Saturday, August 1, 2015

NRC levies $227,500 fine against Philly VA Medical Center

The Philadelphia VA Medical Center was hit with a large fine by the U.S. Nuclear Regulatory Commission today for the failures in a prostate cancer program that resulted in 97 veterans getting incorrect radiation doses.

NRC levies $227,500 fine against Philly VA Medical Center

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Posing questions, Steven Reynolds, director of the Division of Nuclear Materials Safety, Region III (center), addresses staff of the Philadelphia VA Medical Center in December, 2009.
Posing questions, Steven Reynolds, director of the Division of Nuclear Materials Safety, Region III (center), addresses staff of the Philadelphia VA Medical Center in December, 2009. CLIFF OWEN / McClatchy Tribune

The Philadelphia VA Medical Center was hit with a large fine by the U.S. Nuclear Regulatory Commission today for the failures in a prostate cancer program that resulted in 97 veterans getting incorrect radiation doses.

The  $227,500 fine against Department of Veterans Affairs was the second largest ever levied by the NRC against a medical facility. The largest NRC fine was $280,000 in 1996 against the owners of hospitals in Indiana, Pa. and Marlton, N.J.
The VA has 30 days to contest the fine.

The NRC began a detailed investigation of the Philadelphia VA in June 2008 after it was discovered that dozens of patients implanted with tiny radioactive seeds to treat their prostate cancer got substandard care.

The nuclear agency oversees the medical use of radioactive materials.

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So far, 11 of the 114 veterans who underwent the brachytherapy procedures have had recurrences of their cancer, and eight show signs of a possible return. In addition, nine of the men sustained radiation injuries to their rectums, according to the VA’s latest information.

The treatment mistakes led to internal investigations, congressional scrutiny, the NRC probe, an ongoing review by the VA’s inspector general, and a flood of legal claims.

The VA inspector general is expected to issue its report next month.

At least 31 veterans or wives have filed claims seeking a total of $58 million against the VA, according to records obtained by The Inquirer through a Freedom of Information Act request.

Several lawmakers who have investigated the cases said the VA responses to the problems in Philadelphia were weak and slow.

The lead physician lost his VA job when the program closed. Another physician accepted a three-day suspension, and a radiation safety employee received a letter of reprimand in her personnel file.

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

On Feb. 3, 2003, for example, the brachytherapy team implanted its ninth patient, planning to put 74 radioactive seeds into his prostate. A routine check after the implant showed that 40 of the seeds landed in the bladder.

In another case in 2005, 45 of the 90 seeds implanted in an 86-year-old veteran were put in his bladder and had to be extracted.

Some seeds ended up near the rectum, and the patient reported significant pain in urination, records showed. He was one of eight Philadelphia patients whom the VA sent to Seattle last year for reimplantation.

An NRC report in November found the VA had committed eight apparent violations.

Those included failure to train staff on how to identify and report bad implants, a lack of procedures to ensure safe implants, and not reporting mistakes as quickly or fully as required.

In December, at the NRC’s pre-enforcement conference, the mood grew contentious when Philadelphia VA staff denied that they had violated federal regulations.

At that hearing the VA proposed new criteria for what counted as a medical mistake - a so-called medical event. The VA said based on its new criteria it planned to withdraw 78 of the 97 reported medical events in Philadelphia from 2002 through 2008.

A month later Gerald Cross, then-acting undersecretary for health at the VA, changed course and accepted all the violations, setting the stage for the NRC’s enforcement action today.

Also in January, Cross sent a letter to the NRC seeking to retract 80 medical events in Philadelphia. Using the VA’s new methods 17 of the 114 men treated there — 12 percent — got poor quality implants.

Check out some of our earlier stories on the problems at the Philadelphia VA:

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

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

July 23, 2009 Thursday 
Federal official quantifies Phila. VA problems

August 9, 2009 Sunday 
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.

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

November 18, 2009 Wednesday 
NRC cites VA clinic for radioactive-treatment violations

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

December 18, 2009 Friday 
VA apologizes but denies radiation violations

January 16, 2010 Saturday 
VA clinic now concedes violations

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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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