Legislators to hold hearings on lab scandal, meningitis outbreak

November 9, 2012
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State legislators will hold a series of hearings starting Nov. 14 on the state Department of Health (DPH) handling of the meningitis outbreak that has killed at least 30 people and the state drug lab scandal, according to local state Rep. Jeffrey Sánchez.

“It’s a really big deal,” said Sánchez. “We want to be thoughtful and systematic about the approach we take.”

The meningitis outbreak occurred when the New England Compounding Center in Framingham produced a tainted steroid drug that was injected into patients throughout the country.

The state drug lab scandal involves former chemist Annie Dookhan allegedly mishandling thousands of drug samples at the William A. Hinton State Laboratory Institute at 305 South St. Dookhan’s alleged actions have put numerous convictions in doubt and she is facing several criminal charges.

Sánchez, who is chair of the Joint Committee on Public Health, said they want to take a top-down approach, finding out how the state Department of Public Health (DPH) operates. He said that they want to ensure public safety.

The representative said that the first hearing will focus on pharmacies, inspections and consumer protection. A second hearing will be held Nov. 28. It will cover supervisory roles and procedures at the now-closed state drug lab at the Hinton Institute and its interaction nationally with regulators.

The Gazette has learned from DPH that two accrediting bodies cover the other labs that handle human clinical specimens at the Hinton Institute.

The Clinical Laboratory Improvement Amendments (CLIA), which is part of the Centers for Medicare & Medicaid Services, is one of the accrediting bodies. The other is the College of American Pathologists, which accredits the Childhood Lead lab.

The Food and Drug Administration, which appears to oversee CLIA, did not respond to a request for comment.

The Gazette filed on Sept. 28 a request to DPH under the Freedom of Information Act for more information about the accrediting, including inspection reports. The Gazette has not received those documents despite a legal requirement for a response by now. DPH has also not responded to questions about the documents.

A third hearing, which does not have a date, will focus on procedures and communication across DPH.

“We want to find out how incidents like this occurred and how to move forward and prevent them from happening again,” said Sánchez.

Sánchez also said that MassBiologics, a University of Massachusetts lab at the Institute, would not be investigated during the hearings because it does not fall under DPH purview. Dookhan previously worked at MassBiologics under another name, a former co-worker previously told the Gazette, adding that Dookhan lied about her degree and cut corners in a basic procedure there.

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