EA-99-332 - Pocatello Regional Medical Center
March 3, 2000
Kathryn Decker, Interim Administrator
Pocatello Regional Medical Center
777 Hospital Way
Pocatello, Idaho 83201-2797
|SUBJECT:|| NOTICE OF VIOLATION
(NRC Inspection Report No. 030-32225/99-01)
Dear Ms. Decker:
This refers to the predecisional enforcement conference conducted on February 16, 2000, in the NRC Region IV office in Arlington, Texas. The purpose of the conference was to discuss five apparent violations that were identified during a routine inspection we conducted at your facility. The apparent violations related to an incident involving the partial incineration of a molybdenum-99/technetium-99m generator package (generator) on June 10, 1997. The results of the inspection were discussed with you on January 6, 2000, and were documented in the subject inspection report dated February 2, 2000.
Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations include: (1) failure to secure a generator from unauthorized removal as it was stored in an unrestricted area (the hallway); (2) failure to limit the external dose from a generator temporarily stored in an unrestricted area to 2 millirem in any one hour; (3) failure to provide the NRC with a written report within 30 days of an incident involving radiation levels in unrestricted areas exceeding 10 times the limit contained in 10 CFR 20.1301 in the hallway; and (4) failure to conduct adequate surveys to monitor for personnel exposures and to evaluate potential contamination on facilities and equipment and any associated radiological hazards caused by the incident. These violations represent deficiencies in your radiation safety program which contributed to the incident, as well as deficiencies in responding to the incident.
The significance of these violations is that licensed material was not properly secured or controlled, and thus was accessible to members of the public, resulting in the generator being nearly incinerated. Therefore, these violations are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity Level III problem.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 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 whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Your immediate corrective actions were designed to restore safety and included additional training of the housekeeping staff, cautioning the nuclear medicine technologist against leaving generators in the hallway, obtaining advice from your consultant, and reviewing the event in the radiation safety committee meeting. After the inspection, we noted that your corrective actions were markedly more comprehensive and included: a formal root cause evaluation, additional training of your nuclear medicine staff in NRC requirements, additional training of environmental services staff, developing plans to identify another individual to perform as the radiation safety officer (RSO) to improve oversight of the radiation safety program, formally identifying RSO duties, modifying receipt procedures to ensure the generators are promptly placed in locked storage, developing plans to transfer decayed generators in a more timely manner in order to provide adequate storage capacity, developing staff performance assessment tools, and obtaining RSO support from other hospitals within your organization. Although two of the violations related to inadequacies in your immediate actions, on balance we have determined that you are deserving of corrective action credit.
Therefore, to encourage 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 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.
Our inspection report identified an apparent violation that, after further review of the circumstances, we have determined did not occur. The apparent violation was unauthorized disposal of a generator containing byproduct material by incineration. Further, we modified the fourth violation (failure to report to the NRC) from the apparent violation identified in the inspection report. Specifically, we have determined that, in this case, your failure to report the incident to the NRC within 24 hours was not a violation. However, the failure to provide the NRC with a written report within 30 days following the incident was determined to be a violation, and this violation is cited in the attached notice.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room.
|Ellis W. Merschoff
Docket No. 030-32225
License No. 11-27072-01
Enclosure: Notice of Violation
Idaho Radiation Control Program Director
NOTICE OF VIOLATION
|Pocatello Regional Medical Center
|Docket No. 030-32225
License No. 11-27072-01
During an NRC inspection which concluded on January 6, 2000, 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:
|1.||10 CFR 20.1801 requires that the licensee
secure from unauthorized removal or access licensed materials that
are stored in unrestricted areas. 10 CFR 20.1802 requires that the
licensee control and maintain constant surveillance of licensed material
that is in an unrestricted area and that is not in storage. As defined
in 10 CFR 20.1003, unrestricted area means an area,
access to which is neither limited nor controlled by the licensee.
Contrary to the above, on June 9-10, 1997, the licensee did not secure from unauthorized removal or limit access to 530 millicuries of molybdenum-99 and technetium-99m in a radionuclide generator located in a radiology hallway, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. (01013)
|2.||10 CFR 20.1301(a)(2) requires that the licensee conduct operations
so that the dose in any unrestricted area from external sources does
not exceed 2 millirem in any one hour.
Contrary to the above, on June 9-10, 1997, licensee operations resulted in a dose of 27 millirem in any one hour in a radiology hallway, an unrestricted area. (01023)
|3.||10 CFR 20.2203(a) requires, in part, that each licensee
submit a written report to NRC within 30 days after learning
of any incident for which notification is required by § 20.2202
or that involves levels of radiation in an unrestricted area exceeding
10 times any applicable limit in 10 CFR Part 20 (whether or not involving
exposure of any individual in excess of the limits in § 20.1301).
Contrary to the above, as of February 2, 2000, the licensee failed to submit to the NRC a written report after discovery of an incident on June 10, 1997, that involved a radiation level exceeding 10 times the limit in § 20.1301. Specifically, as shown in Violation 2 above, the event involved licensed operations resulting in a dose rate of 27 millirem per hour, which is greater than 10 times the limit of 2 millirem in any one hour specified in § 20.1301, in a radiology hallway, an unrestricted area. (01033)
|4.||10 CFR 20.1501 requires that each licensee make or cause to be made
surveys that may be necessary for the licensee to comply with the
regulations in Part 20 and that are reasonable under the circumstances
to evaluate the extent of radiation levels, concentrations or quantities
of radioactive materials, and the potential radiological hazards that
could be present.
Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.
Contrary to the above, as of January 6, 2000, the licensee did not make surveys to evaluate the extent of radiation levels and quantities of radioactive materials and the potential radiological hazards that could be present following the partial incineration of a radionuclide generator package on June 10, 1997. Specifically, surveys were not conducted to measure the quantities of molybdenum-99 and technetium-99m contamination that may have been present on the internal and external surfaces of the generator and incinerator facility and in the ash following incineration. Surveys were also not conducted to monitor (bioassay) a technologist and incinerator operator for the possible intake of airborne radioactive material released during and following the partial incineration of the generator package, and to assure compliance with the 0.1 rem dose limit for members of the public as required by § 20.1301(a)(1), and for the 5 rem dose limit for occupational exposure as required by § 20.1201(a). (01043)
These violations represent a Severity Level III problem. (Supplements IV and VI).
Pursuant to the provisions of 10 CFR 2.201, Pocatello Regional Medical Center is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
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.
Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Because your response 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).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 3rd day of March 2000