Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2013-0031)
The main purpose is to ensure the safe, efficacious, and quality radiation treatment and protection and safety of patients, workers, and the public from hazards associated with the use of medical linear accelerators in therapeutic X-ray facilities.
The Center for Device Regulation, Radiation Health and Research (CDRRHR) regulates the use of medical linear accelerators and other radiation-emitting devices.
A medical linear accelerator is therapeutic radiation equipment that can operate in X-ray or electron beam mode, using high-frequency electromagnetic waves to accelerate electrons to high energies through a linear tube for cancer treatment.
Stage 1 is the Pre-operational Permit (POP) before construction, and Stage 2 is the License to Operate (LTO) before clinical operation.
A board certified Radiation Oncology Medical Physicist (ROMP), in coordination with the architect and/or engineer, must inspect and supervise the construction phase.
One radiation oncologist for up to 250 patients treated annually, a chief radiation oncologist as head, and one additional staff radiation oncologist for every 200 to 250 new patients annually. Each radiation oncologist may be affiliated with no more than six facilities.
They must be certified by the Philippine Board of Medical Physics Section of ROMP, have appropriate clinical training, and for training/supervision roles, at least five years of clinical experience.
The RPO is responsible for radiation safety, facility compliance with regulations, ensuring radiation activities follow safety policies, and has the authority to stop dangerous activities.
Level 1 - Conventional 2D radiotherapy, Level 2 - Conventional 2D and 3D conformal radiotherapy, Level 3 - Conventional 2D, 3D conformal and intensity modulated radiotherapy (IMRT), Level 4 - All previous plus specialized radiotherapy services.
Workers in controlled areas must use individual radiation monitoring devices approved by the CDRRHR, with monitoring periods not exceeding two months, and replacement must be immediate.
The licensee must notify the CDRRHR within 24 hours, conduct a formal investigation, prepare a written report detailing cause, dose received, corrective actions, and submit the report within 25 days.
It involves policies and review procedures to ensure examinations and treatments are appropriate, necessary, safe, performed by qualified personnel using proper equipment, and includes quality control, audits, and calibration.
Optimization refers to ensuring that radiotherapy doses are kept as low as reasonably achievable while achieving the desired therapeutic effect, minimizing exposure to healthy tissue.
No more than three (3) facilities.
Existing radiotherapy facilities have five (5) years from the effective date of the order to comply with the ROMP staffing requirements outlined in Section VI.A.4.2.