Preventing Needless Hospital Deaths: Q&A With Dr. Ira Williams, Author of "Find the Black Box"

In a nod to the airline industry, a new book out earlier this year by Ira Williams, DDS, calls upon healthcare leaders and policy makers to uncover what causes are plaguing American hospitals and leading to errors and preventable deaths.

"Find the Black Box: The Solution No One Else is Talking About," discusses systemic problems with the industry and how they might be remedied. Here, Dr. Williams, a board-certified oral surgeon and former major in the United States Air Force, discusses his book, the industry and the issue of medical errors with Becker's Hospital Review.

Question: You begin your book by summarizing some of the failures of the healthcare delivery system in America. In particular, you highlight the 1999 Institute of Medicine statistic on preventable hospital deaths — that an estimated 98,000 occur each year in our country — has not improved significantly. In fact, a more recent study actually argues the actual number today could be up to four times as high. Why hasn't more improvement been made in then nearly 15 years since the original report?

Dr. Ira Williams:
First, [Troyen] Brennan and [Lucian] Leape, et al., (1991), were the original source for the estimate of 98,000 NHDs annually that the IOM "To Err Is Human" report relied on almost ten years later. Their study was the primary impetus (in my opinion) for the concerted efforts of the entire quality of healthcare army of experts these past 23 years and counting, and their track record of the annual estimate having doubled during those years speaks for itself.

My contrarian premise is based upon a combination of the following: Our entire healthcare system is, and always has been, devoid of an organizational structure, thus no position of highest authority, and additional positions of delegated authority throughout, necessary for meaningful accountability. Dr. Marty Makary's book "Unaccountable" provides clear evidence of the sad results. Keep in mind that both IOM "To Err Is Human" and Dr. Elizabeth McGlynn, in her seminal Rand Corp. study in 2004, recognized the absence of an organizational structure in that non-system, and every quality of healthcare expert since has passively accepted the absence of that critical element, while never recognizing its absence as a possible source of the huge, needless loss in lives.

Also, the failure of all of the quality of healthcare experts to recognize the two fundamentals of medical care: All medical care is local, and states license doctors. Therefore, each state is responsible to create and maintain a functional healthcare delivery system. The failure to fully recognize and respond to the need for these two different, but inseparable, fundamentals has always been (in my opinion) the missing links in all of the efforts to improve the quality of healthcare and patient safety.

Q: The title of your book references the "black box" within airplanes that help regulators trace the mechanism that led to a crash and improve processes to prevent further failures. However, there is no such thing as a straightforward "black box" in healthcare. Why do you think the reasons the industry has failed to improve medical errors have been difficult to identify?

Commercial aviation black boxes provide the mechanisms that enable fact-finders to more accurately determine the cause of aviation disasters. My black box analogy first used the South Carolina legislature's efforts to reconfigure their state's regulatory mechanism for dealing with DUI investigations and prosecutions. I simply applied similar consideration to the regulatory efforts, or lack there of, regarding the practice of medicine. All 50 state medical examining boards are over 100 years old, yet the practice of medicine has always been (again in my opinion) the least regulated economic endeavor in America.

A major portion of each state medical examining board's mission statement declares the responsibility to "regulate the practice of medicine" in their state. Search any (and every) state medical examining board's Web site and then decide for yourself the degree of success each one deserves. South Carolina has 68 hospitals and 65 surgery centers, and the current regulatory mechanism for meaningful questionable patient care accountability is for all practical purposes non-existent. In fact, as you read the quality of healthcare literature, search for any mention of state medical examining boards, the original source of "medical regulatory authority" in every state for over a century.

Q: You argue the organizational structure of healthcare has led to accountability problems, which have led to continued errors. Could you explain this concept?

I argue that the complete absence of an organizational structure has resulted in a complete absence of positions of delegated authority necessary for meaningful accountability to take place — like that old song, "you can't have one without the other."

Read "Balancing 'No Blame' with Accountability in Patient Safety" by Drs. Wachter and Pronovost in the New England Journal of Medicine on Oct. 1, 2009 (referenced on pg. 107 in my book). Doctors are finally beginning to realize that the public has paid a huge price for their profession's "no blame" nonsense.

Q: Tell us a bit more about the "big tent" structure you advocate in your book. Why do you believe this would alleviate the current problems you highlight?

IW: The "big tent" is phase three of a logical and doable process, but it must follow phases one and two. The quality of healthcare army of experts, along with Congress, federal and state agencies and legislatures, etc., have all been trying to incrementally change a system that none of them can describe in detail and that is devoid of any systematic characteristics. Their efforts have been like putting a Band-Aid on a tumor.

Phase one is based on "Where are we now and how did we get here?" It is focused on the quality of healthcare and questionable patient care accountability. How any state provides questionable patient care accountability is the key to determining the effectiveness of their current "system," and would validate the need for a complete reorganization of that "system."

Phase two is simply an assessment of the findings of phase one and a determination if the current "system" is worthy of reconfiguration. I see no indication any state's current system can be judged to be a keeper.

Phase three, "big tent" phase, would hopefully begin with an opportunity for me to describe my plan for the complete reorganization of a state's healthcare delivery system. My plan will go far beyond anything anyone in healthcare has ever imagined. But healthcare is too enormous for any one person to have all the answers. Still, much of what I would offer can provide the stimulus for others to contribute their refinements. That is why I think the efforts to allow men to walk on the moon and return safely is a good analogy of how it takes the contributions of many to create a modern day healthcare delivery system. I would just like the first opportunity to offer my vision of the first draft.

Think about this, over 150 years ago Semmelweis did not create the facts that hand hygiene and instrument sterilization would save lives. He recognized, tested and proved their life-saving value. Yet his findings were rejected by the medical leadership, first in Vienna, and later in Budapest. And where do we find ourselves now? It is estimated that about 50 percent of all needless hospital deaths today are due to insufficient hand and instrument hygiene, or as Yogi Berra would say. "It's de-ja vu all over again."

Like Semmelweis, I say that since all medical care is local, states license doctors, and every state's medical examining board was created to regulate the practice of medicine in their state over 100 years ago, states must be responsible for the creation of a functional healthcare delivery system for their citizens. The practice of medicine is a scientific endeavor, and true scientific endeavors believe that well-developed offerings should be tested, and not like in the case of Semmelweis, summarily rejected, therefore prove me wrong!

The subject is your healthcare system, your children's healthcare system, and your grandchildren's healthcare system, or what kind of health care delivery system are we going to leave for future generations? So far it is not a pretty picture.

The Picture: The annual rate of needless hospital deaths are estimated to have doubled since 1990 when they first became a nationally recognized major healthcare issue, and not one state can provide specific statistics on how many such tragedies occur within their "regulated system." Needless hospital deaths remain a nebulous statistic while patients continue to die by the thousands, and quality of healthcare experts try to incrementally change a non-system, long recognized as such. The sad fact is that 23 years after Brennan and Leape's original "estimate" of needless hospital deaths, our nation's healthcare system can still only offer highly speculative "estimates" of thousands of patients needlessly losing their lives.

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