BOSTON (WHDH) - Massachusetts health officials on Tuesday confirmed that a COVID-19 testing lab in Boston has been issued three citations after nearly 400 false positives were found.
An investigation into Orig3n was launched on Aug. 3 after the state “became aware of an unusually high positivity rate of tests that were reported by the COVID-19 testing laboratory,” a spokesperson for the Massachusetts Department of Public Health said.
A DPH review included retesting of samples by an independent lab, which found at least 383 erroneous positive results from the lab that came negative upon being retested, health officials said.
On Aug. 27, DPH said it notified Orig3n of their findings and cited them for three “significant certification deficiencies that put patients at immediate risk of harm.” The alleged deficiencies were as follows:
- The laboratory director failed to provide overall management and direction
- The laboratory failed to include a control material in the extraction phase of testing that is capable of detecting errors in the extraction process and the laboratory failed to maintain a suitable copy of corrected reports
- The laboratory failed to meet the applicable analytic systems requirements (i.e. documenting daily sanitization of the laboratory benches and equipment utilized for COVID-19 testing)
Orig3n has not conducted any COVID-19 testing on Massachusetts specimens since Aug. 8 and new testing remains suspended.
The lab now has until Sept. 14 to submit a credible allegation of compliance and acceptable evidence documenting that action has been taken to correct all of the deficiencies in question.
There are said to be about 60 nursing and rest homes that are or have been clients of the lab at one time.
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