But a little more than a week into summer camp training, as baseball careens toward Opening Day scheduled for July 23, MLB’s testing process has been beset by problems, threatening to undermine the players’ confidence in the safety of competing under these trying circumstances.
Test results, which MLB had hoped to turn around in 24 hours, have in some cases taken more than 72 hours to arrive, forcing multiple teams to cancel workouts. There were reports of at least one false positive and one test being lost, in both cases sidelining a player as the situation was sorted out. And the Utah lab, Sports Medicine Research and Testing Laboratory, subcontracted two weeks ago with a second lab at Rutgers University, with MLB’s blessing, to speed up and streamline the process, according to a person familiar with the testing program.
While most of the problems have stemmed from the collection and logistical part of the process, exacerbated by closures over Independence Day weekend, the overall effect has been to place MLB in damage-control mode over its testing process — a daunting development as the sport seeks to guide as many as 1,800 players and hundreds of additional staffers through a three-week training camp, a 60-game regular season and a full postseason.
If the testing system is flawed, players and others have asked, is it really safe to play?
“If we really want this to succeed, we’re going to have to figure this out,” Chicago Cubs star Kris Bryant said Tuesday on a video conference with reporters, echoing a sentiment others have expressed. “I wanted to play this year because I felt that it would be safe and I would be comfortable. But, honestly, I don’t really feel that way.”
MLB and SMRTL argue their testing program isn’t flawed at all and in fact is as accurate and effective as any in the country despite the early hiccups — which they blamed almost entirely on shipping problems stemming from the holiday weekend. The resulting outcry, they said, obscured the fact SMRTL is turning around more than 95 percent of the samples it receives by the end of the same day.
“You couldn’t put a better protocol together,” said Daniel Eichner, SMRTL’s president and laboratory director.
But the major test for MLB will come in the next two weeks — with some players, such as Los Angeles Angels superstar Mike Trout, still deciding whether to play — and into late July as the sport attempts to launch a regular season with teams playing in their home stadiums and traveling between cities, with players and essential staff tested every other day.
That might not be enough: The Kansas City Royals announced Saturday a positive test for catcher Cam Gallagher — who was asymptomatic and had competed in an intrasquad game the previous night.
“We can’t just crush MLB, because this is new to them, too — the testing facility and what they’ve been able to create,” Cubs Manager David Ross said. “I just urge patience for everybody. I know we’ve talked [to MLB] about that, and they’ve assured me that things are getting on the right track.”
The early delays in receiving test results forced five teams to cancel workouts, including the Washington Nationals, whose general manager, Mike Rizzo, issued a pointed statement saying MLB “needs to work quickly to resolve issues with their process and their lab. Otherwise, Summer Camp and the 2020 season are at risk.”
In a statement Monday, MLB said it collected 3,740 samples from intake screening — which players and staff had to take upon arrival and pass before being allowed into stadiums — between June 27 and July 3 and that SMRTL had reported results for 98 percent of the samples by the end of July 5.
In response to the delays blamed largely on the holiday weekend, MLB said the lab would be operating “on a seven-day-a-week schedule from July 5 through the end of the World Series.”
The early stumbles, however, have increased the scrutiny on baseball’s intricate and ambitious testing plan, which is charged with obtaining, shipping and analyzing around 14,000 samples each week and turning around those results quickly — ideally within 24 hours but at most 48.
The margin of error, essentially, is zero, because one large outbreak could scuttle the season.
MLB said Friday that 83 individuals, including 71 players, had tested positive, through intake and every-other-day “monitoring” tests, from 11,149 samples — a rate of 0.7 percent. Of the players who tested positive, 58 were discovered during intake testing, and the other 13 came through monitoring — meaning they tested positive after arriving at camps.
MLB is not naming individual players who test positive, citing health privacy laws and the union’s preferences, though it is typically obvious when a player is absent from workouts without an official explanation that he has tested positive or is isolating after an exposure.
For MLB, the choice of labs to run its coronavirus testing program was a natural. Founded in 2002 as the anti-doping hub for the Salt Lake City Winter Olympics, SMRTL is certified by the World Anti-Doping Agency — with MLB at the top of a client list that includes several Olympic sports, the PGA Tour and the UFC — and has received federal certification to perform diagnostic, lab-specimen testing. Earlier this year, MLB paid to convert part of the lab to coronavirus testing.
“The lab in Utah has assured us of a 24-hour turnaround on all of our tests,” Commissioner Rob Manfred told CNN in May. “So we feel comfortable that, by doing multiple tests a week, we can try to minimize that turnaround time. We’re doing everything humanly possible to make sure that the players are safe.”
Eichner, a former professional field hockey player in his native Australia, has worked in anti-doping for most of his professional life but also has a PhD in viral immunology from Australian National University. Still, the lab’s switch from one realm to the other has invited skepticism from experts.
“Not to say an anti-doping lab couldn’t convert its processes over to test for covid-19, but the methodologies used for drug testing vs. testing for pathogens are just different,” said Kelly Wroblewski, the director of infectious-disease programs at the Association of Public Health Laboratories in Silver Spring. “A lot of the skills are the same, but the methodologies are different. It wouldn’t surprise me if a lab designed to test for one thing that was converted to test for infectious diseases is having some challenges.”
Running 14,000 tests per week, Wroblewski added, “would be hard for any lab to pull off.”
In response, Eichner pointed to his doctorate in viral immunology and the fact that, unlike some other labs still testing for other diseases, SMRTL is focused solely on the coronavirus.
“The criticisms, with people saying we don’t have a lot of experience testing for coronavirus — well, no one does,” Eichner said. “It’s a new virus. We have a ton of experience now because we have done so much of it.”
SMRTL is the final step in a chain. For its samples, MLB uses saliva collection kits manufactured by Spectrum Solutions of Draper, Utah. MLB uses Comprehensive Drug Testing of Irvine, Calif., to distribute, collect and ship the samples. And SMRTL uses a polymerase chain reaction test developed by and purchased from Thermo Fisher Scientific of Waltham, Mass.
To conduct the lab tests, SMRTL uses the “pooling” method, in which a small number of saliva samples are combined and tested as one in the interest of efficiency; only in the event of a positive result are the individual samples tested separately to pinpoint the positive. The pooling method is endorsed by the Food and Drug Administration, which in June released guidelines for labs using it in coronavirus testing.
The FDA didn’t approve the first Emergency Use Authorization for a saliva-based coronavirus test until mid-April; before that, nearly all tests relied on a nasopharyngeal swab.
SMRTL’s test has yet to gain the approval of the FDA, but after validating its test in the lab — through what it called “rigorous” studies — it has filed an EUA with the agency, which is pending. FDA approval for a diagnostic test requires proof of accuracy and typically takes months or even years to receive. However, since the onset of the pandemic, the FDA has allowed labs to sell tests that have been validated in lab testing for up to 15 days before they must submit an EUA application.
The FDA’s current approval process, however, is “very skimpy” compared with the process used before the pandemic, said Diana Zuckerman, president of the National Center for Health Research and a Washington Nationals season ticket holder.
“Normally,” she said, “you wouldn’t even be allowed to sell these tests until the FDA has approved them.”
SMRTL has said the accuracy rate of its testing meets or exceeds the FDA standard of 95 percent. An MLB official put the figure closer to 99 percent.
However, even at 99 percent accuracy, MLB’s testing program, at a volume of 14,000 tests per week, would result in 140 false results each week. MLB has sought to reduce that number, it said, by retesting all positive results — which adds another four or five hours to the process but in theory would reduce the instances of false positives to near zero.
The lab “is conducting a level of analysis and turnaround that is unprecedented in COVID testing, including providing an extra layer of confirmation for all positive test results to rule out false positive concerns,” MLB said in a statement.
False negatives are a much bigger problem than false positives; the latter would result only in a player or staffer being isolated unnecessarily, while the former could result in a larger outbreak if an infected person is mistakenly allowed to continue participating. SMRTL has multiple internal controls to minimize the likelihood of false negatives and said it has yet to receive documentation alleging or proving a false negative.
But in an environment such as baseball, even a false positive can have a deleterious effect, putting a team at a competitive disadvantage as a player isolates.
Joey Gallo, arguably the Texas Rangers’ best player, was sidelined for the first week-plus of summer camp after testing positive via the intake process June 27. A second test confirmed the initial positive diagnosis. According to the protocols, he had to test negative twice via tests taken at least 24 hours apart and show no fever for 72 hours.
But Gallo, who reportedly was asymptomatic, also twice took coronavirus tests at a private lab in Dallas — both times using nasal swabs, as opposed to the saliva tests used by SMRTL — and has told reporters both came back negative. A Rangers spokesman declined to comment Thursday, and an MLB official declined to comment on Gallo’s case but said MLB stands behind the accuracy of its testing.
Under the terms of the testing program, run jointly by MLB and the players’ union, a health and safety committee — made up of one MLB official, one union official and a doctor chosen by each side — is charged with resolving such issues. In any case, Gallo was finally cleared and allowed to join his teammates for their workout Friday.
As Opening Day approaches, baseball insists the rash of problems over the holiday weekend was an aberration that, as it slips into the past, will give way to a smooth operation through the end of October — albeit one operating at maximum effort at all times, with no room for error.
In recent days, a help-wanted ad appeared on job websites. SMRTL, it said, is seeking “highly motivated” and qualified individuals for part-time lab aide positions as “part of our laboratory team testing saliva samples for the novel coronavirus,” focusing on “samples from the sports world.”
The work schedule, the ad stated, includes weekends.
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