PATIENT SAFETY AND QUALITY CARE
| PRACTICE STANDARDS FOR GENERAL SURGEONS: WHAT HAVE WE LEARNED? —Hiram C. Polk, Jr, MD,
Ben A. Reid, Sr, Professor and Chairman, Department of Surgery, University of Louisville School of Medicine, KY
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| Surgery’s history of quality: American College of Surgeons (ACS) origin of hospital accreditation; American Board
of Surgery (ABS) thought adequate, until death rates in common operations worsened (eg, 15%-20% after colon resection);
elective colon resection “litmus test” for quality (complication rates and death rates differ)
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| Quality goals: no pneumothoraces from insertion of central line; no central-line infections in patients on total parenteral
nutrition (TPN); no deaths after elective surgery; example of airline industry; professional atmosphere—lacking in most
operating rooms (ORs; eg, talking, music); vertical leadership no longer practiced, replaced by horizontally built teams
that can utilize crew resource management
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| Kaiser Family Foundation survey (2004): focused on what public thinks about medicine in United States; sources
of information on medical errors—61% from media; nearly 30% of public had direct or indirect experience of major
medical error; perception of medical error—public knows twice as much about medical errors as they do about medical
quality; 75% of respondents blame physicians and favor public reporting of medical results
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 | Markers of physician quality: high volume; board certification; few lawsuits; good communication skills; association
with school of medicine; being named “best doctor in town”
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| Causes of medical errors: overworked and hurried physicians; nursing shortage; poor communication; poor training
(training of surgeons in United States best of any profession in world); impact of health maintenance organizations
(HMOs) that try to drive cost down to detriment of quality; bad physician handwriting; complexity of modern medicine
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| Other determinants of perceived quality: opinion of family and friends—decreasing in importance as public increasingly
seeks information on quality from Internet and other sources; low physician turnover—viewed positively as indicator
of good insurance plan with good physicians; personal experience of quality care—number one determinant of perception
of quality (competing only with access and affordability); convenience—often more important than quality, especially
in rural areas where people do not want to drive long distances for simple surgery
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| Suggestions for preventing errors: give physicians more time; develop error-avoidance system (eg, airline safety); better
training; reporting errors; more nurses; less-fatigued physicians; punish physicians
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| Patient safety: quality movement to date ill-focused; speaker argues for shifting focus to safety; of 85,000 people having
elective operations on any day, many likely to suffer adverse events due to unsafe systems; speaker argues quality needs
to start there
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| Risk assessment: 25 yr ago, cardiac surgeons at Department of Veterans Affairs (VA) devised National Surgical Quality
Improvement Program (NSQIP) method for risk assessment (≈70% risk adjustment; ≈30% quality improvement); effect
to make risk stratification important and to improve VA (NSQIP parameters mandatory for any operation today); ≈20 yr
ago, Society of Thoracic Surgeons began to develop intricate but valid level playing field for coronary artery bypass, resulting
in some practitioners improving and some ceasing to practice; quality standards well implemented in cardiac surgery
in United States today
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| Quality surgical solutions (QSS): from group of small-town surgeons in Kentucky; quality of care—best quality
least expensive; quality initiatives must be led by physicians; reward physicians for implementing QSS; patient advocate
only appropriate public role for physicians; ways to save money—shorten length of stay, especially under diagnosis related
group (DRG) system; choose reusable rather than disposable laparoscopic instruments (add ≈$1000 to cost of average
case); prescribe medications sparingly after laparoscopic procedures; utilize home health services for patients with
short hospital stay; reduce OR turnover time; reduce number of preoperative consultations (especially cardiologists; saves
$500 per case)
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| Ways to ensure quality: standardization—standard set of orders for each admission and entire stay reduces errors;
performance measures—speaker’s group collected data for each patient on 12 risk factors, 15 process measures, and 8
outcomes; led to statistically meaningful data fast; published in Bulletin of the American College of Surgeons
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| Pilot project on quality practices in surgery (Kentucky): Medicare commissioned study from speaker’s group
(2005); looked at outpatient gallbladder surgery, hysterectomy, major vascular surgery, coronary artery bypass and valve
replacement surgery, colon resection, and total hip and total knee replacements; most patients on Medicare (large number;
deaths and complications significant); 200 surgeons contributed; specialty leaders developed and wrote protocol and
report form; results—found reports done by nurse abstractors in hospital more precise, but doctors’ reports more accurate;
did not find single clinical situation where safer practices more expensive, in fact money saved; study report—
excellent manual about what to do in your hospital; available from ACS
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| Public reporting: likely to emerge soon, in speaker’s opinion; to be comfortable with public reporting, surgeon must
have risk-adjustment scheme; malpractice attorneys think participation in active quality program plus for clients
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| Maintenance of certification: ABS now has continuous maintenance of certification and considering requiring surgeons
to be involved in ongoing quality assessment; critical to engage surgeon leaders and pay surgeons for data
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| Surgical Care Improvement Project (SCIP): subcontract from Centers for Medicare and Medicaid Services
(CMS); based on Kentucky pilot project (sampled same 6 procedures); results—0.6% death rate in 5500 elective operations
in Kentucky in 2004, ie, 32 deaths, of which only 15 preventable; only 15 myocardial infarctions (MIs), majority of
which occurred in patients undergoing colon resection; 15 pulmonary emboli (10 in patients undergoing hip or knee replacement;
called public health threat but incidence low); wound infection—rate reported by surgeons 6 times higher
than reported by hospital, due in part to office follow-up, so accuracy of surgeon data very high; antibiotic prophylaxis—
depends on giving first dose before operation, but not done 42% of time; correct drugs given most of time (cephalosporins),
but drugs not stopped on time (40% of time); 8% of physicians do not choose safe prophylactic drug, and their patients
4.5 times more likely to die from surgery (surrogate for “bad doctoring”)
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| Other steps: pay attention to patient’s blood glucose (diabetics and nondiabetics); patients on β-blockers must keep taking
them (lessens postoperative MI rate, and MIs that occur less likely to be fatal); communicate with nurses; never give
prophylaxis >48 hr; never let patient become cold; give formal patient education; elevate head of bed
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| Ideas for action: hospitals should use surgical time out; add temperature, glucose, and antibiotic to monitoring template;
degree in public health good entrée into quality management
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| PREVENTION AND MANAGEMENT OF LAPAROSCOPIC COMMON BILE DUCT INJURIES —Keith D. Lillemoe,
MD, Professor and Chairman, Department of Surgery, Indiana University School of Medicine, Indianapolis
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| Bile duct injury (BDI): >600,000 cholecystectomies annually in United States, and >90% of these done laparoscopically;
before introduction of laparoscopic cholecystectomy (LC), 2 large studies found incidence of bile duct injury 1 to 2
patients per 1000 open cholecystectomies
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| Incidence in LC: most series reporting institutions’ early experience with procedure contained 1 BDI in first 100 LCs,
for incidence of ≈1%; many surgeons report personal series of ≥1000 LCs with no BDI; truly accurate picture comes
from statewide or large population-based surveys; 3 series from early stages of LC found incidence 4 to 6 patients per
1000 LCs, ie, 3 to 5 times higher than rate expected in open cholecystectomy
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| Wherry’s study: large retrospective study of BDI in military facilities during early years of LC (1990s); after 5 yr, when
learning curve past, data collected from same hospitals showed no decrease in incidence, suggesting LC associated with
increased incidence of BDI
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| Mechanisms of injury: misidentification of common bile duct as cystic duct—responsible for majority of injuries;
surgeon incorrectly perceives single tubular structure coming down from neck of gallbladder as cystic duct; anatomic distortions,
including shortened cystic duct, large stone impacting neck of gallbladder, pseudo-Mirizzi syndrome, can lead
surgeon to divide common bile duct instead of cystic duct; common hepatic duct—injury also occurs when surgeon encounters
second tubular structure (common hepatic duct) and misidentifies it as “second cystic duct” (rare); division of
right hepatic artery—leads to bleeding and may make liver ischemic
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| Nature of injury: error results in common bile duct divided in 2 places; removal of segment of bile duct results in shortening
of duct; leakage often follows because duct not clipped adequately, leading to bile leak into peritoneum (bile ascites;
bile fistula)
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| Prevention of injury: define critical view by clearing plane between gallbladder, neck of gallbladder, cystic duct, and
liver before starting; if another structure encountered (eg, hepatic duct), stop and redefine anatomy by careful dissection;
in general, watch for atypical anatomy, particularly accessory duct, and unsuspected bile leakage (not dark bile from gallbladder
but golden bile from liver bed); role of cholangiography—debated; speaker does not do routinely; some data
show incidence of BDI higher in instances where cholangiography not done; cholangiogram must be interpreted correctly;
if bifurcation of hepatic duct and branches of intrahepatic ductal system not distinguishable, cholangiogram not
satisfactory and surgery should not proceed
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| Surgical diagnosis: if injury detected during original surgery (occurs in only 25%-30% of LC-associated injuries), potential
for repair depends on stage at which injury detected; if detected on intraoperative cholangiogram before completely
dividing and clipping duct, many options available; if detected after dividing hepatic duct and excising segment of
bile duct, loss of length precludes end-to-end repair; in most cases, if >1 cm of bile duct lost and surgeon at bifurcation,
Roux-en-Y hepaticojejunostomy necessary step for reconstruction; insert transanastomotic stent for drainage
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| Signs and symptoms: majority of patients present in postoperative period, commonly 4 to 5 days after LC, when patient
home; complaints usually vague and include distention, nausea, anorexia, and low-grade fever; evaluation—
standard laboratory tests, typically liver function tests (LFTs) and serum bilirubin, not necessarily abnormal (free bile
leak into peritoneal cavity may not give cholestatic pattern), and bilirubin elevation may result from reabsorption of bile
from peritoneal cavity
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| Imaging studies: computed tomography (CT)—first step to look for signs of bile leak; bile may present as biloma or free
ascitic fluid throughout peritoneal cavity (bile ascites); bile causes chemical peritonitis, so patient may not have peritoneal
signs; endoscopic retrograde cholangiopancreatography (ERCP)—confirms bile duct transected, but problem is
missing proximal anatomy, ie, segment of bile duct to be used in reconstruction; interventional radiology—next step
before surgery; radiologist can place catheter into biliary tree and decompress system leaking into peritoneal cavity,
transforming condition into controlled bile leak; magnetic resonance cholangiopancreatography (MRCP)—form of
MRI in which contrast given to visualize biliary tree; may enable avoidance of ERCP that may not be helpful
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| Preoperative management of BDI: do not panic; do not need OR immediately; control sepsis; drain collected fluid;
drain biliary tree to control leakage; consider transfer of patient to facility where surgeons have expertise in complex biliary
reconstruction
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| Transhepatic biliary stent: drains biliary tree, closes most bile leaks, so repair done on elective basis
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| Long-term outcomes: reports from pre-LC era with >5-yr follow-up show success rate for bile duct stricture repair
75% to 90%
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| Johns Hopkins study: data on >160 patients from 1990s with major bile duct strictures; of 156 patients with mean age of 43
yr, 145 referred to Johns Hopkins (109 LC injuries); outcomes from 156 patients—mean follow-up in 2001 ≈5 yr; in
series of 107 patients who underwent LC and surgical reconstruction, 94% of patients required no further intervention
during 5-yr follow-up; results better than those in patients who had open cholecystectomy (with or without common duct
exploration); worst results from BDI associated with abdominal trauma or in connection with another surgery, particularly
hepatic resection; of 13 patients that failed, all underwent balloon dilation (only 1 failed and required reoperation); of
overall group of patients, 98% symptom-free and stent-free and on way to return to normal quality of life
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| Quality-of-life assessment: questionnaire sent to patients after successful reconstruction of major BDI; contained 30
items encompassing physical, psychologic, and social domains; compared to unoperated healthy controls and patients who
had LC without complications; significantly impaired quality of life found only in psychologic domain; patients who chose
to sue surgeon had lower quality of life than those who did not sue; among patients who did not sue, quality of life identical
to controls with uncomplicated LC
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Educational Objectives
| The goal of this program is to educate the listener about quality standards in surgery and prevention and management of
laparoscopic common bile duct injury. After hearing and assimilating this program, the clinician will be better able to:
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| 1. Discuss some public perceptions of standards in medicine and medical error.
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| 2. List ways to ensure quality in surgical care.
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| 3. Describe the mechanisms of intraoperative bile duct injury (BDI).
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| 4. Name signs and symptoms of BDI after laparoscopic cholecystectomy.
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| 5. Describe the preoperative work-up of the patient with suspected BDI.
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Suggested Reading
Brush JE Jr et al: Implementation of a continuous quality improvement program for percutaneous coronary intervention
and cardiac surgery at a large community hospital. Am Heart J 152:379, 2006; Choi YS et al: Laparoscopic end-to-
end choledochocholedochostomy for bile duct injury during laparoscopic cholecystectomy. J Laparoendosc Adv Surg
Tech A 16:264, 2006; Davenport DL et al: National Surgical Quality Improvement Program (NSQIP) risk factors can
be used to validate American Society of Anesthesiologists Physical Status Classification (ASA PS) levels. Ann Surg
243:636, 2006; Evans SM et al: Consumer perceptions of safety in hospitals. BMC Public Health 6:41, 2006; Hirano
Y et al: Efficacy of multi-slice computed tomography cholangiography before laparoscopic cholecystectomy. ANZ J Surg
76:693, 2006; Hutter MM et al: Laparoscopic versus open gastric bypass for morbid obesity: a multicenter, prospective,
risk-adjusted analysis from the National Surgical Quality Improvement Program. Ann Surg 243:657, 2006; Joshi
MS et al: Getting the board on board: Engaging hospital boards in quality and patient safety. Jt Comm J Qual Patient
Saf 32:179, 2006; Kaman L et al: Comparison of major bile duct injuries following laparoscopic cholecystectomy and
open cholecystectomy. ANZ J Surg 76:788, 2006; Khuri SF: The NSQIP: a new frontier in surgery. Surgery 138:837,
2005; LEE JG et al: Traumatic rupture of the extra hepatic biliary ducts from external trauma. J Trauma 1:105, 1961;
Manson J: Bile duct injury in the era of laparoscopic cholecystectomy. Br J Surg 93:2006; 158, 2006; McLean TR:
Risk management observations from litigation involving laparoscopic cholecystectomy. Arch Surg 141:643, 2006; Nickkholgh
A et al: Routine versus selective intraoperative cholangiography during laparoscopic cholecystectomy: a survey
of 2,130 patients undergoing laparoscopic cholecystectomy. Surg Endosc 20:868, 2006; Epub 2006 May 12. Pitman
AG: Perceptual error and the culture of open disclosure in Australian radiology. Australas Radiol 50:206, 2006; Ramsey
G: Nurses, medical errors, and the culture of blame. Hastings Cent Rep 35:20, 2005; Way LW et al: Causes and prevention
of laparoscopic bile duct injuries: analysis of 252 cases from a human factors and cognitive psychology perspective.
Ann Surg 237:460, 2003; Wherry DC et al: An external audit of laparoscopic cholecystectomy in the steady state performed
in medical treatment facilities of the Department of Defense. Ann Surg 224:145, 1996; Wootton JC: The quality
of information on women's health on the Internet. J Womens Health 6:575, 1997
Faculty Disclosure
In adherence to ACCME guidelines, the Audio-Digest Foundation requests all lecturers to disclose any significant financial
relationship with the manufacturer or provider of any commercial product or service discussed. For this issue, Dr. Polk discloses
he is one of 50 surgeon owners of a quality improvement company called Quality Surgical Solutions PLLC.
Drs. Polk and Lillemoe were recorded April 27, 2006, in Charleston, SC, at the 35th Annual Postgraduate Course in Surgery,
sponsored by the Medical University of South Carolina, Department of Surgery. The Audio-Digest Foundation thanks
the speakers and the sponsor for their cooperation in the production of this program.
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