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CHAPTER 10

PERIOPERATIVE
PATIENT SAFETY
R. Daniel Beauchamp and Michael S. Higgins

1. Transparency must be a practiced value in everything


history and perspective
we do.
surgical infection prevention and surgical care 2. Care must be delivered by multidisciplinary teams
improvement project working in integrated care platforms.
creating an organizational structure to promote 3. Patients must become full partners in all aspects of
patient safety and quality care health care.
4. Health care workers need to find joy and meaning in
their work.
5. Medical education must be redesigned to prepare
HISTORY AND PERSPECTIVE new physicians to function in this new environment.
Patient safety in the health care environment is recognized as
less than optimal or desirable. A series of eye-opening reports SURGICAL INFECTION PREVENTION AND
were published in the 1990s and provided clear evidence of high SURGICAL CARE IMPROVEMENT PROJECT
rates of serious adverse events that resulted in serious harm to Because surgical site infections (SSIs) were recognized as the
hospitalized patients. The Institute of Medicine (IOM), in its second most common site of nosocomial infections and a major
landmark report, To Err is Human, published in 1999, estimated cause of morbidity, readmissions, excessive costs, and death, the
that as many as 1 million people/year were injured and up to Centers for Medicare and Medicaid Services (CMS) and
98,000 died annually because of medical errors.1 When the the Centers for Disease Control and Prevention (CDC) initiated
focus was specifically turned to surgical patients, surgical care the National Surgical Care Improvement Project (SCIP) in
accounted for between 48% and 66% of adverse events among 2002.4 The goal of surgical infection prevention (SIP) was to
nonpsychiatric hospital discharges.2 In regard to operative pro- reduce the incidence and impact of SSIs in surgical populations,
cedures and deliveries, 3% resulted in adverse events, and surgi- particularly in high-volume procedures. In 2003, the national
cal adverse events were associated with a 5.6% mortality rate, SIP project convened a meeting of the Surgical Infection Preven-
accounting for 12.2% of hospital deaths. Furthermore, 54% of tion Guideline Writers Workgroup of experts and representatives
surgical adverse events were judged to be preventable. from several surgical specialty societies to develop evidence-
Adverse events in surgical patients encompass those based and consensus guidelines for antimicrobial prophylaxis for
common to all hospitalized patients, such as adverse drug events, abdominal and vaginal hysterectomy, hip or knee arthroplasty,
falls, missed diagnoses, deep venous thrombosis, pulmonary and cardiothoracic, vascular, and colon surgery.
embolism, aspiration events, respiratory failure, nosocomial The SIP project focused on three primary quality perfor-
pneumonia, myocardial infarction, and cardiac arrhythmias. In mance measures. The first SIP measure was that prophylactic
addition, surgical specific adverse events include technique- antibiotics should be given within the 60-minute interval imme-
related complications, wound infections, and postoperative diately preceding the surgical skin incision (within 2 hours for
bleeding. vancomycin, with appropriate documentation of the reason).
In 2000, the IOM called for a national effort to reduce The second measure was that the appropriate prophylactic anti-
medical errors by 50% within 5 years; however, progress has biotic for the scheduled procedure should be selected based on
fallen far short of that goal, despite numerous private and public consensus recommendations. The third SIP measure was that
initiatives aimed at finding solutions. Leape and colleagues3 have the prophylactic antibiotic should be discontinued within 24
proposed that these efforts fell short because health care organi- hours of the end of the procedure.
zations did not undertake the major cultural changes required The SIP project has transitioned into the SCIP, and includes
to accomplish true and lasting improvements in performance. additional process performance measures aimed at reducing
They proposed that health care entities must become high- SSIs. Three additional measures to reduce SSIs have been added
reliability organizations that hold themselves accountable to to the original SIP measures: (1) glucose control in cardiac sur-
offer safe andeffective patient-centered care consistently. They gical patients; (2) appropriate hair removal at the surgical site
proposed five transforming concepts for adoption by health care (using clippers, not razors); and (3) maintenance of normother-
organizations seeking such cultural transformative changes: mia in patients undergoing colorectal operations. In addition to
201
202 SECTION I SURGICAL BASIC PRINCIPLES

Table 10-1 SCIP Measures


SET MEASURE ID NO. MEASURE SHORT NAME
Infection
SCIP-Inf-1a Prophylactic antibiotic received within 1hr prior to surgical incision, overall rate
SCIP-Inf-1b Prophylactic antibiotic received within 1hr prior to surgical incision, CABG
SCIP-Inf-1c Prophylactic antibiotic received within 1hr prior to surgical incision, other cardiac surgery
SCIP-Inf-1d Prophylactic antibiotic received within 1hr prior to surgical incision, hip arthroplasty
SCIP-Inf-1e Prophylactic antibiotic received within 1hr prior to surgical incision, knee arthroplasty
SCIP-Inf-1f Prophylactic antibiotic received within 1hr prior to surgical incision, colon surgery
SCIP-Inf-1g Prophylactic antibiotic received within 1hr prior to surgical incision, hysterectomy
SCIP-Inf-1h Prophylactic antibiotic received within 1hr prior to surgical incision, vascular surgery
SCIP-Inf-2a Prophylactic antibiotic selection for surgical patients, overall rate
SCIP-Inf-2b Prophylactic antibiotic selection for surgical patients, CABG
SCIP-Inf-2c Prophylactic antibiotic selection for surgical patients, other cardiac surgery
SCIP-Inf-2d Prophylactic antibiotic selection for surgical patients, hip arthroplasty
SCIP-Inf-2e Prophylactic antibiotic selection for surgical patients, knee arthroplasty
SCIP-Inf-2f Prophylactic antibiotic selection for surgical patients, colon surgery
SCIP-Inf-2g Prophylactic antibiotic selection for surgical patients, hysterectomy
SCIP-Inf-2h Prophylactic antibiotic selection for surgical patients, vascular surgery
SCIP-Inf-3a Prophylactic antibiotics discontinued within 24hr after surgery end time, overall rate
SCIP-Inf-3b Prophylactic antibiotics discontinued within 48hr after surgery end time, CABG
SCIP-Inf-3c Prophylactic antibiotics discontinued within 48hr after surgery end time, other cardiac surgery
SCIP-Inf-3d Prophylactic antibiotics discontinued within 24hr after surgery end time, hip arthroplasty
SCIP-Inf-3e Prophylactic antibiotics discontinued within 24hr after surgery end time, knee arthroplasty
SCIP-Inf-3f Prophylactic antibiotics discontinued within 24hr after surgery end time, colon surgery
SCIP-Inf-3g Prophylactic antibiotics discontinued within 24hr after surgery end time, hysterectomy
SCIP-Inf-3h Prophylactic antibiotics discontinued within 24hr after surgery end time, vascular surgery
SCIP-Inf-4 Cardiac surgery patients with controlled 6 am postoperative blood glucose level
SCIP-Inf-6 Surgery patients with appropriate hair removal
SCIP-Inf-9 Urinary catheter removed on postoperative day 1 or 2, with day of surgery being day 0
SCIP-Inf-10 Surgery patients with perioperative temperature management
Cardiac
SCIP-Card-2 Surgery patients on beta blocker therapy prior to arrival who received a beta blocker during the perioperative period
VTE
SCIP-VTE-1 Surgery patients with recommended VTE prophylaxis ordered
SCIP-VTE-2 Surgery patients who received appropriate VTE prophylaxis within 24hr prior to surgery to 24hr after surgery

From Centers for Medicare and Medicaid Services, The Joint Commission: National Hospital Inpatient Quality Measures: Specifications Manual, Version 3.1, June, 2010
(http://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier4&cid=1228749003528).
VTE, Venous thromboembolism.

the six performance measures aimed at reducing SSIs, measures Use of Quality Data to Improve Outcomes of
aimed at preventing cardiovascular complications and venous Surgical Patients
thromboembolism after major surgical procedures were pro- How do we know which interventions work and which fail to
posed (Table 10-1).5 To reduce perioperative ischemic heart improve outcomes? Despite the intuitive appeal of quality- and
complications, patients who have been on -adrenergic blocking safety-motivated process improvements, it is challenging to gen-
medications prior to operation, should be maintained on beta erate accurate data in a timely manner to support the effective-
blockade in the perioperative period and during hospitalization. ness of the safety measures that have been undertaken. The rise
The final SCIP measures are for the use of appropriate venous of health services research programs and rigorous population-
thromboembolism prophylaxis in surgical patients at risk for based research in academic medical centers and the involvement
deep venous thrombosis and pulmonary embolism. of surgeons in these programs have led to several landmark
Perioperative Patient Safety Chapter 10 203

30-DAY POSTOPERATIVE MORTALITY RATE, 1991 TO 2008

SECTION I SURGICAL BASIC PRINCIPLES


3.5
3.16
3.0 3.16

2.5 2.75
2.57 2.55
2.38 2.28 2.33
(Percent)

2.0 2.14 2.08


1.99
1.5 1.7 1.66
1.52
1.36
1.0

0.5 FIGURE 10-1 Actual mortality trend for the


National Surgery Quality Improvement Program
0 (15 years from inception through fiscal year
1996 1998 2000 2002 2004 2006 2008 2008). (From the Congressional Budget Office:
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studies that have helped identify some risk factors that affect compared with the very low-mortality hospitals (12.5%).
morbidity and mortality in surgical populations. The develop- Although processes and systems aimed at the avoidance of com-
ment of broad-based prospective databases, such as the Ameri- plications seem intuitively important, it is not always possible
can College of SurgeonsNational Surgical Quality Improvement in the performance of complex procedures, particularly in pop-
Program (ACS-NSQIP) database, the Society of Thoracic Sur- ulations at high risk. This report demonstrated that failure to
geons (STS) national database, and the American College of rescue patients after a serious complication was associated with
Surgeons National Trauma Data Bank (NTDB) are all examples an increased death rate in the high-mortality hospitals as com-
of the development of critical tools necessary for such important pared with the low-mortality hospitals. The same authors found
population-based outcomes research to be completed. similar results when analyzing patient outcomes from a Medi-
The National Veterans Affairs Surgical Quality Improve- care database.9
ment Program was initiated in 1991 to improve surgical out-
comes in Veterans Administration (VA) hospitals.6 The NSQIP Effective Teams and Communication
is a risk-adjusted outcomes database comprised of over 90 data Perioperative team building has parallels in the aviation industry
elements gathered by specially trained nurses who review the in that teams intermittently come together for relatively short,
preoperative, intraoperative, and postoperative periods. This defined periods of time to accomplish a complex task, requiring
database was validated in the VA system, in which the data are the specialized skills of each team member, under potentially
provided back to hospitals and providers and used to inform stressful conditions in which there is inherent danger. A recent
strategies aimed at reducing morbidity and mortality, with con- investigation of the impact of implementing a standardized sur-
siderable success (Fig. 10-1).7 gical safety checklist (Box 10-1) has demonstrated that compli-
The ACS-NSQIP is a national civilian database launched cation rates ranged from 6.1% to 21% (total of 11%) of 3733
in 2004 as an outgrowth of the VA NSQIP. The ACS-NSQIP surgical patients across eight major hospitals in eight cities
is a prospectively collected, multi-institution clinical registry worldwide and the rate of postoperative death ranged from 0.8%
database of general and vascular surgery patients that provides to 3.7% (total of 1.5%) prior to implementation of the check-
feedback on risk-adjusted outcomes to member hospitals across list.10 After implementation of the surgical checklist with preop-
the United States for quality improvement purposes; however, erative sign-in, time-out and postprocedural sign-out elements
the data are also available for population-based research. A the overall rate of complications decreased to 7% (range, 3.6%
recent examination of the ACS-NSQIP data reviewed the to 9.7%) and the rate of death declined to 0.8% (range, 0% to
overall and major complication rates and risk-adjusted death 1.7%).10
rates of 84,730 patients who underwent inpatient general or The Joint Commission (TJC) has made the implementa-
vascular surgical procedures from 2005 through 2007.8 Inter- tion of the Universal Protocol for the prevention of wrong site,
estingly, the death rates in these surgical patients ranged from wrong-patient, and wrong-procedure surgery, including the
3.5% in the quintile of very low-mortality hospitals to 6.9% in preprocedural time-out, accreditation requirements.11,12 The
the quintile of very high-mortality hospitals (double the rate of Universal Protocol includes the following elements: pre
the low mortality hospitals), whereas the rates of overall and procedural verification, site marking, and final verification
major complications were not significantly different when com- during the preprocedural time-out. The preprocedural verifica-
paring these two groups of hospitals. The difference in overall tion includes verification of the appropriate history and physical
risk-adjusted mortality was almost twice as high after a major examination in the medical record, presence of a signed consent
complication in the very high-mortality hospitals (21.4%) as form, nursing assessment, and preanesthesia assessment (when
204 SECTION I SURGICAL BASIC PRINCIPLES

BOX 10-1 Elements of the Surgical Safety Checklist The time-out that occurs immediately prior to initiation of
the procedure provides a final verification of the correct patient,
Sign In correct site, and correct procedure. The time-out is most effec-
Before induction of anesthesia, members of the team (at least tive when it is standardized and conducted consistently across
the nurse and an anesthesia professional) state that the follow- all procedural areas of the hospital; it should be conducted
ing have been done: immediately before starting an invasive procedure or making the
The patient has verified his or her identity, surgical site and incision. It is initiated by a designated member of the procedural
procedure, and consent. team and involves the immediate members of the procedure
The surgical site is marked or site marking is not team. During the time-out, other activities are suspended to as
applicable. much as possible so that team members may focus on active
The pulse oximeter is on the patient and functioning. confirmation of the patient, site, and procedure. Any new team
All members of the team are aware of whether the patient members should be introduced. At a minimum, the team
has a known allergy. members must agree on the correct patient identity, correct
The patients airway and risk of aspiration have been procedural site (with the site marking verified when laterality or
evaluated and appropriate equipment and assistance are level is a concern), and procedure to be done. Finally, comple-
available. tion of the time-out should be documented for the patient
If there is a risk of blood loss of at least 500mL (or 7mL/ medical record.
kg body weight in children), appropriate access and fluids This description of the surgical time-out defines the
are available. minimal criteria to satisfy TJC requirements; however, if these
Time-Out are the only elements included in the process, the positive impact
Before skin incision, the entire team (nurses, surgeons, anes- will be limited. The Crew Resource Management (CRM) train-
thesia professionals, and any others participating in the care of ing and discipline around the Universal Protocol enables orga-
the patient) states aloud the following: nizations to enhance communication between health care
Confirms that all team members have been introduced by professionals in the perioperative management teams and to
name and role incorporate process improvement measures, such as those
Confirms the patients identity, surgical site, and procedure defined by the SCIP, into the checklists. These evidence-based
Reviews the anticipated critical events interventions include timely administration of perioperative
Surgeon reviews critical and unexpected steps, opera- antibiotics, administration of beta blockers in patients at risk of
tive duration, anticipated blood loss ischemic heart disease, venous thromboembolism prophylaxis,
Anesthesia staff review concerns specific to patient and intraoperative normothermia. The time-out checklist may
Nursing staff reviews confirmation of sterility, equip- also include availability and sterility of instrumentation and
ment availability, other concerns implantable devices. The conclusion of the optimal surgical
Confirms that prophylactic antibiotics have been adminis- time-out should include an open invitation for any member of
tered 60min before incision is made or that antibiotics are the team to speak up at any time during the procedure if she or
not indicated he recognizes a problem that poses risk to the patient or health
Confirms that all essential imaging results for correct patient care team.
are displayed in OR
Sign Out Handoffs and Surgical Safety
Before the patient leaves the operating room, the following are During the surgical experience, patients are managed by teams
done: of physicians and nurses that commonly transfer primary
Nurse reviews the following aloud with the team: responsibility for patient care between one another. Unfortu-
Name of procedure, as recorded nately, transfers of care have been demonstrated to be associated
That needle, sponge, and instrument counts are com- with an increase in medical errors.13,14 In a recent review of 258
plete (or not applicable) surgical errors from closed malpractice claims, breakdowns in
That specimen (if any) is correctly labelled, including communication were determined to be a factor in almost 25%.15
patients name Another study examined the handover of patients in the inten-
Whether there are any issues with equipment that sive care unit (ICU) and noted that significant degradation of
need to be addressed important patient information occurred frequently during these
The surgeon, nurse, and anesthesia professional review transfers of care.16 Medication discrepancies have also shown to
aloud the key concerns for the recovery and care of the be common in resident sign-out lists.
patient. To address these communications challenges, experts have
turned to other high-risk industries, such as nuclear power and
Adapted from Haynes AB, Weiser TG, Berry WR, etal: A surgical safety checklist the space program, to understand their strategies better and
to reduce morbidity and mortality in a global population. N Engl J Med 360:491 apply useful practices to health care. There are unique differences
499, 2009. between the work environments in these industries and health
care, which can present challenges to the direct transfer of
applicable). It also includes verification that the necessary diag- approaches. However, the use of checklists and structured com-
nostic laboratory, radiology, and other test results are present and munication procedures such as SBAR (situation-background-
properly displayed. The requirement for and presence of blood assessment-recommendation) have been advocated almost
products, implants, devices, and/or special equipment is also universally.17 As a result of this emerging evidence of the impor-
confirmed in the preprocedural verification process. tance of communication in medical errors, TJC made the
Perioperative Patient Safety Chapter 10 205

standardization of hand-off communications a national patient directions by verbal acknowledgment, and a plan of management

SECTION I SURGICAL BASIC PRINCIPLES


safety goal and an area of focus for institutional reviews. Also, should be agreed on. In addition, the surgeon and operating
the use of simulation has been advocated to improve the effec- room (OR) team must communicate regarding the instrument,
tiveness of teaching hand-off procedures and for use in the needle, and sponge counts and requirement, if any, for intraop-
assessment of performance. As reviewed elsewhere in this chapter, erative imaging to confirm the absence of unplanned retained
the use of information technology has been demonstrated to foreign bodies. Confirmation of the disposition of pathologic
improve patient hand-offs and has been leading to the imple- specimens should also occur between the surgeon and circulat-
mentation of new tools in large health care systems, such as the ing nurse prior to the surgeon and patient leaving the operating
Veterans Administration. room. In addition, the checkout procedure should include dis-
cussion between the surgeon and anesthesiologist regarding
Phases in Perioperative Care postoperative disposition of the patient. This should include
Preoperative Phase Preoperative preparation, review of the agreement about the need for special postoperative care, such as
clinical history, relevant radiologic images, pathology, relevant intensive care, anticipated prolonged recovery room stay, and
anatomy, and anticipation of potential problems that may be need for telemetry.
encountered during the course of the operative procedure are
essential components of the surgeons preparation. Communica- Postoperative Phase For most patients, the immediate postop-
tion with the patient and/or family members is critical to ensure erative period consists of a monitored period of transition to
that all are in agreement regarding the operation, site of proce- normal neurophysiologic function, with some treatment of pain,
dure, risks, benefits, and possible alternative approaches. Docu- nausea, and body temperature being relatively common.
mentation of a discussion of these should be included as part of Although relatively rare, catastrophic complications such as
the consent for operation. Comorbidities and their possible myocardial ischemia or infarction, stroke, airway obstruction,
impact on outcome should be assessed and understood by the and acute hemorrhage may occur. In addition, there is occasion-
surgeon, the anesthesiologist, and the patient and family. ally the need for continued pharmacologic and fluid therapy
management during the early postoperative phase. Early recog-
Intraoperative Phase The operating room is a complex and often nition and effective intervention to correct physiologic derange-
high-stress environment in which there are multiple opportuni- ments associated with impending crisis are key to rescuing
ties for the occurrence of errors or events that could adversely patients at risk. This requires an efficient and collaborative team
affect patient outcomes. As noted, the Universal Protocol initi- of caregivers who have instituted a system of excellent commu-
ated in the preoperative holding area is continued and com- nication. Effective intervention also requires multidisciplinary
pleted in the operating room to minimize the risk of wrong collaborative teams of providersoften including specialty con-
surgery. We believe that the time of anesthetic induction, patient sultative servicesappropriate escalation of care, timely imple-
positioning, and performance of the time-out are critical por- mentation of antibiotic therapy for sepsis, effective critical care
tions of any surgical procedure that requires the presence and teams, and appropriate interventions aimed at the source of the
collaborative involvement of the attending surgeon, the anesthe- complication. Ghaferi and colleagues9 have pointed out that
siologist and/or anesthetist, scrub nurse, and circulating nurse effective recognition and communication regarding patient
to achieve the maximum safety and quality of care. This is a status requires a high-quality nursing staff, with staffing ratios
critical time for the surgeon and anesthesiologist to communi- sufficient to enable nurses to perform regular patient assess-
cate regarding the anticipated intraoperative course, anticipated ments. For example, studies have demonstrated an association
problems, including blood loss, anticipated case length, and any between a high nurse-to-bed ratio and decreased perioperative
special requests. Special requests may include avoidance of exces- mortality.18 The higher nurse-to-patient ratios are also associated
sive crystalloid in an older patient with a history of heart failure with greater job satisfaction and reduced rates of burnout among
or chronic obstructive pulmonary disease. It may also include nurses. As noted, appropriate and timely escalation of care is
the avoidance of long-acting muscle relaxants in patients under- crucial for patients who have become ill from a serious compli-
going resections that are near important motor nerve structures, cation. This often involves transfer of a patient to an ICU, in
such as in the face, neck, or axilla. This early phase of the which an increased nurse-to-patient ratio is associated with
operation is also an excellent opportunity to put all in the room reduced resource use and daily rounds by a dedicated inten
at ease, introduce any new team members and, as noted earlier, sive care physician is associated with reduction in inpatient
invite participants to speak up at any time during the procedure mortality.19
if there are questions or concerns. To enhance the safe conduct
of the operation, a neutral zone between the surgeon and scrub Physician Fatigue and Surgical Safety
nurse should be defined and agreed on for sharp instruments. There has been increased focus on the relationship of physician
The surgeons responsibility is to perform the operative fatigue and patient safety that gained prominence with the
procedure with the utmost skill, efficiency, and safety. During publication of To Err Is Human.1 Based in part on emerging data
the surgical procedure, the surgeon should continually com- regarding physician fatigue and performance, including in
municate with the anesthesiologist and the rest of the team the procedural environment,20 the Accreditation Council for
regarding the progress of the operation, any unexpected find- Graduate Medical Education (ACGME) mandated duty hour
ings, hemorrhage, or technical complications. Similarly, the restrictions for physician in training in 2003, with recent recom-
anesthesia team should communicate any significant changes in mendations by an IOM committee to extend those restrictions.21
the physiologic status of the patient, especially those related to Some studies have demonstrated variable results regarding
hypotension, O2 desaturation events, and critical laboratory the impact of these changes on patient safety. A study of interns
values. Such communications should be verified in both working in ICUs has shown that the medical error rate is reduced
206 SECTION I SURGICAL BASIC PRINCIPLES

with work hour restrictions.22 However, another study Use of Information Technology to Enhance
has shown higher error rates after the implementation of work Surgical Patient Safety
hour restrictions in New York.23 Larger scale studies have The IOMs seminal report, Crossing the Quality Chasm: A New
demonstrated similar variability. Investigations of all Medicare Health System for the 21st Century, called for a radical redesign
beneficiaries and VA hospitals24 have failed to demonstrate a of the health care system, with a focus on the use of information
change in mortality for surgical patients. However, a more recent technology as a means to improve the quality and safety of
investigation has noted a reduction in the percentage of surgical health care and reduce cost.33a Since then, the federal govern-
complications attributed to providers, from 48.3% to 38.6%, ment has made significant investments to improve the develop-
and a reduction in mortality rate, from 1.9% to1.1%, after the ment and deployment of health care information technology
restrictions, with the improvement attributed to the increased (HCIT), including the establishment of a federal executive posi-
participation of attending surgeons in clinical care and possibly tion of National Coordinator for Health Information Technol-
to other concurrent improvement initiatives.25 ogy and financial incentives in efforts to promote widespread
Various hypotheses have been advanced to explain the vari- adoption of HCIT.
able results of duty hour restrictions. One argument is that the
initial restriction of duty hours did not limit prolonged shifts Computerized Order Entry
that were thought to have the greatest impact on performance. Computerized provider order entry (CPOE) is recommended
In addition, the resulting increase in patient hand-offs, which by the Agency for Healthcare Research and Quality and the
are known to increase the risk of errors, may offset the improved National Quality Forum as one of the 30 safe practices for better
safety from reduced fatigue. Duty hour restrictions may not health care. The Leapfrog group has also recommended CPOE
necessarily translate into reduced fatigue. It has also been sug- implementation as one of its first three recommended leaps for
gested that shift length has a greater impact on patient safety improving patient safety. These positions are informed by the
than overall hours.26 Hour restrictions may also interfere with evidence that 90% of medication errors occur at the ordering or
physician education, which can negatively affect clinical perfor- prescribing step and that clinical decision support systems
mance and patient safety. These effects are certainly reinforced (CDSSs), which are the engines for CPOEs, have been demon-
by surgical resident perceptions. strated to reduce drug administration errors significantly.34
Several recent surveys have shown a negative impact of Despite these strong recommendations, hospitals have been
resident duty hour restrictions on attending surgeon job satisfac- slow to implement CPOE. A 2009 study found that only 17%
tion, time for teaching, and overall workload.27,28 An early inves- of U.S. hospitals had implemented a CPOE system, and the
tigation after the duty hour restrictions showed that general proportion of outpatient practices using CPOE is even smaller.35
surgeons worked a mean (standard deviation [SD]) of 73.8 Cost is likely a major factor, as is the resistance to change at the
(14.1) hours/week and only 44% reported 1 day/week away organizational and individual provider levels coupled with a lack
from clinical duties.29 In a study of surgical errors, fatigue was of systems that have been implemented successfully in a variety
self-reported by attending physicians as a contributing factor in of clinical settings.
16% of adverse events.30 Although a retrospective review of CPOE and computerized prescription writing already have
cardiac procedures performed by sleep-deprived surgeons has shown the ability to reduce medical errors and variability in
shown no difference in complication rates,31 more recent work surgical patient care. A large study in Texas has demonstrated
has shown an association between limited sleep opportunity, an improvement in mortality for patients undergoing coronary
increased work duration, and complication rates.32 As a result of artery bypass grafting (CABG).36 Vikoren and colleagues37 have
these emerging data, some have argued that attending surgeon demonstrated the ability of a CPOE to reduce variability in
duty hours should be limited as well, and a variety of strategies patient care for patients undergoing total joint surgery. Compli-
have been proposed, such as implementing a surgical hospitalist ance with medication and care protocols related to national
service. quality initiatives, such as SCIP, are improved with the use of
Despite the conflicting data, it seems logical that rested CPOE systems, as demonstrated for perioperative blood glucose
physicians make better decisions that should improve patient control,38 prophylactic antibiotic administration,39 and other
safety. For these reasons, work week and shift length limitations, quality initiatives.
napping, and other validated strategies to reduce fatigue may Other work, however, has shown no change in medication
have beneficial effects on surgical patient safety. However, the errors for surgical patients after CPOE implementation.40 One
resulting expansion of the labor pool is estimated to cost as much study has shown a reduction in medication errors but an overall
as $3.4 million/life saved, making this a substantial economic increase in mortality, thought to have resulted from other effects
issue for the health care system, especially for academic medical on patient care work flow.41 These results have prompted inves-
centers.33 Moreover, the known safety risks that result from the tigations of all the factors related to CPOE implementations that
increased number of lesser trained providers and the increased could affect patient care (Box 10-2).42-44 There are also issues
frequency of hand-offs must be considered. These concerns may related to the underlying clinical decision support systems that
be addressed by strategies to improve competency through the may affect outcomes. Specifically, the guidelines may not be
use of communication tools, such as checklists, and structured applicable to all clinical environments and may not be current.
communications at critical events, such as transitions in care. Consequently, Weir and associates have recommended the
There is also a significant need for additional research to under- implementation of a set of safety indicators that should be
stand the complex association between interventions designed tracked during CPOE implementation to ensure that any risks
to improve physician fatigue and their relationship to the safety are mitigated.45 Also, clinicians must ensure that the decision
of surgical patients in complex health care delivery systems support algorithms are reviewed and validated prior to imple-
better. mentation to benefit from drug interaction alerts and other
Perioperative Patient Safety Chapter 10 207

BOX 10-2 Types of Unintended Consequences of care organizations that seek such transformative changes (see

SECTION I SURGICAL BASIC PRINCIPLES


Computerized Provider Order Entry Systems earlier).
How do we change the culture to incorporate these con-
More or new work for clinicians cepts? At our institution (Vanderbilt University Medical Center,
Unfavorable work flow issues Nashville, Tenn), the commitment has been made to change the
Never-ending system demands culture from the top of the organization. Of the five pillars of
Problems related to persistence of paper orders excellence that form the framework for setting organizational
Unfavorable changes in communication patterns and goals and direction, quality is the central pillar. The other four
practices pillars include people, service, growth and finance, and innova-
Negative feelings toward the new technology tion. Under the quality pillar, institutional goals are set on an
Generation of new types of errors annual basis and the entire medical center is managed and oper-
Unexpected changes in an institutions power structure, ated within a framework to accomplish the goals that have been
organizational culture, or professional roles set. Each year, the goals become more challenging to continue
Overdependence on the technology to drive improvements.
From Campbell EM, Sittig DF, Ash JS, etal: Types of unintended consequences
Institutionally, there is a chief quality officer who works
related to computerized provider order entry. J Am Med Inform Assoc 13:547556, with clinical leadership, nursing, and administration within the
2006.44 patient care areas to identify priorities and identify necessary
resources to support quality improvement and address safety
issues promptly. Our Center for Clinical Improvement provides
critically important decision support measures.46 Similarly, a assistance with resources to support root cause analyses of patient
system was developed to test CPOE systems against the criteria deaths, adverse outcomes, and near-misses. Reporting adverse
established by the Leapfrog group that CPOEs should detect at outcomes and near-misses is encouraged in a blame-free envi-
least 50% of common prescribing errors.47 ronment. Within the Perioperative Enterprise, there is a Surgical
Site Infection Collaborative and Perioperative Quality and
Other Applications for Information Technology in Safety Committee that collaborate with each another and that
Surgical Patient Safety receive input from the various surgical services, perioperative
There is evidence to suggest that a significant number of surgical nursing services, and infection control services. Each surgical
errors occur because of poor communication and lack of access service conducts weekly to biweekly morbidity, mortality, and
to critical patient information. In a root cause analysis of oper- improvement (MM&I) conferences. Cases identified in these
ative and postoperative events from 1995 to 2002, TJC found service-level MM&I conferences that exemplify systems con-
that almost 70% of events were associated with communication cerns or issues are referred to a multidisciplinary MM&I com-
failures. Other studies have shown that transitions of care are mittee, which selects cases for presentation at an institution-wide
associated with higher risk for errors, as well as demonstrating MM&I conference that is held on a quarterly basis.
an increase in medical errors with an increase in the number of Organizational transparency is achieved through the
patient transfers.14 Various strategies have been successfully used sharing of performance data across the institution. Quality and
to improve surgical safety, including the use of standardized safety performance data are fed back to the clinicians and staff
communication events and checklists. Several information tech- on a monthly basis, with benchmark comparators when avail-
nology solutions have been suggested to enhance these and other able. Multidisciplinary teams are central to how we are organized
strategies to improve surgical patient safety. The use of computer around patient care, quality, and safety. The patient is central to
checklists has been demonstrated as a means to transfer patient all we do in the clinical care setting and, within our service pillar
information more effectively and efficiently. Similarly, a comput- goals, are patient satisfaction targets dependent on provider or
erized medication reconciliation process can improve continua- physician-patient communication. Under our people pillar goals
tion of medications postoperatively.48 The use of information are faculty and staff satisfaction goals, because we believe that
management systems for the documentation of perioperative health care workers who are happy in their roles and feel fulfilled
care also provides the opportunity for the use of clinical decision provide better quality care. We reward such behaviors financially
support algorithms and care alerts to improve antibiotic redos- and symbolically. We teach the students in our medical center,
ing49 and compliance with surgical time-out elements. at all levels, how each member of the team contributes to quality
Emerging technologies may also prove to be beneficial, care and safety, and this is incorporated into the medical and
including the use of bar code and radiofrequency tracking nursing curriculum.
systems as a means to eliminate never events, such as wrong-
patient and wrong-site surgery and retained foreign objects.
Intraoperative video systems may also allow the opportunity to
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