Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.
Issue link: http://outpatientsurgery.uberflip.com/i/703764
mum of 20 minutes, according to NECC's own worksheets and USP- 797. But that took too long for NECC staffers, who shortened the time to 15 to 17 minutes, the indictment says. The group never bothered to validate this shorter time with a biologic indicator. Observers suggest- ed a possible reason for the foreshortened autoclaving — it might have allowed for the processing of 2 additional batches per day. Although USP-797 guidelines mandated that at least 20 vials be sent for sterility testing from each batch, NECC sent out only one, regardless of the size of the batch. For a test to detect contamination with 95% confidence, 18% of each batch would need to be tested. At least for some batches, NECC was testing 0.01%, according to the indictment. The company sometimes also didn't bother to wait until the sterility results came back before sending out vials to customers. In the summer of 2012, according to FBI testimony, NECC shipped 150 20 ml syringes of bacitracin to Good Shepherd Hospital in Barrington Ill. On the same day, the company sent a 3 ml sample to the testing lab. Two weeks later, the results came back: not sterile. NECC was so busy it couldn't stop to clean and disinfect the clean rooms. According to legal documents, Mr. Chin, who supervised Clean Room 1, told techs to focus on production rather than cleaning and disinfecting. He also instructed them to falsely complete logs showing that the rooms had been cleaned and disinfected. The cleaning service also apparently was ineffective. According to FBI testimony, in an e-mail to the cleaning service in February 2012, Mr. Cadden wrote "We happened to test the same day, Thursday, 2/23, that your crew cleaned our clean rooms last week. The tests from this day showed more mold on 5 to 6 floor areas than we have ever seen before in any 3-month period." According to FBI testimony, another "fungal bloom" was found in June. Two employees tested positive for bacteria on their hands. Ten 1 5 8 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U L Y 2 0 1 6