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Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

Food Safety and Security are two faces of the coin : Food safety and security are two different, but closely related concepts. Although part of the same aspect, they vary in their application and meaning. Both are equally important in ensuring that populations of the world get food that is sufficient and nutritious. Food safety and security are complete without each other. Food safety complements food security, and vice versa. Food safety : Food safety is essentially about the safety of the ingredients that go into food. If food is being sourced from a farm, the food makers have to ensure that the farm has ensured safety standards in producing this food. Food safety is concerned about the amount of chemicals and fertilizers used in production of food. It is also concerned with how much residual pesticide, which could cause harm to humans when the food that is grown using it, is left in the final product, and so on. Food safety is related to and is dependent on factors such as demographics, inputs that go into the cultivation and production of food, availability of water for production of safe food, the use of energy sources in the safe production of food, climate change, etc. Now, food security : Food security, on the other hand, is about more about the food supply chain. When food arrives from the producer to the consumer, it goes through a complex chain that can many times span entire continents. Food may also be sourced and consumed locally. In either case, there is a need to ensure that the points that food travels in and reaches are secure. Ensuring quality throughout : The aim of food security is to ensure that food which travels through many chains and stages should be clean at all these stages. This means that security has to be ensured from rodents and other forms of disturbances at the agricultural fields in which food is produced, then at the granaries in which it is stored, at the routes that it travels, then at the location at which food is pr

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

What is Corporate Governance? In a broad sense, corporate governance can be defined as a set of processes by which corporations are run and administered. These are a collective function of the critical, core decision makers in the organization, such as Directors, CEO, managers, investors, stakeholders, shareholders, creditors, auditors and others. Corporate Governance sets out the methods and rules for making rules that govern corporate entities. Although business is the main concern and task of an organization, Corporate Governance occupies as important a position, because while the financial aspect of a business is all about profits, the Corporate Governance aspect is primarily about its integrity, values and reputation. Corporate Governance takes into consideration all aspects of the governance of the organization from critical standpoints such as ethics, regulatory aspects, policies and mission, etc. History of the growth of Corporate Governance Although Corporate Governance has been around for a number of decades in some or another form, it came to acquire proper shape and direction of late, following the collapse of very big multinationals such as Enron, WorldCom and others. It was felt that their shady dealings, which led to huge losses for their stakeholders and eventually to the businesses collapse, could have been averted if a proper regulatory framework of Corporate Governance were in place. This is the feeling that led to the passing of the Sarbanes Oxley Act, or SOX in the early 2000's. One of the core principles enunciated in SOX related to Corporate Governance. Elements of Corporate Governance As a result of the SOX Act and other legislations in other developed countries, such as the Cadbury Report of the UK and other legislations in the OECD nations; Corporate Governance is now administered through a well-defined set of principles. As a result of these legislations, Corporate Governance is now concerned with the following: Problems areas of Co

Patient Safety in Medical Education A very important aspect of medical education that had been overlooked for a long time is patient safety. When patient safety in medical education gets relegated to the backseat; the result is there for everyone to see: something like close to a 100,000 deaths at the turn of the previous century, according to the alarming results of a comprehensive study carried out by the Institute of Medicine. The tragedy of these deaths is that these were preventable. This reinforces the belief that patient safety in medical education is the core factor, which if handled properly, can save thousands of lives. How does patient safety in medical education come about? It goes without saying that physicians and other caregivers practice in their professions what they learn in schools. So, patient safety in medical education has to be incorporated into the curriculum at the earliest stages. Hospitals, medical colleges and other institutes that impart medical education have now started taking more than mere baby steps in inculcating patient safety in medical education as a core part of teaching, the already heavily burdened curriculum in medical education notwithstanding. Efforts by medical education bodies Following the publication of the IOM report, the American Association of Medical Colleges (AAMC) and the Curriculum Management and Information Tool (CurrMit) in the US and Medical Schools Council and the General Medical Council (GMC) in the UK sprang into action, announcing a slew of measures aimed at bringing about and reinforcing patient safety in medical education. Entire lessons and chapters are devoted to patient safety in medical education. Keywords and technical jargon relating to patient safety are now a highly visible aspect of patient safety in medical education. These are spread across all disciples and subjects of medical education, be it gynecology or anesthetics. What should curricula teach about patient safety in medical edu

Patient quality and safety in healthcare: Patient quality and safety are core aspects of healthcare. They need to be administered and assessed in the backdrop of a variety of factors. Many healthcare professionals see patient quality and safety in healthcare as being part of the broad canopy of healthcare. There is some disagreement and confusion as to the exact meaning of the terms patient quality and safety, but that is only when it comes to semantics. In broad terms, one can understand patient quality and safety in healthcare as efforts and steps and processes meant to improve the quality care given to patients. Patient quality and safety in healthcare relates chiefly to: Improving the safety of patients and augmenting the quality of health care in the various areas of health Bringing about a reduction in infections that are sometimes a byproduct of provision of health care Reduction in the incidence of adverse drug events Quality healthcare, of which patient quality and safety in healthcare are an integral part, is defined as "…doing the right thing, at the right time, for the right person, and having the best possible result" by The Agency for Healthcare Research and Quality (AHRQ). The AHRQ also describes patient safety as "the act of doing no harm", and which "…underlies all aspects of quality health care." Measuring patient quality and safety: Measuring patient quality and safety in healthcare is of utmost importance because no system or practice is meaningful unless it is capable of being measured. The level and success of patient quality and safety in healthcare is measured against the following parameters: How many patients who underwent surgery experienced infections? How many patients were required to be admitted for a second or subsequent time following discharge from hospital because of complications such as infections or recurrence of the problems for which the patient was admitted? To what extent did the healthcare

Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

A Basic Understanding of Shipyard Workplace Safety Shipyard Workplace Safety is a high importance, high criticality area for safety regulation. This is so because shipyards are among the most hazardous of places to work in. it is estimated that at any point of time, the number and incidences of injuries and fatalities in the shipyard industry is at least twice that of the next most hazardous industry, construction. This calls for urgent and important Shipyard Workplace Safety regulations. Present Shipyard Workplace Safety Regulations OSHA has a number of Shipyard Workplace Safety regulations for this industry. These need to be read with CFR Title 29 Code of Federal Regulations (CFR) Part 1915, which not only lay out regulations, but also prescribe codes and methods of implementation of these regulations. Why these two regulations need to be implemented together is that there may be a few hazards not covered by Shipyard Industry standards set out by OSHA. These gaps are covered by the regulations set out in CFR 1915, making these a well-rounded set of regulations for Shipyard Workplace Safety. The need for Shipyard Workplace Safety regulations The need for Shipyard Workplace Safety is acutely felt because of the sheer variety of hazards that present themselves in shipyards. Shipyards, which employ between a few dozen and a few thousand employees each, are a site of potentially serious accidents. Even if accidents do not occur, the very nature of work done at these shipyards can be dangerous and hazardous. Shipyard Workplace Safety is a core requirement that employers in this industry have to keep in mind and put in place. The nature of their work could range from and include any or many of these: Scrapping Demolition Electrical Fabrication Creating large and heavy steel or iron plates, sheets, beams, pipes and related items Soldering Drilling Dealing with propulsion systems Welding Shipyard Workplace Safety has to begin with an understanding of these issue

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analys

Healthcare Rehabilitation is a vast field: The field of healthcare rehabilitation is very vast and expansive. In traditional societies, most commonly relatable to the Orient and Africa, there is the ages-old cultural belief that it is the duty of children to take care of their parents when they age. On the contrary, for us in the west, healthcare rehabilitation has emerged as a specialized branch of healthcare because of the emphasis our society places on independence of the individual. Healthcare rehabilitation is a product of social mores: Younger generations of people are not expected to spend entire years, as may be the case in some families, to look after people of their previous generations who may be in need of medical care. It is on this outlook towards life of our society that healthcare rehabilitation has come into being. However, it is also possible that younger people could also be in need of healthcare rehabilitation. Even such people are put in the care of healthcare providers which offer these services. The divisions of healthcare rehabilitation: Branching out as a fully developed field of healthcare, healthcare rehabilitation has many specializations. These are broadly the areas in which healthcare rehabilitation is offered: General rehabilitation: General rehabilitation of some or another kind is a primary aspect of healthcare rehabilitation. Those in need of this kind of care typically include patients who have lost their ability to carry out day-to-day tasks such as talking, walking, brushing, eating, etc. many a time, depending on the nature of the ailment, rehabilitation could include therapies, exercises and other activities aimed at bringing in some element of mobility in the patient. This kind of healthcare rehabilitation could also include taking care to revive the patient's memory, when patients with diseases like Alzheimer's or Parkinson's are admitted for healthcare rehabilitation. Skilled nursing: An area in which a skilled and

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Elements of an efficient Healthcare computer system implementation Healthcare computer system implementation lies at the heart of a healthcare delivery information system. The processing and dissemination of information in extremely quick time is indispensable to healthcare, given the number of processes that go into the healthcare information system, and the improvement in care this can bring about. A healthcare computer system, which can be described as the ecosystem of a healthcare delivery information system, is thus a critical component, because this healthcare computer system implementation is what decides between the efficiency of a healthcare information system and lack of it. A healthcare computer system implementation should cover all the core areas that are part of a healthcare delivery information system, such as the patient, the caregiver, the medical records concerning the patient, the healthcare organization, and other aspects of administration, such as admission, billing and so on. What goes into an efficient healthcare computer system implementation? An efficient healthcare computer system implementation consists of taking into account all the major elements of a healthcare delivery information system. It should have the ability to synchronize, coordinate and integrate vital data from across departments and systems. An efficient healthcare computer system implementation should also take into account the technologies that go into them. Technologies keep changing rapidly. New ones come into being and render the old ones obsolete in no time. A healthcare computer system implementation has to take into account the nature of these changes, and should implement them in quick time. Technologies and technological tools that are doing the rounds today include the cloud, mobile technologies and the social media. So, a healthcare computer system implementation has to integrate these. In the particular context of the American healthcare system, healthca

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analy

Overview: This webinar provides an overview of the MACRA legislation and developing regulations and guidelines. We'll help you understand how medical practices will be paid in the future for services to Medicare patients. You'll be asked to choose between two paths. If you choose to participate with other providers in an Advanced Payment Model, the larger organization will be paid for services provided and determine how to share those payments as well as any cost savings among the participants. If you choose the Merit-Based Incentive Payment System (MIPS), your payment rate will vary based on how you perform on a variety of Medicare Quality Programs - PQRS, VBM, Meaningful Use and a 4th new component focused on Quality Improvement. You'll want to know as much as possible about the pros and cons of each option and how to make the right choice for your practice. Why should you Attend: Under the MACRA legislation, your providers will need to choose between participating in an Advanced Payment Model (APM) or participating in the new Merit-Based Incentive Payment System. Making the wrong choice can result in significant reductions in your future Medicare payments. You'll want to understand the options and have a plan in place by January 1, 2017 - that's only 6 months away. Areas Covered in the Session: Learn the requirements of the new MACRA legislation and how it will impact your Medicare payments in 2019 and beyond Find out what you need to be doing now to ensure you don't lose Medicare revenue in future years Understand the options - APM vs MIPS - and how your Medicare payments can increase or decrease under each model Identify what aspects of the new payment methodology are written into the legislation, what has been released through proposed regulations and when final rules are expected. Who Will Benefit: Practice Administrators, CEOs, COOs Physicians and all providers who bill to Medicare Quality Officers Nurse leaders Finance Directors Speaker Pro

Construction Safety Orientation Construction Safety Orientation is part of Occupational Safety and Health Administration (OSHA)'s safety initiatives for those employed in the construction industry. Construction Safety Orientation is offered to employers and employees in the construction industry by OSHA or its authorized trainers. Construction Safety Orientation is offered as either a 10-hour or 30-hour course to employees by OSHA-authorized trainers. The aim of the Construction Safety Orientation training is provide training to employees and employers in this industry to help them recognize, abate, avoid, and prevent injuries in the workplace. In addition, Construction Safety Orientation also involves providing training to the employees and employers about their rights and duties at the workplace. s Outreach Training Program is voluntary There are two reasons for OSHA recommends Construction Safety Orientation: OSHA's Outreach Training Program is voluntary; OSHA's Outreach Training Program, being basic, does not provide the full training requirements that the employer has to meet under set OSHA standards. Because of this reason, OSHA's Outreach Training Program is not considered a certification. The need for Construction Safety Orientation The sheer size of the American construction industry is the best reason for the need for Construction Safety Orientation: A little over two percent of the entire American population - something like 6.5 million people are engaged in the construction industry at more than a quarter of a million construction sites across the nation. This perhaps gives some perspective of the magnitude of the tendency for injuries and deaths in this industry. In fact, it is known that construction accounts for the highest rate of fatal injuries among all industries in the US. In a construction workplace, workers could be prone to almost any kind of injury or hazard. According to osha.gov, the most common reasons include: Falls (from heights);

One aspect of rehab that one physician recognized was that patients admitted to rehab were all admitted to the same drug rehabilitation program, regardless of their needs or background…

One aspect of rehab that one physician recognized was that patients admitted to rehab were all admitted to the same drug rehabilitation program, regardless of their needs or background…