216 R.I. Code R. 216-RICR-40-20-5.7

Current through December 26, 2024

Section 216-RICR-40-20-5.7 - Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above)

Documentation from the manufacturer and installer that the therapeutic radiation machine was manufactured and installed in accordance with most current applicable IEC standards in effect at the time of manufacturing/installation must be sufficient to demonstrate compliance with the applicable requirements of §§5.7.2 through 5.7.16 of this Part.

5.7.1[RESERVED]

5.7.2Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes

A. For each therapeutic radiation machine subject to § 5.7 of this Part, the registrant must determine, or obtain from the manufacturer, the leakage radiation for the specified operating conditions. Records on leakage radiation measurements must be maintained in an auditable form at the installation for inspection by the Agency.

B. The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum-sized useful beam, but within a circular plane of radius two (2) meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient/human research subject plane), must not exceed a maximum of two tenths of one percent (0.2%) and an average of one tenth of one percent (0.1%) of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding one hundred square centimeters (100 cm²) at a minimum of sixteen (16) points uniformly distributed in the plane.

C. Except for the area defined in §5.7.2 of this Part, the absorbed dose due to leakage radiation (excluding neutrons) at one (1) meter from the electron path between the electron source and the target or electron window must not exceed one half of one percent (0.5%) of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding one hundred square centimeters (100 cm²).

D. The neutron absorbed dose outside the useful beam must be in compliance with the appropriate manufacturer specifications; and

E. For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in §§5.7.2(A) through (D) of this Part for the specified operating conditions. Records on leakage radiation measurements must be maintained in an auditable form at the installation for inspection by the Agency.

5.7.3Leakage Radiation Through Beam Limiting Devices

A. Photon Radiation. All adjustable or interchangeable beam limiting devices must attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) must not exceed two percent (2%) of the maximum absorbed dose on the central axis of the useful beam measured in a one hundred square centimeter (100 cm²) radiation field, or maximum available field size if less than one hundred square centimeters (100 cm²).

B. Electron Radiation. All adjustable or interchangeable electron applicators must attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance must not exceed:

1. A maximum of two percent (2%) and average of one half of one percent (0.5%) of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line seven (7) centimeters outside the periphery of the useful beam; and

2. A maximum of ten percent (10%) of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line two (2) centimeters outside the periphery of the useful beam.

C. Measurement of Leakage Radiation

1. Photon Radiation. Measurements of leakage radiation through the beam limiting devices must be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set must be measured independently at the depth of maximum dose. Measurements must be made using a radiation detector of area not exceeding ten square centimeters (10 cm²);

2. Electron Radiation. Measurements of leakage radiation through the electron applicators must be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter (1 cm²) suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements must be made using one (1) centimeter of water equivalent build up material.

5.7.4Filters/Wedges

A. If applicable, each wedge filter which is removable from the system must be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle must appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge must be removed from clinical service.

B. If the absorbed dose rate information required by §5.7.2 of this Part relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter must be removable only by the use of tools.

C. If applicable, for equipment which utilizes a system of wedge filters, inter-changeable field flattening filters, or interchangeable beam scattering foils:

1. Irradiation must not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;

2. An interlock system must be provided to prevent irradiation if the filter selected is not in the correct position;

3. A display must be provided at the treatment control panel showing the wedge filter(s), interchangeable field flattening filter(s), and/or interchangeable beam scattering foil(s) in use; and

4. An interlock must be provided to prevent irradiation if any filter and/or beam scattering foil selection operation carried out in the treatment room does not agree with the filter and/or beam scattering foil selection operation carried out at the treatment control panel.

5.7.5Stray Radiation in the Useful Beam

The registrant must obtain from the manufacturer data sufficient to ensure that stray X-ray radiation in the useful electron beam, absorbed dose at the surface during X-ray irradiation and stray neutron radiation in the useful X-ray beam are in compliance with the appropriate manufacturer specifications and perform as intended.

5.7.6Beam Monitors

A. All therapeutic radiation machines subject to § 5.7 of this Part must be provided with redundant beam monitoring systems. The detectors for these systems must be fixed and functional in the useful beam during treatment to indicate the dose monitor unit rate.

B. Equipment must be provided with at least two (2) independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

C. Equipment must be provided with at least one (1) radiation detector. This detector must be incorporated into a useful beam monitoring system.

D. The detector and the system into which that detector is incorporated must meet the following requirements:

1. Each detector must be removable only with tools and, if movable, must be interlocked to prevent incorrect positioning;

2. Each detector must form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;

3. Each beam monitoring system must be capable of independently monitoring, interrupting, and terminating irradiation; and

4. The design of the beam monitoring systems must ensure that the:

a. Malfunctioning of one system must not affect the correct functioning of the other system(s); and

b. Failure of either system must terminate irradiation or prevent the initiation of radiation.

5. Each beam monitoring system must have a legible display at the treatment control panel. Each display must:

a. Maintain a reading until intentionally reset;

b. Have only one (1) scale and no electrical or mechanical scale multiplying factors;

c. Utilize a design such that increasing dose is displayed by increasing numbers; and

d. In the event of power failure, the beam monitoring information required in §5.7.6(D)(5)(c) of this Part displayed at the control panel at the time of failure must be retrievable in at least one system for a twenty (20) minute period of time.

5.7.7Beam Flatness and Symmetry

Beam flatness and symmetry must be in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed.

5.7.8Selection and Display of Dose Monitor Units

A. Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.

B. The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset for the next irradiation.

C. After termination of irradiation, it must be necessary to reset the treatment delivery parameters before subsequent treatment can be initiated; and

D. After interruption of irradiation, it must be necessary for the operator to follow the manufacturer and facility procedures before irradiation can be re-initiated.

5.7.9Air Kerma Rate/Absorbed Dose Rate

A. A system must be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in §5.7.6 of this Part may form part of this system. In addition:

1. The dose monitor unit rate must be displayed at the treatment control panel;

2. If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated must be a record maintained by the registrant;

3. If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device must be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds four (4) Gy; and

4. For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the maximum value(s) specified in §§5.7.9(A)(2) and (3) of this Part for the specified operating conditions. Records of these maximum value(s) must be maintained in an auditable form at the installation for inspection by the Agency.

5.7.10Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy

A. Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.

B. If the original design of the equipment included a secondary dose monitoring system, that system must be capable of terminating irradiation when not more than fifteen percent (15%) or forty (40) dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and C. An indicator on the control panel must show which monitoring system has terminated irradiation.

5.7.11Termination of Irradiation

It must be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel and in the treatment room.

5.7.12Interruption of Irradiation

If a therapeutic radiation machine has an interrupt mode, it must be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it must be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements must be automatically terminated.

5.7.13Irradiation Control Device

A. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval or pre-set number of monitor units.

B. If applicable, a timer must be provided which has a display at the treatment control panel. The timer must have a pre-set time selector and an elapsed time indicator.

C. The timer or monitor unit indicator must be a cumulative device which activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator.

D. The timer or monitor unit indicator must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

5.7.14Selection of Radiation Type

A. Equipment capable of both X-ray therapy and electron therapy must meet the following additional requirements:

1. Irradiation must not be possible until a selection of radiation type (X-rays or electrons) has been made at the treatment control panel;

2. The radiation type selected must be displayed at the treatment control panel before and during irradiation;

3. An interlock system must be provided to ensure that the equipment can principally emit only the radiation type which has been selected;

4. An interlock system must be provided to prevent irradiation with X-rays, except to obtain an image, when electron applicators are fitted;

5. An interlock system must be provided to prevent irradiation with electrons when accessories specific for X-ray therapy are fitted; and

6. An interlock system must be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

5.7.15Selection of Energy

A. Equipment capable of generating radiation beams of different energies must meet the following requirements:

1. Irradiation must not be possible until a selection of energy has been made at the treatment control panel;

2. The nominal energy value selected must be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it must be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;

3. Irradiation must not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and

4. The selection of energy must be in compliance with the appropriate manufacturer specifications and perform as intended.

5.7.16Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy

A. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy must meet the following requirements:

1. Irradiation must not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel.

2. The mode of operation must be displayed at the treatment control panel.

3. An interlock system must be provided to ensure that the equipment can operate only in the mode which has been selected.

4. An interlock system must be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel.

5. Moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement:

a. Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered must differ by less than five percent (5%) from the dose monitor unit value selected;

b. An interlock must be provided to prevent motion of more than five degrees (5°) or one (1) cm beyond the selected limits during moving beam radiation therapy;

c. An interlock must be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy.

d. An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any ten degrees (10°) of rotation or one (1) cm of linear motion differs by more than twenty percent (20%) from the selected value;

e. Moving beam radiation therapy must be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.

6. Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by §5.7.10 of this Part.

7. An interlock system must be provided to terminate irradiation if movement:

a. Occurs during stationary beam radiation therapy; or

b. Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.

8. In addition to the above requirements, facilities using equipment where the radiation therapy source is mounted on a ring gantry must develop a quality assurance program in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed.

5.7.17Facility Design Requirements for Therapeutic Radiation Machines Operating above 500 kV

A. In addition to shielding adequate to meet requirements of § 5.9 of this Part, the following design requirements are also applicable:

1. Protective Barriers. All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors.

2. Control Panel. In addition to other requirements specified in this Part, the control panel must also:

a. Be in a location that ensures compliance with Part 1 of this Subchapter;

b. Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

c. Provide an indication of whether radiation is being produced; and

d. Include an access control system which will prevent unauthorized use of the therapeutic radiation machine.

3. Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing system must be provided to permit continuous observation of the patient/human research subject following positioning and during irradiation and must be so located that the operator may observe the patient/human research subject from the treatment control panel. The therapeutic radiation machine must not be used for patient/human research subject irradiation unless at least one (1) viewing system is operational.

4. Aural Communications. Provision must be made for continuous two (2) way aural communication between the patient/human research subject and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients/human research subjects unless continuous two (2) way aural communication is possible.

5. Room Entrances. Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF."

6. Entrance Interlocks. Interlocks must be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel.

7. Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with §§1.8.1(A) and (B) of this Subchapter, interlocks must be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s).

8. Emergency Cutoff Switches. At least one (1) emergency power cutoff switch must terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination capability required by §5.7.11 of this Part. All emergency power cutoff switches must include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch.

9. Safety Interlocks. All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine.

10. Surveys for Residual Radiation. Surveys for residual activity must be conducted on all therapeutic radiation machines capable of generating photon and electron energies above ten (10) MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.

5.7.18Qualified Medical Physicist Support

A. The services of a Qualified Medical Physicist must be required in facilities having therapeutic radiation machines with energies of five hundred (500) kV and above. The Qualified Medical Physicist must be responsible for:

1. Full calibration(s) required by §5.7.20 of this Part and protection surveys required by §5.4.1 of this Part;

2. Supervision and review of dosimetry;

3. Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

4. Quality assurance, including quality assurance check review required by § 5.7.21(C) of this Part;

5. Consultation with the Authorized Physician in treatment planning, as needed; and

6. Performing calculations/assessments regarding medical events and unintended treatment deviations.

B. If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures required by §5.7.19 of this Part must also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.

5.7.19Operating Procedures

A. No individual, other than the patient/human research subject, must be in the treatment room during treatment or during any irradiation for testing or calibration purposes.

B. Therapeutic radiation machines must not be made available for medical use unless the requirements of §§5.4.1, 5.7.20 and 5.7.21 of this Part have been met.

C. Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized access and use.

D. When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field where applicable.

E. If a patient/human research subject must be held in position during treatment, mechanical support or restraint devices must be used.

F. A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.

5.7.20Acceptance Testing, Commissioning and Full Calibration Measurements

A. Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to § 5.7 of this Part must be performed under the supervision of a Qualified Medical Physicist and reviewed and approved by a Qualified Medical Physicist.

B. Acceptance testing and commissioning must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed. Acceptance testing and commissioning must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.

C. Full calibration must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed. All applicable parameters (for all energies) must be completed at intervals not exceeding (13) calendar months.

1. Full calibration must include external validation of machine output accuracy for all energies prior to clinical use and at least annually thereafter for photons and protons, and every two (2) years for electrons.

D. The Qualified Medical Physicist must perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:

1. Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent (5%) from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi-energy and/or multi-mode capabilities must only require measurements for those modes and/or energies that are not within their acceptable range; and

2. Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and/or energies, measurements must be performed on the affected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in §5.7.20(D)(1) of this Part.

E. The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the model numbers, serial numbers, and calibration reports of the instruments used to calibrate the therapeutic radiation machine, and the signature of the Qualified Medical Physicist responsible for performance of the calibration.

F. Therapy-Related Computer Systems. The registrant must perform acceptance testing on the treatment planning system of therapeutic radiation machine-related computer systems in accordance with current published recommendations from a recognized national professional association (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol must be followed.

1. Acceptance testing must be performed by, or under the direct supervision of, a Qualified Medical Physicist. At a minimum, the acceptance testing must include, as applicable, verification of:

a. The source-specific input parameters required by the dose calculation algorithm;

b. The accuracy of dose calculations at representative points;

c. The accuracy of isodose plots and graphic displays;

d. The accuracy of the software used to determine radiation source positions from radiographic images; and

e. If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

2. Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the Authorized Physician and the Qualified Medical Physicist for correctness through means independent of that used for the determination of the parameters.

5.7.21Quality Assurance Checks

A. Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to § 5.7 of this Part, which are capable of operation at greater than or equal to five hundred (500) kV. Periodic quality assurance checks must meet the following requirements:

1. The registrant must use a dosimetry system which has calibrated in accordance with §5.11.5 of this Part to make the periodic quality assurance checks required in §5.7.21(A) of this Part.

2. The registrant must perform periodic quality assurance checks required by § 5.7.21(A) of this Part in accordance with written procedures established by the Qualified Medical Physicist and must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed.

B. The registrant must review the results of each periodic radiation output check according to the following procedures:

1. The Authorized Physician or Qualified Medical Physicist must be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine must not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;

2. If all periodic radiation output quality assurance check parameters appear to be within their acceptable range, the periodic quality assurance check must be reviewed and signed by either the Authorized Physician or Qualified Medical Physicist within five (5) treatment days; and

3. The Qualified Medical Physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed thirty-six (36) days.

C. Therapeutic radiation machines subject to § 5.7 of this Part must have applicable safety quality assurance checks that meet the following requirements:

1. The registrant must perform safety quality assurance checks in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed; and

2. Safety quality assurance checks must be performed at intervals not to exceed one (1) week; and

3. Safety quality assurance checks must ensure proper operation of:

a. Proper operation of the "BEAM-ON", interrupt and termination switches;

b. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

c. Electrically operated treatment room door(s) from inside and outside the treatment room.

d. Viewing and aural systems.

e. Electrical interlocks at each external beam radiation therapy room entrance.

f. At least one (1) termination switch. If more than one (1) termination switch is installed and not all switches are tested at once, each switch must be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted as recommended by the manufacturer in order to minimize possible stability problems with the therapeutic radiation machine.

D. The registrant must promptly repair any system identified in §§5.7.21(A) and (D) of this Part that is not operating properly.

E. The registrant must maintain a record of each quality assurance check required by §§5.7.21(A) and (D) of this Part for three (3) years. The record must include the date of the quality assurance check, the manufacturer's name, model number, serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number, and calibration report of the appropriate instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.

5.7.22 Accreditation and External Audits

A. Each registrant providing radiation therapy with therapeutic radiation machines must:

1. Maintain an accreditation in radiation oncology by the American College of Radiology (ACR), American College of Radiation Oncology (ACRO), American Society for Radiation Oncology (ASTRO), or an accrediting organization that is recognized by the Agency; or

2. Conduct an external audit as described in §5.7.22(B) of this Part.

B. An external audit must be completed by an Authorized Physician and Qualified Medical Physicist. This audit must be conducted at intervals not exceeding thirty-six (36) months and when new technology and/or features are used. The auditing Authorized Physician and Qualified Medical Physicist must be external.

1. The Authorized Physician audit requirement consists of a review of all the clinical aspects of the practice such as patient management (medical record review), including treatment response seen in follow-up visits if appropriate, and assessment of staffing levels including physician assistants, therapists and nurses based on patient volume and technology and complexity of services provided at the facility. The reviewing Authorized Physician must meet the requirements of §5.3.3 of this Part.

2. The Qualified Medical Physicist audit requirement consists of a review of the QA manual and records, policies and procedures and an assessment of staffing, training and equipment needs. The reviewing Qualified Medical Physicist must meet the requirements of §5.3.4 of this Part.

3. At a minimum, the external audit must address general questions about the practice including:

a. Therapy modalities;

b. Facility staffing;

c. Patient simulation and treatment;

d. A review of patient charts and images completed by an Authorized Physician who is active in the practice and type of radiation therapy offered by the registrant;

e. A physics component completed by a Qualified Medical Physicist who is active in the practice of the technology and modalities in use at the practice under audit;

f. An audit summary and recommendations as well as the facility's response.

4. Agency Form RCA-14 describes the minimum elements that must be included in an external audit.

C. For a newly registered facility, an initiation for accreditation or external audit must be no later than six (6) months after patient treatment begins.

D. The outcome of the accreditation survey or external audit or must be available for inspection and provided to the Agency upon request.

216 R.I. Code R. 216-RICR-40-20-5.7

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023