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Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use

Tynor Mallet Finger Splint Mallet finger Specially design to correct the mallet finger deformity. Designed to support the dip joint in hyper- extension, while permitting unrestricted movement of the PIP joint. Sleek and convenient. Customizable dorsiflexion. Comfortable cushioning. One universal size. Tynor Mallet Finger Splint Features Coated aluminum body Malleable can be bent and customized Strong, provides rigid immobilization Light weight Ergonomic design Highly practical design to maintain the requisite hyper extension of DIP joint Well ventilated and comfortable Sleek and simple -Better compliance Easy application and removal. Ethafoam lining High cushioning Enhanced comfort Easy to clean and maintain. Inbuilt Hook loop fasteners Close fitting and excellent grip Easy application and removal. Tynor Mallet Finger Splint Measurements Length of Fingers Size Chart - Size Inches CM Universal Below 2-4 Below 5-10

Tynor Cervical Collar Hard Adjustable Cervical Collar Hard Adjustable is used for supporting, immobilizing or adjusting the neck in the flexion, extension, or hyperextension position. Recommended where a rigid immobilization of the cervical region is required. Anatomical shape. Comfortable edge padding. Adjustable height. Slight weight. Latex free. Tynor Cervical Collar Hard Adjustable Features Edge padding by ethafoam Better cushioning and comfort long functional life Light in weight No leaching no allergy Better cushioning and comfort Anatomically designed with height adjustment Ensures perfect fitting Improves immobilsation Enhances comfort Perforated Better ventilation Enhances comfort Better patient compliance. High quality PE Sheet Ensures rigid support Long life of the collar Improves aesthetics. Tynor Cervical Collar Hard Adjustable Measurements Measure distance between edge of sternum and lower jaw with neck in extension position.

Overview: The connection between the Body, its physiology and particularly biochemistry, have been linked to the mind with particular emphasis upon emotions and stress. This can be easily substantiated in common everyday situations. Anyone who has observed a facial red flush triggered by some sort of embarrassment can attest to the foregoing connection. The emotions and stress play a key role in many if not all diseases and disorders: due to the vastness of the subject, we will focus on the application of the mind/body connection(MBC) to skin. This serves as an introduction to the field of psych dermatology which, although still in its infancy in the USA, is expanding as evidence with regard to the psychological component related to the etiology of skin diseases continues to grow. Concurrently, the field of Alternative techniques IN mind/body treatments continue to grow in leaps and bounds providing effective methods for integration with conventional cosmetic and dermaceutical treatment. This provides a dual complimentary pathway both for prevention and treatment of any/most skin disorders. Expanding on this model, we have already shown how the mind influences the body as per the above example. This general proposition can be extended to include specific skin disorders such as acne rosacea psoriasis eczema and atopic dermatitis to name a few. We will concentrate on Acne for the sake of this discussion. First, focusing on the B component of the BMC model, the primary lesion associated with acne is the formation microcomodones, which are small enough to proceed undetected until larger comodones appear later in the cycle. The latter cycle is initiated by peroxidation of squalene and unsaturated fatty acids present in human sebum. This leads to the foregoing lesions and pro- inflammatory mediators such as cytokines and interleukins followed by an increase of p.acnes on the epithelial cell wall together with increased film formation of the p.acnes is the same area This

Overview: Remember spaghetti code? The HIPAA breach area is now almost as convoluted and overlapping and confusing as spaghetti code. Sometimes you think you are both coming and going at the same time when you think through an event to determine if your organization has had a breach. For example: Is a security incident always a beach? Is an ePHI breach a security incident as well? Is a cybersecurity event always a breach? What if it does not steal any clinical information, diagnoses or procedures information, or any payment information? A security incident? Or both? Are all the necessary kinds of notice in the Breach rule? What is Cybersecurity Insurance? Is it really the finger in the dike or itself full of Swiss cheese? Can the loss of patient or member data be a HIPAA breach and identity theft plus a fraud issue? Why should you Attend: HIPAA breaches now number in the multiple thousands, if not multiple millions. Your organization needs to be prepared for the initial sense of panic, a complete investigation, and the federal, state and reputational costs of a mega breach. A breach now costs in money approximately $225/record. And this does not include any fine of any type. The loss and theft of 1000 records may cost you organization from a quarter to $1 M, or more, and 6 months to a year to resolve. You need to know the basics of what PHI and ePHI really are; what puts the event into the breach safe harbor, what breach exceptions keeps the event out of OCR's hands, what the 4 factors are and how they are used. You need to know that your organization's breach plan and your policies and procedures include the need to notify when necessary the police, the FBI and other state and federal organizations beyond the Office for Civil Rights. Your organization needs to know how to protect itself after the fact by considering Cybersecurity Insurance. Areas Covered in the Session: Definition and reporting of a Security Incident Definition of a breach Breach Guidance Br

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

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

A look at disruptive practitioner behavior policies: One of the very important factors needed for a healthcare unit to maintain its decorum and uphold its reputation is the implementation of disruptive practitioner behavior policies. The declaration and implementation of disruptive practitioner behavior policies goes a long way in ensuring that the hospital or healthcare center doesn't lose face. What are disruptive practitioner behavior policies? First, an understanding of disruptive practitioner behavior policies: Disruptive practitioner behavior policies may be termed as the putting in place in a healthcare providing unit a set of policies that are aimed at checking the errant and rude behavior of its staff members towards the patients and other people that use the services rendered by these centers. Who all carry out disruptive practitioner behaviors? Anyone in the healthcare setting can behave in an unbecoming and ungainly fashion with patients or those attending on them. Some of the typical types associated with disruptive practitioner behavior include shouting at them, bullying, intimidating, scolding loudly, being aggressive towards them, gesturing lewdly to them, and so on. This kind of behavior reflects very badly on the healthcare provider. Since there is intense competition in the healthcare providing industry; it is natural for patients to look for other centers when they face this kind of behavior. It is after all human to expect to be treated nicely. If one provider doesn't do that; patients look for other providers. Losing the patient, bad though it is, is not the only loss: When this becomes public, which is all the easier given the extensive reach of the social media; the healthcare unit's name goes for a toss. The role of disruptive practitioner behavior policies It is to curb this kind of behavior that disruptive practitioner behavior policies need to be put in place. Disruptive practitioner behavior policies can go a long way in reining i

Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

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

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Wheeled platforms with specially-molded seating systems interfaced with them for users with a more complicated posture. A molded seating system involves taking a cast of a person's best achievable seated position and the either carving the shape from memory foam or forming a plastic mesh around it. This seat is then covered, framed, and attached to a wheelbase this becomes more of a custom wheelchair then a standard type. Heavy Duty/High Weight Capacity is a collection of mobility products with expanded maximum weight capacities. Heavy duty wheelchairs, bariatric scooters and more, combined with an expert staff. Heavy duty/high weight capacity wheelchairs feature additional crossbraces for support and heavy duty/high weight capacity electric mobility products have stronger motors to accommodate a higher weight. Heavy Duty manual wheelchairs have a reinforced heavy-duty frame that accommodates weight capacities ranging anywhere from maximum weight depending on the chair. Heavy Duty Wheelchair is strongly constructed and offers a high degree of comfort to larger users. As expect from a wheelchair of this quality, the detachable footrests swing away, the armrests flip back, and the backrest can be folded. The frame is as compact as possible whilst still allowing a wide, comfortable seat (available in 20 or 22" seat sizes), and the extra-wide castors are designed to meet the demands of heavy use. Heavy Duty is a quality option for anyone for a self-propelbariatric wheelchair. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Features : Foldable, lightweight frame for easy portability. Steel double cross-brace frame. Adjustable-tension back upholstery. Armrests are padded, adjustable and removable. Adjustable-length controller mount. Adju

Lightweight Ergonomic Wheelchair is designed to cradle patients in comfort while reducing risk of pressure sores, relieving pressure, dispersing weight evenly and improving stability. The Ergo Lite Wheelchair is easy to lift and its small size makes it ideal for travel. Weighing only 19.8 lbs., the chair is easy to store and transport. The chair folds down the middle like a standard wheelchair and the backrest also folds down to make the wheelchair even more compact. Also features companion brakes located on handles for added safety and comfort. Ergonomic Wheelchairs are ultra lightweight and have a supportive seating system to provide pressure relief and anti-slippage giving the user excellent stability and posture support. . Better Ergonomic wheelchair for Comfort: Sit for any length of time in a fixed position in a traditional transport chair and it will feel how painful bad ergonomics can be. It is fully reclined 25° angle, which minimizes slumping and sliding. And because of this can be easily adjusted with the push of a button, it can change positions frequently over time, reducing the chance of secondary conditions that may include pressure sores. Designed to Fit Almost Everyone: It is one of the most extensively researched seat profiles specifically design to accommodate users ranging in size from small women to large men, with the greatest amount of comfort and proper posture/spinal support. The Karman wheelchairs are exceptional in both their function and style. With comfort built right into the frame of a wheelchair eliminating the need for a "thick cushion" to add comfort, S-Shape seat allows the wheelchair to be "ergonomically correct" putting into a seating position and comfort conforming to natural body's curves. These chairs are built for comfort and quality to stand the test of time. Ergonomic Wheelchair is Right: Ergonomic Wheelchair is designed for users who will spend a large amount of time in the chair. This wheelchair'

Cervical Collar Soft Firm Density Cervical Collar Soft (Firm Density) is used for supporting, immobilizing or adjusting the neck in the flexion, extension, or hyperextension position. Recommended where a partial or controlled immobilization of the cervical region is required. Ultimate comfort Effective immobilization Strong support Excellent aesthetics Long life. Cervical Collar Soft Firm Density Features Made of very high density (60 kg./m3) P.U. foam High immobilization, better support , quick relief, no reinforcement, more comfortable, long life. Anatomical design Uniform support to the mandible, Better immobilization, Better comfort Covered with hypoallergenic cotton stockinet Better patient comfort, no allergy or rash even to sensitive skin. Better compliance Perforated collar body Improved ventilation , more patient comfort, better compliance. Fawn colored stockinette Matches skin color, Better aesthetics. Long hook-loop closure tape Ensure snug fitting around neck, easy application and quick removal.

Tynor R O M Knee Brace Prefabricated, custom adjusted R.O.M. Knee Brace controls and restrict flexion/extension of the knee joint through a multi-point joint fixation system to allow a range of motion or immobilization to the knee. Universal design allows it to be used on quite a big range of population and for a multiple orthopedic problems associated with knee joint. Immobilization at any angle Controlled motion between any two angles Quick and easy application and removal. Tynor R O M Knee Brace Features R.O.M. Dial 0 to 120 degree flexion. 0 to 60 degree hyper extention Locking at any angle or motion between any two angles possible Interval of 10 to15 degrees Pleasurable locking, using easy pull mechanism Neoprene Liner with Silicone Coating Enhanced product grip Less slippage of product High cushioning coefficient and more comfort Less discomfort of tight straps Ergonomic Design Light in weight Bilateral symmetrical Improved patient compliance Easy removal and application Universal design, one size fits all Straps with Reverse Buckle Mechanism Enhanced grip Easy to wear Controlled tightening.

Tynor Cervical Pillow Regular Cervical pillow is designed to keep the neck in the slightly hyperextension position at night to counter the stress and strain of the day where we tend to keep the neck in the opposite "flexion" position. It cures the cervical problems while you sleep. Optimal foam density. Scientific design. Plush covering. Resilient PU foam. Tynor Cervical Pillow Regular Features Soft and cushiony, more comfort, good resilience, effective support to the neck and longer functional life. Maintains the neck in slight hyperextension, provides muscle relaxation and proper support to neck. Provides soft feel, good aesthetics and durability. Tynor Cervical Pillow Regular Measurements Measure distance between edge of sternum and lower jaw with neck in extension position.

Tynor Cervical Orthosis Plastazote Cervical orthosis plastazote is an advanced collar with scientific design which ensures complete immobilization on one hand and perfect comfort on the other, It is called as a gold standard in cervical immobilization. Ultimate comfort. Perfect immobilisation. Anatomically moulded. Minimal contact surface. Hypoallergenic. Tynor Cervical Orthosis (Philadlphia) Plastazote Features Pre-formed chin Provides rest to the chin, ensures comfort, improves immobilization. Anatomical and balloon design Offers perfect immobilization, minimal contact of the neck, allows use in burn or trauma patients. Plastazote Light weight, better patient compliance. Non absorbent ensures easy cleaning and maintenance Hypoallergenic, Ensures no rash or allergy even to old age patients Eco friendly manufacturing process Better patient compliance Tracheotomy opening Compatible to use of endo tracheal tube, improves air ventilation. Improves patient comfort and compliance. Two piece design Easy application, firm occipital support, option for varying rigidity. Better immobilization Tynor Cervical Orthosis (Philadlphia) Plastazote Measurements Measure distance between edge of sternum and lower jaw with neck in extension position.