Yasamin Molavi Taleghani， Fatemeh Rezaei， Hojat SheikhbardsiriHealth Management and Economics Research Center， School of Management and Medical Information， Isfahan University of Medical Science， Isfahan， IranDepartment of Disaster and Emergency Medical Management Center， Kerman University of Medical Science， Kerman， Iran Corresponding Author: Hojat Sheikhbardsiri， Email: hojat.sheikhbardsiri@gmail.com

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Original Article

Risk assessment of the emergency processes: Healthcare failure mode and effect analysis

Yasamin Molavi Taleghani1， Fatemeh Rezaei1， Hojat Sheikhbardsiri21Health Management and Economics Research Center， School of Management and Medical Information， Isfahan University of Medical Science， Isfahan， Iran
2Department of Disaster and Emergency Medical Management Center， Kerman University of Medical Science， Kerman， Iran Corresponding Author: Hojat Sheikhbardsiri， Email: hojat.sheikhbardsiri@gmail.com

BACKGROUND: Ensuring about the patient's safety is the fi rst vital step in improving the quality of care and the emergency ward is known as a high-risk area in treatment health care. The present study was conducted to evaluate the selected risk processes of emergency surgery department of a treatment-educational Qaem center in Mashhad by using analysis method of the conditions and failure effects in health care.

METHODS: In this study， in combination （qualitative action research and quantitative crosssectional）， failure modes and effects of 5 high-risk procedures of the emergency surgery department were identified and analyzed according to Healthcare Failure Mode and Effects Analysis （HFMEA）. To classify the failure modes from the "nursing errors in clinical management model （NECM）"， the classification of the effective causes of error from "Eindhoven model" and determination of the strategies to improve from the "theory of solving problem by an inventive method" were used. To analyze the quantitative data of descriptive statistics （total points） and to analyze the qualitative data，content analysis and agreement of comments of the members were used.

RESULTS: In 5 selected processes by "voting method using rating"， 23 steps， 61 sub-processes and 217 potential failure modes were identifi ed by HFMEA. 25 （11.5%） failure modes as the high risk errors were detected and transferred to the decision tree. The most and the least failure modes were placed in the categories of care errors （54.7%） and knowledge and skill （9.5%）， respectively. Also，29.4% of preventive measures were in the category of human resource management strategy.

CONCLUSION: "Revision and re-engineering of processes"， "continuous monitoring of the works"， "preparation and revision of operating procedures and policies"， "developing the criteria for evaluating the performance of the personnel"， "designing a suitable educational content for needs of employee"， "training patients"， "reducing the workload and power shortage"， "improving team communication" and "preventive management of equipment's" were on the agenda as the guidelines.

KEY WORDS:Emergency； Risk assessment； Healthcare failure mode

World J Emerg Med 2016；7（2）:97–105

INTRODUCTION

Health care brings benefi ts to patients basically， but it can put patients at risk of adverse events and medical errors at the same time.［1］Thus， maintaining patient safety is proposed as the main concern in providing treatment and health care.［2］Also， emergency ward is known as a complex， dynamic and prone to medical errors in health care systems.［3，4］In the emergency conditions， time is short for the critical thinking and it leads to delay in decisionmaking and consequently an increase in adverse events.［3］The results indicate that almost one person in 10 people admitted in hospitals experiences a traumatic event that about half of them are preventable.［5］Also according to the performed estimations， 3% of all hospital errors are relatedto the emergency ward.［6］As well as traumatic events in about 10% of patients with surgery that is more common in the emergency section.［7］The results from the New Zealand study indicated that 3.4% of deaths were related to medical mistakes which are preventable.［8］Prevention of treatment errors is the basic rule in the quality of health care.［9］In all programs of the quality improvement， error prevention and risk management approaches are the basic pillars in the creation， establishment and implementation of management systems in organizations.［10］One of the most reliable error prevention and risk management programs of the National Center of Patient Safety and the Commission on Accreditation in the United States of America is Healthcare Failure Mode and Effects Analysis （HFMEA）.［11］In fact， HFMEA is a prospective and systematic approach to identify and avoid the potential errors before they occur which is specially designed for treatment and healthcare organizations.［12，13］This approach is good for identification and prioritization of risks to improve patient safety and reduce the potential errors of each system before they occur.［14，15］The results indicate that the number of medical events from 2008 to 2009 and after implementation of risk management programs by the National Center for Patient Safety was reached to 2412 from 3643.［16］Since maintaining and protection of patient safety is addressed as the main concern in healthcare systems［2］and also due to the emergency ward is known as a high-risk area in healthcare［17］and in high percentages of patients is the first contact unit of the patient with hospital care，［18］the present study was conducted with the aim of risk assessment of the selected processes in the emergency surgery ward of Qaem Treatment-Educational Center in Mashhad with the method of HFMEA.

METHODS

In this study and as a co mbination （qualitative action research and quantitative cross-sectional）， failure modes and effects were identified and analyzed with the method of HFMEA. This study was conducted from December 2012 to June 2013 on fi ve selected processes in the emergency surgery ward of the Qaem Treatment-Educational Center in Mashhad. Qaem Hospital as a first-class and general hospital with 870 active beds，18 sections and 7 emergency and having para-clinical services and clinics is one of the biggest treatmenteducational centers in the area and country. This center is a place for researches of medical education and education of students in specialized and ultra-specialized levels in addition to treating patients. All information after reaching consensus on team comments at the end of each step was entered to HFMEA work sheet. It should be noted that the time taken to carry out the study was 42 hours. The stages of this research according to the five explained steps of the HFMEA method by the National Center for Patient Safety［11］were carried out as below that had some differences with the proposed model according to the conditions in the running:

Step one: selection of a high-risk process

Using the method of "voting method using rating"，ten people of the emergency surgery members were asked to classify five processes from a total of 20 processes listed in that section with regard to the effect severity of the existing problems on patients' dissatisfaction，the possibility of damages caused by process problems，and the need to solve them， from one to five. Then the data of vote were finalized and prioritized according to the matrix or Borda function［19，20］and 5 processes with priority were selected to manage risk. Borda function is the sum of voters who preferred each option over the others and determine the priority of the problem.［21］

Step two: assembling the team

In this process， 17 persons participated in as the members of the HFMEA team including the responsible person of risk management （team leader）， an expert in health services （team advisor）， an assistant professor in the emergency department， the head of the emergency ward， an adviser physician， the supervisor， two assistants （residents）， a technical manager of radiology unit， two nurses， a receptionist， a triage nurse， the chief of the laboratory， a laboratory expert， and a secretary.

Step three: graphically describing the processes

In this step the diagram of selected processes and their sub-processes were drawn by observation and interview. The validity of processes and sub-processes flow was assessed in a focus discussion group by team members， and proper correction was made. The final process fl ow was designed by Visio.

Step four: conducting hazard analysis which was done in 4 phases:

First phase: determining the potential failure modes

In this stage， by means of triangle model，［22］errors in every sub-process of selected processes were identified and they were classified according to the nursing errorsin clinical management model （NECM）.［23］In the triangulated approach， failure modes are obtained by three approaches of literature reviews: ward observations and interviews with patients and staff； brainstorming sessions by members of the project； and focus groups with HFMEA teams.［22］Failure modes according to the nursing errors in the NECM were categorized in 4 main groups of communication， care process， administrative and knowledge， and skill-based errors.［23］

Second phase: determining the hazard score

This score was obtained through a priority matrix （by multiplying the two factors of severity and probability），and it was recorded on the HFMEA worksheet. The errors were grouped according to their hazard scores into four intervention levels， i.e.， emergency， urgency，programming， and monitoring.［24］For determination of the probability of the failures， the sum of the team's scores was used with consideration of a coefficient for each team member. For the severity of the failures， the team members' consensus along with consideration of weight for the severity of failures was used. In the final worksheet， we calculated and documented in the final worksheet the sum of failure mode severity scores according to team members' opinions and by considering weights for the failure mode severity dimensions， and we calculated the sum of the failure mode probability scores based on the involved personnel's opinions （also with considering the coeffi cient for each person） （Table 1）.

Third phase: designing decision making tree

The non-acceptable risks （risk score level more than 8）were transferred to decision tree. Decisions for proceeding or stopping each of failure modes were made based on three items: weakness points， existing control， and detectability.

Fourth phase

In this phase， through cause and effect analysis sessions， effective causes were identified for failure modes which obtain positive response in weakness point and reach negative response in detectability and existing control measures and they are classified by means of Eindhoven model.［25］According to the ECM model， root causes of failures can be categorized in two main groups: latent errors （technical and organizational） and active errors （human errors）.

Step fi ve: actions and outcome measures which were performed in two phases

The fi rst phase

The suggested confronting strategies for each factor that affect failure mode were presented in accept， control or eliminate forms.

The second phase

Redesigning the process and improving strategies for each cause of error with a score≥8 in the team meetings through "theory of problem solving by an inventive method"［26，27］were provided and classifi ed with inspiring by the proposed model of "classification of preventive strategies in incidence of medical errors".［9，28］Finally， the practicability of implementation of any approach with regard to resources of the organization were evaluated.

RESULTS

By implementing the voting method using rating，from among the 20 processes in the emergency surgery， 5 processes with the Borda-number［29］were selected for the process of fi rst visit of patient，［24］for the process of outpatient admission，［18］for the process of performing， sending and tracking the laboratory results，［12］for the process of patient radiology［9］and for the process of nursing and patient care.

According to the results， for 5 selected processes per 23 listed steps， 61 sub-processes and 217 failure modes were identified. The number of identified failure modes，number of intervention levels， and classifi cation of failure modes for the selected processes based on the proposed model are shown by the association of "management of nursing error" （Table 2）. In total， 25 failure modes were identified as the high-risk and unacceptable failure mode （hazard score≥8） in 5 selected processes and transferred to the decision tree. Because of the plurality of high-risk failure modes （hazard score≥8）， only some of the high-risk and unacceptable failure modes are provided in the HFMEA worksheet （Table 3）. The classifi cation of causes of high-risk and non-acceptable risk （hazard score≥8） is shown based on Eindhoven model （Table 4）. The classifi cation of strategies

Table 1. Error scoring matrix and classifi cation of intervention levels

Table 2. Distribution of failure modes in each area of the error scoring matrix and classification of failure modes based on the model of management association of nursing error for the selected emergency surgery processes

Table 3. Classifi cation of the basic causes of failure modes with error score≥8 based on Eindhoven model

Table 4. The worksheet of failure modes techniques and HFMEA for some high-risk failure modes of the selected emergency surgery processes

and the proposed preventive approaches through the theory of problem solving by an inventive method based on the proposed model are shown in Table 5.

DISCUSSION

Using the five-fold stages model HFMEA proposed here by the patient immunity national center， we dealt with the identifi cation of the emergency surgery section selected processes possible failures， factors influencing each of the failure modes， and determination of the improvement solutions and strategies. But， according to the case study conditions and for eliminating the model practical limitations， there were observed differences in the suggested patterns. The major discrepancies include: 1） selection of high-risk processes through some sort ofpolling method via making use of ranking method； 2）failure classifi cation within the nursing failure management model framework； 3） designing more comprehensive and conclusive methods for failure level score determination；4） failure factors classification based on the Eindhoven model； and 5） failure classification within the framework of medical failure preventive strategies classification model. To prioritize and select the high-risk processes，voting method using rating was used to select the highrisk process；［21］whereas Anderson et al［22］used the riskassessment matrix and the average error score for selection and periodization of high-risk process in the surgery ward.

Table 5. Classifi cation of strategies and preventive measures for causes of high-risk error modes （risk score ≥8）

In the present study， a multidisciplinary team was used to identify and assess risk in the emergency surgery ward. The study results of Dominici et al［29］indicate that it is important to evaluate the results of application of HFMEA in the quality of patient care and form multidisciplinary teams to identify and classify possible risks. Since the fi rst step in reducing health care errors is to identify the failure modes， a comprehensive model must be used to categorize all failure modes， and help to identify and compare them.［30，31］Therefore， we used nursing error management model to group failure modes of the selected processes in the emergency surgery ward. According to Dehnavieh et al，［4］the most failure modes were in the categories of care errors （54.7%）， communication errors （20.5%）， administrative errors （15.1%） and knowledge and skill errors， respectively， which are in consistent with the results of the present study. In most studies of HFMEA，the variability of ability to detect failure mode has been eliminated， because the concept of detection risk is hidden in the indicator of degree of occurrence and low possibility of discovering many risks of the health sector.［32］If the error report system in the healthcare sector is applied comprehensively and as a general system in the country，the problem will be resolved.［33］

In the present study， the incidence and error possibility were determined individually and independently. Independent scoring of team members has the advantage of wearing off the halo effect （cognitive bias caused by an observers' overall impression of a person or situation），which exists in group discussions.［22］In addition，the intervention levels of "emergency"， "urgent"，"programing" and "monitoring" for each failure mode were predicted with regard to the score of error level. The advantage of this method is that due to the lack of resources of organization， corrective actions and focus on reducing the risk of errors is due to the levels of intervention.［24］According to Bonfant et al，［24］in 93 errors in the dialysis ward， 0%， 9.6%， 38.7% and 51.6% were placed in the intervention area of emergency， urgent area， programing area and monitoring area， respectively，which are consistent with our fi ndings.

Eindhoven model tested in different industries including hospital is more comprehensive than other models.［34］Using the Eindhoven model， Hung et al［20］discussed the causes of high-risks errors in the selected processes in the emergency surgery ward. They found that 39.7%， 10.4%， 42.4% and 6.8% were related to the human factors， technical factors， organization factors and other factors respectively， which are in consistent with the results of the present study. Most studies using the Eindhoven model showed that the percentages of human and organization factors are higher than those of other factors because of individual prejudices prevailing in each organization.［9，25，35］Moreover， for the safety of patients， ensuring the adequacy of staff， re-designing of the systems and concurrent attention to the obvious and hidden causes are necessary to detect and correct the errors on time.［32］Due to the limited resources in each healthcare organization to implement strategies and eliminate the effective causes on failure modes， the most cost-effective one should be selected.［4］Therefore， in this study to determine the proposed strategies， "theory of problem solving by an inventive method" was used. In this study， most preventive actions in the selected processes of emergency surgery were placed in the strategy category of human resource management.

Strategies of human resource management are the primary solutions that help the organizations to develop skills， attitudes and behaviors of individuals as well as the optimum performance to achieve the organizational goals.［36］Through this strategy， senior managers of treatment section identify and develop strategies for the issues related to human resources.［37］Wong and Beglaryan［37］and Ebrahimipour et al［9］used the strategy of human resources management as the most important strategy to improve patient safety and reduce clinical errors.

Generally， HFMEA as one of the risk evaluation models in a healthcare and treatment organization should be implemented. One reason for maintaining a continuous HFMEA process is that through reducing failure modes risks it is probable to change another failure risk. Thus，after taking measures for improvement and recovery，reviewing risk level scores is deemed necessary both for monitoring the measures' effi ciency rate and determining the established changes in other failure indices in relation to the improved failure. Estimating the fi nal effects of the immunity resulting from the electronic medical documents system in an intensive care unit indicated that HFMEAwould reduce the risks of interactions between nursephysician-physician-tables through calculating the risk rank based on the electronic medical documents system，whereas the physician-patient interactional risks in the examination and evaluation stage and nurse-table would be increased.［38］Therefore， while immunity improvement can bring about performance improvement in other dimensions， it can also be a negative impact on the other performances. Therefore， while investigating the reviser recommendations and suggestions from risk evaluation model， the exact survey of the relationship between enhanced immunity， timing of implementation feasibility and amount of affordability is necessary.［14］

Eventually， HFMEA usefulness has been approved in redesigning treatment and healthcare processes. For instance， Dewe and his colleagues［39］used HFMEA in the intensive care unit and they realized that the successful application of this method is related to strong and effi cient leadership and continuous commitment. Latino and Spath［40］also reported the importance of organizational leadership and management in the application of risk management methods.

Thus， the implementation of strategies and proposed actions has a strong relationship with the participation of individuals and financial and administrative support.［32，41］Duwe et al［42］reported that the successful implementation of prospective risk assessment programs is related to the strong leadership and continuous commitment.

One of the limitations of this study is that the amount of real failure cannot be determined in HFMEA studies［43］and the points of team members are based on their minds. Also， in HFMEA studies， it is diffi cult to show the reduction of adverse events after interventions and to prove the improvement of patient safety and cost-benefi t analysis with HFMEA programs.［26］

"Creation and revision of the approaches and a clear implementation method"， "education of the patients and patients' participation in treatment process"， "revision and re-engineering of processes"， "basic analysis of the events and report of the critical results"， "continuous monitoring and control of the working stages"， "improvement of team communication"， "check-list of maintaining and management of equipment"， "development of the evaluation criteria of staff performance"， and "adapting workload with the staff" should be applied for optimization and to improve the quality of emergency surgical processes. Finally， the effectiveness of the mentioned method in the implementation step was not tested in this study.

In conclusion， using HFMEA to identify the possible errors of treatment processes， causes of each failure mode， and strategies of improvement is highly effective，and prospective risk analysis in healthcare sector is proposed to transmit an organizational culture from the type of reaction to the type of error prevention.

ACKNOWLEDGMENTS

This article is a part of Master's thesis of the management of healthcare services in the faculty of Health， Mashhad University of Medical Sciences， entitled "Assessment of the risks of the selected sections of Qaem healthcare center in Mashhad by the method of Healthcare Failure Mode and Effects Analysis which has been recorded with the code 911089 in the research department. We are grateful to the hospital staff especially those from emergency surgery department for their cooperation.

Funding: None.

Ethical approval: The study was approved by the institutional ethics review board.

Conflicts of interest: No authors declare any actual or potential confl icts of interest.

Contributors: Sheikhbardsiri H proposed the study and wrote the fi rst draft. All authors read and approved the fi nal version of the paper.

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Received November 19， 2015

Accepted after revision March 21， 2016

DOI:10.5847/wjem.j.1920–8642.2016.02.003