EA-99-005 - Central Michigan Community Hospital
April 2, 2001
Vice President of Ancillary Services
Central Michigan Community Hospital
1221 South Michigan Drive
Mount Pleasant, MI 48858-3234
|SUBJECT:||NOTICE OF VIOLATION (NRC Inspection Report No. 030-02078/98001(DNMS) and Investigation Report Nos. 3-98-031 and 3-98-031S)|
Dear Mr. Kerr:
This refers to the inspection conducted June 22 through July 2, 1998, at Central Michigan Community Hospital, Mount Pleasant, Michigan. This also refers to the investigations, by the NRC's Office of Investigations (OI), completed on December 3, 1998 and May 12, 1999. The purpose of the inspection was to review the circumstances surrounding the use of byproduct material by an unqualified individual. The inspection identified an apparent violation of NRC requirements where an unqualified individual, an individual not supervised by an authorized user, conducted licensed activities. The purpose of the OI investigation was to review a potentially deliberate action by hospital staff regarding the use of byproduct material by an unqualified individual, and whether a licensee individual provided inaccurate information to the NRC.
In our January 15, 1999 letter, transmitting a synopsis of the OI investigation (enclosed) we provided you the opportunity to address the apparent violation identified in the letter by either attending a predecisional enforcement conference or providing a written response before we made our final enforcement decision. In a February 18, 1999 letter, you provided a response to the apparent violation.
Based on the information developed during the inspection and investigations, and the information that you provided in your February 18, 1999, response, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. During the inspection and subsequent OI investigation, hospital staff informed the NRC that on August 2, 1996, an emergency lung scan, using technetium-99m, was conducted by an unqualified individual that was not under the supervision of an authorized user. The on-call nuclear medicine technician (NMT) was unable to respond to the hospital's page and arranged for another hospital technician to conduct the scan, with the NMT on the telephone talking the other technician through the procedure. While all activities were properly performed, the second individual was not qualified and was not supervised by an authorized user in accordance with NRC requirements.
Conducting licensed activities by an unqualified and unsupervised individual has potential safety significance in that the individual may not be prepared to respond to an emergency or follow appropriate radiation safety procedures. However, in this case, the safety significance was low, since the individual was being directed by an NMT who was trained to use byproduct material and the procedure was apparently completed without incident. Notwithstanding the above, the NRC is particularly concerned that the NMT and another hospital technician conspired to deliberately violate NRC requirements by having an unqualified individual use byproduct material without being supervised by an authorized user. It is essential that the NRC be able to maintain the highest confidence that licensees and their employees will abide by requirements designed to protect the health and safety of the public. Therefore, the NRC has categorized the violation in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for a Severity Level III violation. Because the violation is considered willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is warranted for identification since you promptly identified the violation, performed an investigation into the circumstances surrounding the violation, and informed the NRC of the incident during the June 1998 inspection. Credit is also warranted for prompt and effective corrective actions that included: (1) taking disciplinary action against the involved individuals; (2) ensuring that employees were aware of the incident; and (3) ensuring employees were aware of the licensee's expectations regarding on call procedures.
Therefore, to encourage prompt identification and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, 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 violation constitutes escalated enforcement action, that may subject you to increased inspection effort.
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 030-02078/98001(DNMS). 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 enclosures, and your response, if you choose to respond, 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library).
|J. E. Dyer
Docket No. 030-02078
License No. 21-08966-01
Enclosure: Notice of Violation
NOTICE OF VIOLATION
|Central Michigan Community Hospital
Mount Pleasant, Michigan
|Docket No. 030-02078
License No. 21-08966-01
During an NRC inspection conducted June 22 through July 2, 1998, and investigations concluded on December 3, 1998 and May 12, 1999, 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 35.11(b) requires, in part, that an individual receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in 10 CFR 35.25.
10 CFR 35.25(a) requires, in part, that a licensee who permits the use of byproduct material under the supervision of an authorized user instruct the supervised individual in the principles of radiation safety and require the supervised individual to follow the instructions of the supervising authorized user.
Contrary to the above, on August 2, 1996, an unqualified individual used byproduct material and was not under the supervision of an authorized user. Specifically, a computed tomography technician conducted a lung study procedure by administering 30 millicuries of technetium-99m aerosol and injecting 4 millicuries of technetium-99m. This individual had not been instructed in the principles of radiation safety and was not under the supervision of an authorized user.
This is a Severity Level III violation (Supplement VI).
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 030-02078/98001(DNMS). 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 III, 801 Warrenville Road, Lisle, Illinois 60532-4351 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 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public 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). 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 2nd day of April 2001.