PATIENT SAFETY IN SURGERY: THE QUALITY OF IMPLEMENTATION OF PATIENT SAFETY CHECKLISTS Medical Interferences IN A REGIONAL HOSPITAL

PATIENT SAFETY IN SURGERY: THE QUALITY OF IMPLEMENTATION OF PATIENT SAFETY CHECKLISTS IN A REGIONAL HOSPITAL

1. 2. 3. 4. 5. 6.

V. Karyadinata1, Zoya Georgieva2, Eleni Anastasiadis3, Sukyee Pang4, Ayo Oshowo5, P. Gogalniceanu6

University College London Medical School, London, UK University College London Medical School, London, UK Whittington Hospital, London, UK Whittington Hospital, London, UK Whittington Hospital, London, UK London Postgraduate School of Surgery, London, UK

ABSTRACT

Introduction. Patient safety and the avoidance of inhospital adverse events is a key focus of clinical practice and medical audit. A large of proportion of medical errors affect surgical patients in the peri-operative setting. Safety checklists have been adopted by the medical profession from the aviation industry as a cheap and reliable method of avoiding errors which arise from complex or stressful situations. Current evidence suggests that the use of periooperative checklists has led to a decrease in surgical morbidity and hospital costs. Aim. To assess the quality of implementation of a modified patient safety checklist in a UK district general hospital. Methods. An observational tool was designed to assess in real time the peri-operative performance of the surgical safety checklist in patients undergoing general surgical, urological or orthopaedic procedures. Initiation of the checklist, duration of performance and staff participation were audited in real time. Results. 338 cases were monitored. Nurses were most active in initiating the safety checklist. The checklist was performed successfully in less than a minute in most cases. 11-24% of staff (according to professional group) present in the operating room did not participate in the checklist. Critical safety checks (patient identity and procedure name were performed in all cases across all specialties. Variations were noted in checking other categories, such as deep vein thrombosis (DVT) prophylaxis or patient warming. Conclusions. There is still a potential for improving the practice and culture of surgical patient safety activities. Staff training and designation of patient safety leadership roles is needed in increasing compliance and implementation of patient safety mechanism, such as peri-operative checklists. There is significant data to advocate the need to implement patient safety surgical checklists internationally.

International Journal of Medical Dentistry

INTRODUCTION Patient Safety

The term ‘patient safety’ implies the presence of a paradox – that the medical institutions in charge of facilitating care and treatment for patients can in fact be harmful to them. Patient safety is defined as ‘freedom from accidental injury and error’ [1] at any stage from diagnosis to treatment. An ‘adverse event’ can be defined as injury or harm resulting from a medical intervention and may be manifested as a patient death, morbidity, disability or prolonged inpatient stay. [1] A retrospective study on 1014 cases in 2 London hospitals found that 10.4% of the patients studied experienced adverse events. [2] The UK Department of Health estimates that 850,000 admissions a year culminate in an adverse event, costing the UK National Health Service (NHS) up to £2 billion a year for extended bed-days alone. [3] In the study 1 in 5 of the adverse events found were a direct result of surgical procedures; of these up to a quarter were considered preventable. [2] In the rest of the world, including the US, Canada and Australia, adverse events in surgery account for between one-half to two-thirds of all adverse events in hospitals. Up to half of these were deemed preventable. [4,5,6,7] This is echoed in the WHO safety guide ‘Safe Surgery Saves Lives’. It reports that 234 million operations are carried out annually in the world; mortality from surgical operations ranged from 1 in 100 in 159

V. Karyadinata, Zoya Georgieva, Eleni Anastasiadis, Sukyee Pang, Ayo Oshowo, P. Gogalniceanu

industrialized nations to 1 in 10 in the developing world. Furthermore, up to half of these are preventable. [8] The causes of clinical errors were not necessarily attributed to a lack of knowledge or ability. They may arise from more subtle circumstances such as strain-induced memory lapses, [9,10] the complexity of challenging procedures [11] or impaired performance as a result fatigue, [12] pressure and stress. [13] ‘High reliability organizations’ (HRO), such as the airline industry and nuclear power plants, have exceptionally low failure rates despite the complex and hazardous nature of their operations. [14] The aviation industry now boasts one of the most robust safety records in the world, with an average adverse event rate for 2010 of 1 per 1.6 million flights. [15] However, the rates were significantly greater in the post-war era when increasing aircraft complexity required pilots to perform up to 50 steps prior to take off. Boeing provided the first solution to this by introducing a simple, versatile and widely applicable pre-flight checklist which allowed pilots to negotiate complexity in a safe and consistent manner. The introduction of safety checklists in medical studies in intensive care units demonstrated a reduction in morbidity and inpatient costs. [16] Subsequently the World Health Organisation (WHO) launched the ‘Safe Surgery Saves Lives’ project [8] which introduced a 19-item surgical safety checklist designed to reduce the risk of adverse events in the peri-operative setting. The Harvard School of Public Health tested a  19 item emergency surgery checklist at the Brigham and Women’s hospital, Boston, in 1750 emergency cases and found that the checklist reduced the complication rate from 18.4% to 11.7% (p-value = 0.0001) and mortality from 3.7% to 1.4% (p-value = 0.0067). They also reported a significant improvement in compliance rates. [17] The WHO Surgical Safety checklist was piloted at 8 sites across the world resulting in a  reduction in the post-operative complication rate by 4% (11.0% – 7.0%; p-value < 0.001), site infections by 2.8% (6.2% – 3.4%, p-value < 0.001) and mortality by 0.7% (1.5% – 0.8%, p-value = 0.003). [18] 160

The list consists of three sections: • “Sign-in”: checks performed in the anaesthetic room; • “Time-Out”: checks performed prior to starting operation; • “Sign-out”: checks performed at end of the operation.

Safety checks performed by the WHO checklist include introduction of team members, identification of the patient, the site and procedure involved, estimated blood loss, patient allergies, antibiotic prophylaxis, anaesthetic concerns, instrument sterility and any foreseeable unexpected operative steps. [22] The checklist was generally well received, with 80% of users finding it easy to use, 84% feeling it improved communication, 79% agreeing that it prevented errors and 93% admitting that they would want the checklist used if they were having surgery. [19] The pre-operative checklist has currently been implemented in 100% of UK hospitals, with examples of local and specialty-specific adaptations emerging. [20] A pilot study in two NHS hospitals in 2009 demonstrated a number of obstacles in implementation, most of which were attributable to existing culture and practices as well as staff safety attitudes. Examples of poor use of the checklist included omission of points on the checklist, pressure on nurses to ensure swifter completion, dismissive or inaccurate replies and absence or lack of active participation of key staff members. [21] Whilst there is evidence that the checklist protocol is being performed and its quantitative implementation assessed, [22] few studies have investigated the effectiveness and quality with which locally modified versions of the WHO checklist were being performed.

AIM

This study aims to audit the quality of implementation of a locally modified surgical patient safety checklist (“Time Out”/Preoperative component) in achieving the outcomes recommended by the WHO. volume 2 • issue 3 July / September 2012 • pp. 159-166

PATIENT SAFETY IN SURGERY: THE QUALITY OF IMPLEMENTATION OF PATIENT SAFETY CHECKLISTS IN A REGIONAL HOSPITAL

METHOD

An observational assessment tool was designed (Appendix 1) to assess in real time the quality with which the peri-operative patient safety check points were performed. The WHO patient safety end-points were utilized as the gold-standard. The following factors were assessed: 1. Execution – whether or not the Checklist was carried out; 2. Completeness – whether or not individual checklist elements were called out and checked for; 3. Participation – whether or not all individuals present in the theatre were actively involved in the carrying out of the checklist; 4. Initiation – how long it took from the first time-out call to initiation of the checklist; 5. Duration – how long it took to carry out the checklist; 6. Instigator – who led the checklist. General Surgical, Orthopaedic and Urology operating lists were monitored in a London District General Hospital. Data end-points were collected to describe the type of surgery, the number of staff members present and their participation in the checklist activity. ‘Active participation’ of an individual was defined as their presence within reasonable distance of the staff member carrying out the checklist, actively listening and replying when prompted or necessary, and not being occupied with any other activity (such as scrubbing or preparing equipment). [23] In addition to the modified WHO pre-operative patient safety checklist, the hospital also operated pre-operative ‘Team Briefing’. This involves a meeting of the multidisciplinary operative team at the start of each day to go over the day’s surgical, anaesthetic and operating room concern, as well as the patients’ clinical conditions. This consisted of a verbal briefing that predated the implementation of the checklist. The assessment tool therefore included a section assessing whether any of the WHO Time-Out checklist protocols were performed during the Team Briefing. The audit received approval from the Hospital’s audit group. Medical student volunteers observed a total of 38 surgical operations International Journal of Medical Dentistry

over a period of 3 months (February to April 2011). All students involved were briefed on the use of the tool. Operations were observed randomly across the three specialties surveyed. The operations sampled were not based on equal probability selection methods (whereby all operations have an equal chance of being sampled for the audit) and that the probability of any operation being observed is unknown.

RESULTS

38 surgical time out procedures were observed (15 in general surgery, 9 in orthopaedics, 13 in urology and 1 ophthalmology case). 18 operations were day case procedures, 16 were elective procedures and 3 was an emergency procedure (1 missing value). Call for time out

The call for “time out” was most commonly led by nurses (50%, n=38), followed by surgeons (26%) and anaesthetists (21%), though there was some variation across specialties (Fig. 1). Although overall nurses and anaesthetists were more likely to commence time out, urologists took the initiative in 54% of the 13 observed urology cases. Duration of time out stages

Time from first call to initiation of the time out checklist varied between 0 and 720 seconds (s). The majority of checklists commenced within 60s of the call (n= 35; median delay 45s). The duration of time out varied from 15s to 300s, but mostly lasted less than 60s (55%, n=38). Surgeons seem to spend the least time carrying out the checklist (n=10,median duration 40s), nurses second (n=19, median duration 60s), and anaesthetists took longest (n = 8, median duration 120s). The small sample limited the possibility of carrying out statistical testing. Active participation in time out

Surgeons did not actively participate in time out in 13% of all cases, anaesthetists in 26%, and scrub nurses in 13% of cases. 161

V. Karyadinata, Zoya Georgieva, Eleni Anastasiadis, Sukyee Pang, Ayo Oshowo, P. Gogalniceanu

Figure 1. Leadership in time out

Participants coming and going during the Time Out itself were only noted on one occasion (2%). Performance of individual components of the checklist

Categories related to patient identity (name, date of birth, hospital number) and procedure check were performed in 100% of cases at this stage across all specialties. The performance of categories related to prevention of peri-operative morbidity was variable (fig. 2). Checks for the prevention of potentially serious post-operative complications such as DVT and surgical site infection were performed in half or more of cases (DVT prophylaxis, measured as application of graduated compression stockings or heparin – 47%; antibiotics – 74%). Categories checked less frequently included ASA status and patient warming. Components such as glycaemic control and hair removal checkpoints were not performed at all. Importantly, site checks (left / right) were performed in the majority of cases (79%).

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Figure 2. WHO checklist performance across all specialties (N=38) and according to type of operation (total N=37, 1 missing value)

There was variation in the performance of checks for the prevention of post-operative complications across specialties (fig. 3).

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sign in and time out stages of the WHO checklist not covered during time out in the operating theatre. Equipment and imaging concerns were addressed most consistently (100% and 83%, respectively), while unexpected steps and estimated blood loss were discussed rarely, or not at all (fig 4).

DISCUSSION

Figure 3. Performance of time out items across specialties

DVT prophylaxis was most frequently checked by general surgeons (60%) and least often by urologists (30%), while antibiotic prophylaxis was checked by 80% of general surgeons compared to 67% of orthopaedic surgeons. Position check was most consistently performed by orthopaedic surgeons (89%) and least often by general surgeons (40%). ASA status was checked in 33% of general surgery cases, but in none of the orthopaedic ones. Team briefing

Figure 4. Team Briefing (N=6). Categories measured are based on items from the WHO Sign in and Time out stages and represent the items usually meant to be discussed at these meetings, as confirmed verbally by surgeons at this hospital

Six meetings were sampled (orthopaedics n=5, general surgery n=1), which comprised informal discussion of some categories from the International Journal of Medical Dentistry

The audit demonstrates that surgical safety checklists can be carried out quickly and effectively in 100% of cases. They do not seem to delay operating theatre activities, challenging the perception that a ‘lack of time’ for pre-operative checks is a barrier to their implementation. [22] Nurses were identified as having a key leadership role in initiating the checklist in the majority of cases. It is also important to note that some surgeons and anaesthetists were not always actively involved in the time out process. One explanation for these observations is that the period when the checklist is initiated is one of the busiest in the operating theatre prior to the beginning of the procedure. It therefore warrants some consideration about improving leadership and engagement of the team in the safety checklist process. The definition of leadership in the operating theatre is controversial: it can pertain to legal responsibility, training and qualifications or experience. A systematic review identified two approaches to leadership in a critical care environment such as the operating theatre. [24] In the ‘formal authority’ model, the most senior clinician may act as decision-maker and mediator of communication between the other team members. This is in contrast with the ‘shared leadership’ model which emphasizes fluidity: team members step up or recede from the responsibility of director and decision-maker as necessary. Irrespective of the model considered, a lack of leadership clarity has been associated with unclear objectives, low levels of participation and low support for innovation. [25] The implication for operating theatre teams is that a designated leader is needed to initiate and perform the safety checklist in order to improve participation and quality of implementation. 163

V. Karyadinata, Zoya Georgieva, Eleni Anastasiadis, Sukyee Pang, Ayo Oshowo, P. Gogalniceanu

Regarding category performance, the core items of patient identity and procedure check were consistently assessed. However, there were some categories which were not always well performed, including glycaemic control, ASA status, VTE prophylaxis, antibiotic use and site check. Performance varied across specialties and we may speculate that this reflects the relative perceived importance of each item for that specialty (e.g. patient position in orthopaedic surgery). The causes of these omissions cannot be ascertained by the current study, but these may have been caused in part by the nature of the specific procedure being performed (e.g. no left/ right marking when operating on a single rightsided organ, such as the gallbladder). In these circumstances the standard protocol is to label these sections of the checklist as ‘non-applicable’. [23] The ‘team briefings’ performed independently of the checklists were shown to be an essential part of local practice in the hospital audited. They served predominantly as a ‘safety-net’ for discussing aspects not covered during the WHO checklist and allowed all members of staff to express any concerns or questions. Despite the small sample of team briefings monitored, the estimated blood loss, equipment concerns and unexpected steps were important but rarely discussed issues. This may be due to the fact that team briefings were not performed according to formal or standardized protocol, allowing for these essential aspects of patient safety to be missed. This does highlight the importance of checklists in assuring the rigorous and consistent practice of patient safety. This is an area that requires further audit and intervention. In summary, this study has identified two key areas applicable outside regional centres: 1. The essential role of a leader in starting time out and monitoring participation 2. The need to improve performance of several frequently missed categories relating to prevention of postoperative morbidity.

Both these issues may be addressed by the introduction of a training programme for operating theatre staff and raising awareness of the evidence basis behind the WHO checklist. The rationale behind the impact of training programs 164

lies not only in improving adherence to checklist use but, more importantly, in the cultivation of a positive patient safety attitude amongst staff members. [26,8] The observational tool designed was found to be a quick, reliable, easily-adaptable and nonobtrusive method of assessing checklist implementation and performance. Its role in assessing quality of implementation on a larger scale is yet to be validated. The authors intend to implement the changes suggested in the same hospital and close the audit cycle through further observational studies once adequate training and cultural change strategies have been implemented.

CONCLUSION

The audit demonstrates that essential aspects of the locally modified surgical safety checklists are well implemented. However, some checks that are recommended by the WHO and which have a significant impact on patient safety are not being verified accurately. The participation of all operating theatre staff in the process is vital and requires further efforts in improving compliance. Checklists require designated individuals to lead their initiation, performance and compliance. Team briefings and pre-operative checklists have an important role in avoiding peri-operative adverse events. Their use should be adopted at a central level in countries outside those with centres in the original pilot studies in order to improve patient safety outcomes. Checklists may be more effective then team briefings, as they create a more systematic and reproducible way of performing patient safety checks. Staff training, better leadership and cultural change are needed to facilitate improved patient safety outcomes through the implementation of patient safety checklists. References

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Appendix 1

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