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State Labs Struggled With Safety Lapses, Records Show

The Wall Street Journal. logo The Wall Street Journal. 3/13/2020 Christopher Weaver, Brianna Abbott
a close up of a device © U.S. Centers for Disease Control and Prevention/Associated Press

More than half of the state-run medical-testing facilities on the front line of the fight against the new coronavirus pandemic have been cited since 2017 by the main U.S. laboratory regulator for failing to meet national standards, federal inspection reports show.

The problems include safety lapses, violations of rules for proving tests are accurate, quality-control failures and the use of unqualified staff, according to the reports reviewed by The Wall Street Journal.

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Three labs—in Idaho, Illinois and Louisiana—had deficiencies so serious as to put their medical-testing licenses at risk, records show.

Louisiana’s lab, regulators said, also put patients at risk by reporting results of tests that couldn’t be trusted because of problems with the handling of lab materials and specimens, the regulators said. All three state labs corrected the most serious problems and maintained their certification, according to state officials and regulatory records.

None of the reports say regulators or labs determined patients had been harmed by the failures. Minor regulatory citations are common at medical laboratories around the country. Yet, experts say, the state-run labs are a crucial part of the nation’s bulwark against the kind of pandemic the world is now battling. Deficiencies at these elite institutions that must be held to a high bar for compliance raise questions about whether they have suffered from too few resources.

When the rules aren’t followed, “it does lead one to worry about the overall approach to quality,” said Geoffrey Baird, professor and interim chair of laboratory medicine at the University of Washington School of Medicine who viewed some of the reports.

The state public-health labs have been driving increases in coronavirus testing around the country in recent days. The labs collectively have now tested nearly 10,000 samples, nearly all of them in March, compared with fewer than 4,000 at the Centers for Disease Control and Prevention, which began running coronavirus tests in mid-January, CDC data shows as of early Friday. Public health labs are testing for coronavirus in all 50 states.

In many cases, the state labs are run by agencies charged with overseeing quality at commercial and hospital labs in their states. Some of those commercial and hospital labs are starting to do testing as well.

The state public-health labs “represent the gold standard,” said Ashish Jha, the director of the Harvard Global Health Institute.

During normal times, the state labs attract little scrutiny.

Between emergencies, public-health labs perform surveillance in areas from water and food safety to newborn screenings, said Scott Becker, the chief executive officer of the Association of Public Health Laboratories. He declined to comment on the state-specific inspection reports.

Over the past decade, CDC funding, including for state and local budgets, was cut by 10% after adjusting for inflation, according to Trust for America’s Health, a public-health advocacy organization.

Public-health officials and other experts say that has left the laboratories chronically strapped for cash even as they compete to hire highly trained doctors and scientists at state-level salaries.

Meantime, some labs have bought or still need to buy new devices, including one used to extract genetic samples that costs roughly $50,000 per machine, to prepare for the new coronavirus, according to Mr. Becker’s group.

To examine the readiness of the labs for the coronavirus threat, the Journal requested more than two years’ worth of inspection reports for all 50 state laboratories and the District of Columbia from the U.S. Centers for Medicare and Medicaid Services, the federal medical-lab regulator. Most labs are inspected about every two years, either by state authorities, or in the case of labs the states themselves run, typically by CMS.

CMS released 44 inspection reports for those labs to the Journal, including 29 reports concerning 27 individual laboratories that listed problems. Some states have more than one state lab included in those totals.

At a Florida state lab in Miami, laboratory workers failed to check quality controls—needed to ensure accurate results—on test materials, according to the documents. In Ohio, the state lab accepted samples that its own manual said it should have rejected and sent on to the CDC for testing, the records say. Vermont’s state lab failed to follow manufacturer’s instructions in reporting some test results and tested a sample that it should have rejected, the records say.

Officials in Florida and Ohio didn’t respond to requests for comment. In all of those cases, and most of the others revealed in the records, the labs responded quickly to address the deficiencies.

“We respond to these types of deficiencies, and we take them very seriously,” said Helen Reid, the health surveillance division director at the Vermont Department of Health Laboratory. “In order to ensure we have the public’s trust, we have to prove that we’re maintaining those quality standards.”

Lab experts say that in today’s regulatory environment, most labs of every type have at least some minor lapses. A 2018 analysis by Medicare officials says about 5% of labs nationwide failed to have the proper policies in place for storing samples, ensuring accurate test-system operation and reporting of results. About 4% failed to follow the accuracy-testing requirement, and the same share failed to meet all the personnel requirements.

“It is everybody’s goal to have a completely clean inspection for their laboratory,” said Ginger Borer, a senior consultant at lab-management adviser Colaborate LLC. “That is almost unrealistic.”

However, some of the state public-health labs, such as the Louisiana lab, have struggled with repeat problems.

The Louisiana lab initially received a serious citation in February 2018. Inspectors found that storage temperatures for samples fell as much as 25% below the range specified by manufacturer’s instructions, between 35 degrees and 46 degrees Fahrenheit. Also among the infractions: frozen specimens were received for testing at temperatures not nearly as cold as required by the lab’s own manual, and the lab tested expired patient results, telling patients: “Results may be compromised due to the age of specimen upon receipt.”

“We should be rejecting the specimens,” the state’s then-acting laboratory director told regulators when confronted with some of the lapses, a report shows.

The Louisiana lab “immediately corrected those practices,” according to an emailed statement from Alyson Neel, a spokeswoman for the state’s Department of Health, to the Journal.

In September 2018, inspectors returned to the Louisiana lab and found additional storage issues. The problems weren’t resolved until the next year.

The statement from Ms. Neel said the September deficiencies were similar but separate problems from the original infraction.

Ms. Neel said the lab is responding to the coronavirus outbreak and a state website says Louisiana has as of early Friday morning identified 19 positive coronavirus cases that the CDC must confirm. 

Last August, inspectors found the Illinois Department of Public Health’s Carbondale, Ill., laboratory violated rules for “proficiency testing.” That is the lab industry’s process for verifying the accuracy of results by processing mock samples provided by a third party that knows the expected results.

During a smallpox proficiency test run by the CDC, the officials from the Carbondale lab and two other Illinois state labs discussed their results, in violation of the rules.

“It would be likened to a student who knew the answers ahead of time taking the test,” said Steffini Stalos, a clinical pathologist and president of Blood Associates LLC, who reviewed the inspection reports at the Journal’s request.

Illinois lab director Onesia Bishop wrote in a letter to U.S. lab regulators at the time that “there was no intentionality by the laboratory under my leadership as a director, to blatantly ignore the CLIA regulations,” referring to the federal law setting standards for labs. The lab issued new policies that Dr. Bishop said would prevent a repeat incident.

Dr. Bishop and other Illinois public-health officials didn’t respond to requests for comment.

As of early Friday, Illinois has reported 32 positive coronavirus cases and 294 negative test results. It isn’t clear whether the Carbondale lab handled those tests.

In Idaho, the state lab faced a range of citations concerning accuracy of testing, storage conditions, quality-control checks on a microbiology device, and patient reports that lacked information doctors might need to interpret the results for influenza, hantavirus and HIV, among other diseases. The main problem that threatened the lab’s medical-testing certificate, however, was more mundane—a staff scientist had a bachelor’s degree in the wrong field.

A spokeswoman for the Idaho Department of Health and Welfare, Niki Forbing-Orr, said the January 2020 lab inspection was “very successful,” that the most serious deficiency had already been fixed and remaining ones should be resolved by April.

“They’re trying to do better, and that’s very encouraging,” said the University of Washington’s Dr. Baird.

The Idaho lab has tested 93 people for the new coronavirus as of early Friday, but has reported no positive cases, according to a state website.

Write to Christopher Weaver at christopher.weaver@wsj.com and Brianna Abbott at brianna.abbott@wsj.com

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