N.M. Admin. Code § 20.3.7.710

Current through Register Vol. 35, No. 21, November 5, 2024

Section 20.3.7.710 - MANUAL BRACHYTHERAPY

A. Use of sources for manual brachytherapy. The regulations of the NRC set forth in 10 CFR 35.400 are hereby incorporated by reference:

B. Surveys after source implant and removal.

(1) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

(2) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

(3) A licensee shall retain a record of the surveys required by Paragraphs (1) and (2) of this subsection in accordance with Subsection P of 20.3.7.715 NMAC.

C. Brachytherapy sources accountability.

(1) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(2) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

(3) A licensee shall maintain a record of the brachytherapy source accountability in accordance with Subsection Q of 20.3.7.715 NMAC.

D. Safety instructions. In addition to the requirements in 20.3.10.1002 NMAC:

(1) the licensee shall provide radiation safety instructions, initially and at least annually, to personnel caring for patients or the human research subjects who are receiving brachytherapy and cannot be released under Subsection I of 20.3.7.703 NMAC; to satisfy this requirement, the instructions must be commensurate with the duties of the personnel and include:

(a) the size and appearance of the brachytherapy sources;

(b) safe handling of the brachytherapy sources and shielding instructions;

(c) a patient or human research subject control;

(d) visitor control, including both routine visitation of hospitalized individuals in accordance with Paragraph (1) of Subsection A of 20.3.4.413 NMAC, and visitation authorized in accordance with Subsection F of 20.3.4.413 NMAC; and

(e) notification of the radiation safety officer, or their designee, and an authorized user if the patient or human research subject has a medical emergency or dies;

(2) a licensee shall retain a record of individuals receiving safety instructions in accordance with Subsection O of 20.3.7.715 NMAC.

E. Safety precautions.

(1) For each patient or human research subject receiving brachytherapy and cannot be released under Subsection I of 20.3.7.703 NMAC a licensee shall:

(a) not quarter the patient or the human research subject in the same room with an individual who is not receiving brachytherapy;

(b) visibly post the patient's or human research subject's door with a "Radioactive Materials" sign; and

(c) note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(2) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(a) dislodged from the patient; and

(b) lodged within the patient following removal of the source applicators.

(3) A licensee shall notify the radiation safety officer, or their designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

F. Calibration measurements of brachytherapy sources.

(1) Before the first medical use of a brachytherapy source, a licensee shall have:

(a) determined the source output or activity using a dosimetry system that meets the requirements of Paragraph (1) of Subsection F of 20.3.7.711 NMAC;

(b) determined source positioning accuracy within applicators; and

(c) used published protocols currently accepted by nationally recognized bodies to meet the requirements of Subparagraphs (a) and (b) of this paragraph.

(2) Instead of a licensee making its own measurements as required in Paragraph (1) of this subsection, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American association of physicists in medicine that are made in accordance with Paragraph (1) of this subsection.

(3) A licensee shall mathematically correct the outputs or activities determined in Paragraph (1) of this subsection for physical decay at intervals consistent with one percent physical decay.

(4) A licensee shall retain a record of each calibration in accordance with Subsection R of 20.3.7.715 NMAC.

G. Decay of strontium-90 sources for ophthalmic treatments.

The regulations of the NRC set forth in 10 CFR 35.433 are hereby incorporated by reference.

H. Therapy-related computer systems. The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(1) the source-specific input parameters required by the dose calculation algorithm;

(2) the accuracy of dose, dwell time and treatment time calculations at representative points;

(3) the accuracy of isodose plots and graphic displays; and

(4) the accuracy of the software used to determine sealed source positions from radiographic images.

N.M. Admin. Code § 20.3.7.710

20.3.7.710 NMAC - Rp, 20 NMAC 3.1.7.709, 4/30/2009, Amended by New Mexico Register, Volume XXXIV, Issue 03, February 14, 2023, eff. 2/14/2023