In the discussion preparation this week, you were asked to evaluate the degree and quality of care established within 18th-century U.S. hospitals, as compared to the level of care seen in today?s hosp

In the discussion preparation this week, you were asked to evaluate the degree and quality of care established within 18th-century U.S. hospitals, as compared to the level of care seen in today?s hospitals. In addition, you should analyze the basic sources of law?common law, statutory law, and administrative law?and identify which one is most prevalent in health care. Present your evaluation and analysis.

In the discussion preparation this week, you were asked to evaluate the degree and quality of care established within 18th-century U.S. hospitals, as compared to the level of care seen in today?s hosp
HEALTH POLICY (AD SHARAN, SECTION EDITOR) Brief history of quality movement in US healthcare Youssra Marjoua &Kevin J. Bozic Published online: 9 September 2012 # Springer Science??? Media, LLC 2012 AbstractThe current healthcare quality improvement infrastructure is a product of a century long experience of cumulative efforts. It began with an acknowledge- ment of the role of quality in healthcare, and gradually evolved to encompass the prioritization of quality im- provement and the development of systems to monitor, quantify, and incentivize quality improvement in health- care. We review the origins and the evolution of the US healthcare quality movement, identify existing initiatives specific to musculoskeletal care, outline significant chal- lenges and opportunities, and propose recommendations for the future. Elements noted to be associated with successful healthcare quality improvement efforts in- clude the presence of physician leadership, infrastruc- tural support, and prioritization of healthcare quality within the culture of the organization. Issues that will require continued work include the development of a valid and reliable evidence base, accurate and replicable performance measurement and data collection methods, and development of a standard set of specialty specific performance metrics, with accurate provider attribution, risk adjustment and reporting mechanisms.KeywordsQuality. Healthcare. Musculoskeletal. Orthopedics. History. Improvement. Performance measurement. Standards. Reporting. Reimbursement. Cost. Value. Public. Private. Government. Evidence-base. Structure. Process. Outcome. Monitoring and evaluation Introduction The roots of the quality improvement movement can be traced back to the work of epic figures such as Ignaz Semmelweis, the 19th-century obstetrician who championed the importance of hand washing in medical care. In addition, Florence Night- ingale, the English nurse, identified the association between poor living conditions and high death rates among soldiers treated at army hospitals. Ernest Codman, a surgeon, pio- neered the creation of hospital standards and emphasized and implemented strategies to assess healthcare outcomes. The modern quality movement has since transformed to in- clude a wide variety of stakeholders, a range of unique and modified approaches, and an evolving set of goals [1]. There have been several notable quality improvement efforts over the past half-century. A substantial number of these efforts were spawned by the academic health quality movement. This was launched with a series of articles that began to outline the deficiencies in the delivery of health- care, which prompted numerous and multidimensional efforts towards healthcare quality improvement [2-6]. These included the re-engineering and restructuring of systems of healthcare delivery, the encouragement of peer review, and the incentivizing of competition among providers and organizations. They also included the identification of med- ical processes that affected patients?health, rewarding of good performance, and reprimanding of poor performance, improvement of methods for monitoring, and evaluation of performance, implementation of rapidly evolving quality improvement tools, public reporting of quality data, and the redesign of professional medical education [7,8]. Y. Marjoua Harvard Combined Orthopaedic Residency Program, 55 Fruit Street, WHT 535, Boston, MA 02114, USA e-mail: [email?rotected].com K. J. Bozic (*) Department of Orthopaedic Surgery, University of California, San Francisco, 500 Parnassus Ave, MUW320, San Francisco, CA 94143-0728, USA e-mail: [email?rotected] K. J. Bozic Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California St, Suite 265, San Francisco, CA 94143-0936, USA Curr Rev Musculoskelet Med (2012) 5:265?273 DOI 10.1007/s12178-012-9137-8 A brief history of healthcare quality efforts in the United States The Institute of Medicine (IOM) defined quality 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?[9]. There have been numerous attempts at conquering the chal- lenges of improving healthcare quality and safety in the United States, which predate and follow this definition. Though there have been several short lived successes, none have been substantial enough to address the complex, and evolving challenges associated with achieving adequate healthcare quality. The following section is a brief timeline chronicling events that contributed to the evolution of the healthcare quality movement to its present form. Improvement efforts in the early days of Medicare In 1965, Congress passed legislation which established the Medicare and the Medicaid programs as Title XVIII and Title XIX of the Social Security Act [10]. Medicaid was established in response to the perceived inadequacy of the “welfare medical care” under public assistance at the time. Title XVIII of the Social Security Act, commonly known as Medicare and entitled?Health Insurance for the Aged and Disabled,?established a health insurance program for aged persons. Under this provision, Americans 65 years and older were qualified to receive compulsory hospital insurance (part A) and voluntary supplementary medical insurance (part B) [11]. In anticipation of the need to assess and direct the care of Medicare patients, Congress established a set of conditions entitled?Conditions of Participation,?which re- quired the implementation of several elements deemed nec- essary for hospital operation. These conditions included staff credentials, 24-hour nursing services, and utilization review [12]. In accordance with these requirements, Utili- zation Review Committees were established in 1972, to identify if hospitals and medical personnel were providing appropriate clinical services that met conditions of partici- pation. While this system of review committees held poten- tial for effective monitoring, its success was limited. The lack of effectiveness was retrospectively attributed to an absent association between the review process and the iden- tification of ways to improve care. In addition there was an absence of formal evaluation criteria to guide providers? decision making, and to adjust payment based on the quality of care [13]. Several years later, in response to the ineffectiveness of the 1965 Utilization Review Committees, Congress established pilot organizations entitled?Experimental Medical Care Re- view Organizations?[11] in 1972. These were physician organizations funded by the National Center for HealthServices Research; they were given the authority and respon- sibility of reviewing healthcare delivery in the inpatient and ambulatory setting, and of assessing the quality and appropri- ateness of care delivered. Unlike the aforementioned Utiliza- tion Review Committees, these organizations developed projects and models that adjoined the findings of the quality review process with appropriate improvement strategies. These pilot projects shortly became a blueprint for Medicare?s Professional Standards Review Organizations (PSROs) estab- lished soon thereafter in 1972. Based on the success of the pilot Experimental Review Organizations, PSRO legislation created a federally funded network of nonprofit physician-run organizations, tasked with assessing the necessity, applicability, and quality of healthcare services rendered [11]. As with Utilization Re- view Committees, the goal of PSROs was to affirm that physicians and hospitals met Medicare specific obligations to provide high quality care, which generally involved the avoidance of unnecessary overuse, inappropriate misuse, and non-indicated underuse of services. However, while promising in concept, PSROs never met governmental expectations and were simultaneously viewed as a form of governmental interposition into the practice of medicine, one that was sternly resisted by the AMA and state medical societies. Thus, by the early 1980s, PSROs were considered unsuccessful in both improving quality and containing costs, and were questioned regarding their prioritization of cost over quality. In 1983, PSROs were replaced by the utilization and quality control Peer Review Organizations (PROs) [11]. PROs were established during the implementation of the hospital prospective cost-per-case, diagnosis-related groups (DRGs) model. Accordingly they were tasked with validat- ing assignments to the DRGs, reducing unnecessary admis- sions and readmissions, and reducing complications, and mortality rates. What set PROs apart from previous models is that beyond simply identifying the problem, they were given the authority to implement different solutions. These solutions ranged from retrospective reviews and continued medical education requirements to disciplinary action and loss of Medicare billing privileges. PROs were successful in achieving the intended goals of quality enhancement and cost containment; as a result they have continued to play a considerable role under the new Centers for Medicare and Medicaid Services (CMS) label of Quality Improvement Organizations (QIOs) [14]. During this time period and preceding it, governmen- tal programs were being supplemented by efforts under- taken by leaders in organized and academic medicine as well as non-profit organizations. In 1951, the Joint Commission on Accreditation of Hospitals (JCAH) was established [15]as a non-profit organization with the intended function of providing voluntary accreditation 266Curr Rev Musculoskelet Med (2012) 5:265?273 of hospitals based on a rubric of defined minimum quality standards. It has since become The Joint Com- mission, with an objective of improving the quality of healthcare by evaluating healthcare organizations and providing guidance on the elements necessary to deliver care that optimizes quality and value. Framework for measuring quality In 1966, Dr. Avedis Donabedian, physician and founder of the study of quality in health care and medical out- comes research published?Evaluating the Quality of Medical Care?[16], a replicable and highly useful mod- el that relies upon the elements of structure, process, and outcomes to examine the quality of care delivered. When applied to orthopedics, the Donabedian Model suggests that care structures (ie, assigning a dedicated arthroplasty care team) and care processes (ie, designing and implementing a standard arthroplasty care pathway) can contribute to patient outcomes. This will also in- clude clinical endpoints such as functional status, pain, complications, morbidity and mortality, as well as pa- tient based experiences, andutilization of resources. This model provides a basis for the current methods used to evaluate healthcare quality [17]. Shortly after Dr. Donabedian?s transformative contri- bution to the field of healthcare quality, The National Academies of Science established the Institute of Med- icine (IOM) in 1970, which has since launched numer- ous concerted efforts focused on evaluating, informing, and improving the quality of healthcare delivered [18]. In 1989, the Agency for Health Care Policy and Re- search?currently known as the Agency for Healthcare Research and Quality (AHRQ)?was created [19,20]. AHRQ replaced the National Center for Health Services Research, and was created by Congress in response to newly reported data that revealed wide geographic var- iations in practice patterns without supporting clinical evidence, and with reports of misuse and overuse of procedural treatments [21]. These findings helped drive Congressional prioritization of this research program, with a focus on investing in clinical effectiveness, treat- ment outcomes, and practice guidelines [22]. Shortly thereafter, the National Committee for Quality Assurance (NCQA) was established in 1990, with an objec- tive of improving health care quality [23]. NCQA is a non- profit organization tasked with managing accreditation pro- grams for individual physicians, health plans, and medical groups. It measures accreditation performance through the administration and submission of the Healthcare Effective- ness Data and Information Set (HEDIS) and the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey.Why has quality been difficult to achieve With the ability to deliver the highest standards of care and to perform the most complex of procedures, the magnitude and ubiquity of healthcare quality challenges in the United States are often attributed to the problems of underuse, overuse, and misuse of resources [9,24]. The underlying causes of these issues are multilayered and complex. They include a previously observed lack of accountability for inadequate quality rendered and for high costs incurred, the existence of diffuse and non-specific goals, and the measurement of processes, structures, and outcomes that only diffusely inform objectives without necessarily im- proving care. They also include the existence of insufficient information on healthcare outcomes and relative effective- ness, and the presence of perversely incentivized payment systems that encourage volume without regard to value [24]. However, while much remains to be achieved, a review of the historical progression of the healthcare quality movement reveals that over the past century, productive steps have been made towards helping providers improve their ability to deliver high quality care. Legislative action, healthcare improvement initiatives, and quality improve- ment organizations continue to equip providers with the tools to quantify, measure, and report their performance, as a means of identifying where the gaps in quality are occur- ring. An increasingly focused healthcare agenda has helped to align different stakeholders around similar fundamental goals for change; an increasing awareness among patients and consumers has helped them to identify their role in recognizing and expecting quality care [25 ]. During the gradual evolution of the quality movement, there was a purposeful attempt to transition towards models that relied on data driven quality improvement initiatives. One example was the 1992 Quality Improvement Initiative proposed by the Health Care Financing Administration (HCFA), which aimed to create a patient care algorithm system based on clinical guidelines and information provid- ed by claims history and data set [26]. This was imple- mented in an effort to achieve evidence-based continuous quality improvement. Another example is the 1994 National Surgery Quality Improvement Project (NSQIP), developed in the VA system at the behest of Congress to address higher surgical mortality in VA hospitals [27]. The VA NSQIP developed an active program of data collection of both risk adjustment and outcome data, which were then used to devel- op risk adjustment models and benchmarks for participating VA s [28]. In 1999, a VA study showed that NSQIP methods were transferable to non-VA hospitals. The American College of Surgeons (ACS) subsequently collaborated with the VA to implement NSQIP at 14 academic hospitals through a pilot project funded by AHRQ, which has since become an estab- lished system of methods at these hospitals [29]. Curr Rev Musculoskelet Med (2012) 5:265?273267 Over the period from 1995 to 2000, several quality improvement initiatives, task forces, and sentinel reports were initiated and published. The IOM launched the comprehensive quality initiative, the Joint Commission established the sentinel event policy, the Quality Inter- agency Coordination Task Force (QuIC) was estab- lished, the Leapfrog Group was founded, and the IOM published the transformative article?To E r r i s H u m a n? [30]followedby?Crossing the Quality Chasm?[31]. The National Quality Forum (NQF) was created [32]. The National Quality Forum (NQF) is a nonprofit orga- nization established in 1999 with a mission to improve the quality of US healthcare. The forum works to define national goals and priorities for healthcare quality im- provement, and to build national consensus around these goals and to endorse standardized performance metrics for quantifying and reporting on national healthcare quality efforts. NQF endorsement has thus become the ?gold standard?for healthcare performance measures, relied upon by healthcare purchasers such as CMS. The forum?s membership includes a wide variety of stakeholders including hospitals, healthcare providers, consumer groups, purchasers, accrediting bodies, and research and healthcare quality improvement organiza- tions. The wide scope and assortment of its membership has allowed for a comprehensive understanding of the challenges associated with quality improvement, and for the design of multidisciplinary and collaborative solu- tions to address them [33]. Several years later along the healthcare quality time- line, in 2003, the Surgical Care Improvement Program (SCIP) was established. SCIP is a voluntary multidisci- plinary partnership of organizations that was created based on the Surgical Infection Prevention (SIP) pro- gram and the NSQIP model, and aimed at reducing surgical complications and mortality [34,35]. The tar- geted measures were related either to infection preven- tion, or venous thromboembolism (VTE) prevention. SCIP transitioned to a mandatory publicly reported sys- tem in 2003, with participation incentivized by a Medi- care payment that would otherwise be withheld for non- participation. The use of public reporting has since then continued to expand, with the 2003 Hospital Inpatient Quality Reporting (IQR) program. IQR was intended to provide consumers with healthcare quality information that assists in making informed decisions regarding their healthcare. It was also intended to guide hospitals and providers towards improv- ing the quality of inpatient care delivered to patients, through the incentive of higher annual update to their pay- ment rates [36]. The information gathered through the program is made publicly available through the Hospital Compare Website.Physician Quality Reporting System (PQRS) With a growing focus placed on the physician as the target of feedback and incentives, public reporting efforts in 2006 led to the development of the Physician Quality Reporting Initiative (PQRI), entitled the Physician Quality Reporting System (PQRS) as of 2011 [37]. Under the Tax Relief and Health Care Act of 2006 (TRHCA), PQRI began as a voluntary pay-for-reporting program. The program was set to provide incentive payments in the form of a 1.5 % bonus on total allowed Medicare Part B Fee-For-Service (FFS) charges for successful reporting on a minimum of 3 quality measures, or for 1 of 14 measure groups for the reporting period of July 1, 2007 through December 31, 2007 [37]. Under the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) [38], PQRI incentive payments were increased to 2 % for successful participation in both the 2009 and 2010 program years, and public reporting became mandatory. A unique element of the PQRS was its focus on pay-for-reporting at the individual physician level [17]. However, while participation in PQRS is currently volun- tary, beginning in 2015, all providers eligible for incentive payments will be subject to penalties for failing to partici- pate. The penalty is set to begin at a 1.5 % reduction for those who fail to report on the minimum measure set and scheduled to increase to a penalty of 2 % reduction in reimbursement in 2016 and beyond [39 ]. The goal of the PQRS program is to incentivize the discussion of quality oriented questions between patients and providers, and to promote awareness among providers of the opportunities for quality improvement present in daily care and process [40]. Recent efforts and the patient protection and accountable care act The intense focus on quality in healthcare was brought to the forefront with the passage of the Patient Protection and Accountable Care Act (PPACA), signed into law by Presi- dent Obama on March 23, 2010 [41]. The law contains multiple provisions designed to modify the manner in which care is delivered to Medicare and Medicaid patients, and the system by which provider payment is determined, with a central objective of improving quality while lowering healthcare costs and expanding access. One of the key provisions centered around quality is the creation of a non- profit Patient-Centered Outcomes Research Institute (PCORI) to conduct research that compares the clinical effectiveness of medical treatments, otherwise known as Comparative Effectiveness Research (CER) [42]. CER is intended to determine which interventions are most effective for certain patient populations under specific circumstances, and to use these findings to guide treatment algorithms that 268Curr Rev Musculoskelet Med (2012) 5:265?273 support patient-centered, evidence-based, high quality care. Another PPCA quality centered provision is a penalty based quality improvement provision, which prohibits federal pay- ments to states for Medicaidservices related to certain hospital-acquired infections starting February 2011 [43], and also the National Quality Strategy, formally released in March of 2011 [44]. The remaining quality related provisions of the law have yet to be implemented. Several are scheduled for implemen- tation in the fall of 2012, including the Medicare Value- Based Purchasing program [45], and the provision to reduce Medicare Payments for Hospital Readmissions, which aims to reduce Medicare payments that would otherwise be made to hospitals to account for excess (preventable) hospital readmissions [46]. Accountable Care Organizations (ACOs) On October 20, 2011, CMS released the final rules for the official implementation of Accountable Care Organizations (ACOs) under the Affordable Care Act. ACOs were estab- lished with the intention to guide healthcare providers and hospitals towards more coordinated, higher quality, and patient centered care for Medicare patients, and to replace the often fragmented care received under the single pay- ment, single provider system of the Fee-for-Service payment system [38]. The Act also delineates that for an ACO to share in any savings created, it must prove that it has met the quality performance measures defined. These currently in- clude 65 process and outcome measures spanning 5 quality domains: patient experience of care, care coordination, pa- tient safety, preventive health, and at-risk population/frail elderly health. Several of the proposed quality measures align with those used in other CMS quality programs, such as PQRS, the Electronic Health Record (EHR) incentive program, and the Hospital IQR [38]. Quality in musculoskeletal care The essential role of quality and safety improvement efforts permeates the general scope of health care. Improving qual- ity in musculoskeletal care has progressively become a goal of increasing importance to payers, hospitals, surgeons, patients, and governmental entities, particularly given the increasing complexity and cost of surgical procedures and the rising public demand for information regarding the safety, quality, and efficacy of treatment [47]. However the complexity of health care delivery in the United States has made quality assessment and improvement a relatively dy- namic and challenging process. Based on the conceptual framework of Donabedian, efforts have generally focusedon assessing data that captures and integrates structural measures (ie, surgical case volume), process measures (ie, SCIP measures linking process to outcome), as well as clinical outcomes (ie, NSQIP data) [16]. A significant focus has also been placed on developing payment and delivery models that incentivize and support the provision of high quality, cost-efficient care. Structural metrics generally revolve around the health care system, and include variables such as organizational structure, material, and human resources [47]. Examples of structural measures include surgical case volume, access to technology and equipment, and provider to patient ratios. The association between surgical case volume and health outcomes is one that has received notable attention in recent years, with research that has revealed a positive correlation between volume and outcomes, and policy discussions have begun to consider volume in reimbursement decisions [48]. The advantage of structural measures in assessing quality hinges on the presence of readily available data usually collected in administrative databases and therefore access to large volumes of data, as well as the opportunity for rapid review of easily analyzed data [49]. The disadvantages however, include a difficulty with discerning whether mea- sured structural differences necessarily correlate with differ- ences in surgical quality, and also include a limitation towards assessing the quality delivered by individual hospi- tals or providers. Most importantly however, most structural measures are not easily actionable [47]. Therefore even if easily defined and measured, allowing for straightforward assessment, they are not necessarily appropriate for achiev- ing quality improvement goals; hence the need for integrat- ing all arms of the structure, process, and outcome model. Process measures are targeted towards assessing the prac- tical, diagnostic and procedural activities carried out when health providers deliver care to patients, including the his- tory and physical exam, diagnostic testing, and the justifi- cations and indications for therapeutic interventions [50]. The theoretic advantage of these measures is that if accu- rately chosen and assessed, they directly measure the care received by the patient, allowing for prompt recognition, and remedial action if needed [47]. These measures are therefore inherently actionable, and relevant in quality im- provement efforts, but the disadvantage often lies in the absence of a firm designative link to patient outcomes, and the challenge of identifying appropriate patient populations for each intervention examined. However since process metrics can be easily tracked and measured, they have often been chosen to be the focus of national quality improvement programs. One such program is the Surgical Care Improve- ment Program (SCIP), which, as previously mentioned, is a voluntary collaborative that was created based on the Sur- gical Infection Prevention (SIP) program and the NSQIP model, aimed at reducing surgical complications and Curr Rev Musculoskelet Med (2012) 5:265?273269 mortality [34]. SCIP processes of care measures that are of importance to musculoskeletal care include; the prevention/ reduction of surgical site infections (SSIs) through assess- ment of whether the proper antibiotics were selected, wheth- er prophylactic antibiotics received within one hour of incision; and if they were discontinued at 24 hours. They also include the prevention/reduction of venous thrombo- embolism (VTE) through the initiation of recommended VTE prophylaxis within 24 hours postoperatively. As the final arm of the 3 part quality assessment model, outcome measures generally assess the effect that delivered care has directly on the health status of patients and pop- ulations [50]. These measures are generally associated with a presumed level of validity, as the achievement of im- proved outcomes is generally the goal of surgical treatment. Historically quality assessment of surgical outcomes has relied on direct measurement of outcomes in the form of average 30-day morbidity and mortality rates. Other meas- ures have included hospital length of stay, hospital readmis- sion rates, cost-effectiveness, and patient experience. The direct measurement of surgical outcomes is challenged by the problem of inadequate patient population sample size, which results from the difficulty in gathering sufficient and meaningful data for individual surgeon or procedure- spe- cific outcomes, as a high frequency, and volume would need to be reached in order to achieve reliable outcomes [47]. An additional disadvantage arises from the inherent nature of outcome measures being delayed events that are difficult to prospectively track and measure. Hence, the measurement of an outcome may be too delayed to allow for intervention if indicated and may only allow for future change should a similar circumstance arise. In addition, outcome measures are influenced by many steps along the continuum of care, and therefore it is difficult to attribute a positive or adverse outcome to any particular intervention along a complex sequence of events. The most critical concern in relying upon outcome meas- ures is the absence of appropriate risk adjustment, which could inaccurately equate outcomes of physicians, and institutions caring for the sickest patients as poor quality care. The public reporting of unadjusted outcome data could therefore lead to the denial of care to the sickest patients for fear of acquiring poor scores and a negative reputation [51]. In the existing team-based care models that define our healthcare delivery system, an added challenge lies in the accurate attribution of physician services. It has been demonstrated that accurate and reliable attribution of costs to the individual physician is very difficult to achieve [52]. Furthermore, in the effort to quantify the reliability of quality measures used in appraising physician performance it has been shown that typical health plan admin- istrative data provided insufficient numbers of reported qual- ity events, rendering the findings of quality measurement unreliable [53].Value-based payment Quality reporting and hospital value-based purchasing program An example of the application of process measures is the Quality Reporting and Hospital Value-Based Purchasing program, a newly proposed program being implemented by CMS under the Affordable Care Act, and scheduled to begin in October 2012 with full implementation to be com- pleted by 2016 [36]. Under the Hospital VBP program, hospitals would be able to earn incentive payments either based on their performance on Clinical Process of Care Measures; there are 12 measures, including several SCIP measures, as well as Patient Experience of Care Measures based on their performance improvement relative to their starting baseline. The Hospital VBP program is designed to improve quality, reduce inappropriate care and promote better health outcomes, and patient experiences during hos- pital stays through a system of financial incentives and penalties. Physician value-based modifier program (CMS) The Physician Value-Based Modifier Program intends to transition physician reimbursement from one that rewards volume to one that reimburses based on value. It functions to provide physicians with comparative performance infor- mation that is actionable and can be used to improve the care they provide. The program contains 2 components: The Physician Quality and Resource Use Reports (QRURs), and the development and implementation of a Value-based Payment Modifier (VBPM) [39]. Many challenges still exist in defining and attributing quality and resource use to a specific physician, and to developing valid, risk-adjusted value-based payment modifiers. What have we learned? There are a number of elements that have been associated with successful healthcare quality efforts and can be deemed essential for the achievement of sustainable systems of quality assurance. Of crucial importance is the presence of physician leadership, infrastructural support, and prioritiza- tion of healthcare quality within the culture of an organiza- tion. Existing performance measurement methods are frequently derived from administrative claims data, as there is a paucity of other sources of data available, and further limited by the low validity of using

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