Information Notice 2002-23, Unauthorized Administration of Byproduct Material for Medical Use

Unauthorized Administration of Byproduct Material for Medical Use

ML060670469
Person / Time
Issue date:	03/21/2006
From:	Chris Miller NRC/NMSS/IMNS
To:
McIntosh A
References
IN-02-023
Download: ML060670469 (5)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 March 21, 2006 NRC INFORMATION NOTICE 2002-23, Supplement 1: UNAUTHORIZED ADMINISTRATION

ADDRESSEES

All medical licensees.

PURPOSE

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to

underscore the requirement in 10 CFR 35.27 that appropriate authorization be obtained before

administration of byproduct material for medical use, and to re-emphasize the seriousness of

deliberate misconduct. It is expected that recipients will review this information for applicability to

their facilities and consider actions, as appropriate. However, suggestions contained in this IN

are not new NRC requirements; therefore, no specific action nor written response is required.

BACKGROUND

NRC previously issued IN 2002-23, Unauthorized Administration of Byproduct Material for

Medical Use on July 16, 2002, informing licensees of the importance of appropriate authorization

before administration of byproduct material for medical use. (Note: IN 2002-23 may be viewed at

the NRC website at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/info-notices/2002/

in02023.pdf). The cases described in IN 2002-23 involved the deliberate unauthorized

administration of licensed material to humans. Since the issuance of IN 2002-23, NRC has

become aware of additional cases involving the deliberate unauthorized administration of licensed

material to humans. The unauthorized administrations in each of these additional cases involved

licensee employees or students and did not involve patients.

DESCRIPTION OF CIRCUMSTANCES

In April 2004, a nuclear medicine technologist (NMT) at a teaching institution deliberately directed

a student technologist to administer a dose of technetium-99m to the NMT for a scan of her brain

knowing that she did not have the approval of a physician authorized user. The student

technologist performed the brain scan as directed by the NMT. Licensee management notified

NRC when they discovered the unauthorized administration. As a result of NRC enforcement

action, the licensee in this case has taken several corrective actions to prevent recurrence, including providing orientation for new students and employees regarding these events, discussing this issue at external meetings, and communicating this issue via articles to be

published in professional journals.

ML060670469 IN 2002-23, Supp. 1 In another case, an NMT at a medical institution was administered a dose of technetium-99m for

a renal scan in July 2003 by an individual with the NMTs knowledge that there was no approval

by a physician authorized user. The NRC Office of Investigation found that the individual was

another NMT at the medical institution; however, the NRC did not make a final determination

regarding the willfulness of the violation. As in the first case, licensee management notified NRC

when it discovered the unauthorized administration.

The licensee in this case has also taken several corrective actions to prevent recurrence including

providing training to employees regarding these events, implementing quarterly audits/inspections

of the Nuclear Medicine Department, and reviewing policies and procedures for areas of

improvement.

DISCUSSION

The deliberate unauthorized medical administration of byproduct material involves violations of

10 CFR 35.27, Supervision and 10 CFR 30.10, Deliberate Misconduct.

The NRCs requirements regarding the medical use of byproduct material are contained in

10 CFR Part 35, Medical Use of Byproduct Material, and provide that only a physician

authorized user or someone under the supervision of an authorized user, may administer licensed

material. Specifically, Section 35.27(a)(2), Supervision, requires that an individual, under the

supervision of an authorized user, follow the instructions of the supervising authorized user

regarding medical uses of byproduct material, written radiation protection procedures established

by the licensee, written directive procedures, and all applicable NRC regulations and license

conditions.

In addition,10 CFR 30.10 (a)(1), which is applicable to medical users, provides in part that any

licensee, certificate of registration holder, or applicant; or contractor or subcontractor of these

entities, who knowingly provides goods or services related to the licensees, certificate holders, or

applicants activities in Part 30, may not engage in deliberate misconduct that causes or would

have caused if not detected, a licensee, certificate of registration holder or applicant to be in

violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued

by the Commission. Under these provisions, persons who have reasonable knowledge that their

actions are related to an activity subject to NRC regulations, and deliberately engage in

misconduct that causes or would have caused a violation have violated section 30.10, and may

be subject to enforcement action. Such deliberate violations are significant in that they pose a

distinct threat to public health and safety.

Violations caused by the deliberate actions of a licensee and/or its employees are of serious

concern to the NRC. Deliberate violations on the part of licensees can seriously undermine the

publics trust in the NRCs ability to effectively carry out its mission to protect the health and safety

of the public and radiation workers. Therefore, NRC has authority to impose significant

enforcement action for such violations, and will consider imposing significant sanctions when

assertions of deliberate misconduct are substantiated.

IN 2002-23, Supp. 1 NRC expects its licensees to ensure that their staff fully understand and adhere to the

requirements associated with the medical administration of licensed material. NRC will consider

enforcement actions for both licensees and individual staff members when NRC requirements are

determined to have been deliberately violated. In the cases described above, the licensees and

some of the involved individuals were issued Notices of Violation. NRC enforcement actions may

be viewed at http://www.internal.nrc.gov/OE/.

This IN requires no specific action nor written response. If you have any questions about the

information in this notice, please contact the technical contact listed below or the appropriate

regional office.

Patricia Holahan for/RA/

Charles L. Miller, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Joseph Nick, RI

610-337-5056 E-mail: jln@nrc.gov

Attachment: List of Recently Issued NMSS Generic Communications

OFFICE RI/DNMS RI/DNMS RIII/DNMS S RIV/DNMS MSIB

NAME JNick PHenderson P. Pelke J. Whitten AMcIntosh

DATE 02/07/06 02/10/06 01/ 30/06 02/08/06 02 /02/06 OFFICE MSIB MSIB IMNS OE OGC

NAME SWastler TEssig PHolahan for SMerchant STreby

CMiller

DATE 3/7/06 3/7/06 3/7/06 03/ 06/06 03/02/06

Attachment

IN 2002-23, Supplement 1 Recently Issued NMSS Generic Communications

Date GC No. Subject

Addressees

01/26/06 RIS-02-15, NRC Approval of Commercial Data All authorized recipients and holders of

Rev. 1 Encryption Products For the sensitive unclassified safeguards

Electronic Transmission Of information (SGI).

Safeguards Information

01/24/06 RIS-06-01 Expiration Date for NRC-Approved The U.S. Nuclear Regulatory Commission

Spent Fuel Transportation Routes (NRC) licensees who transport, or deliver

to a carrier for transport, irradiated reactor

fuel (spent nuclear fuel (SNF)).

01/13/06 RIS-05-27, NRC Regulatory Issue Summary All 10 CFR Parts 71 and 72 licensees and

Rev. 1 2005-27, Rev. 1, NRC Timeliness certificate holders.

Goals, Prioritization of Incoming

License Applications and Voluntary

Submittal of Schedule for Future

Actions for NRC Review

01/19/06 IN-06-02 Use of Galvanized Supports and All holders of operating licenses for

Cable Trays with Meggitt Si 2400 nuclear reactors except those who have

Stainless- Steel-jacketed Electrical permanently ceased operations and have

Cables certified that fuel has been permanently

removed from the reactor vessel; and fuel

cycle licensees and certificate holders.

Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic

Reading Room/Document Collections.