EA-96-056 - Community Hospital
Mr. Charles Myers
2000 Campbell Drive
Torrington, Wyoming 82240
SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,500 (NRC Inspection Report No. 030-20277/95-01 and Investigation Report No. 4-95-049)
Dear Mr. Myers:
This refers to the routine, unannounced inspection and subsequent investigation conducted on September 11, 1995 through February 26, 1996. The inspection findings were discussed with you during a telephonic exit briefing on February 26, 1996, and were documented in the subject inspection report dated March 15, 1996. The inspection report identified three Severity Level IV violations, which were cited in the Notice of Violation which accompanied the report, and two apparent violations which were not cited at the time. As discussed in the cover letter to the inspection report, the apparent violations were being considered for escalated enforcement action, and we provided you with an opportunity to either respond to the apparent violations within 30 days or request a predecisional enforcement conference. You responded to the issues in the report by letter dated April 5, 1996, and you did not request a predecisional enforcement conference.
The first apparent violation identified in the subject report involved the failure to implement a Quality Management Program (QMP) that met the objectives that each administration of sodium iodide I-131 (I-131) in quantities greater than 30 microcuries was in accordance with the authorized users' directives, that written directives were prepared within 24 hours of an authorized user's oral directive, and that any unintended deviation from an oral or written directive was identified and evaluated. The second apparent violation involved a failure to ensure that required records maintained by Community Hospital were complete and accurate. This second apparent violation specifically involved a concern that one of your employees falsified required records related to the administration of sodium iodide I-131 to two patients. In order to obtain more information regarding this apparent violation, representatives from the NRC conducted a predecisional enforcement conference with the employee to discuss our concerns. The conference was transcribed and occurred on April 8, 1996.
Based on the information developed during the inspection, the investigation, the April 8 transcribed predecisional conference with the individual, and the information that you provided in your April 5, 1996 response, the NRC has determined that violations of NRC requirements occurred. The circumstances surrounding the violations were described in detail in the subject inspection report. In brief, the issues involve two administrations of I-131 on September 6 and November 7, 1994. Authorized users requested that doses of 6 and 4 millicuries, respectively, be administered. However, NRC has concluded that the doses administered to the patients were approximately 30% and 40% greater respectively, and therefore, are categorized as misadministrations. This information was identified by NRC during its inspection, when the NRC inspector discovered a discrepancy between administration records and the information provided by the radiopharmaceutical manufacturer.
The hospital's assessment of the consequences of the misadministrations was documented in a letter to NRC dated December 22, 1995. The inspection report also documented the NRC's review of these misadministrations with a medical consultant. The NRC's consultant stated that there was no need for further review by a medical consultant because the risk resulting from the increased dosage of I-131 to patients who have had previous thyroidectomy and ablation of residual thyroid tissue would be negligible. Both NRC's consultant and the hospital's assessment noted that, although the dosages were higher than requested by the authorized user, the dosages were still within the range of doses commonly used in clinical practice.
However, although the actual consequences to the patients may have been negligible, this case is of significant regulatory concern in that the hospital did not implement a QMP which was effective in ensuring that radioactive material was administered in accordance with the authorized users' instructions and that deviations from the authorized users' instructions were not promptly identified and corrected. Furthermore, licensees are responsible for the actions of their employees. In this case, the NRC has concluded that the technologist who administered the higher-than-authorized dosages deliberately falsified dose administration records. 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 $2,500 is considered for a Severity Level III problem. Because the violations involved willfulness, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Given that the issues were identified by an NRC inspector rather than your internal audits, no credit was given for the Identification factor. However, the NRC has determined that credit is warranted for the Corrective Action factor. Your corrective actions included the immediate suspension of nuclear medicine procedures involving the use of I-131, review of your policies and procedures, and disciplinary action against the technologist. Subsequently, you requested termination of your license, based on economic considerations.
Therefore, to emphasize the significance of a deliberate violation of NRC requirements and to emphasize the importance of licensee management responsibility for ensuring that licensed activities are conducted in accordance with applicable requirements, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,500 for the Severity Level III problem.
No response to the violations is required because you requested that your license be terminated. However, in the future, should you seek to obtain an NRC license, you will be required to provide a description of actions you plan to take to prevent recurrence of the violations.
In addition, the NRC is issuing a Notice of Violation to the technologist for his deliberate actions which caused the hospital to be in violation of NRC requirements. Section VIII of the Enforcement Policy states, in part, that "more serious violations, including those involving the integrity of an individual (e.g., lying to the NRC) concerning matters within the scope of the individual's responsibilities, will be considered for enforcement action against the individual as well as the facility licensee." The Commission's regulations at 10 CFR 30.10 provide, in part, that any licensee or any employee of a licensee may not engage in deliberate misconduct that causes a licensee to be in violation of any rule, regulation, or order, or any term, condition, or limitation of any license, issued by the Commission, and that any person who violates these requirements may be subject to enforcement action.
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.
Sincerely, org signed by L. J. Callan Regional Administrator
Docket No. 030-20277
License No. 49-23121-01
Enclosure: Notice of Violation and
Proposed Imposition of Civil Penalty
State of Wyoming
Community Hospital Docket No. 030-20277 Torrington, Wyoming License No. 49-23121-01 EA 96-056
During an NRC inspection and investigation conducted on September 11, 1995 through February 26, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:
A. 10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
1. Pursuant to 10 CFR 35.32(a)(1), the quality management program must include written policies and procedures to meet the objective that, prior to administration, a written directive is prepared for any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.
10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain information. For any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131, the written directive must include the dosage.
Contrary to the above, on September 9 and November 11, 1994, two written directives prepared for administrations of dosages in excess of 30 microcuries of sodium iodide I-131 were not signed by authorized users. (01013)
2. Pursuant to 10 CFR 35.32(a)(4), the quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with a written directive, which is defined in 10 CFR 35.2.
The licensee's quality management program, submitted to NRC by letter dated January 20, 1992, and amended July 5, 1994, specifies that each administration will be in accordance with the written directive and that prior to administration, each dosage shall be confirmed by measurement in a dose calibrator by the person administering the radiopharmaceutical and the result compared to the prescribed dosage in the written directive.
Contrary to the above, a person who administered dosages of sodium iodide I-131 on September 9 and November 11, 1994, did not adequately confirm the dosages in a dose calibrator and compare them with prescribed dosages. Specifically, on September 9, 1994, the administered dose was approximately 30% greater than that prescribed, and on November 11, 1994, the dose was approximately 40% greater than that prescribed. (01023)
3. Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
The licensee's quality management program, submitted to NRC by letters dated January 20, 1992, and amended July 5, 1994, states that any unintended deviation from the written directive will be identified and evaluated, and appropriate action will be taken by the radiation safety officer (RSO).
Contrary to the above, on September 9, 1994, a dose of sodium iodide I-131 was administered which was approximately 30% greater than that prescribed in the applicable written directive, and on November 11, 1994, a dose of sodium iodide I-131 was administered which was approximately 40% greater than that prescribed in the applicable written directive, and as of September 11, 1995, the licensee had not identified and evaluated these unintended deviations from the written directives, and no action had been taken by the RSO. (01033)
B. 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee, or information required by the Commission's regulations to be maintained by the licensee, shall be complete and accurate in all material respects.
10 CFR 35.32(d) requires that records of radiopharmaceutical dosages requiring written directives be retained for three years following the administration.
Contrary to the above, as of September 11, 1995, the licensee's records of radiopharmaceutical dosages requiring written directives which were administered on September 9 and November 11, 1994, were not complete and accurate in all material respects. Specifically, the dosage administered to a patient on September 9 was approximately 30% greater than that recorded in the applicable record and the dosage administered to a patient on November 11 was approximately 40% greater than that recorded in the applicable record. This is material because dose administration records are required to be maintained. (01043)
These violations represent a Severity Level III problem (Supplement VI).
Civil Penalty - $2,500.
The NRC has concluded that information regarding the reason for the violation, the corrective actions taken, and the date when full compliance was achieved is already adequately addressed on the docket in letter from Community Hospital (Licensee) dated April 5, 1996. However, the Licensee is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect its corrective actions or its position. In that case, or if the Licensee chooses to respond, such response should be clearly marked as a "Reply to a Notice of Violation," and should be send to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, 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).
The Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, ATTN: Enforcement Officer, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.
Because the 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. However, if the Licensee finds it necessary to include such information, clearly indicate the specific information that the Licensee desires not to be placed in the PDR, and provide the legal basis to support the request for withholding the information from the public.
Dated at Arlington, Texas,
this 12th day of June 1996