216-40-20 R.I. Code R. § 9.11

Current through June 20, 2024

Section 216-RICR-40-20-9.11 - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

9.11.1Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

For the purpose of this Part, requirements for use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit are defined by 10 C.F.R. § 35.600.

9.11.2Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader Unit

A. For the purpose of this Part, requirements for surveys of patients and human research subjects treated with a remote afterloader unit are defined by 10 C.F.R. § 35.604.

B. A licensee shall retain a record of the surveys required by §9.11.2(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.

9.11.3Installation, Maintenance, Adjustment, and Repair

A. For the purpose of this Part, requirements for installation, maintenance, adjustment, and repair are defined by 10 C.F.R. § 35.605.

B. A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for three (3) years. For each installation, maintenance, adjustment and repair, the record shall include the date, description of the service, and name(s) of the individual(s) who performed the work.

9.11.4Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

A. For the purpose of this Part, requirements for safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.610.

B. A licensee shall retain a copy of the procedures required by §9.11.4(A) of this Part until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

C. A licensee shall retain a record of the surveys required by §9.11.4(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.

9.11.5Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

For the purpose of this Part, requirements for safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.615.

9.11.6Dosimetry Equipment

A. For the purpose of this Part, requirements for dosimetry equipment are defined by 10 C.F.R. § 35.630.

B. The licensee shall maintain a record of each calibration, intercomparison, and comparison of its dosimetry equipment required by §9.11.6(A) of this Part for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include:

1. The date;

2. The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared or compared as required by §§9.11.6(A) and (B) of this Part;

3. The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

4. The names of the individuals who performed the calibration, inter comparison, or comparison, and evidence that the intercomparison was performed by or under the direct supervision of an Authorized Medical Physicist.

9.11.7Full Calibration Measurements on Teletherapy Units

A. For the purpose of this Part, requirements for full calibration measurements on teletherapy units are defined by 10 C.F.R. § 35.632.

B. A licensee shall maintain a record of each calibration required by §9.11.7(A) of this Part for three (3) years. The record shall include:

1. The date of the calibration;

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

3. The results and assessments of the full calibrations; and

4. The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.

9.11.8Full Calibration Measurements on Remote Afterloader Units

A. For the purpose of this Part, requirements for full calibration measurements on remote afterloader units are defined by 10 C.F.R. § 35.633.

B. A licensee shall retain a record of each calibration required by §9.11.8(A) of this Part for three (3) years. The record shall include:

1. The date of the calibration;

2. The manufacturer's name, model number, and serial number for both the remote afterloader unit and the source(s), and the model number and serial number of the instrument used to calibrate the unit;

3. The results and assessments of the full calibrations;

4. The results of the autoradiograph required for low dose-rate remote afterloader units; and

5. The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.

9.11.9Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

A. For the purpose of this Part, requirements for full calibration measurements on gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.635.

B. A licensee shall retain a record of each calibration required by §9.11.9(A) of this Part for three (3) years. The record shall include:

1. The date of the calibration;

2. The manufacturer's name, model number, and serial number for both the gamma stereotactic radiosurgery unit and the sources, and the model number and serial number of the instrument used to calibrate the unit;

3. The results and assessments of the full calibrations; and

4. The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.

9.11.10Periodic Spot-checks on Teletherapy Units

A. For the purpose of this Part, requirements for periodic spot-checks on teletherapy units are defined by 10 C.F.R. § 35.642.

B. A licensee shall maintain a record of each spot-check and a copy of the procedures required by §9.11.10(A) of this Part for three (3) years. The record shall include:

1. The date of the spot-check;

2. The manufacturer's name, model number, and serial number for the teletherapy unit, source and the instrument used to measure the output of the teletherapy unit;

3. An assessment of timer constancy and linearity;

4. The calculated "on-off" error;

5. A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

6. The determined accuracy of each distance measuring or localization device

7. The difference between the anticipated output and the measured output;

8. Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

9. The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.

9.11.11Periodic Spot-checks on Remote Afterloader Units

A. For the purpose of this Part, requirements for periodic spot-checks on remote afterloader units are defined by 10 C.F.R. § 35.643.

B. A licensee shall retain a record of each check and a copy of the procedures required by §9.11.11(A) of this Part for three (3) years. The record shall include, as applicable:

1. The date of the spot-check;

2. The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

3. An assessment of timer accuracy;

4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

5. The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.

9.11.12Periodic Spot-checks on Gamma Stereotactic Radiosurgery Units

A. For the purpose of this Part, requirements for periodic spot-checks on gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.645.

B. A licensee shall retain a record of each check and a copy of the procedures required by §9.11.12(A) of this Part for three (3) years. The record shall include:

1. The date of the spot-check;

2. The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

3. An assessment of timer linearity and accuracy;

4. The calculated "on-off"? error;

5. A determination of trunnion centricity;

6. The difference between the anticipated output and the measured output;

7. An assessment of source output against computer calculations;

8. Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

9. The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.

9.11.13Additional Technical Requirements for Mobile Remote Afterloader Units

A. For the purpose of this Part, additional technical requirements for mobile remote afterloader units are defined by 10 C.F.R. § 35.647.

B. A licensee shall retain a record of each check required by §9.11.13(A) of this Part for three (3) years. The record shall include:

1. The date of the check;

2. The manufacturer's name, model number, and serial number of the remote afterloader unit;

3. Notations accounting for all sources before the licensee departs from a facility;

4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and source transfer tubes, and source positioning accuracy; and

5. The signature of the individual who performed the check.

9.11.14Radiation Surveys

A. For the purpose of this Part, requirements for radiation surveys are defined by 10 C.F.R. § 35.652.

B. A licensee shall maintain a record of the surveys required by §9.11.14(A) of this Part for the duration of the license. The record shall include:

1. The date of the measurements;

2. The manufacturer's name, model number and serial number of the treatment unit, the source, and the instrument used to measure radiation levels;

3. Each dose rate measured around the source while in the "off" position and the average of all measurements, and

4. The signature of the Authorized Medical Physicist who reviewed or performed the survey.

9.11.15Full-Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units

A. For the purpose of this Part, requirements for full inspection and servicing for teletherapy and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.655.

B. A licensee shall maintain a record of the inspection and servicing required by §9.11.15(A) of this Part for the duration of use of the unit. The record shall contain:

1. The inspector's name;

2. The inspector's radioactive materials license number;

3. The date of inspection;

4. The manufacturer's name and model number and serial number for both the treatment unit and source;

5. A list of components inspected and serviced, and the type of service; and

6. The signature of the inspector.

9.11.16Therapy-related Computer Systems

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. § 35.657.

9.11.17Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

For the purpose of this Part, training requirements for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.690.

216 R.I. Code R. § 216-RICR-40-20-9.11

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