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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

Overview: In this webinar, Hope will present the lessons she's learned over her career as a grant writer and editor in medical research. By identifying simple solutions to common problems, participants will learn tools to improve their ability create competitive grant applications and increase their academic and research productivity. To write compelling grant applications, this webinar will cover: How your choice of words will help you stay within page limits without compromising the science How to minimize abbreviations to improve readability and respect reviewer time constraints How to use Microsoft Word efficiently to improve page layout and readability How to manage references by enlisting online databases and reference management software How and when to stop developing the content to meet both grantor and institutional deadlines Why should you Attend: Many Grant Writing workshops do not teach writing per se. Though useful for beginning grant writers, most focus on understanding the application process and the various sections of a grant. For participants wanting to learn to actually write a grant, they are often left to figure out the technique for themselves. In addition, funding opportunity applications (FOAs) have changed quite rapidly in the past few years and require more focused writing in fewer pages. Competition has increased as budgets have shrunk, and knowing how to make the most out of both the time and the length of a grant project can prove challenging and extremely stressful. This webinar is for both new and experienced grant writers, either scientists and principal investigators or writers and other support staff. By using common resources (MS Word, EndNote, PubMed), the webinar content is designed to help grant-writing teams increase their efficiency in the writing process and also meet the requirements of the FOAs. Plus, plain language and good writing practices taught in this webinar will ensure straight-forward, content-rich, and well

Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts.

Scientific medical writing involves writing detailed information about the basic medical sciences, drugs and latest technological innovation in the field of medicine for a range of audiences including medical specialists and health care professionals. This scientific information is written for publication in the medical journals, medical news, and regulatory documents. Contact us at : IND:+91 8754446690 US:+1-972-502-9262 UK:+44-1143520021 info@pepgra.com www.pepgra.com

Pepgra offers global regulatory and clinical writing services. The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies. Contact us at : IND:+91 8754446690 US:+1-972-502-9262 UK:+44-1143520021 info@pepgra.com http://pepgra.com/what-we-do/global-regulatory-clinical-writing-services/

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

Course "New HIPAA Audit and Enforcement Activities: Being Prepared to Show your Compliance " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: * History of HIPAA * HITECH * HIPAA Omnibus Rule * How to perform a HIPAA Security Risk Assessment * What is involved in a Federal audit and how is it conducted * Risk factors for a federal audit * How to avoid a Federal audit * Business Associates and HIPAA audits * EHR and HIPAA * Business Continuity/Disaster Recovery Planning * Assessing your contractors and sub-contractors * In depth discussions on IT down to the nuts and bolts * Risk factors that can cause an audit (low hanging fruit) * New rules which grant states ability to sue citing HIPAA on behalf of a patient * New funding measures Why should you attend : The evolutions of this enigmatic law and how what was once relative benign in terms of enforcement is now fully funded and aggressive. Learn what you can do to be prepared for an audit and how to lower risks of ever being audited. It is absolutely imperative that you are proactive and not reactive with your compliance program, this is a necessary evil and you need to protect your practice or your business and limit risks from the imminent Federal audits. Join me in keeping up with this very confusing law and take advantage of all the templates and information provided as part of the seminar. Areas Covered in the Session: * HIPAA -Brief History * HIPAA Privacy Rule vs HIPAA Security Rule * HITECH Act * Breach Notification Rule * Omnibus Rule and audits * Business Associates and audits * Current Court Cases (precedence) * Paper Based PHI Concerns and how to lower risk

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

Course "Internal Auditing for the Medical Device Industry" 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 provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

Consumption of salt, it states both the positive and negative sides of salt and adds some research reports to add more impact to the writing

Consumption of salt, it states both the positive and negative sides of salt and adds some research reports to add more impact to the writing

Overview: As the healthcare industry moves toward a value based reimbursement model rather than fee for service, it is crucial that the provider and ancillary staff understand how ineffective reporting can lead to dollars lost. We will review the 3 critical areas that require skilled management. Understand that patients are more educated about their healthcare and are increasingly responsible for more out of pocket costs. High dollar deductibles may result in self pay realities and bad debt increases. Learn areas that increase your chances for an audit. Are you ready for the challenge? Why should you Attend: Revenue is dependent upon proficiency in multiple areas. In today's environment, it is risky to maintain the status quo and increasingly important to obtain and maintain skilled business staff. The granularity of the ICD-10 code set requires understanding of the official coding conventions and guidelines, the ability to apply those guidelines, and the ability to recognize when reporting may lead to revenue delay, reduction or loss. Additionally, other factors affect your revenue stream. This includes patients with high deductible plans, collection of much more than a small co-pay, and staff understanding of regulations that govern telephone collection activity. Don't leave money on the table or invite an audit into your practice. Audits are often the result of weak billing and coding skills. This program will review several areas that will cost you money if poorly handled. Areas Covered in the Session: Required specificity in coding Documentation necessary for ICD-10 reporting Why coders must frequently query for clarification How ambiguous diagnosis reporting affects you r bottom line Internal collections versus outsourcing. What should you consider Staff effective in handling problem claims? Developing appeals? Who Will Benefit: Coders Billers Revenue cycle Physicians Mid-level providers Nurses Claims follow-up Managers Managers Speaker Profil

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

Overview: Many medical entities are increasingly struggling to manage revenue effectively. Self pay is on the rise due to high deductibles. Bad debt is increasing. What is your plan to manage these areas? Staff trained in denial management? Variances? Are they handling these areas in a timely manner? Payers have time limits in which dollars can be salvaged. Missing those strategic times mean dollars lost. Don't leave money on the table. We will discuss multiple avenues in which strong training and timely action can equal $$$. Why should you Attend: Don't lose hard earned revenue. Learn tips to strategic follow up, when and how to manage the appeal process. Is the claim appealable? Partial payments and why? Today's industry of high dollar deductibles create the necessity to expend additional efforts on self-pay accounts. There is a significant difference in collecting small co-pays and managing large balances. Bad debt creep? What is your plan for managing these areas? Areas Covered in the Session: Hire the right staff - Then engage in ongoing education Variances and denial management Billing compliance Coding for specificity, co-existing conditions and correct modifiers Supporting medical necessity CCI edits and unbundling Productivity Claims follow up Payer processing edits Additional development requests Handling problem claims and appeals Who Will Benefit: Coders Billers Revenue cycle Physicians, mid-level providers Nurses Claims follow-up Managers Speaker Profile Dorothy D. Steed is an Independent Healthcare Consultant and Educator in Atlanta. She was a Medicare specialist for a large hospital system and a physician coding audit supervisor for another hospital system, with 38 years of experience in healthcare. Additionally, she is an instructor at a state technical college in Atlanta, provides auditing & training in both facility and physician services, and has been a speaker at several healthcare conferences. Ms. Steed has written articles for

The Physician Payment Sunshine Act: The Physician Payment Sunshine Act, also called Physician Payments Act, is a piece of legislation passed by the American Congress in 2010. It came to be enacted along with the Affordable Care Act, or Obamacare. The purpose of this legislation is to ensure transparency in the financial relationships that exist between the pharmaceutical industry, teaching hospitals, and physicians. What the Sunshine Act requires is this: Manufacturers of drugs and medical devices, and organizations that purchase in groups (Group Purchasing Organizations or PGO's) have to report payments or their equivalent that they make to physicians and teaching hospitals. Items that are considered equivalent to money payments, transfers of which have to be reported are clearly mentioned. These include the following: Meals Honoraria or grants Gifts Entertainment Speaking fees Writing services, such as research papers or manuscripts Travel reimbursements Purchase of items such as teaching materials and journals, which are paid either directly to physicians or teaching hospitals, supplied either directly or through a third party Funding for research Another core reporting requirement: Another requirement of the Sunshine Act is that when manufacturers of drugs and medical devices and group purchasing organizations have physicians who have a stake in some or another form in their organizations; this has to be reported to the Centers for Medicare and Medicaid Services (CMS). These reporting requirements apply to all kinds of physicians, who are either specialists or are general practitioners. However, the following are excluded from reporting by the Sunshine Act: Nurses Support and office staff Residents Medical students Physicians assistance Advance practice nurses Physicians need not report: The Sunshine Act requires information about these payments and transfers to be made by the paying medical device and drug companies, and not by physicians.

Overview:   Review 6 points of high quality evidence based clinical documentation Review of 7 criteria that all entries in a patient record should include Impact of documentation on coding and claims Impact on audits and ability to defend an audit When an audit is initiated, the completeness of documentation becomes critical in the ability to support what you have reported. Let's take a look at areas in which weaknesses are often found.  Why should you Attend:  The granularity and accuracy of the ICD-10 code set is supported by quality clinical documentation. It is anticipated that payers will increasingly become less flexible in allowing non-specific codes. The use of unspecified codes will likely lead to rejected claims if it is possible to report the more definitive condition. In most cases, unspecified should not be reported unless there is clear evidence to support the inability to report the detailed option.  Is your E & M level supported in the documentation? If you have never experienced scrutiny of your billing patterns by payers and other entities, you may not be aware of weaknesses that lead to recovery of funds or other costly consequences. Your documentation will be key in supporting diagnoses, service codes and acuity of the patient. It is not just payers who engage in audits. Others include State medical boards, Qui Tam and possible reporting of questionable practices by patients. Do your billing patterns and documentation stand up under reporting scrutiny? This presentation will review areas in which you may not be as strong as you think!  Areas Covered in the Session: Significance of abnormal lab results Measurement of lesions, when taken and inclusion of margins Start & stop times & methodology for infusions & discrepancies in billing Diagnostic testing and medications should be supported in a diagnosis Depth of wounds and cause should be clear Severity of illness Diagnosis present on admission? Who Will Benefit: Coders Billers Rev

Its a pleasure for me to write this testimony about how i got my Genital Herpes cured a month ago. i have been reading so many comments of some people who were cured from various diseases by Dr. Edes, but i never believed them. I was hurt and depressed, I was too curious and wanted to try Dr.Edes, then i contacted him through his email (dredeshome@gmail.com) when i contact him, he assured me 100% that he will heal me, i pleaded with him to help me out. My treatment was a great success, he healed me just as he promised. He sent me his medication and ask me to go for check up after 14 days of taking the medication. i agreed with him and i took his medication and went for check up, to my greatest surprise my result was negative after the treatment, i am really happy that i am cured and healthy again. I have waited for 3weeks to be very sure i was completely healed before writing this testimony. I did another blood test one week ago and it was still Herpes negative. so i guess its time i recommend anyone going through Herpes HSV-1 or HSV-2, HIV, HPV, Hepatitis B, Diabetes, Cancer should reach him through his Email dredeshome@gmail.com OR add him on whatsapp +2348151937428. visit his website on; www.edesherbalhome.webs.com

Its a pleasure for me to write this testimony about how i got my Genital Herpes cured a month ago. i have been reading so many comments of some people who were cured from various diseases by Dr. Edes, but i never believed them. I was hurt and depressed, I was too curious and wanted to try Dr.Edes, then i contacted him through his email (dredeshome@gmail.com) when i contact him, he assured me 100% that he will heal me, i pleaded with him to help me out. My treatment was a great success, he healed me just as he promised. He sent me his medication and ask me to go for check up after 14 days of taking the medication. i agreed with him and i took his medication and went for check up, to my greatest surprise my result was negative after the treatment, i am really happy that i am cured and healthy again. I have waited for 3weeks to be very sure i was completely healed before writing this testimony. I did another blood test one week ago and it was still Herpes negative. so i guess its time i recommend anyone going through Herpes HSV-1 or HSV-2, HIV, HPV, Hepatitis B, Diabetes, Cancer should reach him through his Email dredeshome@gmail.com OR add him on whatsapp +2348151937428. visit his website on; www.edesherbalhome.webs.com

The sabbatical is "a break from work" during which employees can pursue their interests, like traveling, writing, research, volunteering, or other activities (or even rest). During that time, the employee is still employed at their organization, but they don't need to perform their normal job duties or report to work. Well-being sabbatical applies to each employee as per the different policies for different organizations however with one common factor of being paid for the entire period of the sabbatical attaining more productivity and mental/physical wellbeing.

Finding solutions to bring those worry-levels down for healthcare professionals can put an end to burnout and improve the quality of care altogether. Physicians are as humans as us, and in this article, we discuss ways in which they can deal with guilt and shame when they fail to complete their tasks of the day.

P3care Solutions has its finger on the pulse of healthcare, at least that's what we intend to achieve. The topic that we chose to write about today has some interesting yet solid statistics of doctors and their time spent on EHRs per patient.

P3care Solutions has its finger on the pulse of healthcare, at least that's what we intend to achieve. The topic that we chose to write about today has some interesting yet solid statistics of doctors and their time spent on EHRs per patient.

The command over medical billing services cannot come without experience and the right expertise in the industry. It is a tip for medical practices to outsource the billing process to professionals for higher optimization and performance.