EA-96-445 - Citizens Memorial Hospital
Mr. Donald Babb, CEO
Citizens Memorial Hospital
1500 N. Oakland - No. Hwy. 83
Bolivar, MO 65613
SUBJECT: NOTICE OF VIOLATION AND TERMINATION OF LICENSE (NRC Inspection Report No. 030-18261/96001(DNMS) and OI investigation Report No. 3-96-017)
Dear Mr. Babb:
Enclosed is a Notice of Violation (Notice) and Amendment No. 5 which terminates NRC License No. 24-20330-01. The license is terminated in accordance with an NRC Form 314 (Certificate of Disposal) signed by you and dated December 9, 1996.
The violations described in the enclosed Notice represent a significant breakdown in the past management of the radiation safety program at Citizens Memorial Hospital (CMH). These issues were discussed with you and members of your staff during a predecisional enforcement conference on November 14, 1996.
Based upon the information developed during the inspection, the investigation, and the information provided during the conference, the NRC determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice and the circumstances surrounding them were described in detail in the inspection report issued on November 1, 1996. The violations have been characterized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III. If CMH had not requested termination of the license, a civil penalty would have been considered. However, since you decided to terminate licensed activities, we have suspended any further consideration of enforcement action.
A response to this letter is not required. However, you will be required to respond to each violation identified in the Notice in accordance with 10 CFR 2.201 should you apply for a license to re-establish an NRC licensed program.
If you have any questions or require clarification on any of the information stated above, your may contact us at (630) 829-9807.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and the enclosures will be placed in the NRC Public Document Room.
Sincerely, Original signed by W. L. Axelson for A. B. Beach Regional Administrator
License No. 24-20330-01
Docket No. 030-18261
1. Notice of Violation
2. Amendment No. 5
Citizens Memorial Hospital Docket No. 030-18261 Bolivar, MO License No. 24-20330-01 EA 96-445
During an NRC inspection conducted on April 10-11, 1996, with continuing NRC review through October 11, 1996, and the investigation conducted by the NRC Office of Investigations from June 26 through October 11, 1996, 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:
A. 10 CFR 35.22(a)(2) requires that the Radiation Safety Committee meet at least quarterly.
Contrary to the above, the licensee's Radiation Safety Committee did not meet between October 10, 1993, and April 11, 1996, a period in excess of a calendar quarter.
B. 10 CFR 35.50(b)(1) requires, in part, that a licensee check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use.
Contrary to the above, between September 28, 1993, and October 1, 1995, the licensee did not check the dose calibrator for constancy with a dedicated check source at the beginning of each day of use.
C. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at least quarterly.
Contrary to the above, the license did not test its dose calibrator for linearity from June 1992 through April 11, 1996, a period in excess of a calendar quarter.
D. 10 CFR 35.70(a) requires that a licensee survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared or administered.
Contrary to the above, between September 29, 1993, and October 1, 1995, the licensee did not survey with a radiation detection instrument at the end of the day areas where radiopharmaceuticals were routinely prepared or administered.
E. 10 CFR 35.70(e) requires that the licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
Contrary to the above, between September 29, 1993, and October 1, 1995, the licensee did not survey for removable contamination in the areas where radiopharmaceuticals were routinely prepared for use, administered, or stored.
F. 10 CFR 20.1502(a)(1) requires, in part, each licensee to monitor occupational exposure to radiation of adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in 10 CFR 20.1201(a).
Contrary to the above, as of April 10, 1996, the licensee did not monitor the occupational exposure to radiation of an individual who could receive a dose in excess of 10% of the Part 20 limits. Specifically, when handling radioactive materials, the nuclear medicine technologist routinely failed to use the TLD finger monitor. This device is used to monitor the extremity dose.
G. 10 CFR 20.1906(b)(1) requires that each licensee monitor the external surfaces of a package labeled with a Radioactive White I, Yellow II, or Yellow III label for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined by 10 CFR 71.4.
Contrary to the above, as of April 10, 1996, the licensee routinely received Radioactive White I labeled packages which were not gas or special form and did not monitor the external surfaces for radioactive contamination.
H. Condition 16 of License No. 24-20330-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated May 30, 1993. Item 8 of the referenced application states that the licensee will establish and implement the model training program that was published in Appendix A to Regulatory Guide 10.8, revision 2.
Appendix A of Regulatory Guide 10.8, revision 2, states, in part, that personnel will be instructed during annual refresher training, and such training will include applicable regulations and license conditions, potential hazards, and appropriate radiation safety procedures.
Contrary to the above, as of April 10, 1996, the nuclear medicine technologist had not received annual refresher training in at least three years.
These violations represent a Severity Level III problem (Supplements VI and IV).
Dated at Lisle, Illinois
this 28th day of January 1997