Sunday, August 2, 2015

NRC fined VA for prostate cancer programs failures

The U.S. Nuclear Regulatory Commission levied a $39,000 fine Monday against the Department of Veterans Affairs for violations of federal regulations of the use of radioactive materials at prostate cancer programs in VA hospitals across the country. The NRC cited two violations that came to light in inspections after problems were found in the prostate brachytherapy program at the Philadelphia VA Medical Center. Those mistakes led to investigations at other VA hospitals of the treatment that involves implanting tiny radioactive seeds into the acorn sized gland to kill tumor cells.

NRC fined VA for prostate cancer programs failures

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Former Philadelphia VA Medical Center director Richard S. Citron, who retired on April 30 after 42 years of government service.
Former Philadelphia VA Medical Center director Richard S. Citron, who retired on April 30 after 42 years of government service.

The U.S. Nuclear Regulatory Commission levied a $39,000 fine Monday against the Department of Veterans Affairs for violations of federal regulations of the use of radioactive materials at prostate cancer programs in VA hospitals across the country.

The NRC cited two violations that came to light in inspections after problems were found in the prostate brachytherapy program at the Philadelphia VA Medical Center. Those mistakes led to investigations at other VA hospitals of the treatment that involves implanting tiny radioactive seeds into the acorn sized gland to kill tumor cells.

Although the NRC said it was particularly concerned about the VA’s failures to identify problems nationwide that were similar to those in Philadelphia, the nuclear agency decided against taking away the VA’s ability to oversee radiation safety at all its hospitals.

The NRC said it would hold a public meeting “to further discuss the actions” needed to improve the VA’s radiation safety oversight.

More coverage
 
VA on radiation hot seat tomorrow
 
NRC finds problems with radiation use in VA health system

“These violations should have been identified by the [VA] during their own independent inspections,” said Mark Satorius, the NRC regional administrator of Region III which oversees the VA’s radiation safety program. “We expect the [Department] to ensure all facilities with prostate brachytherapy programs not only fully understand and follow NRC regulations but also rigorously implement their oversight role to ensure medical procedures with nuclear materials are delivered safely.”

In Philadelphia, 97 of 114 veterans treated with brachytherapy got improper doses of radiation in brachytherapy procedures performed between February 2002 and June 2008 when the program was shut down.

Prostate brachytherapy involves implanting dozens of tiny radioactive seeds into the acorn-sized gland to kill cancerous cells over several months. It is an effective treatment when done correctly.

Records show that the Philadelphia VA’s program was deeply flawed from its earliest patients and that doctors and officials repeatedly missed chances to fix it.

In March, the commission levied a $227,500 fine against the VA for a series of failures at its Philadelphia hospital's prostate brachytherapy program that resulted in 97 veterans getting incorrect doses of radiation.

The failures in Philadelphia prompted the NRC to take a deeper look at other brachytherapy programs across the VA system. Now the VA has 30 days to accept or challenge the NRC fine. After that, the NRC will set a date for the public meeting to further examine the VA’s oversight of radiation safety.

In May 2010, the NRC cited three apparent violations of federal regulations at other 12 VA medical centers that performed prostate brachytherapy. On June 30, the agency held a conference an allowed the VA to respond to the problems.

Check out other stories on the prostate brachytherapy program at the Philadelphia VA:

Sunday, June 21, 2009
Feds see wider woes in VA's cancer errors

Sunday, July 19, 2009 
VA radiation errors laid to offline computer

Sunday, August 9, 2009
VA's prostate treatment woes began at Penn;
Prior to the VA program, leading brachytherapists said the Penn doctors performing the radioactive seed implants lacked the proper skills and safeguards.

Sunday, November 15, 2009
VA clinic troubles bring few penalties;
Despite poor care in the Phila. prostate program, the agency has only slapped a few hands

Wednesday, November 25, 2009
Claims against Phila. VA up to $58 million

Thursday, Mar. 18, 2010
NRC fines Phila. VA $227,500 over prostate care

Tuesday, May 4, 2010
Mistakes, little oversight cited for Phila. VA prostate cancer treatment

Wednesday, May 26, 2010
NRC finds apparent violations at 13 VA hospitals

To check out more Check Up items go to www.philly.com/checkup.

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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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