EA-02-060 - United Hospital

July 11, 2002

EA-02-060

Barbara Balik, M.Ed.
Administrator
United Hospital
333 Smith Avenue
St. Paul, MN 55102

SUBJECT:

NOTICE OF VIOLATION [NRC OFFICE OF INVESTIGATIONS REPORT NO. 3-2001-043]

Dear Ms. Balik:

This refers to information provided to the U.S. Nuclear Regulatory Commission (NRC) on September 17, 2001, by a representative of United Hospital indicating that on June 17, 2001, a nuclear medicine technologist administered technetium-99m, NRC licensed material, to a relative without prior authorization from a physician for the diagnostic study. The NRC Office of Investigations (OI) conducted an investigation of the matter. From the information developed during the investigation, the NRC determined that the technologist's actions caused United Hospital to be in violation of the NRC regulation concerning the supervised medical use of byproduct material, 10 CFR 35.25(a). It also appears from the information obtained from OI that the technologist violated the NRC regulation prohibiting deliberate misconduct, 10 CFR 30.10. A summary of the OI report and a description of the apparent violations were provided to both United Hospital and the nuclear medicine technologist by letter on April 22, 2002. On May 16, 2002, United Hospital provided a written response to the apparent violations. On May 16 and June 19, 2002, the technologist furnished written replies to the apparent violations.

Based on the information developed during an investigation by United Hospital and the OI investigation, and in the letters from United Hospital and the technologist, the NRC has concluded that a violation of NRC requirements occurred. The violation (Violation A) is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding that violation were described in the previously provided summary of the OI report.

The NRC regulation allowing the use of byproduct material by supervised personnel for medical purposes, 10 CFR 35.25(a), permits the receipt, possession, use or transfer of byproduct material by an individual under the supervision of an authorized user. The supervised individual (e.g., a nuclear medicine technologist) is required to follow the instructions of the authorized user, to adhere to the written procedures of the licensee, and to comply with NRC regulations and license conditions. The United Hospital Radiation Safety Manual requires that a written authorization be obtained from a physician prior to conducting a nuclear medicine procedure. From the information obtained during the investigations, the NRC determined that on June 17, 2001, a nuclear medicine technologist, employed by United Hospital, administered technetium-99m, NRC-licensed material, to a relative without obtaining prior authorization from a physician. This action placed United Hospital in violation of the NRC regulation permitting the use of NRC-licensed material by supervised individuals, 10 CFR 35.25(a).

This deliberate violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation. Additionally, the actions of the nuclear medicine technologist placed the technologist in violation of the NRC regulation prohibiting deliberate misconduct, 10 CFR 30.10.

In accordance with the Enforcement Policy, a base civil penalty of $3,000 is considered for a Severity Level III violation. Because this was a deliberate violation of NRC requirements, 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. United Hospital identified the violation when a physician found that a written report did not accompany the images made during the nuclear medicine procedure on June 17, 2001. Therefore, credit was warranted for the Identification civil penalty adjustment factor. Credit was also warranted for the Corrective Action adjustment factor. Corrective actions consisted of: (1) disciplining the technologist involved in the incident; (2) reviewing the event with all members of the nuclear medicine staff; (3) providing training on the NRC deliberate misconduct rule, 10 CFR 30.10; and (4) developing a competency test for existing staff to ensure an understanding of requirements and 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 the United Hospital facility to increased inspection effort.

The NRC staff also identified a separate violation of NRC requirements while reviewing the May 16, 2002, letter from United Hospital. Information in that letter indicated that the management of United Hospital had not conducted the required training on the provisions of 10 CFR 19.12(a)(4). This regulation requires NRC licensees to instruct certain employees on the employee's obligation to notify licensee management about any condition which may lead to or cause a violation of an NRC requirement or a condition of an NRC license. This violation (Violation B) is cited in the enclosed Notice and has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level IV.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in a letter from United Hospital dated May 16, 2002. Therefore, you are not required to respond to this letter unless the description in your May 16, 2002 letter does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, you should follow the instructions in the enclosed Notice.

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 Website at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be made available to the Public without redaction. In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and the Notice of Violation will be made available electronically for public inspection in the NRC Public Document Room or from the PARS component of ADAMS.

		Sincerely,
		/RA/
		J. E. Dyer Regional Administrator

Docket No. 030-02207
License No. 22-01914-02

Enclosure: Notice of Violation

cc w/encl:
John Morrison, Chairman of the Board and
Chief Executive Officer, Allina Hospitals
and Clinics

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NOTICE OF VIOLATION

United Hospital St. Paul, MN

Docket No. 030-02207 License No. 22-01914-02 EA-02-060

During an NRC investigation concluded on March 13, 2002, 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.

Violation Associated with the Administration of Technetium-99m on June 17, 2001 10 CFR 35.25(a) requires, in part, that a licensee permitting 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 procedures, and comply with the regulations in Title 10, Code of Federal Regulations, Chapter I, and license conditions with respect to the use of byproduct material. Section 7.1 of the April 2000 revision to the United Hospital Radiation Safety Manual provides, in part, that a written, signed request from a practitioner of the healing arts that clearly states the clinical indications for a radiological exam, is required prior to a radiological exam. Patient self-referral is not permitted. Contrary to the above, on June 17, 2001, a nuclear medicine technologist failed to follow the United Hospital Radiation Safety Manual, a written radiation safety procedure, by administering 25 millicuries of technetium-99m MDP, byproduct material, to an individual for a bone scan without obtaining a written, signed request for the procedure from a practitioner of the healing arts. This is a Severity Level III violation (Supplement VI)

B.

Violation of Training Requirement 10 CFR 19.12(a) requires that all individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1mSv) be instructed in specified topics, including the individual's responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material. Attachment 8.1 to Amendment No. 55 of NRC License No. 22-01914-02, issued on April 13, 2001, lists the groups of employees at United Hospital to receive annual refresher training on NRC requirements. Among those groups of employees are the nuclear medicine technologists. Contrary to the above, as of May 16, 2002, the licensee did not provide training to employees on their individual responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material. This is a Severity Level IV violation. (Supplement IV)

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in a letter from United Hospital dated May 16, 2002. Pursuant to 10 CFR 2.201, you are required to submit a written statement or explanation if the description in your May 16, 2002, letter 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, EA-02-060," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 within 30 days of the date of the letter transmitting this Notice of Violation (Notice). At the same time, a copy should be sent to the Regional Administrator and the Enforcement Officer at NRC Region III, 801 Warrenville Road, Lisle, IL 60532-4351.

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 the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be made available to the Public without redaction.

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.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 11th day of July 2002.