EA-96-505 - Fairbanks Memorial Hospital
April 1, 1997
Mr. Mike Powers, Administrator
Fairbanks Memorial Hospital
1650 Cowles Street
Fairbanks, Alaska 99701-5998
|SUBJECT: ||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,500 |
(NRC Inspection Report No. 030-03509/96-01; NRC Investigation Report 4-96-029)
Dear Mr. Powers:
This refers to the predecisional enforcement conference conducted with Fairbanks Memorial Hospital (FMH) representatives on February 27, 1997, in the NRC Region IV's Walnut Creek Field Office. This conference was conducted to discuss an apparent, deliberate failure to follow procedures which require that a written directive be signed by an authorized user prior to administering radioactive material to a patient, as well as a second apparent violation involving an unintentional failure to complete a written directive. The NRC's review of this matter, which included an inspection and an investigation by the NRC's Office of Investigations (OI), was completed on February 6, 1997, when we conducted a final telephonic exit interview. The apparent violation and the circumstances surrounding it were described in an inspection report issued on February 11, 1997. As we informed you during the conference, a copy of your conference presentation has been placed in the NRC's Public Document Room.
Based on the information developed during the inspection and investigation, and the information provided during the conference and a separate conference on the same date with FMH's former radiation safety officer (identified as "the RSO" for the purposes of this action), the NRC has determined that a violation of NRC requirements occurred. This violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty. The violation involves a deliberate failure on the part of the RSO, who was also the chief nuclear medicine technologist, to obtain a signature of an authorized user on a written directive prior to administering sodium iodide iodine-131 to a patient on June 20, 1996. A dosage of approximately 6.6 millicuries of I-131 was administered, significantly more than the intended dosage of 100 microcuries of I-131 for a thyroid scan.
The RSO reported this misadministration to the NRC by telephone on June 21, 1996, and acknowledged at that time that he had administered the dosage without the signature of an authorized user on the applicable written directive. On its own initiative, FMH took several corrective actions, including the removal of the RSO from duties involving nuclear medicine, weekly audits of written directives and the quality management program, revisions of the quality management program to clarify requirements, training of authorized users and other staff, and an independent audit of the radiation safety program. As FMH discussed at the conference, its corrective actions have been instrumental in identifying and correcting other problems.
Based on the findings of the OI Report, and as further evidenced by the RSO's statements at the transcribed enforcement conference, the NRC has concluded that the RSO deliberately proceeded with the administration of this dosage to the patient without the signature of the authorized user on the written directive, which serves as a check to verify that the dosage is correct. The RSO stated that he did this because he noted that the patient was apprehensive and he feared that the patient would not tolerate the time delay required to obtain the physician's signature. However, the RSO's actions circumvented the very purpose of having an authorized user sign and complete the written directive, as well as the intent of the hospital's NRC-required quality management program. As discussed in the inspection report, the NRC's medical consultant reviewed this misadministration and found that the impact of this misadministration on this particular patient's health should be negligible, with no long-term disability. Nonetheless, because of the potential for patient harm from not following this requirement, and the deliberate nature of the failure, this is a matter of significant regulatory concern and is categorized at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. As discussed above, FMH identified the misadministration, promptly informed the NRC and took prompt and comprehensive corrective actions. Normally, this would result in no civil penalty being assessed, in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. However, the NRC believes that the circumstances surrounding this violation, particularly the deliberate nature of the violation, the involvement of the RSO, and the potential for patient harm from such a violation, warrant a civil penalty in accordance with the discretionary provisions of Section VII.A.1 of the NRC's Enforcement Policy.
Therefore, to emphasize the importance of compliance with procedures which are in place to prevent misadministering radiopharmaceuticals, and to reflect the significance of willful noncompliance, 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.
Enforcement action is also being taken against the RSO. You will receive a copy of this action under separate cover.
Regarding the second apparent example of administering a dosage without a completed written directive, which occurred on December 4, 1995, you provided information and an affidavit from the authorized user at the conference which indicates that the authorized user had signed the written directive prior to the dosage being administered. Although a second signature was missing from the form, we have concluded that this constitutes a minor violation in this instance and therefore, a citation is not being issued in accordance with the Enforcement Policy.
FMH is required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing its response. In its response, FMH should document the specific actions taken and any additional actions planned to prevent recurrence. 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 (PDR). Should you have any questions about this, please contact Ms. Linda Howell at (817) 860-8213.
|Sincerely, || |
org signed by J. E. Dyer
Ellis W. Merschoff
Docket No. 030-03509
License No. 50-13648-01
Notice of Violation and Proposed Imposition of Civil Penalty
State of Alaska
Mr. David Kirkland
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Fairbanks Memorial Hospital |
|Docket No. 030-03509 |
License No. 50-13648-01
During an NRC inspection conducted June 26, 1996 through February 6, 1997, and an NRC Office of Investigations (OI) investigation concluded on January 23, 1997, a violation of NRC requirements was 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 violation and associated civil penalty are set forth below:
10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user shall require the supervised individual to follow the written quality management procedures established by the licensee.
The licensee's written quality management program states, at Item II.A, that a written directive specific for each patient will be issued by an authorized user prior to administration of any dosage of sodium iodide I-131 in excess of 30 microcuries. The directive will include identification of the radiopharmaceutical, the dosage to be administered, and the route of administration if other than I-131, and will be signed by the authorized user.
Contrary to the above, on June 20, 1996, the licensee's radiation safety officer/chief nuclear medicine technologist, an individual under the supervision of the licensee's authorized user, did not follow the written quality management procedures established by the licensee; specifically, he administered a dosage of approximately 6.6 millicuries of I-131 to a patient, and a written directive had not been signed by an authorized user prior to the administration of the dosage. (01013)
This is a Severity Level III violation (Supplement VI).
Civil Penalty – $2,500.
Pursuant to the provisions of 10 CFR 2.201, Fairbanks Memorial Hospital (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for the alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. 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 why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under 10 CFR 2.201, 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 violation 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 copies to: 1) the Regional Administrator, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011; and (2) the Chief, Materials Branch, Region IV Walnut Creek Field Office, 1450 Maria Lane, Walnut Creek California 94596.
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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Dated at Arlington, Texas,
this 1st day of April 1997
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