of infection, safe monitoring of patients, and maintenance of a safe working environment. The FMEA can be initiated as a comprehensive strategy, personal initiative, or both. The successful introduction of FMEA into the department can be credited to strong clinical and administrative support.
In our hospitals, the healthcare leads and administrative leaders initiated the idea of FMEA. We started with a comprehensive workshop to introduce and give information on FMEA. The introduction included department expectations (roles, responsibilities, and goals), suggestions and help for the design of FMEA topics, and processes for all clinical divisions in our department. Each FMEA team was formed as an ad hoc committee that consisted of five to seven personnel. The composition of each team can vary depending on the task. Teams can include but are not limited to quality personnel's, clinical auditor, nephrologist, nursing in charge, nurse educator, technologist assistant, and dialysis service representative. Our hospital, Tertiary Healthcare Hospital, UAE is a 50-beded medical center that provides diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery.
It was expected that each area of the department would perform at least one FMEA project. The FMEA topics were selected on the basis of high risk and high vulnerability areas. A total of eight dialysis failure modes (topics) were identified, and projects were undertaken. On average, it took a few months to accomplish each FMEA project. Leadership is important in the selection of FMEA topics, support of teams, and implementation of changes suggested by the teams. The keys to a successful FMEA process include the following:
- Team members represent all levels of clinical and managerial staff,
- Each team member has an established role and responsibility,
- Proper timelines and expected outcomes are set,
- Teams are open to all ideas,
- Teams members are analyze root causes carefully before turning to quick solutions, and
- The process flow is tested before and after the identification of causes and implementation of solutions.
In this article, The FMEA team identified several failure modes associated with each process, from scheduling to examination preparation to the end of the examination, as shown in RCA causes of each failure mode are shown on a RCA and decision tree analysis. The probability and severity of each cause were estimated, and the RPN score was calculated. The decision to pursue the action was based on the criticality of the outcome, the detectability of the cause, and the existence of current effective control measures. Actions were proposed, and the person responsible for performing that action was assigned to do so. The fish bone diagram shows potential failures, potential causes, and potential solutions.
We have observed that team selection, motivation, and training have great significance because this analysis is subjective and depends on every member's abilities and open-minded attitude. The first application of FMEA actively involved all of the team, and it required some work, but it was fulfilled in quite a short time (3 months).
The use of FMEA in our department has led to changes in several processes related to patient care and technical and financial operations. The implementation of FMEA action on "safety and reduce the delay in procedures." The use of several new forms like daily room supply checklist, biomedical waste segregation checklist, clinical evaluation form, and development of new protocols for calibration. The implementation of the training schedule for Dialysis Departmental staffs. The FMEA process in "appropriate safety monitoring of dialysis unit area before and after procedures" resulted in reduce the RPN. Our data for the 3 months period after FMEA was conducted showed a dramatic reduction in infections rate and risk of patients for procedures (from 125 to 56 patients, 44% reduction) when compared with data for the 3 months period before FMEA was implemented.
Plotting failure modes on a matrix that also takes into account the weight of the control measures is a peculiarity of the FMEA model we employed so that it is easy to identify priorities. We believe these results in quicker evaluations because the priority selection is simplified, and thus it reduces action times.
The scope of the FMEA can be initially determined by departmental leaders on the basis of the resources available to support such projects. The scope of the project can also be adjusted by the FMEA team members to expand and pursue topics deemed important by the team or to abandon topics of less interest. The prioritization of action based solely on numeric scores may undermine the importance of a failure mode with high severity but low probability. A failure mode causes with low severity, but the high probability may have a score equal to that of one with high severity but low probability. Thus, one should consider ranking all failure modes with the highest severity scores as high-priority issues to be addressed, regardless of the overall score.
| Conclusions|| |
The implementation of healthcare FMEA into the Dialysis Department has helped in the prospective evaluation of dialysis processes, determination of risks associated with dialysis care, and development of solutions and preventive actions. Thus, reduce the risk and improving the patient safety of the Dialysis Department.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]