EA-96-524 - St. Francis Medical Center
Mr. Myron L. Tong, Assistant Administrator
St. Francis Medical Center
Nuclear Medicine Department
2230 Liliha Street
Honolulu, Hawaii 96817
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-03557/96-01)
Dear Mr. Tong:
This refers to the January 24, 1997, letter St. Francis Medical Center (St. Francis) submitted in response to the apparent violation identified in NRC Inspection Report 030-03557/96-01, issued on January 14, 1997. We note that your letter was received in our office on February 14, 1997. In a separate letter dated January 24, 1997, St. Francis responded to a Notice of Violation issued with the inspection report that cited other violations. We will respond to that letter separately.
The NRC inspection was completed on December 10, 1996. As indicated in the NRC letter transmitting the inspection report, one apparent violation was identified involving the security of licensed radioactive material, i.e., sodium iodide iodine-131 capsules. St. Francis was given a choice of requesting a predecisional enforcement conference or submitting a written response to the apparent violation. St. Francis chose to submit a written response.
In its written response, St. Francis did not dispute the apparent violation but took issue with the statement in the inspection report, which was attributed to the St. Francis radiation safety officer, that iodine-131 capsules were "routinely" stored in the fume hood located in a room adjacent to the hot lab. In a subsequent letter dated February 20, 1997, the radiation safety officer indicated that the capsules found in the fume hood during the inspection may have been left there overnight. Regardless of whether this was a routine practice or was an isolated failure, the facts of the violation discovered during the inspection are not affected.
St. Francis's January 24 letter also described specific actions taken to correct the violation. These actions included the immediate return of the capsules to the hot lab, instructions to all technologists that all radioactive materials must be kept in the hot lab, follow-up checks by the radiation safety officer and chief technologist, and the placement of a sign on the fume hood stating that no radioactive materials are to be stored there.
Based on the information developed during the inspection, and the information that you provided in your response to the inspection report, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and involved a failure in November 1996 to meet NRC requirements regarding the security of radioactive materials.
Although the violation did not result in the theft or loss of radioactive material, the purpose of securing materials is to prevent the unauthorized removal of materials that could pose a health and safety hazard. The NRC considers such violations a matter of significant regulatory concern; thus, this violation has been classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600.
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 action within the last 2 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. Given that the corrective actions described above were both prompt and comprehensive, credit is due for your corrective actions, resulting in no civil penalty being assessed in this case.
Accordingly, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future, particularly violations of a similar nature, could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action which may subject you to more frequent inspection by NRC.
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 Inspection Report No. 030-03557/96-01 and letter from St. Francis dated January 24, 1997. 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 submit one, will be placed in the NRC Public Document Room (PDR).
Should you have any questions concerning this letter, please contact Linda Howell at (817) 860-8213.
Sincerely, org signed by Thomas Gwynn for J. E. Dyer Acting Regional Administrator
Docket No. 030-03557
License No. 53-11966-01
Enclosure: Notice of Violation
State of Hawaii
Sister Davilyn Ahckick
Chairman, Board of Trustees
St. Francis Medical Convent
2715 Pamoa Road
Honolulu, Hawaii 96822
St. Francis Medical Center Docket No. 030-03557 Honolulu, Hawaii License No. 53-11966-01 EA 96-524
During an NRC inspection conducted November 20 through December 10, 1996, 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 20.1801 requires that a licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that a licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, to which access can be limited by the licensee for any reason. An unrestricted area means an area in which access is neither limited nor controlled by the licensee.
Contrary to the above, on November 21, 1996, the licensee did not secure from unauthorized removal or access licensed material stored in a controlled area. Specifically, six capsules containing a total activity of approximately 19 microcuries iodine-131 were stored in a fume hood located in a controlled area, and the capsules were not secured from unauthorized removal or access. (01013)
This is a Severity Level III Violation (Supplement IV).
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 Inspection Report No.030-03557/96-01 and letter from the St. Francis Medical Center dated January 24, 1997. Therefore, no response to this Notice is required. 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, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.
Dated at Arlington, Texas
this 5th day of March 1997