EA-99-175 - Ohio State University
October 7, 1999
Ms. Janet Ashe
Vice President for Business
The Ohio State University
108 Bricker Hall
190 North Oval Mall
Columbus, OH 43212-1362
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report 030-02640/99001(DNMS))
Dear Ms. Ashe:
This refers to the inspection conducted at The Ohio State University (OSU), Columbus, Ohio, campus on March 3 and 4, 1999, with continued review through October 1, 1999. The purpose of the inspection was to review the circumstances surrounding an administration to a human research subject of approximately 45 millicuries of Sn-117m and the subsequent release of said subject. One unresolved item was identified and documented in the inspection report sent to you by our letter dated March 24, 1999. After further review, the unresolved item was determined to be an apparent violation of NRC requirements and was discussed in our letter dated August 5, 1999. As stated in that letter, the apparent violation was being considered for escalated enforcement and you were given an opportunity to request a predecisional enforcement conference and/or respond to the apparent violation. You elected to provide a written response.
Based on the information developed during the inspection and the information that you provided in your letters dated August 23 and 31, 1999, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved the release of a human research subject without determining whether the quantity of radioactive material administered to the individual could potentially cause members of the public to receive radiation exposures greater than 500 millirem.
Between December 1998 and February 1999, OSU participated in a human research protocol to evaluate the effectiveness of Sn-117m on pain relief of patients with bone metastasis. The study was a double-blind comparative study of Sn-117m and Metastron (Sr-89). Four patients participated in the project; three were given Sn-117m, and one was administered Sr-89 Metastron. Only OSU's nuclear pharmacist and a nuclear medicine technologist were unblinded because they prepared the radiopharmaceuticals for administration. All proposals to perform human research experiments including this one are reviewed and approved by at least three formal OSU committees such as the Institutional Review Board and the radiation safety staff. Nonetheless, OSU staff failed to recognize that the quantities of Sn-117m used required an evaluation to determine potential exposures to members of the public (patient family members included) to ensure compliance with 10 CFR Part 35. The NRC provides significant latitude to its broadscope licensees to oversee their own use of byproduct material. Incumbent upon such licensees is the responsibility to thoroughly review all proposed uses of byproduct material to ensure that potential radiological implications are identified and addressed prior to approving the application for use. The NRC concluded that OSU's failure to evaluate the possible dose to family members in this case resulted in a substantial potential for an exposure to the subject's spouse in excess of the regulatory limit of 500 millirem. It is fortunate that the subject's life style was such that the radiation dose to his spouse was only about 440 millirem. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has been the subject of escalated enforcement actions within the last two inspections,(1) the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. The NRC has determined that credit for Identification is warranted based on the Licensee's discovery of problem. Credit is also warranted for Corrective Action which included: (1) the patient questionnaire was revised to include questions relative to patient's living conditions; (2) the patient instruction was revised to include that close contact with family members should be minimized, focusing on time, distance, and shielding; and (3) the pertinent staff received training on 10 CFR 35.75 and Regulatory Guide 8.39.
Therefore, to encourage prompt identification and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.
The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in letters from Licensee dated August 23 and 31, 1999. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to provide one, will be placed in the NRC Public Document Room.
|Original Signed By||J. E. Dyer
Docket No. 030-02640
License No. 34-00293-02
Enclosure: Notice of Violation
cc w/encl: Robert Peterson, RSO
NOTICE OF VIOLATION
|The Ohio State University
|Docket No. 030-02640
License No. 34-00293-02
During an NRC inspection conducted on March 3 and 4, 1999, with continued review through October 1, 1999, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:
10 CFR 35.75 (a) requires, in part, that the licensee may authorize the release from its control any individual who has been administered radiopharmaceuticals if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).
Contrary to the above, the licensee released from its control an individual who had been administered radiopharmaceuticals and did not determine if the total effective dose equivalent to any other individual from exposure to the released individual was not likely to exceed 5 millisieverts (0.5 rem). Specifically, on February 2, 1999 the licensee released from its control a human research subject who had been administered 45.43 millicuries of Sn-117m without determining if the exposure to any other individual was not likely to exceed 5 millisieverts (0.5 rem). (01013)
This is a Severity Level III violation (Supplement VI).
The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in letters from Licensee dated August 23 and 31, 1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 7th day of October 1999
1. A Severity Level III violation and a $13,000 civil penalty was issued on October 23, 1997 (EA 97-258).