Testing at a Massachusetts lab has been halted after false positives were discovered.
Orig3n Laboratory, a federally certified lab in Boston, that is also a state licensed laboratory that has an Emergency Use Authorization from the FDA to perform COVID-19 testing, had a multitude of false positives, according to the Massachusetts Department of Health.
“In early August, the Massachusetts Department of Public Health became aware of an unusually high positivity rate of tests that were reported by the COVID-19 testing laboratory, Orig3n, and opened an investigation. On Thursday, August 27, DPH notified Orig3n of findings from their recent investigation and cited three significant certification deficiencies that put patients at immediate risk of harm. The Boston lab is required to respond with a written plan of correction, and if action is not taken it can face sanctions. Since August 8, at the state’s request, Orig3n has not conducted any COVID-19 testing on Massachusetts specimens and new testing remains suspended.”
According to Ann Scales of the Massachusetts Department of Health, on August 3, 2020, DPH became aware of an usually high positivity rate of COVID-19 tests that were reported by the lab in question, which prompted an investigation by DPH. The review included re-testing by an independent lab, which found that the results were false positives.
DPH states that in Massachusetts, there are a minimum of 383 erroneous positive results from the lab that after re-testing, have been confirmed to be negative.
On August 27, CMS, as a result of the investigation and in collaboration with DPH as its state agency, determined that there was immediate jeopardy due to three significant certification deficiencies that put patients at immediate risk of harm:
1. The laboratory director failed to provide overall management and direction.
2. 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.
3. 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).
DPH, as CMS’s state agency, issued the statement of deficiency to Orig3n to which the lab must respond with corrective action in writing. If action is not taken, CMS may impose sanctions on the laboratory.
According to Scales, the Statement of Deficiency was issued to Orig3n on Friday, September 4th. The lab has until September 14th to submit a credible allegation of compliance and acceptable evidence documenting that the immediate jeopardy has been removed and that action has been taken to correct all of the condition-level deficiencies in question. DPH, as the state agency for CMS, will follow up to ensure that the action steps have been implemented.
Orig3n has not conducted any COVID-19 testing on new specimens since August 8th at request of the Commonwealth of Massachusetts. New testing has also been suspended.
There are approximately 60 nursing and rest homes that are or have been clients of this lab at one time, according to DPH.