|Year : 2014 | Volume
| Issue : 2 | Page : 65-71
Adverse events and patient safety from the surgical perspective
Yahaya A Ukwenya, Adamu Ahmed, Emmanuel A Ameh
Department of Surgery, Ahmadu Bello University, Zaria, Nigeria
|Date of Web Publication||16-Oct-2014|
Yahaya A Ukwenya
Department of Surgery, Ahmadu Bello University, Zaria
Source of Support: None, Conflict of Interest: None
Background: Surgeons practicing in emerging nations like Nigeria which are still struggling to cope with institutionalized approach to patient safety and quality health care have a critical role in ensuring the safety of their patients. This article aims to provide an overview of the surgeon's role in the causation and prevention of surgical adverse events.
Patients and Methods: The literature is reviewed using key terms: Surgical adverse events, postoperative morbidity and mortality, surgical safety and error management from Pubmed, Ajol, Google scholar, and Embase data bases.
Results: An estimated 3-22% of surgical patients suffer adverse events, half of which may be preventable. Over three-quarters of adverse events are traceable to the operating theater from failures of surgical technique during routine operations. Preventable adverse events are symptomatic of both the surgeon and the health care system fallibility.
Conclusion: Minimizing surgical adverse events require integrating safety into all the stages and the processes of surgical care. The surgeon's antidote to adverse events is to deliver quality service and leadership throughout the period of patient care.
Keywords: Error management, postoperative morbidity and mortality, surgical adverse events, surgical safety, surgical error
|How to cite this article:|
Ukwenya YA, Ahmed A, Ameh EA. Adverse events and patient safety from the surgical perspective
. Arch Int Surg 2014;4:65-71
| Introduction|| |
Every surgeon has to be concerned about the prevailing risks of harm to patients during the course of care, resulting in prolonged hospitalization, increased costs, disability, death, erosion of public confidence, and litigation. "First do no harm" advocated by Hippocrates and adverse events have always been part of the history of medicine; except that the latter was relegated mostly to backdoor discussions until the Institute of Medicine (IOM)'s Quality of Health Care in America Committee produced its report in 1999, "To err is human: Building a safer health system."  This document brought to public knowledge the enormity of harm from medical care. Americans were alarmed to find medical error as the eighth leading cause of death ahead of road traffic accidents, breast cancer, and AIDS, accounting for 98,000 annual deaths.  To tackle the problem globally, the World Health Assembly passed a resolution to strengthen patient safety in 2002; and in 2004, launched "WHO Patient Safety," an international alliance to promote patient safety.  The publication of WHO Guidelines for Safe Surgery 2009 followed the selection of surgical patient safety as the second WHO Patient Safety Challenge. 
| Definitions|| |
The IOM's report defines safety as freedom from accidental injury.  On the other hand, the National Surgical Quality improvement Program (NSQIP) considers safety as an integral part, indistinguishable from the quality of surgical care and includes both preventable and unpreventable outcomes.  The National Patient safety Foundation defines safety as the avoidance, prevention, and amelioration of adverse outcomes or injury stemming from a process of care.  Other definitions of interest are compiled in [Table 1]. ,, Leape et al. distinguished error from negligence.  Negligence occurs when the degree of error exceeds the accepted norm and is defined as the failure to meet the standard of practice of an average qualified physician practicing in the same specialty.
|Table 1: Definition of terms commonly used with surgical safety and adverse events|
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| The Problem|| |
Retrospective data from high-income countries estimated that 3-22% of surgical inpatients suffer adverse events with 0.4-0.8% mortality, approximately half of which may be preventable. ,,,, Krizek  has however echoed the suspicion of many observers; that the current data on preventable adverse advents is dependent on self-reporting and may underestimate the problem, largely because health workers, traditionally, are reluctant to document errors to avoid being "named, blamed, or shamed." In his prospective report of 1,047 surgical patients, the frequency of errors was two per patient with a staggering adverse event or error rate of 45.8%, 21.2% of which were either life or limb threatening. Similarly, in a prospective recording of 1,108 consecutive neurosurgical cases, Stone and Bernstein reported an error rate of 87.1%, 22.6% of which were considered major. 
Large-scale data on adverse events from sub-Saharan Africa are hard to come by, but there are publications which give insight into the seriousness of the problem. Report from a teaching hospital in southern Nigeria indicate that 1 out of 239 patients brought for surgery will not leave the operating theatre alive; and in sub-Saharan Africa, an average of 1 in 150 patients die from general anesthesia. , In a series of 100 patients who had delayed treatment of breast cancer in northern Nigeria, 38 were adjudged to have disease advancement due to errors in management. 
| What Causes Surgical Adverse Events?|| |
Adverse events in surgical patients may be an extension of disease process (e.g., incisional infection following surgery for typhoid ileal perforation), patient-related (e.g., thromboembolism from congenital thrombophilia), or due to management. Adverse events from management may be technological in origin but, in most cases, are consequences of human failures. It has been presumed that hazards to patients will decline significantly with advances in medical technology but this has not been the case. Instead, technological advances have simply magnified human contribution to medical hazards, relocating rather than eliminating errors.  Human failure may be in the form of violation of a protocol or guideline, or may be an error. The error could be a planning error (e.g., the ureter is injured in a pelvic tumor surgery because the surgeon has not availed himself to a preoperative intravenous urography) or an execution error such as laceration of vas deference during herniotomy. An estimated 41-79% of adverse events in surgical practice are due to errors preventable with current standards of care. ,,,,
Current evidence suggests that surgical adverse events result, most of the time, from convergence of errors rather than the fault of a single individual as is traditionally believed. ,,, Analysis of surgical errors has shown more than one individual to be culpable in 62-70% of cases and the system involved in 82-90%. ,,, James Reason's organizational accident model highlights the convergence of at least three basic components to produce an adverse event. , First is the individual at the "sharp end" (point of patient care) who errs or violates laid down guidelines by acts of omission or commission because of human fallibility. This individual could be a surgeon, an anesthetist, nursing staff, intensivist, interventionist, laboratory staff, or pharmacist. Second is the presence of unforeseen breeding ground for errors or violations in the system caused by error or violation-prone decisions made by the system managers. These are called latent errors. Thirdly, system defenses must be breached to translate the error or violation to adverse event, representing failure of various error-recovery mechanisms. The leading system factors cited in analysis of surgical errors include inexperience or lack of competence with surgical task (41-57%), failure to use a policy (52%), communication breakdown (24-43%), and excessive workload (33%). ,,,
An estimated 74-83% of surgical adverse events take place in the operating room. ,,, Krizek  drew attention to management of complications as the problem area most often associated with serious adverse event with risk of 38.1%. Other areas identified in his study include surgery (17.9%), monitoring and daily care (17.1%), treatment (9.1%), drugs and medications (5.8%), diagnosis (5.2%), and anesthesia (2.4%). Studies from the USA indicate that the anesthetic contributions to adverse events in theater may be far lower than presumed from the surgeon's view (1-2%) while failures of surgical technique account for 52-64%. ,,,, Regenbogen et al.,  in a review of the patterns of technical errors among surgical malpractice claims in the USA reported that 65% of the technical errors were manual, 9% involved errors of judgment, and 26% involved both.
| Risk Factors for Adverse Events and Errors by Surgeons|| |
Kable et al.,  from Australia studied risk factors for adverse events in five high-volume operations, namely herniorrhaphy, cholecystectomy, transurethral resection of the prostate, and hip and knee arthroplasty. They concluded that age greater 70 years, type of procedure, procedure duration more than 2 hours, contaminated surgical site, and anemia were the factors to be monitored for patients undergoing these procedures. In another study, these authors reported an adverse event risk of 38% for patients who had extensive operating room procedures unrelated to principal diagnosis. 
Among operations listed for increased risk of adverse events, cardiovascular and spinal procedures, reconstructions of hip and knee, colon resection, hysterectomy, cholecystectomy, appendicectomy, and transurethral resection of prostate and bladder tumor appear commonly. , On the other hand, Regenbogen et al.,  reported that 84% of technical errors occurred during the course of routine surgical procedures; and in 73% of cases, errors were caused by experienced surgeons. Failure to operate within proper scope of practice is cited as one of the commonest risk factors for adverse events associated with the surgeon's competence. , Surgical training has traditionally posed special challenges to patient safety because the learning curve in the performance of tasks increases the risk for errors. To identify the factors contributory to the trainee errors, Sing et al.,  studied closed malpractice claims from five insurers in the USA and reported errors of judgment as the most prevalent in 72% of the cases. Among the system factors, teamwork breakdown occurred in 70%; particularly lack of supervision, handoff problems, and lack of clear lines of responsibility. Others included excessive workload, interruptions, and distractions. The socialization process in surgical training and the institutional environment in which the trainee is inculcated should be modeled for the trainees to learn to display confidence and certainty as part of the "hidden curriculum." [Table 2] summarizes factors that may influence the development of surgical adverse events.
| Type of Adverse Events and Errors by Injury|| |
Surgical site infection (39%), bleeding and hematoma (23%), injuries by physical or chemical cause (22%), and other functional disorders (16.5%) were the prevalent injuries reported by Zegers et al.  Other studies report technique-related complications as the most frequent injury in 24-30% of their patients. , Leape et al., produced a clinical classification of medical errors into diagnostic, performance, preventive, drug treatment, and system errors. 
| Prevention of Surgical Adverse Events|| |
In principle, half of the current burden of adverse events in surgical patients may be prevented by minimizing errors and guaranteeing that they are recovered before translation to adverse events. The currently recommended approach to error management (the system or organizational approach) adopted from high-reliability organizations, such as air traffic control systems and nuclear power plants guarantees reliability in presence of risk and differs from the traditional individual approach which is flawed by error repetition ,,, [Table 3].
System or organizational approach to patient safety
The IOM's report  recommended four strategies to combat medical adverse events and improve patient safety and has been summarized in [Table 4].  The WHO Guidelines for Safe Surgery 2009 contains ten essential evidence-based objectives for safe surgery [Table 5], which have been condensed into the WHO surgical safety checklist.  The implementation of WHO surgical safety checklist has significantly reduced adverse events in many operating theaters while the WHO Global Pulse Oximetry Program has improved access to this basic anesthetic monitoring device particularly in poor resource countries. ,,,,,
A limitation of the WHO surgical safety checklist is the confinement in scope to the operating theater. Compromise of patient safety may occur if basic standards are not met at patient evaluation, preoperative preparation and postoperative care. de Vries et al. have developed an alternative checklist; the Surgical Patient Safety System (SURPASS), which monitors critical safety risks and information transfers along the entire surgical pathway.  SURPASS covers five phases of surgical pathway from admission to theater to recovery room or ICU, back to the ward and discharge. Implementation in six Dutch hospitals with high standard of care was associated with considerable reduction in mortality and complications. ,
| The Role of the Surgeon in Preventing Adverse Events|| |
Unique to surgical care is that the patient must be managed in a complex, dynamic, and interdependent environment with the surgeon as the nucleus. Though the performance of the surgeon is not the only determinant of outcome, his or her technical competence, sound clinical judgment, and leadership from evaluation of the patient to discharge and follow-up constitute the cornerstone of the patient's safety. The quality of a surgeon's work is in most cases related to competence, case volume, and case mix. , Surgical competence requires acquisition and integration of knowledge, technical and nontechnical skills developed through residency training, at the end of which the surgeon is certified by a postgraduate college. The responsibility of deciding whether a surgeon or physician can be entrusted with a particular patient at any point in his career rests with the health care system. Where the system abdicates the responsibility by failing to regulate the competence, experience, and fitness of the physician to manage a surgical patient, patient safety suffers.  The surgeon on the other hand, has the additional responsibility of guaranteeing that the system of care is adequate to meet the minimum standards for safe surgery. This is particularly important in environments where challenges of organized approach to quality health care and patient safety exist.
To remain relevant to quality practice, the surgeon must embark on retraining, keep pace with new developments, develop skills to use new technology, and be accountable to review by peers, patients, and stakeholders. The need to protect patients from errors associated with training and learning curves led to advances in surgical simulation and basic surgical skills laboratory, which have additional benefits of providing opportunities to make and learn from errors. ,,,,,
Measures to determine the technical competence of a surgeon remains a subject of concern and surgery lags behind anesthesia, aviation, and other high-reliability organizations in the use of simulation to directly evaluate and improve on technical competence. , A number of tools have evolved for assessing the technical proficiency of surgeons in training and practice. They include checklists; global rating scales, such as objective-structured assessment of technical skills (OSATS); dexterity analysis systems, such as Imperial college surgical assessment device (ICSAD); virtual reality simulators; and error scoring systems. 
A remarkable initiative is the development of the National Surgical Quality Improvement Program (NSQIP) in the USA, first in the Veteran Health Administration in 1991 and made available to the private sector in 2004 by the American College of Surgeons (ACS) by establishing the ACS-NSQIP.  The NSQIP uses the 30-day risk and case mix adjusted morbidity and mortality to measure the quality of surgical care by a surgeon, surgical unit, or hospital. There are currently over 100 hospitals in and outside the USA registered with the program. Using a rich prospectively collected database, continuous quality improvement is achieved by feedback to participating hospitals, allowing performance comparison with similar hospitals and providing readily available data for outcome research.
Surgeons cannot work alone and quality surgical care demands effective and optimal skills of collaboration with other stakeholders in the surgical care. The NOTSS (nontechnical skills for surgeons) project at the Aberdeen University has identified five critical areas; leadership, communication and teamwork, task management, situation awareness, and decision making from which a rating system for identifying the nontechnical training needs of surgeons has emerged. ,,, Equally, surgeons must provide leadership that enhances team competence ahead of individuals in the interest of patient safety, particularly in the operating room. The surgeon leader has to ensure that the operating team and sub-teams have shared understanding of the patient's problems and potential areas of crises during the surgery. Like an airline pilot, he or she has to seek and take inputs from crew members in an environment of flat hierarchy without abdicating responsibility for the patient.  The decision to proceed with an operation at all times has to be in the best interest of the patient rather than the time, efforts, funds, and sentiments invested in the case.  The use of simple tools such as the WHO surgical safety checklist guarantees minimum standard of communication between the surgeon and the operating "crew" in the OR. What then are the safety skills required of a practitioner? In a survey by Long et al.  from London, UK, experienced clinicians rated technical skills (98%), crisis management (98%), and honesty (97.5%) as the most important while technical skills (98%), anticipation, preparedness (84%), and organizational skills/efficiency (83%) were the most trainable.
| The Morbidity and Mortality Review|| |
The traditional forum for surgeons to analyze and learn from errors on case by case basis is the morbidity and mortality (MM) review. In principle, the surgeon exposed to understanding the background, causes and prevention of errors early in career as a trainee learns to confront and profit from rather than cover up or avoid discussion on errors. Quality improvement and investment in safety is achieved in twofolds. The surgeon is unlikely to repeat the errors and should they occur, the errors are easily recognized, corrected, and prevented from progressing to adverse events. MM discussions are expected to be transparent, nonjudgmental, and should emphasize teaching of safety lessons rather than asymmetrically focusing on the activities of the surgeon. ,
Despite two centuries of existence, MM review still faces challenges of precise definition, format, and goals. ,,, Some centers have turned it into a glorified case conference where the educational interests supersede the safety value.  Many suitable cases escape discussion or the consultants and system managers are absent to avoid being "named, blamed, or shamed," especially where emphasis is misdirected toward demonstration of gross mismanagement. The concept of "Matrix conference" proposed by Leo Gordon from Cedars-Sinai Medical Centre, Los Angeles represents a prototype of a number of ongoing attempts to restructure MM review for effectiveness. ,,,
Error reporting and analysis primarily targets system improvement. The IOM's report identifies two types of error reporting, which are complementary, mandatory, and voluntary error-reporting systems.  Mandatory systems cover serious injuries or deaths and are state controlled. The potential for sanctions and public disclosure associated with these adverse events pushes health care systems to make active investments in patient safety. Voluntary reporting system aims to identify, collate, and analyze sentinel events, described by James Reason as the "mosquito swamps" (breeding ground) of errors for the purpose of strengthening system weaknesses.  Fear of discoverability and possible litigation remain real challenges to voluntary self-reporting. , Confidentiality and legal protection are therefore required to encourage health practitioners to come forward.
| Conclusion|| |
Adverse events in surgical patients are symptomatic of both surgeons and health care system fallibility. Minimizing them requires integrating safety into all stages and processes involved in surgical patient care. The surgeon's antidote to adverse events is to deliver quality service and remain safety conscious throughout the period of patient care to discharge and follow-up. The surgeon should lead by example in promoting safety culture within his domain. There is a need for developing countries to increase health-care investment in the technologies, techniques, and training necessary to improve patient safety.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]