Root cause analysis to probe 'extremely rare' COVID-19 lab error in Sask.

The Saskatchewan Health Authority says it's confident in its COVID-19 testing processes going forward, but that a root cause analysis must still be done to explain the origins of a lab error that sowed confusion and worry in the province earlier this week.

The apparent instrument error took place at the Roy Romanow Provincial Lab in Regina and resulted in 206 false-positive test results. The tests were from Regina residents and care home inhabitants, plus a small pocket of people in other parts of the province, all of whom had to be retested. The error affected test results dated Aug. 18 to 22. 

Before the error was detected on Monday by the health authority's own quality assurance program, several care homes in Regina were declared to be outbreak sites, only to have those designations immediately reversed once the testing gaffe was confirmed. 

"We recognize that some actions that we have taken have also created a burden for those impacted," said Scott Livingstone, the CEO of the Saskatchewan Health Authority (SHA), who also apologized for the "extremely rare" type of error.

So what exactly went wrong at the lab? That's exactly what the SHA needs to confirm, said Fergall Magee, director of the Roy Romanow Provincial Lab.

"We don't know," Magee said in a news conference on Tuesday.  

"Is it an issue of swab? Is it an issue of reagent? Is it an issue of instrument? Is it an issue of process? We're actually in the process of doing that and we're doing it for two reasons. One is to find out what went wrong. And the second one is to [answer] what do we do to ensure this doesn't happen again?"

At the same time, Livingstone said it's virtually impossible to be 100 per cent certain it will never happen again.

"It's why we have quality assurance processes across all lab services to ensure that the test result we're getting is the test result that's valid," Livingstone said.

Ryan Meili, the leader of the Opposition Saskatchewan NDP party, said false-positives happen, but that the incident "really gives people a lot of pause for further concern on" the Saskatchewan government's overall management of the COVID-19 situation.