Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.
Charts sent to customers and obtained by the Globe show that in the first half of 2012, there were no instances of contamination exceeding the accepted standard on surfaces in the “clean rooms,” where the company produced sterile injectable medications such as the steroid now linked to 28 deaths.
But during that same period, the company’s own internal testing showed that 33 surface samples from the clean rooms contained bacteria or mold at levels requiring corrective action to remove contamination, according to company records. These test results were disclosed in a report released Friday by federal investigators.
Three consultants who were shown the report card by the Globe said it lacks basic scientific data — such as how many tests were conducted to detect bacterial and mold contamination — that hospitals and other health facilities should have requested from the compounder to determine whether the company’s facility and products were up to the industry standards. They described it as a promotional brochure rather than a technical report.
“Their marketing material is baloney. They are just saying what they want to say,” said Stephen Runge, president of nanoCLEAN Decontamination Services, a Quincy company that decontaminates laboratory clean rooms after impurities are detected.
A New England Compounding spokesman said the company would have no comment.
Two of the three lots of steroids that have been linked to 363 cases of meningitis and joint infections across 19 states were produced during the period covered by the company’s report card, which was sent to an unknown number of its more than 3,000 customers. Those customers include hospitals, clinics, and doctors’ offices.
The report card stated that the company’s “extensive” testing of finished products for sterility and microbial contaminants had a 100 percent success rate from January through June 2012, though the report did not include the number of tests conducted. The customer report, adorned with a picture of a lab technician covered head to toe in protective clothing, stated in a cover letter that its quality systems and facilities are “in a state of control.”
“The results of our internal review . . . demonstrate that NECC meets and is in continued compliance with all applicable requirements and standards,” said the report, signed by Barry Cadden, a co-owner of the company and its former lead pharmacist. Cadden encouraged customers to keep the report on file to show the Joint Commission, a private accrediting agency, and government regulators during inspections.
Elizabeth Zhani, spokeswoman for the Joint Commission, said that the agency’s inspectors do not specifically ask hospitals for a copy of sterility reports from their outside compounding pharmacies. Instead, inspectors typically review copies of contracts a hospital signs with outside contractors, including compounding pharmacies. The commission’s regulations do not specify whether those contracts must include reports from pharmacies about sterility testing.
New England Compounding closed earlier this month and state regulators have sought permanent surrender of its pharmacy license, as well as permanent revocation of the licenses of the company’s three pharmacists, including Cadden and his wife, Lisa Conigliaro Cadden. The Food and Drug Administration, which is among several federal and state agencies investigating New England Compounding, released a report Friday depicting lax safety practices and widespread contamination inside the company’s labs between January and September.
Federal investigators found visible mold, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.” That lot was produced in August.
The FDA report said that the company’s own environmental testing showed bacteria and mold in numerous spots in two clean rooms that were at levels above New England Compounding’s own “action limits” — the level at which remedial action should be taken to remove contaminants. But there is no evidence that the company investigated further or took corrective measures, the report said.
And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.
According to the FDA report, every one of the 62 surface samples taken in two clean rooms contained bacteria or mold, and more than half exceeded the action level.
By comparison, New England Compounding’s report to customers stated that between January and June, there was no contamination found on surfaces in the clean rooms that was outside the norm — what the company called an “excursion rate.”
It reported a 0.25 percent excursion rate for air monitoring in the clean rooms. The FDA report said the company’s internal documents showed two of five air samples taken during the same period exceeded the action level, or 40 percent.
The company’s customer report also stated that its “media fill success rate” — routine tests that certify staffers are correctly preparing sterile medications — found 100 percent success.
New England Compounding “has established an extensive environmental monitoring program for surface and air samples for clean room areas to ensure preparations are compounded in the cleanest environment possible and to document compliance with [industry] requirements,” the company’s report card stated.
Eric Kastango, president of Clinical IQ, a New Jersey-based pharmacist and safety consultant to the industry, said he has found that health care organizations often don’t know what questions to ask compounders to determine whether the companies are complying with industry standards.
“If you have a nice glossy brochure, and you represent that you can fill a need with all the drug shortages, nobody really wants to ask the hard questions,” he said. “You are led to believe by these vendors they are legitimate, but it’s not really independently vetted out.”