QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2013-0031)
The objectives are to assure safe, efficacious, and quality radiation treatment and to ensure protection and safety of (1) patients, (2) workers occupationally exposed to radiation, and (3) members of the general public from hazards associated with medical linear accelerators used in radiotherapy.
It applies to all uses of medical linear accelerators and other X-ray sources in radiotherapy, the facilities where these devices are located, and the individuals involved in this practice.
(a) The Philippine Nuclear Research Institute (PNRI) regulates radioactive materials such as those used in cobalt-60 radiotherapy facilities and brachytherapy units. (b) The CDRRHR (formerly Bureau of Health Devices and Technology), under the DOH/FDA system, regulates devices emitting radiation such as X-ray machines and linear accelerators.
Stage 1: Pre-operational permit (POP) issued prior to construction; the facility must satisfy requirements in Appendix III. Stage 2: License to operate (LTO) issued prior to clinical operation; the facility must again satisfy requirements in Appendix III. The CDRRHR may conduct radiation protection survey and evaluation prior to issuance.
The licensee must ensure shielding is compliant during construction and that the construction engineer/architect sought approval of a board certified Radiation Oncology Medical Physicist (ROMP) during the construction phase. Construction must be inspected and supervised by a board certified ROMP, who must submit a report (with photos if possible) to the CDRRHR.
Facilities are classified as Level 1 (conventional 2-D only), Level 2 (conventional 2-D and 3-D conformal), Level 3 (conventional 2-D, 3-D conformal, and IMRT), and Level 4 (conventional 2-D, 3-D conformal, IMRT, and specialized radiotherapy services). Level 4 is the highest.
For up to a maximum of 250 patients treated annually, one radiation oncologist must be appointed and be an active member in good standing of PROS and PCR. A chief radiation oncologist must be appointed as head of the facility. Additional radiation oncologists: one for each 200–250 new patients annually; each radiation oncologist may be affiliated with not more than 6 facilities.
ROMPs must be active members in good standing of POMP. The minimum number of FTE ROMPs depends on facility level/services and number of linacs (as shown in the table). A board certified ROMP may train and supervise ROMPs if at least five (5) years clinical experience exists. Each board certified ROMP may be affiliated with not more than 3 facilities. (Exact minimum FTEs depend on Level/capability.)
A minimum of four (4) full-time RTTs must be employed for each medical linear accelerator operating for an 8-hour shift. Additional RTTs: two (2) additional full-time RTTs for every additional therapeutic x-ray equipment installed, and two (2) for every additional 8-hour shift per linac.
A qualified RPO must be a full-time employee and appointed in writing. The RPO shall be a medical physicist designated by the licensee, responsible for radiation safety and facility compliance, ensuring radiation activities follow approved policies/procedures, and having authority to stop any activity endangering health and safety. The RPO must be assisted by an Assistant RPO with the same qualifications. An Assistant RPO can act as temporary RPO in the absence of the designated RPO.
The shielding design must be calculated by a board certified radiation oncology medical physicist using optimization principles. Primary and secondary barrier thickness must follow NCRP Report No. 151 (or as revised).
Acceptance: conducted after installation in the presence of the facility’s ROMP and the authorized representative of the equipment manufacturer/supplier to verify compliance with IEC safety requirements. Commissioning: conducted by the facility’s ROMP after acceptance and before clinical operation to characterize performance over clinical use range. Operation: equipment must be operated only per technical specifications; treatment must occur only in clinical mode; periodic quality control must be done regularly and after repairs/maintenance that could alter output.
For existing facilities, a periodic external quality audit must be conducted by a duly recognized entity using the IAEA QUATRO methodology.
The licensee must provide an individual radiation monitoring device approved by the CDRRHR to each occupationally exposed person. The monitoring badge period must not exceed two (2) months, and replacement must be immediate. Monitoring devices must be part of a production batch calibrated with calibration traceable to a standard dosimetry laboratory.
The licensee must notify the CDRRHR within 24 hours of any overexposure of personnel, abnormal operating conditions, radiological accidents/incidents, or other unusual events that may cause exposure beyond operational restrictions. A formal investigation must be initiated as soon as possible, and a written report must be prepared and submitted within 25 days after occurrence.
Treatment plan prescription and plan must be in writing and duly signed by the radiation oncologist prior to initiation of treatment. A written protocol for each of the facility’s top ten clinical procedures must be in place. Responsibilities must be observed per the Manual and relevant sections of the AO.
Machine output calibration must be traceable to a standard dosimetry laboratory, and therapeutic x-ray equipment must be calibrated using the IAEA Code of Practice for radiotherapy. Beam calibrations must be carried out at commissioning, after any maintenance affecting dosimetry accuracy, and at intervals set by the AO/its requirements. Records of beam calibration, measurements, and calculations must be maintained for at least two (2) years.
The licensee must develop emergency response plans based on predictable incidents identified by the safety assessment, including: list of predictable incidents and measures; responsible persons with contact details; responsibilities of specific personnel; concise posted instructions; availability of quick access to responsible persons; and necessary equipment/tools. Emergency procedures must include immediate measures to avoid unnecessary radiation doses (e.g., removing patients) and preventing access to affected areas during ongoing exposure.