ML20058N593

Discusses Seven Citizens (One Telephone Caller & Six Ltr Writers) Whose Records of Contact Were Forwarded to NRC for Investigation & Follow Up on Radiation Safety Concerns

ML20058N593
Person / Time
Issue date:	09/23/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Glenn J SENATE, GOVERNMENTAL AFFAIRS
References
CCS, NUDOCS 9310190314
Download: ML20058N593 (6)

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t UNITED STATES

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NUCLEAR REGULATORY COMMISSION "f

WASHINGTON. D.C. 20566-0001 September 23, 1993 The Honorable John Glenn, Chairman Committee on Governmental Affairs United States Senate Washington, DC 20510

Dear Mr. Chairman:

This letter refers to the seven individuals (one telephone caller and Six J

letter writers) whose records of contact with your office were forwarded to the U. S. Nuclear Regulatory Commission.

i One letter dealt exclusively with an NRC-licensed commercial nucleu pharmacy.

c The letter writer was concerned about possible inadequate radiation safety practices at the nuclear pharmacy -- not patient treatment

'is letter is l

being handled as an allegation, and ERC's regional inspector are following up

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on the concerns.

A review of NRC's allegation and inspection records indicated that NRC was not informed of the writer's concerns 'until NRC received the letter sent to you. We are looking into why NRC was not informed of these concerns earlier.

Both the individual who worked in the nuclear pharmacy and the pharmacy manager should have known how to report these concerns to NRC. Our records show that the licensee posted a copy of NRC Form 3, " Notice to Employees" (Enclosure 1), in the nuclear pharmacy, as required in Part 19 of Title 10 of the Code of Federal Reculations. This form specifically informs employees to report safety concerns to NRC, and how co contact NRC.

The telephone call and remaining five letters were handled in the same manner as the first set of letters received and responded to in my letter to you dated July 7,1993.

The telephone caller and each letter writer, who are identified by initials in Enclosure 2, were contacted by telephone, to obtain additional information.

NRC and the U.S. Food and Drog Administration (FDA) staff coordinated efforts to contact each person, to minimize duplication of effort and inconvenience to them. NRC collected information regarding NRC L

authority over the incidents and the applicability of NRC regulations,

' including the medical treatment facility, year of treatment, and radiation treatment device (also in Enclosure 2), as well as potential concerns about administration error. The FDA collected additional patient incident information, which can be found in the FDA's Product Problem Reporting Program

.(PRP) reports.

g The individual who contacted your office by telephone made it clear that he did not want the government to follow up on his case.

His primar' intent was to let your office know that ne believes that if proper surveys were done, the

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physical complication rates associated with radiation therapy would be high.

He took exceptim to the American College of Radiology's comment that implied E

L that the complic tion rate for radiation therapy was low.

The caller based 1

his conclusion on his own experience, limited personal experiences gained from

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The Honorable John Glenn co-workers,'and his observation that when he and his co-workers' relatives'had complications, they went-to physicians who could treat their symptoms, rather than the radiation therapy physician.

We obtained further information from the letter writers through telephone conversations with these individuals.

Based on this, two of the incidents, described in the letters and discussed in greater oetail below, involved material covered pursuant to the Atomic Energy Act of 1954, as amended (AEA),

and the Energy Reorganization Act of 1974 (Public Law 93-438).

In the first case, the radiation treatment was provided in Texas, an Agreement State. - In the second case, the treatment was provided in 1982, before Illinois became an Agreement State (in 1987).

In both cases, a second radiation therapy modality was also used.

In one case, it was a linear accelerator, and in the other, it was a brachytherapy source that may or may not have contained AEA-regulated material.

In the case involving both cobalt-60 and linear accelerator teletherapy, the' patient's surviving spouse did not allege that there were errors made during the delivery of the radiation therapy treatments.

She was, however, quite concerned because she believed she and her husband were not adequately informed about the complications.

In the case involving both cobalt-60 teletherapy and 'orachytherapy, the patient wanted' to know if there was a device problem and believes she received too much radiation because she was one of the first lumpectomy/ radiation therapy patients.

The appropriate Agreement States are following up on these two letters.

In a third case, although the patient's surviving spouse indicated in her letter that her husband was treated with radium, her telephone description of the treatment indicated either a cesium-137 or linear accelerator teletherapy device. The patient's wife did not allege that there were errors made during the delivery of the radiation therapy treatments. She indicated th.t she was quite concerned that she and her husband were not told of the radiation-complications he may have receiv~1 until she heard a physician discuss her husband's case with a medical student. NRC Region III will attempt to clarify the issue of the. specific t/pe of treatment given, during its upcoming inspection of the facility providing the treatment.

At this point, there are no allegations of either treatment errors or known equipment failures in these cases, but further information is being sought.

The State of Texas did not have a misadministration requirement in 1982, when the patient in that State was treated. NRC did have misadministration requirements when the Ohio and Illinois patients were treated by NRC licensees.

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The Honorable John Glenn !

For the three patients in Texas, Virginia, and Ohio that received treatment delivered by linear accelerators, the FDA is providing copies of the letters, and information gathered, to the appropriate State Regulatory Authority in the States in which the therapy occurred.

In summary, NRC is continuing to follow up on the radiation safety concerns at the radiopharmacy, work with Texas and Illinois on the cobalt-60 cases in their states, and attempt to clarify the type of treatment received in the Ohio case.

FDA will be following the cases involving linear accelerator and I

naturally occurring radioactive materials.

Sincerely,

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esM.Tahkor E/ecutive Director for Operations

Enclosures:

1. NRC Form 3

2. Summary of Treatment Device and Facility Information, by Individual cc: Senator William V. Roth, Jr.

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SUMMARY

OF TREATMENT DEVICE AND FACILITY INFORMATION, BY INDIVIDUAL TREATMENT THERAPY TREATMENT INDIVIDUAL RESIDENCE YEAR DEVICE FACILITY i

Patient Treated with at least one NRC-Reaulated Device CP Lombard,IL 1982 Cobalt-60 Hinsdale Hospital

& Brachy RBC Groves,TX 1982 Cobalt-60 M.D. Anderson

& LINAC Houston, TX Patient Treated with possible NRC-Reaulated Device HH Reynoldsburg,0H 1986

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Ohio State University Hospital Columbus. OH Patient Treated with non-NRC-Reaulated Device EAF Richmond, VA 1992 LINAC Medical College of Virginia Richmond, VA GL

• Perrysburg, OH MHP Fostoria, OH 1985 LINAC Toledo Radiology Toledo, OH Individual does not want the government to follow up on his case.

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L Septeber 23, 1993 The Honorable John Glenn,

For the three patients in Texas, Virginia, and Ohio that received treatment delivered by linear accelerators, the FDA is providing copies of the letters, and information gathered, to the appropriate State Regulatory Authority in the i

States in which the therapy occurred.

In summary, NRC is continuing to follow up on the radiation safety concerns at the radiopharmacy, work with Texas and Illinois on the cobalt-60 cases in their states, and attempt to clarify the type of treatment received in the Ohio case.

FDA will be following the cases involving linear accelerator and naturally occurring radioactive materials.

Sincerely, Original signed by James M. Taylor James M. Taylor Executive Director for Operations

Enclosures:

1. NRC Form 3

2. Summary of Treatment Device and Facility Information, by Individual cc:

Senator William V. Roth, Jr.

DISTRIBUTION ED0-9161 w/enci NHSS r/f NRC File Center NMSS Dir. Off r/f IMNS Central File PRathbun CPoland CEstep DMorris, EDO EDO r/f OSP EDO r/f MKnapp JSniezek, EDO JBl aha, EDO EBeckjord, RES RVollmer, OPP JScinto, 0GC Tech ED, EKraus, 09/13/93

• see previous concurrence

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