Recent Advances in the Patient Safety and Quality Initiatives Movement




The US health care system is fragmented in terms of quality care, costs, and patient satisfaction. With the passage of the Affordable Care Act, national attention has been placed on the health care system, but effective change has yet to be observed. Unnecessary costs, medical errors, and uncoordinated efforts contribute to patient morbidity, mortality, and decreased patient satisfaction. In addition to national efforts, local initiatives within individual departments must be implemented to improve overall satisfaction without the sacrifice of costs. In this article, the current issues with the health care system and potential initiatives for neurosurgery are reviewed.


Key points








  • A large proportion of morbidity and mortality due to medical errors contribute to unnecessary medical costs within the United States health care system.



  • Quality initiatives and cost control can be improved if started from within individual departments on the local scale.



  • Neurosurgery has the opportunities to become a leader in quality improvement, cost control, and patient satisfaction.






Introduction


It is widely recognized that the United States’ (US) healthcare system faces a number of challenges in medical errors, leading to increasing costs, which are unsustainable and threaten the national economy. In November 1999, the Institute of Medicine (IOM) published the landmark report, To Err is Human , which placed the issues of patient safety and medical errors in the US health care system under the national spotlight. This report estimated that medical errors were responsible for up to 98,000 deaths annually in hospitals across the nation, at a cost of $17 billion to $29 billion per year. However, this conservative estimate did not include outpatient medical errors or morbidities from lapses in the quality of medical care.


Quality improvement initiatives must be implemented and reformed at the local level within individual departments, understanding the challenges of health care at a national scale with the challenging movements for large-scale reform. It is imperative that our physician leaders understand the need to reform health care from within, beginning from their own departments, to improve quality and control cost. In this article, we review the quality improvement initiative and analyze the opportunities within the field of neurosurgery for individual neurosurgery departments to integrate initiatives promoting quality improvement and patient safety into their institutional and departmental priorities.




Introduction


It is widely recognized that the United States’ (US) healthcare system faces a number of challenges in medical errors, leading to increasing costs, which are unsustainable and threaten the national economy. In November 1999, the Institute of Medicine (IOM) published the landmark report, To Err is Human , which placed the issues of patient safety and medical errors in the US health care system under the national spotlight. This report estimated that medical errors were responsible for up to 98,000 deaths annually in hospitals across the nation, at a cost of $17 billion to $29 billion per year. However, this conservative estimate did not include outpatient medical errors or morbidities from lapses in the quality of medical care.


Quality improvement initiatives must be implemented and reformed at the local level within individual departments, understanding the challenges of health care at a national scale with the challenging movements for large-scale reform. It is imperative that our physician leaders understand the need to reform health care from within, beginning from their own departments, to improve quality and control cost. In this article, we review the quality improvement initiative and analyze the opportunities within the field of neurosurgery for individual neurosurgery departments to integrate initiatives promoting quality improvement and patient safety into their institutional and departmental priorities.




The national problem


Although the United States is a leader in creating innovative technologies and treatments, the progress has not translated to overall higher quality health care. Since the release of the IOM report in 1999, the National Institutes of Health has doubled its budget and invested more than $32.2 billion to advance medical research. Recently, the McKinsey Global Institute and the Kaiser Family Foundation report that the United States spends more per capita and spends a higher percentage of its national gross domestic product (GDP) on health care than any other country listed under the Organization for Economic Cooperation and Development. In 2007, US health expenditures increased to $2.3 trillion, accounting for nearly 17% of the nation’s GDP, and are expected to reach more than 20% of the nation’s GDP by the end of 2015. Despite these increasing expenditures, the United States fairs poorly compared with other nations in multiple health metrics. The World Health Report 2000 states that despite spending the highest percentage of its GDP on health care, the United States is ranked 37th for its health care performance. The United States fares worse than 46 countries in infant mortality and 48 countries in life expectancy. In a 2003 study by McGlynn and colleagues, roughly only half of all recommended preventative, acute, and chronic care were received by Americans with significant variability based on the medical condition, ranging from 11% to 79% of recommended care. There is a large discrepancy between the quality of care that Americans receive and their cost.


Medical errors and system inefficiencies not only decrease the quality of health care that patients receive but also come at a huge cost to the nation by compromising the nation’s economy, limiting access to health care, and threatening the security of present and future generations. Increasing health care costs threaten the sustainability of government programs like Medicare and force employers to cut coverage or shift part of the financial burden onto their employees. The increasing costs are shifting health care patterns, and hospitals are seeing decreases in admissions and increases in uncompensated care. However, some estimates project that almost 30% of health care costs can be decreased without compromising the quality of health care delivered. Thomson Reuters estimate that wasted health care expenditures account for between $600 million and $850 billion annually, with 40% of wasteful spending attributed to the overuse of unnecessary services or procedures. Of the 6 categories of waste identified in this report, medical errors and unsafe clinical practices accounted for $25 billion to $50 billion annually, an increase from the IOM’s initial annual figure of $17 billion to $29 billion. However, medical errors negatively affect more than mere health care costs and may lead to further readmissions, additional procedures, complications that compromise quality of life, and increase overall mortality.


Now, more than a decade after the IOM To Err is Human report, there seems to be little progress in patient safety reform and quality control to make health care safer, more cost effective, and more assessable for the American public. The obstacles to controlling costs, ensuring patient safety, and improving health care quality are rooted in a highly fragmented and complicated health care system. In addition, the unsustainable health care expenditure growth is fueled by several factors, including technological innovations, for which cost-effectiveness and comparative clinical usefulness and evidence are not readily available, and an expanding aging population with chronic medical conditions who require costlier end-of-life care. With more than 40 million Americans uninsured, equitable access to quality and efficient care also remains elusive.




National initiatives: legislative reform and their challenges


Some national initiatives have been initiated, and several system-wide solutions have been proposed to address health care safety and quality. One of the key recommendations in the IOM’s To Err is Human report included creating a comprehensive national reporting system that is mandatory, validated, and public. In light of the ongoing deficits in patient safety and quality initiatives, there is a need for an adequate and universal system of metrics that can track and follow progress. However, there is still no consensus on which metrics should be focused on or what should be measured. One potential metric is patient outcomes, which examines aspects including patient mortality and morbidity. Another aspect of quality improvement is processes of care: the services and therapies that physicians or hospitals provide to their patients. For example, patients with myocardial infraction treated with aspirin, which has been correlated to improve patient survival, could be a process measure.


With this aim, several different groups have made fragmented progress toward creating process measures to assess a provider’s performance. With more assessable quality metrics, patients will have the ability to identify safer providers, and payers could refuse to reimburse substandard care, pushing providers to prioritize higher quality of care. The National Quality Forum (NQF) uses a consensus development process that lists hundreds of performance metrics, safe practices, and quality frameworks to assess the overall quality of health care. In their 2008 Physician Quality Reporting Initiative (PQRI), the Center for Medicare and Medicaid Services collected data on and proposed 119 different quality metrics of physician performance, ranging from adhering to guidelines for chemotherapy and radiation therapy to blood glucose control for diabetic patients. Another arm of the government, the US Department of Health and Human services, through its Hospital Compare Web site, publishes hospital-specific process of health care quality metrics for surgical, cardiac, and pneumonia treatment ( http://www.hospitalcompare.hhs.gov/ ). In addition to these national organizations, various states and independent groups have also begun collecting and publishing quality metrics, but these efforts remained complicated and fragmented, as shown here.


Despite the move toward improved metrics in patient safety, health care quality metrics have certain limitations. Outcome measures are confounded by the health of a hospital’s patient population. There are also issues of statistical power, because outcome measures may not adequately reflect quality of care between physicians if the comparative sample sizes are too small. Process measures and metrics cannot account for the unquantifiable but still important clinical decisions made in providing quality health care. Some studies show only a weak correlation between process measures and improved clinical outcomes.


National reform is needed to create a uniform and mandatory national reporting system, which promotes accountability through transparency. There have been only fragmented efforts on the state level to require reporting. Throughout the past few years, an increasing number of hospitals have been required to report incidence of medical errors under different state laws. Only 28 states require hospitals to make annual infection rates available to the public. Several states have passed their own safety reform laws to hold hospitals accountable for medical errors, but implementation has been slow. In 2006, California passed patient safety legislation requiring the California Department of Public Health to complete several patient safety provisions. However, in a recent Consumer’s Union report, the California Department of Public Health has been slow to accomplish several key requirements, including creating a hospital-acquired infection protection program, collecting and reporting infection rates from hospitals, reporting medical errors to the public, and conducting inspections to ensure that hospitals are following patient safety policies. The Agency for Healthcare Research and Quality (AHRQ) is the closest national agency that comprehensively aggregates and tracks national progress based on claims from Medicare, hospital data from states, and other sources. However, these data are often dated and presented as a national and state aggregate rather than for specific providers, limiting their usefulness.


Other national priorities have been to introduce payment reform that places a financial incentive for health care quality reform. Through implementing pay-for-performance and bundling payment, the government can provide economic incentives for hospitals to provide better quality care at a lower cost, rather than merely the quantity of procedures. Furthermore, Medicare, as one of the largest payers into the US health care system, is reducing and removing reimbursements for several avoidable hospital-acquired conditions. Although Medicare has made efforts such as these reimbursement changes to realign financial incentives with clinical quality and safety goals, progress has been slow and challenging without clear evidence that these efforts are resulting in improved patient safety and health care quality. For example, the Tax Relief and Health Care Act of 2006 created the 2007 PQRI, a voluntary, Medicare provider quality reporting program. This program offers a bonus payment of up to 1.5% of total Medicare reimbursements for physicians who report various quality measures through medical registries. However, the PQRI has been criticized as “insufficiently funded and overly burdensome,” poorly crafted, without input from all stakeholders, and improperly incentivized, because the rewards do not balance the costs to implement such a reporting program.


With the implementation of the Affordable Care Act (ACA), the United States has shifted the national spotlight to a triple aim focusing on improving quality, experience of care, and decreasing costs. A component of the ACA penalizes hospitals for acquired infection rates and readmission rates to improve the quality of care delivered. Medicare also uses the Value-Based Payment Modifier program to reward or fine physicians based on their quality data. As a provision, the ACA requires the use of PQRI by 2015, and physicians are mandated to report 138 different quality practice measures; those who are unable to comply will face payment reductions. Furthermore, Accountable Care Organizations, which were created to provide financial incentives for provider networks who are able to improve outcomes without higher costs, have increased since the passage of the ACA. Because the ACA is still in its infancy, data on its effectiveness are still being tracked. More time and evidence are needed to elucidate the full effects of the ACA on the quality and cost of health care in the United States.




The local initiative: health care reform from the inside


Issues of patient safety and health care quality initiatives have been under the national spotlight for more than a decade, yet progress has been slow, unwieldy, and challenging. Although the national movement toward patient safety and quality initiatives should be a multidisciplinary endeavor, progress in this movement can and should be initiated locally. As legislators struggle to create patient safety reform on a state and national scale, we as clinicians and leaders in medicine and neurosurgery have our part to improve and reinvent health care. The significant and critical components needed for comprehensive restructuring of the US health care system may be achieved only through the creative insights, interventions, and leadership of the physicians and health care providers working every day in the trenches of the operating room and on the frontlines of medicine. The IOM, in their subsequent report Ensuring Quality Cancer Care , noted that “for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care.” In the same report, the National Cancer Policy Board further addresses the decentralization at the patient and illness level, noting that the “fragmented cancer care system does not ensure access to care, lacks coordination, and is inefficient in its use of recourse” and concluded that “efforts to improve cancer care in many cases will therefore be local or regional and could feasibly originate in a physician’s practices, [or] in a hospital.” With 83% of all national health expenditures categorized under direct clinical care, reform within regional hospitals and individual departments, led by physicians and hospital leaders through a health care reform from within approach, is especially promising, with great potential. The Institute for Healthcare Improvement (IHI), New England Healthcare Institute (NEHI), and Thomson Reuters have all recently published studies addressing specific waste and inefficiencies in clinical care and provided a detailed review of various categories of waste and opportunities to cut spending.


In The Fragmentation of US Healthcare , Elhauge identifies 4 levels of fragmentation. In the broadest level, coverage and access are fragmented across different patient groups. Care for patients can be fragmented over time, when beneficiaries move among different insurers. Similarly, care for a particular patient can be fragmented if there is miscommunication between different hospitals and providers treating the same patient for different conditions. In the narrowest level, care for a certain illness can be fragmented as a patient visits different professions during the course of a hospital stay. For example, care for a patient with a brain tumor may move from a neurosurgeon to the intensive care unit (ICU) hospitalist to a neuro-oncologist and then to a radiation oncologist. Addressing fragmentation at the patient and illness levels can be most effectively addressed at the local level of improving patient safety and developing quality initiatives.


One of the largest costs of national health care spending originates from great regional variations in care and services that are not correlated to significant differences in overall clinical outcomes. Depending on geography, Medicare beneficiaries have been documented to receive wide variations in the intensity of medical care, which includes greater referrals to specialists, office visits, diagnostic tests, and procedures. There is an especially high variation in spending on chronic medical conditions, end-of-life treatment, and medical care delivered at academic medical centers. For example, Medicare spending per patient in 2005 ranged from $5358 in Oregon to greater than $14,000 in Florida. A study of 226 California hospitals revealed that Medicare spending varied from $24,722 to $106,254 per patient per year during the last 2 years of life. However, many studies have found that the variation in demography and health status does not account for the variation in health care expenditures. Many studies have found that increased health care spending is not positively correlated to improved clinical outcomes at the level of states and Hospital Referral Regions. Instead, higher costs are correlated with higher intensities of medical care, including longer ICU stays and more frequent tests and procedures, and, at times, result in decreased quality of medical care based on process-of-care measures and less patient satisfaction. A study analyzing hospital performance for 2712 national hospitals and their spending intensity showed either a zero or negative correlation between quality of care (through process-of-care measures) and spending both among and within regions. Furthermore, a NEHI report estimates that 30% of national health care expenditure or $600 billion in annual savings can be reduced without compromising health care quality, because of unnecessary care.


These challenges and opportunities present an opportunity for improving patient safety, quality initiatives, and efficiency of care on a local and regional level if providers, health care professionals, and individual departments work to implement evidence-based medicine to eliminate avoidable costs within their respective hospitals and departments. Quality initiatives at this narrow local scale within individual departments have huge potential for significant gains, because progress is more easily measured, and efforts are more quickly focused in responding to patient needs and improving safety.


Neurosurgery is in an optimal position in this movement toward improving patient safety, quality initiatives, and health care reform from within. Neurosurgery has always been at the forefront of clinical and technological advances and should continue to lead in this realm of safety and quality. Neurosurgery is inherently high risk, with a low margin of error, and possesses a real potential for catastrophic outcomes. Neurosurgery also requires the close collaboration between a myriad of services, departments, and professionals within every hospital. A single neurosurgical patient may require multiple costly scans and tests, require the coordinated care of a multidisciplinary team, and represent a multitude of opportunities to lead improvements in patient safety and quality initiatives. Because of the high degree of complexity and risks involved, neurosurgery stands in a unique position to incur significant risks and costs, affect many medical processes, and have a significant impact on the quality and safety of medical care. As leaders in the growing movement for patient safety and quality improvements, neurosurgery can make significant contributions in making health care a more integrated, efficient, and safe process. Although there are few published studies that specifically address comprehensive quality improvements in neurosurgery, there are many reports on specific areas in which neurosurgeons can lead health care reform from the inside.




Scope of local quality initiatives


Systems Approach


In both the IOM’s reports, Crossing the Quality Chasm and To Err is Human , deficits in the safety and quality of the US health care system are attributed to system failures, rather than to the fault of a single physician or department. Challenges arise from the lack of proper metrics, reporting systems to track progress, and coordinated multidisciplinary effort that prioritizes safety and quality. Consequently, efforts at the hospital and department level to improve clinical quality should focus on the systems of medical care.


A report summarizing lessons learned from the NSQIP’s 15-year experience in the Veterans Affairs and private sector promoted a new conceptual framework, encouraging providers to consider surgical safety as safety from all adverse events, not merely preventable errors or sentinel events as addressed by IOM’s To Err is Human and The Joint Commission , respectively. This new framework suggests that not all preventable errors are easily identifiable and places the focus on system failures, rather than individual’s errors. These results, along with reports from the National Surgical Risk Study, highlight the importance of systems that facilitate clear communication and coordination among all professionals involved in surgical care.


Tracking Progress


Quality efforts using metrics, including thorough process-of-care measures and risk-adjusted outcomes, are critical in identifying system problems and tracking progress. The NSQIP initially originated with the Veterans Administration in 1991 and has now grown into the private sector in collaboration with the ACS. As the only “multispecialty, clinically based, prospectively collected, quality improvement program,” the NSQIP is working toward improving surgical quality and safety through rigorous collection and reporting outcome data. The main metrics on which the ACS-NSQIP focuses are risk-adjusted 30-day surgical outcomes in mortality and morbidities, further classified into areas ranging from wound and urinary tract to central nervous system. Quality improvement is achieved by providing hospitals with timely, outcomes-based, risk-adjusted data and patient risk factors to empower providers to accurately track and improve clinical safety.


In a recent study analyzing the progress of 118 hospitals participating in ACS-NSQIP from 2006 to 2007, Hall and colleagues found marked improvements in surgical quality, with 66% of participating hospitals improving in risk-adjusted mortality and 82% improving in risk-adjusted complication rates. These improvements provide a strong precedent that local process-of-care improvements can result in clinical outcome improvements. In addition, embracing a culture that values metrics can pave the way for evidence-based medicine, in which the best practices are identified to minimize variations in practice among physicians and ensure that the quality of care is held to a proper standard.


Quality Through Evidence-Based Medicine


The scope of quality initiatives must include cost efficiency and medical waste. Traditionally, motives for quality improvement focused on patient safety, and resulting financial savings were considered secondary benefits. However, the IHI recently reported changing economic pressures and mounting evidence that better care can come from lower costs, and this has paved a new approach for quality improvement: “the systematic identification and elimination of waste, while maintaining or improving quality.”


In 2008, the National Priorities Partnership, a collaboration between the NQF and 28 other health organizations, published a report detailing 9 priorities to cut wasteful health care spending. During the same year, the NEHI published a comprehensive review on a system-wide approach toward improving quality and efficiency, which focused on cutting out waste, which was defined as “healthcare spending that can be eliminated without reducing the quality of care.” The variation in the intensity of clinical care can also be attributed to several factors. Some argue that variations arise not from a medical need but from supply-side forces and practice-style variations, such that facilities with more beds, specialists, and resources tend to have more services and procedures. Variations may also be caused by patient demands. Patient safety is intimately tied to cost, and a movement toward greater reliance on evidence-based medicine will help reduce variation through reducing uncertainty and identifying the best practices that are most cost effective.


A clear and thorough understanding of best practices supported by evidence-based reports in the literature will empower physicians to make informed, patient-centered decisions that minimize the use of excess procedures, tests, and medications may unnecessarily expose patients to further health risks and complications. Given the increased risks inherent in neurosurgery, an assessment of the risk factors, prognosis, clinical outcomes, and impact on quality of life of a potential treatment is especially important. This understanding, combined with personal experiences, will help physicians make clinical decisions that maximize safety and quality by providing a guideline for the best practices with the best outcomes. During the Congress of Neurological Surgeons (CNS) 2009 Annual Meeting, the American Association for Neurological Surgeons and CNS led neurosurgeons in this patient safety and quality initiatives movement and released the nation’s first evidence-based, multidisciplinary treatment guidelines for patients with brain metastases. These guidelines provide up-to-date and best treatment practices that produce optimal clinical outcomes and incorporates the latest research through evaluating the myriad of treatments available, including surgical resection, stereotactic radiosurgery, whole brain radiation therapy, partial brain radiation, and chemotherapy.


However, clinical practice guidelines created from evidence-based medicine may have unclear medical-legal ramifications during malpractice suits. In addition, there is a concern for the slow replacement of the art of medicine, based on a neurosurgeon’s own clinical experience and expertise, by the rigid science of evidence-based medicine: a movement that may reduce the practice of medicine to a set of protocols. However, evidence-based medicine is a tool that is meant to complement a physician’s own clinical knowledge, not a means to deny a patient’s or physician’s choice of treatment, stifle the intimacy of the physician-patient relationship, or hinder innovation of new methods and protocols.




Opportunities in neurosurgery


Quality and Safety in Neurosurgical Care


The most immediate area for quality improvement is to address issues of patient safety and medical errors, because these cost savings have been well documented. In the 2008 National Healthcare Quality report, avoidable hospitalizations from errors in 2005 cost the nation $29.6 billion. A 2009 report by the Healthcare Cost and Utilization Project estimated that avoidable complications cost hospitals 30.8 billion, roughly 10% of total hospital expenditures. Nearly 18% of Medicare’s reimbursements are for preventable hospitalizations. The elimination of these factors can significantly contribute to the improvement of safety, quality, and cost.


Surgical errors


Despite the widespread implementation of the Universal Protocol since its introduction by the Joint Commission in 2004, wrong-site and wrong-patient surgeries still occur with uncomfortable frequency. The 3 steps of the protocol, which included a preprocedure verification, surgical site marking, and a presurgical time-out, were designed to ensure that the correct surgical procedure was performed for the correct patient on the indicated side every time. Although such errors, often termed never-events, are considered 100% avoidable given proper safety protocols and procedures, a 2007 study of Pennsylvania hospitals over a 30-month period reported 427 accounts of wrong-site, wrong-patient, and wrong-procedure operations. The study also noted that a formal time-out was unsuccessful in preventing 31 of these accounts. However, reports of the prevalence of wrong-site procedures have been mixed. A review of the National Practitioner Data Bank and other claims databases showed that wrong-site surgeries in the United States occurred with a frequency of 1300 to 2700 per year. A study by Kwaan and colleagues reviewing cases of wrong-site surgery reported to a malpractice insurer showed only 25 accounts of wrong-site surgery from almost 3 million procedures over a 20-year period. Critics suggest that this study is a gross underestimate of the errors, because many wrong-site surgeries never result in a malpractice claim, and surgeons are often reluctant to disclose errors because of legal and professional repercussions.


Of all surgical fields, neurosurgery is third highest risk in wrong-site surgeries, after orthopedic and general surgery. The complexity of neurosurgery and the required coordination of several surgeons are contributing factors for the increased risk. Jhawar and colleagues conducted a national survey of 138 practicing neurosurgeons to examine the prevalence of wrong-site and wrong-level craniotomies and diskectomies. Based on the self-reported data from 4695 lumbar diskectomies, 2640 cervical diskectomies, and 10,203 craniotomies, the frequency of wrong-level lumbar surgery and incorrect-site cervical diskectomies and craniotomies was 4.5, 6.8, and 2.2 per 10,000, respectively. Of all participating neurosurgeons, 25% reported cutting skin at the wrong site at least once in their careers, and 32% reported removing lumbar disk material at the wrong level at least once in their careers. This study, along with others, also showed that incidence of wrong-site surgery varied with number of surgeries performed rather than the number of years of practicing, suggesting that experience alone does not guarantee a reduction of errors.


Despite the increasing attention given to wrong-site surgeries and new safety protocols, these never-events still occur. Many experts suggest that these avoidable errors are largely caused by communication errors. In a systematic review of 35 cases of wrong-site craniotomy, the leading and common cause was human error. Four cases resulted from the surgeons’ inaccurate assumptions, and 7 cases were attributed to time pressures and fatigue. Other main causes for wrong-site craniotomies in the study include communication breakdowns within surgical teams and among departments, inadequate preoperative checks that led to failed site marking, mixing of the identities of patients with similar names, improper surgical time-outs, mixing of scans, technical factors, imaging that included mislabeled images, and unconventional operating room setup. Causes of wrong-site errors in spine surgery included odd patient anatomy and inadequate use of radiographic verification of surgical site.


Although some investigators recognize that wrong-site surgeries will not be completely eliminated, rigorous adherence to systems of prevention at various stages of a patient’s treatment can reduce error incidence. Several of the risk factors, including communication breakdown and inadequate checks, can be addressed through proper protocols and checklists. Makary and colleagues found that operating room briefings improved team communication and significantly reduced wrong-site surgeries. An 8-year experience with a neurosurgical checklist at the Mayo Clinic observed high compliance among neurosurgeons and reported increased awareness of safety of surgical teams. Connolly and colleagues reported on the effective clinical usefulness of a neurosurgery operational checklist for movement disorder surgery because of the ease of implementation of the checklist and the consistent ability to identify errors over time. However, protocols and checklists have limited efficacy without a culture of safety and the coordination of the entire team. Neurosurgeons need to not only lead the use of appropriate checks and safety protocols but, more importantly, lead in the adoption of an improved culture of safety and communication to improve the systems delivery of the inherently high-risk field that is neurosurgery.


Nosocomial infections


Nosocomial infections also comprise another area of opportunity in improving clinical safety and efficiency. Nosocomial infections, or hospital-acquired infections, result in an estimated 90,000 deaths and a cost of 4.5 to 5.7 billion dollars annually. However, a study by the Pennsylvania Health Care Cost Containment Council reported a greater incidence. Hospitals in Pennsylvania alone reported 11,668 hospital-acquired infections in 2004, 15.4% of which led to death, with an overall cost of $2 billion.


The US Centers for Disease Control and Prevention (CDC) National Nosocomial Infections Surveillance system noted that in participating acute care hospitals in the United States, surgical site infections (SSI) comprised 38% of all nosocomial infections in surgical patients. The National Healthcare Safety Network and the National Center for Health Statistics estimate that 250,000 to 1 million cases of SSI occur each year in the United States. Patients facing SSIs are at least 60% more likely to be admitted to an ICU, 15 times as likely for readmission within 30 days of discharge, and stay in hospitals an average of 7.5 days longer. Beyond costing $1.6 billion in avoidable health care expenditures, SSIs can lead to increased morbidity, mortality, and compromised quality of life. The University of Pennsylvania Medical Center reported savings of 1.2 million over 2 years from reducing hospital-acquired infections.


Although rare compared with other surgical specialties, neurosurgical cases of surgical infections may have devastating consequences, including meningitis, permanent functional and cognitive deficits, and pseudarthrosis. For example, nearly 75% of patients with diskitis from a surgical complication or infection may experience chronic back pain and functional deficits. Developing safety protocols to address SSI requires a thorough understanding of prevalence, incidence, and risk factors. There have been several reports proposing best practices and identifying risks for SSIs from neurosurgical procedures.


In a 2010 retrospective case study of 103 patients undergoing craniotomies, Cha and colleagues identified increased length of stay and low level of consciousness, among other risk factors, as causes for increased incidence of SSI. Studies of infections resulting from spine surgery cite several risk factors for surgical infections, including patient age, previous surgical infection, diabetes, malnutrition, obesity, operation length, and operation complexity. Inamasu and colleagues examined the differing efficacies of bone flap storage methods in reducing the incidence of SSI after decompressive craniotomy followed by cranioplasty. The study found that temporary storage in a subcutaneous pocket for traumatic brain injury could be beneficial over cryopreservation, although both methods seem to be equal for nontraumatic brain injury causes.


Cerebrospinal fluid (CSF) shunts are commonly used to treat hydrocephalus and other intracranial conditions to relieve intracranial pressure. However, shunt infections cost an average of $50,000 per hospital treatment and billions of dollars nationally and are the single most expensive implant-related infection in the United States. Rates of reported shunt infection range from 0% to 39%. Many published studies exist, documenting proper techniques, different preventive and safe practices, and antibiotic treatment options, yet, infections still occur. Risk factors include presence of CSF leak, patient age (<40 weeks’ gestation), and improper handling of the shunt system. Safe practices include using antibiotic-impregnated shunts (AISs), antibiotic prophylaxis, limited hardware and skin edge manipulation, and using the double gloving technique. After implementing AISs, Johns Hopkins Hospital reduced shunt infection rates from 12% to 3.2% and reduced infection-related costs. Many other studies have shown that adherence to safe protocols for shunt surgery is successful in reducing shunt infections and controlling costs. Neurosurgeons must use the evidence-based medicine in the literature to lead in the implementation of protocols and culture to improve patient safety and decrease surgical errors.


Use of an external ventricular drain (EVD) is a common approach for monitoring and controlling intracranial pressure while treating brain tumors and hydrocephalus and is used in emergency neurosurgery. However, the most common complication from EVDs is CSF infection, which is associated with morbidity, including bacterial meningitis and ventriculitis, and mortality. Frequency of CSF infections resulting from ventriculostomy has been reported within a range of 2.2% to 10.4%. Several studies have documented several risk factors, including craniotomy, depressed cranial fracture, intraventricular hemorrhage, systemic infection, CSF leakage, operation length, and inadequate closure of skin or dura. Other risk factors, including duration of catheter use, use of antibiotics, and EVD exchange, have been noted, but associations are still controversial.


In implementing safety initiatives to control nosocomial infections and minimize antibiotic resistance, neurosurgeons should implement safety protocols that consider evidence-based strategies on infection prevention and risk factors identified in the literature. Although reducing nosocomial infections remains a challenge, several successes have been reported. In 2006, the Michigan Health and Hospital Association Quality Keystone ICU project reported its state-wide success in decreasing catheter-related bloodstream infections in 103 participating ICUs. An estimated 80,000 catheter-related blood stream infections occur each year, resulting in up to 28,000 deaths, costing hospitals an average of $45,000 per patient and costing the nation $2.3 billion annually. Through leadership, team training and education, consistent data reporting, a culture of patient safety, and adherence to a safety checklist of evidence-based procedures from the CDC’s recommendations, hospitals observed up to 66% reduction in catheter-related bloodstream infections. Within 3 months, the median infection rate was 0, and remained at 0 through an additional 15 months of follow-up. Implementation of the safety program was simple, inexpensive, and cost effective.


In a 2006 study, Dasic and colleagues reported a significant reduction in EVD infections, from 27% to 12% over a 2-year period, through the adoption of an evidence-based protocol. A 2010 study from Leverstein-van Hall and colleagues observed a reduction in external ventricular and lumbar drain–related infections from 37% to 9% through a multidisciplinary effort that focused on 5 pillars, which included increased vigilance, standardized operation protocols, and a diagnostic and therapeutic algorithm. Classen and colleagues reported $0.7 million annual savings from reducing deep surgical wound infections, from 1.8% to 0.4%, through a protocol that included proper prophylactic administration of antibiotics. Neurosurgeons must lead in the development of team training and education, consistent data reporting, a culture of patient safety, and adherence to safety checklist to develop a simple, inexpensive, and cost-effective practice to prevent EVD and shunt infections to dramatically improve patient outcomes and reduce neurosurgery care costs.


Improvements in neurosurgery processes for patient safety and quality


There have also been several studies on process improvements specific to neurosurgery. After implementing a protocol that included 3 clinical pathways for patients with CSF shut malfunctions at the Texas Children’s Hospital, total time for completion of emergency department physician evaluation and initiating diagnostic imaging was reduced from 147 to 104 minutes. The department’s ability to triage and treat more severe cases improved, and patients in the expedited pathway experienced a shorter hospital stay. In 1990, the University of Michigan Medical Center implemented a critical pathway for lumbar laminectomy and transphenoidal pituitary tumor resection, as part of a hospital-wide multidisciplinary effort to standardize processes of care, cut costs, and maintain clinical quality. During the first 14 months, the center observed a decrease in length of stay at the ICU and routine care unit. Similarly, Arriaga and colleagues reported a decrease in length of ICU and hospital stays after implementing a clinical pathway for acoustic neuroma surgery. Recently, a study of 106 patients on the implementation of a clinical pathway for lumbar laminectomy found an average reduction in hospital stay, decreased variability in length of stay, and improved patient satisfaction. The use of process improvements presents as an opportunity for neurosurgery to provide a more streamlined care to augment overall quality care and lower costs.

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Oct 12, 2017 | Posted by in NEUROSURGERY | Comments Off on Recent Advances in the Patient Safety and Quality Initiatives Movement

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