EA-99-174 - V.A., Department of, IA

October 14, 1999

EA 99-174

Gary L. Wilkinson
Medical Center Director
Department of Veterans Affairs
Medical Center
Iowa City, IA 52246-2208

SUBJECT:  NOTICE OF VIOLATION (NRC Inspection Report 030-01680/99001(DNMS))

Dear Mr. Wilkinson:

This refers to the inspection conducted at the Veterans Affairs Medical Center (VAMC), Iowa City, Iowa, on February 16 through 18, 1999, with continued review through October 1, 1999. The purpose of the inspection was to review the circumstances surrounding VAMC's failure to assess dose consequences to members of the public following the administration of Sn-117m to two human research subjects. Unresolved issues were identified and documented in the inspection report sent to you by our letter dated April 1, 1999. After further review, the unresolved issues were determined to be apparent violations of NRC requirements and were discussed in our letter dated August 10, 1999. As stated in that letter, the apparent violations were being considered for escalated enforcement and you were given an opportunity to request a predecisional enforcement conference and/or respond to the apparent violations. You elected to provide a written response.

Based on the information developed during the inspection and the information provided in your letter dated September 7, 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 failure to determine that members of the public were not likely to receive a total effective dose equivalent (TEDE) greater than 500 millirem from released human research subjects administered therapeutic doses of Sn-117m and the subsequent failure to provide the released subjects with written instructions on how to maintain doses to others as low as is reasonably achievable.

In 1998 VAMC participated in a double blind comparative study to evaluate the effectiveness of Sn-117m and Metastron (Sr-89) for pain relief in patients with bone metastasis. During the course of this study, two research subjects received dosages of 40 millicuries and 8 millicuries of Sn-117m respectively. Neither subject was evaluated by the staff to show compliance with 10 CFR 35.75 prior to release. On May 13, 1998, one research subject received 40 millicuries of Sn-117m, an amount requiring hospitalization for radiation purposes unless a calculation and/or radiation measurement determined that the subject was releasable.

The evaluation was not performed and the subject was released but remained in the hospital for medical reasons.

Because the subject was not being held for radiation purposes, the subject's room was not posted with a "Radioactive Materials" sign, dose rates in contiguous restricted and unrestricted areas were not measured, items removed from the subject's room were not surveyed, and the room was not surveyed before it was occupied by another patient or human research subject. Release of this subject resulted in a significant potential for members of the public to receive a TEDE in excess of 500 millirem. In addition, the subject dosed with 8 millicuries of Sn-117m in December 1998 was not given adequate written instructions addressing actions recommended to maintain doses to other individuals as low as is reasonably achievable. The failure of VAMC's radiation safety committee to recognize that the human use research protocol for Sn-117m included dosages that would normally require hospitalization and that the model instructions to the human research subjects were inadequate for the radiation emitted is unacceptable.

The NRC provides significant latitude to its broadscope licensees to oversee their own use of byproduct material. Incumbent upon such licensees, including VAMC, is the responsibility to thoroughly review all proposed uses of byproduct material to ensure that all potential radiological implications are identified and addressed prior to approving the application for use. The NRC recognizes that VAMC has historically used the resources of a neighboring facility to support its review of such activities; however, the ultimate responsibility for those reviews rests with VAMC, including any errors or omissions on the part of that facility. The NRC concluded that VAMC's failure to evaluate the possible doses to family members and others resulted in a substantial potential for exposures to members of the public in excess of the regulatory limit of 500 millirem. Fortunately, in these two instances, doses to members of the public (including family members) did not exceed regulatory limits; however, individuals received between 113 millirem and 250 millirem. Therefore, the violation is 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 not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for 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 Corrective Action is warranted based on the following actions taken and/or planned: (1) the radiation safety officer (RSO) has been administratively moved and will report to the Chief Operations Officer; (2) the Radiation Safety Committee (RSC) implemented a policy requiring the use of a form, "Worksheet for Documentation of Release of Patients Administered I-131 or Therapeutic Amounts of Radioactive Material"; (3) technical and clerical staff received training covering the release of patients, the provision of written instructions for safety purposes, and documentation of the justification of early release of patients; and (4) all human use research proposals involving radiation will be forwarded to the RSO with an abstract of the research and the consent form for RSC review.

Therefore, to encourage prompt 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 a letter from VAMC dated September 7, 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.

		Sincerely,
	Original Signed By	J. E. Dyer Regional Administrator

Docket No. 030-01680
License No. 14-00822-01

Enclosure: Notice of Violation

cc w/encl:
E. Lynn McGuire
National Health Physics Program (1 15HP/NLR)
Department of Veterans Affairs
Veterans Health Administration
2200 Fort Roots Drive
North Little Rock, Arkansas 72114

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NOTICE OF VIOLATION
Department of Veterans Affairs Medical Center Iowa City, Iowa		Docket No. 030-01680 License No. 14-00822-01 EA 99-174

During an NRC inspection conducted on February 16 through 18, 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) and (b) require, in part, that (1) 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 is not likely to exceed 5 millisieverts (0.5 rem) and (2) the licensee provide released individuals with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (100 millirems).

Contrary to the above, the licensee released individuals who had been administered radiopharmaceuticals and the licensee did not determine if the exposure to any other individual could potentially exceed 5 millisieverts (0.5 rem). In addition, the licensee did not provide instructions to the individuals on actions recommended to maintain doses to those other individuals as low as is reasonably achievable when the total effective dose equivalent to other individuals was likely to exceed 1 millisievert. Specifically, on May 20, 1998 and December 9, 1998, the licensee released human research subjects who had been administered 40 millicuries and 8 millicuries of Sn-117m without determining if the exposure to any other individual could potentially exceed 5 millisieverts (0.5 rem) and without providing written instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable. (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 a letter from the Department of Veterans Affairs Medical Center dated September 7, 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 14th day of October 1999