Volume 30, Issue 1 (1-2020)                   JHNM 2020, 30(1): 35-44 | Back to browse issues page


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Moradi L, Emami Sigaroudi A, Pourshaikhian M, Heidari M. Risk Assessment of Clinical Care in Emergency Departments ByHealth Failure Modes and Effects Analysis. JHNM 2020; 30 (1) :35-44
URL: http://hnmj.gums.ac.ir/article-1-677-en.html
1- Nursing (MSN), School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
2- Associate Professor, Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran , emamisig@gmail.com
3- Assistant Professor, Social Determinants of Health Research Center (SDHRC), Department of Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
4- Associate Professor, Department of Occupational Health, Research Center of Health and Environment, School of Health, Guilan University of Medical Sciences, Rasht, Iran
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Introduction
Preventing medical errors in the health sector is highly essential. As a result, the quality of health care services is considered as error-free delivery of health services, at the right time, by the right person and with the use offewest resources. Increasing awareness of the number, causes, and consequences of medical errors indicates the need to improve knowledge about this problem and to provide practical and strategic solutions to its prevention [1]. The emergency department is among the most critical, sensitive, and risky wards of hospitals [2-4]. 
Clinical care and its associated adverse events are the major health problems and of international concern [5]. Approximately one in every four people admitted to the hospital experiences an adverse event; about half of which is preventable. Moreover, nearly one-third of the events harm the patient, causing adverse effects,varying from increased stay duration to death [6, 7]. Studies suggested that the human error in medical care, in addition to causing death and disability, can increase the healthcare sector costs [8]. It is estimated that almost 5-10% of healthcare costs are due to unsafe clinical services that can harm patients [9]. 
Among the official statistics ofmedical error rate among the medical staff, 42-53 related to complaints, 22-42 to deaths, 35% to adverse events, and 27% to physical injuries [10]. The best approach to prevent medical errors is to identify errors and their root and systematic causes [5].
Systematic thinking has been introduced in identifying and treating health sector errors; accordingly, applying various risk management techniques have been frequently used to improve patient safety in this sector [11]. There are various methods to assess risk. Healthcare Failure Modes and Effects Analysis (HFMEA) is the most common method in this regard [8]. It is a systematic tool to manage, execute, and document the activity of identification, evaluation, prevention, elimination, or control of the causes and effects of potential errors in a service system before a final product or service is delivered to the customer [12, 13].
Unlike many other risk assessment tools, this method does not require complicated statistical analysis [14]. The HFMEA technique, which is implemented with a preventive, team-based approach, increases employee’s precision and focuses on functional defects and strives to eliminate them.The primary purpose of HFMEA is to identify and correct potential failures. It is among the most accurate tools for evaluating and eventually managing risk [13]. Applying the HFMEA method in the health care system establishes systematic thinking for the safety of the patient care process [6].
There are two phases in HFMEA.The first phase relates to failure detection and its effects.The second phase analyzes critical points to determine the severity of each failure by ranking them.The method consists of 5 steps. In the first step, after selecting the process, activities are listed using focus group discussions and through meetings and individual interviews. In the second step, the potential failure modes of each listed activity are determined using focus group discussions as well as team members’ brain storming.
Then, after agreeing and reaching a common conclusion by all members, it is recorded in the final worksheet and the potential failure mode column. The immediate and direct effect of failure on the patient’s treatment processis also recorded. In the third step, each identified failure mode is prioritized based on the Risk Priority Number (RPN). RPN results from multiplying three factors; occurrence, detection, and severity. Next, in the fourth step, the causes of the failure modes with a high RPN are identified.
In the fifth step, the proposed coping strategies for failure modes with high RPN in each selected process are presented. The advantages of this approach include the existence of multi-tasking teams, involving patients, and improving the understanding of current processes, ease of understanding, lower cost of implementation, and ability to run it by necessity [5, 13].
Using HFMEA is effective in all sectors of the healthcare system.Furthermore,studies have revealed that HFMEA is useful for detecting errors and improving patient safety [15-18]. Petrillo et al. concluded that implementing HFMEA can significantly reduce errors. With the precautionary approach, HFMEA can reduce costs,help the hospital deliver quality services, and provide satisfaction [11, 19]. Shahrami et al. argued that HFMEA could be a reliable and efficient approach to reduce emergency department costs and increase its revenue [20]. 
The patient evaluation process, as the source of many risk management issues, is highly essential in the emergency department. Thus, this study aimed to use the HFMEA method to identify and prevent emergency department failures.

Materials and Methods
This analytical and cross-sectional study was conducted in the emergency department of a hospital in Rasht City, Iran, in 2015 (May-June). The study population consisted of all nursing staff of the emergency department. Qualitative data were collected using the Focus Group Discussion (FGD). Purposive sampling technique was used for selecting the FGD members.The average required the number of participants for FGD is 4-12 people.
Therefore, in this study, the FGD consisted of nine members; one was in charge of education and eight were the nurses working at the emergency department. The studied nurses were selected by the matron and ward supervisors based on their work experience.We aimed to familiarize the FGD members with applying the human error risk assessment method and its scoring. Moreover, we familiarized them with the teamwork principles as a feature of the HFMEA method. Therefore, a retraining program was implemented by the permission of the Continuing Education Secretariat and in collaboration with university faculty members.
To collect the required qualitative data, all clinical care processes of the emergency department were identified with the presence of the researcher. Then, using Hierarchy Technique Analysis (HTA), the tasks and sub-tasks of nurses in providing emergency clinical care services were analyzed.The main processes of the emergency department were listed using a literature review, interviewing with nurses, direct observation, and checking patient records. The processes were ranked by the FGD members, given the severity of the impact of errors on patients and the need to resolve their problems on a 5-point Borg scale from 0 to 10. Score 10 was assigned to a process with the highest priority for error detection.Thus, all processes with scores ˃9 were selected for the study. Next, potential hazards and human errors were identified by FGD members through group discussion and brain storming.
Additionally, among all identified hazards, hazardous processes with potential harm to the patient were identified and entered into the standard HFMEA worksheet.Consequently, the research was conducted in 5 steps.In the first step, after the process selection, related activities were prepared using the work book and group discussion by the FGD members.In the second step, the potential errors of each listed activity were determined and recorded in the final worksheet. The immediate and direct effect of the error on the patient’s treatment process was also recorded.
In the third step, to obtain quantitative data, each error was prioritized based on RPN,obtained for each error mode by multiplying occurrence, detection, and severity indices. Based on the error severity index, team members assigned scores 10 and one to processes with the most severity,and without an effect, respectively. According to the error occurrence index, scores 10 and one were assigned to errors that certainly occur and highly unlikely to occur during the clinical process, respectively. Based on the error detection index, scores 1 and 10 were assigned to detectable and undetectable errors, respectively.
Thus, the team members rated the errors identified by group discussion and brain storming using a table containing three indices. In this regard, for these verity index of ≥6 (very severe, but compensable), occurrence index of ≥6 (1 in 80 cases), and detection index of ≥6 (low chance of error detection), the errors with RPN ≥216 were considered as high priority risks (at 65% confidence level). 
In the fourth step, the probable causes of error modes with high RPN were identified using Root Cause Analysis (RCA). It is a structured survey to identify the real causes of a problem and suggests solutions to eliminate them. Finally, in the fifth step, the proposed coping strategies for high RPN error modes in each selected process were presented.
Results
The FGD members had a Mean±SD age of 30±6.78 yearsanda Bachelor’s degree. They reported mean work experience of 12.96±5.80 years. Their average work experiencein the emergency department was 7 years; 6 of them had experience of ˃10 years. In the first stage, 67 main processes of clinical care in the emergency department were identified in 10 general categories. Of these, 26 processes in 7 categories were selected based on a Borg scale.
 A total number of 66 potential error modes were listed and recorded in the worksheet. Of these, 5 were related to general measures; 6 to infection control and wound care;15 to medication orders; 3 to laboratory tests; 4 to nervous system care; 15 to cardiovascular system care; and 19 to respiratory system care (Table 1). After obtaining the RPN number of each error mode, a total number of 13 errors with RPN ≥216 were identified as high-risk and unacceptable (Table 2).
Discussion
The present study evaluated emergency department clinical care errors by the HFMEA method. The error with the highest priority in the “general practice” category in our study was the failure to record clinical practice as an examination and practical error. According to Mazlom et al. a physician’s failure to provideverbal instructions was among themost common errors [5]. Attar JannesarNobari et al. categorized delays in initiating the patient care process and failure to follow physician’s orders, as high priority errors [6]. 
Delayed care by the nurse, forgetting to execute orders or executing erroneous instructions, physician’s refusalto provide orders via phone, failing to execute the order, and writing wrong instructions in the patients’ medical records were the results of providing poor quality clinical services to patients. The emergency department is among the crowded hospital wards. It is somewhat uncontrollable and increases the workload and fatigue of nurses, resulting in increased odds of errors.
In the “infection control and wound care” category, the most common errors were non-compliance with the aseptic technique during wound dressing and insufficient attention to the wound site (considered aspractical errors). According to Attar Jannesar Nobari et al. poor dressing quality and wound suture were categorized as functional errors but not considered as high priority errors [6]. This may be due to differences in the study settings,considering the type of admitted patients.
In our study, due to the high admission rate of traumatic patients requiring wound care, proper clinical practice in the area of infection control and wound care was critical. Amini et al. suggested that most nurses were not adequately aware of nosocomial infections [21]. Failure to properly perform dressing can lead to complications, likean infection. Consequently, it might cause increased treatment costs and a lack of proper treatment provided for patients.
In the category of “executing medication orders”the most frequent errors were the lack of attention to the blood transfusion speed and drug expiration date, the use of inappropriate drug dosage for the patient, and failure to observe intravenous line replacement time. Dehnavieh et al. investigated blood transfusion errors and reported that most errors occurred in the early stages of the transfusion [22].
Blood transfusion speed must be considered when transfusing blood. Transfusion of blood products should take place within a specified time, and prolonged transfusion could cause complications for the patient. Similar to our study, Kermani et al. reported the lack of attention to the drug expiration date and the use of inappropriate drug dosage form as the most critical medical errors [23]. Poor Aghaee et al. reported medication prescription with inappropriate speed, wrong dose prescription, adverse medicationeffects, and drug interactions, as identified low-risk errors [24].
The incidence of these clinical errors in the emergency department can be increased due to the high workload and overcrowding of patients. According to Farzi et al. reducing the workload of nurses can be usefulin reducing the incidence of such errors [25]. Another error was a failure to observe intravenous line replacement time which can have some consequences, including phlebitis, not receiving a proper amount of serum and the lack of providing proper treatment for the patient. Adjusting the intravenous line replacement protocol in each department and having more control overit at the beginning of each work shift can be effective in reducing it.
In this study, factors, such as improper equipment or failure of medical devices and equipment, were the causes of errors, including the malfunction of the ventilator alarm and errors in measuring blood glucose level with a glucometer. Poor Aghaee et al.reported the use of non-calibrated devices, as medium risk errors [24]. Rezaee and Salehi reported the malfunction and misuse of equipment as the reasons for the damages caused by medical equipment; they can reduce patients’ safety [26]. Therefore, it is vital to educate staff on how to check the proper functioning of the devices before using them. Defects in equipment and incorrectuse of them can imposes ubstantial financial losses and irreparable injuries.
In the category of “respiratory system care”, the most frequent errors were the lack of oxygenation during endotracheal suctioning, and lack of airway suctioning inweaning adult patients from the ventilator. Khalili et al. recognized oxygenation failures as high-priority errors [27]. Identifying such processes as high-risk in this study and other studies and its clinical consequences in patients are observed in the form of dyspnea, reduced arterial oxygen saturation and the lack of suction tolerance. Such matters indicate the importance of oxygenation during the patient suction process and the need for error reduction.
The lack of airway suctioning during ventilator weaning can have some consequences, including the aspiration of secretions, shortness of breath, and patient’s intolerance during weaning. No study investigated such failure mode. Valencia et al. and Kesieme et al. found airway suctioning critical [28, 29]. Suctioning may reduce airway resistance. Therefore, attention to airway suctioning and its appropriateness can improve respiratory function and make the weaning process tolerable.
Regarding errors in respiratory system care, results reported that failure to control vital signs during the placement of a chest tube and the lack of attention to the function of the chest tube drainage system had high-risk priorities. One of the causes of this clinical error was the lack of awareness to understand the importance of drainage system care. Based on Kesieme et al. nurses’ knowledge of the care of chest drain is poor and they require education in this area [29].
The incidence of this clinical error in the study department indicates inadequate patient care provision fordrainage. This can be due to poor training or high workload and fatigue. Staff training is among the suggested strategies that can effectively reduce the incidence of such clinical errors.
In the present study, the most important reasons that influenced all clinical errors were lack of knowledge, high workload, and fatigue. Khalili et al. reported the causes of failure as the lack of knowledge, attention, motivation, and time [27]. Salavati et al. and Kaboodmehri et al. stated that considering the emergency nurses’ working conditions, including the workload level and the number of treated patients, could be effective in preventing clinical errors [30, 31]. One of the suggested solutions to reduce clinical errors is to educate staff and raise their awareness about treatment principles and their proper implementation.
Identifying unacceptable clinical errors, investigating the causes and effects of these errors, as well as controlling and suggesting measures indicate the high efficiency of the HFMEA method. These factors also highlight the preventability of these errors by increasing the knowledge and awareness of staff through holding training courses. In this study, the leading causes of human error in clinical care processes were the high workload and fatigue of nurses. This has made access to nurses whose clinical care processes were studied extremely difficult; this is asignificant limitation of our study.
It is recommended that the HFMEA method be applied to all critical wardsin public and private hospitals. Moreover, it is suggested touse the results to reduce human errors which can save resources, reduce costs, reduce complaints, and increase patient safety.
Based on the results obtained through RCA, one of the causes of error was poor training. It is recommended that continuing education courses be planned and implemented. Training on the necessity of writing orders in the medical record and Kardex, minimizing verbal instructions in the department, emphasizing the presence of a physician in the patient’s bedside, obtaining written instructions, and receiving the written instructions and supervisions by matron are other necessary suggestions to control the occurrence of human errors.
Other measures include the periodic expert control of device, nurse control of the device at the beginning of each work shift, providing sufficient workforce, reducing workloads, periodically controlling the expiry date of drugs, and the disposal of out dated drugs, assigning a person in charge of the medication at each shift, controlling the vein line at the beginning of each shift, and following the intravenous line replacement protocol in each department.
Ethical Considerations
Compliance with ethical guidelines
This research was approved by Ethics Committee of Guilan University of Medical Sciences (Code: IR.GUMSREC1394.289).
Funding
This paper was extracted from MS.c thesis of the first author, with the approval and financial support of Guilan University of Medical Sciences, Rasht, Iran. This research was supported by the Vice-Chancellor of Research and Technology of Guilan University of Medical Sciences (Grant No. 922246).
Authors contributions
Conceptualization, supervision: Abdolhosein Emami Sigaroudi, Majid Pourshaikhian; Support for the design of the study and data collection: Mahmood Heidari; Data collection, assembly, possession of raw data, drafting the final report: Leila Moradi.
Conflict of interest
The authors declared no conflicts of interest.
Acknowledgements
The authors would like to thank the faculty members of Shahid Beheshti Nursing and Midwifery school, Guilan University of Medical Sciences of Guilan University of Medical Sciences, the head of the study hospital, and the nursing staff of the emergency department for their valuable cooperation.
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Article Type : Research | Subject: Special
Received: 2019/10/25 | Accepted: 2019/11/28 | Published: 2020/01/1

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