Regulatory Update

Brooklyn Toxicology Lab Suspended for 30 Days by NY Department of Health

IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly,

The lab company is Advanced Clinical Laboratory Solutions Inc., which describes itself as, “a physician-driven, patient-minded, client-focused clinical toxicology-testing laboratory.”

In an email response to a query from THE DARK REPORT, the DOH said, “On Sept. 9, 2016, the department issued an administrative order suspending Advance Clinical Laboratory Solutions, Inc.’s (ACLS) clinical laboratory permit in the category of clinical toxicology for 30 days. As set forth in the order, the suspension was deemed necessary after department inspectors found serious deficiencies at ACLS’ clinical toxicology laboratory, which could potentially result in the laboratory’s reporting of invalid test results.”

In the email, the department said, “Deficiencies include: using unlicensed personnel to perform testing; failing to properly perform calibration and quality control procedures; and following technical procedures that are not in accordance with the laboratory’s own guidelines and/or New York State and federal requirements.”

The department could take additional enforcement action, including revocation or suspension of its license, DOH said.

“The department continues to review information from the laboratory to determine the potential impact, if any, the above described deficiencies may have had on previously reported test results,” the email said.

In response to an inquiry by THE DARK REPORT, ACLS CEO Leon Reyfman, MD, FIPP, RpH, sent the following statement: “ACLS is committed to providing quality laboratory services and we are proud of the services we provide to the healthcare community. We continue to work with the NYSDOH to improve and ensure our ongoing quality. ACLS continues to provide toxicology services by utilizing a national reference laboratory. ACLS also continues to provide molecular genetic testing.”

anesthesiologist Is Director

Reyfman is an anesthesiologist and a pain medicine specialist at Mount Sinai Beth Israel in New York City. He is also the director, Interventional Pain Management, for Pain Physicians NY. In his LinkedIn profile, Reyfman says he is board-certified through the American Board of Anesthesiology in both anesthesiology and pain management.

On its website, ACLS says it is a CLIA-certified lab and licensed to perform testing in all of the United States. For New York State, it is a DOH-accredited clinical laboratory for molecular genetic testing. It also meets the standards for Secure Laboratory Information Systems (LIS), Code of Federal Regulations (CFR) 21 compliant, and is Health Insurance Portability and Accountability Act (HIPAA) compliant, it says.

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