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R. Howard and J. B. Dimick
mortality and complications by nearly half [24]. A particular example of a surgical
checklist is the “timeout” that is performed prior to any invasive procedure. These
“timeout” procedures are now ubiquitous at virtually all health systems and are
endorsed as a best practice by the World Health Organization. Standardization of
the timeout procedure is ensured by providers using a pre-made card or poster with
a list of items that should be veried and discussed during the timeout. Common
items discussed prior to beginning an operation include verifying the correct patient,
procedure, surgical site, positioning, and medications.
One of the most important realms in which human error takes place is in communication. The Joint Commission estimates that communication errors are one of
the three most common root causes of sentinel events in hospitals and play a role in
65% of these adverse events [21]. These errors typically occur during transitions of
care (“handoffs”) between providers or patient care groups [25]. Therefore, check-
lists or other means of standardization are now routinely employed during handoff
situations. A popular example of this standardization is the use of the SBAR format,
or “situation, background, assessment, and recommendation,” which is widely used
among nurses [26]. This often templated format strives to ensure that all key pieces
of information are discussed during a transition of care.
One of the most effective strategies for mitigating human error—which human
factors analysis acknowledges is inevitable—is referred to as “forcing functions,” or
designing a system in such a way that it is virtually impossible to perform an incorrect action. A classic example of this, which demonstrates the effect of these various
safety strategies, is the management of medical gasses that are used in many areas
of patient care. On March 5, 2002, the Veterans Health Administration issued a
Patient Safety Advisory addressing the critical issue of incorrect administration of a
medical gas. This was issued due to a variety of sentinel events in which patients
who required oxygen, for example, were administered a different gas, such as compressed air or carbon dioxide. It is not hard to imagine how an error like this could
occur—the wrong canister is brought into a patient’s room from storage, or tubing
is connected to the wrong gas outlet on the wall. Ineffective measures at preventing
this error would be educating providers how to recognize which medical gas is
being administered (perhaps by use of a color code). A provider who is in haste or
who does not remember the training may still inadvertently make a mistake. A more
effective countermeasure would be using an aforementioned checklist that may
involve verifying which medical gas is about to be administered to a patient. Lastly,
however, the practice of “forcing functions” would involve making the physical
regulator on a carbon dioxide cannister—which would never be administered
directly to a patient—functionally incompatible with any device or tubing that
would deliver a medical gas to a patient. In this case, even if the provider obtains the
wrong equipment, fails to recognize the mistake, and tries to connect face mask tubing to the canister, they would be physically prevented from carrying out the task
and causing patient harm. Another example of a forcing function is administration
of epinephrine for an anaphylactic reaction. In order to prevent administration of the
wrong dose, a premeasured dose is provided in an EpiPen injector, leaving any decision about the dose out of the hands of the provider [27].
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Prospective andRetrospective Error Analysis
While the above strategies are designed to prevent errors from happening in the
moment, knowing what strategies and measures to implement requires identication of weaknesses in a system that are vulnerable to human error. A strategy to
evaluate the safety of new or existing processes in healthcare is healthcare failure
mode and effect analysis (HFMEA), which is an extension of a safety analysis process commonly used within the engineering community [28]. A description of this
entire process is beyond the scope of this chapter, but what follows is a brief outline
of this process and an example of a specic case, drawn from work conducted at the
VA.There are ve steps to HFMEA:
1. Dene the topic under investigation. This should be a high-risk and high-
vulnerability area within the health system.
2. Assemble a team. Convening a multidisciplinary team comprised of individuals
both familiar and unfamiliar with the process under investigation will ensure
critical review.
3. Describe the process. This is typically done graphically with the use of a pro-
cess ow diagram.
4. Conduct hazard analysis. This is the heart of HFMEA and involves listing all
of the potential failure modes of a given process, determining the probability of
failure, the severity of failure, and the downstream effects of a potential failure.
An example found in an HFMEA tutorial published by the Joint Commission
would be hazard analysis of conrming drug allergies. Failure modes would
include (1) not recording drug allergies and (2) incompletely recording drug
allergies. The cause, in this case, may be poor integration of allergy conrmation
into automated medical record systems. There are a number of freely available
worksheets that outline the steps to completely capture the modes and effects of
healthcare process failure.
5. Develop actions and outcomes measures. The nal step of HFMEA involves
developing countermeasures to mitigate potential failures. In the allergy conrmation example, the countermeasure may be developing an automated hard stop
in the medical record system that requires conrmation of drug allergies prior to
ordering a medication.
Root Cause Analysis
Root cause analysis (RCA), on the other hand, is a way to retrospectively analyze
an adverse event. RCA is a systematic approach to investigating a sentinel event in
order to prevent similar events from occurring in the future. Although RCA focuses
on identifying both the errors that were committed by the individuals involved in a
sentinel event, as well as the latent errors inherent in the system, the overriding goal
is to recognize and correct the systematic weaknesses that allowed a major error to
occur [29, 30].
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R. Howard and J. B. Dimick
Much like HFMEA, RCA can be conducted in a stepwise manner as follows:
categorizing the level of harm due to an incident, gathering information, identifying
the problems in care delivery that led to the problem, analyzing these problems to
identify root causes, generating recommendations and solutions, and ultimately
implementing these solutions [29]. A team should be convened to conduct the RCA,
typically composed of at least one administrator, one patient representative, and an
individual skilled in RCA [31].
Categorization of an incident includes no harm (a “near miss”), severe harm or
death, or severe harm or death with public interest (such as a “never event” that
becomes newsworthy). In the case of our initial scenario, we would categorize the
incident as one that resulted in severe harm to the patient.
Gathering information is a multifaceted process that involves obtaining as much
data about the incident as possible. Facts are obtained by verifying actions and
orders that occurred within the medical record system. A hospital’s paging system
can be queried to look at the timing of communication between teams. Interviews
are conducted to collect each provider’s perspective on the event. Interviews are
particularly important in ascertaining institutional biases or opinions as to why certain procedures were carried out a certain way. Again, in our case scenario, some
critical information gathering would involve the timing of when the emergency
department contacted the medicine team, when the medicine team contacted the
surgery team, the language of the pages used to notify other teams of the patient, the
patient’s vital signs and clinical condition during these events, and the orders that
were placed for the patient.
Next, the care delivery problems are identied, which in our case, are numerous:
the failure of the emergency department physician to recognize and diagnose a
patient with mesenteric ischemia due to an internal hernia; the failure of the radiologist to comment on radiographic ndings concerning for an acute surgical pathology; the inappropriate admission of a patient with a surgical pathology to a medical
service without notifying a surgical team; the failure to notify the medicine team
once the radiographic interpretation of mesenteric ischemia had been updated; and
even the delay in notifying the surgical team until the patient’s condition had signicantly deteriorated.
Identifying the root causes of each of these problems involves recognizing the
factors that contribute to each of these problems. Strategies for conducting this
analysis are commonly described as part of the Lean Thinking methodology, the
two most popular of which are “the ve whys” and creating a shbone diagram.
The ve whys is an exercise in going beyond the most supercial explanations for
an adverse event. A simple answer to the question “Why did this adverse event
happen?” may be “Because the team caring for this patient missed the correct
diagnosis.” But stopping there results in a situation in which there is no real room
for improvement, other than to perhaps have a teaching session about mesenteric
ischemia, which is an ineffective solution. Conducting the ve whys forces the
group conducting the RCA to reach explanations that may have more actionable
remedies. For example:
1 Human Factors andPrinciples ofPatient Safety: TheJames Reason Model
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Problem: A patient underwent highly morbid, emergency surgery because her mes-
enteric ischemia was not diagnosed until she was clinically unstable.
Why?
Because the medicine team did not realize that she had a surgical problem.
Why?
Because they were only aware of the initial radiology interpretation, which did not
comment on any ndings suggestive of internal hernia or mesenteric ischemia.
Why?
Because once the interpretation was updated, the team was not made aware of this.
Why?
Because when radiologic interpretations are updated in the electronic medical
record system, no notication is sent to any provider that the interpretation has
been changed. It is up to the provider to go back and review the radiology
ndings.
Why?
Because this kind of notication system has never been implemented.
The ultimate conclusion to that exercise identies the lack of a notication system for changed radiology results as one of the root causes of this event. The countermeasure or remedy to prevent future events like this, therefore, becomes obvious:
implementing a notication system that updates providers when a radiographic
interpretation is changed. In this case, had the medicine team been notied the following day that there was radiographic evidence of a surgical emergency, the patient
would have likely been taken to the operating room 48h before she ultimately was,
and in a much more stable condition.
Lastly, the solutions identied following RCA should be implemented in a systematic manner. One strategy to achieve this is by using “SMART” goals, or goals
that are specic, measurable, achievable, relevant, and timely. Simply having the
solution of “don’t miss a critical diagnosis again” has no way to guarantee its
enforcement. However, the goal of “implementing a radiology notication system
in the next 6months” gives a very measurable outcome and timeframe by which to
assess whether the root cause of this incident has been corrected. Another strategy
is the use of a “plan, do, study, act” (PDSA) cycle, which is also described commonly in quality improvement in Lean Thinking.
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14. O’Connor S, Carlson E.Safety culture and senior leadership behavior: using negative safety
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15. Developing a reporting culture: learning from close calls and hazardous conditions. Sentinel
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16. Kohn LT, Corrigan J, Donaldson MS. To err is human: building a safer health system.
Washington: National Academy Press; 2000. p. xxi, 287.
17. Brunsveld-Reinders AH, Arbous MS, De Vos R, De Jonge E. Incident and error reporting systems in intensive care: a systematic review of the literature. Int J Qual Health Care.
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18. Simmons D, Mick JA, Graves K, Martin SK. 26,000 close call reports: lessons from the
University of Texas close call reporting system. In: Henriksen K, Battles JB, Keyes MA, Grady
ML, editors. Advances in patient safety: new directions and alternative approaches (vol 1:
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19. Hutchinson A, Young TA, Cooper KL, McIntosh A, Karnon JD, Scobie S, et al. Trends
in healthcare incident reporting and relationship to safety and quality data in acute hospitals: results from the National Reporting and learning system. Qual Saf Health Care.
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20. Wetterneck TB, Karsh B-T.Human factors applications to understanding and using close calls
to improve health care. In: Wu A, editor. The value of close calls in improving patient safety:
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2011. p.39–53.
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2015;35(6):1694–705.
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2009;360(5):491–9.
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R. Howard and J. B. Dimick
1 Human Factors andPrinciples ofPatient Safety: TheJames Reason Model
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27. Pennsylvania Patient Safety Advisory. Let’s stop this “epi”demic! Preventing errors with epinephrine. PA PSRS Patient Saf Advis. 2006;3(3):16–7.
28. DeRosier J, Stalhandske E, Bagian JP, Nudell T.Using health care failure mode and effect
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Comm J Qual Improv. 2002;28(5):248–67.
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Education; 2018. p. xviii, 510.
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Commission Resources; 2017.
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Further Reading
Classic case report of sentinel event: Chassin MR, Becher EC.The wrong patient. Ann Intern Med.
2002;136(11):826–33.
The Joint Commission’s recommendations for patient safety for accredited hospitals: “Patient
Safety Systems” chapter. Joint Commission Accreditation. Comprehensive accreditation manual 2019: CAMH for Hospitals Effective January 1, 2019: Standards elements of performance
scoring accreditation policies. Jt Comm Accred Health; 2018.
Outline and examples of healthcare failure mode and effect analysis: DeRosier J, Stalhandske
E, Bagian JP, Nudell T. Using health care failure mode and effect analysis™: the VA
national center for patient safety’s prospective risk analysis system. Jt Comm J Qual Improv.
2002;28(5):248–67.
An overview of Reason’s “just culture” in healthcare: Developing a reporting culture: learning
from close calls and hazardous conditions. Sentinel Event Alert. 2018;(60):1–8.
Primer on conducting root cause analysis in healthcare: Joint Commission International. Root
cause analysis in health care: tools and techniques: Joint Commission Resources; 2017.
Preoperative Testing intheEra ofCost
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Containment: Is There aLimit?
GeorgiosTsoulfas
Introduction
This chapter aims to help the reader understand the rationale for approaching preoperative testing in an evidence-based manner. Essentially, the goal is to decide when
preoperative testing is not indicated, which is really most of the time! Preoperative
testing is commonly ordered for most patients scheduled to undergo general,
regional or (even) local anesthesia, and it usually includes a panel of tests used for
all patients, or tests used for specic patient groups (i.e., elderly) or for patients
undergoing specic procedures. This is one side of the equation, which is also the
most commonly practiced one, whereas the other is doing no preoperative testing or
doing tests based on the clinician’s evaluation of the patient’s condition. In order to
make the decision about which strategy to follow regarding preoperative testing, it
is important to consider a series of factors.
On the one hand, those advocating in favor of routine preoperative testing argue
that this strategy may help identify latent health issues that can ultimately affect the
course and outcome of the surgical procedure or impact the anesthesia risk. In addition, this strategy allows for the accumulation of data, which can be used postoperatively for comparison, as well as possibly predict the possibility of postoperative
complications. On the other hand, we have all come across false-positive testing,
which can then lead to further tests, thus not only delaying a necessary surgical
procedure, but also subjecting the patient to unnecessary care and psychological
stress. Other times, even if a preoperative test is “positive,” it may have absolutely
nothing to do with the upcoming operation, and thus lead to an unnecessary delay.
Additionally, there is the human factor, which is something that we have all been
witnesses to, and which is exemplied by the positive preoperative test that goes
unnoticed and for which nothing is done—by itself a patient safety issue at the
2
G. Tsoulfas (*)
Department of Transplantation Surgery, Center for Research and Innovation in Solid Organ
Transplantation, Aristotle University School of Medicine, Thessaloniki, Greece
© 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_2
17
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G. Tsoulfas
system level. Obviously, on top of all this, one has to consider the nancial aspect
of the testing, as the higher number of preoperative testing means increased and
likely unnecessary utilization of valuable resources. All of the above essentially
means that clinicians have to balance the urgency and complexity of the surgical
procedure, the cost involved, the patient’s overall health, their personal experience,
and last but not least, medico-legal concerns. An evidence-based approach has the
potential to provide the necessary roadmap in this challenging situation, thus balancing both the patient’s and society’s well-being.
Risk Classification
In order to decide what preoperative testing should be done, one of the rst things
to consider is the risk(s) involved. Specically, this has to do with the risk and complexity of the procedure and the health of the patient.
Type ofProcedure
Different procedures have different degrees of complexities having to do with the
part of the anatomy or the organ involved and the nature of the procedure. This has
been documented in several studies, including a large analysis of 68,831 patients
from Veterans Affairs hospitals and another one involving more than 400,000 major
surgeries, again from the Veterans Affairs system [1, 2]. As a result, it is possible to
classify procedures into high-, intermediate-, and low-risk ones during the perioperative period, based on the type of the procedure, as can be seen in Table2.1.
Table 2.1 Perioperative risk classications for surgical procedures [1, 2]
Low (<1%)
Supercial surgery Intrathoracic
Breast Intraperitoneal Major abdominal surgery, prolonged
Dental Carotid
Cataract Endovascular
Endoscopic Head and neck surgery Lung, liver, or pancreas transplantation
Thyroid
Gynecologic,
minor
Orthopedics, minor Renal transplantation
Urologic, minor
Reconstructive or
cosmetic
Intermediate (1–5%)
(nonmajor)
endarterectomy
aneurysm repair
Neurologic or
orthopedic, major
Urologic or
gynecologic major
High (≥5%)
Aortic, major vascular surgery, peripheral
vascular surgery
procedures with large uid shifts or blood loss
Esophagectomy
Pneumonectomy
Adrenal resection
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Existing Chronic Comorbidities
It should come as no surprise that chronic conditions and comorbidities can increase
the perioperative risk of complications. This is especially true today with an increasing elderly patient population. One of the most practical ways to evaluate this
increased perioperative risk is to use the American Society of Anesthesiologists
(ASA) physical status classication system, which is presented in Table2.2 [3].
This uses the preoperative functional status of the patient, with examples provided
in order to classify the perioperative risk involved. Such comorbidities include, but
are not limited to, ischemic heart disease, cerebrovascular disease, heart failure,
diabetes mellitus, chronic kidney disease, liver disease, bleeding disorders, and pulmonary disease. The degree of these comorbidities and whether they are under
adequate treatment can play a signicant role in the perioperative outcome.
Table 2.2 American Society of Anesthesiologists classication system [3]
ASA PS
classication
ASA I A normal healthy
ASA II A patient with
ASA III A patient with
ASA IV A patient with
ASA V A moribund
ASA VI A declared
Denition
patient
mild systemic
disease
severe systemic
disease
severe systemic
disease that is a
constant threat to
life
patient who is
not expected to
survive without
the operation
brain-dead
patient whose
organs are being
removed for
donor purposes
Examples, including, but not limited to:
Healthy, non-smoking, no or minimal alcohol use
Mild diseases only without substantive functional
limitations. Examples include (but not limited to): current
smoker, social alcohol drinker, pregnancy, obesity
(30<BMI<40), well-controlled DM/HTN, mild lung
disease
Substantive functional limitations; One or more moderate to
severe diseases. Examples include (but not limited to):
poorly controlled DM or HTN, COPD, morbid obesity
(BMI ≥40), active hepatitis, alcohol dependence or abuse,
implanted pacemaker, moderate reduction of ejection
fraction, ESRD undergoing regularly scheduled dialysis,
premature infant PCA<60weeks, history (>3months) of
MI, CVA, TIA, or CAD/stents
Examples include (but not limited to): recent (<3months)
MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or
severe valve dysfunction, severe reduction of ejection
fraction, sepsis, DIC, ARD, or ESRD not undergoing
regularly scheduled dialysis
Examples include (but not limited to): ruptured abdominal/
thoracic aneurysm, massive trauma, intracranial bleed with
mass effect, ischemic bowel in the face of signicant cardiac
pathology or multiple organ/system dysfunction
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G. Tsoulfas
Social, Obesity, andFunctional Status Factors
Social factors may include habits such as tobacco, alcohol, or illicit substance use;
or factors such as nutritional status, obesity, ability to exercise, and even level of
stress. These factors need to be quantied for each patient in order to determine the
threat posed. Examples include measuring tobacco use in packets per year (how
many packets of cigarettes multiplied by the number of years), whether it is cigarettes or other types of tobacco, the type, frequency, and amount of alcohol that the
patient uses or, in the case of obesity, measurement of the patient’s body mass index
(BMI). These can increase the risk for cardiopulmonary complications.
Preoperative Testing
Before the decision is made to conduct preoperative tests, there are several questions that need to be asked and considered.
1. Why do we need to test preoperatively? In 2010, the Committee on Standards
and Practice Parameters of the American Society of Anesthesiologists, in an
effort to evaluate the need for changes in the then existing recommendations in
the Practice Advisory from 2001, formed a task force on preanesthesia evaluation. The result was an updated Practice Advisory for Anesthesia Evaluation,
which was eventually published in 2012 [4]. We have to remember that practice
advisories are not the same as guidelines or standards, because they are not supported by scientic literature to the same extent as guidelines, given the lack of
an adequate number and quality of randomized controlled trials. They are meant
to be treated as useful suggestions, which are the result of consensus and synthesis between experts on the topic.
Having identied the limitations of the practice advisory, we also need to
understand its importance. The reasoning behind preoperative testing is that it
can help identify acute or chronic conditions that may interfere with the anesthesia or the surgical plan, as well as conrm the existence and degree of severity of
known health problems. The information from the preoperative testing can be
useful in formulating the best anesthesia plan for the specic procedure and for
the specic patient. At the same time, it is supposed to help delineate the overall
health status of the patient, so that the surgical team can also decide whether the
patient can be operated upon, and what the best procedure for the specic patient
is. All of this is important in order to provide the patient with the best possible
information regarding the upcoming procedure and the various alternatives
(especially regarding the anesthesia plan) in an effort to obtain a truly informed
consent.
The main reason for the need to reevaluate existing protocols is the importance of periodically examining new data and information in anesthesia and
adjusting the relevant policies accordingly. Specically, although the rationale
behind preoperative testing appears to be solid, there have been studies going
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