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Overview: Safe hospital care in neither a science nor an art. It is a practice just like the practice by a doctor who combines hindsight of experience and foresight of imagination to come up with an outsight of the best interventions and best protocols. Over time the doctor standardizes the process but is vigilant to any unique requirements of each patient. Such an approach in patient safety is called hazard analysis and mitigation process. This webinar goes a big step farther. It covers innovation strategies to assure that the safety improvements result in a high return on investment and high value to the hospital, and protects the patients. Why should you Attend: About 400,000 patients die each year from hospital mistakes according to a senate hearing. Evidence based methods to reduce adverse, sentinel, and never events are available and successful in aerospace, nuclear, and chemical industries. Why not use them? We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risks Areas Covered in the Session: The Etiologies of Unsafe Care Sufficient Understanding is a Pre-requisite to Safe Care Preventing "Indifferencity" to Enhance Patient Safety Continuous innovation is better than Continuous Improvement Innovations Should Start with Incidence Reports Hazard Analysis Fault Tree Analysis-the Best Tool for Harm Prevention Doing More with Less is Innovation Re-Invent Quality Management Human Errors may be Unpreventable, Preventing Harm is an Innovation Managing Safety: Lessons from Aerospace Protect Patients from Dangers in Medical Devices The Paradigm Pioneers Aequanimitas,The Best Known Strategy for Safe Care Who Will Benefit: Hospital senior management Hospital administrators Doctors Nursing staff Clinical engineers Radiology staff Infection control staff Patient advocates Speaker Profile Dev Raheja

This article is about marketing for orthopedic surgeons and includes eight specific orthopedic marketing strategies that will help them grow their practices.

Overview: This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. In this webinar Mr. Wolfe will provide an overview of the health care regulatory issues related to implementing value-based physician compensation models. Why should you Attend: Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to value-based physician compensation arrangements, they will need to make sure their arrangements continue to be compliant with the Stark Law. Areas Covered in the Session: Provide a general overview of the Stark Law, Anti-Kickback Statute and the False Claims Act. Explain the requirements for compliance with key regulatory exceptions and safe harbors. Compensation and valuation issues unique to the group practice model Discuss best practices when implementing value-based physician compensation models. Summarize the recent changes to the Stark Law for 2016. Who Will Benefit: In-House Counsel Health Care Compliance Officers Health Care Human Resources Health Care CFOs Health Care executives Speaker Profile Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engi

Clinical Risk Management Lies at the Heart of Patient Safety : Clinical Risk Management is the process of identifying and mitigating risks in a healthcare setting. Risks are inherent in a clinical or healthcare practice, as they are in any other activity. But the field of healthcare has to be doubly wary of risk management because an adverse risk can cause irreparable loss if it leads to an event such as death. To a healthcare organization or practice, a bad event can harm the name beyond repair. How is risk identified? The first step to implementing a Clinical Risk Management is identifying the risks in the practice. This can be done in a number of ways: Why do healthcare providers need to implement a Clinical Risk Management strategy? Healthcare providers need to put in place a very sound Clinical Risk Management strategy for a number of reasons: Steps to putting a good Clinical Risk Management program in place A healthcare organization can put an effective Clinical Risk Management in place through a four-step process: Click Here for More Information: http://bit.ly/1OcHFXm

Overview: The idea of providing health care treatments and insurance coverage according to "medical necessity" determinations seems eminently reasonable. Its obvious ethical thrust is to discourage unnecessary, wasteful or fraudulent practices. As practically implemented, however, "medical necessity" regulations and determinations have proven remarkably controversial and elusive. First of all, the language connected with medical necessity is inherently vague. Language to the effect that a treatment is medically necessary if it is "likely to achieve a significant practical improvement," is "realistic," or "reasonable" will predictably cause disputes between payors and providers of care. Second, the persistence of these disputes calls into question whether evidence based practices have evolved to a point where they are all that reliable and useful. Third, medical necessity determinations incur problems as to who should ultimately make them: payors, health providers or the courts. Obviously, whoever controls the definition of medical necessity controls the flow of health care dollars. While ethical theory can offer important insights about our moral obligations, it remains unable to reliably translate its theoretical principles and rules bearing on harms, benefits and justice into informing medical necessity determinations. Thus, resolving disputes over medical necessity have taken a procedural approach that looks to the interpretation of contractual language in insurance policies, often at the bench of an administrative law judge. This presentation will advance a reasonable set of strategies whereby a convincing case can be made for certain care interventions qualifying as "reasonable and necessary." Why should you Attend: Despite their central importance as a locus for determining reimbursement, "medical necessity" regulations and determinations have proven remarkably controversial and vexing for at least the last 20 years. Yet, whoever controls the definition

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.

Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates. The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations. The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective. The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information. Among other areas to be presented are The required method for individuals to opt-out of receiving fund raising communication The methods of informing patients and clients of their right to opt-out from receiving fund raising communication The broadly expanded types of fund raising communication subject to opt-out rights How providers, hospital, and related fund raising foundation apply an opt-out election by an individual The type of patient and client information that health charities may use for fund raising The contents of provider's Notice of Privacy Practice How clinicians can assist both their patients/clients and the

Autoclaves are also known as steam sterilizers and are used to expose each item to direct steam contact at the required temperature and pressure for the specified time. They are used for healthcare or industrial applications to eliminate the protein structure of the bacteria and spores. Compatible of steam autoclaves for crisis strategy decontamination of N95 respirators is expected to propel growth of the global steam autoclave market. For instance, in October 2020, 3M, a U.S-based multinational conglomerate corporation, announced that Belimed steam autoclaves are compatible for crisis strategy decontamination of specific single-use N95 Respirators. Moreover, launch of biological indicators for steam autoclaves is also expected to aid in growth of the market. For instance, in December 2020, Steris Corporation, a U.S-based medical equipment company, launched Spordex Self-Contained Biological Indicator Ampoules to confirm sterilization of liquids in steam autoclave cycles. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global steam autoclave market. For instance, globally, as of 4:03pm CET, 1 March 2021, there have been 113,820,168 confirmed cases of COVID-19, including 2,527,891 deaths, reported to the World Health Organization. Moreover, high prevalence of hospital-acquired infections is also expected to aid in growth of the market. For instance, according to an observational epidemiological study of intra-abdominal infections published in December 2019, in NEJM Journal Watch, of the 2621 critically ill adults with intra-abdominal infections at 309 international centers between January and December 2016, 32% were community-acquired, while 68% were hospital-acquired. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/emergence-of-covid-19-and-lunch-of-new.html

Struggling with denial management in gastroenterology billing? Instapay Healthcare Services has got you covered! Our specialized strategies help streamline your billing process and minimize denials.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Overview: Have you ever had a student who was excessively dramatic or who repeatedly monopolized discussions in a know-it-all, domineering, or aggressive fashion? Perhaps you've encountered a student who was so odd or anxious that they weren't able to participate in group activities or complete assignments. It's hard to know what to do when a student's personality just seems to take over your class, but you can't just stand by and do nothing. If they are not managed effectively, students with personality disorders take up a lot of time and can move your whole class in counterproductive directions. Sometimes these challenging students have a Personality Disorder, which is a persistent pattern of perceiving, relating to, and thinking about the environment and themselves that is maladaptive, rigid, pervasive, and enduring. Personality Disorders also manifest in the student's emotional response and impulse control and can negatively impact classroom teaching and learning as well as a student's personal and academic success. Unless you are a particular student's psychiatrist, it's not your job to diagnose them as having a personality disorder, but it is helpful to recognize and understand signs of a personality disorder. This webinar will identify different personality disorders and review their common traits and characteristics. You will learn essential tools for dealing with Personality Disorders such as boundary setting, clear communication, and effective classroom management. In addition, you will review relevant mental health resources and when and how to make appropriate referrals to counseling, accessibility services, and student conduct. Why should you attend: If students with personality disorders are not managed effectively, their behavior can have a negative impact on teaching and learning. Areas Covered in the Session: Ten types of Personality Disorders Prevalence and Demographics Developmental issues Common traits and characteristics of Personality Dis

Overview: Final regulations for the new HIPAA Breach Notification Rule require much more than notifying individuals affected by a Breach of their Protected Health Information (PHI). Covered Entities and Business Associates first must follow and document a very specific process to determine if a Breach occurred. If no Breach occurred documentary proof must be kept for six years. If a Breach did occur timely notifications and other actions must be undertaken and documented. This webinar will explain: What Covered Entities and Business Associates must do to comply with the Breach Notification Rule What is and is not a Breach Three exceptions - when an acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is not a Breach How to perform a Breach Risk Assessment to determine if you can demonstrate a a low probability that the PHI was compromised Who must be notified in case of a Breach When notifications must be provided What information must be contained in each notification Other requirements in case of a Breach Investigate Mitigate harm to affected individuals Protect against further Breaches Document everything Planning and preparation for the worst - public relations and mitigation strategies to limit damage to the organization's reputation and financial well-being Why should you attend: Breaches and incidents that might be Breaches happen all the time! More than 173,000 separate breaches of Protected Health Information (PHI) affecting less than 500 individuals were reported to the U. S. Department of Health and Human Services (HHS) between September, 2009 and May 31, 2015 and in the same period HHS received approximately 1240 reports of PHI breaches that affected 500 or more individuals An acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is presumed to be a Breach unless it falls within an exception or the Covered Entity or Business Associate can demonstrate a low probability that the PHI was compromi

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

The entire course of treatment took 10 months to finish. It took another 2 to 3 months for him to recoup from symptom of chemotherapy. He was great when we had another set back in the time of June 2008 in the wake of knowing another tumor developing in Left Lobe of Liver. At that point we began attempting flighty treatment strategies, for example, Ayurveda, Touch treatment, A Medicine Claiming to Cure Cancer, Rituals Believes and Faiths, Cyclotron Treatment, Medicine of D.S. Inquire about Center Banaras and Wave Therapy. Just few of previously mentioned truly helped us to some degree yet none of them truly worked 100% according to their claim. I will go to every treatment techniques independently and give a reasonable assessment in view of my experience. I trust that may help individuals to take educated choice. Also, they can keep away from missteps which we did either because of absence of data or false trust.

"Global Medical Devices Survey 2013-2014" is a new report by ICD Research that analyzes how medical devices industry companies' procurement expenditures, business strategies, and practices are set to change in 2013-2014.

Overview: You need to attend in order to control your own destiny. Get involved up front instead of being a "sitting duck". More Audits are coming and government & private payers are increasing their budgets for increased audit activity around the health care provider industry. The Department of Justice is zeroing in on providers who are aberrant. Private insurance special investigations units are also gearing up and local prosecutors who are hungering for these types of prosecutions are all part of building machinery to eliminate fraud and abuse in the nation's health care system. The concern about the audit/investigative machine that has been developed should create horrendous concern for the health care provider community, because these entities will have to come up with results. Don't become one for their "results". Areas Covered in the Session: Overview of audit risks 14 Strategies to tackling auditors: i.e. Appoint Audit Manager Appoint Audit Committee Proactively seek out info from audit visitors Respond quickly to audit visitor requests Identify On Site control person Provide strong support for onsite control person Onsite control person must be close to the visitors Audit committee to meet daily with visitors Respond quickly to early findings Request feedback from visitors Request Exit conference Carefully review preliminary findings Respond to final report Correct problem findings Who Will Benefit: Health Care Professionals Health Service Providers Compliance Officers CEO's Corporate Attorneys Speaker Profile Joseph R. Batte is president of Kristall Associates, a compliance, and risk assessment specialist for the health care provider community as well as the litigation support community. He is a former special agent with the US Office of Inspector General and participated in the development of that Departments compliance guidance's. He is a nationally known speaker on compliance and has authored the book "Doctors are from Jupiter, Compliance is from