 improved outcomes in colon and rectal surgery 22. Mathews WC. Screening for anal dysplasia associated with human papillomavirus. Top HIV Med 2003; 11: 45–9. 23. Wexner SD. AIDS: what the colorectal surgeon needs to know. Perspect Colon Rectal Surg 1989; 2: 19–54. 24. Cohen SM, Schmitt SL, Lucas FV, Wexner SD. The diagnosis of anal ulcers in AIDS patients. Int J Colorect Dis 1994; 9: 168–73. 25. Viamonte M, Dailey TH, Gottesman L. Ulcerative disease of the anorectum in the HIV positive patient. Dis Colon Rectum 1993; 36: 801–5. 26. Danzig JB, Brandt LJ, Reinus JF, Klein RS. Gastrointestinal malignancy in patients with AIDS. J Gastroenterol 1991; 86: 715–8. 27. Laine L, Amerian J, Rarick M, Harb M. The response of symp- tomatic gastrointestinal Kaposi’s sarcoma to chemotherapy: a prospective evaluation using an endoscopic method of disease quantification. Am J Gastroenterol 1990; 85: 959–61. 28. Burack JH, Mandel MS, Bizer LS. Emergency abdominal operations in the patient with AIDS. Arch Surg 1989; 124: 285–6. 29. Zelnick R, Poulard JB, Auguste LJ, Vretakis G, Margolis IB. Surgery in the AIDS patient. AIDS Patients 1991; 1: 10–4. 30. Macho JR. Gastrointestinal surgery in the AIDS patient. Gastroenterol Clin NA 1988; 3: 563–71. 31. Welch K, Finkbeiner W, Alpers CE et al. Autopsy findings in AIDS. JAMA 1984; 252: 1152–9. 32. Chachova A, Dietrich D, Krasinski K. 9 (1,3-dihydroxy- 2-propoxymethyl) quanine (gancylovir) in the treatment of cytomegalovirus gastrointestinal disease in AIDS. Ann Intern Med 1987; 107–33.  6 Quality and outcome measures Janak A Parikh, Sushma Jain, Marcia L McGory, and Clifford Y Ko CHALLENGING CASE A 64-year-old male is scheduled for a left colectomy for a carcinoma. His past medical history is significant for a 3 vessel cardiac bypass. CASE MANAGEMENT The patient’s primary care physician has placed the patient on beta-blockers. Prophylactic antibiotics (second generation cephalosporin) are ordered to be given within 1 hour of surgery. Pneumatic compression stockings are ordered for placement in the holding area. Unfractionated heparin (5,000 units subcutaneously) is ordered for 2 hours before start of the operation. The patient’s body hair is removed with a clipper. Efforts are made to keep the patient normothermic during and after surgery. Prophylactic antibiotics are not continued after surgery. Final pathology docu- ments a T3N1M0 adenocarcinoma. The patient is referred to a medical oncologist for consideration of adjuvant chemotherapy. For the first time in its history, the United States is at an impasse in healthcare. Rising healthcare costs, an aging population, and a growing number of uninsured Americans are causing concern among payers and lawmakers. These concerns have led to a large- scale effort to assess and improve the quality of healthcare delivered to Americans. A major impetus for quality improvement was the realization that continuing to increase healthcare expenditure was not feasible. In 2007, the United States spent approximately 16% of its gross domestic product, or $2.3 trillion on healthcare, with pro- jections forecasting a rise to 20% of GDP by 2016.(1) While these numbers far exceed what other countries spend on healthcare, they do not ensure that Americans receive better healthcare than other countries. In fact, with over 46 million people who are uninsured, and an infant mortality that is ranked 37th in the world, Americans are arguably not getting the most value out of their healthcare dol- lar.(2) The focus on quality in healthcare is a reality that current and future physicians will have to acknowledge, as transparency via public reporting of physician performance is likely in the near future. Currently, most efforts remain at the hospital level. In this chapter, we explore the concept of quality, the various methodolo- gies of quality improvement (including the use of performance measures), and examine some of the quality improvement efforts that are currently ongoing. Defining Quality of Care Though interest in healthcare quality is seemingly new, some have long understood the need to measure and improve the quality of healthcare in the United States. In the arena of quality improvement research, the challenges have been how to define quality, how to measure it, and how best to improve it. As defined by the Institute of Medicine (IOM), quality of care is defined as “the degree to which health services for individuals and popula- tions increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”(3) A more basic but equally accurate definition is the delivery of appropriate care at the right time to the right patient, and done right. In the past, the concept of healthcare quality was not at the political and social forefront as it is today. Many probably assumed that healthcare in the United States is of the highest quality and far superior to healthcare elsewhere in the world given our techno- logical advances and expenditures. However, in 1999, this notion visibly began to be challenged in the public eye. The 1999 IOM report “To Err is Human: Building a Safer Health System” was the first report that challenged the perception of a safe high quality healthcare system in the United States.(4) The IOM report pointed out the human errors in the healthcare industry and helped identify potential faulty systems, processes, and conditions within our current healthcare system that led healthcare providers to make mistakes. It is estimated that as many as 98,000 people die in hospitals every year as a result of preventable medical errors.(4, 5) INTRODUCTION These types of medical errors not only affect patient’s physical and psychological discomfort, but also increase hospital costs and decrease a patient’s societal productivity. Most importantly, the IOM report forced creation of national goals and recommended a four- tiered approach to achieve patient safety—first, to create leadership; second, to have a nationwide public mandatory reporting system to identify and learn from medical errors; third, to raise performance standards and expectations for improvements in safety; and fourth, to implement safety systems in healthcare organizations.(4) Based largely on the results of the 1999 IOM report, the IOM next developed a report entitled “Crossing the Quality Chasm: A New Health System for the 21st Century”, which defined six specific aims for improvement: (1) Safety (e.g., avoiding errors in drug administra- tion by simplifying the protocols for drug delivery), (2) Effectiveness (e.g., appropriate chemotherapy for stage II or III colorectal cancer), (3) Patient-Centeredness (e.g., patients having access to their own medical record information and to healthcare providers by email, phone etc.), (4) Timeliness (e.g., reducing waiting time for provider appointments or in the emergency room), (5) Efficiency (e.g., stream- lining forms to reduce paperwork so that providers can spend more time on patient care), and (6) Equity (e.g., patients should receive appropriate care regardless of race, age, gender, ethnicity, income, geographic location).(6) The goal of outlining these six specific aims was to help our current healthcare system to cross the chasm that lies between what is currently being delivered by the healthcare system and the quality of care that should be delivered.(3) History of Quality Assessment and Quality Improvement in Surgery The goal of improving quality and outcomes is actually not new to the discipline of surgery. Ernest Amory Codman, M.D. (1869– 1940), a surgeon, was the founder of the “End Result Idea”, and 6 improved outcomes in colon and rectal surgery father of the medical quality movement.(7, 8) In 1895, he gradu- ated from Harvard Medical School and interned at Massachusetts General Hospital (MGH). He later joined the surgical staff at MGH and became a member of the Harvard faculty. In 1914, he proposed evaluating surgeon competency at MGH. He believed that “every hospital should follow every patient it treats long enough to determine whether the treatment has been successful, and then to inquire ‘if not, why not’ with a view to preventing similar failures in the future.” In fact, he is quoted as saying: “… I am called eccentric for saying in public that hospitals, if they wish to be sure of improvement, 1. Must find out what their results are. 2. Must analyze their results, to find their strong and weak points. 3. Must compare their results with those of other hospitals. 4. Must care for what cases they can care for well, and avoid attempting to care for those cases which they are not quali- fied to care for well…. 5. Must assign cases to the members of the staff (for treatment) for better reasons than seniority, the calendar or temporary convenience 6. Must welcome publicity not only for their successes, but for their errors, so that the Public may give them help when it is needed. 7. Must promote members of the Staff on a basis which gives due consideration to what they can and do accomplish for their patients.”(7) In this regard, Dr. Codman made one of the most important contributions in the history of outcomes research in health- care. However, his thinking was well before its time. The MGH refused his plan and asked him to resign. Dr. Codman eventu- ally established his own hospital (which he called the “End Result Hospital”) to pursue his performance measurement and improvement objectives. To support his “end results theory,” Dr. Codman publicly reported these data in a book entitled A Study in Hospital Efficiency. Of the 337 patients discharged between 1911 and 1916, Dr. Codman recorded and published 123 errors. He systematically documented errors in diagnosis and treatment for every patient, and followed each patient for years after discharge to evaluate the end results of care. Not surprisingly, he was the first to institute the mortality and morbidity conference. Due to his immense interest in the quality of care delivered to patients, Dr. Codman helped lead the founding of the American College of Surgeons’ (ACS) Hospital Standardization program which later became the Joint Commission on Accreditation of Healthcare Organizations.(7, 8) Unfortunately, Dr. Codman’s ideas were probably too revolutionary for that time period and, as a result, were not well received. In point of fact, we are still working today towards implementing many of Dr. Codman’s original concepts with respect to documentation of complications and evaluating the end results of surgical care in our patients. THE DONABEDIAN MODEL OF QUALITY OF CARE Today, the most commonly used paradigm for quality improve- ment is the Donabedian model. In 1988, Donabedian developed a framework for assessing quality of care that involved three domains: structure, process, and outcomes.(9) The structural components of care refer to the physical characteristics of the institution. In a hospital, these would include the characteristics of the hospital and provider. Examples of structural components would be the hospital’s volume for a particular procedure, board certification of its physicians, or the presence of a computerized order entry system. Process components include interactions that occur between the provider and patient, and are com- monly considered the most direct predictors of quality of care because they identify a priori steps to make improvements and are not affected by patient characteristics (i.e., higher mortality rates for surgeons/hospitals with sicker patients). Examples of specific process measures include such things as timely administration of preoperative antibiotic prophylaxsis, use of sequential compression devices and/or heparin to prevent deep venous thrombosis, and the use of postoperative chemo- therapy in patients with stages III colon cancer. Finally, outcome components of care are probably most familiar to surgeons, and include morbidity, complications, and mortality. Two important issues to consider when using outcome to judge quality are that in order to be optimally used, outcomes require risk-adjustment to compare different providers or facilities. Additionally, while out- come measures may be used to identify poor care, in and of itself, outcomes might not readily identify how to actually improve care. If a surgeon’s risk-adjusted anastomotic leak rate is high, the cause may not be immediately or readily known, or identifiable. Nevertheless, outcome measurement is an important component of quality improvement because it has great face validity, as well as being the “standard” by which structural and process-based measures are validated. In point of fact, there have been numer- ous projects that have made comparisons between hospitals and physicians outcomes. Improvement based on Structural Measures Established as a nonprofit organization in 2000 by a small group of large corporations that purchase healthcare for their employees, the Leapfrog Group’s growing consortium of major companies and other large private and public healthcare purchas- ers provide health benefits to more than 37 million Americans. (10) The mission of the Leapfrog group is to use the purchas- ing power of its members to influence the quality and afford- ability of healthcare. In mid-2001, the Leapfrog Group began collecting hospital data to evaluate healthcare quality in six regions in the United States. Currently, the Leapfrog data cover over half the U.S. population and 58% of all hospital beds with over 1,300 participating hospitals nationwide.(11) Their efforts to improve the value of healthcare have been important. The Leapfrog Group encourages its member companies to adhere to the following four purchasing principles in buying healthcare for their enrollees: Educating and informing enrollees about the safety, quality • and affordability of health care and the importance of compar- ing the care providers give with initial emphasis on the safety and quality practices. Recognizing and rewarding healthcare providers for major • advances in the safety, quality, and affordability of their care. 6 quality and outcome measures Holding health plans accountable for implementing the • Leapfrog purchasing principles. Building the support of benefits, consultants and brokers to use • and advocate for the Leapfrog purchasing principles with all of their clients.(11) In their quest, the group established measures by which to rate hospitals. Each quality measure had to meet four criteria: There is overwhelming scientific evidence that these quality • and safety leaps will significantly reduce preventable medical mistakes. Their implementation by the health industry is feasible in the • near term. Consumers can readily appreciate their value. • Health plans, purchasers, or consumers can easily ascertain • their presence or absence in selecting among healthcare pro- viders.(11) Using these criteria, the Leapfrog Group identified four struc- tural measures to improve care. These included the existence of a computer physician order entry system, evidence-based hospital referral (EHR), intensive care unit (ICU) staffing by physicians experienced in critical care medicine, and the Leapfrog Safe Practices Score.(11) Of these measures, the one that has probably gained the most attention in surgery is the evidence-based hospital referral. This measure is founded on literature that demonstrates a volume-out- come relationship for certain complex procedures—more specifi- cally, that higher volume hospitals purportedly have better outcomes. The procedures currently with established volume- outcome rela- tionships and the current EHR procedures include coronary artery bypass grafting (CABG) (≥450/year), percutaneous coronary inter- vention (AAA) (≥400/year), aortic valve replacement (≥120/year), abdominal aortic aneurysm repair (AAA) (≥50/year), esophagec- tomy (≥13/year), pancreatic resection (≥11/year), and bariatric surgery (>100/year).(12) Other procedures that have evidence to suggest a volume-outcome relationship include carotid endarter- ectomy, lower-extremity bypass, mitral valve replacement, gastrec- tomy, cystectomy, pneumonectomy, lobectomy, and nephrectomy. (13) Relative to this textbook, the volume-outcome relationship in colorectal cancer surgery is varied. While a recent systematic review found a significant surgeon volume-outcome relationship in color- ectal cancer surgery, the magnitude of effect on mortality was small (1–2%).(14–17) This is consistent with the analysis by Birkmeyer et al. upon which the Leapfrog criteria are based.(13) Although there are multiple studies to support the volume- outcome relationship established by The Leapfrog Group, there are several potential issues that warrant further discussion. First, the analyses in most studies do not account for the possibility that surgeons with similar volumes may have very different outcomes because of systematic differences in processes of care. Thus, a high degree of clustering of outcomes may lessen the impact of volume on outcomes.(18) A second concern is the somewhat arbitrary nature of the cutoffs. For example, several recent studies exploring the volume-outcome relationship for CABG and AAA have demonstrated similar outcomes at lower volumes than the Leapfrog cutoffs. Finally, selective referral may potentially increase disparities, as the disenfranchised likely will not be able to participate in the referral process. Still, volume is being used as a proxy for quality of care, and in this regard, volume-based referral is probably a reasonable way to improve quality at this point in time. Improvement Based on Process Measures Compared to both structural and outcome measures, the use of process measures has the advantage of identifying a priori steps that lead to improvements in quality. Furthermore, process measures are not affected by patient characteristics and thus do not require risk-adjustment. For these reasons, process measures play an important role in the Centers of Medicare and Medicaid Services (CMS) effort to improve quality of care. In October of 2005, CMS introduced the Surgical Care Improvement Project (SCIP).(19) The goal of SCIP was to reduce surgical complications by 25% by the year 2010.(19) Many national organizations came together to form an expert panel to develop the SCIP measures. At present, there are approximately 20 measures. These measures target four domains of care, namely, prevention of postoperative infection, prevention of postoperative venous thromboembolism, prevention of cardiac events, and prevention of ventilator-associated pneumonia. There are specific process measures in each domain. For example, prevention of post- operative infection involves such things as administration of appro- priate prophylactic antibiotics 1 hour before incision, use of clippers to remove hair, maintainence of normoglycemia postoperatively for cardiac surgery patients, and postoperative normothermia for color- ectal surgery patients. A full list of measures is provided in Table 16.1. Hospital participation in SCIP is voluntary at the time of this writ- ing, and at present there is financial incentive for hospitals to enroll in the program since there is “pay for participation.” However, the SCIP measures may become pay-for-performance measures in the future. Currently, CMS has several surgical pay-for-participation measures scheduled to be implemented in October 2008 (Table 16.2).(20–22) In December 2007, CMS unveiled its most recent effort to improve healthcare quality by launching the Physician Quality Reporting Initiative (PQRI). Mandated by the 2006 Tax Relief and Health Care Act, PQRI is a provider-level quality improve- ment project whose initial aim is to have providers submit data on several CMS quality measures.(23) PQRI is another pay-for- participation program in which physicians who participate will earn an incentive payment of 1.5% of their total allowed charges for the Medicare Physician Fee Schedule covered services. The incentive payments are based on reporting from January 1, 2008 through December 31, 2008 and are scheduled to be disbursed in mid-2009 from Medicare Part B funds. In total, there are 134 reportable measures that span all areas of care. Healthcare pro- fessionals that are eligible to participate in the PQRI program include physicians, dentists, optometrists, nurse practioners, and physical therapists to name a few. For surgeons, there are approx- imately 14 measures, with an additional 7 measures which are generally applicable to all physicians (Table 16.3).(24) OUTCOMES Similar to the ideas of Dr. Codman, knowing one’s outcomes may help drive quality improvement. One of the best examples of this 6 improved outcomes in colon and rectal surgery notion is the National Surgical Quality Improvement Program (NSQIP) and its association with the marked improved surgical care in the Veteran Affairs (VA) hospitals. During the mid-to-late 1980s, the VA hospitals came under a great deal of public scrutiny over the quality of surgical care in their 133 VA hospitals. In 1991, Congressional leaders were concerned that the operative mortal- ity at VA hospitals was higher than that at private hospitals for the same procedure. In an effort to address this quality issue, congress passed a law which mandated the VA to report its risk-adjusted surgical outcome annually and to compare them to national aver- ages. In response to this mandate, the VA established the National VA Surgical Risk Study (NVASRS) in 44 VA medical centers.(25) In this study, a dedicated nurse at each site collected preoperative, intraoperative, and 30-day postoperative data on over 95 outcome variables for more that 117,000 major operations. Using this data, researchers developed a risk-adjustment model and were able to determine risk-adjusted 30-day morbidity and mortality rates in nine surgical specialties. Given the feasibility of the study, helped by the nationwide electronic medical record which has been in place in VA hospitals since 1985, the VA established the NSQIP in 1994. Each year, data from 110,000 major surgical cases are added to the database. Most importantly, the program has been highly successful, reducing 30-day mortality rates by 31% and 30-day morbidity rates by 45%.(26) This success was further solidified when, in 2002, the IOM named NSQIP “the best in the nation” for measuring and reporting surgical quality outcomes.(25) Given the success of NSQIP and the increasing focus on healthcare quality, private hospitals questioned whether or not Table 16.1 Surgical Care Improvement Project (SCIP) measures. SCIP Measures Target Areas Measures 1. Surgical Site Infection 1. Prophylactic antibiotic received within 1 hour prior to surgical incision. 2. Prophylactic antibiotic selection for surgical patients. 3. Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients). 4. Cardiac surgery patients with controlled 6 a.m. postoperative serum glucose. 5. Postoperative wound infection diagnosed during index hospitalization. (OUTCOME) 6. Surgery patients with appropriate hair removal 7. Colorectal surgery patients with immediate postoperative normothermia. 2. Adverse Cardiac Events 1. Surgery patients on a beta-blocker prior to arrival that received a beta-blocker during the perioperative period. 2. Intra- or postoperative acute myocardial infarction (AMI) diagnosed during index hospitalization and within 30 days of surgery. (OUTCOME) 3. Deep Vein Thrombosis 1. Surgery patients with recommended venous thromboembolism prophylaxis ordered. 2. Surgery patients who received appropriate venous thromboembolism prophylaxis within 24 hours prior to surgery to 24 hours after surgery. 3. Intra- or postoperative pulmonary embolism (PE) diagnosed during index hospitalization and within 30 days of surgery. (OUTCOME) 4. Intra- or postoperative deep vein thrombosis (DVT) diagnosed during index hospitalization and within 30 days of surgery. (OUTCOME) 4. Postoperative ventilator related pneumonia 1. Number of days ventilated surgery patients had documentation of the Head of the Bed (HOB) being elevated from recovery end date (day zero) through postoperative day seven. 2. Patients diagnosed with postoperative ventilator-associated pneumonia (VAP) during index hospitalization. (OUTCOME) 3. Number of days ventilated surgery patients had documentation of stress ulcer disease (SUD) prophylaxsis from recovery end date (day zero) through postoperative day seven. 4. Surgery patients whose medical record contained an order for a ventilator weaning program (protocol or clinical pathway). Miscellaneous 1. Mortality within 30 days of surgery. 2. Readmission within 30 days of surgery. 3. Proportion of permanent hospital end stage renal disese (ESRD) vascular access procedures that are autogenous AV fistula. Table 16.2 Centers for Medicare and Medicaid Services (CMS) surgical pay-for-participation measures. CABG 1. Aspirin prescribed at discharge 2. CABG using internal mammary artery 3. Prophylactic antibiotic within 1 hour prior to surgical incision 4. Prophylactic antibiotic selection for isolated CABG patients 5. Prophylactic antibiotics discontinued within 487 hours after surgery end time 6. Inpatient mortality rate 7. Postoperative hemorrhage or hematoma 8. Postoperative physiologic and metabolic derangement Hip & Knee Replacement 1. Prophylactic antibiotic received within 1 hour prior to surgical incision 2. Prophylactic antibiotic selection for hip and knee replacement patients 3. Prophylactic antibiotics discontinued within 24 hours after surgery end time 4. Postoperative hemorrhage or hematoma 5. Postoperative physiologic and metabolic derangement 6. Readmissions 30 days postdischarge 7. Hip/Knee Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered 8. Hip/Knee surgery patients Who Received Appropriate Venous Thromboembolism Prophylaxis Within 24 Hours Prior to Surgery to 24 Hours After Surgery 6 quality and outcome measures Table 16.3 Surgery-related Physician Quality Reporting Initiative (PQRI) measures. Surgery Specific Measures Perioperative Care: Timing of Antibiotic Prophylaxis—Ordering Physician Description: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic antibiotic to be given within 1 hour (if fluoroquinolone or vancomycin, 2 hours), prior to the surgical incision (or start of procedure when no incision is required) Perioperative Care: Selection of Prophylactic Antibiotic—First OR Second Generation Cephalosporin Description: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for cefazolin OR cefuroxime for antimicrobial prophylaxis Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures) Description: Percentage of noncardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic antibiotics AND who received a prophylactic antibiotic, who have an order for discontinuation of prophylactic antibiotics within 24 hours of surgical end time Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients) Description: Percentage of patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time Perioperative Care: Timing of Prophylactic Antibiotics—Administering Physician Description: Percentage of surgical patients aged 18 and older who have an order for a parenteral antibiotic to be given within 1 hour (if fluoroquinolone or vancomycin, 2 hours) prior to the surgical incision (or start of procedure when no incision is required) for whom administration of prophylactic antibiotic has been initiated within 1 hour (if fluoroquinolone or vancomycin, 2 hours) prior to the surgical incision (or start of procedure when no incision is required) Use of Internal Mammary Artery (IMA) in Coronary Artery Bypass Graft (CABG) Surgery Description: Percentage of patients aged 18 years and older undergoing isolated coronary artery bypass graft (CABG) surgery using an internal mammary artery (IMA) Preoperative Beta-blocker in Patients with Isolated Coronary Artery Bypass Graft (CABG) Surgery Description: Percentage of patients aged 18 years and older undergoing isolated coronary artery bypass (CABG) surgery who received a beta-blocker preoperatively Perioperative Care: Discontinuation of Prophylactic Antibiotics (Cardiac Procedures) Description: Percentage of cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic antibiotics AND who received a prophylactic antibiotic, who have an order for discontinuation of prophylactic antibiotics within 48 hours of surgical end time Prevention of Ventilator-Associated Pneumonia—Head Elevation Description: Percentage of ICU patients aged 18 years and older who receive mechanical ventilation and who had an order on the first ventilator day for head of bed elevation (30–45 degrees) Prevention of Catheter-Related Bloodstream Infections (CRBSI)—Central Venous Catheter Insertion Protocol Description: Percentage of patients, regardless of age, who undergo central venous catheter (CVC) insertion for whom CVC was inserted with all elements of maximal sterile barrier technique (cap AND mask AND sterile gown AND sterile gloves AND a large sterile sheet AND hand hygiene AND 2% chlorhexidine for cutaneous antisepsis) followed Vascular Access for Patients Undergoing Hemodialysis Description: Percentage of patients aged 18 years and older with a diagnosis of end stage renal disease (ESRD) and receiving hemodialysis who have a functioning AV fistula OR patients who are referred for an AV fistula at least once during the 12-month reporting period HIT- Adoption/Use of Health Information Technology (Electronic Health Records) Description: Documents whether provider has adopted and is using health information technology. To qualify, the provider must have adopted a qualified electronic medical record (EMR). For the purpose of this measure, a qualified EMR can either be a Certification Commission for Healthcare Information Technology (CCHIT) certified EMR or, if not CCHIT certified, the system must be capable of all of the following: • Getnerating a medication list • Generating a problem list • Entering laboratory tests as discrete searchable data elements HIT- Adoption/Use of e-Prescribing Description: Documents whether provider has adopted a qualified e-Prescribing system and the extent of use in the ambulatory setting. To qualify this system must be capable of ALL of the following: • Generating a complete active medication list incorporating electronic data received from applicable pharmacy drug plan(s) if available • Selecting medications, printing prescriptions, electronically transmitting prescriptions, and conducting all safety checks (defined below) • Providing information related to the availability of lower cost, therapeutically appropriate alternatives (if any) • Providing information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient’s drug plan Pain Assessment Prior to Initiation of Patient Treatment Description: Percentage of patients aged 18 years and older with documentation of a pain assessment (if pain is present, including location, intensity and description) through discussion with the patient or through use of a standardized tool on each initial evaluation prior to initiation of therapy Surgery-Related Measures Chemotherapy for Stage III Colon Cancer Patients Description: Percentage of patients aged 18 years and older with Stage IIIA through IIIC colon cancer who are prescribed or who have received adjuvant chemotherapy during the 12-month reporting period (continued) 6 improved outcomes in colon and rectal surgery a NSQIP-style program could be implemented in non-VA hos- pitals and if it would have the same benefits. To explore these questions, a pilot study was launched in 1999 at three non-VA hospitals: Emory University, the University of Michigan, and the University of Kentucky.(25) Despite the study being limited to general and vascular surgery cases, the study determined that the data collection and transmission methods, as well as the risk- adjustment models were applicable in the private sector. The success of this pilot study attracted the attention of the American College of Surgeons (ACS) which, in 2001, began to take an active role in developing a NSQIP system for private hospitals by obtaining funding from the Agency for Healthcare Research and Quality (AHRQ) to expand the pilot program to 14 additional hospitals, including several community-based hospitals.(25) Using the AHRQ grant, the ACS developed the infrastructure to make it feasible to roll the NSQIP to private sector hospitals. This included the development of a web-based data collection system, training nurses to abstract and enter data, and to gather a team of analysts to risk-adjust the outcomes and prepare reports of the member hospitals. Once the infrastructure was in place, the ACS opened the ACS NSQIP to all private hospitals in October of 2004. The current program has over 200 participating hos- pitals and has expanded its scope to address over 10 surgical specialties, with additional ones being developed.(25) One area of outcomes-based quality improvement that has gained a lot of recent attention is the so-called hospital acquired conditions, or “never events.” These are a list of 27 events first released publicly by the National Quality Forum (NQF) in November of 2006 (Table 16.4).(27) In 2007, The Leapfrog Group recognized hospitals that met certain criteria in the situation of when a “never event” occurred. These criteria included apologiz- ing to the patient and/or family, reporting the event to JCAHO, performing a root cause analysis to prevent future events, and to waive all costs directly related to the adverse event.(10, 27) Recently, CMS has made a push not to reimburse the hospital for costs attributable to a “never event.” This is one of the best exam- ples to date of a payer levying a financial disincentive against a hospital for poor quality. Quality of Care in Colorectal Disease There are a number of quality assessment/quality improvement projects in colorectal surgery and colorectal disease. In addition to the already described “performance measures” (e.g., SCIP), a number of investigative projects have been performed that have studied and identified some potential additional quality meas- ures, as well as importantly studied how we might collect such data. A few of these projects are discussed below to offer a feel for the type and variety of projects that have been performed. One important project initiated with the support of the American Society of Colon and Rectal Surgery (ASCRS) is The Vermont Colorectal Cancer Project.(28) This project demon- strated that a statewide quality improvement project that required surgeons to input case data was feasible, with a compliance rate of 78%. Using these principles, the project was expanded to the New England area with the New England Colorectal Society project registry, a prospective, multiinstitutional regional database of patients undergoing surgery for colorectal cancer at 13 partici- pating hospitals.(29) The study importantly found that surgeons were willing to participate in a collaborative, multi-institutional database, and this set the groundwork for successful data collec- tion to evaluate and improve colorectal cancer care. A number of additional studies have addressed colorectal can- cer quality of care. For example, the American Society of Clinical Oncology (ASCO) in part established the National Initiative on Cancer Care Quality (NICCQ) to develop quality of care meas- ures for breast and colorectal cancer.(17, 30, 31) The NICCQ project team developed 25 process-based quality measures that spanned four domains of care: (1) diagnostic evaluation (10 measures); (2) surgery (4 measures); (3) adjuvant therapy (10 measures); and (4) surveillance (1 measure). Using a different set of processes and methodologies, the ACS developed a similar set of quality measures for breast and colorectal cancer. Both the NICCQ and the ACS submitted these measures to the NQF for their endorsement. Facilitated by the NQF, the ACS and NICCQ agreed to synchronize their measures (Table 16.5).(32) After development of the NICCQ measures, compliance was determined using multiple sources (e.g., hospital cancer registries, Radiation Therapy Recommended for Invasive Breast Cancer Patients who have Undergone Breast Conserving Surgery Description: Percentage of invasive female breast cancer patients aged 18 through 70 years old who have undergone breast conserving surgery and who have received recommendation for radiation therapy within 12 months of the first office visit Universal Documentation and Verification of Current Medications in the Medical Record Description: Percentage of patients aged 18 years and older with written provider documentation that current medications with dosages (includes prescription, over- the-counter, herbals, vitamin/mineral/dietary [nutritional] supplements) were verified with the patient or authorized representative Patient Co-Development of Treatment Plan/Plan of Care Description: Percentage of patients aged 18 years and older identified as having actively participated in the development of the treatment plan/plan of care. Appropriate documentation includes signature of the practitioner and either co-signature of the patient or documented verbal agreement obtained from the patient or, when necessary, an authorized representative Screening for Cognitive Impairment Description: Percentage of patients aged 65 years and older who have documentation of results of a screening for cognitive impairment using a standardized tool Screening for Future Fall Risk Description: Percentage of patients aged 65 years and older who were screened for future fall risk (patients are considered at risk for future falls if they have had 2 or more falls in the past year or any fall with injury in the past year) at least once within 12 months Table 16.3 (continued). Surgery Specific Measures 6 quality and outcome measures Table 16.4 National Quality Forum (NQF) hospital acquired conditions (never events). 1 Unintended retention of a foreign object in a patient after surgery or other procedure 2 Patient death or serious disability associated with patient elopement (disappearance) 3 Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration) 4 Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products 5 Patient death or serious disability associated with an electric shock or elective cardioversion while being cared for in a healthcare facility 6 Patient death or serious disability associated with a fall while being cared for in a healthcare facility 7 Artificial insemination with the wrong donor sperm or donor egg 8 Surgery performed on the wrong body part 9 Surgery performed on the wrong patient 10 Wrong surgical procedure performed on a patient 11 Intraoperative or immediately postoperative death in an ASA Class I patient 12 Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility 13 Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended 14 Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility 15 Infant discharged to the wrong person 16 Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility 17 Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility 18 Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility 19 Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates 20 Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility 21 Patient death or serious disability due to spinal manipulative therapy 22 Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances 23 Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility 24 Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility 25 Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider 26 Abduction of a patient of any age 27 Sexual assault on a patient within or on the grounds of the healthcare facility 28 Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the healthcare facility patient surveys) in a sample of stage II-III colon cancer survivors in 5 metropolitan areas approximately 4 years after diagnosis. Overall compliance was 78% for all 25 measures; by domain, compliance was 87% diagnostic evaluation; 93% surgery; 64% adjuvant therapy; and 50% surveillance.(17, 32) Interestingly, this is much higher than the 55% compliance rate found for most types of care.(33) Potential reasons for higher compliance may be the urgency of a cancer diagnosis (beyond chronic conditions such as diabetes) and the multidisciplinary approach to cancer treatment. However, selection bias may increase compliance rates since the NICCQ study only examines 4-year survivors and it is possible that those who died received lower quality care. In 2001, the National Cancer Institute (NCI), in collaboration with the VA, launched a project entitled “Cancer Care Outcomes Research and Surveillance Consortium” (CanCORS) to measure the quality of care patients received in colorectal cancer and lung cancer care. This prospective observational cohort study on nearly 10,000 patients (4,921 with colorectal cancer and 5,105 with lung cancer) addressed how patient, provider, and system character- istics affected the care patients received and their outcomes.(34) The goal was to better understand the reasons behind disparities in cancer care. The two central goals of the project were to: 1) Determine how the characteristics and beliefs of cancer patients and providers and the characteristics of health-care organiza- tions influence treatments and outcomes, spanning the contin- uum of cancer care from diagnosis to recovery or death. 2) Evaluate the effects of specific therapies on patients’ survival, quality of life, and satisfaction with care.(34) Table 16.5 American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), Colorectal Quality Measures, and Commission on Cancer (CoC) Joint Quality Measures for Colorectal Cancer. Area Colon 1. Receipt of adjuvant chemotherapy within 4 months of diagnosis for patients <80 years of age with AJCC Stage III (lymph node positive) colon cancer 2. ≥12 lymph nodes should be removed and pathologically examined for resected colon cancer 3. Receipt of radiation therapy within 6 months of diagnosis for AJCC stage III colon cancer patients Rectum 4. Receipt of postoperative adjuvant chemotherapy within 9 months for AJCC stage II or III rectal cancer 66 improved outcomes in colon and rectal surgery Data collection was completed in April 2007, with 15 years of followup data on the initial cohort. The study used surveys of patients, providers, and caregivers to meet the study objectives. Currently, data are being analyzed to understand the regional variation in cancer care. A number of studies have attempted to develop quality indicators, which serve to distinguish acceptable from unacceptable care. In 2006, McGory et al. published a comprehensive set of quality indicators for patients undergoing colorectal cancer surgery. McGory et al. used the RAND/UCLA Appropriateness Method to determine the validity of the candidate indicators using colorectal cancer experts. (35–39) This method uses an expert panel and a systematic review of the literature to identify candidate quality indicators. McGory et al. focused on process and structural measures. The 142 indicators (92 rated as valid) fall under 6 quality domains: surgeon privileging (e.g., credentialing for laparoscopic colectomy), preoperative evalu- ation (e.g., staging), patient-provider discussions (e.g., informed consent), medications (e.g., antibiotic prophylaxis), intraoperative care (e.g., prevention of ureteral injury), and postoperative manage- ment (e.g., control of blood glucose). Similar to McGory et al. Gagliardi et al. used a 3-step modified Delphi approach to identify the 45 key indicators, of which 37 (82%) were considered valid by the panel.(40) This method also used an expert panel and a systematic review of the literature to identify candidate quality indicators. This study reports the top 15 prioritized quality indicators as their final recommendation for improving the quality of colorectal cancer surgery as rated by the expert panel, including 4 outcome measures (e.g., 30-day mortality) and 4 province level measures (e.g., 5-year survival). Putting it together Overall, the development and use of quality and outcome meas- ures still remains a work in progress with the current levels of underuse, overuse, disparities, and inefficiencies. The goal to improve the quality of care is not the issue. What remains the issue is how to improve the quality of care. We have attempted to show how strategies for improvement have been based on structural, process, and outcome components—all with their individual advantages, but also with their recognizable limitations. To date, there doesn’t appear to be one best way to improve care, which probably means that a combination of measures and metrics will be needed. In the field of colon and rectal surgery, the basic qual- ity measures applicable to most every colorectal surgeon are the SCIP measures at the hospital level, and the PQRI measures at the individual (surgeon) level, but more are probably forthcoming. There are some potential “disease related” measures for colorectal cancer, but they generally address chemo and radiation therapies. The only potential surgery-related measure, which is clearly not solely a surgical issue, is the 12-node measure (i.e., evaluation of a minimum of 12 lymph nodes in a colon cancer resection). There has been demonstrable pushback to this measure, and at present, is not endorsed by the NQF as an “accountability” measure. Probably the single most important measure for evaluating and improving care, regardless of strategy, is obtaining accurate data that is actionable. Specifically, the collection, analysis, and feedback of data have yielded quality improvement in a variety of environments and fields, including colorectal surgery. The future of quality of care evaluation and improvement is difficult to predict. The use of quality and outcome measures as described in this chapter may only be in its infancy. As data systems become increasingly powerful and sophisticated, and as evidence in the literature continues to build, we suspect that increasingly more quality and outcome measures will be developed and used. The developed measures will likely become increasingly actiona- ble and clinically meaningful, which will help to advance the field of quality improvement. For us to improve our outcomes in colorectal surgery at the present time, knowing our own quality is paramount. In this regard, participation in quality improvement programs that col- lect, feedback, and benchmark data is probably warranted. In addition, participation in studies that advance the levels of evi- dence is needed. Finally, recognizing that quality improvement is an iterative process is essential. All of this highlights the impor- tance of surgeon involvement to guide quality improvement in surgery in the right direction. REFERENCES 1. http: www.nchc.org/facts/cost.shtml. Accessed May 30, 2008; Abstract. 2. http: www.geographyiq.com/ranking/ranking_Infant_Mortality _Rate_aall.htm. Accessed May 30, 2008; Abstract. 3. Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. 2001; Abstract. 4. Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. 2000; Abstract. 5. 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