Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees.
This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information.
This 6-hour webinar takes the participants through HIPAA compliance from start to compliance.
The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program.
This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs."
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.
This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Human error is known to be the major cause of quality and production losses in many industries.
Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Incident-to coding for your non-physician practitioners (NPPs) services in conjunction with a supervising physician continues to generate confusion- and 2021 will be no exception.
So, it's no surprise that these claims generate higher than average denials, and lead to hefty penalties for physician practices ranging from $163K to $1.5 million - but they don't have to.
In this session Mr. Wolfe will provide an overview of the Stark Law, including its recent changes.
He will also discuss best practices for auditing physician compensation arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
Healthcare reimbursement systems can be complex and difficult to understand. Each pay or may use a different method to reimburse providers, or they may use a variation of a commonly used method. This course will provide a foundation for understanding the common reimbursement systems in use today.
Regular (unencrypted) Email and Text Messaging are effective engagement and communication tools that patients like and have the right to use.
A simple 3 Step HIPAA Safeguard fully protects Covered Entities from violating both HIPAA and the TCPA (Telephone Consumer Protection Act) to ward off expensive TCPA class actions. The Internet is awash with mis-information about Health Care Email and Text Messaging that can lead Covered Entities into serious trouble.
HIPAA Rules generated by the HITECH Act and OCR guidance clearly explain how Covered Entities must comply with a patient's right to communicate by unencrypted Email and Text Messaging. The new HIPAA Rules and a directive from the CMS Center for Clinical Standards and Quality/Survey & Certification Group also clarify when Covered Entities must use encrypted Email and Text Messages when communicating PHI.
This course will cover the proper methodologies on conducting a HIPAA Risk Assessment based on the formula used by Federal auditors and via the guidelines of the NIST (National Institute of Standard for Technologies).
The course will also cover the most important aspects to be aware of in terms of the Federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.
In this session Mr. Wolfe will provide an overview of the Anti-Kickback and Stark Laws and their fair market value and commercial requirements.
He will distinguish between what is legally required, what is a developing best practice and finally, will discuss common misunderstandings and misconceptions related to fair market value and commercial reasonableness in the industry.
This webinar will provide participants with an overview and in-depth examination of compelling documentation issues in behavioral health.
Dr. Frederic Reamer will explore high-risk ethical issues and practical strategies designed to protect clients and practitioners.