From an article in yesterday’s New York Times, “U.S. Regulators Find More Flaws at Plant Where Doses Were Ruined”:
WASHINGTON — Federal regulators have found serious flaws at the Baltimore plant that had to throw out up to 15 million possibly contaminated doses of Johnson & Johnson’s coronavirus vaccine, casting doubt on further production in the United States of a vaccine that the government once viewed as essential in fighting the pandemic.
The regulators for the Food and Drug Administration said that the company manufacturing the vaccine, Emergent BioSolutions, may have contaminated additional doses at the plant. They said the company failed to fully investigate the contamination, while also finding fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.
The F.D.A. has not yet certified the plant, in Baltimore’s Bayview neighborhood, and no doses made there have gone to the public. All the Johnson & Johnson shots that have been administered in the United States have come from overseas.
The report amounted to a harsh rebuke of Emergent, which had long played down setbacks at the factory, and added to problems for Johnson & Johnson, whose vaccine had been seen as a game changer because it requires only one shot, can be produced in mass volume and is easily stored.
Right, “harsh rebuke.” As someone who works in the field–health-care environmental services (EVS), tasked with cleaning and disinfecting health care-related spaces–let me let you in on a little trade secret. If every health-care related facility were put under fine-grained regulatory scrutiny of the kind described in this article, the shortcomings ascribed to this one plant would suddenly become forthcoming just about everywhere you looked.
The question is what inference to draw from that. Horror or resigned acceptance? Or a firm resolve to “do better”? If so, “do better” how? More regulatory scrutiny by the government, or more industry-based self-regulation? Greater transparency to the public, or more discreet work out of the public eye? Greater investment in technology, in labor–or both (but prioritized how)? More worker training by management, or more autonomous worker control?
The one utterly pointless reaction is indignation at this particular occurrence, at this particular facility, by this particular set of players. It’s not a particular occurrence. It happens every day at every facility everywhere. “Shortcomings” don’t magically appear under FDA audits any more than police malfeasance magically appears when it’s caught on video. Don’t confuse the sporadic revelation of a fact with its real-world frequency.
I hate to get all Jordan Peterson on you, but think of it this way: if the average family can’t keep its house immaculate, why expect the average health-care-related facility to be absolutely immaculate? “Because it’s cleaned by professionals.” Right. How, exactly, does that change anything? Who do you think these professionals are, anyway? Mr Clean? Go to their homes, and you’ll find the same messes there that you find in your own imperfect home.
From time immemorial, cleaning staff have been regarded as an afterthought to health care, and to its administration. This is obvious from the way in which they’re managed in health care institutions, and also obvious from the way administrators are educated, recruited, hired, and promoted. No one gets a master’s in health care administration or goes into the field itself thinking, “Damn, I’m going to be the one to professionalize EVS, and fully integrate it into the decision-making and power structure of my institution!” Nor does the average EVS worker go around thinking, “Damn, I’m an applied epidemiologist!” You’d get your ass kicked before you got that sentence out in the average EVS unit. And yet, maybe both thoughts are worth having, saying, and acting on.
A pipe dream, I know. This is how the top health care administration program advertises itself to prospective candidates:
UNC-Chapel Hill offers an executive master of healthcare administration that students can complete mostly online. This program offers working students the opportunity to hone their healthcare-specific leadership strategies, while also creating space for learners to become reflective professionals through methods like journaling, reflection, and hands-on experience.
Shaped around a cohort and competency-based model of education, UNC-Chapel Hill requires students to demonstrate proficiency in a specific competency core before graduation. Students produce a business or technical paper as a capstone project during their last year. Course highlights include advanced analytics, strategic planning and marketing, and health law.
You really think you can get a sense of how to terminally clean an ED, an ICU, an OR, a pharmaceutical facility, or even an ambulance by sitting in front of a computer, poring over “advanced analytics”? Because if you do, you’re the same kind of idiot as the people who run these programs. It can’t be done. But it can certainly be attempted–and is attempted, with predictable results, at every institution in the country.
As long as EVS is an afterthought to every other deliberative consideration in health care–the last priority in the budget, in logistical planning, in the politics of health care itself–don’t expect it genuinely to function as “the last line of defense against infection,” whether we’re talking about hospital-acquired infections, or contamination of the kind that scuttled the vaccinations in the preceding news item. Expect it to limp along as the institutionally crippled creature it is, producing little-noticed casualties along the way.
In a sense, though, the slogans are right: we are the last line of defense against infection, at least in the way that the Maginot Line was the last line of defense against a German invasion of France. But germs, like Nazis, know their way through the institutional equivalent of the Ardennes Forest. And so, germs, like Nazis, find a way to enjoy the equivalent of springtime in Paris. If that analogy doesn’t sober you up, I don’t know what will. But since 565,000 deaths in one year haven’t sobered some people up, maybe nothing will.
The Times item tells us, almost in passing, that workers at Emergent BioSolutions “failed” at this, and “failed” at that. Very convenient. I’d love to have been a fly on the wall at these “failures.” Whose failures were they, really? And in general, whose failures do they tend to be? How did they arise, when, where, and why? Few will ask, because few care: that’s part of the explanation for the failures themselves. EVS politics is not exactly the sexiest topic under the sun. The only people with a vested interest in the answers to such questions are regulators (the FDA, the Joint Commission, etc.), who are paid to find and report on failure–at least when the failures are not their own. But those unasked questions are where the unenacted action is: a matter of life, death, and dirt.
Cleanliness, it’s said, is next to godliness. Too bad Environmental Services isn’t staffed by gods. And too bad it isn’t administered or regulated by them, either.
*Title changed after initial posting.