EA-02-008 - Avera McKennan Hospital
June 14, 2002
Mr. Fredrick W. Slunecka, Regional President
Avera McKennan Hospital
800 East 21st Street
P.O. Box 5045
Sioux Falls, South Dakota 57117-5045
|SUBJECT:||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$3,000 (NRC INSPECTION REPORT 030-11252/01-01 AND INVESTIGATION REPORT NO. 4-2001-024)|
Dear Mr. Slunecka:
This refers to the predecisional enforcement conference conducted with Avera McKennan Hospital (AMH) on May 2, 2002, in the NRC's Region IV office in Arlington, Texas. The conference was conducted to discuss two apparent violations of NRC requirements, the most significant of which involved a nuclear medicine technologist administering technetium-99m to a student technologist for a bone scan that had not been ordered by a physician. The findings from our inspection and investigation were discussed with you on April 4, 2002, and were documented in an inspection report issued on April 20, 2002.
Based on the information developed during our inspection and investigation, as well as the information that you provided during the conference, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty and involve: (1) the administration of technetium-99m to a nuclear medicine technology student when such use had not been approved by an authorized user at AMH; and (2) the failure of AMH's radiation safety officer to conduct an adequate investigation following the occurrence of this incident.
The unauthorized administration of technetium-99m to a student is of particular concern to the NRC because a non-patient was administered radioactive material without authorization from a physician and without a determination that it was necessary for medical purposes. Since diagnostic quantities of the Tc-99m labeled bone scanning agent were administered, no significant adverse health effects for the student would be expected. Nonetheless, this is contrary to the NRC's expectations that licensed radioactive material will be administered to humans only when deemed appropriate and necessary by a physician. In addition, we have concluded that this violation was intentionally committed, i.e., we do not believe that this was an inadvertent error on the part of the nuclear medicine technologist. This violation has been 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 civil penalty in the base amount of $3,000 is considered for a Severity Level III violation for medical licensees. Because the violation was committed willfully, we 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. With regard to identification, AMH identified that an unauthorized procedure had been performed. Although AMH did not identify this as a violation of NRC requirements, it did identify this as a violation of AMH policies, and did so before the NRC became involved. The NRC believes identification credit is warranted. With regard to corrective actions, AMH's initial corrective actions were focused on the technologist and not on the broader implications of this incident. This resulted in disciplinary action against the technologist on June 6, 2001. Although AMH became aware of this incident in early May 2001, a meeting with all nuclear medicine personnel to discuss this incident, and to discuss NRC requirements for a physician's order to be in place to perform a nuclear medicine procedure, did not occur until July 5, 2001, after the NRC became involved in conducting its investigation into this incident. Although AMH ultimately did take appropriate corrective actions, the NRC finds AMH's initial corrective actions lacking and does not believe corrective action credit is warranted. This results in the assessment of a civil penalty at the base value.
Therefore, to emphasize the significance that NRC attaches to the willful, unauthorized administration of radioactive material, and the importance of taking prompt corrective action in response to significant violations of NRC 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 $3,000 for this Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.
The second violation described in the enclosed Notice involves the failure of your radiation safety officer to conduct an adequate investigation once becoming aware of this incident. Specifically, as discussed above, AMH's initial investigation of this incident appeared to be focused entirely on whether disciplinary action against the technologist should be taken. No determination of whether a violation of NRC requirements occurred, and no follow-up action with other nuclear medicine staff occurred until after the NRC became involved in investigating this incident in late June 2001. While the lack of an adequate investigation does factor into the civil penalty assessment process, as discussed above, the violation itself is appropriately classified at Severity Level IV and is not a candidate for a civil penalty.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. 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 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.
|Ellis W. Merschoff|
Docket No. 030-11252
License No. 40-16571-01
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. NUREG/BR-0254 Payment Methods
cc w/Enclosure 1: Wyoming Radiation Control Program Director
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Avera McKennan Hospital
Sioux Falls, South Dakota
|Docket No. 030-11252 |
License No. 40-16571-01
During an NRC inspection and investigation completed December 18, 2001, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC 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:
|I.||Violation Assessed a Civil Penalty|
10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by 10 CFR 35.11(b) shall require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct material.
10 CFR 35.2 defines a Diagnostic Clinical Procedures Manual (DCPM) as a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.
The licensee's DCPM specifies, in part, that all diagnostic nuclear medicine procedures involving licensed material, must be approved and ordered by an authorized user, and must include the radiopharmaceutical, dosage, and route of administration.
10 CFR 35.25(c) specifies that a licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.
Contrary to the above, on April 26, 2001, a licensee employee administered approximately 20 millicuries of technetium-99m to an individual who was not a patient or human research subject, and the procedure had not been approved by an authorized user.
This is a Severity Level III violation (Supplement VI).
Civil Penalty - $3,000
|II.||Violation Not Assessed a Civil Penalty|
10 CFR 35.21(a) specifies that a licensee shall appoint a radiation safety officer (RSO) responsible for implementing the radiation safety program, and that the licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
10 CFR 35.21(b)(1) requires that the RSO shall investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, misadministrations, and other deviations from approved radiation safety practice and implement corrective actions as necessary.
Contrary to the above, during the week of April 30, 2001, the licensee's RSO was made aware of the unauthorized use of licensed material involving the administration of technetium-99m to an individual who was not a patient or human research subject, a procedure that had not been approved by the authorized user, and as of June 28, 2001, the RSO had not performed an adequate investigation of this deviation from approved radiation safety practice to address the root causes of the incident and implement corrective actions as necessary.
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Avera McKennan 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 each 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. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. 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 to 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 proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, 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.C.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, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Frank Congel, 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, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, TX 76011.
Because 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), 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).
Dated this 14th day of June 2002