Employee misread smear test results
7,200 pap smear tests conducted in Norrbotten County over a four-year period will be re-evaluated after a follow-up check found that an employee had deemed cell samples of twenty women as normal, when in fact, they were abnormal and needed treatment.
"There was an employee who misread test results," said Nicholas Holthuis from the Swedish company Unilabs, which took over responsibility for gynecological specimens in Norrbotten County in 2014, according to Swedish Radio news. Previously, the county of Norrbotten supported by Västerbotten County Council had medical responsibility for the tests.
An internal quality check within Unilabs in June 2015 found that twenty women, whose samples had been deemed normal, had actually indicated mutations that needed treatment.
The women in the quality test were called for a new examination. One of the women had developed cervical cancer. All women are now receiving treatment. The woman who had developed cancer was in the early stages, with good prognosis, according to Anna Pohjanen, the director for gynecology in Norrbotten.
The County Council has now contracted Unilabs to re-examine all the analyses made by the diagnostician in question. 7,200 tests will be looked at, and women who need to be retested will be notified.
At a press conference Monday personnel from the Sunderby Hospital in Luleå and county officials said they would open a hotline for anyone who might be affected by the mistake. Anyone who submitted cell samples can call 0920-28 27 97 to find out if their sample will be re-evaluated.
The Norrbotten County council and Unilabs have filed a so-called lex Maria report with the Health and Social Care Inspectorate (IVO).
Earlier Monday the CEO of Unilabs, Jan Hörnström, told TT that the company has agreements with several counties around the country. He said it was unlikely that the errors had occurred elsewhere as follow-up checks on those cell analyses would have identified any problems.