Regulations on Therapeutic X-Ray Facilities

Legal basis and regulatory authorities

Republic Act No. 9711 (Food and Drug Administration Act of 2009) provides the legal basis for issuance and regulation under its implementing rules and regulations.
CDRRHR (Center for Device Regulation, Radiation Health and Research) is the national agency under the FDA/DOH system that regulates devices emitting radiation such as X-ray machines and linear accelerators (linacs).
PNRI (Philippine Nuclear Research Institute) regulates the use of radioactive materials such as those used in cobalt 60 radiotherapy facilities and brachytherapy units.
Compliance with radiation protection standards in prior DOH regulations applies, including DOH Administrative Order No. 149 s. 2004 and DOH Department Circular No. 323 s. 2004.

Policy, purpose, and scope of coverage

The regulations assure safe, efficacious, and quality radiation treatment in radiotherapy facilities.
The regulations ensure protection and safety of patients, occupationally exposed workers, and the general public from hazards arising from operation of radiotherapy facilities using medical linacs.
The regulations apply to all uses of medical linear accelerators and other x-ray sources in the practice of radiotherapy.
The regulations apply to the facilities where these devices are located and to the individuals involved in that practice.
Any legal person that intends to operate a therapeutic x-ray facility must notify the CDRRHR in writing of the intention.

Defined terms governing implementation

Acceptance testing verifies compliance with contractual specifications after installation of new equipment or after major modifications.
Commissioning characterizes equipment performance for clinical use over the whole range of operation.
Compliance testing verifies imaging equipment compliance with performance specifications set by the CDRRHR.
Controlled Area includes irradiation rooms for external beam therapy and the control panel area, requiring specific protection measures.
Interlock automatically terminates machine operation when system parts malfunction or function outside standard operation.
Medical linear accelerator delivers therapeutic radiation in x-ray or electron beam mode by accelerating electrons to high energies through a linear tube.
Therapeutic x-ray equipment means medical linear accelerator equipment used to treat patients with malignancies.
Therapeutic x-ray facility means a free-standing or hospital-based radiotherapy center using medical linear accelerator x-ray machines.
Radiation accident covers unintended events with non-negligible consequences for protection or safety.
Radiation incident covers events confirmed to affect a defined area with actual or projected radiation levels expected to result in overexposure of a worker exceeding the annual dose limit based on ICRP 60.
Radiation Protection Officer (RPO) is a qualified individual charged with radiation safety and regulatory compliance duties under Appendix II responsibilities.
Radiation Oncology Medical Physicist (ROMP) is charged with duties indicated in the Order and Appendix I.
Radiotherapy Technologist (RTT) is a PRC-licensed technologist responsible for operating equipment and documentation tied to prescribed treatment.
Supervised areas include areas not designated as controlled areas but requiring continued review of occupational exposure conditions.

Authorization, facility classification, and staffing

Entities must obtain authorization from the CDRRHR through a two-stage process:
- Stage 1: Pre-operational permit (POP) authorizes prior to construction of the therapeutic x-ray facility and requires compliance with Appendix III.
- Stage 2: License to operate (LTO) authorizes prior to clinical operation and requires compliance with Appendix III.
POP construction requirements require:
- Shielding compliant with applicable requirements during construction.
- The construction engineer and architect to seek approval of a certified ROMP during construction.
- Construction inspection and supervision by a board certified ROMP, with a report submitted to the CDRRHR documenting supervision (with photos if possible).
- Review and approval by a board certified ROMP of selection and purchase of dosimetric and QA test tools.
- Review and approval by the head radiation oncologist of selection and purchase of ancillary equipment.
LTO requirements and control require:
- Compliance with Appendix III before issuance of the license to operate.
- The initial LTO to be valid for one (1) year and renewable based on CDRRHR criteria and guidelines.
- Any plans for modification affecting LTO conditions to be reported and approved by the CDRRHR.
- The CDRRHR to conduct verification of compliance and to warrant amendment or revocation of the LTO.
Radiotherapy facilities are classified by service category:
- Level 1: conventional 2-D radiotherapy only.
- Level 2: conventional 2-D and 3-D conformal radiotherapy only.
- Level 3: conventional 2-D, 3-D conformal, and IMRT only.
- Level 4: conventional 2-D, 3-D conformal, IMRT, and specialized radiotherapy services.
Personnel and training must be sufficient for protection and safety:
- The licensee must appoint qualified professionals for tasks tied to protection and safety.
- Only qualified personnel in terms of training and experience may work in the radiation oncology facility.
- Personnel must be aware of license conditions and limitations, including emergency drills, incident/accident lessons learned, quality assurance and quality control, equipment use, and patient instruction procedures.
- Facilities must provide specific instructions on radiation protection to non-radiotherapy personnel entering controlled areas.
- Specialized radiotherapy facilities must provide adequate training for appropriate clinical use, operation, quality control, and safety.
Authorized personnel requirements require the following minimum structures:

Radiation oncologists

Each facility must appoint one radiation oncologist who is an active member in good standing of PROS and PCR for up to a maximum of 250 patients treated annually.
A chief radiation oncologist must be appointed as head of the facility.
One additional radiation oncologist must be hired for each 200 to 250 new patients treated annually.
Each radiation oncologist may be affiliated with not more than 6 facilities.

ROMP (Radiation Oncology Medical Physicists)

ROMPs who are active members in good standing of POMP must be hired to meet the minimum FTE requirements for the facility level and number of linacs, following the table requirements:
- Level 1 (Conventional only): minimum 1 FTE ROMP for 1 LINAC, 2 FTE ROMP for 2 LINACs (with associated in-house/CMP-ROMP minima as stated in the table), and additional minima for 3 LINACs and 4 LINACs & above.
- Level 2 (Conventional, 3-D): minimum and in-house/CMP-ROMP numbers follow the corresponding table for 1 LINAC, 2 LINACs, 3 LINACs, and 4 LINACs & above.
- Level 3 (Conventional, 3-D, IMRT): minimum and in-house/CMP-ROMP numbers follow the corresponding table for the linac counts.
- Level 4 (Conventional, 3-D, IMRT, and Special Radiotherapy Procedures): minimum and in-house/CMP-ROMP numbers follow the corresponding table.
A board certified ROMP may train and supervise ROMPs if there is at least five (5) years clinical experience in radiation oncology medical physics.
Each board certified ROMP may be affiliated with not more than 3 facilities.

RTT (Radiotherapy Technologists)

An RTT must have undergone therapeutic X-ray facility training for at least six (6) months under supervision of a senior RTT and a board certified ROMP.
For initial facilities and/or upgrades in equipment, the RTT must undergo at least one (1) week hands-on training under supervision of the supplier’s application specialist.
The CDRRHR recognizes specialty training certificates issued by radiologic technologists’ professional organizations or by a board certified radiation oncology medical physicist; the training in Section VI-A-4.3.1 is no longer required once the certifying board for radiologic technologists specializing in radiotherapy technology has been established.
A minimum of four (4) full-time RTTs must be employed for each medical linear accelerator operating for an 8-hour shift.
Among the four RTTs, one must be designated exclusively as chief radiotherapy technologist for the radiotherapy department.
Two additional full-time RTTs must be employed for every additional therapeutic x-ray equipment installed.
Two additional full-time RTTs must be employed for every additional 8-hour shift per linac.
One additional full-time RTT must be employed for every x-ray or CT simulation equipment in the radiation oncology facility.
RTTs may support daily quality control, treatment planning, and immobilization device work under direct supervision of the medical physicist.

RPO (Radiation Protection Officer)

The RPO must be a qualified full-time employee of the facility and appointed in writing.
The RPO must be a medical physicist designated by the licensee and must be responsible for radiation safety and facility compliance with Appendix II.
The RPO must ensure radiation activities follow approved safety policies and procedures and may stop any activity endangering health and safety.
The RPO must be assisted by an assistant RPO with the same qualifications.
An assistant RPO may act as temporary RPO in the absence of the designated RPO.

Radiation protection requirements and exposure monitoring

The justification of practice, dose limitation, optimization of protection, and dose constraints must follow the radiation protection standards in Section IV Part A of DOH A.O. 149 s. 2004 (or revised).
The Order requires application of dose constraints in radiotherapy in line with:
- Section 1.4 Part IV of A.O. 149 s. 2004, and
- Chapter II of DOH Department Circular No. 323 s. 2004.
Investigation levels must be established for every task of each radiotherapy staff member, and existing procedures must be reviewed if levels are exceeded.
Area classification requires that:
- All irradiation rooms and radioactive source storage and handling areas in a radiotherapy department are controlled areas.
- Supervised areas include remaining areas in the department excluding the public area/waiting room.
Local rules and supervision follow the Manual requirements in Chapter IV.
The licensee must provide personal protective equipment, including protective aprons and gloves for use only during work on a simulator or with a superficial x-ray unit, and must ensure suitable personal protective equipment meets relevant regulations.
Individual monitoring requires:
- Monitoring of all personnel working in controlled areas using individual monitoring devices approved by the CDRRHR.
- RPO oversight to ensure proper use of individual monitoring devices.
- Each badge’s monitoring period not to exceed 2 (two) months, with immediate badge replacement.
- Monitoring devices to be part of a production batch with calibration traceable to a standard dosimetry laboratory.
The licensee must notify the CDRRHR within 24 hours of:
- Overexposure of personnel,
- Abnormal operating conditions,
- Radiological accidents and incidents, and
- Any unusual event with potential to cause exposure beyond operational restrictions imposed on the installation.
The licensee must initiate formal investigation and prepare a written report containing cause, dose determination/verification, corrective/mitigating actions, instructions to prevent recurrence, and other information listed in Appendix VI.
The written report must be submitted to the CDRRHR within 25 days after occurrence of the events.
Workplace monitoring requires:
- Programs for initial and continuous monitoring of radiation levels.
- Annual calibration of survey meters in a standard dosimetry laboratory and after any repair.
- Initial monitoring conducted immediately after installation of new therapeutic x-ray equipment.
Health surveillance must provide medical supervision to ensure initial and continuous fitness for intended tasks.
The licensee must maintain and preserve exposure records for each worker and make them available to the CDRRHR health physics team during RPSE.

Safety of x-ray sources: defense in depth, design, operation

Defense in depth must be established in the radiation oncology facility as described in DOH A.O. 149 s. 2004, Section IV-A, subsection 3.1.
Facility design, equipment, and sources must follow optimization requirements for medical exposures in DOH A.O. 149 s. 2004, Section 4-B, subsection 1.2.

Equipment and operational requirements

Each therapeutic x-ray facility must have at least:
- A single-photon energy therapeutic x-ray unit,
- Beam measurement and quality assurance and radiation protection physics equipment,
- A radiotherapy simulator or a CT simulator,
- A computerized treatment planning system (TPS),
- Image processing equipment,
- Beam shaping devices, and
- Patient immobilization devices.
X-ray sources, equipment, and accessories must be purchased only from authorized manufacturers/suppliers and must have a valid type test issued by them.
Equipment compliance with ISO/IEC standards or equivalent national standards must be demonstrated with written evidence.
Additional equipment requirements must be reflected in Appendix V, and the CDRRRHR may issue supplemental requirements for additional test tools/devices due to procedure complexity and emerging technologies.
Licensees must develop written methods for acceptance, commissioning, use, and maintenance, including quality control, with responsible staff and/or radiation protection committee involvement.
Licensees must ensure therapeutic x-ray equipment conforms with the Manual.
OEM performance and safety certification must be obtained before importation.
All radiotherapy equipment (new or previously used) must undergo performance testing, commissioning, and safety evaluation by a board certified ROMP.
The licensee must perform physical inventory of all equipment and accessories to confirm presence and security.
All X-ray equipment must include protection and safety systems capable of preventing use by unauthorized personnel.

Facility and room safety features

Access control must be considered in locating radiotherapy treatment rooms.
Facility design must align with technical specifications of radiotherapy equipment and include safety systems/devices such as emergency OFF switches, safety interlocks, and warning signals to lower probability of abnormal situations.
Shielding design must be calculated by a board certified ROMP using optimization principles, and primary and secondary barrier thickness must be calculated using NCRP Report No. 151 (or revised).
Standard warning sign and notice must be installed on the exposure room door.
A red warning light must be installed at the top of the exposure room door.

Acceptance, commissioning, and routine operation

Acceptance testing, performance testing, and commissioning must be conducted for all therapeutic radiation emitting equipment and for non-radiation emitting equipment/systems affecting safety (including treatment planning systems).
Acceptance testing should occur after equipment installation, in the presence of the facility’s radiation oncology medical physicist and the equipment manufacturer/supplier authorized representative, to verify safety compliance with IEC standards.
Commissioning must be conducted by the facility’s radiation oncology medical physicist after acceptance and before clinical operation.
Equipment operation must always follow technical specifications.
Patient treatment may be done only when the machine operates in clinical mode.
Periodic quality control checks must be undertaken regularly and after repairs or maintenance that might alter radiation beam output, using procedures included in the facility’s QA program approved by the CDRRRHR.
Imaging equipment must undergo and pass compliance testing before patient use.
Existing facilities must conduct periodic external quality audits by a duly recognized entity using IAEA QUATRO methodology.
Survey meters and their warning devices must be available for daily operation.
An intercom must provide two-way voice communication between patient and radiotherapy technologist at the control room, and a CCTV camera must monitor the patient during treatment.

Maintenance and records

Preventive and corrective maintenance must be adequate to retain design specifications for radiation protection and safety throughout useful life.
Preventive and corrective maintenance must be performed only by qualified maintenance/service personnel authorized by the equipment manufacturer.
Records of the preventive and corrective maintenance program must be kept.
Records of removal from and return to clinical service for maintenance must be properly kept.
If maintenance could affect physical or clinical dosimetry accuracy, tests and measurements must be performed by or under supervision of a board certified radiation oncology medical physicist before patient use.

Medical exposure and clinical governance

The licensee must ensure all responsibilities for medical exposure required in the Manual and in relevant sections of the Order are observed at all times.
The licensee must maintain a written protocol for each of the top ten clinical procedures of the facility.
Persons involved in delivery of medical exposure must follow applicable rules/procedures for patient protection and safety specified by the licensee and must ensure written, signed treatment prescriptions and treatment plans by the radiation oncologist before initiation.
Justification must be applied to all therapeutic x-ray exposures under A.O. 149 s. 2004.
The licensee should ensure that radiation oncologists follow a documented and signed justification procedure and consider efficacy, benefits, and risks of alternative modalities such as surgery and chemotherapy (alone or with radiation therapy).
Exposure of comforters and care givers must follow dose constraints in Appendix I of the Manual.
Optimization provisions in the Manual for therapeutic x-ray exposures must be implemented.
Calibration requirements require:
- Machine output calibration traceable to a standard dosimetry laboratory.
- Therapeutic x-ray equipment calibration using the IAEA Code of Practice for radiotherapy.
- Beam calibrations at commissioning time, after maintenance affecting dosimetry, and at intervals set in the Order.
- Records of beam calibration, measurements, and calculations maintained for at least two (2) years.
- Implementation of the latest IAEA Code of Practice for absorbed dose determination in x-ray and electron beams or equivalent national protocol.
Clinical dosimetry documentation requires:
- For each patient treated with external beam radiotherapy equipment: maximum and minimum absorbed doses to the planning target volume, absorbed dose to a relevant point such as the center of the target volume, and absorbed doses to other relevant points selected by the prescribing medical practitioner.
- Absorbed doses to relevant organs in all radiotherapeutic treatments.
Quality assurance for medical exposure requires:
- Development and implementation of a comprehensive QA program for medical exposures with participation of appropriate qualified experts.
- QA program inclusion of all items stated in Chapter V of the Manual.
- During commissioning of new equipment, sufficient physics data measured for clinical dosimetry in treatment planning.
- Facility participation in an independent national or international postal dose verification program (e.g., IAEA/WHO).
Investigation of accidental medical exposure requires:
- Prompt investigation of events involving accidental medical exposure and implementation of actions under Chapter V of the Manual.

Public exposure control and decommissioning

The licensee must control public exposure resulting from radiotherapy practice.
Therapeutic x-ray sources must be properly shielded and secured, including locked areas, functional interlocks, and secured keys to the control panel to prevent unauthorized access or use.
Shielding design and facility use must consider public access and facility staff access to areas within and near the radiotherapy department.
Safety and security measures to control public exposures must be developed and implemented according to CDRRHR requirements.
Visitor access control rules follow Chapter VI of the Manual.
If therapeutic x-ray equipment is intended to be transferred, disposed, or decommissioned, the licensee must notify the CDRRHR prior to initiating any action.
Public exposure monitoring must follow Chapter VI of the Manual and requires a program including dose assessment in the surroundings of irradiation rooms, stability check device storage room, and waiting rooms.

Potential exposure, safety assessments, and emergency plans

The licensee must prepare a safety assessment for all stages of design, construction, and operation and submit it to the CDRRHR.
The safety assessment must be documented and revised by an independent expert when:
- Modifications of x-ray sources or facilities are made,
- Operational experience or information on accidents/errors indicates review is needed, or
- Techniques are modified in a way that safety may be compromised.
Accident prevention and mitigation follow the rules in Chapter VII of the Manual.
Emergency response plans must be developed based on events identified by the safety assessment and include:
- Lists of predictable incidents and accidents and measures to deal with them,
- Persons responsible for actions with complete information including phone numbers,
- Responsibilities of individual personnel in emergency procedures (radiation oncologist, medical physicists, radiotherapy technologists, etc.),
- Concise instructions posted in a visible area,
- Quick access to responsible persons,
- Equipment and tools necessary to carry out procedures,
- Training, periodic rehearsal, and a recording and reporting system.
Emergency procedures must include immediate measures to avoid unnecessary radiation doses to patients, staff, and public (including removal of patients from the therapeutic x-ray unit) and measures to prevent access to the affected area while x-ray exposure is ongoing and normal conditions are not restored.

Enforcement, radiation protection program, and reporting

The CDRRHR of the Food and Drug Administration, Department of Health enforces this administrative order and other relevant regulatory standards on operating therapeutic x-ray facilities utilizing medical linear accelerators.
The licensees and employers are the principal parties mainly responsible for application of the Order.
Subsidiary responsibilities are assigned to:
- Radiation protection officer,
- Assistant radiation protection officer,
- Radiation oncologist,
- Radiation oncology medical physicist,
- Radiotherapy technologist,
- Suppliers,
- Workers,
- Maintenance engineer,
- Ethical review committee,
- Any other party delegated specific responsibilities by the licensee.
The management/licensee must develop, implement, maintain, and document a radiation protection and safety program commensurate with the risks of radiation oncology.
The management/licensee must issue a written policy assigning prime importance to protection and safety in radiotherapy while recognizing patient treatment and well-being as the prime objectives of medical care.
The radiation protection and safety program must describe and include items stated in Appendix IV.
A Radiation Protection Committee must be organized in the facility and must include, but not be limited to:
- RPO,
- Assistant RPO,
- Chief radiation oncologist,
- Radiation oncology medical physicist,
- Chief radiotherapy technologist,
- Maintenance engineer (or person coordinating equipment maintenance),
- Administrator representing management/licensee.
The licensee must prepare an annual report indicating workload, radiotherapy procedures/techniques, manpower data, and accidental exposure data for patient, staff, and general public, using the form provided, and submit it to the CDRRHR together with required renewal documents.

Repeal, separability, and transitional compliance

All administrative orders, rules, or regulations inconsistent with DOH Administrative Order No. 2013-0031 are repealed, superseded, amended, or modified accordingly.
Provisions are separable; unconstitutional provisions do not affect validity of the remaining provisions.
Transitional compliance deadlines for existing facilities require:
- Five (5) years from effectivity to comply with Section VI.A.4.2 requirements on ROMP minimum numbers.
- Two (2) years from effectivity to comply with Section VII.B.1.4 requirements on equipment testing tools/devices as shown in Appendix V.
During the transition period for facilities planning to put up a therapeutic x-ray facility, manpower requirements for a ROMP require:
- A minimum of 1 (one) full-time or part-time board certified ROMP.
- If the board certified ROMP is part-time, an additional full-time ROMP must have: a PhD or Masters degree in Medical Physics, structured clinical training including at least three (3) months conventional radiotherapy procedures under close supervision of a board certified ROMP, and work on site under supervision of a board certified ROMP for at least two (2) more years following guidelines; the non-board certified ROMP may have visiting consultant status for review activities until certification.
- For existing facilities upgrading to special procedures, an additional board certified ROMP must be employed part-time or full-time.
- For Level 3 and 4 facilities, an additional ROMP must be employed depending on workload for IMRT and special procedures.