Shaping the Future of Surgery

Abstract

Objective:

To educate surgeons about the growth of the private regulatory movement and its potential implications for the practice of surgery.

Methods:

An in-depth analysis and literature review of one of the largest private regulatory groups, the Leapfrog Group, provides a model for understanding the impact of these groups on the practice of surgery. A detailed discussion of the history, mission, structure, and quality initiatives of Leapfrog is included.

Results:

Private regulatory groups are using quality standards as a method for controlling the rising cost of health care. Traditionally, little financial support, manpower, or incentives have existed for individual surgeons and hospitals to report and maintain their own outcomes data. However, as surgical outcomes have increasingly become the target of quality improvement initiatives, the need to measure performance is gaining importance. Surgical quality has been both a direct target of private regulation, as illustrated by the evidence-based hospital referral guidelines of Leapfrog, and an indirect target with initiatives like computerized physician order entry and ICU staffing guidelines.

Conclusions:

Private regulation is rapidly reshaping the way we practice and teach surgery. It is almost a certainty that their power, popularity, financial support, and missions will all continue to expand. As surgeons, we must decide soon if we wish to be an active participant in shaping the movement or, rather, if we are going to let it shape us by remaining largely uninvolved.

Surgical outcomes are a target of private regulatory groups interested in patient safety. With the growth of these groups, surgeons must become knowledgeable about their history, mission, structure, and initiatives because they are rapidly reshaping the way we practice and teach surgery.

More than 10 years ago, the surgical community began to explore evidence based practice guidelines with the National Surgical Quality Improvement Program (NSQIP), a program sponsored by the American College of Surgeons (ACS) and the Veterans hospitals (VA). The NSQIP is “a national, validated, outcomes-based, risk-adjusted program for the measurement and enhancement of surgical care,” which has demonstrated tremendous declines in mortality (27%) and morbidity (45%) in the VA system.¹ Since its inception, the NSQIP has stimulated interest within the surgical community in using clinical outcomes data to judge performance and to improve patient outcomes. A plethora of literature examining surgical outcomes data from NSQIP studies is now available, and a pilot program utilizing NSQIP methodology has recently been initiated in private sector hospital systems. In addition, although largely informal, discussions are now underway to consider revising the current training system and recertification process and to focus educational efforts on competency criteria and not just volume criteria.

Despite the ACS's decade-long commitment to the NSQIP and surgical outcomes research, surgeons continue to play a limited role in setting the quality standards used by private regulatory groups. The reason for this situation is that surgeons and hospitals have lacked the financial support, manpower, or incentives to report and maintain their own outcomes data. However, as private regulatory groups increasingly target surgical outcomes, the need for surgeons to measure their own performance is becoming increasingly important. As private regulatory influence grows, it is imperative that surgeons are knowledgeable about the history, mission, structure, and initiatives of these groups who are rapidly reshaping the way we practice and teach surgery.

PRIVATE REGULATION

Before exploring the connection between private regulation and its impact on general surgery practice, it is first important to understand the sources of these quality standards. Over the last decade, many national regulatory groups have either adjusted their missions to include quality standards or have been formed primarily to advocate for such standards. These regulatory groups include the Joint Commission on Accreditation of Health Care Organizations, the National Quality Forum, the Agency for Healthcare Research and Quality, the National Committee on Quality Assurance, and the Leapfrog Group. A number of these agencies have formed partnerships to strengthen their market power. One of the largest private regulatory groups, Leapfrog, was proposed in 1998 to pool the purchasing power of Fortune 500 companies in an effort to influence healthcare quality and affordability.² Since its official inception in November 2000, the Leapfrog Group has become one of the most powerful forces in the private regulatory sector and provides an excellent model for understanding the impact of these groups on surgery.

History

Leapfrog began in 1998 as an informal working group formed by large, major employers to discuss how to evaluate healthcare quality. The working group sought assurance that their billions of dollars in healthcare expenditure would result in high quality outcomes.^2,3 An Institute of Medicine report released in 1999 revealed that 98,000 Americans die each year from preventable medical errors,^2,3 stimulating the Leapfrog working group to explore forming a more permanent organization with a goal of pooling their health care purchasing power to exert market pressure and obtain the highest quality health care for their employees. In November 2000, a formal organization comprising of 60 corporate members was founded with initial financial support from the Business Roundtable, an association of Fortune 500 company chief executive officers.^2,3

Mission

Leapfrog's mission is twofold: to improve healthcare quality by implementing safety initiatives by January 2007 and to increase consumer knowledge through Web-based hospital performance data. Ultimately, Leapfrog plans to “preferentially direct” their corporate members' health care to those organizations that adhere to patient safety standards.⁴ Leapfrog works by “building transparency” about the performance of select hospital systems to provide patients and employers with information regarding the quality of care they are purchasing.² Hospitals that implement the quality and safety practices advocated by Leapfrog will be encouraged with incentives and rewards for compliance. These safety practices include widespread institution of computerized physician order entry (CPOE), intensive care unit staffing by specialists trained in critical care (intensivists), and the introduction of evidence-based hospital referral (EHR).² Leapfrog is working to “create consistency and leverage for change” by partnering with other regulatory organizations to “develop and recommend other quality and safety initiatives for both hospitals and physician offices.”² To date, Leapfrog has joined with key, powerful partner organizations including the largest hospital accreditation body, Joint Commission on Accreditation of Healthcare Organization, the National Quality Forum, the Agency for Healthcare Research and Quality, and the National Committee on Quality Assurance.²

Organizational Structure

The initial 60 member collaborative group has blossomed in 4 short years and now includes 159 corporate members, including many Fortune 500 companies. Nineteen public and private organizations and several federal offices including the Centers for Medicare & Medicaid Services participate as members and liaisons with the Leapfrog Group. Powerful healthcare policy research foundations such as the Robert Wood Johnson Foundation and the Commonwealth fund provide additional funding.² The group is now widely recognized as a leader in the movement for patient safety⁵ and has even been cited as an “innovator and visionary” by the Foundation for Accountability.² In total, Leapfrog members spend over $62 billion on health care each year and represent 34 million beneficiaries.²

Expert panels and clinical advisors are used to help identify the areas of medical practice most likely to result in improved patient outcomes through institution of the Leapfrog quality initiatives. A physician with expertise in the respective topic area chairs each of the three expert panels, one for each of the initial major safety practices. In total, 30 members, including physicians, researchers, and industry leaders comprise the expert panels.² An 18-member clinical advisory panel supplements the expert panel mainly by identifying appropriate uses for EHR.

Leapfrog has identified geographic regions where “market characteristics [are] favorable for turning Leapfrog from a purchaser-driven movement to a community-wide collaboration.”⁶ Hospitals in 24 regions are targeted through a “regional roll-out” program. The regional roll-out program is a strategy to guide local community efforts in implementing Leapfrog safety recommendations. Each region has a designated healthcare purchaser responsible for recruiting and advising additional purchasers, hospitals, physicians, and consumer groups with interest in approaching safety standards from a community-based collaboration.⁷ Currently, approximately 50% of United States healthcare consumers fall within the Leapfrog targeted regions and as of December 2004, 60% of hospitals located within regional roll-out areas participate.⁸ For hospitals and purchasers outside of targeted regions, it is hoped that they will participate individually resulting in eventual “full-scale regional implementation.”⁶ Currently, the organization is focusing on private and public hospitals in urban areas, although they have recently announced intent to begin “targeting” rural hospitals in the near future.⁹

Data Collection and Dissemination

Leapfrog has created a voluntary, online patient safety survey to provide consumers and purchasers with comparative ratings of adherence to safety initiatives by participating hospitals. Although the intention is for all acute-care, short-term adult and children's hospitals to voluntarily complete the survey, hospitals within regional roll-outs are actively recruited.⁷ The survey is not designed to evaluate specialty hospitals like psychiatric or rehabilitation facilities.⁶ Participation is time intensive. The initial survey requires on average 1 to 3 days to obtain the necessary information for survey completion.⁶ Participation is a long-term time investment as the survey is revised annually with a new survey released on April 1st and an update expected by June 30th from participating hospitals. As an added responsibility, respondents are asked to regularly update their survey results to document progress toward implementation of a safety practice.⁶

Leapfrog delegates to a healthcare information technology firm, Medstat (www.medstat.com), primary responsibility for data collection, online survey development, Web support, data analysis, and dissemination of results. Medstat is recognized as one of the leading healthcare industry consultants for research services for managing cost and quality of health care.⁶ Medstat has developed a scoring algorithm that credits hospital systems based upon the progress made toward safety practice implementation. The comparative performance ratings are then disseminated to consumers through multiple modalities, including directly through participating employer purchasers and indirectly through press releases and a public Website searchable by region and hospital system. Purchasers are also encouraged to use performance ratings in negotiations with providers and healthcare plans.² Although survey participation is voluntary, a concerted effort is made to pressure nonparticipating institutions into participating by publicly designating them on the website as facilities that “Did not disclose.”² The Leapfrog Website has become a particularly powerful information dissemination modality considering in its infancy it is already receiving more than 200,000 hits per month for survey results and includes information on healthcare institutions spanning over 69% of the U.S. population.⁷

CURRENT SAFETY INITIATIVES

Proposed Benefits

Although the Leapfrog mission continues to grow, their three initial safety initiatives computerized physician order entry, intensive care unit staffing by intensivists, and EHR remain the primary focus of their efforts.

CPOE

Traditionally, physician orders are either manually transcribed onto patient charts or order sheets and sometimes, verbally communicated to nursing staff. The opportunity for medication errors (including illegible handwriting, decimal point errors, and overlooked drug interactions) is enormous. Birkmeyer concluded that more than 1 million serious medication errors occur each year in U.S. hospitals, leading to 7000 deaths annually and $2 billion dollars in added healthcare costs.^10,11 CPOE was developed to streamline the order process. Key features include allowing automatic screening for erroneous orders and cross checks against pertinent patient information such as allergies and drug interactions because researchers estimated that these errors would be reduced 55% by such systems.¹² The Leapfrog CPOE standard requires hospitals: 1) to have 75% of physician orders entered directly through a computer system with prescribing-error detection technology, 2) to detect a minimum of 50% of common, serious prescribing errors in inpatient CPOE systems measured by a testing protocol under current development, and 3) to require physicians to electronically document reasons for overriding flagged errors prior to medication administration.¹¹ Partial credit for this safety initiative is awarded to a hospital if a minimum of one hospital unit is utilizing CPOE.

Intensive Care Unit Staffing by Intensivists

Prior to the development of the Leapfrog standards, there was no widespread standard for the qualifications of the physician providing care to intensive care unit (ICU) patients. Only about 10% to 15% of hospital systems² have what is known as a “closed ICU,” indicating that once admitted to the unit the patient's care is primarily coordinated by a board-certified intensivist; while others have an “open ICU” where any physician can admit and care for a patient directly. A growing body of literature indicates that treatment in a closed ICU (both medical and surgical) results in lower ICU mortality and morbidity^13–17 with a potential of avoidance of 54,000 deaths annually,¹³ shorter lengths of stay,14,15,18,19 and decreased hospital costs.^14,15,19 As a result, the Current Leapfrog ICU standard requires that adult and/or pediatric ICUs must be at minimum comanaged by intensivists who 1) are present during daytime hours and provide care exclusively in the ICU and 2) at other times are reachable by pager 95% of the time within 5 minutes of being paged.²⁰ Partial credit is given when intensivists lead daily, multidisciplinary team rounds and are involved in admission/discharge decisions.

EHR

EHR was introduced as a safety initiative by the Leapfrog Group in response to the expanding volume of surgical literature demonstrating improved patient outcomes for high-risk procedures performed at the highest-volume institutions.^21–24 The original standards required that patients in metropolitan areas undergoing the selected high-risk procedures (coronary artery bypass surgery [CABG], carotid endarterectomy [CEA], percutaneous coronary intervention [PTCA], abdominal aortic aneurysm repair [AAA], and pancreas resection) have those procedures performed at institutions with the largest clinical experience measured by volume criteria alone. The original recommendations have undergone the most change of any of the safety initiatives due in large part to published data refuting the specifics of some volume-outcome relationships included in the Leapfrog safety standards (for example, CEA standards were eliminated^25–27) and the recognition that most institutions would never be able to meet the high-volume standards.^27,28 In addition, EHR attracted a significant amount of attention from critics who wanted not only volume criteria included in future standards but also process measures and outcomes adjusted for patient characteristics.²¹ As a result, the most current revision of the Leapfrog standards includes a direct outcome measure (risk-adjusted mortality) for CABG and PTCA, as well as a decrease in the hospital volume criteria for CABG (from 500/year to 450/year), an increase for AAAs (from 30/year to 50/year) and esophageal resection (from 7/year to >13/year), and the introduction of a new procedure standard for pancreatic resection (>11/year).²¹ The standards continue to require 400 PTCA procedures per year.²¹ Unfortunately, process measures still receive little emphasis.

General Criticisms and Barriers to Implementation

CPOE

CPOE implementation is a formidable task considering that even Leapfrog acknowledges that less than 2% of U.S. hospitals require CPOE usage¹¹ and only 400 (10%–15%) even have it partially available.^3,12 One major barrier is the development cost for such systems with realistic estimates ranging between $3 million to $30 to $40 million dollars for initial implementation,^3,12 with the average 500-bed hospital needing $7.9 million to develop and $1.3 million per year to maintain a CPOE system.²⁹ Several critics have acknowledged that hospital systems may not invest the capital and time commitment to CPOE due to a lack of direct financial benefit from doing so (because reduction in medical errors reduces hospital expenditures)^12,30 and a lack of external financial incentives (although such incentives are under development) from groups like Leapfrog to encourage such investment.³⁰ Moreover, a 2003 report found that one third of all hospitals are operating with a deficit and hospital systems on average planned to spend less money on information systems in 2004 than in previous years.²⁹ An additional significant barrier, particularly for smaller hospital systems with less financial and manpower capital, is the information technology industry itself.³⁰ No off-the-shelf product is currently available, no standards have been developed among vendors, and interchangeability of differing vendor programs is problematic,^12,30 resulting in the need for expensive, customized programs for individual hospitals. There is also recent evidence (one study found a 200% increase in errors) that CPOE may introduce new errors into the system.^4,30,31

Perhaps the largest barrier to CPOE is physician reluctance to behavioral change.4,12,30,32 Thus far, research indicates that overall efficiency (time from ordering to delivery of service) is improved;^12,33 however, concern remains among physicians that CPOE will add additional time burdens to their already busy clinical practices^12,30 and interfere with physician education (ie, less incentive to remember important drug interactions).^4,33 One study estimated that CPOE would require 5% of a resident's weekly work hours (which were recently restricted by ACGME) for computerized order entry.⁴ Additionally, in January 2003, Cedars-Sinai Health System (Los Angeles) ceased all efforts to use the system they had invested millions of dollars in due to “almost unanimous protest from the medical staff.”⁴ In general, facilities that have achieved widespread CPOE have done so with “… long-term commitment of resources, extensive training and support, and involvement of physicians.”³⁰

Intensive Care Unit Staffing by Intensivists

Among the many barriers to implementation of the ICU standard is a shortage of qualified physician intensivists. Currently, there are too few intensivists to meet the standards if applied to today's demands.³⁴ Indeed, in 2003, only 22% of hospitals reported meeting the ICU standard.⁷ Furthermore, the Committee on Manpower for Pulmonary and Critical Care Societies has estimated that a 46% shortage of intensivists will occur by 2030 (due to the aging population) based upon the current ICU structure and not accounting for substantial increases needed if the Leapfrog standard was applied.^34,35 As a result, the Leapfrog Group has already modified its ICU standard to allow telemedicine (constant remote monitoring or consultation) to supplement ICU care. Despite this, minimal research is available to support mandatory implementation of such modifications.³⁵

In addition, the research that Leapfrog has relied upon to support its ICU standards are largely retrospective, and comparisons between studies are difficult due to differing research questions/design. Although acknowledged as a common sense starting point for improving patient outcomes, a 2004 critical reanalysis of the data Leapfrog used to develop its standards concluded that the standards “… are based either on weak or no scientific evidence.”³⁵ In addition, the financial benefits from ICU care delivered by intensivists for individual hospitals may be offset by the need for higher salaries to attract qualified staff given current and projected workforce shortages;³⁴ conversely, a 2004 study concluded that, although intensivists' salaries were the most costly expenditure in the implementation of the ICU standard, in all but the worse case scenario, hospital systems would save between $510,000 and $3.3 million per year with implementation.³⁶ Therefore, the largest barrier and potentially most difficult to overcome to implementation is workforce supply and not financial concerns.³⁶

EHR

There are significant barriers to full-scale implementation of EHR, also known as a regionalization of care. Institutions and practitioners are reluctant to accept the standards as a meaningful measure of quality, and this reluctance represents a powerful barrier to implementation. For instance, most research studies to date do establish that there is something about high volume that leads to better outcomes for some (but not all) high-risk procedures or high-risk patients.22,24,28,37 However, the exact critical volume necessary to achieve these outcomes for each procedure or exactly which critical process components are important in high volume institutions (is it surgeon volume, overall hospital volume, a combination of the two, etc …) remains difficult to fully define.24,26,27,37–41 The majority of available literature is characterized by differing, somewhat arbitrary volume determinations for analysis, administrative data (which is less meaningful than clinical data), is not adequately controlled for patient characteristics (like preexisting conditions) or volume clustering, and is often retrospective resulting in conflicting results for a given procedure.22,24–28,41–46 The strength and direction of volume-outcome relationships found for some disciplines, like peripheral vascular surgery and heart surgery, have later been questioned once more rigorous research methodology has been applied.25,26,44,47,48 Many researchers now recognize that using quantity alone as substitute measure of quality is problematic.^27,43–46 In other words, there are inadequate data to support implementing specific volume criteria.⁴⁶

SPECIFIC IMPLICATIONS FOR THE PRACTICE OF GENERAL SURGERY

Private regulatory groups have in a relatively short period of time stimulated intense discussions and in many hospital systems changed the way surgery is practiced. Surgical quality has been both a direct target of these groups as illustrated by the EHR guidelines of Leapfrog, and an indirect target with initiatives like computerized physician order entry and ICU staffing guidelines. Unfortunately, most in the surgical community are largely unaware of these efforts that carry significant potential impacts for the general surgery field.

Reconciling Supply and Demand Mismatch With Leapfrog: Training Implications

Attracting, educating, and retaining general surgery residents have gained considerable interest among our field over the last several years. Although some effort has been undertaken to fully define the surgical workforce and determine if it meets the current or future demand, these measurements have been difficult to reliably and accurately determine.^49,50 Despite controversies with determining workforce supply, demand is rising with the aging population predicted to result in a 33% increased need for general surgeons by 2010.⁵⁰ Recently, the Association for American Medical Colleges called for a 15% nationwide increase in medical school class sizes to meet the needs of the aging population.⁵¹ In addition to concern in the overall supply of medical professionals, general surgery has seen a steady decline in the number of medical students entering general surgery residency since 1990. Reasons widely cited for the declining interest include call schedules, training length, and lifestyle issues.^49,50,52 After the introduction of work hour restrictions in 2003, the number of students matching in general surgery rebounded slightly.⁴⁹

With declining interest in general surgery from United States medical school graduates and projected supply and demand mismatch in the near future, the manner in which surgical residents are educated has to be considered in light of the Leapfrog safety standards. The Leapfrog Group through its intensivist and EHR standards is fueling the movement toward the designation of centers of excellence for surgical care. Surgical training is carried out in variety of residency programs based not only at large, tertiary care centers, but also in many smaller community hospital systems. If Leapfrog standards drive practicing surgeons away from smaller, community hospital systems (which may not be able to meet the standards), the number of residency programs based at these institutions may be dramatically reduced. Even if surgeons were to remain at these smaller institutions, the patients may not. The net result of these shifts will be a reduction in both volume and learning opportunities. Although the standards only currently apply to urban hospitals, it isn't unrealistic to anticipate that with increasing public awareness of such standards, patients will demand treatment from larger hospital systems that do meet the standards.

As a field, we have to consider the possibility that training institutions may reach a point where they are not able to train the general surgery resident to be competent in the full range of surgery. For example, each general surgery resident is required to complete a certain number of index cases in categories spanning the breadth of general surgery. AAA and pancreatectomy are two such procedures that are also included in Leapfrog volume initiatives. Based upon procedure volumes of graduating residents, many training programs are not meeting the initial or revised Leapfrog volume standards and have seen a decline in the volume of index cases like AAAs in recent years.^53,54 If standards force the regionalization of certain procedures, training programs will see a diversion of these procedures to select institutions and, therefore, will likely have even more difficulty meeting training requirements in certain topic areas.

From a policy prospective, it would appear to the public that the bulk of our trainees are being trained at institutions that are unable to fulfill the Leapfrog standards, however, this illustrates a fundamental flaw with the Leapfrog volume (and process) standards. These criteria do not differentiate those lower volume institutions, both tertiary centers and community facilities, that perform well or higher volume centers that perform more poorly.^40,47,55 Training institutions, regardless of procedure volume, have some of the most gifted surgeons who are vested in passing on skills to the next generation. Educating future surgeons reduces productivity in the operating room because it just simply takes longer to teach while operating. Indeed, academic surgeons perform the fewest procedures of all surgeons recertifying,⁵⁶ but these procedures often require profound technical skill. With the push to achieve standards and the consequences high for not reaching those volume goals, the question becomes for institutions and surgeon-educators, what the trade-off will be for resident education?

The recognition that volume does not equal competency has stimulated discussions in the surgical community regarding moving toward a competency-based system, and away from a simple volume and time-based training program.^28,46,57 Until recently, these discussions were largely informal because changing to a competency-based system would not only require abandonment of decades of tradition, but more importantly, would require surgeons themselves to develop a national standard for evaluating quality—a daunting task. Recently, the American Board of Surgery committed to piloting competency-based training and an outcomes assessment for recertification.⁵⁷ Although a competency system would likely achieve improvements in quality, it would not likely provide residents with increases in case numbers (the target of many regulatory groups). Consequently, surgeons have to integrate themselves into the world of the consumer and purchaser to help guide further regulatory initiatives to include innovated strategies to bridge the gap between achieving volume and educating future surgeons. For example, there has been tremendous interest in developing training simulators for surgical procedures, an issue no regulatory group has even considered. To argue persuasively to protect surgical training programs, a more fundamental understanding of what makes an excellent program produce a surgeon capable of providing the highest quality care in any hospital system is needed.⁵⁵

EHR and ICU Leapfrog Standards Influence on Surgical Care

Beyond the general criticisms discussed previously (based on the strength of the literature used to develop the Leapfrog standards), the EHR and ICU Leapfrog standards have further potential for altering general surgery practice characteristics. Historically, many surgeons were attracted to general surgery for the wide breadth of the operative procedures. As medicine has become more complex and regulatory groups have focused on quantity as a substitute for quality with initiatives like EHR, the existence of the general surgeon who did a wide range of procedures in the past is quickly being replaced by a drive towards specialization within the field in areas such as breast or colorectal surgery. However, as the population ages and the demand for surgeons grows in both rural and urban communities, the number of new cases in many disease areas will outpace the number of specialty trained surgeons.⁵⁸ Indeed, by 2020, a 51% increase in patients needing oncologic procedures is anticipated.⁵⁸ It is unrealistic to think that every patient needing an oncologic or vascular procedure could be cared for at a high volume institution.^10,46,58 Currently, only 5% of surgeons performing AAA repairs are high-volume vascular surgeons, whereas general surgeons with some vascular experience perform the majority of cases.²² Furthermore, Leapfrog standards do not account for patient preference for local care as highlighted in a 1999 report from Finlayson et al, which demonstrated that many patients would prefer care at a local hospital over a regional hospital 4 hours away, even with an operative mortality rate twice as high as a regional center.⁵⁹ Regardless, diversion of large patient populations that would be necessary to satisfy some of the Leapfrog standards might actually negate the benefits of being treated in a high volume centers as the system could become overwhelmed.^47,55 An additional downside to diversion from low-volume centers, may arise when emergent cases (like a rupture AAA) occur at such centers. A skilled practitioner may not be readily available to address the emergency,^38,46,55 leading to a high likelihood of an adverse outcome.

Generally speaking, the surgical community should be concerned that volume based performance standards (like EHR) will be falsely interpreted by consumers to reflect the overall quality of care provided by an individual institution. Despite a lack of concrete evidence supporting a direct volume-outcome relationship for more common, low-risk procedures including colorectal surgery^26,42,60 and hernia surgery²⁶ or higher-risk procedures performed in average risk patients,⁴⁴ the Leapfrog Group has done little to emphasize that its performance standards only apply to a hospital's experience level for specific indications. The Website helps the public select the “best hospital” for only a few procedures leaving the consumer to infer performance capabilities in other unrelated circumstances. This volume-based assessment also fails to account for the individual surgeon effects, such high volume surgeons in a low volume hospital or a lower volume surgeon with excellent outcomes. Consequently, the dissemination of information likely biases consumers toward selecting high volume hospitals for procedures unrelated to those evaluated by the quality standards.

Furthermore, continuity has been an important characteristic of surgical care, and private regulation may reduce the capacity of individual surgeons to care for their own patients, particularly in the ICU. Currently, surgical patients are cared for in both open and closed ICU settings. Many tertiary care hospitals have their own dedicated surgical ICUs, and the Leapfrog standard would require that all surgical patients be cared for in conjunction with a board-certified intensivist. This individual may or may not be board certified in surgical critical care. The requirement that the intensivists' only responsibility be care of the ICU patient makes it difficult to maintain control of surgical patients in the ICU setting.

Moreover, most hospitals do not have access to surgical intensivists given that only 3% of all critical care specialists are board certified in surgical critical care.³⁴ To comply with Leapfrog standards, a higher number of consultations and care would have to be undertaken by medical intensivists for surgical patients where the patient population and pathology can be vastly different than the medical ICU patient. Accordingly, the approach to the patient is also dramatically different. With major medical critical care societies projecting eminent intensivist shortages, it is unlikely medical intensivists could or would want to absorb this additional burden.

In addition to reducing our ability to manage our own critically ill patients, the Leapfrog standards could create barriers to access as the incentives for hospitals systems to care for higher-risk patient changes. There simply is not a perfect or near perfect way to control for all the variables involved in case-mix¹⁰ (patient characteristics and comorbidities), which could create a disadvantage for those institutions rendering care to riskier patients. Hospitals and surgeons would have nothing to gain and much to lose by taking on higher-risk patients, whereas they would have greater incentive to care for lower-risk patients who are less likely to suffer an adverse outcome. Continuity of care may also be jeopardized. High-volume hospital systems could theoretically become overwhelmed with a large-scale influx of patients with widespread EHR implementation resulting in decrease contact time between patients and their surgeon. In addition, physicians may be pressured to manage complex complications in the outpatient setting (which could lead to longer recoveries or decreases in patient quality of life) or to divert their complications to other hospital systems to shift readmission numbers from one institution to another. Moreover, if hospitals or surgeons have to achieve a volume criterion, there may be a tendency to operate on patients with borderline indications simply to meet that standard.⁴⁷ This is especially problematic when the stakes are high and the standards are difficult to meet. Examples of this dilemma include highly complex procedures such as AAA and CABG, as only 36% of academic centers meet the Leapfrog requirements. For esophagectomy, the picture is even bleaker with only 20% of academic institutions meeting the volume standard.²⁷

Is This Just the Beginning?

The Leapfrog Group is only one example of several private regulatory organizations that have not only gained popularity with the general public, but financial and political support as well. In many arenas, these organizations are viewed with the highest regard for not only taking on the medical field but also translating initiatives into practice. It is almost a certainty that their power, popularity, financial support, and missions will all continue to expand. As surgeons, we must recognize that many safety initiatives were initially developed with little surgical input (beyond a few surgeons who have long been interested in surgical outcomes), yet they have profound implications for surgical practice. In the case of the Leapfrog Group, it is impractical to believe that an organization composed of primarily business leaders could fully understand every critical aspect of caring for surgical patients when developing safety standards. They can make logical recommendations with expert input based upon the data available; however, assessing and properly interpreting outcomes is an especially challenging endeavor. The surgical community has little choice but to actively partner with such organizations to ensure that the intended effect of advocated practice changes translates into good surgical practice. Leading the effort in the surgical community, the ACS has recently taken a large step toward educating its members through the publication of the ACS Manual on Patient Safety.⁶¹ Improving member education on safety standards will hopefully translate into a renewed interest in helping to set such standards.

Many of the harshest criticisms of the early Leapfrog standards arose from their use of flawed retrospective research studies used to justify the safety initiatives. The only way to ever convince surgeons, or any medical professional, that the growing pains of change will be beneficial is to have sound scientific data. Unfortunately, in Leapfrog's ambitious push for practice changes, their rapid move toward policy recommendations based upon early methodologically flawed data has raised skepticism among clinicians. More importantly, they did not realize that their “best practice” dreams would very quickly be translated into the “standard of care” without full consideration of the realistic nature of their initiatives. Nevertheless, they continue pushing forward by developing new initiatives.

Although the standards now only apply to urban hospital systems, private regulatory groups could plausibly begin to advocate for a form of implementation in rural facilities or even extrapolation of volume standards to individual surgeons or to more procedures in the future. Leapfrog has already recently announced plans to “invite” rural hospitals to participate this year in their safety practices and intents to “target” rural hospitals next year.⁹ Thus, it is likely that surgeons will soon be forced to collect their own outcomes data while still facing all the other changes in healthcare that have already translated into “… a never-ending increase in bureaucratic requirements resulting in mountains of paperwork.”⁵⁴ Although having being cognizant of one's own abilities and limitations is an important part of being a good surgeon, we will soon probably have to collect and report data formally either for recertification, hospital privileges, or to third party reimbursers. The simple fact is that this will require tremendous individual surgeon effort for which there currently is no infrastructure, financial support, or agreement on what data should be collected.

In addition, there is no consensus about which private regulatory groups we should be held accountable to or what the standard of scientific justification for a standard should be. In 2003, Dimick et al noted, “very few procedures are performed commonly enough [by individual surgeons or groups] to generate statistically precise estimates of morbidity and mortality.”¹⁴ So, how will we compare outcomes reliably and precisely? It is common sense that as a purchaser or consumer receiving care from the most experienced surgeon would be viewed as desirable. However, the scientific literature has not reached a definitive conclusion regarding a link between experience judged by volume and outcomes for many high-incidence conditions like breast cancer.⁶² For example, Birkmeyer et al recently published data demonstrating that, among elderly patients surviving major cancer surgery, there was no difference in long-term survival for those undergoing the procedure at National Cancer Institute-designated centers of excellence compared with control hospitals.⁶³ Yet, Skinner et al found that, although treatment at a specialty center did not affect survival, treatment by a surgical oncologist did result in a 33% risk reduction for death at 5 years.⁶⁴ Despite the difficulties of determing optimum clinical outcome measurements, private and public pay for performance initiatives are gaining steam. Pay for performance directly links physician reimbursement to various clinical outcomes. Indeed, Congress is currently considering revisions to Medicare payment to include performance pay.⁶⁵ Surgeons need to be aware of the current literature to prevent policy implementation in areas where controversy remains in the literature.

In addition, no regulatory group has even considered the liability issues with the existence of such standards or data. Will surgeons be subject to additional liability if they knowingly practice in a hospital that does not measure up to the “best practice standards” of groups like Leapfrog? No one really knows, but legal experts have already recognized that private regulatory changes are beginning to redefine the medical standard of care.⁶⁶ Historically, courts have been conservative in defining the standard of care, as “that [which] would customarily be expected of a physician in the same specialty practicing in a similar community.”⁶⁶ Nevertheless, courts have begun to allow clinical practice guidelines, which are not necessarily customary medical practice to define standard of care. Surgeons operating in noncompliant hospitals should be concerned that a state court system may accept the Leapfrog standards as practice guidelines. Mello and Studdert cite the Illinois appellate courts decision in Kramer v. Milner, where the appeals court determined that “… practice guidelines [were] an appropriate consideration in determining negligence even when there exists conflicting evidence about the appropriate medical standard of care.”⁶⁶ Hence, even if the scientific validity of the Leapfrog standards remains controversial, the possibility exists that a court system could be persuaded to view them as a reasonable standard of care. This could force surgeons to have to include discussions of adherence to Leapfrog standards in the informed consent process to avoid future litigation.⁶⁶ Already, the Supreme Court of Wisconsin, in Johnson v. Kokemoor, found a neurosurgeon denied a patient the opportunity for true informed consent because the patient was not told that a nearby tertiary care center had more experience in performing the procedure in question.⁶⁶ As a result, surgeons should recognize that private regulatory groups are going to affect the legal standard of care in the near future.

THE FUTURE

Quality patient outcomes are a goal shared by surgeons and regulatory groups alike. The popularity of private regulatory organizations are most certainly going to continue expanding. The surgical community has to decide soon if we wish to be an active participant in shaping the movement or, rather, if we are going to let it shape us by remaining largely uneducated and uninvolved. First, under the leadership of the ACS, a concerted effort should be undertaken to educate the surgical workforce about private regulation. Second, the ACS should form, at a minimum, partnerships with reputable private regulatory groups to facilitate knowledge transfer regarding how quality initiatives affect the surgical field. The ultimate goal would be to twofold: 1) to be on the ground floor with developing initiatives to ensure they function as originally intended; and 2) to help surgeons identify what private regulatory groups to respond to. On the other hand, if we as a profession respond to private regulation by remaining autonomous and self-regulating, purchasers and consumers will remain skeptical of the degree of true “transparency.” Third, surgeons should continue to investigate the volume-outcome relationship using rigorous research methodology to identify the critical characteristics of high-volume institutions that translate into improved patient outcomes. It is our responsibility as a profession to educate ourselves in surgical quality measurement and facilitate development of measurement tools that lead to improved patient care.⁶⁷ Fourth, an infrastructure should be created to assist individual surgeons in objective outcome measurement and reporting. The ACS has recently led this effort with the introduction an outcomes course and the 3-year trial of the NSQIP in 17 private sites.⁶⁷ Fifth, training programs need to be innovative in training surgeons to overcome decreases in procedural volume and potential workforce shortages. Finally, we must embrace the reality that private regulatory groups have already forever changed the way health care is delivered. There will never be a time again that the average patient-consumer or third party purchaser doesn't want to know what they are buying.