EA-00-187 - Wheeling Hospital, Inc.
October 12, 2000
Wheeling Hospital, Inc.
ATTN: Donald H. Hofreuter, M.D.
Chief Executive Officer
1 Medical Park
Wheeling, West Virginia 26003-6300
|SUBJECT:||NOTICE OF VIOLATION (INSPECTION REPORT NO. 47-05322-02/00-01)|
Dear Dr. Hofreuter:
This refers to the Nuclear Regulatory Commission (NRC) inspection conducted on July 25, 2000 at your Wheeling, West Virginia facility, and our subsequent review and discussions of documentation you provided the NRC on August 7, 2000. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The results of the inspection, including two apparent violations, were discussed with you on September 7, 2000, and formally transmitted by letter of the same date. This letter also provided you the opportunity to either respond to the apparent violations in writing or request a predecisional enforcement conference. By letters dated September 15 and September 20, 2000, you declined a conference and responded to the apparent violations, addressing the cause and corrective actions to prevent recurrence. We have reviewed your response and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.
Based on the information developed during the inspection and the information you provided in your 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), and the circumstances surrounding them are described in detail in the subject inspection report. Violation A, cited in the Notice, involves the failure to maintain adequate security or control of licensed materials. Specifically, a high dose rate (HDR) brachytherapy device, containing an 8.98 Curie (Ci) Iridium-192 sealed source, and a transportation container, containing a 3.422 Ci Iridium-192 sealed HDR sealed source, were located in the hospital's brachytherapy room which was not maintained under constant surveillance or locked when unattended.
In your response of September 20, 2000, you did not specifically deny the violation; however, you indicated that in your judgement access to licensed material was rigorously controlled during working hours. Based on direct observation of the physical layout of the facility as maintained at the time of inspection, the NRC concluded that licensed materials were potentially accessible to unauthorized individuals during working hours. The entrance through the main oncology lobby was routinely monitored for access; however, the remaining two entries, although reasonably visible from other locations in the facility, were not constantly surveilled. When unattended, constant surveillance of licensed material is required except when such material is secured (i.e., locked). As noted in the subject inspection report, the door to the HDR brachytherapy room could not be secured due to an inoperable lock. In addition, an operable lock is specifically required by the license to secure the door during non-working hours.
Based on the amount of material involved, e.g., significantly greater than 10 CFR Part 20, Appendix C quantities, the failure to secure and maintain constant surveillance of licensed material is of concern due to the potential for significant exposure if the material were improperly handled by unauthorized and/or untrained individuals. Therefore, in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions - May 1, 2000" (Enforcement Policy), NUREG-1600, the two described examples of the failure to comply with 10 CFR 20.1801 and 1802 and Condition 21 of your license are categorized as a Severity Level III violation.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy. Based on our subsequent discussions with you and your September 20, 2000, letter, your corrective actions included prompt installation of a new lock on the HDR brachytherapy room door; posting of a sign on the door reminding employees that the door must remain locked when the room is not in use; and plans for the door to remain locked unless the area is under the direct supervision of one or more Schiffler Cancer Center employees. Based on these actions, the NRC determined that credit for Corrective Action was warranted.
Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, I have been authorized to propose that no civil penalty be assessed in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.
Violation B, cited in the enclosed Notice, has been characterized as a Severity Level IV violation and involves your repeated failure to perform surveys for removable contamination in an area where radiopharmaceutical waste was stored. Your September 20, 2000, letter advised that you had re-instituted weekly contamination surveys, implemented an administrative method for tracking performance of these surveys, and disseminated information regarding the occurrence of this repetitive violation to all licensed areas at the hospital through the Radiation Safety Committee.
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 was achieved is already adequately addressed on the docket in your August 7, and September 20, 2000, letters. Therefore, you are not required to respond to this letter unless the description herein 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 responses will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.
If you have any questions regarding this matter, please contact Douglas M. Collins, Director, Division of Nuclear Material Safety at 404-562-4700.
Signed by B. S. Mallett
Docket No. 030-12570
License No. 47-05322-02
Enclosure: Notice of Violation
State of West Virginia
Wheeling, West Virginia
|Docket No. 030-12570
License No. 47-05322-02
During an NRC inspection conducted during the period July 25 through September 7, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions - May 1, 2000," NUREG-1600, the violations are listed below:
|A.||10 CFR 20.1801
requires that the licensee secure from unauthorized removal or access
licensed materials that are stored in controlled or unrestricted areas.
10 CFR 20.1802 requires that the 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, access to which can be limited by the licensee for any reason;
and, unrestricted area means an area, access to which is neither limited
nor controlled by the licensee.
License Condition No. 21 of NRC License No. 47-05322-02 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the License Application dated February 1, 1993, and the letter dated September 5, 1995.
Item 10.16 of the letter dated September 5, 1995, states, in part that the door to the high dose rate (HDR) brachytherapy room is locked when the radiation oncology department is closed.
Contrary to the above, the licensee failed to comply with the requirements of 10 CFR 20.1801, 10 CFR 20.1802 and Condition 21 of the License as evidenced by the following:
|(1)||From July 21 to July 25,
2000, the licensee did not secure from unauthorized removal or limit
access to an HDR brachytherapy sealed source containing approximately
3.422 Curies of Iridium-192, located in the HDR brachytherapy room,
which is an unrestricted area, nor did the licensee control and maintain
constant surveillance of this licensed material. Specifically, the
source was located in an unlocked HDR brachytherapy room in a transportation
|(2)||As of July 25, 2000, the licensee routinely
did not secure from unauthorized removal or limit access to an HDR
brachytherapy device containing a shielded sealed source of up to
a maximum activity of 10 Curies of Iridium-192, located in the HDR
brachytherapy room. Specifically, the licensee did not lock the HDR
brachytherapy room to prevent the removal of the device/source and
did not maintain constant surveillance of this licensed material.
|This is a Severity Level
III violation (Supplement IV).
|B.||10 CFR 35.70(e) requires
that a licensee survey for removable contamination once each week
all areas where radiopharmaceuticals are routinely prepared for use,
administered, or stored.
License Condition No. 21 of NRC License No. 47-05322-02 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the License Application dated February 1, 1993.
Item 10.12 of the License Application states that the licensee will follow and implement the model procedure for area surveys that was published in Appendix N to Regulatory Guide 10.8, Revision 2. Item I.C of Appendix N requires that licensee survey weekly for removable contamination areas where the licensee stores radiopharmaceuticals and radiopharmaceutical waste.
Contrary to the above, as of July 25, 2000, the licensee did not survey weekly for removable contamination the sub-basement area of the hospital which was an area where Iodine-131 waste was routinely stored. (02014)
|This is a Severity Level
IV violation (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 was achieved is already adequately addressed on the docket in the letter transmitting this Notice of Violation (Notice) and in Wheeling Hospital's letters of August 7 and September 20, 2000. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description herein 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 II within 30 days of the date of the letter transmitting this 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.
Because any response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 12th day of October 2000