All Features
Davis Balestracci
Finally, the medical industry is putting aside its “We’re medicine; we’re different” mindset and taking a more practical look at quality improvement. Bravo! Although an element of physician culture remains convinced that improvement is all about outcomes and double-blind clinical trials, the…
The QA Pharm
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask…
American College of Surgeons
The American College of Surgeons (ACS) has set a goal to enlist at least 1,000 hospitals into its respected National Surgical Quality Improvement Program (ACS NSQIP). The commitment is part of the ACS Inspiring Quality initiative, an effort to raise awareness of proven models of quality…
William A. Levinson
Dr. Gary Brandeland’s article, “The Day Joy Died,” which appeared in the Oct. 20, 2006, edition of Modern Medicine, underscores the primitive nature of quality thinking—and more specifically, safety thinking—in hospitals. Although I’m not going to give formal engineering advice about medical…
Bill Kalmar
Sseems the Diet Police are once again running rampant in our nation. It has been said that close to 30 percent of Michigan residents are overweight, and thus there is a movement afoot to curtail our eating habits, not only in that state but also nationally. Believe it or not, there is some…
Davis Balestracci
After reading Joe De Feo’s July 8, 2011, Quality Digest Daily article, “A Positive Prognosis: Transforming Health Care in America,” I took another look at the wonderful book, Escape Fire (Jossey-Bass, 2003), a compendium of Dr. Donald Berwick’s inspiring plenary speeches at the Institute for…
FDA
As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”
The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in…
Joseph A. DeFeo
In the U.S. health care system, quality and safety have developed into strategically important issues. Progress is being made at the local level, even if it is slow and doesn’t get much of the public’s attention. Health care improvement has certainly come a long way since the early 1990s, when an…
Michael Causey
Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification process wasn’t doing so badly (the FDA), or that it was…
Dennis Payton
With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner with the countries exporting the supplies. Perhaps…
The QA Pharm
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.
I have reported before that the FDA…
Don Sayre
There is a new international standard published June 9, 2011, that might just warrant your attention. This standard’s purpose is help organizations follow a systematic approach to improving energy performance, including energy efficiency, energy use, and consumption. It applies to variables that…
ACLASS
Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation
Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow:
The…
Kimberly Egan
I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (FDA) sent a Warning Letter to Jonathan’s Sprouts Inc. informing the company that it was (among other things) marketing its organic mung bean, alfalfa, and broccoli sprouts as drugs. The FDA said it has…
Mayo Clinic
“We can do better” was the underlying takeaway message from the 15th annual Mayo Clinic Quality Conference. This year’s theme was “Creating and Paying for Value in Health Care.”
The conference, held May 3–4, 2011, in Rochester, Minnesota, drew about 1,000 people to hear national leaders in…
Mike Richman
Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief Dirk Dusharme and I also covered this story on the April 29th edition of Quality Digest Live (QDL). QDL, by the way, is our live video show wrap-up of the week’s top industry news and…
Bruce Hamilton
About six years ago I was meeting with a clinical team to kick off an early improvement effort at their hospital. We began with a reflection on the problems with traditional business management practices. To break the ice, I played a short clip from an I Love Lucy episode that has now become a…
The QA Pharm
Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material…
Cor Groenveld
How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…
Mike Chamberlain
According to the National Center for Health Care (NCHC), emergency department (ED) crowding has been a concern in U.S. hospitals for more than a decade. The Centers for Disease Control and Prevention (CDC) report the number of visits to EDs rose 19 percent from 1995 to 2005, even as the number of…
This is one of the first questions that executives always ask me. Because it is a broad question, the answer is often challenging. I usually respond with a few examples that have been gathered in Juran Institute’s 20-year benchmarking practice database, such as Company A is this, and Company B is…
American Sentinel University
Critical care units at St. Joseph’s Hospital Health Center in Syracuse, New York, were faced with a formidable task. They had applied to receive the Beacon Award for Critical Care Excellence, a distinction given only to the top intensive care units in the United States. One of the components on…
Mike Richman
Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which we first launched nearly two years ago. I hope you notice that we’ve added more video content to the newsletter as well as greater editorial…
David Schwinn
“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is certainly true today.
I am in the middle of a sabbatical that requires me to buy and learn to use new…
Laurel Thoennes @ QD
“What makes a personal kanban any better than a to-do list?” asked Julie, crossing out a completed task on her “ta da!” list with exaggerated strokes.
“With personal kanban you visualize your work, it becomes tangible, you get kinesthetic feedback, it’s flexible, contextual, and it promotes…