• Patient care that is compassionate, appropriate, and effective
• Medical knowledge of biomedical, epidemiologic, and socio-behavioral sciences as applied to patient care
• Practice-based learning and improvement that involves investigation and evaluation of their own patient care, appraisal and assimilation of scientific evidence, and improvements in patient care
• Interpersonal and communications skills that result in effective information exchange and collaboration with patients, their families, and other health professionals
• Professionalism as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to a diverse population
• Systems-based practice as manifested by actions that demonstrate an awareness of and response to the larger context and system of health care and effectively call on system resources to provide optimal care
Largely in response to concerns for patient safety , the ACGME implemented duty hour restrictions in all programs in 2003. These generally limited resident duty hours to 80 per week (although minor exceptions for sound education purposes could be granted to individual programs) [9]. In addition, the standards called for residents to be provided 1 day in seven free from all educational responsibilities, in-house call no more frequently than every third night, continuous duty not to exceed 24 h, plus 6 additional h, “to participate in didactic activities, maintain continuity of medical and surgical care, transfer care of patients, or conduct outpatient continuity clinics.” Importantly, the 2003 standards also clearly stated that, “All patient care must be supervised by qualified faculty. The program director must ensure, direct, and document adequate supervision of residents at all times” [10].
The next major revision of the ACGME Requirements occurred in 2007 [11]. That change further refined some of the requirements regarding patient safety and introduced the term “quality improvement ” into ACGME requirements. They stated that residents are expected to, “systematically analyze practice using quality improvement methods , and introduce changes with the goal of practice improvement ,” “work effectively as a member or leader of a health care team or other professional group,” be accountable “to patients, society and the profession,” “coordinate patient care within the health care system relevant to their clinical specialty, advocate for quality patient care and optimal patient care systems, work in interprofessional teams to enhance patient safety and improve patient care quality and participate in identifying system errors and implementing potential systems solutions.”
In 2009, the ACGME convened a “Duty Hours Task Force ” to reexamine ACGME resident duty hour requirements [12], partly in response to the 2009 Institute of Medicine report on resident duty hours [13]. Based on Task Force recommendations, the ACGME added several requirements regarding resident duty hours to those in place since 2003. Notably, PGY-1 residents were limited to 16 h of continuous duty and a minimum of 8 h between scheduled on-duty periods. Other residents were limited to 24 continuous h plus 4 h for transitions in care. Intermediate-level residents were given a minimum of 8 h between scheduled duty periods and at least 14 h free of duty after 24 h of in-house duty. Residents in the final years of education were allowed somewhat more flexibility within the context of the 80-h per week limit. Strategic napping was encouraged. Finally, the 2011 requirements mandated that all moonlighting be counted toward the maximum weekly hour limit of 80 [14].
What began as a Duty Hours Task Force expanded its mission to encompass quality care and professionalism. Their recommendations in these areas are also reflected in the 2011 Requirements [14]. An entire section was added titled, “Professionalism, Personal Responsibility, and Patient Safety,” which emphasized the need for physicians to appear for duty appropriately rested, the need of the [residency] program to be both committed to and responsible for promoting patient safety and the active participation of residents in interdisciplinary clinical quality improvement and patient safety programs. The program director and the institution were charged with ensuring a culture of professionalism that supports patient safety and personal responsibility. This requires the residents and the faculty members to demonstrate an understanding and acceptance of their roles in assuring patient safety, provision of patient-centered care, and their fitness for duty. It requires their management of their time during, but equally importantly, before and after clinical assignments, recognition of impairment from any cause in themselves and their colleagues and monitoring of their patient care performance improvement indicators. It also emphasizes the need for residents and faculty members to demonstrate responsiveness to patient needs that supersedes self-interest.
A new section on “Transitions of Care ” was also added. It emphasized the need to minimize the number of transitions, resident competency in the handover process and the need for programs and institutions to ensure and monitor hand-over process that facilitate both continuity of care and patient safety [15]. A third section was added titled, “Alertness Management/Fatigue Mitigation .” It underscored the importance of educating faculty members and residents regarding signs of fatigue and sleep deprivation, alertness management and fatigue mitigation strategies. It also required programs to have processes to ensure continuity of patient care in the event that a resident was unable to perform his/her duties. Prior to 2011, the ACGME Requirements said only that the [training] program must ensure that qualified faculty provide appropriate supervision of residents in patient care activities [11]. The 2011 Requirements “Supervision of Residents” contains nearly two pages of specific requirements . Among other things, these requirements address the need for the patient to be informed of the role of the resident, codify the levels of supervision that residents should have based on their abilities, and call for programs to set guidelines regarding circumstances under which the attending physician must be informed of a patient’s condition [16]. They also set specific limits on the degree of autonomy granted to PGY-1 residents.
Patient Safety and Quality for Institutions Seeking to Sponsor ACGME-Accredited GME (Institutional Requirements)
Beyond the Common Program Requirements, the recommendations of the 2009 ACGME Duty Hours Task Force were also manifested in the ACGME Institutional Requirements and in the ACGME Policies and Procedures. Notable additions to the Institutional Requirements included requirements that the Sponsoring Institution and its ACGME-accredited programs to assign residents only to sites that facilitate patient safety and health care quality; that residents have access to systems for reporting errors, adverse events, unsafe conditions and near misses in a protected manner; and that residents have opportunities to contribute to root cause analysis or other risk-reduction processes [17]. Quality improvement was also emphasized by requiring that residents have access to data to improve systems of care, reduce health care disparities and improve patient outcomes and opportunities to participate in quality improvement initiatives [18]. Also added were requirements that Sponsoring Institutions must facilitate professional development for faculty members and residents regarding effective transitions of care and ensure that residents utilize standardized transitions of care consistent with the setting and type of care. The revised Institutional Requirements also required the addition of a quality improvement/safety officer to the Graduate Medical Education Committee which oversees the quality of the GME learning and working environment [14]. Like the ACGME Institutional Requirements, the first major revision to the ACGME Policies and Procedures following the report of the Task Force became effective 1 July 2013. That document provided the policy structure for the Clinical Learning Environment Review (CLER) [19] (Fig. 47.1).
Fig. 47.1
Quality improvement CLER findings
The Clinical Learning Environment (CLE)
The previous section highlighted the evolution that ACGME has taken to increasingly address the issues of patient safety and quality improvement through its regulatory function, specifically its accreditation process for sponsoring institutions and residency and fellowship programs. As noted at the beginning of this chapter, the ACMGE has recently added a new program, CLER, to further address the issues of patient safety and health care quality in the graduate medical education community.
The program was an additional outcome of the 2009 ACGME-convened “Duty Hours Task Force” to reexamine ACGME resident duty hour requirements [10]. This new program has a direct link to the accreditation process ; specifically that each ACGME-accredited sponsoring institution must complete a CLER site visit every 18–24 months. Failure to meet that single requirement places the sponsoring institution and all of its residency and fellowship programs at risk for an adverse accreditation decision, including withdrawal of ACGME accreditation. It is important to note that as a formative learning activity each CLER visit concludes with a summary report of findings specific to that CLE and not a summative judgment that influences accreditation decisions. The findings are confidential, shared only with the leadership of the sponsoring institution and the CLE that was visited. In designing the CLER program, the assessment assumes that the basic issues at that sponsoring institution and its training programs are compliant with ACGME standards. ACGME standards set the basis for patient safety and quality improvement, whereas the CLER program seeks to drive continual learning and systems improvement.
A full description of the CLER program is beyond the scope of this chapter and can be found elsewhere [20]. In short, each CLER visit consists of 2–3 days that include structured group interviews with CLE and GME leadership, quality and patient safety leadership, residents and fellows, faculty members, and program directors. Also a series of walking rounds through the clinical areas that are managed by the site visitors in an effort to have a series of interviews with other, non-physician, members of the clinical teams. Each visit ends with an exit interview where a summary of the findings is presented and that is followed up in approximately 8 weeks with a written summary of the visit.
Currently the CLER program does not have a set of published guidance or recommendations on the clinical learning environment specifically designed for the surgical community . It is first worth considering why ACGME establishes a program that examines the clinical learning environment.
Why Is the CLE Important in the Training of Residents and Fellows ?
The clinical learning environment (CLE) represents the structural space in which knowledge and skills are transferred by experiential learning in the course of patient care. The CLE also represents the community of colleagues in which learners are exposed to attitudes and behaviors related to teamwork [21], communication, and professional interactions. Two recent studies underscore the importance of the clinical learning environments and their impact on the resident experience and life-long patterns of care. A study by Asch and colleagues assessing obstetrics residency programs and their graduates demonstrated that women treated by obstetricians trained in residency programs in the bottom quintile for risk-standardized major maternal complication rates had an adjusted complication rate approximately one-third higher than that for women treated by obstetricians from programs in the top quintile [22]. Similarly a study by Chen, et al, compared the regions of residency training and found that the way trainees were trained correlated with subsequent expenditures for care provided by practicing physician spending patterns associated with Medicare expenditures [23].
Why the Current Need for Attention to the Clinical Learning Environment for Surgeons in Training?
The Surgical Health Care Environment
The rapidly evolving needs of the US health care system, the current skills of surgical faculty, and expectations of surgical residents all are important reasons to examine the clinical learning environment. The health care environment is undergoing significant evolution, and factors outside of the surgical CLE are presenting surgeons and surgical training with new challenges. Clinicians face the need to manage a rapidly changing body of knowledge and dramatically changing technologies as well as integration of the electronic health record in daily practice. There are also changing technologies for learning, such as increased use of simulation for training and assessment and just-in-time audiovisual learning (e.g., watching a video on a new or unfamiliar procedure is replacing the former practice of reading about the procedure in a textbook).
The health care environment calls for clinicians to have leadership skills that include team dynamics management to a greater extent than ever before [24]. Clinicians are also increasingly expected to focus on clinical efficiency and Lean [25] production methods, which at times may seem to physicians to be in conflict with time for patients and for teaching. There is a heightened emphasis on clinical accountability and transparency. Expectations for public reporting of patient care quality and outcomes continues to grow and is increasingly accompanied by changes in the reimbursement model to one based on value—i.e., quality and safety metrics—that are attributed to the surgeon of record and the health care system in which surgical care was delivered [26].
Surgical Faculty: Teaching Clinicians, Clinical Educators
Historically, surgical training has focused on the quality of care of individual patients; and very few faculty were formally trained in population-based care management and health systems design and performance [27]. While working hard to maintain proficiency or expertise in the knowledge and skills of their own surgical specialty, surgeon educators are also challenged to have or gain mastery in systems thinking and design, by which to improve patient flow, information flow, and surgical team productivity [28]. Additionally, there is a need to manage team dynamics effectively. For example, new team management techniques, such as crew resource management [29], were not likely part of the training of most of the surgical faculty. High functioning teams require a change from the traditional hierarchical model of surgeon as leader to a flatter, more horizontal culture of teamwork [30], with deference to expertise and an environment that encourages all on the team to speak up and contribute fully to the team’s approach to patient safety and quality [31].
Surgical Learners
The young surgeon learners are also different—inquisitive, yet very oriented toward instant communication, and with greater expectations for attention to their learning, as well as to work–life balance and wellness [32, 33]. Young surgical learners are also coming into surgical training as natives to computers and gaming skills. In the advancing implementation of the electronic health record, it is frequently seen that the students and trainees are quick to identify the issues with functionality and connectivity across health care settings, and they are also quick to contribute to problem-solving and improving design [34]. Their comfort with gaming skills puts them at a significant advantage for rapid adaptability to new technologies in health care—such as minimally invasive, robotic, and catheter-based procedures—and often with faster and more adept acquisition of skills than those who are responsible for training them.
Challenges and Barriers for Surgeons
It is relatively easy and straightforward for clinicians to be strongly in favor of patient safety, high quality health care, and professionalism. However simply identifying these and other focus areas in the clinical environment, then implementing policies, staff roles, and didactic curriculum does not guarantee a quality CLE [35]. There are numerous challenges and barriers to improving the clinical learning environment [36], a few of which are noted here.
One challenge for surgeon faculty in their assessment of the CLE is to separate themselves and their reputation from the way surgeons have traditionally viewed their own educational processes. Surgical faculty may consider that their many years of hard work and lost sleep invested in education and training is the principal link to the quality of work that each delivers on behalf of his or her patients. Thus, any critique of this model for training surgeons cannot help but be taken personally and interpreted as an attack on the individuals themselves. Rites of passage and longstanding traditions that view the ability to power irrespective of patient complexities, competing obligations, and extreme exhaustion are deserving of reexamination in light of increasing literature in the fields of quality improvement and patient safety.
Another challenge or barrier to improved surgical training has been the often times absent or inconsistent availability of relevant measures with meaningful definitions of quality of surgical care for both processes and outcomes. If surgeons do not find the measures relevant to delivery of quality care or the definitions reflecting meaningful activity of the surgical team, then it is difficult to engage surgeons in contributing to improving the metrics [37]. If the data sources are not perceived by the practicing surgeon as valid and reliable, then the data that are provided will not be trusted, much less acted upon, except under mandate or duress.
The use of data for improvement has advanced with use of data registries such as the National Surgical Quality Improvement Project (NSQIP) [38], or data shared among members of the University Health System Consortium [39]. Trauma registries and tumor registries have added data and information for improving practice. There are some surgical specialty societies (such as the Society of Thoracic Surgeons) that have demonstrated the value in use of such national databases to improve patient care outcomes at the local, regional and national levels [40, 41].
Surgeons who regularly review data on their patient care processes and their patients’ clinical outcomes and demonstrate use of data to better understand the patient population served and to improve their processes of care, model important attitudes and behaviors that residents and fellows will begin to incorporate into their practice. This is particularly true of efforts to reduce health care disparities —i.e., if the efforts to provide access to care regardless of ability to pay or other population characteristics are not analyzed for the impact on outcomes, then the surgeon and his/her team are working hard, but not learning how to make a meaningful impact on the health of the population served [42–44].
Focus Areas and Key Questions
The ACGME Board of Directors recognized in developing the CLER program, the necessity of signaling the need for improvement that would lead to higher quality and reliability of care . For this new effort they chose to employ a formative learning effort rather than a summative, regulatory assessment built on requirements. In establishing what would become the CLER program, the Board identified six areas within the CLE that at the time they thought were of highest priority to assess. These focus areas included: patient safety, health care quality and quality improvement, transitions of care, supervision, fatigue management and mitigation, and professionalism. Within health care quality and quality improvement, there is an opportunity to consider vulnerable populations and the risk for and improvement of health care disparities [45]. These focus areas are not unique to surgical specialties, but within the surgical learning environment, there are specific and/or special characteristics and functions to be called out for practical application. Also, these six areas may evolve overtime as the ACGME Board of Directors identifies new priorities within CLEs to target for improvement.
The CLER program has been built on a framework of both the six focus areas as well as five key questions related to each clinical learning environment for GME, as shown in Fig. 47.2.
Fig. 47.2
Central questions for the CLER evaluation . Modified from the AGME CLER executive summary, 6/10/2012
These focus areas and questions help assess the CLE to provide formative feedback to teaching medical centers and hospitals across the USA, as they consider how their strategies and priorities translate to patient care at the bedside. This approach may help the GME community begin to learn and apply what innovative surgeon educators and health care organizations are doing to integrate the surgical learners and faculty into the system approach to patient safety and health care quality and quality improvement. As patterns and practices are identified to improve both patient care outcomes and GME outcomes, such assessments will begin to influence and inform the accreditation standards for GME institutions and their clinical sites.
Early CLER Findings
The first cycle of ACGME clinical learning environment review (CLER) site visits in 2012–2015 visited the primary clinical participating site for each of 297 sponsoring institutions that sponsored three or more core programs . These CLER visits included group interviews with 111,482 resident and fellow physician representatives, of which 21.8 % were in surgical specialty programs, 57.4 % in medical specialty programs, and 20.8 % in hospital-based specialty programs. These visits also included interviews with hundreds of CEOs, executive leadership teams from the hospitals and medical centers, as well as hundreds of other clinical staff, primarily nursing. A full report of the findings from this first cycle of visits can be found elsewhere [46]. The next section explores some of the findings in light of how surgical residents and fellows experience their CLE as compared with those residents and fellows in medical specialties or other hospital-based specialties .
When asked if they, as residents or fellows, experienced a patient safety event in the past year while training at the hospital or medical center ; 71 % of surgical learners reported such an experience, compared to 68 % of medical learners and 64 % of hospital-based learners (p < 0.0001). Forty-six percent of the surgical residents and fellows reported that they reported an adverse event through their hospital or medical centers patient safety system. This was less frequent than medical specialty learners with 51 % (p < 0.0001).
Patient safety is enhanced when providers and systems learn from near misses, rather than focusing only on the post hoc learning when the patient has already suffered harmed and in morbidity and mortality conferences [47]. Of the physician learners interviewed, surgical residents and fellows who had reported a near miss event was 19 %, compared to 22 % for medical specialty learners and 17 % for hospital-based specialties (p < 0.0001).
Beyond the reporting of patient safety events to help the system learn and improve, the percentage of PGY3 and above resident and fellow physicians who reported participating in a hospital- or medical center-led patient safety investigation, such as a formal root cause analysis, varies by specialty group, with surgical learners reporting greater participation—45, 40, and 37 % for surgical, medical, and hospital-based specialty learners, respectively (p < 0.0001). In discussions, these activities were primarily through departmental morbidity and mortality conferences with infrequent interprofessional participation and variable system-based problem solving [18].
Surgical learners report lower participation in a quality improvement (QI) project, either of their own design or one designed by their program or department—66 % as compared with 81 % and 73 %, for surgical, medical, and hospital-based specialty learners, respectively (p < 0.0001). A higher percentage (59 %) of surgical learners, versus 52 % of medical learners and 45 % of hospital-based learners, believed their project linked to one or more of the clinical site’s QI goals (p < 0.0001).
Ninety percent of medical and surgical specialty group learners reported following a standardized process for handling transitions of care during handoffs between shifts, compared with 80 % of hospital-based specialty learners (p < 0.0001). Of those who reported following a standardized process, 84 % of medical learners, 76 % of surgical learners, and 63 % of hospital-based learners reported using a standardized written template for communication during change-of-shift handoffs (p < 0.0001). Of note, the use of a standardized handoff process at change-of-shift was not currently maintained by surgical residents as they progressed through training: 92.7 % for PGY2s, 91.7 % of PGY3s, and 87.5 % for those PGY4 and above (p < 0.01).
Twenty percent of surgical learners reported that they had been placed in a situation or witnessed one of their peers placed in situations where they believed there was inadequate supervision (e.g., the attending physician was not available). Thirty-four percent of surgical resident and fellow physicians reported that they would power through to handoff, rather than notify someone and be taken off duty, if placed in a situation in which they are maximally fatigued and impaired in spite of caffeine and a nap.
Forty-two percent of the surgical specialty learners reported having documented a history or physical finding in a patient chart that they did not personally elicit—e.g., copying and pasting from another note without attribution—compared to 40 % of medical learners and 39 % of hospital-based learners (p = NS). Though not found to show a statistically significant difference between surgical specialty learners and the other specialty groups, 16 % of the surgical resident and fellow physicians reported to have been pressured to compromise their honesty or integrity to satisfy an authority figure during training at the clinical site.
Practical Approach to the Surgical CLE Focus Areas
In 2014, the CLER evaluation committee, which provides oversight for the CLER program development and then published the CLER Pathways to Excellence: a set of expectations for an optimal clinical learning environment [48]. The document was based primarily on the observations from the approximately first hundred CLER site visits, along with the clinical experts on the evaluation committee and what little published information existed on CLEs in the literature. That document describes in each of the six focus areas a series of paths by which a clinical learning environment might seek self-improvement based on the findings from the CLER visit.
This next section of the chapter provides some informal, select thoughts of the authors on where improvement strategies might be gain perched in clinical learning environments for the surgical community.
Patient Safety
Physician leaders, along with practice and organization leaders, serve as role models by the way in which they recognize patient safety events (adverse events, near misses, unsafe conditions), and use the reporting systems of the hospitals and medical centers that serve as a their CLE.
The full range of reportable events includes near misses, events without harm, unsafe conditions, unexpected deteriorations, delays in diagnosis and care, and procedural complications, as well as events with harm [49, 50]. Common understanding among all members of the team and organization about what constitutes a reportable event provides an important context for situational awareness while delivering patient care and for system improvements. Patient event reporting should drive the follow-up system for event investigation and identification of cause, with focus on reporting events and processes, rather than reporting as a means of retaliation or assigning blame to people. The patient safety reporting system will be most likely used if it is perceived as adding value to patient care. If a hospital or medical center’s leadership is not aware if its physicians are reporting patient safety events, there is the risk of having a significant component of the health care workforce not seeing the reporting of patient safety concerns as a valuable contribution to system improvement.
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