§ 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:

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