A story that had been brewing for months has finally broken into the
mainstream media; the New York Times reports on a series of botched procedures at a V.A. hospital in Philadelphia. While regulatory agencies had
some clue that things were awry, the clinic was allowed to continue
operating on patients for six years before it was shut down. During those
six years, 92 of 116 prostate brachytherapy procedures were deficient in
some manner; as a result, patients were subjected to procedures that caused
painful complications and/or failed to deliver enough dose to treat their
cancer. The story is an example of how, in many ways, radiation therapy
clinics operate with very little oversight.
Prostate brachytherapy is a procedure in which radioactive seeds are placed
into the prostate to deliver a curative dose of radiation without dosing
surrounding tissue. Hollow needles are placed, usually by an urologist, in a
grid pattern in the prostate. The radiation oncologist, working from a
planned pattern of seed positions, then pushes the radioactive seeds through
the needles to the proper depth. The seeds have a half life of a month or
two (depending on the isotope used), and remain in the patient indefinitely,
delivering most of their dose over a period of three to six months.
It is important that the seeds be placed in the correct position. Critical
structures surrounding the prostate include the rectum, the bladder and the
urethra. The seeds are typically placed around the periphery of the
prostate, avoiding the urethra and keeping them safely away from the rectum
and bladder. Typically, two imaging modalities are used to verify the
placement of the seeds. While the needles are being inserted, their position
is monitored by an ultrasound probe. An x-ray technique known as fluoroscopy
is used to watch the seed insertion in real time to make sure that the seeds
do not migrate to a different part of the body.
In these procedures, the number of seeds used depends on the volume of the
prostate. About a week before the implant date, the patient undergoes a
procedure called a volume study in which the volume of the prostate is
measured using ultrasound. The physicist and radiation oncologist then
determine the number of seeds needed based on clinical guidelines.
Usually, the number of seeds ordered is increased by about 20% to account
for lost seeds or changes in the prostate volume. The number of seeds
depends on the technique used, but usually is in the neighborhood of sixty
to eighty. The seeds are shipped to the hospital where the medical physicist
measures their radioactivity to ensure that they will deliver the correct
dose of radiation.
In at least two of the procedures performed by Dr. Gary D. Kao at the
Philadelphia V.A. hospital, more than half of the seeds used ended up in the
bladder instead of the prostate. Rarely, during these procedures, one or two seeds
will migrate to the bladder. This is typically no big deal; the urologist
uses an instrument called a cystoscope to look through the urethra into the
bladder and retrieve any seeds he finds. I assisted on a number of these
procedures when I was going through my clinical training, and I remember at
least once when a seed had to be retrieved via cystoscopy. In one of the
procedures at the V.A., however, approximately 40 seeds ended up in the
bladder. The seeds were all removed, but could not be reused. This exceeded
the number of extra seeds available and therefore the planned distribution
of seeds could not be delivered.
The incident was reported to the V.A.’s Radiation Safety Committee, who
reported it to the Nuclear Regulatory Commission (NRC). The V.A. argued that
Dr. Kao had adapted his treatment plan in the operating room to fit the
number of seeds available, and that there was therefore no error. The NRC
agreed in this case, and also in a second case of Dr. Kao’s in which the
same error occurred.
Other mistakes also occurred. One patient, who was interviewed for the
article, had a painful radiation burn in his anal canal that required
surgery to correct. The article states,
All told, 57 of the implants delivered too little radiation to the prostate,
either because the seeds missed the prostate or were not distributed
properly inside the prostate. Thirty-five other cases involved overdoses to
other parts of the body. An unspecified number of patients were both
underdosed in the prostate and overdosed elsewhere.The NRC also found that from December 2006 to November 2007, 16 patients
received seed implants in Philadelphia even though computer interface
problems prevented medical personnel from determining whether those
treatments had been successful. The V.A.’s radiation officials knew of the
problem but took no action, the nuclear commission charges.
How could so many implants be performed incorrectly? Another article in the Philadelphia Inquirer, quotes an NRC staffer named Darrel Wiedeman saying “He refused to use fluoroscopy; said he didn’t need it.” Without being able to see where the seeds were placed in real time, it’s no wonder that so many ended up in the wrong position.
I first heard about this case in October of last year, when the V.A. shut
down the brachytherapy programs in Philadelphia and two other hospitals.
This article was posted on the medical physics listserv. Details, as usual
for cases that might lead to litigation, were sketchy; although many
speculated as to what the cause could be. With this new information, it
seems obvious that the problem was that the team was inexperienced and was
not subject to sufficient oversight. The article blames the NRC and the V.A.
radiation safety committee for not providing peer review. They also blame
the Joint Commission, which is responsible for accrediting hospitals. I
believe that misses the mark.
It is true that peer review is one of the strongest tools we can employ to
ensure the quality of our patient’s treatments. However, the NRC and the
Joint Commission are not equipped to provide that peer review. The mandate
of the NRC is to enforce regulations regarding the handling of radioactive
material. Steven A. Reynolds, director of nuclear materials safety for the
NRC is quoted in the article as saying “The N.R.C. isn’t in the business of
practicing medicine”. They do not have the authority to second guess the
decision of a doctor. The Joint Commission does a great job in enforcing
standards of patient care in many departments of a hospital. However, in all
of the Joint Commission inspections I have been through, I have never spoken
to a medical physicist or a radiation oncologist. The inspectors are often
nurses or doctors in a different specialty, but they do not have the
experience with radiation therapy necessary to know what a medical physicist
or radiation oncologist even does, much less if they are doing it correctly.
I agree that peer review is necessary, but the article does not mention the
body that has done the most work in developing an accreditation process to
ensure quality treatments in radiation oncology and radiology. The American College of Radiology has teams of radiation oncologists and medical
physicists who make site visits to a clinic and conduct a review of every
aspect of its medical and technical operation. These people are experts in
their field and would have quickly discovered errors such as the ones that
occurred in the Philadelphia V.A. Currently, this accreditation process is
costly and has no benefit besides public relations. On the radiology side,
however, Medicare has required that freestanding (not hospital) clinics with
CT or MRI must be accredited by the ACR to receive payment for imaging
services rendered. Other insurers are expected to follow suit, making ACR
accreditation a de facto requirement for a clinic to operate.
In my opinion, errors like this will continue to occur until radiation
therapy clinics are subject to the proper oversight. The ACR accreditation
process has been shown to work for diagnostic imaging clinics, and can work
for radiation therapy clinics. There is a push within the radiation therapy
community to mandate certain clinical standards (e.g., ACR accreditation and
the CARE bill, which has languished in Congress since 1999) Hopefully, with
the new focus on cost effectiveness in health care, ensuring the minimum
quality of treatments will become a priority.
