...today’s highly competitive regulated healthcare environment, it is so important for different companies to bring to their market new medical technology and to keep them in their market. Therefore, managing different regulatory issues is an essential key to a strategic advantage. Currently, there are strong standards and guidelines put into place to ensure that all devices are well safety equipped, well studied before putting it out in the market and have less negative reactions. The strongest way to judge efficacy of any technology is data acquisition through randomized clinical trials (Berkowitz, Robert, 2010). Off course, this is not possible or even feasible in certain cases. Properly designed case series and cohort studies can provide and prove hypothesis. Observational and epidemiological studies can help identify unexpected deviations and outcomes. Meta-analysis can then take in to consideration all the available evidence and summarize the current state of knowledge. Incorporation of Cost-Effectiveness Analysis and Cost-Benefit Analysis help calculate and extrapolate economic aspects of any medical technology. Technology continues to affect the healthcare industry (Berkowitz, Robert, 2010). Currently, the industry is moving towards the electronic medical record (EMR), data reporting from the EMR, and availability from systems that can communicate with each other. As technology changes, so must the healthcare industry. The ability to change, adapt, and use new technologies...
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...Quality Improvement in Healthcare In today's healthcare industry, many facilities search for ways to obtain an advantage from other facilities in the market. One way to obtain an advantage over other facilities is to have a reputation of providing the highest quality of care to the patients. Maintaining and continuously striving to improve the quality of various processes and procedures within the facility is important. Foundation frameworks, stakeholder differences, roles of clinicians and patients, need for quality management, areas to monitor, regulatory agencies, and resources represent the various points that will be addressed throughout the paper. Foundational Frameworks of QI There are several foundational frameworks within the subject of QI. There are several QI models derived from ideas and theories of leaders. According to Ransom, Joshi, Nash, and Ransom, (2008) PDSA/PDCA, API, FOCUS PDCA, Baldrige Criteria, ISO 9000, Lean, and Six Sigma represent various frameworks used to improve the quality of healthcare. Edward Deming described the Plan-Do-Study-Act (PDSA) cycle a plan to learn and improve the quality of work dated back to 1950s. Later Walter Shewhart developed the Plan-Do-Check-Act (PDCA) cycle for the basis for planning and expressing QI endeavors. The PDSA/PDCA model helps the facility to focus on how to plan for the improvement, how the improvement will be implemented, how the improvement will be identified/monitored, and what was learned from the...
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...IOM Issues Recommendations for Transforming Nursing Practice If you were going to dream big, what changes would you make to your profession, as a practicing nurse? In November of 2010, the Institute of Medicine (IOM) issued a special report titled “The Future of Nursing: Leading Change, Advancing Health.” It’s an in-depth look at the role nurses should play in a changing healthcare system, as the new legislative reforms are phased in over the next decade. And it definitely “dreams big” in terms of expanding the scope of the nursing profession, stating that: A number of barriers prevent nurses from being able to respond effectively to rapidly changing health care settings and an evolving health care system. These barriers need to be overcome to ensure that nurses are well-positioned to lead change and advance health. Three points about nursing leadership The committee that authored the report developed four key messages that form the basis for the discussion and recommendations presented within it. The first three deal directly with nursing practice, and these are as follows: • Nurses should practice to the full extent of their education and training. • Nurses should achieve higher levels of education and training, through an improved education system that promotes seamless academic progression. • Nurses should be full partners with physicians and other health professionals, in redesigning health care in the United States. So how does the IOM’s vision...
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...Management and Healthcare Nicholas Drzycimski Operations Management SCMS 3510-003 University Of Memphis November 9, 2015 Introduction Most people would agree that access to healthcare is an issue with definite room to improve; there are constant demands from both taxpayers and the society for change. Organizations which provide healthcare are faced with economic limitations and constraints, long waiting times and queues of patients. Healthcare organizations are also affected by strict budgets that prevent them from procuring additional resources. One solution to combat all three of these constraints simultaneously would be to implement ideas and concepts from the Operations Management field of business. The most effective concept would likely be Lean production, that is, limiting as much waste as possible while using what resources are on hand to their most effective state possible. Of course, this is a very difficult goal to achieve when dealing with the unpredictability of day-to-day operations at a hospital, but measures can and should be taken to limit as much waste as possible and maximize efficiency of resources used. While new ways to implement more ideas and concepts of Operations Management into the healthcare industry are constantly being researched, there are aspects and tasks that are performed in a Hospital that can be considered the operations of a hospital. The goal of this paper is to explain some of these operations of a hospital. Regulatory Reporting ...
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...include comforting, engaging, and empowering patients. The new approach implements patient-centered care environments. It has been adopted by care providers, research bodies, funding agencies, and regulatory agencies, among others. To enhance patient-centered care, business practices, regulatory requirements, and reimbursement regulatory procedures have been adopted. This is evident by the regulations of Joint Commission and the provision of services by Medicare Medicaid services (CMS). In this paper, the impact of business practices, regulatory requirements, and reimbursement procedures on patient-centered care is discussed. A multidisciplinary approach on a process improvement enhancing Patient and Family Centered Focus Care is outlined in a hospital located in Arizona. Regulatory Requirements and Healthcare Business In 1996 the Institute of Medicine took on healthcare improvement to resolve unsafe care by ambitiously moving toward quality initiatives. The release of “To Err Is Human: Building a Safer Health System19 (1999) and Crossing the Quality Chasm (2001)” focused on the fails of the healthcare systems pointing out that over 98,000 patients die in hospitals annual due to some sort of medical error (Roussell, 2011). This report was the source of the new transformation of healthcare delivery brigding gaps from a state of broken system to an ideal state of evidence based care. Consumers are well aware of the possibilities of hospital errors and quality care and have become...
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...Within the last decade, healthcare has transitioned from a time when each separate discipline existed with its own specific task to one where multi-disciplinary teams now work together to provide complex care to individuals with increasingly complicated co-morbidities while attempting to meet regulatory requirements, addressing best business practices and ensuring that they receive optimal reimbursement for services rendered.(Roussel, 2013, p. xvii)Click and drag to move Regulatory requirements in healthcare are overseen by many managing entities, such as the Centers for Medicare and Medicaid Services, the US Department of Health and Human Services, The Food and Drug Administration on a federal level. Hospital accreditation agencies include...
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...The Future of Nursing: Leading Change, Advancing Health Grand Canyon University: NRS-430V July 27, 2014 The Institute of Medicine (IOM), established in 1970 was created to inform the nation on healthcare issues. The reports and findings of this group assist the divisions of healthcare in making knowledgeable decisions. The Robert Wood Johnson Foundation together with the IOM issued a special report called “The Future of Nursing: Leading Change, Advancing Health” There are four key messages the IOM focuses on: Nurses should practice to the full extent of their education and training, nurses should achieve higher levels of education of education and training through an improved education system that promotes seamless academic progression, nurses should be full partners with physicians and other health professionals in redesigning healthcare in the United States, effective workforce planning and policy making require better data collection and an improved infrastructure (IOM, 2010). The IOM recommends that by the year 2020, 80% of all nurses have a Bachelor of Science in Nursing (BSN). To achieve this recommendation, the nursing profession must decide that a BSN would be the entry-level into practice. There are multiple ways to achieve a nursing degree from Diploma, Associate Degree to Bachelor’s Degree. Students who have a four year degree in another field of study can easily obtain a nursing degree in an accelerated second degree bachelor’s program. Patient...
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...Shriners Hospital Healthcare Delivery System Imagine a child experiences a traumatic event such as a house fire sustaining life-threatening injuries or develops a musculoskeletal disorder and may not walk again. Where would one go with a child such as this? A child that would need an individualized care plan catered to meet his or her needs without financially crippling their family and incorporating them in the healing process. A place of such magnitude and offers multidisciplinary services does exist and that place is Shriners Hospital for Children. Shriners Hospital, founded in 1922, aims to achieve optimum health for its patients by helping each child become healthy and independent. Through its broad range of medical and rehabilitative services, it accomplishes this goal through treatments, surgeries, and therapies in orthotics, prosthetics, occupational, and recreational. To deliver exceptional care, its healthcare delivery structure and the many factors that affect it contributes to its weaknesses and strengths as a non-profit healthcare provider. The following addresses Shriners Hospital healthcare delivery system, the economic, licensing, and regulating factors, trends affecting the industry, and pricing dynamics it encounters. Health Care Delivery Structure Health care delivery structure is the system through which a healthcare organization provides health care services that met the heath needs of the targeted population. The healthcare delivery structure...
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...Regulatory Agency Regulatory agencies ensure health care practitioners and facilities promote safety, legal compliance, and quality patient services. If health care were not regulated of if accreditation were not required patients would not have a sense of comfort and safety. The regulatory agency the Joint Commission on the Accreditation of Healthcare Organizations commonly known as JCAHO, which “conducts periodic on-site surveys to verify that an accredited organization substantially complies with Joint Commission standards and continuously makes efforts to improve the care and services it provides” (The Joint Commission, 2010, p. 3). The JCAHO ensures that health care providers and facilities are maintaining the required standards of care in place by the regulatory agency. JCAHO is constantly improving the quality and safety of care provided in any health care facility. History of the Joint Commission of Health Care Organizations In 1910, Ernest A. Codman, M.D., found that many health care practitioners were practicing medicine that was outside their scope of training. It was then that he “proposed the end result system of hospital standardization. Codman thought that if hospitals were to track every patient and the patient were treated long enough it could be determined whether the treatment was effective and use the results to improve care” (2010, A Circular Century, p. 26). In 1913, the American College of Surgeons (ACS) was established and by 1917, the...
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...strong today3. Over time many of these chemical companies moved into the production of pharmaceuticals and other synthetic chemicals and they gradually evolved into global players. The introduction and success of penicillin in the early forties and the relative success of other innovative drugs, institutionalized research and development (R&D) efforts in the industry 4. The industry expanded rapidly in the sixties, benefiting from new discoveries and a lax regulatory environment. During this period healthcare spending boomed as global economies prospered. The industry witnessed major developments in the seventies with the introduction of tighter regulatory controls, especially with the introduction of regulations governing the manufacture of ‘generics’5. The new regulations revoked permanent patents and established fixed periods on patent protection for branded products, a result of which the market for ‘branded generics’6 emerged. 2. Environmental Analysis (PEST) Technological advancements, tighter regulatory-compliance overheads, rafts of patent expiries and volatile investor confidence have made the modern pharmaceutical industry an increasingly tough and competitive environment. Below is an analysis of the structure of the pharmaceutical industry using the PEST...
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...Health Law and Regulations Paper Veronica Jenkins HCS/544 May 26, 2014 Professor: Kelly Gantt In the health care industry, regulations play an important role “Through various regulatory bodies, the Department of Health and Human Services (HHS) protects the public from a number of health risks and provides programs for public health and welfare” (fiercehealthcare.com). Implementing these two helps protect health care agencies and also regulate public health on every level. “The Centers for Medicare and Medicaid (CMS), founded in 1965, oversee most of the regulations related directly to the healthcare system” (fiercehealthcare.com). CMS provide numerous programs through the government. The health care industry has numerous regulations in healthcare. One example of laws and regulations facing health care is HIPPA. The transformation from paper charts to electronic records raises a great concern in the breach of security. “In addition, interoperability of systems is expected to create yet more breaches, as information is traded between networks. Laptop theft is the most common type of data breach, accounting for 24 percent of reported breaches, according to HHS. Desktop computers were involved in 16 percent of breaches and portable devices such as smart phones were involved in 14 percent” (beckershosiptalreview.com). Human and Health Service (HHS) require individual to notify patients when their information was breach. “The regulations, developed...
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...Dimensions of Quality in Healthcare Presented by: Connie Kirkpatrick, PhD, MS, RN Franciscan Health System Tacoma, Washington Quality Basics Series Taught by quality experts for staff in Quality Improvement Organizations, Quality Basics focuses on the fundamentals of quality in areas such as the history of quality improvement, methods and models, performance measurement and other key topics. 1 Quality Basics Dimensions of Quality in Healthcare Connie Kirkpatrick, PhD, MS, RN Director, Quality & Clinical Support Franciscan Health System, Tacoma, Washington Question from a seminar participant: “I can see that it must work in practice. But does it work in theory?” 2 Dimensions of Quality Learning Objectives Define Quality Define Quality Improvement Describe six key “Dimensions of Quality” Describe seven key “Pillars of Quality” Quality Institute of Medicine: “Quality of Care” is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Institute for Healthcare Improvement (IHI): Quality is turning into outcomes management, and involves minimizing unnecessary variation so that outcomes become more predictable and certain. 3 Quality Basic Principles: All work is a process The process is the main source of quality defects (versus human error) Understanding variability in processes is the key to improving quality Quality Improvement ...
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...1. Introduction What is the goal or the idea behind risk management one of their focus is to reduce the financial risk other areas that may seem not important is the regulation. One of the principal issues facing health care risk management is governmental regulation. Over the last few decades, there has been a growing public demand for accountability in health care delivery. The consequent tightening of governmental regulation has led to a greater allocation of an organization's resources to regulatory compliance. Some states, including New York, enacted stringent incident reporting requirements for hospitals, requiring additional staff to investigate and prepare such reports. Additionally, competition among hospitals has also fostered a greater concern over the community's perception of quality of care. Many hospitals have had to compete harder for patients as inpatient lengths of stay decrease and more procedures are performed on an outpatient basis. Risk management in the health care In the past risk management and quality improvement job was separate in the health care organization. Even though, the job function may have been different the goal was the same. Managing risks is the quality of services provided & the safety of patients, their careers & visitors. To manage risks to staff & subsequent risks to service quality. To manage risk of failing to meet national & local priority targets to manage risks to the efficiency of services...
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...Prison Healthcare Healthcare is a big topic no matter how you view it, but when looking at it from the point of a person who is in prison, it takes on a whole new view. Those who are in prison have federal and state laws that say that the prisons must provide them with medical facilities for their healthcare needs. This paper will identify a governmental agency that regulates the healthcare that is provided to prisoners in an institution within the United States, along with the foundation of such an agency and who regulates the licenses, accreditation, certifications, and authorization for employment for those who work within one of these facilities. The Federal Bureau of Prisons The Federal Bureau of Prisons (BOP) is an agency that was created on May 14, 1930 and approved of by then president Herbert Hoover. Its main headquarters is in Washington, D.C. The BOP is a subdivision of the United States Justice Department and is responsible for the administration of the federal prison system. Its sole purpose is to provide more open-minded and compassionate care to those who are federal inmates within the United States prison system. This agency is also responsible for providing medically needed health care to inmates in agreement with federal and state laws. One of the most negative aspects that the BOP is responsible for is carrying out all judicially mandated federal executions, including the lethal injection of inmates who have been sentenced to death for a...
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...actionable responses and in so doing allow a structured framework for defensive or offensive actions. The Pharmaceutical Industry environment is an ethical drugs industry aimed at providing beneficial products and services for human consumptions as well as chemical medicaments and biotechnology. The 21st century has brought about changes within the pharmaceutical industry. The pharmaceutical industry today is highly competitive non-assembled global industry. To define the non-assembled aspect of the industry is where manufactures components parts or materials are relied on for example glass, woodwork and chemicals. It was in the sixties and seventies that the pharmaceutical industry was to expand rapidly as it was a period referred to as the spending boom. Research and development (R and D) was also a major investment and trust which was provided for Universities and education institutions. Pencillin which was the major discovery in the pharmaceutical industry in the 40’s, which led to research and development in the 50’s becoming firmly established in the industry the seventies, saw many remarkable changes within the pharmaceutical industry with tighter regulatory controls being enforced within the industry. This could be seen in the way generics were to be manufactured, generics are medicines that are manufactured after patent expiry date by...
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