IG Finds Some Flaws in VA Compounding

By Walter F. Roche Jr.

A review of drug compounding practices at Veterans Administration facilities showed that more than a quarter of those reviewed could not provide evidence that shelving and storage areas in sterile drug preparations area were cleaned at least once a month, the required standard.
In a 20-page report issued today,  the VA's Inspector General concluded that while there was generally high compliance with sterility and other standards at VA health facilities, there were about a half dozen areas needing improvement.
The report comes as national attention has been focused on the dangers of sterile drug compounding stemming from the recent criminal trial of the president and part owner of a now defunct Massachusetts drug compounding company.
A federal jury in Boston, Mass. recently convicted Barry J. Cadden on 57 counts of racketeering and mail fraud following a 10-week trial. Cadden headed the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak which took the lives of 76 patients across the country.
As VA officials pointed out in response to the audit, none of the deaths resulted from treatment at VA facilities, although several veterans were among the victims.
In the report, which covered 28 VA facilities where sterile drug compounding takes place, the IG found that in 26 percent there was no documented evidence that shelving and storage areas were cleaned at least once a month, as required under the national standard, the U.S. Pharmacopeia. At 11 percent of the facilities, the IG found that there was no documentation of daily cleaning of floors in so-called clean rooms where sterile drugs are compounded.
The report states that competency assessments for those compounding sterile drugs failed to include gloved fingertip sampling in 18 percent of some 267 employees reviewed. Written tests were not included for 20 percent of the employees and 15 percent of the assessments did not include"visual observation or hands on skills assessment of aseptic techniques."
The IG also found that at 24 facilities where high risk chemotherapy drugs were prepared, special protective gloves needed in such procedures were not available.
The IG noted that at some facilities the reporting requirements for so-called "near misses," cases in which patients could be at risk, were unclear. He recommended that guidance be provided by VA administrators to ensure that all near misses are being reported.
In its response, the VA agreed with the findings and submitted a timetable for achieving compliance.
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