ML20045A987
| ML20045A987 | |
| Person / Time | |
|---|---|
| Issue date: | 05/11/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Gorton S SENATE |
| Shared Package | |
| ML20045A988 | List: |
| References | |
| CCS, NUDOCS 9306160027 | |
| Download: ML20045A987 (2) | |
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- t UNITED STATES j jkg 1, j NUCLEAR REGULATORY COMMISSION D 22 h ' j WASHINGTON. D.C. 20555-0001 J
s May 11, 1993 The Honorable Slade Gorton United States Senator 130 Federal Building 500 West 12th Street Vancouver, Washington 98660
Dear Senator Gorton:
This information is provided in response to your letter of February 9,1993, concerning a request from your constituent, Ms. Jan Kirkpatrick, regarding several nationally-publicized medical misadministration events involving the use of radiation.
My staff recently provided the Commissioners with information (Enclosure 1) concerning the national (NRC and Agreement States) medical use program and our current regulatory activities, which are intended to prevent radiation injury or death from medical misadministrations.
Particular attention was directed toward medical radioisotope therapy, the principal practice in which serious radiation injury or death has occurred. NRC is aware that such consequences have occurred (Enclosure 2) and is reviewing the entire matter to determine if additional measures are warranted in our regulatory program.
Ms. Kirkpatrick mentions several events that occurred during 1975-1976 at the Riverside Methodist Hospital in Columbus, Ohio.
In April 1976, the hospital reported that a number of patients received radiation doses in excess of that intended.
In April and May 1976, the NRC Region III office conducted an investigation into the matter. The investigation disclosed that, during a ten-month period, approximately 385 patients received exposures in excess of 10% above the prescribed amounts; and that violations had occurred of NRC regulations current at the time.
A number of patients died soon after their treatment at the hospital.
In order to determine the cause of death, autopsies were performed. An NRC medical consultant, Dr. Eugene Saenger, reviewed three of 30 reported autopsy case and attributed excess radiation exposure as a major contributor to death in two of those cases.
Subsequent to correspondence between the NRC and Dr.
Saenger (Enclosures 3-6), further investigation of these cases by the NRC was stopped. However, it was recognized (Enclosure 7) that the Franklin County EA Coroner's office would continue its review in order to meet the public and legal need to know the actual cause of death. The results of the coroner's review are provided in Enclosure 8.
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If such an incident were to occur today, our actions in response would be g
different, in keeping with today's standards, policies, and requirements.
For oz example, the NRC now requires that all patients subject to misadministration, or a responsible relative or guardian, be notified by the licensee in writing.
3b Also, we now retain a medical consultant to review each misadministration and om provide us with advice on the medical consequences. To this extent, we do follow-up on each patient subject to misadministration. The NRC is now reevaluating the extent to which it should provide additional follow-up on g
patients involved in misadministrations.
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The Honorable Slade Gorton Your constituent believes that the NRC's medical consultant, Dr. Saenger, halted the investigation of the Riverside incident and that he did so out of concern for the liability of the hospital. However, the NRC, not Dr. Saenger, determined that "since the regulatory aspects relating to this matter have been resolved, there is no need for further medical review and evaluation of autopsy cases on behalf of the NRC" (Enclosure 5).
It is the NRC's position that an investigation following a medical misadministration will not be terminated due to a concern over medical liability.
Dr. Saenger said only that he questioned whether the mandate of the NRC required reviewing a larger number of autopsy cases, which, however, he acknowledged were of " medical-legal importance to the individuals concerned" (Enclosure 3). He also said that he would be " delighted to proceed with the inquiries at Riverside" (Enclosure 4).
A more recent case of a medical misadministration (Enclosure 9) has raised new concerns regarding certain aspects of safety in radiotherapy.
Over the years, the Nuclear Regulatory Commission has modified its medical use regulatory program to add specific requirements and to increase its oversight to reduce the likelihood of misadministrations.
Changes include the 1987 misadministration reporting criteria and the 1992 Quality Management Program and Misadministrations Rule. We will continue our review of our regulatory program to determine what additional measures are necessary to assure the public health and safety.
I trust this responds to your constituent's concerns.
Sincerely,
\\
C.
M.Taydr g-
[ tive Director xecu for Operations
Enclosures:
1.
SECY-93-007 " Aspects of the National Medical Use Program Related to Prevention of Misadministrations" dtd January 19, 1993 2.
James M. Taylor memo for the Commissioners on " Patient Deaths Attributed to Medical Radiation Exposure" dtd January 8,1993 3.
Eugene L. Saenger ltr to James Allen, Region III dtd November 17, 1977 4.
Eugene L. Saenger ltr to William L. Fisher, Region III dtd March 4, 1978 5.
A.B. Davis, Region III ltr to Eugene L. Saenger dtd May 11, 1978 6.
Eugene L. Saenger ltr to A.B. Davis, Region III dtd August 14, 1978 7.
James R. Flynn ltr to Jerry Phillip, Region III dtd May 28, 1976 8.
Myron Polycove, M.D. ltr to John E. Glenn dtd January 13, 1993 9.
Loss of an Iridium-192 Source and Therapy Misadministration at Indiana Regional Cancer Center Indiana, Pennsylvania, on November 16, 1992, U.S. Nuclear Regulatory Commission Report NUREG-1480, February 1993