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Brownstone Institute - The Rise and Fall of Quality Improvement in America

The Rise and Fall of Quality Improvement in America

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The past four years of the Covid response, by any metric, has been a total disaster, but it fits in with what I believe is the end game of the people who perpetrated this atrocity. My goal is to go from the process utilized to release the Covid mRNA vaccine; to the legal and governmental details surrounding that release, and efforts to normalize these tactics; to the overriding historical context within which all of this occurred, of which the Covid response was a key component; to the academic and philosophical milieu that has brought us to the current state of affairs; leading, finally, to my take on the ultimate end game. I will approach this from a quality improvement (QI) perspective.

A significant part of my healthcare training, knowledge, and experience over the past 50 years involves QI. It has been an integral part of my professional work, including long stints as Chair of the QI Committee at a small rural hospital, and QI Manager at a private not-for-profit community healthcare agency that also engaged in research. With the caveat that many of the so-called “experts” have not acquitted themselves with much distinction over the past four years, I’ll plow ahead. 

The godfather of modern QI activities that have been adopted in all industries worldwide was W. Edwards Deming (1900-1993). He received his BA in electrical engineering, and MS and PhD in mathematics and physics, the latter from Yale in 1928, well before that institution went ‘woke.’ Dr. Deming’s work revolved around a simple premise: There are no bad workers; there are only bad systems. He first took that premise to the Detroit automakers in the late 1940s to show them how they could improve their vehicle manufacturing processes. 

At the time, with Europe and Japan in tatters, Detroit controlled 98% of the entire world’s automobile market, so they passed on Dr. Deming’s suggestions. He then went to Japan, and they adopted his principles completely. It took more than 20 years, but when the first oil shock hit in 1974, Japan was ready with small, reliable, fuel-efficient cars. Detroit, on the other hand, had vehicles like the Ford Pinto, which, due to fuel tank placement, had a tendency to explode when rear-ended, and the Chevy Vega, which was described by one auto magazine as sculptured rust! Japan’s share of the US auto market immediately rose from about 8% to almost 33%, and they never looked back.

Those events sparked a flurry of QI efforts in virtually every industry. It came into the healthcare industry in the mid-1980s as a replacement for quality assurance (QA) programs that had been in place for at least a decade. The major downside of QA programs was that they reacted to problems with the addition of new rules to the point where the system was overloaded with layers of conflicting policies and procedures that did nothing to improve patient care. QI, on the other hand, looked at the systems for delivering care in order to make them more efficient.

This did have a positive impact on patient care, though not nearly as robust as has been seen in other industries. In my opinion, this is because bad workers in healthcare, whether due to incompetence, unethical/unprofessional behavior, and/or corruption, can still do great damage, no matter how good the system in which they work is designed.

Using the foregoing as a jumping off point, I’ll now show the ways in which QI principles and processes were subverted in healthcare in order to push a predetermined agenda. The Covid mRNA vaccine, a Phase 3 research pharmaceutical, was released under Emergency Use Authorization (EUA). In so doing, Institutional Review Boards (IRBs) specifically charged with reviewing, approving, and monitoring all research on human subjects, were bypassed.

As a result, the Nuremberg Code, covering informed consent, the Belmont Report, covering among other elements, bodily autonomy, and the requirement for a data and safety monitoring plan to flag problems as early as possible were completely discarded. These elements of oversight were, in effect, QI efforts even if that term was not in use at the time when they were developed and implemented. 

I have stated elsewhere that if regular order had been observed, proper informed consent would have been done, and millions of people who took the vaccine when it was first available would have refused it. Further, if proper data and safety monitoring had been done, the vaccine would very likely have been removed from the market by the late spring of 2021, prior to even being considered for children under the age of 18. Given that these protections were put in place in response to medical atrocities (the Holocaust and the Tuskegee experiments), you’d think that they’d be sacrosanct. 

In addition, the legality of using EUA in civilian populations is rather tenuous, at best. Most recently, we have new regulations from the FDA that allow IRBs to approve research in some instances without the requirement for informed consent. We could conceivably have a situation where the next pandemic is declared in a neighborhood near you, and a “safe and effective” jab will be recommended (or mandated) that will have an IRB seal of approval, but without informed consent! Given what we’ve seen over the past four years, this is not a welcome development.

In early January, my Brownstone post, Racism, Anti-Semitism, Genocide, and Eugenics in the Covid Era provided an historical context for the Covid response. I sought to show the links between the Progressive movement in the US and Hitler’s Nazi Party, and how the tactics used back then (fear, division, deception, coercion, intimidation, censorship) are alive and well, and have been used to devastating effect over the past four years as the cornerstones of the Covid response. These tactics are diametrically opposed to recognized healthcare QI principles. 

The character deficiencies and ideological flaws that contributed to the current state of affairs were well articulated in Rob Jenkins’ post, The Collapse of Credentialism, and in Bert Olivier’s post, On Wokism and Broken Homes. To me, the key point is that there has been a complete break from QI by a group that Olivier refers to as ‘woke’ progressives. In many cases, they substituted diversity, equity, and inclusion for QI. Unfortunately, this is a pattern that has occurred in virtually every industry, including healthcare. While there remains a remnant of healthcare professionals that has seen through the ruse, and has attempted to adhere to QI principles, many of them have been threatened with loss of employment or licensure, silenced, censured, and/or canceled.

Let’s now take QI principles, and see how they apply to national governance. Based on empirical results (socioeconomic status, freedom of movement, and ability to make life choices), I would posit that the Declaration of Independence, the Constitution, and the Bill of Rights (the foundation of our Constitutional Republic), and the legal and economic systems that flow from those documents represent the highest quality system of governance ever developed by humankind. Or…if you’re a cynic, the US system is the second-worst system ever devised…with every other system of governance tied for first! As such, any QI effort in the realm of national governance would have to demonstrate superiority over the empirical results seen under the current system.

Progressives believe they have a better way, but let’s take a look under the hood. One of the basic tenets of progressivism from its beginning has been that humankind has evolved for the better since the aforementioned founding documents were put in place, such that those founding documents are out-of-date and out-of-touch. 

That premise is alive and well today, as demonstrated by the activities of ‘woke’ progressives; a group that controls academia, the administrative state, the mainstream media, and currently, the White House. Those activities include rewriting the history of our founding (i.e., The 1619 Project); destruction of the cultural and legal systems (through open borders, judicial activism, and a perverse view of social justice that is designed to create a sense of victimhood); destruction of the economy (again through open borders that overload the social services infrastructure, and wasteful spending on the latest “existential threat”); to the ultimate goal of collapsing our founding documents, and then claiming that they have failed. 

In reality, it’s nothing but a self-fulfilling prophecy, but when you control the educational system, you can frame things as you please, and no one will be the wiser. In effect, magical thinking in service of an ideology has swept QI principles aside.

As someone who has been following these developments for almost 30 years, I’ve noticed a change in strategy with regard to attacks on our founding documents. For years, progressive Constitutional scholars would look for subtle ways to end-run the Constitution. Not anymore! 

Today, they are actively trying to bulldoze the Constitution, believing that they have achieved a critical mass of support to carry this out successfully. They may be right. However, if they are successful, the useful idiots who created the critical mass will become nothing but useless eaters, once the progressive goals are achieved, and a totalitarian state is firmly in place. Hopefully, these people will realize before it’s too late that this will not improve their quality of life (QI), and as such, are not good national or individual trajectories.



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Author

  • Steven Kritz

    Steven Kritz, MD is a retired physician, who has been in the healthcare field for 50 years. He graduated from SUNY Downstate Medical School and completed IM Residency at Kings County Hospital. This was followed by almost 40 years of healthcare experience, including 19 years of direct patient care in a rural setting as a Board Certified Internist; 17 years of clinical research at a private-not-for-profit healthcare agency; and over 35 years of involvement in public health, and health systems infrastructure and administration activities. He retired 5 years ago, and became a member of the Institutional Review Board (IRB) at the agency where he had done clinical research, where he has been IRB Chair for the past 3 years.

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