EA-97-529 - V.A., Department of, CA
Acting Medical Center Director
Department of Veterans Affairs
4150 Clement Street
San Francisco, California 94121
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01214/97-01)
Dear Ms. Cullen:
This refers to your letter dated December 23, 1997, in response to apparent violations described in an NRC inspection report issued on November 26, 1997. The NRC's inspection was completed November 14, 1997, and was in response to an event involving the loss of a phosphorus-32 (P-32) source on August 18, 1997. The Department of Veterans Affairs reported this incident to the NRC on September 2, 1997. Prior to making an enforcement decision, we provided you with an opportunity to respond in writing to the apparent violations or to request a predecisional enforcement conference. You chose to provide a written response and did so on December 23, 1997. You did not dispute the apparent violations.
Based on the information developed during the inspection and the information that you provided in your December 23, 1997, response to the inspection report, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice). The circumstances surrounding them were described in more detail in the subject inspection report. The first violation involved a failure to verify that the contents of a package containing three P-32 vials agreed with the packing list for the shipment received and to survey the package for contamination before it was disposed to normal trash. The second violation involved the unauthorized disposal of a single P-32 vial to normal, non-radioactive trash.
Approximately 305 microcuries of P-32 was estimated to have been inadvertently disposed of in normal trash, and is not believed to have resulted in any actual safety consequences to your staff or members of the public. As you indicated in your response, this event appears to have been isolated and was caused by the lack of attention to detail by a single researcher. Nonetheless, the NRC considers the lack of control of radioactive material to be a serious matter, especially in cases of inadvertent disposal because of the potential for inadvertent exposures to employees and members of the public. Therefore, the violations that caused this incident are classified in the aggregate as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered only 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 corrective actions described in your December 23 letter included: 1) a prompt and thorough search for the missing material; 2) the issuance of a violation to the responsible laboratory; 3) surveys of laboratories and garbage receptacles; 4) bioassays of laboratory personnel; 5) a thorough investigation to determine root and contributing causes ; 6) promptly informing all researchers of the events leading to the loss of the material and the need to survey packages prior to disposal; 7) retraining of all radiation safety personnel and annual refresher training of all radioactive material users; 8) performance based audits of package receipt; and 9) procedural revisions to assure that users are aware of the number of vials of materials in each package. As such, we have determined that you are deserving of credit for your prompt and comprehensive corrective actions.
Therefore, to recognize and encourage comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action at your facility, I have been authorized not to propose a civil penalty in this case. However, you are on notice that significant violations in the future, particularly any involving the loss of radioactive material, could result in a civil penalty. In addition, issuance of this Severity Level III problem constitutes escalated enforcement action that may subject you to increased inspection effort.
The NRC has concluded that information regarding the reason for the violations, 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 the subject NRC Inspection Report and in your December 23 letter. 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 and its enclosure will be placed in the NRC Public Document Room (PDR).
Sincerely, Ellis W. Merschoff Regional Administrator
Docket No. 030-01214
License No. 04-00421-05
Enclosure: Notice of Violation
California Radiation Control Program Director
Dr. Milton Gross
Department of Veterans Affairs
Nuclear Medicine Program
24 Frank Lloyd Wright Drive
P.O. Box 505
Ann Arbor, Michigan 48106
Edwin M. Leidholdt, Jr., Ph.D
Radiation Safety Program Manager (134RAD)
Department of Veterans Affairs
301 Howard Street, Suite 700
San Francisco, CA 94105-2241
Department of Veterans Affairs Docket No. 030-01214 San Francisco, California License No. 04-00421-05 EA 97-529
During an NRC inspection conducted October 16 through November 14, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:
A. 10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain specified procedures.
Contrary to the above, on August 18, 1997, the licensee disposed of approximately 305 microcuries of phosphorus-32 by release to non-radioactive trash, a method not authorized by §20.2001. (01013)
B. License Condition 24.A requires the license to conduct its program in accordance with the statements, representations, and procedures, including any enclosures contained in the application dated October 11, 1990. The application October 11, 1990, states in Item No. 10.7 that, except for radiopharmaceuticals and kits procured and administered to patients directly by the Nuclear Medicine Service, the licensee will establish and implement the model procedure for opening packages containing radioactive material as described in Appendix L to Regulatory Guide 10.8, Revision 2. Model procedure 2.d.(3), Appendix L in the above regulatory guide, requires the licensee to open a shipment's inner package and verify that the contents agree with the packing slip. Appendix L model procedure 2.g. requires the licensee to monitor the packing material and the empty packages for contamination with a low-range GM survey meter before discarding.
Contrary to the above, on August 18, 1997, a licensee researcher who opened an inner package of a shipment enclosing three vials, each containing 305 microcuries of phosphorus-32, did not verify that the radioactive contents agreed with the packing slip accompanying the shipment. Also, on August 18, 1997, the researcher did not monitor the packing material and package with a low-range GM survey meter to ensure that it was empty and free of contamination before it was discarded as normal, non-radioactive waste. The discarded package, containing a single vial of approximately 305 microcuries of phosphorus-32, was later disposed as normal trash in a general waste landfill. (01023)
These violations represent a Severity Level III problem (Supplement IV).
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will was achieved is already adequately addressed on the docket in Inspection Report No. 030-01214/97-01 and the letter from the Licensee dated December 23, 1997. 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, D.C. 20555 with a copy to the Regional Administrator, Region IV.
If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001, and a copy to the Enforcement Officer, NRC Region IV.
Because any response you choose to submit will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).
Dated at Arlington, Texas
this 15th day of January 1998