All Features
Dirk Dusharme @ Quality Digest
This past November, three winners of the 2013 Malcolm Baldrige National Quality awards were announced, one in education and two in healthcare. Quality Digest Daily is fortunate that one of the winners, Sutter Davis Hospital (SDH) is practically in our back yard. This gave us an opportunity to meet…
Arun Hariharan
Last week, I accompanied my father to an eye hospital to get his eye examined for a suspected cataract. The hospital examined his eye and confirmed the presence of a cataract. They recommended surgically implanting an artificial lens in his eye—a fairly common procedure these days for cataract…
Gerry Cronin
At GBMP’s recent Northeast Shingo Prize Conference in Hyannis, Massachusetts, the Center for Comparative Medicine (CCM) displayed adaptations of lean to biomedical research in its Community of Lean Lounge. Conference attendees were drawn in by the wacky display of dangerous animals and props, but…
Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
Patrick Stone
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.
International food inspections will surely be a focus area…
Stewart Anderson
A recent news story here in Ontario detailed how health officials were reviewing the results of 3,500 CT scans and mammograms at two Toronto-area hospitals because of potential errors caused by a radiologist’s “performance issue.” Although the results of that review are still pending, the story…
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…
