All Features
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
MIT News
Moore’s Law predicts that every two years the cost of computing will fall by half. That’s one reason why tomorrow’s gadgets may be better, and cheaper, too. But in American hospitals and doctors’ offices, a very different law seems to hold sway: Every 13 years, spending on U.S. healthcare doubles…
Gallup
Hospitals are facing ever-increasing pressure to evaluate and cut costs. This isn’t surprising. Medical supplies represent as much as 30 percent of an average hospital’s total operating expenses. Regulatory and economic changes, and initiatives such as value-based purchasing, are also pushing…
Michael Causey
School bells have sounded the death knell of summer across the land. But as we’ve noted before, the U.S. Food and Drug Administration (FDA) didn’t take much time off to enjoy surf and sand. The agency capped a busy season last week by issuing a new guidance aimed at investigational review boards (…
Bakul Patel
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse, which…
The QA Pharm
Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of this series, I discussed the management…
Christine Tremblay
Most people are surprised to learn that more than half of small medical practices are still using handwritten paper charts to collect and store demographic and clinical information about patients. Although every medical office has computers, many doctors never touch them.
Other professions have…
Patrick Stone
How often do we see Health Insurance Portability and Accountability (HIPAA) violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large-scale security breaches and, sometimes, reports of illegal sales of electronic medical records by…
Knowledge at Wharton
When you overhear a person five spots ahead of you at the coffee shop ordering a mocha light decaf, no whip, one pump, it might be enough to make you abandon your place in line and walk out. But what if the context is different and what’s at stake isn’t a hand-crafted drink, but your health—or…
John Roth
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4…
Gallup
If you’re a hospital leader, the safety of your patients and your employees might be keeping you up at night. That’s because senior management is accountable for creating and maintaining a safe environment for hospital staff and patients. You’re right to be concerned. Research has shown that the…
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
Harry Hertz
According to a recent PBS report based on information from the Organization for Economic Co-operation and Development (OECD), the United States’ healtcare expenditures are 2.5 times greater than that of the most developed nations around the world. Depending on which report you read, our healthcare…
Matthew E. May
Recently I had a conversation with a friend who was upset about some directional shifts and a looming job shuffle within his company. As I listened to the lament, I recognized that the changes he described focused on the symptoms of the issue. All of his reactions and proposed courses of action…
Davis Balestracci
The 24th Institute for Healthcare Improvement (IHI) Annual Forum took place on Dec. 9–12, 2012. It is probably the leading health care improvement event in the world. I have presented there for 20 consecutive years and watched it evolve from barely 1,000 attendees to well over 5,000. What’s changed…
Margaret A. Hamburg
Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international…
Matthew E. May
I remember when I first discovered the work of Mark Graban. The year was 2008, and I was preparing to speak to the Massachusetts Hospital Association, an audience of about 400 hospital CEOs and administrators. They wanted me to tie my work with Toyota to healthcare, which I had no firsthand…
Jay Arthur—The KnowWare Man
The United States spends $2.5 trillion for healthcare. Healthcare spending is expected to reach $4.5 trillion by the end of the decade. With Obamacare becoming a reality, we need to find a way cut the cost of healthcare to help pay for these increasing costs. The Institute of Medicine (IOM)…
University of Michigan
At hospital shift changes, doctors and nurses exchange crucial information about the patients they’re handing over—or at least they strive to. In reality, they might not spend enough time talking about the toughest cases, according to a study led by the University of Michigan.
These quick but…
Johns Hopkins University
Computational medicine, a fast-growing method of using computer models and sophisticated software to figure out how disease develops—and how to thwart it—has begun to leap off the drawing board and land in the hands of doctors who treat patients for heart ailments, cancer, and other illnesses.…
Gallup
The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country. And as many health systems adopt new strategies to reduce patient readmission rates and improve Hospital Consumer…
Michael Causey
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of…
Tefen Management Consulting
One of the many hidden challenges in hospital systems is to ensure required supplies are readily available and in the right quantity. Significant manpower is invested in material management so that patients receive care without interruption. An optimized supply system that uses modern technology…
Tefen Management Consulting
When a medical institution aspires toward excellence and patient safety, quality enhancement proves to be a key factor essential to the process.
It goes without saying that there are countless risks in the healthcare system, and that it is always a priority to minimize these. There is nothing new…
Institute of Medicine
America’s healthcare system has become too complex and costly to continue business as usual, according to the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” from the Institute of Medicine.
Inefficiencies, an overwhelming amount of data, and other…