Safety in the Surgical Environment

Fostering a Culture of Safety Through Leadership

Creating a culture of safety in the perioperative system requires leadership investment from surgeons. In the perioperative system, just as in the operating room (OR) and procedure suite, the surgeon sets the tone, but he or she cannot achieve success alone. Creating a joint governance structure in the perioperative system wherein nursing staff, advance practice nurses, anesthesiologists, and other medical consultants are fully engaged in leadership is vital to capturing the engagement and expertise of these clinicians in the patient safety effort. Health systems are recognizing this fact and trying to cement the multidisciplinary approach by creating service lines wherein all the clinician and nonclinician individuals engaged in the care of selected disease categories or patient populations are grouped into one organizational structure. For example, at Vanderbilt University Medical Center, there are major service lines organized around the care of the surgical patient, and these are jointly led by the chairs of the departments of surgery and anesthesiology and by the nursing leaders of inpatient, outpatient, and perioperative care. The leadership of the perioperative enterprise is tripartite, with the chairs of surgery and anesthesiology and the associate chief nursing officer for perioperative services as coexecutives.

These leadership teams create transparency and fair adjudication of conflicts over scarce resources such as OR time and access to hospital beds, which builds trust and reduces conflict. The tripartite leadership executive models promote behavioral modeling by example. The leaders articulate the expectation of engagement with quality initiatives such as hand hygiene by fully participating themselves and by using executive authority to encourage good performance in subordinates. They also demonstrate commitment to patient safety by investing departmental and institutional resources into the creation and operation of quality and safety organizations within their respective departments and across the service line.

At Vanderbilt University Medical Center, there is a perioperative chief quality officer who works with clinical leadership, nursing, and administration within the patient care areas to identify priorities and to identify necessary resources to support quality improvement and to address safety issues promptly. The Center for Clinical Improvement in the institution provides assistance with resources to support root cause analyses of patient deaths, adverse outcomes, and near misses. Reporting of adverse outcomes and near misses is encouraged in a “blame-free” environment, both in person and via a confidential web-based reporting tool. Within the Perioperative Enterprise, there is a Surgical Site Infection Collaborative and a Perioperative Quality and Safety Committee that collaborate with one another and that receive inputs from the various surgical services, perioperative nursing services, and infection control services. Each surgical service conducts weekly to biweekly morbidity, mortality, and improvement (MMI) conferences. Cases identified in these service-level MMI conferences that exemplify “systems” concerns or issues are referred to a multidisciplinary MMI committee that selects cases for presentation at an institution-wide MMI conference that is held on a quarterly basis. System-level quality projects identified in these various venues are “worked” by quality improvement teams until the quality problems are solved, usually as evidenced by diminution or elimination of the problem for an extended period or a number of cases.

Local Organizational Structures to Promote Perioperative Safety

When considering the local working environment, procedures, and policies in any health care organization, it is important to remember that almost every step, check, and double-check in the perioperative process, no matter how apparently redundant or pointless, was almost certainly developed as a reaction to a near miss or an event involving patient harm. Nevertheless, it is important to revisit continually and optimize patient care processes in a proactive way to engineer systems deliberately to ensure patient and personnel safety.

Effective health care organizations develop and maintain a multidisciplinary patient safety program that operates in a blame-free culture where deference to expertise is one of the norms of behavior. Input to the program includes proactive scans for opportunities to improve systems but importantly features many routes for reporting nonroutine events, near misses, and critical events for analysis and system redesigns when needed. At Vanderbilt University Medical Center, each of the major role groups has an appointed patient safety officer (PSO) operating in concert with the perioperative chief quality officer. These individuals are chosen for their discretion and effectiveness at taking in and appropriately routing information about safety problems and for their ability to shepherd such investigations and process improvements through to completion. The quality management structure created in the Department of Anesthesiology at Vanderbilt University Medical Center can serve as one illustration of an effective and equitable system ( Fig. 9.2 ). The PSO can receive reports from the confidential web-based reporting system, reports from self-disclosures as part of routine medical documentation, and in-person reports. Institutional Risk Management is also included in report review so as to integrate risk mitigation with improvement activities. The surgical departments have an almost identical quality and safety organizational structure. The surgical and anesthesiology organizational structures are closely associated, and continuous communication links surveillance and intervention activities.

The PSO serves as the primary input point and clearing house for safety considerations and can refer issues to a Quality, Morbidity, Mortality Improvement (QMMI) Committee to deal with system-of-care problems amenable to structural, procedural, and technical solutions or to a Peer Review Committee to deal with events related more to individual performance, knowledge, and decision making, or both. The departmental PSO collaborates with PSOs from other professional departments and from Perioperative Services, all under the umbrella of a multidisciplinary QMMI Committee cochaired by the surgery and anesthesiology PSOs.

Projects referred to the QMMI Committee have included refreshing protocols for cardiac implantable electronic device management, multidisciplinary development of policies and procedures for management of surgical patients receiving dual antiplatelet therapy for maintenance of drug-eluting intracoronary stents, optimization of perioperative assessment and management of the patient with sleep apnea, and adoption of postsurgical structured debriefs. These are public projects. Alternatively, most of the work of the Peer Review Committee is confidential and protected from discovery by legal statute. The Peer Review Committee comprises individual clinicians selected for their clinical acumen, probity, and discretion.

The departmental PSO maintains a confidential database of reports, analyses, projects, and dispositions of QMMI projects as well as Peer Review Committee referrals. Because of the sensitive nature of the work and the need to preserve a safe environment for reporting, the entire safety reporting and peer review process is firewalled from operational leadership (i.e., the people who make decisions about OR access, team assignments, salaries) unless there is a QMMI Committee recommendation or a Peer Review Committee recommendation for executive action. This process is illustrated in Fig. 9.2 —the departmental executive leadership charters and supports the quality and safety structures, but they are depicted out of the critical path of function of the structures they sponsor.

Increasing emphasis is now being placed on the experience of the patient and the patient’s family and their satisfaction with care, and the importance of optimizing that experience is now a priority for health care delivery systems. Physicians and providers may occasionally have suboptimal interactions with patients and families. Most of these instances represent aberrancies; however, a relatively small number of professionals exhibit patterns of behavior or performance that may affect team performance or the experience of the patient and family. ^, At our institution, to promote professionalism, when a single event or pattern of events is observed or reported, timely feedback is provided by trained physician messengers to the individual who is the subject of the report. To facilitate the documentation of events or patient concerns, an electronic record exists to support reporting. This database provides a surveillance tool that can identify events or patterns associated with providers or microenvironments within the institution. Using these data, an intervention algorithm is applied based on the type, frequency, and pattern of events or concerns. Using this accountability model, a nonjudgmental, nondirective conversation occurs between a “concerned professional” and a colleague regardless of hierarchy. When repeated nonprofessional behaviors become manifest, institutional structures exist to provide opportunities to access a variety of resources to support physician and provider wellness, inclusive of counseling support, substance abuse intervention, and psychologic/cognitive evaluation.

The identified importance of team-based interactions centered on collegiality, effective communication, and mutual respect has resulted in an evolution and extension of the above summarized patient-facing system to a parallel process for care team members known as the Co-Worker Reporting System. Using a similar infrastructure (inclusive of anonymized reporting database, faculty and staff leadership engagement and interaction, and access to institutional wellness support structures), identified suboptimal professional behaviors have been markedly affected, with three-quarters of identified providers avoiding recidivistic interactions after initial structured intervention (as summarized above). These observations are particularly important in light of data demonstrating that patients operated upon by surgeons who had higher numbers of coworker reports about unprofessional behavior in the 36 months before the patient’s operation experienced a higher risk of surgical and medical complications in the perioperative period.

This system has been associated with a substantial improvement in patient satisfaction and a significant reduction in malpractice-related costs. The patient reporting system has also been recently identified as signaling the potential for provider-centric suboptimal outcomes.

Team-based satisfaction has also been enhanced and has resulted in microenvironment team satisfaction improvements, which have had reciprocal effects on patient and family approbation of care. This system has been expanded more recently to include concerns of other members of the team about providers that may have adverse consequences for health care team interactions and care outcomes. The team-based concerns have identified numerous areas for improvement in provider behaviors and have increased within-team functionality.

Safety in the perioperative environment should also be pursued from the orientation of optimizing surgical and health outcomes, both on the individual patient level and across populations. Accelerating interest in implementing and testing scientifically founded (or at least well-reasoned) approaches to optimize preparation for and recovery from surgery, collectively known as enhanced recovery after surgery (ERAS) techniques, reflects this orientation. To the extent that complications are avoided and recuperation is accelerated and ensured, ERAS approaches improve perioperative safety.

Safety improvements whose benefits include financial ones that drop directly to the bottom line (such as length of stay reductions from effective ERAS programs) are likely to receive interest and support from all stakeholder parties. Thoughtful ERAS implementation can simultaneously reduce length of stay and complications, ^, while also favorably impacting topical considerations such as postoperative opioid consumption and postoperative nausea and vomiting. It is important to keep the focus on application of scientifically sound tactics to speed and improve the recuperation from surgery, rather than focus on surrogate endpoints such as cost or length of stay. A well-implemented, patient-centered ERAS program will produce better patient outcomes in which the economic outcomes become incidental, yet are virtually assured.

Despite more than 20 years since the formal description of ERAS pathways, there is much to be discovered and many opportunities for broader implementation. The original ERAS protocol focused on colorectal surgery, and it is unclear whether many of the tactics developed for this patient population are relevant or translatable to other surgical patient populations. The focus on length of stay is an outcome in the ERAS literature along with reflexive transfer of ERAS tactics between surgical domains without reassessment of their benefit/risk profile have led the originator to caution that ERAS interventions should be scientifically based and holistically studied, rather than focused on operational or financial outcomes. Ideally, ERAS protocols should be developed and implemented using formal quality improvement methods, including rigorous effectiveness and risk testing of new techniques or tactics transferred between patient populations. The implemented protocols should be parsimonious, including only those tactics yielding the best benefit-to-ratios, and they should be presented in easy-to-remember formats as shown in Fig. 9.3 . At our institution, ERAS protocols are periodically subjected to formal literature review to update evidence and revise the protocols, and the protocols themselves are accessible via direct link from the sidebar of the electronic health record. The Perioperative Quality Initiative ( https://.org/ , accessed May 19, 2019) is an international consortium focused on early surgical recovery and who produce readily accessible guidelines and evidence syntheses focused on ERAS and early recovery protocols, again, all subject to revision as the quality of evidence improves over time.

National and Health Care System–Level Safety Initiatives

High-performing organizations also create an efficient bureaucracy to monitor clinician quality and apply expected standards of performance fairly and consistently. Many of these structures, such as the organized medical staff, are mandated by accrediting bodies such as The Joint Commission (TJC), and they serve meaningful purposes in terms of ensuring a consistent level of quality in the medical staff. For example, the requirement for ongoing professional practice evaluation is intended to ensure that all members of the medical staff are frequently evaluated in their specialty practice by methods that are objective and applied more frequently than annually. These evaluations take many forms, ranging from document review to direct observation. Key features of a well-designed ongoing professional practice evaluation process include direct mapping to the clinician’s unique medical practice, frequent review, and objective criteria for identifying clinicians whose practice falls outside of normative expectations.

Frequent peer-to-peer assessment via survey is a middle ground between the nonspecific nature of chart reviews and the substantial effort required by direct observations. Box 9.1 demonstrates the series of nine peer-to-peer questions used in the Vanderbilt University Department of Anesthesiology (but transferable to virtually any specialty) to assess specific performance elements that map to the six Accreditation Council for Graduate Medical Education general competencies. There are also summative, general questions. In the Vanderbilt Department of Anesthesiology, these questions are automatically assigned (by a program that runs alongside and is accessible from within the electronic medical record [EMR]) to clinician pairs who have worked together recently. Confidential responses are collected by the same software, and the data are presented to designated individuals (the Peer Review Committee Chair in our case). The Vanderbilt University Medical Center system handles all of the transactions automatically and electronically, but other practices operate such systems using e-mail, for example.

Clinicians who are new members of the medical staff, clinicians who request new or expanded privileges, and clinicians identified as differing from normative expectations all are subject to a focused professional practice evaluation. TJC allows the medical staff organization substantial latitude in the construction of a focused professional practice evaluation; however, in most instances, a focused professional practice evaluation involves some form of direct proctoring in the identified area of medical practice. In addition to a robust and efficient bureaucracy focused on normative expectations of practice, high-performing organizations establish quality and safety improvement teams (see earlier) that operate autonomously but with the support of the departmental or practice hierarchies.

Major government and third-party payers are becoming increasingly interested in quality and safety in health care, and much attention at the present time focuses on high criticality environments such as perioperative and periprocedural systems. Payers now regularly collect process outcomes (e.g., timely preoperative antibiotic administration) and health outcomes (e.g., surgical site infection) and report them publicly ( http://www.medicare.gov/hospitalcompare ). Accrediting bodies, specialty boards, and government payers all are applying pressure to clinicians to focus on quality and safety in their practices ( Table 9.2 ).

Perioperative team building has parallels in the aviation industry in that teams intermittently come together for relatively short, defined periods of time to accomplish a complex task requiring the specialized skills of each team member under potentially stressful conditions in which there is inherent danger. Haynes and colleagues demonstrated the impact of implementing a standardized surgical safety checklist on patient outcomes. In a study of more than 3700 surgical patients from eight major hospitals in eight cities worldwide, they found that implementing the checklist reduced complication rates from 11% to 7% and reduced postoperative death rate from 1.5% to 0.8%.

Shortly after the landmark study by Haynes and colleagues, de Vries and coworkers reported that the implementation of a comprehensive, multidisciplinary surgical safety checklist that included medications, marking of the operative site, and postoperative management plans in six hospitals in the Netherlands resulted in a significant decrease in complication rates and in-hospital mortality. These results were compared with data from a control group of five hospitals. When compared with a 3-month baseline period, the rates of total complications in surgical patients were reduced from 27.3 per 100 to 16.7 per 100. The proportion of patients with one or more complications decreased from 15.4% to 10.6%, and the inpatient mortality rate decreased from 1.5% to 0.8% in the surgical population among the study group of hospitals. Control hospitals did not experience a change in these outcomes over the same time intervals.

Neily and associates demonstrated that implementation of a medical team training program with intraoperative briefings and debriefings in 74 Department of Veterans Affairs hospitals resulted in 18% improvement in annual risk-adjusted surgical mortality compared with a 7% decrease in mortality among 34 facilities that had not received such training. The mortality rates did not begin to show improvement until the second quarter after such training was completed and improved more through the third quarter. Other improvements reported during structured interviews of participants in the team training included improved communication among OR staff, increased staff awareness, improved overall efficiency, and improved overall teamwork.

In contrast to the aforementioned positive observational studies, Urbach and colleagues reported the results of a group of 101 surgical hospitals in Ontario, Canada, using administrative health data to compare operative mortality, rates of surgical complications, and other 30-day postdischarge outcomes before and after adoption of a surgical safety checklist. In assessment of the 3 months before and after adoption of the surgical safety checklist including more than 100,000 procedures for each time interval, they observed that adjusted risk of death within 30 days of an operation was 0.71% before implementation and 0.65% after implementation of the checklist, a nonstatistically significant difference. Also, there was no significant difference in the adjusted risk of surgical complications in comparing the time periods before and after implementation. On the surface, this study did not support the efficacy of surgical safety checklists, but the study has several important limitations, including the short study intervals of only 3 months, resulting in inadequate levels of adoption of the checklists and inadequate assessment of the compliance and quality of the practice of the checklists. Also, the study included a skewed and likely low-acuity patient population of 60.8% ambulatory cases with 20% of all cases being eye cases and 28.7% being musculoskeletal cases. This low acuity is likely to have contributed to the low rates of complications and deaths observed in both periods in this study.

A different but important focus for checklist deployment is the prevention of rare, devastating events. Nearly half of surgical “never” events resulting in indemnity payments in the United States result from “wrong surgeries”—a concept encompassing a wrong procedure, wrong site, or surgery on the wrong person. Wrong surgery often results in patient death and is devastating to the care team. Estimates of wrong surgery incidence range from 1:112,994 to 1:5000 and may be increasing. Checklist application ^, has reduced the frequency of complications resulting in injury and death. TJC has made the implementation of the Universal Protocol for the prevention of wrong-site, wrong-patient, and wrong-procedure surgery, including the preprocedural time-out, an accreditation requirement. The Universal Protocol includes the following elements: preprocedural verification, site marking, and final verification during the preprocedural time-out. Preprocedural verification includes verification of the appropriate history and physical examination in the medical record, the presence of a signed consent form, nursing assessment, and preanesthesia assessment (when applicable). At Vanderbilt University Medical Center, a nonemergency patient cannot be transported to the OR without completing these components of the preprocedural verification. This preprocedural verification continues in the OR, including verification that the necessary diagnostic laboratory, radiology, and other test results are present and properly displayed. The requirement for and presence of blood products, implants, devices, or special equipment is also confirmed in the preprocedural verification process.

The time-out that occurs immediately before initiation of the procedure provides a final verification of the correct patient, correct site, and correct procedure. The time-out is most effective when it is standardized and conducted consistently in all procedural areas of the hospital; it should be conducted immediately before starting an invasive procedure or making the incision. It is initiated by a designated member of the procedural team and involves the immediate members of the procedure team. During the time-out, other activities are suspended so that team members may focus on active confirmation of the patient, site, and procedure. Any new team members should be introduced. At a minimum, the team members must agree on the correct patient identity, correct procedural site (with the site marking verified when laterality or level is a concern), and correct procedure to be done. Finally, completion of the time-out should be documented for the patient medical record.

This description of the surgical time-out defines the minimal criteria to satisfy TJC requirements; however, if these are the only elements included in the process, the positive impact is limited. The Crew Resource Management training and discipline of the Universal Protocol enables organizations to enhance communication between health care professionals in the perioperative management teams and to incorporate process improvement measures, such as those defined by the Surgical Care Improvement Project, into the checklists. These evidence-based interventions include timely administration of perioperative antibiotics and administration of beta blockers in patients at risk of ischemic heart disease, venous thromboembolism prophylaxis, and intraoperative normothermia. The time-out checklist may also include availability and sterility of instrumentation and implantable devices. The conclusion of the optimal surgical time-out should include an open invitation for any member of the team to speak up at any time during the procedure if they recognize a problem that poses risk to the patient or health care team. Box 9.2 summarizes elements of surgical safety checklists.