Fig. 2.1
General and specific interventions across the system and evaluation end points (modified from Brown et al.)
This epistemology of surgical safety is applicable to a wide range of settings. In low-income countries many people don’t have access to safe surgery and the study of surgical safety differs methodologically, because of lack of access to high-quality data and care.
Nevertheless, data on surgical safety in low- or middle-income countries is starting to emerge [7]. It represents a significant problem, especially considering the global strategy towards universal healthcare coverage (which currently may imply access to unsafe surgical practices).
The Scale of Harm in Surgery
There have been major achievements in surgery in the last 100 years, made possible through infection prevention, safe anaesthesia, modern operation theatres and minimal invasive techniques. The World Health Organization (WHO) estimates that about 234 million major surgical procedures are undertaken every year worldwide [8]. Despite improvements in surgical safety , reducing the amount of harm caused by surgery remains a challenge, as the nature of surgery changes and becomes much more complex, involving an ever-increasing number of team members in surgical preparation, conducting the procedure and providing complex follow-up care.
For example, the number of team members (surgeons, anaesthesiologists, operating room nurses) directly involved in a typical surgical procedure might be, six, but the total number of staff involved in organising, administering and delivering the clinical care process leading to, and following from, the surgery might be ten times this number [9]. Due to the complexity of the care pathway, perioperative care processes are becoming more prone to both latent and active errors. Patients may experience severe harm and even death even if the actual surgical operation is uneventful, because of latent and active errors in recognising and effectively managing a major complication following the surgery [10, 11].
The United Kingdom’s National Reporting and Learning System (NRLS) , the largest repository of patient safety incidents worldwide, gives an indication of the scope of incidents and harm: About 1.3 million incidents were reported by NHS organisations between July 2011 and June 2012 in England, although it is recognised that probably only about 25 % of incidents in hospitals are reported. The majority of incidents (875 k) caused no harm, with 7773 causing severe harm and 3263 resulting in death. The most common type of incident reported was a patient accident (25.8 %), followed by treatment/procedure (12.7 %) or medication error (12.1 %) [12].
The most detailed data on patient harm comes from retrospective care record reviews. This method traditionally consists of two stages: a nurse reviewer identifies patient records where certain preset criteria suggests patient harm, followed by a second-stage review by an experienced clinician who judges whether patient harm indeed occurred, and whether it was due to acts of omission or commission. Compared to routine data sources, the method has the advantage of being based on a rich description of the care pathway and supported by explicit standards and criteria. However, the review has also been shown to have low inter-rater reliability, particularly regarding the assessment of the causes of patient harm and its preventability.
A meta-analysis of the seminal retrospective case record reviews, which included 74,485 patients, found an adverse event rate of 9.2 %. Of these nearly half (43.5 %) were deemed preventable [13]. Surgery was the largest area where adverse events occurred (39.6 % of all cases), followed by drug-related events (15.1 %). The rates of harm measured differed substantially between individual studies, mainly because the methods and the definition of harm varied.
Selected results of seminal retrospective care record reviews are presented in Table 2.1.
Study | Harvard Medical Practice study | Quality in Australian Health Care study | Utah and Colorado Study | Vincent et al. study | Adverse events in New Zealand Public Hospitals | Canadian Adverse Event Study |
---|---|---|---|---|---|---|
Country | USA | Australia | USA | England | New Zealand | Canada |
Year | 1984 | 1992 | 1992 | 1998 | 1998 | 2000 |
Cases reviewed | 30,121 | 14,179 | 14,700 | 1014 | 6579 | 3745 |
Adverse event rate | 3.8 % | 16.6 % | 3.9 % | 10.8 % | 11.2 % | 6.8 % |
Preventable adverse events | 1.0 % | 8.5 % | 0.9 % | 5.2 % | 4.8 % | 2.8 % |
Key areas for surgical safety relate for example to site infections, anaesthesia or retention of instruments [14]. Surgical site infections account for 15 % of all nosocomial infections and in surgery represent the most common nosocomial infection (37 %) [15]. The overall risk of acquiring a surgical site infection is low (2–5 % of all surgical patients); however, considering the volume of operations the absolute number of surgical infections is significant. Patients with a surgical site infection need a longer hospital stay, have higher rates of readmission and are at high risk of substantial permanent morbidity, or mortality [16]. The retention of objects after surgery is another rare event, but where it happens it can cause major morbidity and mortality. A study at the Mayo clinic found that in one of every 5500 operations a foreign object was retained, in the majority of cases (68 %) surgical sponges. The greatest risk from retained objects is an infection, but surgical instruments can also cause perforations and granulomas [17]. Anaesthesia has become very safe in developed countries. Studies vary in suggesting that an adverse event leading to death occurs in every 10,000 to every 185,000 patients; that is, even in the worst case an anaesthesia-related death will be a very rare event. However, in developing countries anaesthesia represents a tangible risk, leading to a death in every 3000 patients (Zimbabwe) or even every 150th patient (Togo). The causes are predominantly related to airway problems or anaesthesia in the presence of hypovolaemia .
Despite the advances in surgical safety, with the increasing volume of operations and the complexity of procedures and team organisation a systematic approach towards improving perioperative safety is needed. Considering the large volume of surgical procedures and the rates of harm caused by surgery, WHO considers surgical safety as a public health crisis, particularly in low-income countries.
Solutions to Prevent Errors and Harm in the Perioperative Arena
Since the publication of the influential ‘To Err is Human’ report in the year 2000, there has been substantial increase in research on improving surgical safety. Early findings on evidence-based strategies are summarised in the AHRQ report ‘Making Health Care Safer : A Critical Analysis of Patient Safety Practices ’ [18]. However, the report also identified major gaps in knowledge , in particular the limitations in the epistemology for the study of patient safety, the relevance of context factors for the implementation and the impact of the broader health system environment. Since then a major international effort has focused on reviewing patient safety practices , supporting original research and widening the scope of implementation efforts. An update of strategies to improve patient safety was published in 2013, based on a review of strategies contained in Making Health Care Safer, Joint Commission standards, Leapfrog Group strategies [19]. The report identified 22 strategies ready for adoption, with a ‘top ten’ list of patient safety strategies that were so strongly recommended for adoption that the authors stated that ‘our expert panel believes that providers should not delay adopting these practices’. Of the top ten patient safety strategies, recommendation number 1 relates specifically to the perioperative area, namely the introduction of preoperative checklists and anaesthesia checklists to prevent operative and post-operative events (Chap. 26) (Text Box 2.1).
Text Box 2.1: Strongly Encouraged Patient Safety Practices (Modified from Shekelle et al.)
Preoperative checklists and anesthesia checklists to prevent operative and post-operative events
Bundles that include checklists to prevent central line-associated bloodstream infections
Interventions to reduce urinary catheter use, including catheter reminders, stop orders, or nurse-initiated removal protocols
Bundles that include head-of-bed elevation, sedation vacations, oral care with chlorhexidine and subglottic suctioning endotracheal tubes to prevent ventilator-associated pneumonia
Hand hygiene
The do-not-use list for hazardous abbreviations
Multicomponent interventions to reduce pressure ulcers
Barrier precautions to prevent health care-associated infections
Use of real-time ultrasonography for central-line placement
Interventions to improve prophylaxis for venous thromboembolisms
Six of the recommended patient safety strategies are very germane to the perioperative area, namely obtaining informed consent on potential risk of procedure, team training, computerised provider order entry, use of surgical outcome measurements and report cards, rapid-response systems, use of complementary methods for detecting adverse events or medical errors to monitor for patient safety problems, simulation exercises, or documentation of patient preferences for life-sustaining treatment.
This list also demonstrates that in order to improve surgical safety, a broader view of the surgical pathway is needed than encompassed by the activities and actual procedure conducted in the operating theatre. Improving safety and quality in the surgical domain requires actions that go beyond the responsibility of the surgical microsystem where the problem is observed (for example the failure to rescue after high-risk surgery) [20, 21].
The international DUQuE Consortium conducted the largest collaborative project investigating the effects and impact of quality management systems in European hospitals [22]. It formulated and tested hypotheses regarding the implementation of quality management systems, their associations with other factors known to affect quality and their effect on quality of care in various care pathways that reflect the diversity of hospital operations [23]. In addition, the consortium conducted a series of systematic reviews of the key strategies to improve quality and safety in hospitals, extracting information on their effectiveness and on contextual factors affecting their implementation [24]. Based on this body of work, seven key strategies to improve quality and safety were recommended [25] (Table 2.2).
Table 2.2
Seven key strategies to improve quality and safety in hospitals (modified from Groene, Kringos, Sunol [25])
Strategy | Evidence |
---|---|
Aligning internal organisational processes with external pressure | There is mounting evidence from close to 100 scientific studies to suggest that undergoing external assessment improves the organisation of work processes, and promotes changes and professional development |
Putting quality high on the agenda | Simply put, research suggests that hospitals in which leaders are involved in quality reach better quality-of-care outcomes. Lack of senior leadership affects patient care even where patient care in clinical units is pursued by competent and dedicated professionals |
Implementing supportive organisation-wide systems for quality improvement | Multiple quality systems operate within any hospital. These quality systems need to be well aligned to maximise impact and minimise unnecessary bureaucracy or documentation that takes time away from patient care |
Assuring responsibilities and team expertise at departmental level | High-quality care cannot be provided without well-trained and motivated professionals. A key strategy to improve the quality of care is thus the recruitment, retention and development of professionals with the right competences |
Organising care pathways based on evidence of quality and safety interventions | The majority of hospital departments still follow a traditional organising principle according to the medical specialisation. To better respond to current patient’s needs, an organisation based on care pathways should be pursued in which all clinical activities are centred on the patient’s overall journey |
Implementing pathway-oriented information systems | Hospital information systems (covering computerised clinical decision support systems in hospitals, electronic health records, computer-assisted diagnosis, reminders for preventive care or disease management or drug dosing and prescribing) have an enormous potential to improve quality and safety of healthcare. The effectiveness of computerised clinical decision support systems has been evaluated by more than 300 studies |
Conducting regular assessment and providing feedback | Audit and feedback are key quality improvement strategies, which can be applied individually or as part of multifaceted interventions. Audit and feedback have been well researched in more than 100 studies to support the assumption that professionals improve their performance when feedback demonstrates deficiencies in process or outcomes of care
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