Tuesday, August 25, 2020

Laboratory Kerfuffle

Navigating a global pandemic had been going smoothly for the NFL. The positive test rate was ridiculously small, less than a single percent. The players were doing great. They were respecting their teammates, their families, their teammates' families, their community, and the rules that were put in place. Like the fans of football, the players want a complete season. The best way to have a season is to be smart, wear a mask!, and do what needs to be done. The smooth sailing hit rocky waters this past weekend when 77 tests from 11 teams came back positive. The Minnesota Vikings were one of those teams and had 12 of the positive tests.

Eight players tested positive.
Eric Kendricks
C.J. Ham
Ezra Cleveland
Jalyn Holmes
Alexander Hollins
Dillon Mitchell
Kenny Willekes
Nakia Griffin-Stewart

One coach tested positive.
Ryan Ficken

As well as three staff members.

Mike Zimmer was planning to run the team through the first game-like situations of training camp on Sunday. He was going to put his young team through two simulations of the last 10 minutes of the fourth quarter. Real hitting, live play-calling, real-time stuff. For a season without preseason games, this was a very significant practice. Zimmer was now going to have to do this without his starting middle linebacker and fullback as well as six players that he probably wanted to see. Seeing as he already knows what he has in Kendricks and Ham, this practice was likely more important for the six youngsters, especially rookies Ezra Cleveland, Kenny Willekes, and Nakia Griffin-Stewart.

Instead of seeing a full-team practice, Zimmer was forced to put his team through a medical and availability scramble drill and a practice without eight players. As the coach said when grilled on the situation by the media during a Zoom conference call, it was better that it happened now than during the season. It was a learning experience. 

It turned out that it was much more than a learning experience. The whole thing was a laboratory kerfuffle from the start. BioRefence Lab should've known that there was a problem before they threw 11 teams into disarray. I've worked in an analytical lab for over 30 years. I've worked on the chemistry side of testing rather than biology but the only real differences between the two are the reagents and instruments used. BioReference Lab has the COVID testing contract with the NFL. I imagine that it's a real sweet contract for them. I'm sure that being able to sample, analyze, and return results in less than a day was what sealed the deal. Seriously, collecting thousands of sample from all over the country, getting the samples to only five labs, preparing and analyzing the samples, returning results within 24 hours, and repeating the process every single day is a remarkable accomplishment. It really is. Still, they should not have reported the 77 positive results last weekend. There were too many things that should've raised doubt about those results. This sort of testing is all about reliability and accuracy. It's more important than the quick turnaround of results. What good is a quick result if it isn't accurate? There were red flags all over those 77 positive tests. Here's what BioReference Laboratories had to say about their laboratory kerfuffle. 

“On August 22, BioReference Laboratories reported an elevated number of positive COVID-19 PCR test results for NFL players and personnel at multiple clubs. The NFL immediately took necessary actions to ensure the safety of the players and personnel. Our investigation indicated that these were most likely false positive results, caused by an isolated contamination during test preparation in the New Jersey laboratory. Reagents, analyzers and staff were all ruled out as possible causes and subsequent testing has indicated that the issue has been resolved. All individuals impacted have been confirmed negative and informed.”

Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories

So, according to Dr. Cohen, the New Jersey laboratory experienced contamination during test preparation but reagents, analyzers, and staff were ruled out as sources of that contamination. Seeing as reagents, analyzers, and staff are the only ways to contaminate a sample in the laboratory, how were these samples mysteriously contaminated? On a conference call with NFL reporters Monday afternoon, Patti Walton, an independent medical adviser to the league who is also director of laboratory services and occupational health at Williamson Medical Center in Tennessee, was more helpful than Dr. Cohen. Walton said that BioReference performed a root cause analysis of this weekend’s errors to determine where the contamination and testing failure may have originated. The belief is this weekend’s contamination occurred as genetic material from PCR testing swabs was transferred to the analyzer machine for testing. Dr. Cohen, that would make staff the source of the contamination. With the minute amounts of sample being handled it doesn't take much of one little thing to contaminate a whole bunch of things, like a sweep of the samples sent from 11 different teams. Mistakes happen everywhere and anyone can make them. Even in labs. The key is recognizing those mistakes before they become even bigger mistakes. Red flags should've been flying all over BioReference's New Jersey lab Saturday night. The league's pristine testing record through several weeks was one reason to question a sudden explosion of positive tests. Seeing the explosion at only one of BioReference's five labs is another. Don't these labs communicate? 11 of the NFL's 32 teams were hit with these positive tests and all 11 were tested in New Jersey. These positive tests should've been seen as probable false positives immediately. The samples should've been re-analyzed before the positive test tally hit 20. One or more of the lab's staff caused the contamination but the real mistake was made by those that reported suspicious results. Having worked in analytical labs for as long as I have, I've never understood how labs let this sort of thing happen. Hell, it doesn't take 30 years in a lab to know that this wasn't handled properly. The analysts should've been suspicious of the results. The supervisors should've been suspicious. The lab managers should've been suspicious. Dr. Cohen should've been suspicious. Those false positive results should never have left the building without confirmation. And Mike Zimmer should've been able to put the entire team through two fourth quarter simulations on Sunday. 

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