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Renewal of Surgical Quality and Safety Initiatives: A Multispecialty Challenge
SPECIAL ARTICLE
RENEWAL OF SURGICAL QUALITY AND SAFETY INITIATIVES
Renewal of Surgical Quality and Safety Initiatives: A Multispecialty Challenge HIRAM C. POLK, JR, MD The quality and safety movement in surgical specialty practice is gaining momentum. On the basis of risk-adjusted outcomes of coronary artery surgery and the improved risk assessment in the Veterans Affairs system, a growing array of surgical specialists has focused on recognition of legitimate risk factors, identification of performance measures that are valid surrogates for better practices, and refinement of risk-adjusted outcomes. Recognition of educational needs, personal practice patterns, and systems deficiencies now permits a broad-based application of long-standing primarily medical issues to elective surgical procedures in an organized and integrated fashion. Approximately 85,000 patients per day undergo elective operations in the United States. A platform based on physician involvement and leadership has been tested in the Surgical Care Improvement Project, funded by a subcontract from the Centers for Medicare and Medicaid Services. This effort has defined factors worthy of further verification and provides a framework for an ethical and valid pay-for-performance scheme.
Mayo Clin Proc. 2006;81(3):345-352 ASA = American Society of Anesthesiologists; CMS = Centers for Medicare and Medicaid Services; DVT = deep venous thrombosis; NSQIP = National Surgical Quality Improvement Program; SCIP = Surgical Care Improvement Project; STS = Society of Thoracic Surgeons; VA = Veterans Affairs; VTE = venous thromboembolism
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here is an abiding and renewed emphasis in quality and safety in medicine. This interest reflects public attitudes, which are inevitably prodded by print and visual media. A recent Kaiser Family Foundation study1 was summarized and edited for its surgical implications.2 Clearly, the public is aware of quality variations, is progressively knowledgeable about indices of quality and safety, and tends to use this information, to some degree, in its personal medical choices. Major monographs from the Institute of Medicine3,4 have sequentially provided more focus, notably the latest one explicitly entitled Patient Safety.5 These renewed efforts have to date emphasized the outpatient medical management of chronic diseases such as diabetes mellitus, obesity, and hypertension. Physicians and nurse practitionFrom the Department of Surgery and Price Institute of Surgical Research, University of Louisville School of Medicine, Louisville, Ky. Dr Polk is one of 60 surgeon-owners of Quality Surgical Solutions, PLLC, currently a nonprofit entity, which contributed data to this article. Address reprint requests and correspondence to Hiram C. Polk, Jr, MD, Department of Surgery, University of Louisville, Louisville, KY 40292 (e-mail: [email protected]). © 2006 Mayo Foundation for Medical Education and Research
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ers in internal medicine and family practice have identified and further refined treatment benchmarks, and growing numbers of professionals meet these targets. Notably, elective surgery, which serves 85,000 patients per day in the United States, has received scant attention. Because death and measurable disability as a result of subpar medical or surgical care are uncommon, surrogates for quality outcomes have become popular and mathematically sound measures of performance. Surgeons’ commitments to these standards are at least a century old, but application has been uneven and inconsistent. However, there is hope. The longstanding and lamented surgical mortality and morbidity conference is being replaced by new and improved versions.6 The purpose of this article is to examine current trends related to surgical quality and safety and to stress that this is a multispecialty challenge for all surgeons, anesthesiologists, internists, and family practitioners. RECENT SURGICAL PROGRESS Early studies of death after surgery varied between celebrating surgical virtuosity and misapplying credit for improvements.6 A good example is the sharp reduction in hospital deaths after major resections of the colon or rectum, widely ascribed to the benefits of oral bowel preparation and/or systemic antibiotics. In fact, the improvements a decade earlier (1935-1939) coincide better with the institution of modern blood banking.7 In any case, an early contemporary quality improvement program is attributed to the Society of Thoracic Surgeons (STS) and included a detailed examination of death associated with elective coronary artery bypass operations, which created a stratification of risk scheme that is now an accepted national norm.8,9 This process can be viewed as a sophisticated extension of the New York Heart Association classification. More precise adjustments in risk factors for perioperative deaths set the stage for more objective comparisons, and patient referrals began to reflect documented quality in risk-adjusted clinical outcomes. In a similar sense, the Veterans Affairs (VA) medical system was under intense scrutiny 15 years ago for unacceptably high death rates after cardiac surgery. As with the STS work, the first step toward quality improvement was a clinically relevant and validated risk assessment. The subsequent review was then expanded to the VA system as a
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TABLE 1. Key Performance Measures Proposed for Elective Operations Surgical infection Antibiotic prophylaxis 1. First dose on time 2. Appropriate drug choice 3. Prompt discontinuation of antibiotic after prophylactic dose(s) Other 1. Proper hair removal 2. After colorectal resections, patients should be normothermic in recovery room 3. Glucose control (≤200 mg/dL) Patients undergoing major cardiac surgery In general, patients with diabetes mellitus Cardiovascular measures 1. Patients undergoing noncardiac vascular surgery receiving β-blockade, unless specifically contraindicated 2. Patients with known coronary artery disease or other cardiovascular diseases receiving β-blockade, unless specifically contraindicated 3. Maintenance of β-blockade in patients previously receiving such therapy Venous thromboembolism (VTE) prophylaxis 1. Percentage of patients undergoing major surgery receiving any perioperative prophylaxis 2. Percentage of patients undergoing major surgery receiving appropriate VTE prophylaxis based on their level of risk of VTE Respiratory measures 1. Elevate head of bed for patients undergoing mechanical ventilation, in intensive care unit, or in a stepdown unit 2. Percentage of such patients receiving peptic ulcer prophylaxis unless contraindicated 3. Percentage of patients undergoing ventilation in whom a weaning protocol will be implemented
whole and all the surgical services.10,11 With unswerving energy and effort, the VA surgeons began to examine specific risk factors and introduced, accepted, and adhered to the National Surgical Quality Improvement Program (NSQIP). The NSQIP has evolved to the point that virtually all VA medical centers contribute data, and there is a firm standard of performance by which institutions are studied with respect to observed mortality rate compared to expected rates, again with substantial adjustments for patient risk. This has surely improved the quality of care for veteran beneficiaries and at the same time has promoted a realistic assessment of operative risk. These improved outcomes have restored confidence in the system, and the NSQIP is now available to private hospitals after initial but TABLE 2. Adverse Outcomes of Elective Operations 1. 2. 3. 4. 5. 6. 7. 8. 9.
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Surgical site infection Acute myocardial infarction Cardiac arrest Pulmonary embolism Deep venous thrombosis Ventilator-associated pneumonia Readmission within 30 days Unscheduled reoperation Death within 30 days
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limited rollouts in some university medical centers. Obviously, these efforts have been major steps forward, both with respect to innate quality and the transparency that has involved lay press reports on virtually all these activities. The surgical efforts of the VA medical system and in cardiac surgery follow, by more than 2 decades, the standardsetting quality and safety improvements in anesthesiology in the 1960s and 1970s.12-14 Most now recognize that these efforts directly enhanced patient safety and reflect measurable improvement in professional liability insurance premiums for anesthesiologists. RATIONALE FOR QUALITY SURROGATES Surrogates for traditional quality outcomes include minimization of infection, avoidance of other complications, and minimization of postoperative deaths. As noted previously, short-term disability and death are uncommon, especially after elective operations.15 The Centers for Medicare and Medicaid Services (CMS) and others have taken the lead in proposing and examining a larger number of surrogates for quality, which provide more numerators and in turn become benchmarks for comparison and measurement of subsequent improvement. Instead of a single yes/no outcome for an operation (such as dead or alive, infected or uninfected, etc), modern metrics allow assessment of several risk factors and numerous performance measures for each case. Many of the current performance measures for surgery, especially elective surgery, are medical aspects of surgical care. The data supporting their use are often better documented in the medical literature than in the surgical literature and, not surprisingly, many practicing surgeons have been somewhat slow to accept and then implement these parameters. Table 1 gives the key performance measures from the Surgical Care Improvement Project (SCIP), which was funded by the CMS via a contract with Health Care Excel, the quality improvement organization for Kentucky.16 Table 2 enumerates the monitored outcomes from the same trial. In Table 1, prominent numerical items are those related to proper antibiotic use and the direct alignment of highrisk state with respect to thromboembolism and appropriate prophylaxis, as well as tight glucose control17,18 and judicious β-adrenergic blockade,19 in patients with severe cardiovascular disease. Inevitably, the number of key performance measures will increase. Because many aspects of contemporary surgical risk assessment are primarily medical issues, an expanded role for anesthesiologists, internists, and family practitioners will set the next stages for further quality improvement. All physicians should understand that surgical safety goes hand-in-hand with surgical quality, and numerous other
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RENEWAL OF SURGICAL QUALITY AND SAFETY INITIATIVES
TABLE 3. Truncated List* of Current Procedural Terminology–Based Procedures Studied by a Surgical Quality Improvement Group
components are worthy of emphasis, including surgical judgment, the recognition of prohibitive risks, incorrect sponge counts, erroneous medications, and especially the unintended overuse of pain medication. Technical variations in surgery are also important; improvements and greater consistency in surgical residencies, to include the now popular “skills labs,” may actually decrease the importance of technical variations, as likely will the expanding role of surgical robotics.
Cholecystectomy Inguinal hernia repair Bariatric procedures Appendectomy—early appendicitis Colon and rectal resection/stoma closure Gastric fundoplication Mastectomy or lumpectomy for breast cancer Biopsy or wide local excision for melanoma Carotid endarterectomy/abdominal aortic aneurysm repair Long-term central venous access Total hip or total knee replacement/knee arthroscopy Transurethral resection of the prostate Ureteroscopy for stone/radical nephrectomy Hysterectomy Tympanostomy/tonsillectomy/adenoidectomy Diabetic foot procedures Upper gastrointestinal endoscopy Endoscopic retrograde cholangiopancreatography Colonoscopy
REGIONAL QUALITY IMPROVEMENT EFFORTS An additional point regarding the importance of individual surgeon factors is the development of a quality improvement program in Kentucky led by practicing surgical specialists.20,21 We hold that too many of the medical quality efforts are being developed and led by nonclinicians. For example, practicing surgeons have the most concentrated skill set for dealing with these issues. This group developed its cohesion and effectiveness on the 10 most common procedures within several surgical specialties, and, at the request of our hospital partners, expanded our protocol and simple report items to 43 current procedural terminology– based operations (Table 3).22,23 The critical issue in this process was physician involvement at every level, including development of simple protocols and efficacious report forms that reflected common surgical concerns: • Why was the patient operated on? • How was the disease diagnosed? • Was the preoperative evaluation complete; what risk factors were identified? • Where was the operation done? • What anesthetic method was used? • Did the patient die or experience a complication? • How long did the patient stay in the facility? • When did the patient resume work or normal activities? Other simple or specific items, such as antibiotic and/or deep venous thrombosis (DVT) prophylaxis, were added later. Lengthy monthly board meetings built consensus, and initial publications focused on issues related to both cost23 and quality.20 Subsequently, CMS awarded a subcontract to assist with defining surgical quality measures and outcomes that could be worthy of consideration for inclusion in pay-for-performance criteria for common operations. The procedures, which were studied in more detail in an expanded group of hospitals and in a much broader group of specialties and surgeons, were coronary artery or cardiac valvular surgery, major vascular surgery (not access), laparoscopic cholecystectomy, colon or rectal resections, hip or knee replacements, and hysterectomy. Mayo Clin Proc.
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*Selected from a total of 43 procedures.
Broader protocols and more detailed report forms were developed via conference calls with specialty leaders in Kentucky; most hospitals used nurse abstractors for the report, but about 20% of the studied cases were in hospitals where both nurse abstractors and surgeons reported on overlapping aspects of the entire surgical patient care process for some cases. These parallel reports are interesting and pertinent in an era in which the cost of data and its applicability are ever more important. Surgeons can complete the 109-item report at the time of a patient’s 4- to-6week follow-up in the office. Such reports have proved to be accurate and fairly candid.20 The critical issue is handson physician engagement from start to finish. Small payments, depending on the degree of detail, have been given to surgical specialists for providing these data; their reports have been sampled separately for audit. We believe these principles of physician engagement could apply to any specialty in any region as long as they are physician led and the guidelines and reports are physician approved. The next sections of this article contain numerous data (currently unpublished) from the SCIP in the Kentucky pilot trial. PATIENT EDUCATION Legitimate risk assessment and correlation of performance measures with objective outcomes are the touchstones of the modern quality effort. However, an important aspect of this exercise is to create the genuinely informed patient;
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TABLE 4. Traditional Risk Factors Serum albumin level <2.0 g/dL American Society of Anesthesiologists physical status Age Operative complexity Functional status Chronic obstructive pulmonary disease History of smoking Hemoglobin concentrations (<10.0 g/dL) Serum creatinine levels (>2.0 mg/dL) Weight loss >10% in 6 months Disseminated cancer
patient education has become ever more complex, but the information era has made this both more daunting and easier than ever before. The linchpin of this surgical effort has been the traditional face-to-face sit-down visit addressing the likelihood of health, death, or disability that attend a major operation. We were not surprised when selected, highly motivated surgical specialists claimed to be committed to patient education nor were we surprised when ubiquitous patient satisfaction surveys confirmed this.20 Whether information is obtained from the Internet, video, comic book style brochures, or slickly printed society manifestos, the process appears to work. However, it was surprising how many of the broader groups of patients were similarly well-informed about their operations, their aftercare, and their recovery. Frequently performed operations, such as those studied in these trials, lend themselves to precise educational tools, and use of professional material is now common, even in rural areas. Most of our patients who come armed with Internet printouts are the most informed in the true sense of the word. As in all areas, progress remains to be made, but the 91% or more level of achievement for each procedure, especially in the surgeon’s office, is a good start ( R. Schell, MD, unpublished data, October 2005). PROGRESS IN RISK ASSESSMENT The NSQIP has been remarkably effective in helping VA surgeons recognize the often prohibitive risk of some surgical procedures and what amounts to medical and surgical futility. No one wants to see a patient denied an opportunity to be well because of a legitimate high risk. In contrast, little is achieved, either for society or for the individual, by proceeding in the face of overwhelming primary illness and an unalterable list of associated serious diseases. Traditional risk factors that have been considered are chronic obstructive pulmonary disease that requires medication and/or inhaler therapy, cardiac disease sufficient to warrant treatment of congestive heart failure, poorly controlled 348
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diabetes mellitus, and a limited status of self-sufficiency or functional dependency (Table 4). A backbone of these observations has often been the American Society of Anesthesiologists (ASA) physical status score, which ranges from a 1 for virtual immortality to a 5 for impending death, a scheme that has been generally reliable and valuable. We were surprised about the variation between surgeons and anesthesiologists regarding the ASA physical status score. This in no way reflects what might be a traditional undervaluing of risk by the surgeon and/or overvaluing by the anesthesiologist. There are honest disagreements at the 2-3 and 3-4 interfaces that are notable. Among 457 dually reported cases, anesthesiologists and surgeons agreed in 312; anesthesiologists estimated the greater risk in 103 and surgical specialists in 33. The ASA score is still the basis for many forms of risk assessment and has utility. The surgeon should—from his office and/or other prior contacts—be afforded an excellent opportunity to assess the patient’s overall operative risk. However, the increase in work-force physicians among anesthesiologists and their increased training and access to patient information (eg, through electronic medical records) in recent years will allow them ever-increasing roles in such assessment.24 Many clinicians have been surprised by the absence of some parameters as consistent risk factors. Often, surgeons who choose patients for an elective operation will have already stratified by pure clinical judgment some of these into lesser risk groups. Conversely, we noted surprising adverse risk factors, such as the dominant role of a serum albumin value lower than 2.0 g/dL from the NSQIP.10 Recently, we recognized the presence of a white blood cell count higher than 11 × 109/L in patients presenting for elective operations as an adverse risk factor. Obviously, this may be a sign of an occult infection and may be far more important than many of us have previously recognized. In patients who may be admitted to an intensive care unit, the medically based performance measures that seem to be durable and meaningful relate to cardiac medications19 and the progressively tighter control of glucose.14,15 One can think back a dozen years when the patient taking β-blockers was assumed to be at high risk for surgery and the drug was uniformly discontinued well before the operation was undertaken. We now recognize that, in patients undergoing cardiac or vascular operations who have intrinsic underlying heart disease, maintenance of β-blockers may actually protect against acute myocardial infarction postoperatively. A recent high profile report19 cautions against overexpansion of this concept and precise selection of cardiac risk. As aforementioned, progressively tighter control of blood glucose is important, especially in patients in the intensive care unit.17,18 It has often been assumed that mild
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RENEWAL OF SURGICAL QUALITY AND SAFETY INITIATIVES
hyperglycemia was inevitably far better than any hypoglycemia and that as long as ketoacidosis was avoided blood glucose control was often a minor matter. Currently, there is a rapidly growing collection of medical literature, some primarily from Europe and from intensivists, that shows that extremely tight control of blood glucose is desired and is associated with both a decrease in complications and a diminished likelihood of death.21-23 It is not known if this situation is true for intraoperative control of blood glucose. Paradoxically, there is a growing concern that insulin itself, through a complicated receptor mechanism process, may lessen some important host defenses against infection and may aggravate this situation25; obviously, one seeks to keep the blood glucose controlled in the first place. In our recent study for CMS, we found that nearly a third of diabetic patients had blood glucose concentrations greater than 200 mg/dL during the course of hospitalization for an elective operation and that 20% of nondiabetic patients were in the same predicament (J. N. Lewis, MD, unpublished data, November 2005). The progressive refinement of measurement of operative risk (of which there are but a few examples) is a vital target for advances in computational science, and it will grow. ANTIBIOTIC PROPHYLAXIS Not surprisingly, a vast number of traditional surgical performance measures are thought to be legitimate surrogates for the best possible outcome. The first of these is obviously a thoughtful assessment of risk, preferably based on both a national database and valid regional adjustments. One aspect that is surely valuable is the opportunity to talk to the patient and family and accurately explain the actual risk of an operation. Another keystone of many measures to date is the old concept of idealized antibiotic prophylaxis.26,27 This is another example in which virtually all surgeons agree with the recommendation, but practices vary widely. For example, only 8.3% of Kentucky surgeons choose inappropriate drugs for systemic antibiotic prophylaxis. However, more than a third cannot get the desired preoperative antibiotic given before the operation, and nearly 40% of surgical specialists cannot get the drug stopped within 24 hours after the operation. Minute improvements have occurred, but unfortunately this is an almost national norm.28-31 Delaying the initial dose reduces the chance to prevent imminent infection, and continuing the drugs for too long increases antimicrobial resistance. In most cases, these are not issues of education. They are issues of quality and safety systems that are implemented by the surgeon and his or her office in the holding area, before increasingly short stays for outpatient surgery, and are implemented by the Mayo Clin Proc.
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anesthesiologist in the operating room and in the recovery area. I believe, at this point, that the concepts are well understood and that there needs to be an institutional and/or surgical team protocol as to who should give the drug, when should the drug be given, and which drug should be given. Indeed, a new concern about the choice of drugs is the observation in Kentucky that a poor choice of drugs for systemic prophylaxis was associated with a tripling of overall operative risk (P=.01) (J. N. Lewis, MD, unpublished data, November 2005), something unlikely to be directly related to the effects of antibiotic prophylaxis but more likely a surrogate marker for other measures of imperfect medical practice. There are some legitimate concerns within a few surgical specialties that so-called prophylaxis should extend beyond the 24th to the end of the 48th hour.30 In fact, the 24- to 48-hour termination debate is a minor issue because, even if one accepts continuation of prophylaxis to the 48th hour, at least 1 patient in 4 has antibiotic preventive treatment continued beyond that. The ecological impact of prolonged antibiotic prophylaxis is huge and dangerous; one of the essences of 4 decades of success with antibiotic prophylaxis has been the short duration of use in any individual patient, which in turn minimizes the likelihood of the development of resistant strains to preferred classes of prophylactic antibiotics. VENOUS THROMBOEMBOLISM PREVENTION The prevention of venous thromboembolism (VTE) is a remarkable subject in which surgical specialty choices seem to be little influenced by the relative degrees of risk of a given patient. Recent published articles have highlighted issues related to VTE.32,33 On the basis of our experience with more than 20,000 patients studied prospectively in Kentucky, there is a substantial mismatch between the intensity of preventive measures outlined in Table 5 and the need for such measures. Curiously enough, in the more recently completed study of 5285 patients, clinically diagnosed pulmonary embolism itself occurred in 15 patients and DVT, as recognized and reported, was only slightly more common (n=20) (J. N. Lewis, MD, unpublished data, November 2005). Imprecise antibiotic prophylaxis is a modest risk for an individual patient undergoing elective surgery and, as yet, is associated with relatively little danger to the hospital ecology. Imprecise and possibly inappropriate VTE prophylaxis is a far greater hazard. Obviously, the ideal situation would encompass a perfect match between the risk of VTE and extent of prophylaxis.33 However, based on our unmasked study of network-reported patients, this seldom occurs. Surgeons tend to be “believers” or “nonbelievers”
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TABLE 5. Graded Variations in Choices for the Prevention of Venous Thromboembolism (N=1133)* Early ambulation only Elastic stockings Sequential compression devices Subcutaneous heparin Low-molecular-weight heparin Warfarin sodium Other Oral medications Subcutaneous dalteparin sodium Fondaparinox study cases Combinations Sequential compression devices and subcutaneous heparin Low-molecular-weight heparin and other treatment Sequential compression devices and elastic stockings
298 128 353 143 77 87 8 2 2 4 39
tion (J. N. Lewis, MD, unpublished data, November 2005). Finally, some regimens, such as enoxaprin sodium, require prolonged administration, often by a home health professional, which is intrinsically one of the most expensive choices a surgeon can make. In Kentucky, for example, the average charge for a single home health nurse visit is $129 for Medicare patients, and this price does not include medications or other activities. If surgeons have been 35 years late in accepting standards for relatively black-and-white systemic antibiotic prophylaxis, how long will it take to reach consensus of ideas and practice on the prevention of rare events by methods that are intrinsically dangerous and/ or expensive?
*Some operations, such as laparoscopic cholecystectomy, were performed in the outpatient setting.
in VTE prophylaxis and tend to treat most patients alike. For example, one respected senior surgeon is critical of VTE prophylaxis and tends to use nothing; however, if the patient has a documented history of DVT and/or pulmonary embolism, this surgeon chooses a combination of both mechanical and medicinal measures. Another surgical specialist, despite the findings of a National Institutes of Health consensus panel in his field,34 chooses aggressive and prolonged medicinal prophylaxis for most patients, again varying practice only slightly in response to documented risk. The truth is that DVT and/or pulmonary embolism was uncommon; perhaps our catch-as-catch-can practices are highly effective. Interestingly, most patients with either diagnosis had received relatively aggressive prophylaxis. To compound the issue further, postoperative bleeding that required reoperation was reported in 5 of 1131 patients, none of whom received medical measures of anticoagulaTABLE 6. Some Early Achievements of a Voluntary Quality Improvement Surgical Group Identified and altered length of hospital stay Identified unnecessary expense of disposable laparoscopic devices Identified some expensive drugs and suggested alternatives Focused on unnecessary home health visits and diminished use of such visits Compared a surgeon who works alone in a hospital with other surgeons in the region Created and published a book about when and to whom to refer Created a Web site for patient education Focused on turnover times in the operating room Created unique anesthesiology-surgery interactions in 1 hospital Developed and improved patient satisfaction surveys Successfully completed a subcontractor role regarding surgical complications by recruiting surgeons and hospitals, developed meaningful performance measures, and collected surgical case data from surgeons for analysis and, when possible, comparison with hospital-submitted reports
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FOCUSED SURGICAL EFFORTS IN QUALITY ENHANCEMENT Our renewed interest in this field actually grew from an initiative that began 7 years ago among practicing surgical leaders in Kentucky. Our small quality improvement group initially focused on some then-current cost control issues, which indeed are another subject but are still worthwhile. Physicians influence costs enormously and can have a favorable effect, perhaps more than any other health care professional. In those 7 years of study, we did not find a single example of when the most expensive care in any arena proved to be the best care. We now have a group that encompasses some 60-plus surgeons who have studied 43 current procedural terminology–based codes during the past 7 years in various prospective protocols. Table 6 highlights some of our effort, the most notable of which is the willingness of surgeons to promply emulate other surgeons whom they respect, especially when geographically close. We believe that it is relatively easy to encourage surgeons to adapt or to alter their practices based on the successful premises of their respected neighbor. A second highlight is that for small payments, we have been able to get detailed and largely accurate reports from surgeons about their work with varying degrees of complexity, whether considering appropriate stratification of risk or a prompt return to work. These all represent legitimate surgical quality performance measures and outcomes and are amenable to study and to sharing of results in a constructive sense. One of our most interesting experiences was a “1surgeon hospital” in a small rural town; our group was able to reassure the board of trustees of that hospital that its surgeon met or exceeded 8 of 10 quality criteria, and the surgeon rapidly brought the other two into a desired range when given the data and opportunity during the next 6 months.22 We were disappointed to find that the financial measurements associated with elective surgery, on the part of
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TABLE 7. Surgical Time-Out or Reflective Pause*
both hospitals and health plans, were cumbersome and often unable to recognize substantial dollar improvements. Some of our early observations were the profound expense of disposable surgical devices, especially for laparoscopy, and in surgeons’ preference cards, which tended to be updated every 5 years, whether this cycle was appropriate or not. In any case, virtually all our quality observations have been associated with decreased costs.
1. Verify patient identity 2. Verify site 3. Check antibiotic prophylaxis Justified Given Documented 4. Monitor intraoperatively Temperature Glucose 5. Check if blood is needed/available 6. Check venous thromboembolism prophylaxis Justified Given Documented
QUALITY INDICATORS The development of verifiable quality indicators in the field of surgery is an enormous proposition. While industryled groups continue to encourage some medical parameters, indicators for quality surgical practice are largely lacking. We expect to pursue this avenue and to make proposals that could be meaningful additions to surgical practice parameters that can be accepted widely and measured accurately. There are daunting concepts of and applications to this process; cautious implementation is essential.35 The future of this effort is obviously promising. The most important beneficiary will be the public. Increasing transparency associated with enhanced safety and quality, diminished risk, disability, and discomfort is overdue and something that is within the ready grasp of the 21st century surgical community. The broad base of growing awareness among surgeons is important. The early efforts by the STS and the VA medical system have set high standards. It seems that the American College of Surgeons is giving credence to these issues and has the capacity to teach meaningful change with respect to both safety and quality. Indeed, the elected chair of its board of regents has classified safety and quality as “an educational emergency.”36 The range of initiatives that are currently available is genuinely surprising. For example, in Pennsylvania, there is now obligatory reporting of all adverse events from the state’s hospitals and some of their ambulatory surgery centers. The program has already begun to identify patterns and/or clusters of events that allow for feedback to an individual institution and has developed a newsletter that communicates dominant themes back to the health community (Clarke JR, ed, Patient Safety Advisory Quarterly Newsletter). Another example is the leadership in a relatively small surgical training program based in a private hospital on the New Jersey shore, where one surgeon’s 7-year work with a traditional mortality and morbidity conference has transposed the culture of the hospital into a safer one with higher quality.37 Additionally, surgical practitioners in that hospital now have uncommon data on the quality of their work, the infrequency of death and/or complications, and a stringent definition of corrective measures that have been obtained for each of these issues.37 Mayo Clin Proc.
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*Taking time immediately before surgery to perform a final check to ensure that the correct patient is about to undergo the correct surgical procedure at the correct site.
Furthermore, these intramural standards must be matched by new staff applicants through the credentialing process. If one were to look a decade ahead, he or she might well see an atmosphere in which the operating room is more like the flight deck of a commercial air carrier. There will be checklists that begin with proper and honest assessment of operative risk and are followed by a variety of considerations in the best interests of the patient. The surgical “time out” or, as it has been called by some more articulate people, the “reflective pause,” (ie, taking time immediately before surgery to perform a final check to ensure that the correct patient is about to undergo the correct procedure at the correct site) is a perfect opportunity to not only avoid wrong site surgery but also to expand that list, to a reasonable degree, in surrogate measures of quality. Table 7 includes a list of options from which to choose. SUMMARY There are substantial discussions about the value of the quality and safety movement in virtually all medical entities. Third-party payers or health plans are anxious to espouse pay for performance and take credit for what are modest payments for performance. We must admit that Anthem Blue Cross and Blue Shield in Kentucky, in an imaginative way, began to do this with the surgeons involved in the aforementioned projects. Although the impact is small, both in the aggregate and with the individual, it is surely a step in the right direction. The federal government’s obsession with a budget-neutral approach could be used to justify pay-for-performance formulas, adjusted for physicians performing in the upper or lower 25% on any given set of performance measures or outcomes. Whether this actually happens or not is an important but secondary issue. General surgery is currently a remarkably stressed specialty financially,38 and meaningful pay for those dem-
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onstrating the best performance could be a genuine lifeline. These concepts and principles apply to most medical specialties, both to objectives and, to some degree, methods. We have found that these strategies are predictable and that they create a favored platform for ultimate medical transparency. There are many slips between the cup and the lip in this matter, but the critical issue is to realize that the patient must benefit in the short term and that the American public will be the long-term beneficiaries of this effort, just as occurred with the remarkable improvements in anesthesiology more than 2 decades ago. REFERENCES 1. Kaiser Family Foundation. Quality of care. Available at: www.kaiseredu .org/topics.asp?id=70&isID=30&refID=31&sidenav=249. Accessibility verified January 20, 2006. 2. Polk HC Jr. Quality, safety, and transparency. Ann Surg. 2005;242:293301. 3. Kohn LT, Corrigan J, Donaldson MS, Institute of Medicine, Committee on the Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000. 4. Institute of Medicine, Committee on the Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001. 5. Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds, Institute of Medicine, Committee on Data Standards for Patient Safety. Patient Safety: Achieving a New Standard of Care. Washington, DC: National Academies Press; 2004. 6. McCafferty MH, Polk HC Jr. Addition of “near-miss” cases enhances a quality improvement conference. Arch Surg. 2004;139:216-217. 7. Polk HC Jr, Spratt JS Jr, Bennett D, Copher GH, Butcher HR Jr. Surgical mortality and survival from colonic carcinoma. Arch Surg. 1964;89:16-23. 8. Shahian DM, Torchiana DF, Normand SL. Implementation of a cardiac surgery report card: lessons from the Massachusetts experience. Ann Thorac Surg. 2005;80:1146-1150. 9. Plogman PL, Pine M, Reed DC, Byrwa KJ, Berman JI. Anthem Blue Cross and Blue Shield’s coronary services network: a managed care organization’s approach to improving the quality of cardiac care for its members. Am J Manag Care. 1998;4:1679-1686. 10. Best WR, Khuri SF, Phelan M, et al. Identifying patient preoperative risk factors and postoperative adverse events in administrative databases: results from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Am Coll Surg. 2002;194:257-266. 11. Khuri SF, Daley J, Henderson W, et al, National VA Quality Improvement Program. The Department of Veterans’ Affairs NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. Ann Surg. 1998; 228:491-507. 12. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery: based on a study of 599,548 anesthesias in ten institutions 19481952, inclusive. Ann Surg. 1954;140:2-35. 13. Keenan RL, Boyan CP. Decreasing frequency of anesthetic cardiac arrests. J Clin Anesth. 1991;3:354-357. 14. Warner MA, Shields SE, Chute CG. Major morbidity and mortality within 1 month of ambulatory surgery and anesthesia. JAMA. 1993;270:14371441.
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15. Lagasse RS. Anesthesia safety: model or myth? a review of the published literature and analysis of current original data. Anesthesiology. 2002;97:16091617. 16. Polk HC Jr, Lewis JN, Garrison RN, et al. Process and outcome measures in specialty surgery: early steps in defining quality. Bull Am Coll Surg. 2005; 90:8-15. 17. Turina M, Fry DE, Polk HC Jr. Acute hyperglycemia and the innate immune system: clinical, cellular, and molecular aspects. Crit Care Med. 2005; 33:1624-1633. 18. Krinsley JS. Association between hyperglycemia and increased hospital mortality in a heterogeneous population of critically ill patients. Mayo Clin Proc. 2003;78:1471-1478. 19. Lindenauer PK, Pekow P, Wang K, Mamidi DK, Gutierrez B, Benjamin EM. Perioperative beta-blocker therapy and mortality after major noncardiac surgery. N Engl J Med. 2005;353:349-361. 20. Shively EH, Heine MJ, Schell RH, et al. Practicing surgeons lead in quality care, safety, and cost control. Ann Surg. 2004;239:752-760. 21. Galandiuk S, Rao MK, Heine MF, Scherm MJ, Polk HC Jr. Mutual reporting of process and outcomes enhances quality outcomes for colon and rectal resections. Surgery. 2004;136:833-841. 22. Allen JW, DeSimone KJ. Valid peer review for surgeons working in small hospitals. Am J Surg. 2002;184:16-18. 23. Allen JW, Hahm TX, Polk HC Jr. Surgeon-led initiatives cut costs and enhance the quality of endoscopic and laparoscopic procedures. JSLS. 2003;7: 243-247. 24. Miller RD, Lanier WL. The shortage of anesthesiologists: an unwelcome lesson for other medical specialties [editorial]. Mayo Clin Proc. 2001;76:969970. 25. Turina M, Miller FN, Tucker C, Polk HC Jr. Short-term hyperglycemia in surgical patients and a study of related cellular mechanisms. Ann Surg. In press. 26. Polk HC Jr, Lopez-Mayor JF. Postoperative wound infection: a prospective study of determinant factors and prevention. Surgery. 1969; 66:97-103. 27. Polk HC Jr, Trachtenberg L, Finn MP. Antibiotic activity in surgical incisions: the basis of prophylaxis in selected operations. JAMA. 1980;244: 1353-1354. 28. Bratzler DW, Houck PM, Richards C, et al. Use of antimicrobial prophylaxis for major surgery: baseline results from the National Surgical Infection Prevention Project. Arch Surg. 2005;140:174-182. 29. Polk HC Jr. Continuing refinements in surgical antibiotic prophylaxis [editorial]. Arch Surg. 2005;140:1066-1067. 30. Dellinger EP, Hausmann SM, Bratzler DW, et al. Hospitals collaborate to decrease surgical site infections. Am J Surg. 2005;190:9-15. 31. Polk HC Jr. Keeping score and the application of known principles [editorial]. Am J Surg. 2005;190:16-17. 32. Gajic O, Warner DO, Decker PA, Rana R, Bourke DL, Sprung J. Longhaul air travel before major surgery: a prescription for thromboembolism? Mayo Clin Proc. 2005;80:728-731. 33. Jaffer AK, Barsoum WK, Krebs V, Hurbanek JG, Morra N, Brotman DJ. Duration of anesthesia and venous thromboembolism after hip and knee arthroplasty. Mayo Clin Proc. 2005;80:732-738. 34. NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004;86:1328-1335. 35. Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol. 1993;46:1075-1079. 36. Copeland EM. A patient safety curriculum for surgical residency programs. Statement to Joint Invitational Conference, American College of Surgeons; Chicago, Ill; May 1, 2005. 37. Larson KA, Wiggins EF, Goldfarb MA. Reducing medication errors in a surgical residency training program. Am Surg. 2004;70:467-471. 38. Russell TR. From my perspective. Bull Am Coll Surg. May 2001;86:3-4.
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Renewal of Surgical Quality and Safety Initiatives: A Multispecialty Challenge HIRAM C. POLK, JR, MD The quality and safety movement in surgical specialty practice is gaining momentum. On the basis of risk-adjusted outcomes of coronary artery surgery and the improved risk assessment in the Veterans Affairs system, a growing array of surgical specialists has focused on recognition of legitimate risk factors, identification of performance measures that are valid surrogates for better practices, and refinement of risk-adjusted outcomes. Recognition of educational needs, personal practice patterns, and systems deficiencies now permits a broad-based application of long-standing primarily medical issues to elective surgical procedures in an organized and integrated fashion. Approximately 85,000 patients per day undergo elective operations in the United States. A platform based on physician involvement and leadership has been tested in the Surgical Care Improvement Project, funded by a subcontract from the Centers for Medicare and Medicaid Services. This effort has defined factors worthy of further verification and provides a framework for an ethical and valid pay-for-performance scheme.
Mayo Clin Proc. 2006;81(3):345-352 ASA = American Society of Anesthesiologists; CMS = Centers for Medicare and Medicaid Services; DVT = deep venous thrombosis; NSQIP = National Surgical Quality Improvement Program; SCIP = Surgical Care Improvement Project; STS = Society of Thoracic Surgeons; VA = Veterans Affairs; VTE = venous thromboembolism
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here is an abiding and renewed emphasis in quality and safety in medicine. This interest reflects public attitudes, which are inevitably prodded by print and visual media. A recent Kaiser Family Foundation study1 was summarized and edited for its surgical implications.2 Clearly, the public is aware of quality variations, is progressively knowledgeable about indices of quality and safety, and tends to use this information, to some degree, in its personal medical choices. Major monographs from the Institute of Medicine3,4 have sequentially provided more focus, notably the latest one explicitly entitled Patient Safety.5 These renewed efforts have to date emphasized the outpatient medical management of chronic diseases such as diabetes mellitus, obesity, and hypertension. Physicians and nurse practitionFrom the Department of Surgery and Price Institute of Surgical Research, University of Louisville School of Medicine, Louisville, Ky. Dr Polk is one of 60 surgeon-owners of Quality Surgical Solutions, PLLC, currently a nonprofit entity, which contributed data to this article. Address reprint requests and correspondence to Hiram C. Polk, Jr, MD, Department of Surgery, University of Louisville, Louisville, KY 40292 (e-mail: [email protected]). © 2006 Mayo Foundation for Medical Education and Research
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ers in internal medicine and family practice have identified and further refined treatment benchmarks, and growing numbers of professionals meet these targets. Notably, elective surgery, which serves 85,000 patients per day in the United States, has received scant attention. Because death and measurable disability as a result of subpar medical or surgical care are uncommon, surrogates for quality outcomes have become popular and mathematically sound measures of performance. Surgeons’ commitments to these standards are at least a century old, but application has been uneven and inconsistent. However, there is hope. The longstanding and lamented surgical mortality and morbidity conference is being replaced by new and improved versions.6 The purpose of this article is to examine current trends related to surgical quality and safety and to stress that this is a multispecialty challenge for all surgeons, anesthesiologists, internists, and family practitioners. RECENT SURGICAL PROGRESS Early studies of death after surgery varied between celebrating surgical virtuosity and misapplying credit for improvements.6 A good example is the sharp reduction in hospital deaths after major resections of the colon or rectum, widely ascribed to the benefits of oral bowel preparation and/or systemic antibiotics. In fact, the improvements a decade earlier (1935-1939) coincide better with the institution of modern blood banking.7 In any case, an early contemporary quality improvement program is attributed to the Society of Thoracic Surgeons (STS) and included a detailed examination of death associated with elective coronary artery bypass operations, which created a stratification of risk scheme that is now an accepted national norm.8,9 This process can be viewed as a sophisticated extension of the New York Heart Association classification. More precise adjustments in risk factors for perioperative deaths set the stage for more objective comparisons, and patient referrals began to reflect documented quality in risk-adjusted clinical outcomes. In a similar sense, the Veterans Affairs (VA) medical system was under intense scrutiny 15 years ago for unacceptably high death rates after cardiac surgery. As with the STS work, the first step toward quality improvement was a clinically relevant and validated risk assessment. The subsequent review was then expanded to the VA system as a
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TABLE 1. Key Performance Measures Proposed for Elective Operations Surgical infection Antibiotic prophylaxis 1. First dose on time 2. Appropriate drug choice 3. Prompt discontinuation of antibiotic after prophylactic dose(s) Other 1. Proper hair removal 2. After colorectal resections, patients should be normothermic in recovery room 3. Glucose control (≤200 mg/dL) Patients undergoing major cardiac surgery In general, patients with diabetes mellitus Cardiovascular measures 1. Patients undergoing noncardiac vascular surgery receiving β-blockade, unless specifically contraindicated 2. Patients with known coronary artery disease or other cardiovascular diseases receiving β-blockade, unless specifically contraindicated 3. Maintenance of β-blockade in patients previously receiving such therapy Venous thromboembolism (VTE) prophylaxis 1. Percentage of patients undergoing major surgery receiving any perioperative prophylaxis 2. Percentage of patients undergoing major surgery receiving appropriate VTE prophylaxis based on their level of risk of VTE Respiratory measures 1. Elevate head of bed for patients undergoing mechanical ventilation, in intensive care unit, or in a stepdown unit 2. Percentage of such patients receiving peptic ulcer prophylaxis unless contraindicated 3. Percentage of patients undergoing ventilation in whom a weaning protocol will be implemented
whole and all the surgical services.10,11 With unswerving energy and effort, the VA surgeons began to examine specific risk factors and introduced, accepted, and adhered to the National Surgical Quality Improvement Program (NSQIP). The NSQIP has evolved to the point that virtually all VA medical centers contribute data, and there is a firm standard of performance by which institutions are studied with respect to observed mortality rate compared to expected rates, again with substantial adjustments for patient risk. This has surely improved the quality of care for veteran beneficiaries and at the same time has promoted a realistic assessment of operative risk. These improved outcomes have restored confidence in the system, and the NSQIP is now available to private hospitals after initial but TABLE 2. Adverse Outcomes of Elective Operations 1. 2. 3. 4. 5. 6. 7. 8. 9.
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Surgical site infection Acute myocardial infarction Cardiac arrest Pulmonary embolism Deep venous thrombosis Ventilator-associated pneumonia Readmission within 30 days Unscheduled reoperation Death within 30 days
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limited rollouts in some university medical centers. Obviously, these efforts have been major steps forward, both with respect to innate quality and the transparency that has involved lay press reports on virtually all these activities. The surgical efforts of the VA medical system and in cardiac surgery follow, by more than 2 decades, the standardsetting quality and safety improvements in anesthesiology in the 1960s and 1970s.12-14 Most now recognize that these efforts directly enhanced patient safety and reflect measurable improvement in professional liability insurance premiums for anesthesiologists. RATIONALE FOR QUALITY SURROGATES Surrogates for traditional quality outcomes include minimization of infection, avoidance of other complications, and minimization of postoperative deaths. As noted previously, short-term disability and death are uncommon, especially after elective operations.15 The Centers for Medicare and Medicaid Services (CMS) and others have taken the lead in proposing and examining a larger number of surrogates for quality, which provide more numerators and in turn become benchmarks for comparison and measurement of subsequent improvement. Instead of a single yes/no outcome for an operation (such as dead or alive, infected or uninfected, etc), modern metrics allow assessment of several risk factors and numerous performance measures for each case. Many of the current performance measures for surgery, especially elective surgery, are medical aspects of surgical care. The data supporting their use are often better documented in the medical literature than in the surgical literature and, not surprisingly, many practicing surgeons have been somewhat slow to accept and then implement these parameters. Table 1 gives the key performance measures from the Surgical Care Improvement Project (SCIP), which was funded by the CMS via a contract with Health Care Excel, the quality improvement organization for Kentucky.16 Table 2 enumerates the monitored outcomes from the same trial. In Table 1, prominent numerical items are those related to proper antibiotic use and the direct alignment of highrisk state with respect to thromboembolism and appropriate prophylaxis, as well as tight glucose control17,18 and judicious β-adrenergic blockade,19 in patients with severe cardiovascular disease. Inevitably, the number of key performance measures will increase. Because many aspects of contemporary surgical risk assessment are primarily medical issues, an expanded role for anesthesiologists, internists, and family practitioners will set the next stages for further quality improvement. All physicians should understand that surgical safety goes hand-in-hand with surgical quality, and numerous other
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TABLE 3. Truncated List* of Current Procedural Terminology–Based Procedures Studied by a Surgical Quality Improvement Group
components are worthy of emphasis, including surgical judgment, the recognition of prohibitive risks, incorrect sponge counts, erroneous medications, and especially the unintended overuse of pain medication. Technical variations in surgery are also important; improvements and greater consistency in surgical residencies, to include the now popular “skills labs,” may actually decrease the importance of technical variations, as likely will the expanding role of surgical robotics.
Cholecystectomy Inguinal hernia repair Bariatric procedures Appendectomy—early appendicitis Colon and rectal resection/stoma closure Gastric fundoplication Mastectomy or lumpectomy for breast cancer Biopsy or wide local excision for melanoma Carotid endarterectomy/abdominal aortic aneurysm repair Long-term central venous access Total hip or total knee replacement/knee arthroscopy Transurethral resection of the prostate Ureteroscopy for stone/radical nephrectomy Hysterectomy Tympanostomy/tonsillectomy/adenoidectomy Diabetic foot procedures Upper gastrointestinal endoscopy Endoscopic retrograde cholangiopancreatography Colonoscopy
REGIONAL QUALITY IMPROVEMENT EFFORTS An additional point regarding the importance of individual surgeon factors is the development of a quality improvement program in Kentucky led by practicing surgical specialists.20,21 We hold that too many of the medical quality efforts are being developed and led by nonclinicians. For example, practicing surgeons have the most concentrated skill set for dealing with these issues. This group developed its cohesion and effectiveness on the 10 most common procedures within several surgical specialties, and, at the request of our hospital partners, expanded our protocol and simple report items to 43 current procedural terminology– based operations (Table 3).22,23 The critical issue in this process was physician involvement at every level, including development of simple protocols and efficacious report forms that reflected common surgical concerns: • Why was the patient operated on? • How was the disease diagnosed? • Was the preoperative evaluation complete; what risk factors were identified? • Where was the operation done? • What anesthetic method was used? • Did the patient die or experience a complication? • How long did the patient stay in the facility? • When did the patient resume work or normal activities? Other simple or specific items, such as antibiotic and/or deep venous thrombosis (DVT) prophylaxis, were added later. Lengthy monthly board meetings built consensus, and initial publications focused on issues related to both cost23 and quality.20 Subsequently, CMS awarded a subcontract to assist with defining surgical quality measures and outcomes that could be worthy of consideration for inclusion in pay-for-performance criteria for common operations. The procedures, which were studied in more detail in an expanded group of hospitals and in a much broader group of specialties and surgeons, were coronary artery or cardiac valvular surgery, major vascular surgery (not access), laparoscopic cholecystectomy, colon or rectal resections, hip or knee replacements, and hysterectomy. Mayo Clin Proc.
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*Selected from a total of 43 procedures.
Broader protocols and more detailed report forms were developed via conference calls with specialty leaders in Kentucky; most hospitals used nurse abstractors for the report, but about 20% of the studied cases were in hospitals where both nurse abstractors and surgeons reported on overlapping aspects of the entire surgical patient care process for some cases. These parallel reports are interesting and pertinent in an era in which the cost of data and its applicability are ever more important. Surgeons can complete the 109-item report at the time of a patient’s 4- to-6week follow-up in the office. Such reports have proved to be accurate and fairly candid.20 The critical issue is handson physician engagement from start to finish. Small payments, depending on the degree of detail, have been given to surgical specialists for providing these data; their reports have been sampled separately for audit. We believe these principles of physician engagement could apply to any specialty in any region as long as they are physician led and the guidelines and reports are physician approved. The next sections of this article contain numerous data (currently unpublished) from the SCIP in the Kentucky pilot trial. PATIENT EDUCATION Legitimate risk assessment and correlation of performance measures with objective outcomes are the touchstones of the modern quality effort. However, an important aspect of this exercise is to create the genuinely informed patient;
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TABLE 4. Traditional Risk Factors Serum albumin level <2.0 g/dL American Society of Anesthesiologists physical status Age Operative complexity Functional status Chronic obstructive pulmonary disease History of smoking Hemoglobin concentrations (<10.0 g/dL) Serum creatinine levels (>2.0 mg/dL) Weight loss >10% in 6 months Disseminated cancer
patient education has become ever more complex, but the information era has made this both more daunting and easier than ever before. The linchpin of this surgical effort has been the traditional face-to-face sit-down visit addressing the likelihood of health, death, or disability that attend a major operation. We were not surprised when selected, highly motivated surgical specialists claimed to be committed to patient education nor were we surprised when ubiquitous patient satisfaction surveys confirmed this.20 Whether information is obtained from the Internet, video, comic book style brochures, or slickly printed society manifestos, the process appears to work. However, it was surprising how many of the broader groups of patients were similarly well-informed about their operations, their aftercare, and their recovery. Frequently performed operations, such as those studied in these trials, lend themselves to precise educational tools, and use of professional material is now common, even in rural areas. Most of our patients who come armed with Internet printouts are the most informed in the true sense of the word. As in all areas, progress remains to be made, but the 91% or more level of achievement for each procedure, especially in the surgeon’s office, is a good start ( R. Schell, MD, unpublished data, October 2005). PROGRESS IN RISK ASSESSMENT The NSQIP has been remarkably effective in helping VA surgeons recognize the often prohibitive risk of some surgical procedures and what amounts to medical and surgical futility. No one wants to see a patient denied an opportunity to be well because of a legitimate high risk. In contrast, little is achieved, either for society or for the individual, by proceeding in the face of overwhelming primary illness and an unalterable list of associated serious diseases. Traditional risk factors that have been considered are chronic obstructive pulmonary disease that requires medication and/or inhaler therapy, cardiac disease sufficient to warrant treatment of congestive heart failure, poorly controlled 348
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diabetes mellitus, and a limited status of self-sufficiency or functional dependency (Table 4). A backbone of these observations has often been the American Society of Anesthesiologists (ASA) physical status score, which ranges from a 1 for virtual immortality to a 5 for impending death, a scheme that has been generally reliable and valuable. We were surprised about the variation between surgeons and anesthesiologists regarding the ASA physical status score. This in no way reflects what might be a traditional undervaluing of risk by the surgeon and/or overvaluing by the anesthesiologist. There are honest disagreements at the 2-3 and 3-4 interfaces that are notable. Among 457 dually reported cases, anesthesiologists and surgeons agreed in 312; anesthesiologists estimated the greater risk in 103 and surgical specialists in 33. The ASA score is still the basis for many forms of risk assessment and has utility. The surgeon should—from his office and/or other prior contacts—be afforded an excellent opportunity to assess the patient’s overall operative risk. However, the increase in work-force physicians among anesthesiologists and their increased training and access to patient information (eg, through electronic medical records) in recent years will allow them ever-increasing roles in such assessment.24 Many clinicians have been surprised by the absence of some parameters as consistent risk factors. Often, surgeons who choose patients for an elective operation will have already stratified by pure clinical judgment some of these into lesser risk groups. Conversely, we noted surprising adverse risk factors, such as the dominant role of a serum albumin value lower than 2.0 g/dL from the NSQIP.10 Recently, we recognized the presence of a white blood cell count higher than 11 × 109/L in patients presenting for elective operations as an adverse risk factor. Obviously, this may be a sign of an occult infection and may be far more important than many of us have previously recognized. In patients who may be admitted to an intensive care unit, the medically based performance measures that seem to be durable and meaningful relate to cardiac medications19 and the progressively tighter control of glucose.14,15 One can think back a dozen years when the patient taking β-blockers was assumed to be at high risk for surgery and the drug was uniformly discontinued well before the operation was undertaken. We now recognize that, in patients undergoing cardiac or vascular operations who have intrinsic underlying heart disease, maintenance of β-blockers may actually protect against acute myocardial infarction postoperatively. A recent high profile report19 cautions against overexpansion of this concept and precise selection of cardiac risk. As aforementioned, progressively tighter control of blood glucose is important, especially in patients in the intensive care unit.17,18 It has often been assumed that mild
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hyperglycemia was inevitably far better than any hypoglycemia and that as long as ketoacidosis was avoided blood glucose control was often a minor matter. Currently, there is a rapidly growing collection of medical literature, some primarily from Europe and from intensivists, that shows that extremely tight control of blood glucose is desired and is associated with both a decrease in complications and a diminished likelihood of death.21-23 It is not known if this situation is true for intraoperative control of blood glucose. Paradoxically, there is a growing concern that insulin itself, through a complicated receptor mechanism process, may lessen some important host defenses against infection and may aggravate this situation25; obviously, one seeks to keep the blood glucose controlled in the first place. In our recent study for CMS, we found that nearly a third of diabetic patients had blood glucose concentrations greater than 200 mg/dL during the course of hospitalization for an elective operation and that 20% of nondiabetic patients were in the same predicament (J. N. Lewis, MD, unpublished data, November 2005). The progressive refinement of measurement of operative risk (of which there are but a few examples) is a vital target for advances in computational science, and it will grow. ANTIBIOTIC PROPHYLAXIS Not surprisingly, a vast number of traditional surgical performance measures are thought to be legitimate surrogates for the best possible outcome. The first of these is obviously a thoughtful assessment of risk, preferably based on both a national database and valid regional adjustments. One aspect that is surely valuable is the opportunity to talk to the patient and family and accurately explain the actual risk of an operation. Another keystone of many measures to date is the old concept of idealized antibiotic prophylaxis.26,27 This is another example in which virtually all surgeons agree with the recommendation, but practices vary widely. For example, only 8.3% of Kentucky surgeons choose inappropriate drugs for systemic antibiotic prophylaxis. However, more than a third cannot get the desired preoperative antibiotic given before the operation, and nearly 40% of surgical specialists cannot get the drug stopped within 24 hours after the operation. Minute improvements have occurred, but unfortunately this is an almost national norm.28-31 Delaying the initial dose reduces the chance to prevent imminent infection, and continuing the drugs for too long increases antimicrobial resistance. In most cases, these are not issues of education. They are issues of quality and safety systems that are implemented by the surgeon and his or her office in the holding area, before increasingly short stays for outpatient surgery, and are implemented by the Mayo Clin Proc.
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anesthesiologist in the operating room and in the recovery area. I believe, at this point, that the concepts are well understood and that there needs to be an institutional and/or surgical team protocol as to who should give the drug, when should the drug be given, and which drug should be given. Indeed, a new concern about the choice of drugs is the observation in Kentucky that a poor choice of drugs for systemic prophylaxis was associated with a tripling of overall operative risk (P=.01) (J. N. Lewis, MD, unpublished data, November 2005), something unlikely to be directly related to the effects of antibiotic prophylaxis but more likely a surrogate marker for other measures of imperfect medical practice. There are some legitimate concerns within a few surgical specialties that so-called prophylaxis should extend beyond the 24th to the end of the 48th hour.30 In fact, the 24- to 48-hour termination debate is a minor issue because, even if one accepts continuation of prophylaxis to the 48th hour, at least 1 patient in 4 has antibiotic preventive treatment continued beyond that. The ecological impact of prolonged antibiotic prophylaxis is huge and dangerous; one of the essences of 4 decades of success with antibiotic prophylaxis has been the short duration of use in any individual patient, which in turn minimizes the likelihood of the development of resistant strains to preferred classes of prophylactic antibiotics. VENOUS THROMBOEMBOLISM PREVENTION The prevention of venous thromboembolism (VTE) is a remarkable subject in which surgical specialty choices seem to be little influenced by the relative degrees of risk of a given patient. Recent published articles have highlighted issues related to VTE.32,33 On the basis of our experience with more than 20,000 patients studied prospectively in Kentucky, there is a substantial mismatch between the intensity of preventive measures outlined in Table 5 and the need for such measures. Curiously enough, in the more recently completed study of 5285 patients, clinically diagnosed pulmonary embolism itself occurred in 15 patients and DVT, as recognized and reported, was only slightly more common (n=20) (J. N. Lewis, MD, unpublished data, November 2005). Imprecise antibiotic prophylaxis is a modest risk for an individual patient undergoing elective surgery and, as yet, is associated with relatively little danger to the hospital ecology. Imprecise and possibly inappropriate VTE prophylaxis is a far greater hazard. Obviously, the ideal situation would encompass a perfect match between the risk of VTE and extent of prophylaxis.33 However, based on our unmasked study of network-reported patients, this seldom occurs. Surgeons tend to be “believers” or “nonbelievers”
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TABLE 5. Graded Variations in Choices for the Prevention of Venous Thromboembolism (N=1133)* Early ambulation only Elastic stockings Sequential compression devices Subcutaneous heparin Low-molecular-weight heparin Warfarin sodium Other Oral medications Subcutaneous dalteparin sodium Fondaparinox study cases Combinations Sequential compression devices and subcutaneous heparin Low-molecular-weight heparin and other treatment Sequential compression devices and elastic stockings
298 128 353 143 77 87 8 2 2 4 39
tion (J. N. Lewis, MD, unpublished data, November 2005). Finally, some regimens, such as enoxaprin sodium, require prolonged administration, often by a home health professional, which is intrinsically one of the most expensive choices a surgeon can make. In Kentucky, for example, the average charge for a single home health nurse visit is $129 for Medicare patients, and this price does not include medications or other activities. If surgeons have been 35 years late in accepting standards for relatively black-and-white systemic antibiotic prophylaxis, how long will it take to reach consensus of ideas and practice on the prevention of rare events by methods that are intrinsically dangerous and/ or expensive?
*Some operations, such as laparoscopic cholecystectomy, were performed in the outpatient setting.
in VTE prophylaxis and tend to treat most patients alike. For example, one respected senior surgeon is critical of VTE prophylaxis and tends to use nothing; however, if the patient has a documented history of DVT and/or pulmonary embolism, this surgeon chooses a combination of both mechanical and medicinal measures. Another surgical specialist, despite the findings of a National Institutes of Health consensus panel in his field,34 chooses aggressive and prolonged medicinal prophylaxis for most patients, again varying practice only slightly in response to documented risk. The truth is that DVT and/or pulmonary embolism was uncommon; perhaps our catch-as-catch-can practices are highly effective. Interestingly, most patients with either diagnosis had received relatively aggressive prophylaxis. To compound the issue further, postoperative bleeding that required reoperation was reported in 5 of 1131 patients, none of whom received medical measures of anticoagulaTABLE 6. Some Early Achievements of a Voluntary Quality Improvement Surgical Group Identified and altered length of hospital stay Identified unnecessary expense of disposable laparoscopic devices Identified some expensive drugs and suggested alternatives Focused on unnecessary home health visits and diminished use of such visits Compared a surgeon who works alone in a hospital with other surgeons in the region Created and published a book about when and to whom to refer Created a Web site for patient education Focused on turnover times in the operating room Created unique anesthesiology-surgery interactions in 1 hospital Developed and improved patient satisfaction surveys Successfully completed a subcontractor role regarding surgical complications by recruiting surgeons and hospitals, developed meaningful performance measures, and collected surgical case data from surgeons for analysis and, when possible, comparison with hospital-submitted reports
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FOCUSED SURGICAL EFFORTS IN QUALITY ENHANCEMENT Our renewed interest in this field actually grew from an initiative that began 7 years ago among practicing surgical leaders in Kentucky. Our small quality improvement group initially focused on some then-current cost control issues, which indeed are another subject but are still worthwhile. Physicians influence costs enormously and can have a favorable effect, perhaps more than any other health care professional. In those 7 years of study, we did not find a single example of when the most expensive care in any arena proved to be the best care. We now have a group that encompasses some 60-plus surgeons who have studied 43 current procedural terminology–based codes during the past 7 years in various prospective protocols. Table 6 highlights some of our effort, the most notable of which is the willingness of surgeons to promply emulate other surgeons whom they respect, especially when geographically close. We believe that it is relatively easy to encourage surgeons to adapt or to alter their practices based on the successful premises of their respected neighbor. A second highlight is that for small payments, we have been able to get detailed and largely accurate reports from surgeons about their work with varying degrees of complexity, whether considering appropriate stratification of risk or a prompt return to work. These all represent legitimate surgical quality performance measures and outcomes and are amenable to study and to sharing of results in a constructive sense. One of our most interesting experiences was a “1surgeon hospital” in a small rural town; our group was able to reassure the board of trustees of that hospital that its surgeon met or exceeded 8 of 10 quality criteria, and the surgeon rapidly brought the other two into a desired range when given the data and opportunity during the next 6 months.22 We were disappointed to find that the financial measurements associated with elective surgery, on the part of
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RENEWAL OF SURGICAL QUALITY AND SAFETY INITIATIVES
TABLE 7. Surgical Time-Out or Reflective Pause*
both hospitals and health plans, were cumbersome and often unable to recognize substantial dollar improvements. Some of our early observations were the profound expense of disposable surgical devices, especially for laparoscopy, and in surgeons’ preference cards, which tended to be updated every 5 years, whether this cycle was appropriate or not. In any case, virtually all our quality observations have been associated with decreased costs.
1. Verify patient identity 2. Verify site 3. Check antibiotic prophylaxis Justified Given Documented 4. Monitor intraoperatively Temperature Glucose 5. Check if blood is needed/available 6. Check venous thromboembolism prophylaxis Justified Given Documented
QUALITY INDICATORS The development of verifiable quality indicators in the field of surgery is an enormous proposition. While industryled groups continue to encourage some medical parameters, indicators for quality surgical practice are largely lacking. We expect to pursue this avenue and to make proposals that could be meaningful additions to surgical practice parameters that can be accepted widely and measured accurately. There are daunting concepts of and applications to this process; cautious implementation is essential.35 The future of this effort is obviously promising. The most important beneficiary will be the public. Increasing transparency associated with enhanced safety and quality, diminished risk, disability, and discomfort is overdue and something that is within the ready grasp of the 21st century surgical community. The broad base of growing awareness among surgeons is important. The early efforts by the STS and the VA medical system have set high standards. It seems that the American College of Surgeons is giving credence to these issues and has the capacity to teach meaningful change with respect to both safety and quality. Indeed, the elected chair of its board of regents has classified safety and quality as “an educational emergency.”36 The range of initiatives that are currently available is genuinely surprising. For example, in Pennsylvania, there is now obligatory reporting of all adverse events from the state’s hospitals and some of their ambulatory surgery centers. The program has already begun to identify patterns and/or clusters of events that allow for feedback to an individual institution and has developed a newsletter that communicates dominant themes back to the health community (Clarke JR, ed, Patient Safety Advisory Quarterly Newsletter). Another example is the leadership in a relatively small surgical training program based in a private hospital on the New Jersey shore, where one surgeon’s 7-year work with a traditional mortality and morbidity conference has transposed the culture of the hospital into a safer one with higher quality.37 Additionally, surgical practitioners in that hospital now have uncommon data on the quality of their work, the infrequency of death and/or complications, and a stringent definition of corrective measures that have been obtained for each of these issues.37 Mayo Clin Proc.
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*Taking time immediately before surgery to perform a final check to ensure that the correct patient is about to undergo the correct surgical procedure at the correct site.
Furthermore, these intramural standards must be matched by new staff applicants through the credentialing process. If one were to look a decade ahead, he or she might well see an atmosphere in which the operating room is more like the flight deck of a commercial air carrier. There will be checklists that begin with proper and honest assessment of operative risk and are followed by a variety of considerations in the best interests of the patient. The surgical “time out” or, as it has been called by some more articulate people, the “reflective pause,” (ie, taking time immediately before surgery to perform a final check to ensure that the correct patient is about to undergo the correct procedure at the correct site) is a perfect opportunity to not only avoid wrong site surgery but also to expand that list, to a reasonable degree, in surrogate measures of quality. Table 7 includes a list of options from which to choose. SUMMARY There are substantial discussions about the value of the quality and safety movement in virtually all medical entities. Third-party payers or health plans are anxious to espouse pay for performance and take credit for what are modest payments for performance. We must admit that Anthem Blue Cross and Blue Shield in Kentucky, in an imaginative way, began to do this with the surgeons involved in the aforementioned projects. Although the impact is small, both in the aggregate and with the individual, it is surely a step in the right direction. The federal government’s obsession with a budget-neutral approach could be used to justify pay-for-performance formulas, adjusted for physicians performing in the upper or lower 25% on any given set of performance measures or outcomes. Whether this actually happens or not is an important but secondary issue. General surgery is currently a remarkably stressed specialty financially,38 and meaningful pay for those dem-
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onstrating the best performance could be a genuine lifeline. These concepts and principles apply to most medical specialties, both to objectives and, to some degree, methods. We have found that these strategies are predictable and that they create a favored platform for ultimate medical transparency. There are many slips between the cup and the lip in this matter, but the critical issue is to realize that the patient must benefit in the short term and that the American public will be the long-term beneficiaries of this effort, just as occurred with the remarkable improvements in anesthesiology more than 2 decades ago. REFERENCES 1. Kaiser Family Foundation. Quality of care. Available at: www.kaiseredu .org/topics.asp?id=70&isID=30&refID=31&sidenav=249. Accessibility verified January 20, 2006. 2. Polk HC Jr. Quality, safety, and transparency. Ann Surg. 2005;242:293301. 3. Kohn LT, Corrigan J, Donaldson MS, Institute of Medicine, Committee on the Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000. 4. Institute of Medicine, Committee on the Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001. 5. Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds, Institute of Medicine, Committee on Data Standards for Patient Safety. Patient Safety: Achieving a New Standard of Care. Washington, DC: National Academies Press; 2004. 6. McCafferty MH, Polk HC Jr. Addition of “near-miss” cases enhances a quality improvement conference. Arch Surg. 2004;139:216-217. 7. Polk HC Jr, Spratt JS Jr, Bennett D, Copher GH, Butcher HR Jr. Surgical mortality and survival from colonic carcinoma. Arch Surg. 1964;89:16-23. 8. Shahian DM, Torchiana DF, Normand SL. Implementation of a cardiac surgery report card: lessons from the Massachusetts experience. Ann Thorac Surg. 2005;80:1146-1150. 9. Plogman PL, Pine M, Reed DC, Byrwa KJ, Berman JI. Anthem Blue Cross and Blue Shield’s coronary services network: a managed care organization’s approach to improving the quality of cardiac care for its members. Am J Manag Care. 1998;4:1679-1686. 10. Best WR, Khuri SF, Phelan M, et al. Identifying patient preoperative risk factors and postoperative adverse events in administrative databases: results from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Am Coll Surg. 2002;194:257-266. 11. Khuri SF, Daley J, Henderson W, et al, National VA Quality Improvement Program. The Department of Veterans’ Affairs NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. Ann Surg. 1998; 228:491-507. 12. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery: based on a study of 599,548 anesthesias in ten institutions 19481952, inclusive. Ann Surg. 1954;140:2-35. 13. Keenan RL, Boyan CP. Decreasing frequency of anesthetic cardiac arrests. J Clin Anesth. 1991;3:354-357. 14. Warner MA, Shields SE, Chute CG. Major morbidity and mortality within 1 month of ambulatory surgery and anesthesia. JAMA. 1993;270:14371441.
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