All Blog Posts (1,471)

The final regulations for the new HIPAA Breach Notification Rule place a far greater burden on Covered Entities and Business Associates than earlier. It is not enough for them to just notify individuals whose Protected Health Information (PHI) have been affected. For them to determine if a breach occurred, they must follow and document a very specific process. Their work does not end here. If no Breach occurred, then documentary evidence to this effect must be compiled and kept for…

The Centers for Medicare and Medicaid Services (CMS) has proposed major changes into the Conditions of Participation for Discharge Planning. These changes will have a profound effect on case management departments, which are now required to put in place a plan of action that addresses the new requirements that will affect their departments. Among the changes that will be made are out-patient discharge planning assessments, 7 days a week/24 hours a day discharge planning, and care…

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment;…

The criticality of risk analysis to HIPAA implementation can be understood from the fact that inability to carry out this activity is the principal reason for which The United States Department of Health and Human Services (DHHS or just HHS) levies civil money penalties on Business Associates and Covered Entities.

This means that Covered Entities and…

With the advent of globalization, the profile and nature of spread of many infectious diseases have changed. Earlier, many infectious diseases were limited to certain specific geographical regions. But this has changed with the emergence of the globetrotter. Additional factors such as globalization of trade and commerce and global warming have contributed significantly to propelling and motivating people to travel more and more all over the world. This trend has brought about a…

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring…

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

It is important to ensure food safety in hospitals

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

Airline and airport management courses are designed for those who want to make a career in the skies. Aviation has always been a preferred choice for a career. The existence of thousands of airports across the US -it has more than a third of the entire world's airports -and the large presence of aircraft for military and logistical purposes are major factors that prepare the ground for a career in airline and airport management. The prelude to a career in this field is to choose the right…

Workplace Safety Regulations :

Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more.

Governments the world…

Project management is one of the core areas of expertise in today’s corporate career. Defined as a temporary allocation of resources to accomplish a defined goal and objective; project management may be considered the building blocks of an organization’s business. Given the importance of project management to any business; it is imperative that the organization implements a set of checks and balances into the whole system of project auditing to ensure that its project management is on track…

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…