Notification of potential data quality issues by a Massachusetts laboratory is raising concerns about the possible impact on current and closed remediation sites in Massachusetts that relied on that data.
Accutest Laboratories New England (ANE) sent letters in late 2015 notifying some clients of potential data quality issues in particular lab results. Based on the letters we have reviewed, the data at issue was developed pursuant to volatile analytical methods (numbers 524.2, 624 and 8260B/C) between January 2012 and March 2015. According to the letters, ANE is performing a review of the data and will notify clients of the results of that review by March 31, 2016.
The potential data issues reported by ANE relate to VOC analyses and sites contaminated with VOCs, such as tetrachloroethylene (PCE) and trichloroethylene (TCE), are under intense scrutiny by MassDEP due to the possibility that the contaminant could volatize into indoor air of occupied commercial or residential buildings. Indeed, as reported elsewhere in this alert, MassDEP is beginning to notify owners of certain previously closed TCE sites that additional testing is necessary to determine if the contamination at these sites poses an imminent hazard under today’s standards. An accurate understanding of the concentration of VOCs in groundwater, soil vapor, and indoor air is often critical to understand the potential for human exposure, as well as to characterize and remediate the site.
It is possible that these notifications are an outgrowth of two recent settlements by an affiliate of ANE, Accutest Corporation, which is known as Accutest Laboratories, with the U.S. Department of Justice (DOJ) and New Jersey to resolve allegations of improper testing of environmental samples. According to the Settlement Agreement with the DOJ, the United States alleged that Accutest Laboratories violated the False Claims Act by submitting, under contract with various federal agencies, results of analytical testing which were not performed in accordance with U.S. EPA guidelines. The allegations were disputed by Accutest Laboratories, and it has not admitted any wrongdoing. More specifically, the allegations involved analyses performed during 2011 through 2013 involving semi-volatile organic compounds. The DOJ alleged that, in some cases, the lab did not strictly follow the applicable method by:
- “not performing the required number of ‘shakes’ and/or not waiting the required period of time between ‘shakes’ of waste water samples, potentially resulting in the inability to fully extract all of the SVOA compounds in the samples;”
- not ‘spiking’ a soil or waste water sample with a known compound in the correct sequence or manner, potentially affecting the quality control process that ensured all SVOA compounds in a sample were likely to be fully extracted;” and
- “altering the settings on GC/MS instruments or disregarding calibration protocols.”
The DOJ settlement requires Accutest Laboratories to pay a penalty of $3 million. In addition, it requires Accutest Laboratories to notify any customer “that could have been impacted” by the alleged activities, which may be the impetus for the Massachusetts notifications by the related Accutest company.
In the New Jersey Settlement Agreement, the state alleged that Accutest Laboratories failed to comply with the requirements of its certification to conduct laboratory testing. In addition to incorporating certain allegations in the federal action described above, New Jersey alleged that, during periods of time between 2007 and June 2013, Accutest Laboratories deviated from required extraction methods including by not always performing “the required number of extractions, potentially preventing the full extraction of all of the compounds in the samples ….” The allegations were disputed by Accutest Laboratories, and it has not admitted any wrongdoing in the Settlement Agreement.
The New Jersey settlement requires Accutest Laboratories to pay $2 million to resolve the allegations and notify any impacted customers in New Jersey.