|Year : 2013 | Volume
| Issue : 4 | Page : 237-242
Risk assessment in eye surgery: A hospital in Iran
Alireza Jabbari1, Fateme Rezvani2, Elahe Khorasani3, Marzieh Fattahi2
1 Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran
3 Research Center for Health Services Management, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
|Date of Web Publication||16-Apr-2014|
Student Research Committee, Isfahan University of Medical Sciences, Isfahan
Source of Support: None, Conflict of Interest: None
Introduction: Clinical risk management and medical errors have become a basic part in every hospital management. The critical complexity that controls the conditions of very ill patients in some specialized units like the operating room may increase the number of errors in providing healthcare services. Using failure mode and effect analysis (FMEA) method, the present study attempts to identify, assess and provide appropriate actions to control, reduce and eliminate the potential risks in the operating room in Feiz hospital in 2012. Materials and Methods: The present study is a qualitative research conducted in 2012 through direct observation, interview with the officials and authorities in the operating room, and available document review. The participants include the authorities in hospital units and those aware of processes in the operating room. To collect the data, the standard worksheet of the FMEA technique was used. Findings: Based on the authorities' point of view, eight main actions were selected to analyze the potential errors. The finding suggested that 35 failure modes were identified in the operating rooms at the Feiz hospital in Isfahan from among which seven potential failure modes were related to injection and transfusion, four to prechecking the apparatuses, 14 to the cares before and during the surgery, four to the cares after the surgery, one to the sterilization of the apparatuses, three to admitting the patients in the operating room, one to checking the blood glucose, and one to checking the doctors' instructions and prescriptions. Discussion: Based on the results presented, the following priorities were found to eliminate or reduce the identified errors: teaching the Haemovigilance system and an identification guideline of the patient to the personnel, full awareness of drugs and their possible side effects, teaching fluid therapy, controlling the operation of the apparatuses, teaching the health processes and controlling infection, and so on. Hospitals can easily provide a list of the required specific errors reported in the centers and introduce some approaches to deliver the services and enhance their quality, by performing a simple comprehensive technique and analysis, like the one presented in this study in all units.
Keywords: Eye surgery, failure mode and effect analysis, hospital, Iran, operating room, risk management
|How to cite this article:|
Jabbari A, Rezvani F, Khorasani E, Fattahi M. Risk assessment in eye surgery: A hospital in Iran. Int J Health Syst Disaster Manage 2013;1:237-42
|How to cite this URL:|
Jabbari A, Rezvani F, Khorasani E, Fattahi M. Risk assessment in eye surgery: A hospital in Iran. Int J Health Syst Disaster Manage [serial online] 2013 [cited 2021 Mar 1];1:237-42. Available from: https://www.ijhsdm.org/text.asp?2013/1/4/237/130745
| Introduction|| |
One of the most crucial aspects of health services is patient safety and nothing is more inconsistent to this than hurting a "health-seeker" who is looking for a cure.  Therefore, clinical risk management and medical errors have become vividly existent in every hospital management. , In fact, one important challenge in a health system that every country is faced with is medical error. , In Iran, there is an increase in medical errors as the health services are developing. 
Quality is really important in the health sector, because it is responsible for maintaining health in the society.  Thus, the health ministry presents standards, techniques, and approaches to deliver good services in all hospitals through out Iran. Some of these are providing and performing clinical governance and the recent accreditation standards in hospitals through out Iran.  According to the Joint Committee of Assessment, medical errors are unintentional action taking place ignorantly or a treatment which does not lead to the intended result. 
As the statistics demonstrate a high number of patients are hurt when using the services in the health systems especially in hospitals, leading to deterioration of their problems. Naturally, in these situations the healthcare services are more prone to risks; the experimental results also reveal the number of patients hurt by medical errors is significantly high. 
The increasing number of medical errors has become a controversial issue among the health policy-makers, service providers, and experts.  The patient safety focuses on presenting a system to deliver services committing no error, emphasizing on learning from previous errors and dealing with different aspects of patient safety concerning the health experts, organizations, and patients.  Moreover, it is estimated that 1 out of 10 patients admitted to hospitals experience a catastrophic incident, half of which may be prevented and one third may harm the patients; these harms can vary from length of stay in the hospital to death.  It is vital to reduce the possibility of risks in hospitals in order to improve the quality of health services, establish a more effective relationship among the hospital staffs, patients and their desires, and to limit the failures in treatment. , Therefore, it is an essential need of every hospital to identify and analyze the errors of some units like the operation room.
One feature of the units like the operating room and the intensive care unit is that the patients need careful persistent care. The critical and serious situations in these units are always a concern to the staff and the care givers of the patients. Since there is a critical complex situation in controlling ill patients and there are more people dying in these units than the other units in the hospital, there will be more and more job anxiety in treating and caring processes for the patients that can lead to more errors in providing healthcare services.  To reduce the number of risks, the patients, staffs, and organizations, it is necessary to limit the related risks by improving and designing safe environment.  Qualitative researches are, then, needed to study risk via different methods. 
One of the most practical methods is failure mode and effect analysis (FMEA), which is a systematic integrated model used to identify and prevent the problems in the products and processes. One of its main differences with other qualitative techniques is that it is an action not a reaction, , that is, an action done before occurring, not a practice done after revealing the problems.  FMEA is used to define, identify, prevent, eliminate or control the modes, causes and effects of the potential errors in a service system, and manage performing and documenting the actions before the customer receives the final modes of services. ,
If done correctly and in a timely manner, FMEA is an ever-living process and a dynamic tool used in a continuous improvement cycle. Finally, FMEA is a systematic tool and a fully abstract preventive method  and a collective method which necessitates the experts' knowledge, awareness, interest, and their ability to collectively take actions. , The most important outcome of this method is determining the vulnerable elements as well as the critical points in the system, which requires predicting the errors and identifying their prevention. The main purpose in FMEA is to discover and solve the potential problems of providing service to patients. There are two phases in this model: in the first phase, the error modes are identified and their effects are recognized, and the second phase analyzes critical points and determines the intensity of the error modes by assessing and classifying their risk priority numbers (RPNs). ,
Using FMEA method, the present study is, then, an attempt to identify, assess, and provide appropriate actions to control, reduce, and eliminate the potential errors committed in the operating room in Feiz Hospital in 2012. Feiz is a specialized and subspecialized 172-bed eye hospital in Isfahan. Since, in this hospital, health services are to be provided according to the national and regional standards such as establishment and implementation of hospital accreditation standards in Iran and the clinical governance system to ensure a good quality in performing their strategic program, and establishing the clinical governance in the hospital to reduce the risks and medical errors. Thereby, because of the crucial importance of eye surgery is in this hospital, this study seeks to assess the errors in the operating room.
| Materials and Methods|| |
The present study is a qualitative research conducted in 2012 through direct observation, interview with the officials and authorities in the operation room, and review of available documents in the unit. The participants include the authorities and those aware of processes in the operation room (54 persons including: 9 individuals with a BSc in nursing, 9 health workers, 20 technicians in the operation room, 14 technicians in anesthesiology, 1 nurse assistant, and 1 secretary). In order to collect the data, the standard worksheets of the failure mode effect analysis technique were used. It should be mentioned that those worksheets had the same content and format as those in the previous researches, but the ranking was different. These worksheets were provided based upon the ministry of health and medical education's 2/12/2013 correspondence No. 409/15577 and the multimedia files named "risk management and the required skills" [Table 1],[Table 2] and [Table 3].
After authorized permission to enter the hospital, the researchers collected some data regarding the actions taken in the operation room keeping in mind the authorities' point of view; all the related actions were then listed from among which the key and crucial ones were selected. Hereby, the researchers taught the required points for using FMEA method. After authorized permission from the hospital administrator and head of department, the researchers continued their works collectively in a team whose members were selected by the head of department according to their skills and experience. Being a qualitative research, the study analyzes the data as following:
- Reviewing the specialized team members' opinions
- Summarizing, classifying the data via coding and classifying the opinions, and rewriting the team members' opinions in the related columns in FMEA forms
- Giving the opinions back to the participants to confirm the data reliability
- Authenticating the participants' opinions in the final forms
- Making the final decision on the recommended action.
Using FMEA method, the present study scored three criteria named severity, occurrence, and detection according to the related tables. Each error was calculated with a RPN of 125 according to which the failure modes were divided to nonobvious risk (RPN <2) and obvious risk (RPN ≥20) levels. It's worth mentioning that in spite of having a low RPN, some errors were given the first priorities by the team members and hospital authorities, because they were important and had a severity, and high occurrence or low probability of discovering. Some solutions were also recommended to overcome their related errors.
| Results|| |
Based on the authorities' point of view, eight main actions were selected to analyze the potential errors. The finding suggested that 35 overall potential failure modes were identified in the operation room in Feiz hospital in Isfahan from among which seven potential failure modes were related to injection or transfusion, four to prechecking the apparatuses, 14 to the cares before and in the surgery, 14 to the cares during and after the surgery, 1 to the sterilization of the apparatuses, three to admitting the patients in the operating room, one to checking the blood glucose, and one to checking the doctors' instructions and prescriptions.
Regarding injection or transfusion, "wrong blood transfusion" got the highest RPN, 20 and "wrong dose and wrong drug injection" got the lowest point, 6. The authorities believed "wrong blood transfusion" potential risk occurred with the highest RPN, because the personnel did not check the blood bag label or the patient's file. Moreover, in order to prevent this risk, it is recommended to teach the personnel Hem vigilance system and provide a guideline for identification.
Regarding prechecking the apparatuses, "the apparatuses' inefficiency during the surgery and the suction not being ready in extubation" got the highest (RPN = 6) and "routinely filling the vaporizer in the beginning of the shift" got the lowest one (RPN = 3). The participants believed "the apparatuses' inefficiency during the surgery" occurs because the personnel are not aware how the apparatuses work and there is no specific plan to check all the apparatuses in the operation room; in addition, to reduce this risk, it is recommended to calibrate the apparatuses in a timely manner and follow a comprehensive instruction to examine them as well as the systems regularly and periodically in order to find their defections. Moreover, "the suction's not being ready in extubation or not being used" happens because the anesthesia staffs are ignorant of the required time for anesthesia during the surgery. Then, it is recommended to allocate a specific time for the anesthesia technician to inject anesthesia and to teach how to fill the efficiency checklist for apparatuses' efficiency, in every room, in every shift, and for every patient before the surgery.
Regarding the cares before and during the surgery, "putting a used cutter in the sets" got the highest (RPN = 45) and "breaking laryngoscope and damaging the patient's teeth" did the lowest one (RPN = 2). As the authorities believed, the former risk occurred because the nurses do not cooperate in the circular; in order to prevent this risk it is necessary to train the nurses.
Regarding the cares after the surgery, the highest (RPN = 10) was related to "not fastening the stretcher belt" and the lowest one (RPN = 2) to "carrying the patient with out his/her file to the recovery room". Having the highest RPN, "not fastening the stretcher belt" occurs potentially because the staffs in the service unit are ignorant, the recovery room is small, and the operating room is crowded. The risk, therefore, would be resolved if the staffs in the service unit learn how to carry the patients and balance entrance and exit of the patients to and from the recovery room and warning the staff about the risk.
Regarding patient admission in the operating room, the highest (RPN = 15) was related to "the patient's waiting in the operation room especially for the emergencies" and the lowest one (RPN = 6) to "some patients' not being nil per os (NPO) and using some medicines like aspirin to remove an obstruction by Dacryocystorhinostomy of lacrimal sac." The participants found the absence of an anesthesia expert and a surgical resident before the patient as the reason of "the patient' waiting in the operating room especially for the emergencies;" then, they believed this risk will be reduced if the doctors came on time to the operating room and established a balance between the number of surgeries.
| Discussion|| |
In the study "Patient Safety Climate in Medical Centers of Kashan," Sabahi-Bidgoli et al.,  showed there is a weak safety situation in the hospitals under study. Moreover, Kabirzadeh et al.,  suggested 190 (68.3%) chief managers have had medical errors in their hospitals, and most of them have agreed to make an open context and a suitable system to report and analyze the errors.
Also, Zarafshani et al.,  investigated the safety attitude among operating room staffs and revealed 20% have the desired attitude, 67% moderate attitude, 11.5% weak attitude, and the rest have low attitude toward the safety. Then, it is essential, as in the following, to identify and analyze the errors committed in the operation room and to discuss the actions recommended to improve the quality of service and to enhance patients' and personnel's safety.
Baghaei et al.,  divided the predisposing factors of nursing errors in critical care units of hospitals to managing (30.2%), coordinating (42.1%), environmental (61.9%), and educational (53%), and believed there should be an observation-based strategy to eliminate the causes of errors.
The findings revealed the following priorities and actions recommended eliminating or reducing the identified errors. A total of 7 failure modes were identified in injection from among which the highest (RPN = 20) is related to wrong blood transfusion and it is recommended to reduce it by teaching the personnel Hem vigilance system and providing a guideline to identify the patients. The next one (RPN = 20), in the nonobvious risks with the highest severity, is becoming fully aware of the medicine and its side effects, learning fluid therapy, and paying attention to the patient's condition and profile when opting the fluid.
The most common treatment in the units providing healthcare service is drug. The abundant use of drugs and the necessity to use them would increase the failure coefficient automatically. In fact, medication errors occur repetitively in the units caring after the patients.  The pharmaceutical incidents are the harms realized as the result of medical intervention in drug use. The medication errors are "the predictable incidents which can lead to an inappropriate use of drug or harm the patient, while the healthcare centers, patients, or consumers are in control of the drug."
Several studies have demonstrated that approximately 1/3-1/2 of medication incidents is predictable. According to the studies done in hospitals, pharmaceutical incidents vary between 2.4 and 6.5 in every 100 patients, and lead to lengthening the stay in the hospital, increasing the economic burden, and increasing the risk of death. 
According to Kabirzadeh et al.,  from among 75% of the incidents reported in the study, 50% are related to giving, distributing and prescribing medicine.  It is reported that an approximate one third of the pharmaceutical incidents is the result of medication errors; therefore, less than 1/5 of the hospital injuries is attributed to medication errors and their unintended outcomes. Reporting incidents can lead to patient safety in one hand and be regarded as valuable repertoire of information to prevent the upcoming medication errors on the other hand.  In addition, as one reason regarding the process of giving medicines, the study suggested that the healthcare system authorities should focus on the effective processes such as educating the employees which reduce the medication errors. 
Medication errors can be regarded as a universal problem. Then, six common identified errors in giving medicines are giving the medicines in the wrong time, giving them more or less than the prescribed dose, wrong density of the medicines, wrong ways to use the medicine, giving medicines to another patient because of a wrong patient identification. 
The nurses also committed some errors particularly because they do not have the sufficient specialized knowledge on drugs, do not calculate the drugs properly, do not follow the planned protocols, and because the doctors have unreadable handwriting and there are some similarities in the form, packaging or the name of drugs.  In addition, insufficient number of employees, fatigue, and time pressure are among other factors which indirectly increase the medication errors.
In a study on frequency and type of pharmaceutical errors in Tehran, wrong dose, wrong drug, and the infusion speed are among the most common medication errors reported. Also, Heparin, cefazolin and aspirin were the drugs with the highest record of errors; most pharmaceutical errors had occurred in perfusion. The study also revealed that the first priority includes the errors for carelessness and lack of knowledge in fluid therapy, similarities in drug packaging − the formal similarity of atropine and heparin, lack of education and attention in proper drug dope and fatigue, occurred during the working hours. 
In line with the findings of the present study, Nikpeyma and Gholamnejad  quantitatively prioritized the medication errors as: wrong dose of the drug, not doping the drug on time and not taking the drug, respectively, and the reasons are hard work, few employees, and physical or mental tiredness.
When checking the apparatuses in the operation room in advance, it is necessary to compile, complete, and assess different units in the operation room according to the accreditation standards of the operation room to regularly check the operation of apparatuses such as electrocardiography, anesthesia machine, oxygen, CO 2 , blood pressure, patients' temperature, suction and defibrillator, and to check if the required apparatuses and tools, verified by the anesthesia technician and expert, are ready to be used to safely anesthetize each individual patient. Thereby, the patient's safety is ensured and the factors leading to the personnel's inattention in checking the important and vital apparatuses are reduced.
As for the care given before and during the surgery, the study recommended to educate the individuals on health processes and infection controlling in the operation room, draw personnel's attention to the proper performance of the processes in the hospital like carefully monitoring the patient, applying the main apparatuses, and their alarms. Then, in fulfilling help in all recommendations, it is suggested that all employees collaborate with the personnel in the operation room to design the clinical and nonclinical processes; then, based on this and the accreditation standards, they develop a checklist to see the operation of all the apparatuses and equipments and to monitor and evaluate them regularly. Also recommended teaching hygienic processes and infection controlling has been presented with emphasis on cleaning, disinfecting, and sterilizing processes in the procedures of sterilization of the apparatuses.
Another related aspect to nosocomial infections surveillance system, is the possibility of staff needle stick in the review process of blood glucose. The personnel should follow the job security and health instruction which is taught by the central or governing organizations like the ministry and the health vice chancellor in the province.
Since most of the errors identified in the present study are humane errors, it is strongly proven that the fewer number of nurses in a unit, the more infection in hospital and longer stay. Then, the human resource manager, by allocating the working time to each member according to his/her capacity, will reduce fatigue among team members which has direct relation with the amount of error. The results of the present study also emphasize the role of a precise human resource management in reducing errors; moreover, the health organization has focused, in his regional report, on the role of human resource management strategy in preventing medical errors and enhancing the patients' safety. 
One basic item in patient safety is the patient falling (from the bed). In the cares after the surgery, it gets the highest RPN in this study as "not fastening the stretcher belt when carrying the patient" which should be overcome by teaching the personnel how to carry the patients.
In admitting the patients in the operation room, there are some failure modes such as the patient's long waiting and inappropriate anesthesia consultation for the patient. These should be overcome by accurately following the managed instruction care before surgery, educating the patients appropriately and timely before transferring them to the operation room, modifying the preparation process, and admitting the patient from a day clinic to the operation room.
As quoted from Sabahi-Bidgoli et al.,  showed in their study entitled "patient safety climate from the viewpoint of nurses", relation with the doctor is important in patient's safety and nurses find it as an important factor in preventing errors. In this study, it is also suggested that the doctor's unreadable hand writing leads to the nurse's error when checking the instruction and providing the healthcare services based upon it. These results are in line with Soozani et al.,'s results  which indicate the nurses' believe illegibility of the doctors' instruction and a lower nurse to patient ratio to be the most influential factors in medication errors. Furthermore, as the safe medical institute in Canada reported about 10% of big pharmaceutical errors are the result of imperfect communication when the handwriting is not illegible and there are some abbreviations. 
As quoted from Sabahi-Bidgoli et al.,  Anooshe and coworkers showed (author of the study entitled "comparing the causes of working errors in nursing") that the personnel are not ready enough to provide services in some units and their lack of knowledge is the reason for the errors. In line with Anooshe's study, the present study revealed that about 40% of recommended actions, to eliminate or reduce the errors, were related to educational issues.
In his study, Maghari showed that the managers should prioritize their colleagues and the nurses' expectations and to be aware of the needs in different ways and improve the quality of the services for patients by promoting the standards. In addition, by adopting quality management in hospitals and holding suitable educational courses for those responsible in looking after the patients including nurses, the managers should learn the recent standards in performance and methods in treatment. They should also hold some courses in clinical governance and accreditation standards in order to limit the medical errors via educating the staffs and promote their knowledge in patient safety. 
Nasiripour et al.,  regarded the policies and administrative ways as the guidelines to deliver the services in the hospitals and realize the strategies. Therefore, as the study also showed, by recording or documenting these policies and methods, the hospital requires all individuals to follow these guidelines in order to reduce the errors and provide an error-free and safe climate for the patient. This is also one of the suggested actions for this research.
| Conclusion|| |
The study proves the necessity of a list of specific errors and threats in patient safety to be recorded in the developed countries. For instance, it is urgent in America to record and report incidents such as wrong surgery, surgery in a wrong position, leaving external tools in the body, pharmaceutical errors, patient falling and burning.
Performing a simple comprehensive technique and analysis, like the one presented in this study, in all units, the hospitals can easily provide a list of the required specific errors reported in the centers and introduce some approaches to deliver the services and enhance their quality. This also helps introducing, performing, and monitoring the risk management programs in the hospitals and facilitates the patient safety and its related items to identify and analyze the indices.
It is also concluded that it benefits the service providers and receivers in good and safe service delivery to identify, examine, and analyze the errors committed in the operation room and introduce and accurately perform an intervention program. FMEA helps establish error and risk reporting system in the hospitals identify and introduce clinical and nonclinical processes in the centers, identify the potential failure modes related to each action, modify the imperfect processes, introduce intervention programs to eliminate or reduce the identified risks, establish clear, precise, and practical policies and methods in the center, introduce approaches, improve quality, manage risks and patient safety, and promote the indices of patient safety in line with the hospital programs.
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[Table 1], [Table 2], [Table 3]
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