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AdventHealth terminates contract with testing lab amid reliability questions

The hospital group says this will impact about 33,000 people throughout the AdventHealth West and Central Florida Divisions.

TAMPA, Fla. — AdventHealth says it has terminated a contract with a third-party COVID-19 coronavirus testing lab after the lab was unable to fulfill its obligation and some of the tests might prove unreliable.

The unnamed testing lab is one of many the hospital group utilizes to provide COVID-19 testing to the Tampa Bay area. 

"AdventHealth has terminated its contract with this lab and we share in the disappointment and frustration this situation has created. We are deeply sorry for the inconvenience and uncertainty it has caused," the group said in a release.

AdventHealth says this issue impacts about 33,000 people throughout the AdventHealth West and Central Florida Divisions, creating delays in testing.

About 8,000 of those impacted fall under AdventHealth's West Florida Division, while 25,000 fall under its Central Florida Division.

The hospital group says because of the delays, it doesn't have confidence in the reliability of the tests. It says it's working to notify and appropriately accommodate those who are impacted. If your test was impacted, you'll receive a letter from AdventHealth and may also receive a phone call.

AdventHealth says people who will be notified fall into one of two categories:

  • Those whose samples were processed, and whose results provided by the lab are not deemed reliable. 
    • Individuals who had unreliable positive results will require retesting.
    • Individuals with unreliable negative results who are symptomatic need to seek care and may require retesting.
    • Individuals with unreliable negative results who are asymptomatic but request to be retested will be offered testing pending availability.   
  • Those whose samples are at the lab in question and are part of the backlog will not be tested; therefore, no result will be available. 
    • These patients may require retesting if they are symptomatic. 
    • We have directed the lab to destroy these samples in accordance with the law.  

AdventHealth says if you're experiencing COVID-19 symptoms you should seek care immediately.

“It has been a privilege to serve our community during these unprecedented times, and we remain committed to our promise to keep you safe and provide the best care possible,” said Mike Schultz, President and CEO of AdventHealth West Florida Division. “We are taking ownership of these issues and are reaching out to the thousands of those who were impacted to help make it easy for them to understand the next step in their care.”

It is unclear what the breakdown is between false negatives and false positives. For those who were given false negatives, when they did in fact have the virus, it could create a larger problem.

“We’re entering a time as we’re reopening, so to speak, where identifying individuals who might have COVID or who potentially are asymptomatic and can spread it, is really important to prevent additional outbreaks from occurring,” said Dr. Marissa Levine, a public health expert at USF Health. “And what we want to do, ultimately, is prevent a large second wave of disease. That’s our important goal right now. In addition to dealing with what we already have here."

This follows questions from 10Investigates to AdventHealth about the occurrence of inaccurate results and whether hospital systems were tracking false negatives. 

Questions were sent on Monday, May 11. AdventHealth never responded.

Other major hospital systems in Tampa Bay did including BayCare, HCA, Sarasota Memorial Hospital and Tampa General Hospital which provided an emergency room doctor to speak to the subject.

Dr. Jason Wilson acknowledged test results are not 100 percent accurate but explained that with the physical PCR tests and nasopharyngeal swabs, it most often is because of incorrect collection by a health care worker. 

Wilson said he had seen a handful of false negatives since in-house testing began at TGH but added that is rare and they take clinical symptoms into account when viewing results.

RELATED: Test results for COVID-19 not 100 percent accurate, says FDA

BayCare told us they validate any new test before bringing it online for patients. This is for hospitals and urgent care centers.

A representative told 10Investigates:

“The BayCare lab team has been diligent in studying and validating COVID-19 tests and has worked closely with vendors who have a strong history of molecular testing performance and reliability. There has been a rush to develop COVID-19 tests to meet demand and multiple vendors have developed and released the new tests without the usual level of analysis and assessment by the FDA. The tests instead have received Emergency Use Authorization (EUA) approval by the FDA.

We use a variety of tests including Roche, DiaSorin, BD Max, Cepheid and Abbott that may differ in their sensitivity. Our lab team will continue the validation process as new tests are brought to market. One thing to note, while the Abbott test in known to have a lower sensitivity rate, it is helpful as a screening test, as the results are available faster.“

HCA West Florida Division shared that its hospitals also use multiple vendors and perform Polymerase chain reaction (PCR) tests which they say “is very accurate, both in terms of specificity and sensitivity.”

“Providing an accurate diagnosis is our primary focus with this evolving pandemic. If a PCR test is negative and a clinician feels the patient has COVID-19, a second test at a later date can be performed. If performed too early in the disease process, the patient can test negative,” said a spokesperson for HCA West Florida Division.

Sarasota Memorial Hospital says the testing platforms it uses are “highly reliable” and they began tracking the occurrence of false-negative results since testing at the hospital started on March 2.

“Of more than 500 repeat tests performed on patients across different test systems and laboratories, we have received only two positives after an initially negative result,” said a spokesperson for SMH.

Sarasota Memorial added that it uses the standard polymerase chain reaction (PCR) testing systems.

“SMH uses two companies, Cepheid GeneXpert and Biofire Torch, for in-house testing for SARS-CoV-2, and we recently partnered with Hologic to expand our capacity. As with Cepheid and Biofire, Hologic has a long history of quality and reliability almost exclusively in the molecular biology diagnostics field. It is important to note that our physicians treat the patient, not the test results. Medical care is based on clinical observation and medical history, and physicians do not rule out COVID-19 based solely on negative test results.”

RELATED: AdventHealth opens drive-up COVID-19 testing site in Pasco County

RELATED: Hospital staff cheers for COVID-19 patient who gets to go home

RELATED: Tampa General Hospital, AdventHealth develop in-house coronavirus testing

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