Primer on risk management for the gynaecological laparoscopist

Best Practice & Research Clinical Obstetrics and Gynaecology Vol. 21, No. 4, pp. 675–690, 2007 doi:10.1016/j.bpobgyn.2007.02.006 available online at http://www.sciencedirect.com

11 Primer on risk management for the gynaecological laparoscopist Sukhbir S. Singh *

MD, FRCSC (Ob/Gyn)

Clinical Fellow

George Condous

MBBS, MRCOG, FRANZCOG

Associate Professor, Nepean Clinical School/University of Sydney

Alan Lam

MBBS (Hons), MRCOG, FRANZCOG

Associate Professor, Royal North Shore Hospital/University of Sydney Centre for Advanced Reproductive Endosurgery, Royal North Shore Hospital, University of Sydney, Suite 408, 4th Floor, 69 Christie Street, St Leonards, Sydney 2065, NSW, Australia

The gynaecologist practising operative laparoscopy should be seen as part of a team that actively promotes patient safety, minimizing risks and optimizing outcomes. Building a culture of safety which focuses on proactive initiatives to manage risk and remove individual ‘blame’ should be an integral part of any operative laparoscopy unit. Thus, when adverse clinical incidents or outcomes occur, reporting of such events is encouraged and seen to be acceptable behaviour within the framework of complete patient care. By recognizing and analysing adverse outcomes, the team can develop strategies to prevent or manage a recurrence of such events. Implementing systems or solutions to prevent harm to patients is the cornerstone of any risk management programme. In this review, we discuss the development and implementation of risk management strategies in the clinical setting, and in particular how this applies to operative laparoscopy. Key words: risk management; risk; risk triggers; operative laparoscopy; laparoscopist; systems; patient safety.

The practice of gynaecological surgery has seen significant and rapid developments over the past 20 years, especially in the field of ‘operative laparoscopy’.1 In the early 1990s this term encompassed relatively straightforward procedures such as tubal sterilization, simple ovarian cystectomy, and diathermy of endometriosis. Today, operative * Corresponding author. Tel.: þ61 2 9966 9121; Fax: þ61 2 9966 9126. E-mail address: [email protected] (S.S. Singh). 1521-6934/$ - see front matter ª 2007 Elsevier Ltd. All rights reserved.

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laparoscopy has advanced significantly and includes a myriad of benign gynaecology procedures such as hysterectomy, tubo-ovarian surgery, adhesiolysis, myomectomy, colposuspension, pelvic floor repair and major excisional surgery for severe endometriosis.2 These advances in operative laparoscopy have taken place because of improved endosurgical equipment and a commitment to achieving better patient care, recovery and outcomes. However, as our specialty advances technically, we must also further our understanding of patient well-being and safety. Patient safety in healthcare has taken much of its design and approach from the aviation industry. The surgical setting is akin to the system for taking a flight: there are the pre-boarding (preoperative), boarding (patient preparation in the operating theatre), take-off (surgery) and landing (postoperative) stages. Over the last 25 years, the aviation authorities have protected the public by introducing risk management strategies in order to minimize harm during flight.3 This approach abandons the traditional concept of individual blame, and instead asks the leadership to critically evaluate the underlying problems: i.e. the system failures on multiple levels. Such an approach then enabled the aviation authorities to implement multilayered systems which ensured that airline disasters were minimized, and in turn the risk to the flying public was reduced. This doctrine has formed the basis of minimizing risk to patients in the hospital environment and, in particular, the operating theatre. The systems approach to preventing harm and addressing poor clinical or surgical outcomes for patients is essential to the principle of risk management in the operating theatre. BACKGROUND AND RATIONALE: ‘PATIENT SAFETY ON THE FRONT PAGE’ Although all surgeons are confronted with operative risks and possible harm to their patients, little direction has been provided with respect to risk management within the realm of gynaecological laparoscopy. Patient safety has gained tremendous attention globally since the USA-based Institute of Medicine (IOM) published its 1999 report ‘To Err is Human’, which suggested that 44,000–98,000 patients die in hospital each year because of preventable medical errors.4 The Canadian Adverse Events Study found similarly alarming numbers, including a possible 232,250 admissions to acute care hospitals that were associated with an adverse event, and that up to 23,750 deaths could have been prevented from such events.5 Similar reports from Australia, New Zealand and the United Kingdom echo the importance of addressing the safety of our patients in hospital.6–8 In Australia, figures from a major medical defence organization which indemnified approximately 45% of Fellows of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) reported a doubling of obstetrics and gynaecology claims from 14 per 100 members in 1991 to 29 per 100 members in 2000. The report also identified that while obstetric claims were more expensive, gynaecological claims were more frequent, and operative laparoscopy was the second most common group of procedures involved in claims after hysterectomy.9 The resulting impact has been a greater focus on patient safety through hospital, government and specialty society initiatives in the area of risk management. The international response in our specialty includes development of risk management practice guidelines for practitioners by both the American College of Obstetricians and Gynaecologists and the Royal College of Obstetricians and Gynaecologists in the UK.10,11 In the USA the response has involved every level of government, including the Joint

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Commission on Accreditation of Healthcare Organizations (JCAHO), which requires that patient safety policy be implemented for hospital accreditation.12,13 The Society of Obstetricians and Gynaecologists of Canada has created the MOREOB (Managing Obstetrical Risk Efficiently) program with expansion throughout Canada and the USA (see Chapter 4 of this issue).14 MOREOB provides a new model of care where patient safety is the priority, and its success illustrates the need and possibilities to make a difference in this growing area of clinical care. Whilst specialities like medicine and obstetrics have recently focused intensively on patient safety and adverse outcome, the field of operative gynaecological laparoscopy has not seen a similar flourish. THE OPERATING THEATRE ‘SYSTEM’ With the advancement of operative laparoscopy, there has been a responsibility to develop a parallel system that ensures accountability, quality of care, patient safety and best practice. Complications of operative laparoscopy have been documented extensively in the literature, including injury secondary to abdominal entry, electrosurgery, and advanced procedures such as laparoscopic hysterectomy.15–19 The main vehicles for addressing the risks associated with operative laparoscopy are educational sessions during specialty training, review articles, and the ‘weekend course’. These initiatives focus on the individual surgeon without taking into account the global perspective which requires looking at healthcare as a ‘system’. The operating theatre and perioperative setting is an example of a complex system involving many individuals working in concert to provide patient care. Within this setting there are equipment and technological aspects which further complicate the delicate flow of any surgical procedure; this is especially so in advanced operative laparoscopy. Any interruption or ‘error’ in this system may lead to patient harm which results in a spectrum of minor to devastating consequences. By introducing risk management principles and practice to the operative laparoscopy setting, it may be possible to implement strategies to optimize patient outcomes and limit or prevent complications and injury. This review will discuss the basic concepts in the developing field of risk management and apply these principles to operative laparoscopy. Risk management strategies assist the surgical team in providing a safer environment for patients and staff. As mentioned previously, the aviation industry serves as a model for an intricate system which manages the flow of millions of passengers every minute.3 Without a systemic approach to organizing this massive industry, safety would be compromised. Likewise, surgical care requires a systemic approach. Using aviation management principles as a guide, we may look at the surgical ‘crew’ and their roles in the pre-, intraand postoperative periods. The surgical team The operative laparoscopy theatre requires the involvement of several individuals who work in concert to provide surgical care. The nursing staff, clinicians, trainees and administration must all come together to ensure that the service can be provided. Crew management principles from aviation indicate the importance of creating a work environment which empowers all members to fulfil their own duties and to

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speak up when a risk or adverse outcome is identified.3 The hierarchy of the medical system can often be a barrier to managing patient safety issues. As an example, a surgeon accidentally burns the patient’s skin with the light source used for the laparoscope at the end of the case. He or she does not notice, but other staff members witness this adverse event. It is the responsibility of the staff in the theatre to speak up and let the surgeon know, and furthermore report this incident to help prevent similar problems in the future. This requires recognition that all members of the ‘team’ are able to play the role of safety officer and crew member to achieve the end-point of patient-centred care. Stress and fatigue will also impact on our team and should be addressed clearly in the work environment if it becomes an issue. Sleep deprivation and fatigue can result in impaired cognitive and technical performance which directly impacts patient well-being and safety in the surgical setting.10,20,21 The detrimental effect on our medical trainees’ performance has been recognized, and new work restrictions on duty hours have come into effect in many jurisdictions.22 Exhaustion, fatigue and stress among senior surgeons have not received the same attention as has been given to our trainees, but are nevertheless likely to play a significant role in adverse events in the operating theatre. This requires further study, consideration and education. Preoperative preparation and consent The operating theatre represents only one aspect of the patient’s pathway from admission to discharge for an operative laparoscopic procedure. Preoperative patient counselling, decision-making, preparation and consent are vital steps in ensuring the best outcome possible for the individual. Perioperative care includes appropriate prophylaxis against complications such as infection and deep venous thrombosis, and thus it requires careful planning and consideration within one’s own institution. Most institutions will now carry policies with respect to prophylactic antibiotics and anticoagulation, and these should be in agreement with broader regional, national and international consensus based on evidence. The use of standardized preoperative forms and checklists aid the busy practitioner in ensuring that certain measures for care are met prior to the surgical date. Pre-operative consent should be obtained in an environment free of coercion and pressure, since it is a fundamental legal principle.23 With few exceptions, any person’s bodily integrity should be protected. It is the responsibility of the health professional carrying out the operative laparoscopy to ensure that the patient is fully aware of what operation is to be performed. Ultimately it is the health professional who will be held responsible in a court of law if this is to be challenged at a later date.24 Careful and clear documentation should be made as to the potential risks and benefits of laparoscopic surgery discussed with the patient. Surgery of any kind undertaken without consent could result in criminal charges of assault or, more commonly, civil actions for damages.24 Generally speaking, a surgeon is not negligent if he or she acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion.25 This is referred to as the ‘Bolam principle’, and has been applied in law not only to diagnosis and treatment but also to the information provided when obtaining consent. A surgeon under this principle would not be found guilty of negligence if he or she can demonstrate to the court that the information provided to the patient about outcome and complications of laparoscopic surgery is in accordance with that provided by a responsible body of other laparoscopists in that field.24 It must be noted, however, that

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the courts have increasingly applied the ‘prudent patient’ principle which sets the standard for sufficient information not on the basis of peer opinion but at the level of what a reasonable person in the patient’s position would want to know. Consent before operative laparoscopy must include a description of the procedure, alternatives to the surgery being offered, the expected outcomes, the limitations and the risks or possible complications associated with the proposed approach. In our setting we find it helpful to provide patients with time to consider their options, and to bring patients back on a separate visit for a discussion of consent if possible. Also, the use of a nurse educator and prepared presentations and brochures has helped provide more information and manage postoperative expectations. The complications of laparoscopic entry are inherent to all forms of operative laparoscopies, whether diagnostic or operative, and these include bowel or vascular injury at primary port entry, injury to abdominal wall vasculature during secondary port placement, and very rarely CO2 gas emboli.26 Intraoperative complications are procedure-specific. For example, bladder or ureteric injuries need to be explained to women undergoing laparoscopic hysterectomy, whilst bile-duct injuries need to be explained to those undergoing laparoscopic cholecystectomy.27–29 It is the responsibility of the anaesthetist to also obtain consent, and any information about anaesthesia should be made available to patients before their preoperative review on the day of surgery. Any patient from whom consent is obtained prior to admission for their operation must have the consent affirmed on admission, and any concerns regarding the operation must be addressed at that time. Patient operative preparation Once in the operating theatre, the surgical environment should be treated in the same fastidious manner as management outside this microcosm. Safety practices in place prior to the first ‘cut’ are vital to the well-being of both patient and staff.30 At this point in the flow of surgical patients, ensuring correct patient and correct site surgery are basic yet of vital importance.30 The universal protocol used to facilitate this includes: (a) preoperative verification process; (b) marking the operative site if applicable; and (c) ‘time out’ before the procedure starts (ACOG).10 The standard use of the ‘time out’ concept is a prime example of employing a risk reduction strategy in healthcare. By having all members of the team pause to ensure that the consent, patient’s identity and site of surgery all match is a safety mechanism created to prevent harm within this complex ‘system’. The ‘systems approach’ demands that we look at all operating theatre members participating in the surgical process as a team, including the surgeon, anaesthetist, nurses, porters and cleaning staff. Any breach in this system can lead to devastating outcomes, and as a result, it must flow with careful appreciation for everyone’s role and involvement. ‘Latent’ error is a concept described by J. Reason and refers to the deficiencies in design, organization, maintenance, training and management that create an environment at risk, where the ‘team member’ is more likely to make a mistake.31 The surgical count is yet another example of the importance of the team approach.32 Often we hurry our staff to get the case started due to time pressures, and the ‘count’ is often felt to be an impediment to our progress. Even in operative laparoscopy, nursing and operating theatre protocol must be followed, as exemplified by a recent case in our city of a retrieval bag being left in the patient postoperatively despite the ‘count’ being correct. All team members are responsible for the safety of our patients.

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Anaesthetic administration, securing the airway, and patient positioning prior to surgery are also vital to the process and should be respected with the same vigilance as the actual surgical procedure. The issues surrounding operative laparoscopy and anaesthesia have been reviewed and should be required reading for the surgeon and his/her staff.33,34 The responsible surgeon Once prepared, and having the patient under anaesthetic, the surgeon is now the ‘pilot’ and will help lead the ‘crew’ through the stages of the procedure. An in-depth knowledge of the equipment – including cameras, trocars, energy sources and specimen retrieval devices – is vital to the success of a laparoscopic procedure. Unfortunately there remains a deficiency in knowledge among practitioners of basic concepts in some of these areas. As an example, electrosurgery is one of the most commonly used energy sources, yet knowledge of this modality is limited. The risk of electrosurgical injury during laparoscopic surgery is related directly to the laparoscopist’s knowledge of instruments, surgical technique, applicable biophysics and relevant surgical anatomy.15,35 Unfortunately, the results of one study demonstrated that practising gynaecologists were unable to successfully complete a basic exam about electrosurgery.36 Education and practical knowledge should be evaluated prior to practice, and consideration should be given to evaluation of those already practising which may indicate deficiencies requiring re-education. The surgeon’s abilities and capabilities are put to the greatest test upon introduction of new technologies and techniques. Laparoscopy has been the most significant novel technique introduced in surgery over the last 20 years. As a result, all surgeons must be are aware of their own ‘learning curves’, and it is well accepted that complication rates may be appreciable in this time.37,38 It is not only the surgeon’s own responsibility but also that of the physician governing bodies and hospitals to ensure competency in the service being provided. Core competency in laparoscopic surgery among gynaecology trainees is being addressed at the national and local levels with several initiatives internationally.39–41 Raymond et al demonstrated that many senior Ob/Gyn trainees perceived a lack of preparedness in performing some basic and many advanced endoscopic procedures upon graduation.40 Einarsson et al observed similar findings in a US survey of 133 accredited residency programs and recommended more emphasis on laparoscopic training during residency.41 The development of a standard contemporary and comprehensive gynaecological endoscopy teaching curriculum appears timely and desirable. The goal of surgical training is to produce competent individuals able to provide safe and effective care to their patients. But when an individual is considered ‘postgraduate’, who is responsible for monitoring their competency and skills? At the international level there is a growing question of practising physician credentialing and privileging, especially with new technologies.10 Concepts such as clinician report cards to monitor complications and outcomes have been suggested in order to be publicly accountable.42 However, there is much controversy on this topic, including concerns with misinterpretation of results released to the public affecting the reputation of surgeons.43,44 At the present time, self-learning and assessment is the key to surgeon education.

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Buschemeyer et al, in their recent article on teaching emerging technologies, emphasize the importance of providing the surgical community with accountability in surgeon performance.45 They suggest the development of structured, preceptor training programs for practising surgeons, systematic review and accreditation of those training programs, and the application of systems to document outcomes. Further leadership and guidance on the issue of surgeon competency, accreditation, credentialing and privileging for specific procedures and skills sets will be required from local, regional, national and international interests. Postoperative care: communication and dialogue Upon completing surgery, the theatre focuses on ensuring safety measures already discussed, such as sponge counts and anaesthetic care. The surgeon has a duty to continue the flow of safe patient care into the postoperative period. Furthermore this represents an opportunity for clinicians to dialogue and communicate surgical outcomes, findings and complications to the family and patient. Communication has been cited as an important component in improving clinician– patient relationships, including a reduction in legal action for complications. Patients may feel rushed or ignored, which leads to an interpretation as receiving less attention and possibly inadequate care.14 Consent as discussed above allows a preoperative forum for communication, and similarly postoperative discussion should always occur. Disclosure of adverse events or complications in surgery is vital to providing good patient care, and also promotes a healthy physician–patient relationship. The legal implications of such events may require prior discussion and consultation with a risk manager or designated support person (often available through indemnity providers as well). The National Patient Safety Foundation Statement of Principle helps guide physicians in this matter.46 DEFINING RISK MANAGEMENT Operative laparoscopy provides a minimally invasive approach to many of our patient care problems that would previously have been managed by laparotomy. This allows us to manage benign gynaecological conditions requiring surgical interventions, and in return offers quicker patient recovery, discharge and return to normal activity. Despite the ideal provision of care, risks exist in this approach and in the system that provides the service. Managing risks in our operating theatres requires recognition that ‘hazards’ exist in the environment and may include conditions, events, objects or circumstances that may lead to an undesired outcome. ‘Risk’ refers to the significance or potential impact of a hazard and may be measured by persons or resources affected (exposure), the likelihood of loss (probability), and the extent of possible loss (severity).47 Risk management is the global process that requires a system-based approach to develop initiatives to improve safety and outcomes. It is the deliberate development of practices or strategies aiming to optimize the outcomes of patient care and prevent or reduce hazards which have the potential to cause harm or damage the health, safety or well-being of patients.24 The development of strategies, also known as the risk management cycle, can be remembered by the acronym of:

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 Recognition – the process of identifying, classifying and defining hazards;  Interpretation – the process of assessing and analysing the significance of the risk(s) and the likelihood of this occurring in one’s own setting;  Strategy – the process of developing and implementing plans to treat the recognized risk(s); and  Keeping track – the process of monitoring and evaluating the outcomes of the introduced strategies or measures to improve patient safety and outcomes. When an error occurs in medicine the response is often reactive, with resultant disciplinary action or apportioning of blame. Risk management, the process, seeks to take a proactive strategy to common problems in the operative laparoscopy environment without pointing fingers at individuals, but rather continually assessing the greater system that surrounds us daily. Risk management should therefore be an integral part of operative laparoscopy if we are to prevent or limit patient injury. In turn, risk management also aims to reduce or mitigate financial and legal harm to the provider, hospitals and health authorities involved. Recognition of risk Surgical risk must consider both organizational and human (surgeon) components. Errors made within either of these two paths may lead to an adverse event (mishap) or a ‘near miss’. An active error is the immediate cause of an incident or outcome, whereas the latent error involves a systems issue such as organization, protocol, staffing and hospital policy.31 Regardless of the outcome, a patient safety incident is a significant event and should be addressed as such in the risk management cycle. The elements of recognition and assessment are: 1. 2. 3. 4.

setting up risk triggers and reporting adverse events (Table 1); audit of own practice and operative experience; team approach within ‘no blame’ environment; and mandatory reporting for identified issues.

Table 1. Trigger list for reporting in operative laparoscopy. Clinical incident Visceral injury (i.e. bowel/bladder/ureter) Large vessel injury (i.e. inferior vena cava, aorta) Nerve injury (i.e. femoral neuropathy) Anaesthetic complications Failed procedures (e.g. sterilization) Omission of planned procedure Unexpected blood loss requiring transfusion Procedure performed without consent Venous thromboembolism Unplanned intensive care admission Unplanned return to theatre Unplanned return to hospital within 30 days Modified from RCOG Guidelines.11

Organizational incident Faulty equipment (e.g. electrosurgical burn due to worn insulation) Staff injury Potential patient complaint Medication error Retained swab or instrument Violation of local protocol Conflict over case management Delay following call for assistance

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Identifying risk should begin with assessment of one’s own clinical area and operating theatre to determine obvious issues that may be dealt with immediately (Appendix 1). For example, after walking through theatre as part of this process you notice that there is clutter surrounding the emergency crash cart in the hallway which would delay access to emergency care of patients in the theatre. After clearing the clutter the risk has been modified. Staff consultation would be appropriate to allow for sharing of experiences and knowledge. Next, an audit or prospective database of one’s own practice is important to identify recurring errors or problems encountered. This self reflection is important for medical education and for quality of care. Incident reporting should be instituted in all hospitals and theatres. At the time of an identified and reportable complication or problem, it should be followed up with a report to allow further analysis (Appendix 2). Complaints and legal claims would also be an opportunity for recognizing areas of concern; however, the risk management process needs to be kept separate from the patient chart and the disciplinary actions. Reporting patient safety incidents becomes very challenging for the individual with fear of humiliation among colleagues and litigation from patients. In order to overcome these fears and concerns, it may be prudent to use anonymous and confidential reporting mechanisms. Blame is not the goal of this process; rather it is to identify systemic or individual issues which may be improved upon to lead to greater patient safety. A true risk management program will be kept separate from the patient record and disciplinary hearings. Many hospitals now appoint a separate quality-of-care or risk management committee to handle matters of patient safety in such a manner. Interpretation/analysis Understanding why something has resulted in an adverse situation or outcome is the cornerstone of risk management. Through analysis of an incident, whether it be a ‘near miss’ or ‘mishap’, it may be possible to prospectively prevent similar incidents in the future. In order to facilitate analysis, a core risk management team should be given the charge to move this forward. In the operative gynaecology setting this would include:        

the the the the the the the the

gynaecological laparoscopist (a senior and junior representative); gynaecological laparoscopy fellow/trainee/surgical assistant; nurse representative; anaesthetist; operating department practitioner/technician; theatre manager; medical staff from a non-obstetrics/gynaecological subspecialty; hospital administrator/manager.

This process requires cooperation, group work and leadership to function appropriately. In some instances an assigned clinical risk manager may be available through hospital initiatives in risk management. Root cause analysis (or system analysis) refers to the investigation and study of the underlying organizational causes or factors that may result in an event and for identifying strategies to reduce the likelihood that a similar error may occur.48 The London Protocol, featured in the RCOG guidelines, provides a general outline for the process

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of examining clinical incidents (available online).11 In analysing an event, the importance of viewing the cases through a ‘systems approach’ must be emphasized, including the concepts of active and latent failures or errors. The goal is to deal with the factors resulting in the incident, not to punish an individual for the current situation. Strategies Through analysis, certain failures or deficiencies in the system may be recognized and require attention. The development of constructive and cost-effective strategies requires time and a dedicated unit. In many instances staff education and greater communication among team members is all that is required. In other cases it may be that a large financial outlay may be required, as in the case of equipment purchases. Every disease or illness requires a treatment, and similarly in risk management several options exist. Table 2 outlines the concepts of risk avoidance, reduction, retention and transfer using bowel injury in operative laparoscopy as an example.24 Implementing a strategy to reduce risk will require that there is ‘buy-in’ from the staff, a commitment to patient safety and participation in the process from the beginning. An essential component to this part of the cycle is building a culture of safety that is free of blame and fosters team work. Communication and feedback are essential parts of the strategies that should see them materialize and impact on change. Keeping track Patient safety and risk management literature and guidelines support the prospective monitoring of incidents considered to be near misses or mishaps.10,11 This is most easily done through the management of a database which is kept prospectively and is reviewed regularly. Keeping track of our own practices is the next logical step and should be part of ongoing medical education and promotion. Quality assurance monitoring may include several parameters already set in place in one’s institution. However, it may also be expanded for the operative laparoscopist to include surgical outcomes, complication rates, equipment failure or injury rates. As part of this monitoring, regular educational rounds and review should occur to continue the process. On the basis of the principles and unique issues in operative laparoscopy discussed above, the following practical points should be considered in the gynaecological Table 2. Risk treatment options using bowel injury as an example. Risk ‘treatment’ Risk avoidance: avoid activities with identified risks Risk reduction: introduction of strategies which minimize loss Risk retention: accept the chance that a loss or harm may occur and be prepared to deal with it when it occurs Risk transfer: using another party/ organization to accept consequences of a risk

Laparoscopy example Avoiding laparoscopy in patients with severe adhesions which may result in significant bowel injury Consultation of general or colorectal surgeon in cases of severe rectovaginal endometriosis if bowel entry is likely Bowel injuries at time of entry are not always avoidable, so some injuries will occur and will need to be managed Medical indemnity or medical protection insurance for the hospital, staff and surgeons

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laparoscopy unit. The processes discussed above are outlined in Table 3 and summarize the issues under each principle to guide the risk management process. Limitations Although intended to promote the ideal outcomes of better patient care and safety, the implementation of risk management may be costly, time-consuming and misdirected. Committed leadership and appropriate provision and deployment of resources are needed to optimize the process. The process also requires dedication from all stakeholders including hospital administration, insurers and staff. The National Patient Safety Agency (NPSA) in the UK has set out ‘Seven Steps to Patient Safety’ to guide National Health Service (NHS) organizations to improve care.49 Guidelines such as this should be reviewed and considered by the gynaecological surgeon in a leadership role. The return on investment for such projects is not often tangible or recognizable on initiation. However, the improvement in quality and steps taken to improve service should be seen as outcomes worth financing. The initial implementation and risk recognition steps must be thorough and well conducted to allow the rest of the cycle to succeed. Too much focus on low-level risks may waste time and resources while more significant risks may go untreated. Acceptance among practitioners will also be seen as a barrier in many surgical settings. For example, many clinicians may oppose public reporting of medical errors or the idea of a surgeon ‘report card’ for reasons outlined already.44 We must move past the individual surgeon and promote the greater societal benefits of disclosure and risk recognition in order to provide better patient care. Table 3. Risk management in the surgical setting. Risk management principle

Actions

Recognition

Develop an audit tool for your practice and theatre to determine areas of risk A system for incident reporting in the operating theatre (web- or computer-based) with an anonymous option Create a ‘list’ of mandatory reportable incidents such as visceral injuries, equipment malfunction etc

Investigation/analysis

Identify a core risk management ‘team’ to review incidents and undertake audits on a regular basis Encourage feedback and participation of all staff in understanding the factors contributing to patient safety incidents Keep documentation separate from patient records and under auspices of quality assurance

Strategy

Develop and implement strategies Education through posters, rounds, reading materials and self assessments Promote a ‘safety first’ environment

Keeping track

Monitor implementation of strategies; evaluate outcomes Monitor incident reporting and participation Encourage and reward involvement in process

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As seen in North America and elsewhere, patient safety is a priority that requires attention in all realms of medicine.12,13 Although there may be cultural and financial barriers, these must be overcome to improve our delivery of surgical and perioperative care. Practice points  operative laparoscopy is part of a system that involves a team approach to providing perioperative care  the gynaecological surgeon should take a leadership role in promoting a culture of safety within the operating theatre  risk management is a process to aid in patient safety and best practice initiatives  risk management is a cycle involving recognizing risks, interpreting the findings, developing strategies to alter risk and lastly, keeping track of the process outcomes  in each surgeon’s institution, common operative risks and complications in gynaecological laparoscopy should have well-established, practised and documented strategies for prevention and management

Research agenda  review of current practices in gynaecology units with respect to risk management programs  study of the acceptability of reporting adverse incidents and developing strategies to increase participation  need to assess the outcomes of implementing risk management programs such as number of complications/adverse events and financial benefit or loss  impact of risk management programs on legal action

SUMMARY Operative laparoscopy presents unique surgical challenges, risks and outcomes when compared to other types of surgery. As a result, it would be reasonable to suggest that laparoscopy be dealt with as part of a risk management program in one’s own clinical setting. The issues surrounding patient selection, equipment needs and maintenance, skills required by the surgeon, and complications that may occur in this area require special attention. The gynaecologist with an interest in operative laparoscopic procedures will need to take a leadership role in their own surgical setting to ensure that risk management standards are implemented and executed. Pre-emptively disseminating risk triggers to all health practitioners who work within an operative laparoscopic unit; encouraging reporting of patient safety incidents; openly discussing such cases in an anonymous and blame-free atmosphere; sustaining a risk management forum; and ensuring feedback loops for the team involved in these often complex and advanced endosurgical procedures are all encompassing strategies that modern operative laparoscopy units should adopt. Ultimately, this expectation will become mandatory in Western medicine not only to protect the patients’ well-being and health in the complex system of the operating theatre but also minimize risk.

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STATEMENT OF INTEREST None of the authors has any financial interest related to the topics discussed.

Appendix 1: The surgeon’s safety check list Preoperative U Patient:  Consent: patient has received the appropriate information, counselling and expectations for the surgical procedure  Preparation such as bowel preparation and preoperative medications (i.e. antibiotics, anticoagulation, pain relief) U Surgeon/anaesthetist:  Review patient history and indications  Be clear regarding the surgical procedure and operative site  Communicate any specific concerns about the individual such as allergies U Nursing:  Ensure correct set-up has been collected and that all necessary equipment and staff are present U Operating room staff:  Ensure room has been cleaned and prepared for the incoming patient  Supplies and safety checks completed Operating theatre entry U Patient support and comfort measures U Equipment is set up U Display screens in correct and ergonomically strategic position U Energy sources clearly labelled and checked U Time out: ensures correct patient, procedure and operative site Patient preparation U Induction of anaesthesia: critical exercise to ensure patient airway and circulation parameters are protected and monitored U Patient position: avoid neurological, crush or burn injury Surgical start U Communication with nursing and anaesthesia staff throughout procedure U Best practice technique for procedure Surgical stop time U Communicate orders/concerns with staff U Document surgical procedure including findings, complications and blood loss Postoperative U Communicate surgical findings and outcomes to patient and family U Monitor well-being and address any questions or concerns U Organize follow-up U Pathology results to be discussed

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Appendix 2: Sample risk management program incident report Issue: Injury on primary entry Date: Patient Number: Technique used: Closed (Veress®) Open (Hasson)

Direct trocar

Injury type: Vascular: large vessel Vascular: minor vessel Bowel: small

Bowel: large Urinary: ureteric Urinary: bladder

Other: ________________________________ Comment on injury (i.e. describe)

Was it recognized at the time of entry?

_______YES

__________NO

Management: ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ Patient outcome: ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________

Factors involved in injury (i.e. surgeon, equipment or patient-related) ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________

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