Abstract
Abstract
Background:
Compliance with the World Health Organization (WHO) surgical safety checklist may reduce preventable adverse events. However, compliance may be difficult to implement in Thailand. This study was conducted to examine compliance with the WHO checklist at a Thai university hospital.
Methods:
A descriptive study was conducted among 4,340 patients undergoing surgery in nine departments from March to August 2009. The compliance rates were computed.
Results:
The highest compliance rate (91.4%) during the sign-in period was with patients' confirmation of their identity, operative site, procedure, and consent. However, only 19.4% of the surgical sites were marked. In the time-out period, surgical teams had introduced themselves by name and role in 79% of the operations; and in 95.7% of the cases, the patient's name, the incision site, and the procedure had been confirmed. Antibiotic prophylaxis had been given within 60 min before the incision in 71% of the cases. For 83% of the operations, the surgeons reviewed crucial events whereas only 78.4% were reviewed by the anesthetists. Sterility had been confirmed by the operating room nurses for every patient, but the essential imaging was displayed at a rate of only 64.4%. In the sign-out period, nurses correctly confirmed the name of the procedure orally in 99.5% of the cases. Instrument, sponge, and needle counts were completed and the specimen was labeled in most cases, 96.8% and 97.6%, respectively. Equipment-related problems were identified in 4.4% of the cases, and 100% of them were addressed. The surgeon, anesthetist, and nurse reviewed the key concerns for recovery and management of the patient at the rate of 85.1%.
Conclusions:
The WHO checklist can be implemented in a developing country. However, compliance with some items was extremely low, reflecting different work patterns and cultural norms. Additional education and enforcement of checklist use is needed to improve compliance.
Surgical site infection (SSI) is one such harmful event. The U.S. Centers for Disease Control and Prevention (CDC) reported 500,000 SSIs yearly [11]. The incidence rate of SSI differs depending on the procedure and the country in which the surgery is performed. In the U.S., the SSI rates among in-patients ranged from 0.2% for gallbladder surgery to 26.7% for rectal surgery [12]. In Scotland, inpatient SSI rates were 0.2% for knee arthroplasty and 1.1% for abdominal hysterectomy and hip hemiarthroplasty [13]. Reported SSI rates for clean wounds range from 2–5%, which increases to 20% for abdominal surgery [14]. In Thailand, the average SSI rate was 1.7%, with a range of 0.8–2.8% [15,16]. In developed countries, SSI resulted in an increase in the length of the hospital stay by 3.7 million days and extra cost of $1.6 billion [17] to $3 billion [18] each year. In Thailand, SSI was the cause of a 14-day prolongation of post-operative stay and increased cost by approximately $890 per case [19]. The potential risk factors for SSI were improper hair removal [20], inappropriate antibiotic prophylaxis [21,22], retained surgical equipment [23–26], and other factors, such as equipment-related problems. The incidence of retained foreign bodies after surgery was 1 per 1,000–1,500 operations. The foreign bodies most commonly retained were surgical sponges (52%) and instruments (43%). These adverse events occurred mainly in abdominal (46%) and thoracic (23%) surgery [25]. The complications of retained foreign bodies were SSI, reoperation, and death [26]. Equipment-related problems, including inadequate or damaged equipment, can lead to unsafe conditions such as prolonged duration of surgery or cancellation of the operation [27]. A study found that after the incision was made, 15 instruments were requested per operation [28]. In 87% of laparoscopic procedures, one or more equipment-related problems were identified [29]. Surgical specimen errors such as incorrect labeling or loss of the specimen accounted for 8% of the errors [30]. The incidence of specimen errors was 3.7 per 1,000 specimens [31]. These mistakes could lead to misdiagnosis or delayed or improper treatment [32].
The safety of surgical care therefore is a global concern. It is the second most important global patient safety challenge of the World Health Organization (WHO). In 2008, WHO developed the first edition of the Guidelines for Safe Surgery [33], and it was revised in 2009 [34]. The WHO surgical safety checklist is an important tool. Several studies found that using the checklist has the potential to reduce preventable adverse events in surgery [35–39]. However, it may be difficult or inappropriate to implement the tool in a developing country such as Thailand. We therefore conducted a pilot study to examine compliance with the WHO surgical safety checklist in our country.
Patients and Methods
Setting
The study was conducted in a 1,400-bed university hospital in northern Thailand. The average number of operations per year is 21,877. There are nine surgical departments: Obstetrics and gynecology; general surgery; orthopedics; cardiovascular surgery; eye; ear, nose, and throat surgery; urologic surgery; neurosurgery; and plastic surgery. All departments participated in this study.
Ethical considerations
This project was approved by the Ethics Committee, Faculty of Nursing, and the Ethics Committee, Faculty of Medicine, of Chiang Mai University, Thailand.
Research instruments
We used the WHO surgical safety checklist and the checklist manual, which were modified and translated into the Thai language by the researchers. Most items on the checklist were similar to the WHO surgical safety checklist. Hair removal was added to the checklist because it was one component of the SSI prevention bundle that was considered important.
Data collection
A prospective study was conducted from March to August 2009. At least 20% of the operations during the study period were to be selected for study. Data were collected by the circulating nurse working in the operating room. After two meetings and a one-day data collection training session, the nurses collected and recorded data on printed forms. The data collected were the hospital number, date of operation, operating room number, procedure, type of surgery (emergency or elective), shift (day, evening, or night), type of anesthesia, and adherence to the surgical safety checklist (sign-in, time-out, and sign-out). During data collection, if the nurses had any problems, they could read the instructions from the manual or contact the researchers directly.
Statistical analysis
The data collection forms were sent to the researchers for editing, processing, and analysis. Data forms with errors or incomplete information were sent back to the operating room nurses for correction. Data clean-up and analysis were done after completion of the data entry process. All data were reported as numbers and percentages or rates.
Results
Demographic characteristics
During the study period, 10,184 operations were performed, and 4,340 operations (42.6%) were selected to employ the surgical safety checklists. The checklists were implemented most commonly in obstetrics-gynecology (18.1% of procedures), general surgery (17.4%), and orthopedics (14.2%). Most checklists were employed on the day shift, for elective surgery, and in procedures involving general anesthesia, which accounted for 92.2%, 83.3%, and 72.8% of operations, respectively (Table 1).
Compliance with WHO Surgical Safety Checklist
Sign-in period (before induction of anesthesia)
Most of the patients (91.4%) confirmed their identity, site, and procedure and gave consent; however, only 19.4% of the surgical sites were marked. In 69.5% of the cases, hair removal was not needed. In the cases in which hair removal was required, the procedure often was performed incorrectly, with a razor being used in 84.7% of the cases and shaving being done >2 h before surgery in 68.0%. Anesthesia equipment and medication were checked in most cases (90.3%). The pulse oximeter was applied and its function was verified in nearly all of the cases (95.1%). The risk of drug allergy, difficult airway or aspiration risk, and >500 mL blood loss (7 mL/kg in children) were assessed in every case. Aspiration risk was assessed and appropriate equipment was prepared or assistance was requested. Adequate intravenous access and fluid was planned when a risk of excessive blood loss was identified (Table 2).
One structure.
No oral verification by anesthetist.
Local anesthesia and healthy patient.
Time-out period (before skin incision)
In only 79.0% of cases did all surgical team members introduce themselves by name and role. The patient's name, incision site, and procedure were confirmed in most cases (96.0%, 95.7%, and 95.9%, respectively). Antibiotic prophylaxis was given within 60 min prior to surgery in 71.0% of the patients. For 83% of the cases, the surgeons anticipated and reviewed possible critical events, whereas for only 78.4% of the cases did the anesthetists report patient-specific concerns. Sterility (including indicator results) was confirmed in all cases by the operating room nurses. Essential imaging was displayed in 64.4% of the cases (Table 3).
According to World Health Organization Guidelines for Safe Surgery. First Edition. Geneva. WHO Press. 2008.
Sign-out period (before patient left operating room)
For almost all cases, the nurses confirmed orally the name of the procedure (99.5%) and the completion of instrument, sponge, and needle counts (96.8%). Almost all specimens were labeled correctly (97.6%). A total of 4.4% of the equipment-related problems were addressed, and 100% of the reported problems were recorded. In 85.1% of the cases, the surgeons, anesthetists, and nurses discussed key concerns about recovery and management of the patient (Table 4).
Discussion
The study showed that compliance rates with the WHO surgical safety checklist were high when the items related to life-threatening issues such as drug allergy, risk of difficult airway, and profuse blood loss. By contrast, the rates were low for items such as marking the surgical site and following on appropriate hair removal procedure. In a developing country such as Thailand, where resources are limited, it might be difficult to expect high compliance rates initially when the WHO checklist is implemented.
Patient identity, site, procedure, and consent were not confirmed during the sign-in period in 8.6% of the cases because the patients were children or incapacitated without a guardian or family member present. Some cases were emergencies. Some of the patients did not cooperate with the procedure because they were irritated when personal information was asked for repeatedly [40]. A few patients did not know the surgical site or procedure because they did not receive an adequate explanation from the surgical team [40] or they had memory impairment, especially those who were elderly [41]. To ensure that the identity, surgical site, procedure, and consent are confirmed, operating room nurses have to resort to verification of this information from the medical record [34,36,39].
Marking of the surgical site was uncommon in our study. The major reasons were shortage of marking materials, need for emergency operations, and the Thai culture. According to societal norms, Thais do not make marks on other people, especially on the head. Touching someone on the head may be considered rude [42]. Another reason was that some surgeons assumed that wrong-site surgery would not occur because they had not experienced it themselves. Wrong-site surgery is an infrequent event, but it is devastating and easily preventable [9,10,43,44].
Improper hair removal also was one of the serious issues. For the cases in which a hair removal procedure was performed, shaving was done using a razor, usually more than 2 h before the incision. This procedure was not done properly because of insufficient equipment, such as clippers, and a shortage of personnel. Being unfamiliar with the shaving technique, struggling to use clippers, requests by the surgeons, and having inadequate knowledge were also causes of this procedure being done inappropriately. Improper hair removal increases the risk of SSI [20,34,45,46]. To prevent the problem, proper hair removal procedures should be introduced to surgical personnel, and patients and razors should be removed from the clinical area and operating theater [46].
When a functioning pulse oximeter was not placed on the patient, it was the result of a lack of equipment or the assumption that the patient or surgery was low risk. Assessment of risks, including drug allergy, likelihood of a difficult airway, and risk of profuse blood loss, was performed without exception because these were crucial issues [34], and they had already been implemented as the standard procedure in this hospital using a previously implemented surgical risk assessment form. For the patients admitted to the hospital, anesthetists, physicians, and nurses visited them to assess these risks one day before surgery. In emergency cases, these risks were evaluated immediately before surgery. Thyroidmental distance and Mallampati classification were used for airway assessment [34]. Risk was assessed repeatedly by anesthetists during the sign-in period. For one-day surgery or emergency cases, although risk assessment was completed in the operating theater within the sign-in period, the anesthesia machine and medication checking were not confirmed orally by the anesthetists. Ineffective communication and collaboration among the surgical team members could lead to serious complications [34–39]. For this reason, better communication and teamwork and a creation of a culture of safety should be encouraged [36–39].
In the time-out period, some surgical team members did not introduce themselves by name and role to the other members. In Thai culture, people usually introduce themselves only when they first meet someone, and they are shy about publicizing their roles [42]. It may require time for the staff to become comfortable introducing themselves and their roles. However, the compliance rates with the confirmation of the patient's name, the incision, and the procedure were high because this is one of the key performance indices for hospital accreditation [47] with which the staff is already familiar. Moreover, there were many cases in which crucial patient issues were not reviewed. Non-compliance with this procedure usually occurs in emergency operations [34] because the surgical teams, particularly the surgeons and anesthetists, believe that the procedure must be expedited [36–39]. To increase compliance rates and sustainability, surgical teams should be encouraged to use the checklist as a part of routine work [36–39]. On the other hand sterility usually was confirmed by the nursing team because the nurses perceive that this procedure is a vital standard that cannot be omitted [48]. In addition, equipment-related problems were found, and these problems could lead to prolonged surgery or cancelation of the operation [27–29]. Monitoring and controlling the sterilization process in the supply service department is necessary as well in order to ensure asepsis [48].
Some prophylactic antibiotics were not given within the last 60 min before incision because of incorrect (i.e., “on-call”) or standing orders. Additionally, misunderstanding among operating room nurses and anesthesia nurses, lack of knowledge, and emergency cases or critically ill patients could lead to non-compliance. Thus, a comprehensive education and training program that emphasizes the importance of proper antibiotic administration may be essential [46].
Some essential imaging was not displayed during surgery because it had not been sent from the ward to the operating theatre or the imaging had not been printed. Our hospital is moving toward the use of electronic radiology files [49], but many operating rooms do not have access to them. This policy may be reconsidered; otherwise, providing a computer in all operating rooms may be crucial.
In the sign-out period, compliance was high with all items. This may be because these were a part of our standard practice. However, compliance was not perfect. In cases of non-compliance, sentinel events, such as a retained foreign body, SSI, or death may occur after surgery [34–39].
The strengths of this study were that the sample was large and all surgical departments in the hospital were included. Moreover, the research instrument was modified to make it applicable for the setting, and it was translated into Thai, a language that all surgical team members could understand. All levels of surgical teams cooperated with this implementation. Providing the manual was meant to assist in implementing the checklist with data collection. In addition, the data were collected by trained surgical team members and were rechecked by the researchers.
This study has some limitations. First, it was conducted in only one setting and in a brief period of time; therefore, the results might not be applicable to other settings throughout the country. A multi-center study or national campaign and a long-term prospective study should be initiated to ensure the sustainability of the implementation, such as the study in the U.K. that revealed that the surgical safety checklist was implemented in 96% of the Acute Trusts [6,36,39,50]. Moreover, the checklist could not be applied to every patient during the study period because there were not enough nurses to complete it and some operations were done in a very short time. In addition, some operations were performed and completed during the busy hours such as lunchtime. When time was limited, the circulating nurses could not complete the checklist emphasizing instead their routine work. For this reason, the operations performed during that time period were not selected. This may have led to selection bias [50]. Lastly, this implementation was new for the surgical teams in Thailand, and the team members were not familiar with some procedures, such as introducing themselves. It will take time to change attitudes and practices. Strategies for enhancing compliance such as using a training videodisk made in the Thai language showing the use of the checklist by Thai surgical teams, as well as demonstrating efficient methods for using the checklist [34,36,39] could be effective. In addition, a clinical champion [6] and the feedback from the surgical teams after the checklist is used [6,34,36,39] may be needed.
In conclusion, compliance rates with most items on the surgical safety checklist. The study suggests that the checklist could be implemented successfully in a country with limited resources, such as Thailand. Increasing awareness, providing knowledge and educational tools, giving time for recording, enhancing feedback, and supporting crucial materials and equipment may increase the rates of compliance with the checklist.
Footnotes
Acknowledgments
Thank you to the Deans of Faculty of Nursing and Faculty of Medicine, Chiang Mai University, as well as the Director of Maharaj Nakorn Chiang Mai Hospital for kindly supporting this project. Thank you to the surgical team members and others who assisted with the data collection. This work was funded by Chiang Mai University, Thailand.
There are no conflicts of interest or competing financial interests for any of the authors.
Author Disclosure Statement
No conflicting financial interests exist.