216-40-20 R.I. Code R. § 9.9

Current through June 20, 2024

Section 216-RICR-40-20-9.9 - Manual Brachytherapy

9.9.1Use of Sources for Manual Brachytherapy

For the purpose of this Part, requirements for use of sources for manual brachytherapy are defined by 10 C.F.R. § 35.400.

9.9.2Surveys after Source Implant and Removal

A. For the purpose of this Part, requirements for surveys after source implant and removal are defined by 10 C.F.R. §§ 35.404(a) and (b).

B. A licensee shall retain a record of the surveys required by §9.9.2(A) of this Part for three (3) years. Each record shall include the date and results of the survey, the serial number and the model number of the survey instrument used, and the name of the individual who made the survey.

9.9.3Brachytherapy Sources Accountability

A. For the purpose of this Part, requirements for brachytherapy sources accountability are defined by 10 C.F.R. §§ 35.406(a) and (b).

B. A licensee shall maintain a record of the brachytherapy source accountability as follows:

1. For temporary implants, the record shall include:

a. The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use;

b. The number and activity of sources not implanted, the time and date they were returned to storage, and the name of the individual who returned them to storage; and

c. The number and activity of sources temporarily implanted in the patient or human research subject.

2. For permanent implants, the record shall include:

a. The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

b. The number and activity of sources returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and

c. The number and activity of sources permanently implanted in the patient or human research subject.

C. A licensee shall maintain the records required in §9.9.3(B) of this Part for three (3) years.

9.9.4Safety Instruction

A. For the purpose of this Part, requirements for safety instruction are defined by 10 C.F.R. § 35.410(a).

B. A licensee shall keep a record of individuals receiving instruction required by §9.9.4(A) of this Part for three (3) years. The record shall include a list of the topic(s) covered, the date of instruction or training the name(s) of the attendees, and the name(s) of the individual(s) who provided the instruction.

9.9.5Safety Precautions

For the purpose of this Part, requirements for safety precautions are defined by 10 C.F.R. § 35.415.

9.9.6Calibration Measurements of Brachytherapy Sources

A. For the purpose of this Part, requirements for calibration measurements of brachytherapy sources are defined by 10 C.F.R. § 35.432.

B. A licensee shall retain a record of each calibration of brachytherapy sources required by §9.9.6(A) of this Part for three (3) years after the last use of the source. The record shall include:

1. The date of the calibration;

2. The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

3. The source output or activity;

4. Source positioning accuracy within applicators;

5. The signature of the Authorized Medical Physicist; and

6. For surface applicators where the calibration was performed by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists, a complete copy of all calibration measurements provided for that source.

9.9.7Decay of Strontium-90 Sources for Ophthalmic Treatments

A. For the purpose of this Part, requirements for decay of Strontium-90 sources for ophthalmic treatments are defined by 10 C.F.R. § 35.433.

B. A licensee shall retain a record of decay calculations required by §9.9.7(A) of this Part for three (3) years after the last use of the source. The record shall include:

1. The date and initial source output or activity as determined under §9.9.6(A) of this Part;

2. For each decay calculation, the date and the source output or activity as determined under §9.9.7(A) of this Part; and

3. The signature of the Authorized Medical Physicist.

9.9.8Therapy-related Computer Systems

A. For the purpose of this Part, requirements for acceptance testing on the treatment planning system of therapy-related computer systems are defined by 10 C.F.R. § 35.457.

B. In addition to the requirements of §9.9.8(A) of this Part, acceptance testing shall include verification of the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

9.9.9Training for Use of Manual Brachytherapy Sources

For the purpose of this Part, training requirements for use of manual brachytherapy sources are defined by 10 C.F.R. § 35.490.

9.9.10Training for Ophthalmic Use of Strontium-90

For the purpose of this Part, training requirements for ophthalmic use of Strontium-90 are defined by 10 C.F.R. § 35.491.

216 R.I. Code R. § 216-RICR-40-20-9.9

Adopted effective 1/1/2019
Amended effective 5/25/2022