[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.32]

[Page 560-562]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
             Subpart B--General Administrative Requirements
 
Sec. 35.32  Quality management program.

    (a) Each applicant or licensee under this part, as applicable, shall 
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. The 
quality management program must include written policies and procedures 
to meet the following specific objectives:
    (1) That, prior to administration, a written directive \1\ is 
prepared for:
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    \1\ If, because of the patient's condition, a delay in order to 
provide a written revision to an existing written directive would 
jeopardize the patient's health, an oral revision to an existing written 
directive will be acceptable, provided that the oral revision is 
documented immediately in the patient's record and a revised written 
directive is signed by the authorized user within 48 hours of the oral 
revision.
    Also, a written revision to an existing written directive may be 
made for any diagnostic or therapeutic procedure provided that the 
revision is dated and signed by an authorized user prior to the 
administration of the radiopharmaceutical dosage, the brachytherapy 
dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or 
the next teletherapy fractional dose.
    If, because of the emergent nature of the patient's condition, a 
delay in order to provide a written directive would jeopardize the 
patient's health, an oral directive will be acceptable, provided that 
the information contained in the oral directive is documented 
immediately in the patient's record and a written directive is prepared 
within 24 hours of the oral directive.

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[[Page 561]]

    (i) Any teletherapy radiation dose;
    (ii) Any gamma stereotactic radiosurgery radiation dose;
    (iii) Any brachytherapy radiation dose;
    (iv) Any administration of quantities greater than 30 microcuries of 
either sodium iodide I-125 or I-131; or
    (v) Any therapeutic administration of a radiopharmaceutical, other 
than sodium iodide I-125 or I-131;
    (2) That, prior to each administration, the patient's or human 
research subject's identity is verified by more than one method as the 
individual named in the written directive;
    (3) That final plans of treatment and related calculations for 
brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in 
accordance with the respective written directives;
    (4) That each administration is in accordance with the written 
directive; and
    (5) That any unintended deviation from the written directive is 
identified and evaluated, and appropriate action is taken.
    (b) The licensee shall:
    (1) Develop procedures for and conduct a review of the quality 
management program including, since the last review, an evaluation of:
    (i) A representative sample of patient and human research subject 
administrations,
    (ii) All recordable events, and
    (iii) All misadministrations

to verify compliance with all aspects of the quality management program; 
these reviews shall be conducted at intervals no greater than 12 months;
    (2) Evaluate each of these reviews to determine the effectiveness of 
the quality management program and, if required, make modifications to 
meet the objectives of paragraph (a) of this section; and
    (3) Retain records of each review, including the evaluations and 
findings of the review, in an auditable form for three years.
    (c) The licensee shall evaluate and respond, within 30 days after 
discovery of the recordable event, to each recordable event by:
    (1) Assembling the relevant facts including the cause;
    (2) Identifying what, if any, corrective action is required to 
prevent recurrence; and
    (3) Retaining a record, in an auditable form, for three years, of 
the relevant facts and what corrective action, if any, was taken.
    (d) The licensee shall retain:
    (1) Each written directive; and
    (2) A record of each administered radiation dose or 
radiopharmaceutical dosage where a written directive is required in 
paragraph (a)(1) above, in an auditable form, for three years after the 
date of administration.
    (e) The licensee may make modifications to the quality management 
program to increase the program's efficiency provided the program's 
effectiveness is not decreased. The licensee shall furnish the 
modification to the appropriate NRC Regional Office within 30 days after 
the modification has been made.
    (f)(1) Each applicant for a new license, as applicable, shall submit 
to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a 
quality management program as part of the application for a license and 
implement the program upon issuance of the license by the NRC.
    (2) Each existing licensee, as applicable, shall submit to the 
appropriate NRC Regional Office in accordance with 10 CFR 30.6 by 
January 27, 1992 a written certification that the quality

[[Page 562]]

management program has been implemented along with a copy of the 
program.

[56 FR 34121, July 25, 1991, as amended at 59 FR 61783, Dec. 2, 1994]