Objectives of the Regulations
- Ensure safe, effective, and quality radiation treatment.
- Protect patients, workers, and the public from radiation hazards.
- Legal basis: pursuant to Republic Act No. 9711 (FDA Act of 2009).
Scope and Coverage
- Applicable to medical linear accelerators and other X-ray sources in radiotherapy.
- Covers facilities operating such equipment and personnel involved in radiotherapy practice.
Key Definitions
- Terms cover equipment (linac, ancillary equipment), personnel roles (radiation oncologist, medical physicist, radiotherapy technologist, radiation protection officer), procedures (acceptance testing, commissioning), exposure concepts (radiation accident, incident), classification of facilities, and regulatory bodies.
- Definitions ensure clarity on responsibilities, equipment types, and safety concepts.
General Guidelines for Operation
- Prior notification and securing of permits from CDRRHR required for operators.
- Radiation protection surveys before authorization issuance.
- Personnel must be properly trained and qualified.
- Management to implement radiation safety policies and invest in protection measures.
- Radiation doses must not exceed limits set by CDRRHR.
- Establishment of comprehensive quality assurance programs mandatory.
Specific Administrative Requirements
- Two-stage authorization:
- Pre-operational permit (POP): before construction, including shielding and equipment acquisition oversight.
- License to Operate (LTO): prior to clinical function, initially valid for one year.
- Facility classifications (Level 1 to 4) based on radiotherapy service complexity.
Human Resources and Staffing
- Appointment of qualified professionals matching workload:
- Radiation oncologists: one for up to 250 patients; limit of 6 facility affiliations.
- Radiation oncology medical physicists (ROMP): minimum numbers per facility level, requirements for board certification, training, and affiliations.
- Radiotherapy technologists (RTT): training requirements, staffing ratios per equipment and shifts.
- Radiation Protection Officer (RPO): full-time, qualified medical physicist with delegated safety authority.
Radiation Protection Requirements
- Adherence to dose justification, limitations, and optimization principles.
- Implementation of protection strategies consistent with previous DOH Administrative Order No. 149 s. 2004.
Safety of X-ray Sources and Facility Design
- Implementation of "defense in depth" safety approach.
- Facility equipment standards:
- Use of approved, type-tested equipment complying with IEC or equivalent standards.
- Comprehensive acceptance, commissioning, and quality control processes.
- Shielding design per NCRP Report No. 151.
- Installation of warning signs and safety interlocks.
Testing, Commissioning, and Operation
- Acceptance testing at installation.
- Commissioning by certified medical physicist before clinical use.
- Operation strictly per manufacturer specifications.
- Periodic quality control and safety checks.
- Compliance testing of imaging equipment before patient use.
- Periodic external quality audits.
- Facility equipment shall have communication systems for patient monitoring.
Maintenance Requirements
- Preventive and corrective maintenance by qualified personnel only.
- Maintenance records and tracking removal/return of equipment from clinical service required.
- Ensuring equipment functionality and safety before patient use post-maintenance.
Occupational Exposure Provisions
- Compliance with IAEA/ILO occupational radiation safety standards.
- Use of dose constraints and monitoring.
- Classification of controlled and supervised areas.
- Enforcement of local rules and protective equipment provisions.
- Mandatory individual radiation dose monitoring with proper device calibration and timely badge replacement.
- Investigation and reporting of radiation overexposures and incidents within prescribed timelines.
- Workplace radiation monitoring and health surveillance.
- Maintenance of exposure records accessible during inspections.
Medical Exposure Protocols
- Written protocols and prescriptions signed by radiation oncologist required.
- Justification of all exposures, weighing benefits and alternative treatments.
- Optimization of exposures per approved procedures.
- Calibration of equipment traceable to international dosimetry standards.
- Documentation of patient dose levels.
- Implementation of comprehensive quality assurance with independent verification participation.
- Prompt investigation of accidental exposures.
Public Exposure Controls
- Shielding and securing equipment to prevent unauthorized access.
- Visitor access controls in accordance with DOH Manual provisions.
- Notification to regulator prior to transfer, disposal, or decommissioning of equipment.
- Monitoring programs for public exposure surrounding facilities.
Potential Exposure and Emergency Preparedness
- Development and periodic review of safety assessments covering design to operation.
- Accident prevention and mitigation consistent with DOH Manual directives.
- Emergency plans detailing incident scenarios, response personnel and procedures, communication systems, training, and equipment availability.
- Procedures to minimize exposure during emergencies and restrict access to affected areas.
Roles and Responsibilities
- CDRRHR as regulatory enforcement authority.
- Licensees and employers bear primary responsibility for compliance.
- Defined subsidiary roles for radiation protection officers, specialists, technologists, maintenance staff, suppliers, ethical review committees, and other delegated parties.
- Requirement for a radiation protection and safety program developed and supported at senior management level.
- Creation of a Radiation Protection Committee comprising key personnel for oversight.
- Annual reporting of facility workload, procedures, staffing, and incident data to CDRRHR.
Repealing and Separability Clauses
- Prior conflicting regulations repealed or amended.
- Provisions declared separable to preserve validity if parts are declared unconstitutional.
Transitory Provisions
- Existing facilities given up to five years to meet certain staffing requirements.
- Two years to comply with ancillary equipment standards.
- Transitional requirements for employment and training of radiation oncology medical physicists.
- Additional ROMPs required for level upgrades and specialized services.
Effectivity
- Order effective 15 days after publication in official gazette or general circulation newspaper.