Академический Документы
Профессиональный Документы
Культура Документы
PERIOPERATIVE
PATIENT SAFETY
R. Daniel Beauchamp and Michael S. Higgins
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
2.5 2.75
2.57 2.55
2.38 2.28 2.33
(Percent)
95
99
19
.1
Au
4
99
99
www.cbo.gov/ftpdocs/104xx/doc10453/08-
t. 1
1
n.
Oc
Ja
13-VHA.pdf].)
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
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
Fry DE: Surgical site infections and the surgical care improvement 6. Khuri SF, Daley J, Henderson W, et al: The Department of
project (SCIP): Evolution of national quality measures. Surg Infect Veterans Affairs NSQIP: The first national, validated, outcome-
(Larchmt) 9:579584, 2008. based, risk-adjusted, and peer-controlled program for the mea-
surement and enhancement of the quality of surgical care. National
This is a recent comprehensive review of the national SCIP effort to VA Surgical Quality Improvement Program. Ann Surg 228:
reduce SSI. The National SIP Project was an initiative sponsored jointly 491507, 1998.
by the Centers for Medicare and Medicaid Services and the U.S. Centers 7. DePalma RG: Surgical quality programs in the Veterans Health
for Disease Control and Prevention to decrease the incidence of SSI in Administration. Am Surg 72:9991004 11331048, 2006.
major surgical procedures. 8. Ghaferi AA, Birkmeyer JD, Dimick JB: Variation in hospital
mortality associated with inpatient surgery. N Engl J Med 361:
Ghaferi AA, Birkmeyer JD, Dimick JB: Variation in hospital mortal- 13681375, 2009.
ity associated with inpatient surgery. N Engl J Med 361:13681375, 9. Ghaferi AA, Birkmeyer JD, Dimick JB: Complications, failure to
2009. rescue, and mortality with major inpatient surgery in medicare
patients. Ann Surg 250:10291034, 2009.
This was a landmark study of 84,730 patients who had undergone 10. Haynes AB, Weiser TG, Berry WR, et al: A surgical safety check-
inpatient general and vascular surgery from 2005 through 2007, using list to reduce morbidity and mortality in a global population.
data from the American College of Surgeons National Surgical Quality N Engl J Med 360:491499, 2009.
Improvement Program. 11. The Joint Commission: National patient safety goals, 2010
(http://www.jointcommission.org/PatientSafety/NationalPatient
Haynes AB, Weiser TG, Berry WR, et al: A surgical safety checklist SafetyGoals).
to reduce morbidity and mortality in a global population. N Engl J 12. Traynor K: Joint Commission updates National Patient Safety
Med 360:491499, 2009. Goals for 2010. Am J Health Syst Pharm 66:20622064,
2009.
Surgery has become an integral part of global health care, with an esti- 13. Horwitz LI, Moin T, Krumholz HM, et al: Consequences of
mated 234 million operations performed yearly. This study demonstrates inadequate sign-out for patient care. Arch Intern Med 168:
the efficacy of the surgical safety checklist in diverse settings. 17551760, 2008.
14. Kitch BT, Cooper JB, Zapol WM, et al: Handoffs causing patient
Khuri SF, Daley J, Henderson W, et al: The Department of Veterans harm: A survey of medical and surgical house staff. Jt Comm J
Affairs NSQIP: The first national, validated, outcome-based, risk- Qual Patient Saf 34:563570, 2008.
adjusted, and peer-controlled program for the measurement and 15. Greenberg CC, Regenbogen SE, Studdert DM, et al: Patterns of
enhancement of the quality of surgical care. National VA Surgical communication breakdowns resulting in injury to surgical
Quality Improvement Program. Ann Surg 228:491507, 1998. patients. J Am Coll Surg 204:533540, 2007.
16. Pickering BW, Hurley K, Marsh B: Identification of patient infor-
This study was designed to provide reliable risk-adjusted morbidity and mation corruption in the intensive care unit: Using a scoring tool
mortality rates after major surgery to the 123 Veterans Affairs Medical to direct quality improvements in handover. Crit Care Med
Centers (VAMCs) performing major surgery, and to use risk-adjusted 37:29052912, 2009.
outcomes in the monitoring and improvement of the quality of surgical 17. Haig KM, Sutton S, Whittington J: SBAR: A shared mental
care to all veterans. model for improving communication between clinicians. Jt
Comm J Qual Patient Saf 32:167175, 2006.
Veasey S, Rosen R, Barzansky B, et al: Sleep loss and fatigue in resi- 18. Aiken LH, Clarke SP, Sloane DM, et al: Hospital nurse staffing
dency training: A reappraisal. JAMA 288:11161124, 2002. and patient mortality, nurse burnout, and job dissatisfaction.
JAMA 288:19871993, 2002.
The authors reviewed studies addressing the effects of sleep loss on 19. Pronovost PJ, Jenckes MW, Dorman T, et al: Organizational char-
cognition, performance, and health in surgical and nonsurgical residents. acteristics of intensive care units related to outcomes of abdominal
aortic surgery. JAMA 281:13101317, 1999.
20. Weinger MB, Ancoli-Israel S: Sleep deprivation and clinical per-
REFERENCES formance. JAMA 287:955957, 2002.
1. Kohn LT, Corrigan JM, Donaldson MS, editors: To err is human: 21. Ulmer C, Wolman DM, Johns MME, editors: Resident duty
Building a safer health system, Washington, DC, 1999, National hours: Enhancing sleep, supervision, and safety, Washington, DC,
Academy Press. 2008, National Academies Press.
2. Gawande AA, Thomas EJ, Zinner MJ, et al: The incidence and 22. Landrigan CP, Rothschild JM, Cronin JW, et al: Effect of reducing
nature of surgical adverse events in Colorado and Utah in 1992. interns work hours on serious medical errors in intensive care
Surgery 126:6675, 1999. units. N Engl J Med 351:18381848, 2004.
3. Leape L, Berwick D, Clancy C, et al: Transforming health care: A 23. Poulose BK, Ray WA, Arbogast PG, et al: Resident work hour
safety imperative. Qual Saf Health Care 18:424428, 2009. limits and patient safety. Ann Surg 241:847856, 2005.
4. Bratzler DW, Houck PM: Antimicrobial prophylaxis for surgery: 24. Volpp KG, Rosen AK, Rosenbaum PR, et al: Mortality
An advisory statement from the National Surgical Infection Pre- among patients in VA hospitals in the first 2 years following
vention Project. Am J Surg 189:395404, 2005. ACGME resident duty hour reform. JAMA 298:984992,
5. Fry DE: Surgical site infections and the surgical care improvement 2007.
project (SCIP): Evolution of national quality measures. Surg 25. Privette AR, Shackford SR, Osler T, et al: Implementation of
Infect (Larchmt) 9:579584, 2008. resident work hour restrictions is associated with a reduction in
Perioperative Patient Safety Chapter 10 209
mortality and provider-related complications on the surgical 38. Donaldson S, Villanuueva G, Rondinelli L, et al: Rush University