EA-99-210 - Saint Clare's Hospital
August 16, 1999
Stanley R. Sebastian
Vice President, Professional Services
Saint Clare's Hospital
400 W. Blackwell Street
Dover, NJ 07801-2525
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-02576/99-01)
Dear Mr. Sebastian:
This refers to the NRC inspection conducted on July 27 and 28, 1999, at your facility in Denville, New Jersey. The inspection was performed to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. During the inspection, the NRC learned, during a review of the minutes of one of your Radiation Safety Committee (RSC) meetings, that there was a loss of three iodine-125 brachytherapy seeds at your Dover, New Jersey, facility in April 1998. The NRC also learned that the loss of this material, which amounted to 0.79 millicuries of iodine-125 per seed, was not reported to the NRC as required. In a telephone conversation on August 11, 1999, you informed Dr. M. Shanbaky of my staff that St Clare's Hospital did not believe that a predecisional enforcement conference was needed to discuss this matter, nor did you believe that you needed to provide a written response prior to the NRC deciding on appropriate enforcement action.
The loss of the three seeds occurred after 57 other seeds had been implanted in a patient at your Dover facility. Prior to the implant procedure, a physicist loaded 80 seeds into cartridges (10 seeds per cartridge) which in turn were placed in a surgical instrument used to implant the seeds. After a physician performed the implant procedure, the physicist took the instrument and the used cartridges to a sink for cleaning, even though such cleaning was not specified in your written procedures. Apparently, the physicist was not aware that one of the cartridges contained three seeds which had not been implanted. Further, he did not perform a survey to determine whether the cartridge contained any seeds. Subsequently, when the physicist disassembled the cartridge, a spring in the cartridge pushed the three remaining seeds out of the cartridge into the sink where they were immediately washed down the drain and into the sewage system.
Based on the information developed during the inspection, three violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice). The violations involve (1) failure of the physicist to perform an adequate survey prior to cleaning the cartridges; (2) the subsequent loss of control of radioactive material when the seeds were pushed into the sink which resulted in the improper disposal of the radioactive seeds when they were washed down the sink and into the sanitary sewage system; and (3) the failure to notify NRC, within 30 days, after the material was lost. The licensee subsequently reported the loss of material to the NRC on July 28, 1999.
During the inspection, the NRC determined that this incident appeared to be an isolated occurrence which you identified, and for which you took appropriate corrective action. Nonetheless, these violations were significant because they resulted in the improper disposal of radioactive material into the sanitary sewage system. Therefore, collectively, these three violations are categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), 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 or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years or 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. Credit for corrective actions is warranted because your corrective actions, at the time of the inspection, were considered prompt and comprehensive. These actions include, but are not limited to, instruction of all personnel to (1) not clean the appliance or any cartridges in a sink; and (2) sterilize the equipment and to disassemble it on a stainless steel table. Also, your Radiation Safety Committee directed that the procedures be revised to include monitoring and surveying of applicators.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described adequately during the inspection and are adequately addressed on the docket in this 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).
James T. Wiggins
Docket No. 030-02576
License No. 29-13746-02
Enclosure: Notice of Violation
State of New Jersey
|St. Clare's Hospital
Denville, New Jersey
|Docket No. 030-02576
License No. 29-13746-02
During an NRC inspection conducted on June 27-28, 1999, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, the violations are listed below:
|A.||10 CFR 20.1501 (a) requires,
in part, that each licensee shall make or cause to be made, surveys
that may be necessary for the licensee to comply with the regulations
in this part; and are reasonable under the circumstances to evaluate
the extent of radiation levels; and concentrations or quantities of
radioactive material; and the potential radioactive hazard that could
Contrary to the above, the licensee did not make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in this part, and are reasonable under the circumstances to evaluate the extent of radiation levels, and concentrations or quantities of radioactive material, and the potential radioactive hazard that could be present. Specifically, on April 27, 1998, the licensee did not survey a surgical instrument that contained radioactive iodine (I-125) seeds, before cleaning the instrument in the operating room sink. As a result, the iodine seeds contained in the surgical instrument were washed down the sink drain and lost into the sewage system. (01013)
|B.||10 CFR 20.1802 requires that the licensee
shall control and maintain constant surveillance of licensed material
that is in a controlled or unrestricted area and that is not in storage.
10 CFR 20.2001 (a) requires, in part, that a licensee shall dispose of licensed material only by certain specified procedures.
Contrary to the above, the licensee did not maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. Specifically, on April 27, 1998 the licensee lost control of licensed material consisting of three seeds of iodine-125 with a total activity of approximately 2.1 millicuries when the seeds were inadvertently pushed into a sink in the operating room with water running. As a result, the licensee disposed of licensed material in a manner not authorized by 10 CFR 20.2001(a). This method of disposal is not authorized for encapsulated I-125 seeds. (01023)
|C.||10 CFR 20.2201 (a)(i)(ii) requires,
in part, that each licensee report by telephone to the NRC Operations
Center, within 30 days after the occurrence of any lost, stolen, or
missing licensed material becomes known to the licensee, all licensed
material in a quantity greater than 10 times the quantity specified
in appendix C to part 20 that is still missing at this time.
Contrary to the above, the licensee did not report the loss of licensed material by telephone to the NRC Operations Center, within 30 days after it became aware that the material was missing. Specifically, the licensee did not report the loss of 3 iodine-125 seeds with a total activity of 2.1 millicurie, a quantity greater than 10 times the quantity specified in Appendix C to Part 20. These seeds were determined to be lost on April 27, 1998 when they were inadvertently disposed of to the sanitary sewer system. (01033)
These violations are categorized as a Severity Level III problem (Supplement VI).
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence were adequately described during inspection, and are already adequately addressed on the docket in the NRC inspection report. 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 I, 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 or proprietary information so that it can be placed in the PDR without redaction.
Dated this 16th day of August 1999