Safety does not reside in a person, device or department, but emerges from the interactions of components of a system

(Institute of Medicine, 1999 To Err is Human: Building a Safer Health System) [1]

Systems engineering is a comprehensive approach to analyze, design, and manage complex systems. It incorporates a broad range of methods and tools to integrate and coordinate personnel, information, materials, and financial resources [4, 26]. The origins of systems engineering date back to quality improvement initiatives at Bell Laboratories during the 1930s and 1940s and the work of Walter Shewhart and W. Edwards Deming. Shewhart is regarded as the father of statistical process control and developed the first statistical process control (SPC) chart . W. Edwards Deming promoted Shewhart’s work and was later known for the Deming Plan-Do-Study-Act (PDSA) Cycle . During the post-World War II period systems engineering methodologies became widely adopted in industries outside of health care, where it has been used to successfully improve quality, efficiency, safety, and customer satisfaction [27, 28]. Only recently have systems engineering tools and models for quality improvement been applied to health care. Commonly used management models include Total Quality Improvement , Lean, and Six Sigma. Where Lean identifies and eliminates waste (non-value added processes), Six Sigma identifies and eliminates sources of variability. Frequently used tools adopted from systems engineering include statistical process controls, queuing theory, root cause analysis (RCA ) , failure-mode effects analysis (FMEA ) , and human-factors engineering [4, 10] (Fig. 53.3).

The application of systems engineering tools to improve health care has been advocated by several organizations. In 2005, collaboration between the National Academy of Engineering (NAE) and the Institute of Medicine promoted a framework for a systems approach in their landmark publication, Building a Better Delivery System: A New Engineering/Health Care Partnership [26]. This was later followed in 2009 by a report from the Agency for Healthcare Research and Quality (AHRQ ) entitled Industrial and Systems Engineering and Health Care: Critical Areas of Research, and in 2014 by a report to the President of the USA from the Council of Advisors on Science and Technology entitled Better health Care and Lower Costs: Accelerating Improvement through Systems Engineering [4, 11]. The report to the President called for systems-engineering know how to be propagated throughout all levels of health care delivery and recommended that the USA build a health care workforce equipped with systems engineering competencies to enable system redesign. Despite these efforts and data suggesting that systems engineering techniques have been associated with significant improvements in health care quality and efficiency , these tools remain underutilized. Their adoption has been hindered by multiple barriers, including inadequate access to relevant data and analytics, health professionals not trained to think analytically about the delivery of health care, and industrial and systems engineers without sufficient knowledge of the health care industry. Most significant is a fee-for-service payment system. A fee-for-service system rewards the performance of procedures and not quality. It favors volume over value and does not provide an incentive for efficient or coordinated care [29].

In recognition of the shortcomings of a fee-for-service payment system, the Patient Protection and Affordable Care Act, commonly known as the Affordable Care Act (ACA ) was passed in 2010. The ACA called for the creation of a pilot program to improve the coordination, quality, and efficiency of services by restructuring Medicare reimbursements from a fee-for-service model to bundled payments. Under a bundled-payment system hospitals and providers will no longer be reimbursed for individual services (pay for volume). Instead, a single payment is divided among hospitals and care providers for each episode of care (pay for value). An episode of care is based on a specific condition and typically includes the initial inpatient stay plus the post-acute care and all related services up to 90 days after hospital discharge. The Medicare Bundled Payments for Care Improvement (BPCI) pilot program began in 2013 [30], and it is anticipated that 50 % of Medicare payments will be tied to alternative payment models by the end of 2018. Alternative payment models include Accountable Care Organizations (ACOs ) or bundled payment arrangements.

The implementation of new payment models that focus on episodic care is just beginning to drive hospitals and providers to develop a more coordinated care model . Increasingly, health care organizations are incentivized to focus on value by providing higher quality care at lower cost. Health systems will need to deliver care more efficiently and effectively through the evidence-based and standardized processes. Costly complications, such as length of stay and readmissions, will need to be avoided in order for health care organizations to maintain their financial viability. In surgery, this has led to the development of models for perioperative care such as Enhanced Recovery After Surgery (ERAS ^® ) protocols and the Perioperative Surgical Home (PSH ) [31–33]. ERAS is an evidence-based care protocol with recommendations for patient care throughout the perioperative care pathway. Approximately 20 elements have been shown to influence outcomes such as length of stay, morbidity, and complication rates. Key components include:

The Perioperative Surgical Home represents a fully integrated perioperative care model . It applies a patient-centered approach and promotes standardization, coordination, transition, and value of care throughout the perioperative period (preoperative, intraoperative, immediately postoperative, and post-hospital discharge) [34]. While the PSH incorporates certain components of ERAS, it is a broader concept that uses systems engineering methods and management strategies (Lean and Six Sigma) to optimize care [32]. Although the PSH remains in its operational nascence, there is little doubt there will be multiple future iterations of this concept. At this time published outcomes are sparse and data-based documenting and reporting of institutional experiences will be critical in shaping future efforts (Fig. 53.4).

A culture of safety is an essential part of preventing or reducing errors and improving quality. As defined by The Joint Commission, a culture of safety within health care represents “the summary of knowledge, attitudes, behaviors and beliefs that staff share about the primary importance of the well-being and care of the patients they serve, supported by systems and structures that reinforce the focus on patient safety” [35]. Four key features of a safety culture provided by the AHRQ Patient Safety Network include:

Trust, reporting, and improvement are three mutually reinforcing imperatives for achieving and maintaining a culture of safety [20]. Trust among staff can only be achieved within a blame-free environment where behaviors that prohibit error reporting have been removed [37]. Staff will then be empowered to report risks, errors, and near misses in order to learn and drive improvement. Ideally, within a culture of safety early reporting identifies problems before serious harm has occurred. Unfortunately, this has not been the case in health care. In health care unsafe conditions and adverse events are typically not reported until after harm has occurred. A recent study [38] identified five key challenges for why incident reporting in health care has not reached its full potential:

Although a great deal of attention has been focused on the technical aspects of incident reporting in health care such as data collection, online reporting systems, and analytic tools, future efforts need to focus on engaging frontline workers in the process. Physicians, in particular, must feel safe reporting errors and should be encouraged to be as proactive in reporting risks and near misses as they are for sentinel events [40]. Reports must be handled in a transparent process and appropriate feedback provided to the reporters and relevant people within the organization [41]. Additional strategies to improve the culture of safety outside of the operating room include executive walk rounds and unit-based safety teams. During executive walk rounds senior leaders can informally discuss safety issues and demonstrate the organization’s commitment to building a culture of safety. Unit-based safety teams frontline staff, physicians, managers, and senior leaders affiliated with one unit to provide sustained engagement and consistent follow through in driving quality and safety [42, 43].

Operating rooms are complex systems, and communication and teamwork are essential to establish and maintain a reliable culture of safety [44]. Patients are cared for by multiple providers in different locations, the procedures are invasive and often technologically complex, and the patients are sedated or anesthetized so they cannot participate in the procedure. As a result, nearly 50 % of hospital errors occur in the OR, and failures in communication represent the most common cause for these errors [45]. Recent studies of OR clinicians and staff suggest that communication and teamwork in the OR are suboptimal [46]. This is based on perceptions of teamwork that vary widely among members of the OR teams. Surgeons believe their style of leadership is collaborative and respectful, and that teamwork in the operating room is good [47]. This is in contrast to other members of the OR team who perceive the surgeon’s style of leadership as autocratic, and view the communication and teamwork in the OR less favorably [48, 49]. The largest discrepancy among members of the OR team was the establishment of a shared understanding of the procedure. For complex operations, a shared understanding by all participating team members is essential for optimal team performance, patient safety, and outcomes [50].