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16 Peer Review ofPerioperative Adverse Events
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emphasized and highlighted. An example that may be considered unpreventable is the
death of an elderly trauma patient arriving hypotensive and unconscious to the hospital, who eventually succumbs to the severity of her injury despite best efforts by the
team. While discussions happen surrounding the perioperative management of this
patient to ensure it was consistently appropriate, most surgeons would classify it as
unpreventable. On the other hand, there are a vast range of complications that would
be considered “preventable.” Technical complications are often labeled as such.
Another example would be a patient who was not started on deep vein thrombosis
(DVT) prophylaxis after an elective operation, and then subsequently developed a
DVT.This would be considered preventable and would likely be subject to considerably more scrutiny and criticism as to the decision of not initiating prophylaxis.
Traditionally, the benet of discussing these cases was to help all faculty surgeons
and trainees to avoid making the same mistakes, when appropriate. The extent to
which systemic change or broader policy is implemented as a result of M & M can
vary and is generally more limited. One of the criticisms of the M & M conference is
that the lens of adjudication is often narrow, where the discussion focuses on diagnosis, surgical technique, and perioperative management. Bosk describes it best in his
book: “When the patient of an internist dies, the natural question his colleagues ask is,
‘What happened?’ When the patient of a surgeon dies, his colleagues ask, ‘What did
you do?’.” [4] We know, however, there are many other systems factors that can contribute to perioperative adverse events. Potential solutions are often discussed under
the lens of changing decision-making, with the classic question, “What would you
have done differently?” While considering personal responsibility for patient outcomes is imperative, patients exist in a sociodemographic context and hospital system, which should be considered when discussing adverse events and interventions.
Consider the hypothetical example of a young, female, Spanish-speaking patient
who undergoes elective, open ventral hernia repair, with extensive lysis of adhesions, and mesh placement. An abdominal binder is placed. The evening of the
operation she spikes a fever. The intern on overnight is covering multiple patients
and does not see the patient, but reassures the nurse that fevers are very common the
night of surgery. The patient also tells the nurse that she saw some green staining on
the binder. The team does not use an interpreter on rounds and misses this history.
On post-op day 3, she then becomes tachycardic and hypotensive, the abdominal
binder is removed and she has green liquid coming out of the incision. She is taken
back to the OR urgently where a missed enterotomy is found. The complication
reported at M & M conference would likely be presented in a more streamlined
fashion, for example: “35 y/o female with a history of a ventral hernia underwent
open ventral hernia repair with component separation, lysis of adhesions, and retrorectus mesh. On post-op day 0 she developed a fever but was otherwise hemodynamically stable. On post-op day 3 she became hemodynamically unstable and was
found to have green uid coming out of her wound. At this point, given concern for
a missed enterotomy she was taken back to the OR urgently.”
The discussion for a case like this could go multiple ways but would likely focus
on the operation itself—how the lysis of adhesions was performed, what type of
mesh was placed, and how it was secured. Some may ask whether the complication
could have been identied sooner with a better physical exam. What is often omitted, however, is how this patient’s language status, and the team’s lack of interpreter
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L. R. Maurer et al.
use, may have contributed to delays in recognizing what was really going on. She
was not able to tell them that she saw green staining on the abdominal binder the
day before she became unstable, a critical piece of information that could have led
to earlier diagnosis and treatment. What might also go undiscussed are the system
barriers that prevented the intern from seeing the patient the rst night (covering a
large number of patients overnight) that may have affected this patient’s care. In
some cases, M & M conference is an effective venue for experts in the eld to discuss perioperative adverse events and give important advice to their peers and trainees. In other cases, it can miss more nuanced system factors that should be addressed
to avoid similar adverse events in the future.
Some have argued that this lack of standardized procedures and limited scope
diminishes the effectiveness of the M & M conference and limits the potential for
actionable change. Sacks etal. published in 2015 on changes they made in their
department to make their M & M conference more actionable [6]. After identication by leadership of three to four cases per conference, the resident presenting is
encouraged to pursue a root cause analysis to more thoroughly evaluate the factors
that may have contributed to the complication. This encouraged residents to look at
more systemic factors that may have inuenced the outcome. Concerns that emerge
from these discussions then create the fodder for future quality improvement (QI)
projects pursued in the department. Many institutions have moved toward a more
formalized M & M structure that incorporates root cause analysis and explicit discussion of contributing factors as QI and is emphasized by the Accreditation Council
for Graduate Medical Education (ACGME) [7]. Incorporating root cause analysis
[8] into M & M reviews will allow a more comprehensive understanding of what
happened, and identify the contributing factors, while still allowing for discussion
of technical skills and other clinical errors.
Additionally, there has been some concern that because the faculty surgeons
select cases, there is a risk of under-reporting of complications. In 2002, Hutter etal.
compared complications presented at M & M conference to data collected via
American College of Surgeons National Surgical Quality Improvement Program®
(ACS-NSQIP) in the general surgery division and found that considerably fewer
deaths and complications were presented in M & M conference than were collected
via ACS-NSQIP. [9] As a result, they changed the M & M reporting system to include
discrete and well-dened complication categories to improve reporting. This chapter
illustrates the challenge with the peer review M & M conference format—that ultimately the faculty surgeon decides what is presented, and what constitutes a “complication,” despite concerted efforts to better dene and report complications.
In cases with particularly negative outcomes, there are additional more formal
review procedures the hospital pursues to examine the event, and that we will not
discuss in this chapter. Additionally, in certain types of cases, there is mandatory
reporting of adverse events, which goes beyond the peer review format to a regulatory review. The National Quality Forum (NQF) has established and maintained a list
of 27 serious, preventable adverse events deemed “never events” that require “mandatory reporting” (Table16.1). This will be discussed in more depth in another chapter of this text.
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Table 16.1 NQF’s never events
Surgical or invasive procedures
1A. Surgery or other invasive procedure performed on the wrong site
1B. Surgery or other invasive procedure performed on the wrong patient
1C. Wrong surgical or other invasive procedure performed on a patient
1D. Unintended retention of foreign object in a patient after surgery or other invasive
procedure
1E. Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1
patient
Product or device events
2A. Patient death or serious injury associated with the use of contaminated drugs, devices, or
biologics provided by the healthcare setting
2B. Patient death or serious injury associated with the use or function of a device in patient
care, in which the device is used or functions other than intended
2C. Patient death or serious injury associated with intravascular air embolism that occurs
while being cared for in a healthcare setting
Patient protection events
3A. Discharge or release of a patient/resident of any age, who is unable to make decisions, to
other than an authorized person
3B. Patient death or serious injury associated with patient elopement (disappearance)
3C. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being
cared for in a healthcare setting
Care management events
4A. Patient death or serious injury associated with a medication error (e.g., errors involving
the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation,
or wrong route of administration)
4B. Patient death or serious injury associated with unsafe administration of blood products
4C. Maternal death or serious injury associated with labor or delivery in a low-risk
pregnancy while being cared for in a healthcare setting
4D. Death or serious injury of a neonate associated with labor or delivery in a low-risk
pregnancy
4E. Patient death or serious injury associated with a fall while being cared for in a healthcare
setting
4F. Any Stage 3, Stage 4 or unstageable pressure ulcers acquired after admission/
presentation to a healthcare setting
4G. Articial insemination with the wrong donor sperm or wrong egg
4H. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable
biological specimen
4I. Patient death or serious injury resulting from failure to follow up or communicate
laboratory, pathology, or radiology test results
Environmental events
5A. Patient or staff death or serious injury associated with an electric shock in the course of
a patient care process in a healthcare setting
5B. Any incident in which systems designed for oxygen or other gas to be delivered to the
patient contains no gas, the wrong gas, or are contaminated by toxic substances
5C. Patient or staff death or serious injury associated with a burn incurred from any source in
the course of a patient care process in a healthcare setting
5D. Patient death or serious injury associated with the use of physical restraints or bedrails
while being cared for in a healthcare setting
Radiologic events
6A. Death or serious injury of a patient or staff associated with the introduction of a metallic
object into the MRI area
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Voluntary Reporting Systems
While the peer review format of the M & M conference in a department of surgery
has many benets for analyzing and learning from adverse events, a downside of
this venue is that the decision to bring forward a specic adverse event is often reliant on the surgical staff.
To address this, the Joint Commission has required that hospitals implement voluntary incident reporting systems to capture adverse events and “near miss” potential errors picked up by other perioperative staff members. At our institution, the
Massachusetts General Hospital (MGH), a “safety report” can be led by anyone in
the Mass General Brigham system, and every safety report is reviewed and triaged
to the appropriate person or group for peer review in a peer review protected setting.
This process is managed by skilled nurses, trained in safety science at root cause
analysis. These nurses review the reports for both severity and specialty, and then
work with departmental staff safety champions, who may be either nurses or physicians, to conduct the investigations. At MGH each clinical department has a designated Chair of Quality and Safety who is assigned by the service chief to oversee the
review of safety events as well as many other quality and safety functions in the
department. Each clinical department also has a designated trainee who represents
the department on the quality and safety committee for trainees. Safety events
undergo investigation and, at times, these investigations are extensive, particularly
if there is an unexpected adverse outcome or when there is a signicant event that
had no harm, but was considered a near miss and well worth investigating to prevent
an adverse event from occurring. In this peer review format, adverse events can be
investigated in a collegial way by initiating a conversation with the other providers
involved, and trying to identify the factors leading to the event and a root cause
analysis can be performed [10]. This system utilizes a very different approach than
the in-person M & M conference format, and supplements additional data and wellrounded review of adverse events. In our institution, we have held cross-departmental M & Ms. to share learnings across disciplines. This work continues to evolve as
we promote more transparency, and appreciate more that teamwork and communication across groups is often an important contributing factor in adverse events.
Conclusion
Reviewing performance with the goal of improving outcomes has been embedded in
professional surgical activities for most of the last century. The M & M conference
offers a condential venue for candid discussion of perioperative complications and
mortality where surgeons can learn from each other to avoid similar complications.
Over time, our methods and procedures have changed and migrated from focusing on
the accountability of the individual surgeon to considering a range of contributing
factors and systems issues that impact the quality of care we, as surgeons, deliver. We
believe that the M & M conference offers an important learning environment for
faculty and trainees alike and are working to rene and improve these processes.
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References
1. La LR.Philosophie de La Chirurgie [The philosophy of surgery]. Paris: Flammarion; 1951.
2. Codman EA.The classic: a study in hospital efciency: as demonstrated by the case report of
rst ve years of private hospital. Clin Orthop Relat Res. 2013;471(6):1778–83. https://doi.
org/10.1007/s11999- 012- 2751- 3.
3. American College of Surgeons. Ernest A. Codman, MD, FACS (1869–1940). https://www.
facs.org/about- acs/archives/pasthighlights/codmanhighlight. Accessed 27 July 2019.
4. Bosk CL.Forgive and remember: managing medical failure. 2nd ed. Chicago: University of
Chicago Press; 2003.
5. Peer Review Protection Act. 63 Pa. Stat. § 425.1. 1974.
6. Sacks GD, Lawson EH, Tillou A, Hines OJ.Morbidity and mortality conference 2.0. Ann
Surg. 2015;262(2):228–9. https://journals.lww.com/annalsofsurgery/Fulltext/2015/08000/
Morbidity_and_Mortality_Conference_2_0.6.aspx.
7. ACGME. ACGME program requirements for graduate medical education in general surgery. https://www.acgme.org/globalassets/pfassets/programrequirements/440_generalsur-
gery_2020.pdf.
8. National Patient Safety Foundation. RCA2 improving root cause analyses and actions to prevent harm.; 2016.
9. Hutter MM, Rowell KS, Devaney LA, Sokal SM, Warshaw AL, Abbott WM, et al.
Identication of surgical complications and deaths: an assessment of the traditional surgical morbidity and mortality conference compared with the American College of SurgeonsNational Surgical Quality Improvement Program. J Am Coll Surg. 2006;203(5):618–24.
https://doi.org/10.1016/j.jamcollsurg.2006.07.010.
10. Aaronson EL, Brown D, Benzer T, Natsui S, Mort E.Incident reporting in emergency medicine: a thematic analysis of events. J Patient Saf. 2019;15(4):E60–3. https://doi.org/10.1097/
PTS.0000000000000399.
Enhanced Recovery After Surgery
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Protocols
TimothyE.Newhook andThomasA.Aloia
Enhanced Recovery After Surgery
Fast-track surgery as a concept is almost 30years old, as streamlining perioperative
care to reduce intensive care stay following cardiac surgery was initially reported in
the 1990s [1]. However, at a time when the length of stay (LOS) following colon
surgery was 10days or more in most European countries, Kehlet and Mogensen
reported that most patients had recovered enough for discharge 2days after sigmoid
resection by following a multimodal approach to recovery [2]. After initial skepticism, what resulted from this was a complete paradigm shift, emphasizing best
practices and evidence-based approaches to the perioperative care of the surgical
patient, and that this care was as important to outcomes as the surgical technique [3,
4]. In an effort to promote these principles throughout Europe and beyond, as well
as develop further research opportunities and present implementation guidelines,
the ERAS® Society (http://www.erassociety.org) was created, and its members rep-
resent various disciplines involved in the perioperative care of the surgical patient.
The application of ERAS principles to the care of patients following surgery
began more than 20years ago, originally focusing on fast-track recovery of patients
following colorectal surgery [2]. Protocols involving ERAS concepts have now
been applied to the perioperative care of patients within most surgical specialties,
and contemporary management of most patients undergoing surgery involves at
least some ERAS concepts. These fundamental perioperative care principles, or
“four pillars,” including early feeding, early ambulation, goal-directed uid therapy,
17
T. E. Newhook
Department of Surgical Oncology, Division of Surgery, MD Anderson Cancer Center,
Houston, TX, USA
T. A. Aloia (*)
Oncology Services, Maternal Health and Perinatal Medicine, Ascension, Houston, TX, USA
e-mail: thomas.aloia@ascension.org
© Springer Nature Switzerland AG 2024
J. J. Hoballah et al. (eds.), Principles of Perioperative Safety and Efciency,
https://doi.org/10.1007/978-3-031-41089-5_17
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Fig. 17.1 The four pillars
of perioperative care,
essential multidisciplinary
components of
modern ERAS
T. E. Newhook and T. A. Aloia
and opiate-sparing analgesia, rest upon a foundation of effective patient education
and engagement (Fig.17.1). These are the essential multidisciplinary components
of modern ERAS.
Initial reports on ERAS principles were focused on colorectal surgery beginning
with Kehlet, subsequently igniting many reports on multimodal approach to perioperative care and reduced length of stay (LOS) [2]. Use of epidural analgesia, early
enteral nutrition, and early mobilization reduced what was a 6–12-day LOS to
5days [5–8]. The inclusion of laparoscopic techniques further improved reported
LOS to 2–3days following colon surgery [9]. However, the major goal of ERAS is
not just the rapidity of recovery, but also the quality of recovery [4]. Great efforts
have been made by the ERAS® Society and surgical community in general to
improve the quality of perioperative care via these protocols, now being applied
across many disciplines including colorectal, hepato-pancreato-biliary, gastric, bariatric, gynecologic, and head and neck surgery [10–16].
Perioperative Safety andEfficiency
As the overarching theme of ERAS evidence-based approaches is to create perioperative care pathways that reduce stress associated with surgery, patients may
recover faster with reduced complications and delays in planned postoperative therapies [4, 17, 18]. Further results following implementation have supported both the
safety and efciency of this approach as compared to traditional perioperative care
strategies.
Safety
Adoption of ERAS has been shown to reduce complications rates and to reduce
hospital LOS without increasing readmission rates after surgery [18, 19]. These
outcomes are a result of coordinated, multimodal, and multidisciplinary approaches
to the care of a patient undergoing surgery.
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Regarding oncology surgery, evaluation of the safety of ERAS has been limited.
As enhanced recovery principles were largely initiated for patients undergoing
colorectal surgery, much of the experience in the oncologic space has been in protocols for patients with colorectal cancer. Randomized clinical trials of patients
undergoing colorectal surgery along with ERAS principles have resulted in a
decrease in complication rates of 50% [20, 21]. However, efforts have been made to
dene the impact of ERAS on both short-term and long-term outcomes for patients
undergoing oncologic surgery. In an evaluation of more than 1200 patients cared for
along ERAS pathways across multiple surgical specialties from 2011 to 2016 at a
large-volume cancer center, complication rates and LOS were signicantly reduced
as compared to patients cared for along non-ERAS pathways [18]. Specically,
patients managed on ERAS pathways had signicantly reduced rates of surgical site
infections (SSIs), wound complications, urinary tract infections (UTIs), and any
severe complications [18]. Conclusions from many of these studies support a lower
rate of perioperative complications following surgery if managed according to
ERAS principles. In none of these studies did ERAS pose a risk of harm. In fact,
ERAS may be one of the most impactful perioperative therapies, based largely on
the fact that its strategies produce tremendous benet without the risk of harm.
The reduction in surgical stress afforded by following ERAS principles allows
patients to recover more rapidly and effectively; however, beyond endpoints such as
LOS and complication rates is patient functional recovery [22]. Unfortunately,
benchmarks for measuring the rapidity of recovery are lacking. An effective measure of functional recovery is to decipher the efciency with which patients are
moving onto planned adjuvant therapies, further interventions, or resumption of
chronic therapies following surgery [23]. An example from oncologic surgery is the
return to intended oncologic therapy (RIOT) concept, which is not only a valuable
midterm quality metric in oncologic surgery, but also an effective measure to evaluate ERAS and rates of recovery [22–24]. Initial investigations into the RIOT concept in patients undergoing hepatic resection revealed a RIOT rate of 75% and a
median time to RIOT of 42days, which was improved to 86% and 36days after
internal quality improvement [23, 24]. After introduction of ERAS after liver surgery at our institution (termed ERILS), we found an astounding improvement in the
rate of RIOT readiness to 95% at 21 postoperative days, which reinforced the ability
of ERAS principles to return patients to functional baseline and beyond following
surgery [25].
279
Efficiency
The benets observed for patients managed according to ERAS principles translate
to more efcient care, with reduced LOS and decreased complications, resulting in
cost reductions. A systematic review and meta-analysis by Visioni and colleagues
found that length of stay and complication rates were signicantly reduced across
39 studies of non-colorectal abdominal surgical procedures, and that this translated
to cost savings of over $5000 (USD) per patient [26]. Implementation of an ERAS
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for elective colorectal surgery across an entire provincial healthcare system in
Canada resulted in a cost saving of between $2806 and $5898 (USD) per patient,
largely due to decreased rates of complications and readmissions [27]. Further,
Thiele and colleagues reported that implementation of an ERAS following colorectal surgery at a single academic center resulted in over $7000 (USD) direct cost
saving per patient, translating to over $777,000 (USD) total savings across 109
patients. Moreover, patient-reported satisfaction scores improved signicantly
throughout the protocol implementation period [28]. The ability to deliver superior
outcomes as previously described in this chapter, while decreasing costs, identies
ERAS as a major driver of improved surgical efciency and overall value.
Maintaining adherence to protocols once implemented, as well as regular audit
to allow for dynamic changes to optimize care pathways, is important for realization
of the full potential of ERAS [29, 30]. Many aspects of ERAS are vulnerable to
omission, likely due to the multidisciplinary approach to care, and compliance rates
of many components of these pathways are incompletely reported in the surgical
literature [31, 32]. Increasing protocol compliance was correlated with fewer complications and shorter LOS following elective colorectal cancer operations in more
than 1500 patients from an international registry [31]. The benet of adherence to
increasing components of an ERAS following elective colorectal surgery was demonstrated in the Postoperative Outcomes Within Enhanced Recovery After Surgery
Protocol (POWER) study, where an increase in adherence was associated with
decreases in postoperative complications [33]. Specically, patients with the highest adherence rates incurred approximately 65% less moderate-to-severe complications, overall complications, and almost 75% less risk of mortality as compared to
low adherence rates [33]. It is possible that individual components of ERAS are not
as effective in isolation, and that a synergistic response occurs with high adherence,
thus highlighting the importance of protocol compliance.
T. E. Newhook and T. A. Aloia
Principles ofEnhanced Recovery After Surgery Protocols
As previously mentioned, a modern ERAS approach to the surgical patient consists
of four fundamental perioperative care principles underpinned by a foundation of
effective patient education and engagement [34]. These “four pillars” include early
feeding, early ambulation, goal-directed uid therapy, and opiate-sparing analgesia,
as seen in Fig. 17.1. Further considerations for inclusion within ERAS are discussed below.
Foundation: Patient Evaluation, Education, andEngagement
As with every patient being considered for operative intervention, a thorough preoperative evaluation is imperative. A complete history and physical examination
are compulsory, including review of all comorbid conditions, prior surgical history,
and current medications. If patients are undergoing surgery for oncologic
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indications, a thorough oncologic history and review of multimodal therapies, such
as radiation, systemic cytotoxic/targeted/immunologic chemotherapies, and adjuvant therapy plans, should be reviewed and communicated in a multidisciplinary
fashion.
Review of chronic comorbid conditions and potential intervention to correct
medical decits prior to planned surgery are important for quality of recovery.
Particular attention should be paid to optimization of conditions leading to borderline operability. Using data from the American College of Surgeons National
Surgical Quality Improvement Program, Kim and colleagues demonstrated that
patients with borderline operability (age >75years, dependent function, lung disease, ascites/varices, myocardial infarction, stroke, steroids, weight loss >10%, and/
or sepsis) have a threefold higher mortality following hepatectomy [35]. Patient
functional status should be evaluated and graded via reported outcome tools [36–
40]. Identication of conditions that can be modied may be part of a coordinated
“prehabilitation” program prior to elective surgery, such as smoking cessation,
physical activity, and nutritional counseling. This allows for a greater preoperative
“starting point” prior to undergoing a potentially stressful surgery (Fig.17.2). In
fact, prehabilitation as part of an operative plan along with ERAS is the subject of
an ongoing clinical trial for patients undergoing surgical management of colorectal
cancer [41].
Patient education and engagement are essential to the successful implementation
of ERAS and for realization of maximal benets of this approach to perioperative
care. Patients should receive materials describing their proposed operations and
expectations for inpatient care and length of hospital stay, including pain control
and physical activity. Moreover, educational literature should be provided on ERAS
principles and goals to ensure time for the patient and caregivers to align themselves
with their expected recovery, as well as allow for ample time for questions. As with
core ERAS principles, a multimodal approach to patient education reduces anxiety
and improves compliance [42]. Consistent language and communication regarding
expectations are important, including use of scripted telephone calls and education
materials to improve outcomes [43].
Fig. 17.2 Identication of
conditions that can be
modied may be part of a
coordinated
“prehabilitation” program
prior to elective surgery,
such as smoking cessation,
physical activity, and
nutritional counseling. This
allows for a greater
preoperative “starting
point” prior to undergoing
a potentially stressful
surgery
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