Federal regulators will be investigating and reviewing the District of Columbia public health lab after an error resulted in hundreds of botched Zika blood tests, local officials reported Tuesday. The error, which reported publicly in February, led to at least 9 pregnant mothers being given false negatives for Zika when they did in fact have the mosquito-borne viral infection known for causing severe birth defects. In total, over 400 blood samples had to be retested.
In a recent oversight hearing, DC officials reported that regulators from the Centers for Medicare and Medicaid Services (CMS) audited the lab to review procedural operations and delve further into how errors that led to the false negatives occurred. Lab representatives also clarified additional causes for the Zika blood test mistakes, including improper use of chemical solvents and mathematical errors when test results were entered into a spreadsheet and analyzed.
The CMS is the primary federal agency responsible for overseeing lab tests in the U.S., including tests of blood and DNA. As part of the audit, regulators will look into determining whether the DC public health lab complied with federal laws, and whether any violations or egregious acts of negligence could cause the lab to lose its Clinical Laboratory Improvement Amendments (CLIA) certification. The DC public health lab has faced scrutiny over its procedures and integrity in the past, and was issued a 10-month suspension of its DNA forensic testing accreditation in 2015.
Accreditation is the top concern for officials from the DC Department of Forensic Sciences, which has worked to address the Zika blood test errors since they were discovered last fall and has taken steps to fix problems and avoid loss of CLIA certification.
Information available to the public has revealed that the DC public health lab faced a tumultuous time when the errors were made and initially discovered. Problems included a lack of staff, no permanent leadership, overburdened employees, and a reliance on newer staff to handle blood tests for Zika. Officials state that the results of the audit and any repercussions for the lab will be made public once finalized.
A Mistake with Consequences
While the DC public health lab may very well face consequences from federal regulators, the most pressing concern still remains with patients who were given false negatives, especially the at least 9 pregnant women who were initially told they did not have Zika. As retests of the 400+ blood tests are still ongoing, more pregnant women could be affected.
For women and mothers who were told that they did not have Zika as a result of the botched tests, there are real and alarming consequences. Zika is a significant health threat to mothers and their babies, as the virus can be passed to a fetus during pregnancy and lead to a number of adverse side effects, such as microcephaly, a life-altering condition in which babies are born with smaller heads and underdeveloped brains. Detection of Zika in mothers early in pregnancy is critical to minimizing risks of these defects.
Because the errors may result in tremendous losses suffered by mothers and their families, Chaikin, Sherman, Cammarata & Siegel, P.C. is reviewing the circumstances at the DC public health lab and or legal team is readily available to consult with affected patients who received false negatives and later discovered they had Zika after their blood samples were retested and to discuss their legal rights and options.