Safety in the operating room (OR) has always been a major public health concern. It refers to the safety of both the patient and the working personnel 1. Improving patient safety is an increasing priority for surgeons and hospitals as sentinel events can be catastrophic for patients, caregivers, and institutions. Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical errors that often lead to adverse healthcare events. Recognizing that healthcare errors impact one in every 10 patients around the world, the WHO calls patient safety an endemic concern. Therefore, the ‘Safe Surgery Saves Lives’ initiative was established by the World Alliance for Patient Safety as part of the WHO efforts to reduce the number of surgical deaths across the world. The aim of this initiative is to harness political commitment and clinical will to address important safety issues, including adequate anesthetic safety practices, avoidable surgical infection, and poor communication among team members. These have proved to be common, deadly, and preventable problems in all countries and settings 2.
Accordingly, the WHO has developed guidelines for safe surgery and a first edition (2008) checklist of surgical safety standards has been developed to be applicable in all countries and health settings with a recommendation for modification according to local needs. The revised (2009) checklist was issued in some languages including Arabic. The checklist identifies crucial safety steps corresponding to the following three stages: the induction of anesthesia (sign in); before skin incision (time out); and before the patient leaves the OR (sign out). The list is associated with an implementation manual 3. The ‘Safe Surgery Saves Lives’ initiative in Egypt and surgical safety checklist as a tool for guidance and control of patient safety have been adopted by a few organizations including the Egyptian Group for Surgical Science and Research.
Risk assessment is a structural and systematic procedure that depends on the correct identification of the hazards and an appropriate estimation of the risks arising from them, with a view to making inter-risk comparisons for the purposes of their control or avoidance. Risk assessment in a numerical manner will help hospitals to assess their safety status and prioritize their action plan in view of their resources 4.
Hazards and risks are often misinterpreted as one term, while actually they are not the same. A hazard is something with the potential to cause harm, whereas a risk is the likelihood that illness, injury, or even death might result because of the hazard. Risk management comprises five basic steps: identifying hazards, assessing and prioritizing risks, deciding on control measures, implementing control measures, and monitoring and reviewing 5.
The ultimate objective of this study is to aid any hospital in attaining better quality of patient care in the OR by achieving patient safety according to WHO safety guidelines. Specific objectives include the assessment of patient safety status in OR, the identification of hazards, and the assessment of risks in terms of exposure of patients to surgical work, anesthesia, and nursing practices that jeopardize this safety.
Materials and methods
The present work is a descriptive observational study carried out in three ORs in a governmental hospital.
The study was carried out in three phases, preparatory phase, data collection, and data management and analysis phases, and over a period of 6 months. According to ethical and administrative regulations, an official letter was submitted to the ethical and registration committee in the hospital under study to clarify the objectives of the study in order to insure maximum cooperation. The letter was approved by the hospital administration.
A sample of 100 patients undergoing general surgical and urological surgical procedures was selected.
The following data collection tools were used:
- The WHO surgical safety checklist (2008) was used in three ORs of a governmental hospital.
- Nonstructured interviews with the surgeons and anesthesiologists were conducted to know more about the patient medical condition, any history of any chronic diseases he/she had, and special concerns in terms of patient safety.
- Records were used to determine the patient’s medical history and any special medical condition.
- Checking the proper use of anesthesia checklist for all the patients was performed in the form of a sheet filled by junior anesthesiologists.
In terms of the patient safety checklist, the checklist used was implemented for 100 surgical encounters. Data were analyzed as frequencies and percentages of the total number of encounters.
Risk assessment of data was carried out using the risk assessment method adapted from the guideline of the Occupational and Health Unit of University of Queensland, Australia 5.
Risk assessment was performed using a matrix. The matrix rows present the severity (S) graded from 2 through 10 on two increments according to the impact of this risk on the personnel’s health and the possible consequences. Columns of the matrix present the likelihood (L) graded from 2 through 10 on two increments according to the frequency of the occurrence and availability of suitable controls, masking the chance of their occurrence. Judgment of S and L was carried out on the bases of occurrence of frequencies of different items studied within the WHO patient safety checklist and occurrence of incidents during the study period taking into consideration the existing control measures. Risk (R) was calculated as R=S×L and accordingly grading and prioritizing of hazards were performed.
Guided by the WHO surgical safety checklist, the results were presented according to three stages: sign in, time out, and sign out.
During the ‘sign in’ stage, the patient identity and site of surgery were not confirmed by the checklist coordinator. The names of the procedure and the consent for surgery were properly done in 99 and 91% of the cases, respectively. Only 3% of all the patients had the operation site marked for surgery and an incident of a single wrong side surgery was recorded. There was a clear lack of communication between doctors and patients. The anesthesia checklist for patient safety was used properly, whereas the one for the anesthesia apparatus was used only once daily (Table 1).
During the ‘time out’ stage, verbal confirmation for the patient identity and site of surgery was carried out improperly in 100% of cases, whereas the name of the procedure was confirmed in 99% of cases. Eighty percent of surgeries lacked organized discussion among surgical team members for anticipated critical events. Also 77% of anesthesia patient concerns lacked sharing or communication of information from some of anesthesia team. This indicates a clear communication breakdown among OR staff members, which may be a common cause of medical errors and adverse events. Prophylactic antibiotics were administered to 59% of patients undergoing surgeries (Table 2).
Finally, the ‘sign out’ stage was properly performed in 100% of procedures, where the nurses recorded the name of the procedure, counted the equipment used, and labeled the specimens. Also, the surgeons wrote their key concerns for the recovery and management of patients (Table 3).
Risk assessment in the ‘sign in’ stage showed six of 11 procedures implying a major risk to patients. Also, in the ‘time out’ stage, three of eight procedures implied a major risk (Figs 1 and 2).
Safety in the OR is a very important issue in any hospital safety concerns as it does not only involve the safety of the working personnel facing occupational hazards in the OR but it also jeopardizes the patients’ safety.
Application of the surgical safety checklist, ‘first edition’, was difficult to interpret in terms of titles of the three sections ‘sign in, time out, and sign out stages’. Also, the same difficulty was encountered in answering collective questions. The current revised version overcomes these difficulties as it is more illustrative and organized 6.
According to the WHO surgical safety checklist, patients’ safety was checked during three stages: the sign in stage (before the induction of anesthesia), where patient identity, site of surgery, and the name of the procedure performed were apparently known to working staff, but they were not confirmed by a single person (checklist coordinator) whose role is important in order to reduce the incidence of faulty identification errors occurring in surgeries.
Only 3% of the patients in the study had the operation site marked for their surgeries; a single incident of wrong side surgery was recorded, which was a wrong-sided vascular leg surgery. Universal protocols state that the site or sites operated on must be marked unless in case of emergencies 7.
For 9% of the patients in our study, no consent was obtained, although ordinary surgical consents are regularly obtained for all the classic routine surgical procedures, and informed consents are only obtained for research purposes. There was a clear lack of communication between the doctors and the patients in terms of the explanation of the suggested surgical procedure and clarification of the possible complications. There should be a mutual agreement between the patient and the physician on the course of the treatment. This shared decision making represents the best blending of physician expertise and patient choice 8.
Two anesthesia checklists were applied: the patient safety checklist and the anesthesia apparatus checklist. The one related to patient safety was filled properly before, during, and after the operation, whereas the one related to anesthesia apparatus was filled out once each day in the form of filling of data rather than actual checking of each item by the junior staff.
It was found that 35% of the patients in the present study had a risk of losing more than 500 ml of blood, and precautions were taken by providing blood ready for transfusion and a plan for appropriate fluid resuscitation in the majority of patients (Table 1). In a study carried out by Nisanevich et al. 9, it was found that for patients undergoing elective intra-abdominal surgery, intraoperative use of restrictive fluid management may be advantageous because it reduces postoperative morbidity and shortens hospital stay.
During the time out (before skin incision) stage, for 80% of the surgeries, there was no organized discussion among the surgical team members for the anticipated critical events and the remaining 20% surgeries were reviewed improperly (Table 2). A discussion of the anticipated critical events should be performed by the surgeon to inform all the team members of any steps that place the patient at risk for rapid blood loss, injury, or other major morbidity, but it was observed that none of this occurred; there was a clear breakdown in communication among the OR staff members. There is growing evidence that communication failures among team members are a common cause of medical errors and adverse events. A study of communication failures in the OR found that they occur in ∼30% of team exchange 10.
Only 59% of the patients undergoing surgery in our study sample were administered prophylactic antibiotics in a random manner without a clear verification for their actual need (Table 2). Antibiotics were administered either before skin incision or in the middle of surgery and sometimes they were not even administered in case of minor operations, but generally, no special strategy was followed, although the infection control protocol in the hospital studied recommends that antibiotics should be administered only if needed according to the nature of surgery and the patient’s medical condition and they should be administered 30–60 min before skin incision. The main goal of surgical prophylaxis is to use antimicrobials in an evidence-based manner while minimizing the risk of adverse events and the effect of antibiotics on the patient’s own flora 11.
The sign out stage was properly implemented (Table 3). Nurses in the current study recorded the names of 100% of the procedures, counted the instruments, sponges, and needles in 100% of the procedures, and whenever there was an equipment problem, it was reported immediately for correction. Also, surgeons wrote their key concerns for the recovery and management of patients and reported them verbally if needed.
In terms of risk assessment, which aims to improve the quality of the decision-making process, Fig. 1 shows that the site of the procedure and its marking as well as the risk of blood loss account for a major risk (R=8×8=64). Also, Fig. 2 shows that verbal confirmation of the patient, site of operation, and procedure performed imposed a major risk (R=8×8=64), thus confirming a clear breakdown in communication among the OR staff members, which may be an important cause of adverse events.
Therefore, the proposed risk reduction program should emphasize the presence of procedures for patient and procedure identification, surgical site marking, complete preanesthesia checkup of patients, and establishment of protective actions for unexpected incidences and availability of blood transfusion.
Conclusion and recommendations
To achieve an optimal level of patient safety in the OR, checking of certain points using a checklist should be performed, in which some should be strictly applied by the hospital administration and others should be modified in personal work practices to ameliorate the level of patient safety in surgery.
The checklist should be implemented as part of the daily surgical routine as an organized documented way to verify:
- The patient’s identity, site of surgery, and the name of the procedure in order to minimize the percentage of errors of identification.
- Checking the patient presurgical condition, especially known allergies and difficult airway or risk of aspiration, in a simplified manner is essential. Also, surgical site marking should be a routine procedure, as it was found that in most of the cases, the surgical sites are not marked, in order to minimize the possibility of wrong site surgery.
- The importance of filling in and clarifying surgical consent to the patient or a responsible relative by increasing the level of communication between the surgeons and the patients and discussing their conditions and the possible outcomes of the surgeries.
- The importance of assessing the possibility of blood loss before surgery in order to be prepared for any blood loss emergency.
- There should be organized discussions between the surgical team before surgeries, as it was found that for most of the surgeries, there was no organized discussion of the patients’ medical condition and the surgical procedures applied.
- The application and monitoring of a clear prophylactic antibiotics policy with a defined frame and roles as it was found that a policy was formulated by the infection control, but the application of the policy was not strictly monitored.
- Development of a risk management program for patient safety in the OR with defined roles, monitoring, evaluation, analysis, and continuous improvement.
The authors thank Professor Gerald Dziekan (MD, MSc), Former Head Safe Surgery, Pulse Oximetry, Care Checklists & AMR Programs, WHO Patient Safety, Switzerland, for his support and encouragement.
Conflicts of interest
There are no conflicts of interest.
1. Herick RF, Wallace RB, Kohatsu NWallace RB, Last JM.Industrial hygiene.Wallace/Maxcy-Rosenau-Last Public health and preventive medicine2008.USA:The McGraw-Hill Companies Inc.
2. .WHO Guidelines on Hand Hygiene in Health Care First Global Patient Safety
Challenge Clean Care is Safer Care2009.Geneva:WHO Press.
3. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat A-HS, Dellinger EP.A surgical safety checklist to reduce morbidity and mortality in a global population.N Engl J Med2009;360:491–499.
4. Sadhra SS, Rampal KGSadhra SS, Rampal KG.Basic concepts and developments in health: risk assessment
and management.Occupational health risk assessment
and management1999:4th ed..Oxford (UK):Blackwell Science Ltd;2–3.
5. .Occupational Health & Safety Unit (OHS)2010.Australia:University of Queensland (UQ).
6. .Surgical safety checklist; 2012. Available at: http://www.who.org
. [Accessed 13 April 2012].
7. Saufl NM.Universal protocol for preventing wrong site, wrong procedure, wrong person surgery.J PeriAnesthesia Nurs2004;19:348–351.
8. Whitney SN, McGuire AL, McCullough LB.A typology of shared decision making, informed consent, and simple consent.Ann Intern Med2004;140:54–59.
9. Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I.Effect of intraoperative fluid management on outcome after intraabdominal surgery.Anesthesiology2005;103:25–32.
10. Lingard L, Espin S, Whyte S, Regehr G, Baker GR, Reznick R, et al..Communication failures in the operating room
: an observational classification of recurrent types and effects.Qual Saf Health Care2004;13:330–334.
11. Prtak LE, Ridgway EJ.Prophylactic antibiotics in surgery.Surgery2009;27:431–434.
Keywords:© 2013 Egyptian Public Health Association
operating room; patient safety; risk assessment