Cancer is a leading cause of death in the Philippines and in the world. Cancer can be treated or cured when diagnosed early. Radiation therapy is one of the major modalities for cancer treatment in addition to surgery and chemotherapy. It is estimated that radiotherapy solely or in combination with the other modalities will be the choice of treatment that will account for at least 60 percent of known cancer diseases worldwide.

Radiotherapy is the application of high doses of ionizing radiation in the treatment of cancer diseases. Radiation therapy is the intentional delivery of accurate and precise amount of high radiation doses to defined and localized cancer volumes at the same time minimizing the radiation doses to neighboring normal cells of the patients.

The increasing number and complexity associated with radiotherapy equipment, procedures, and techniques necessitate the regulation of radiotherapy practices in order to minimize the risks associated with the use of ionizing radiation and ensure the radiation protection and safety of the patients, workers, and members of the public from the operation of radiotherapy facilities in the Philippines.

There are two (2) government regulatory authorities in the Philippines. The Philippine Nuclear Research Institute (PNRI) regulates the use of radioactive materials such as those used in cobalt 60 radiotherapy facilities and brachytherapy units. The Center for Device Regulation, Radiation Health, and Research (CDRRHR), formerly named the Bureau of Health Devices and Technology, regulates the use of devices emitting radiation such as X-ray machines and linear accelerators (linacs).

There were only two linac facilities in the Philippines in 1995. However, since 2000 there has been an increase of about two linac facilities a year. Presently, there are 27 linac facilities operating in the country. The number of linacs is increasing while the number of cobalt 60 facilities has considerably decreased.

II. OBJECTIVES

These regulations are promulgated for the purpose of assuring safe, efficacious, and quality radiation treatment and of ensuring the protection and safety of the patients, the workers occupationally exposed to radiation, and the members of the general public from the hazards associated with the use of medical linear accelerators.

These regulations are hereby issued pursuant to Republic Act No, 9711 known as the Food and Drug Administration (FDA) Act of 2009 and its Implementing Rules and Regulation.

III. SCOPE AND COVERAGE

These regulations shall apply to all uses of medical linear accelerators and other x-ray sources in the practice of radiotherapy, to the facilities where these devices are located and to the individuals involved in this practice.

IV. DEFINITION OF TERMS

Acceptance testing - the activity where tests are carried out after new equipment has been installed or after major modifications have been made to existing equipment, in order to verify compliance with contractual specifications.

Ancillary Equipment - equipment such as Treatment Planning System (TPS), simulator, Quality Assurance (QA) tools, dosimetry, imaging equipment, information systems, radiation protection equipment, Uninterruptible Power Supply (UPS) and other equipment as may be classified as ancillary by the CDRRHR.

Assistant Radiation Protection Officer - an individual who has proper training and qualifications in radiation protection and safety.

Center for Device Regulation, Radiation Health and Research (CDRRHR) - the national agency under the Food and Drug Administration of the Department of Health that regulates the production, import, export, distribution, sale, promotion, and use of electrical/electronic devices capable of emitting radiation. Its former name is the Bureau of Health Devices and Technology.

Certified Medical Physicist in Radiation Oncology Medical Physics (CMPROMP) - a qualified expert in radiation oncology medical physics by virtue of certification of the Philippine Board of Medical Physics Section of ROMP. This also refers to the board certified ROMP in this Administrative Order (AO).

Commissioning - a process undertaken following the acceptance of the equipment, to fully characterize the performance of the equipment for a clinical use over the whole range of possible operation.

Compliance testing - the activity where test procedures are done on imaging equipment to verify its compliance to the performance specifications set by the CDRRHR.

Conventional radiotherapy - a basic radiation treatment delivery using simple beam arrangements, with or without custom blocks, as opposed to using multileaf collimators.

Controlled Area - an area in which specific protection measures and safety provisions are needed to control normal exposure and to prevent potential exposure. It includes all irradiation rooms for external beam therapy and the control panel area.

Corrective Maintenance - actions that restore, by repair, overhaul or replacement, the capability of a failed structure, system or component to function within acceptance criteria.

Full-time - refers to the standard number of working hours which is eight (8) hours a day for five (5) days a week.

Individual monitoring device - a radiation sensitive device [e.g. film badge, Thermoluminescent Dosimetry (TLD) badge, pocket dosimeter, Optically Stimulated Luminescence Dosimetry (OSLD) badge, etc.] used to estimate the dose received by a person occupationally exposed to radiation.

Interlock - a device or system that automatically terminates the machine operation once the system detected any parts malfunctioning or functioning but not within the standard operation.

International Atomic Energy Agency (IAEA) - an independent intergovernmental organization within the United Nations System that serves as the world ™s central intergovernmental forum for scientific and technical cooperation in the nuclear field, and as the international inspectorate for the application of nuclear safeguards and verification measures covering civilian nuclear programs.

International Electrotechnical Commission (IEC) - an independent organization that prepares and publishes International Standards for all electrical, electronic and related technologies, collectively known as œelectrotechnology .

International Commission on Radiological Protection (ICRP) - an independent non-governmental organization of scientists that serves as an advisory body providing recommendations and guidance on radiation protection.

Maintenance/service personnel - persons certified by the equipment manufacturer to have completed a training program in the maintenance (preventive and corrective) and servicing of a particular brand and model of therapeutic x-ray equipment or its component spare parts, including the scope of the service/maintenance work. He/she shall have completed a training course in radiation protection for use of radiotherapy equipment conducted by an institute or organization recognized/accredited by the CDRRHR.

Manual - DOH Department Circular No. 323 s. 2004, Manual on Basic Radiation Protection and Safety of X-ray Sources in the Philippines.

Medical linear accelerator - a type of therapeutic radiation equipment which can be operated either in the x-ray or electron beam mode. It uses high frequency electromagnetic waves to accelerate electrons to high energies through a linear tube.

Philippine Nuclear Research Institute (PNRI) - a scientific institution under the Department of Science and Technology (DOST) dedicated to the promotion, research and regulation of the peaceful uses of atomic energy.

Preventive maintenance - the planned, scheduled, visual, mechanical, engineering, and functional evaluation of equipment conducted at specified intervals throughout the equipment ™s lifetime to maintain equipment performance within manufacturers guidelines and specification.

Quality assurance program - a management tool which, through the development of policies and the establishment of review procedures, aims to ensure that every examination or treatment is necessary, appropriate and performed according to previously accepted clinical protocols by adequately trained personnel using properly selected and functioning equipment to the satisfaction of the patient and referring physicians safely and at minimum cost.

Quality audit - a comprehensive review and evaluation of the quality of all the elements involved in radiation therapy, including staff, equipment and procedures, patient protection and safety, and overall performance of the radiotherapy department, as well as its interaction with external service providers.

Quality control - a system where specific tests are required to ensure effective and safe equipment performance and/or measures that are taken to restore, maintain and/or improve the quality of treatment.

Qualified expert - an individual who, by virtue of certification by appropriate boards or societies, professional licenses or academic qualification and experience, is duly recognized as having expertise in radiation oncology.

Radiation accident - any unintended event, including operating errors, equipment failures or other mishaps, the consequences or potential consequences of which are not negligible from the point of view of protection or safety.

Radiation incident - any event which has occurred and has been confirmed to have affected a specifically defined area in the radiation therapy department with actual or projected radiation levels which are expected to be in significant quantities resulting in overexposure of a worker exceeding the annual dose limit based on ICRP 60.

Radiation Oncologist - a medical specialist certified in the practice of radiation oncology by the Philippine Board of Radiology in Radiation Oncology (PBR-RO) and is at least responsible for consultations, dose prescriptions, on-treatment supervision and evaluations, treatment summary reports, follow-up monitoring and evaluation of treatment outcome and morbidity.

Radiation oncology - is the discipline of human medicine concerned with the generation and dissemination of knowledge concerning the causes, prevention and treatment of cancer and other diseases involving special expertise in the therapeutic applications of ionizing radiation. As a discipline at the juncture of physics, medicine and biology, radiation oncology addresses the therapeutic uses of ionizing radiation alone or in combination with other treatment modalities such as surgery, chemotherapy, oxygen, heat and drugs.

Radiation Oncology Medical Physicist (ROMP) - an individual who has a PhD or Master ™s Degree in Medical Physics with the appropriate clinical training in radiation oncology medical physics and is charged with specific duties and responsibilities indicated herein and in Appendix I of this AD.

Radiation Protection Officer (RPO) - an individual who has proper training and qualifications in radiation protection and safety and who is charged with specific duties and responsibilities indicated herein and in Appendix II of this AO.

Radiation Therapy (Radiotherapy) - is a clinical modality dealing with the use of ionizing radiation in the treatment of patients with malignant (and occasionally non-malignant) neoplasms. The aim of radiation therapy is to deliver a precisely measured dose of irradiation to a defined tumor volume with as minimal damage as possible to surrounding healthy tissue, resulting in the eradication of the tumor, an improved quality of life and prolongation of survival.

Radiological emergency - a radiological incident that poses an actual, potential or perceived hazard to public health or safety, loss of life, disability or damage to property. Radiotherapy Equipment - linear accelerators, Cobalt 60 and Cesium 137 teletherapy equipment, and brachytherapy equipment.

Radiotherapy Technologist (RTT) - a radiologic technologist duly licensed by the Professional Regulation Commission (PRC), who is practicing radiotherapy technology and is responsible for operating simulators, computed tomography (CT) scanners, treatment units, etc; for accurate patient set-up and delivery of a planned course of radiation therapy prescribed by a radiation oncologist; and for documentation of treatment.

Specialized radiotherapy services - refers to complex radiotherapy procedures and techniques which usually require equipment modifications, special quality assurance procedures, and heavy involvement and support from medical physicists. These include image-guided radiotherapy (IGRT), stereotactic radiosurgery (SRS), stereotactic radiotherapy (SRT), stereotactic body radiotherapy (SBRT), total body irradiation (TBI), total skin electron irradiation (TSEI), intra-operative radiotherapy (IORT), intra-operative electron radiotherapy (IOERT), adaptive radiotherapy (ART), respiratory gated radiotherapy (4-DRT), Tomotherapy, Cyber Knife and other techniques as may be classified as specialized by the CDRRHR.

Supervised areas - any area not already designated as a controlled area but where occupational exposure conditions need to be kept under review even although specific protection measures and safety provisions are not normally needed.

Therapeutic X-ray equipment - medical linear accelerator equipment used for the treatment of patients with malignancies.

Therapeutic x-ray facility - a free standing or a hospital based radiotherapy center utilizing medical linear accelerator x-ray machine/s.

Worker - any person who works, whether full time, part time or temporarily, in a radiation oncology facility and who has recognized rights and duties in relation to occupational radiation protection.

World Health Organization (WHO) - a specialized agency of the United Nations with primary responsibility for health matters and public health established on 7 April 1948, whose objective is the attainment by all peoples of the highest possible level of health that will lead them to a socially and economically productive life.

V. GENERAL GUIDELINES

1. Any legal person who intends to operate a therapeutic x-ray facility shall notify the CDRRHR of his/her intention in writing.
2. All entities that plan to operate a therapeutic x-ray facility shall secure the appropriate authorizations from the CDRRHR following the two - stage process of authorization set by the CDRRHR.
3. The licensee shall allow the authorized representatives of the CDRRHR to conduct radiation protection survey and evaluation (RPSE) of the radiation oncology facility prior to the issuance of appropriate authorizations.
4. All personnel in therapeutic x-ray facility on whom protection and safety depend shall be appropriately trained and qualified.
5. The radiation protection requirements on justification of the practice, dose limitation, optimization of protection and the use of dose constraints shall apply.
6. The management/licensee shall be committed to an effective protection and safety policy, particularly at the senior level, and shall demonstrate support for those persons with responsibility for radiation protection.
7. The design of the radiation oncology facility, safety of equipment and sources shall comply with the requirements for optimization of radiation protection.
8. The licensee shall ensure that an individual radiation monitoring device is provided to each occupationally exposed person.
9. The licensee shall ensure that radiation doses to occupationally exposed person and members of the public do not exceed the dose limits specified by the CDRRHR.
10. The licensee shall establish a comprehensive quality assurance program for radiation protection and safety to ensure that all necessary procedures are developed and implemented in order to comply with the regulations for radiation protection within the terms and conditions of the authorization.

VI. SPECIFIC GUIDELINES

A. Administrative Requirements

B. Radiation Protection Requirements

The radiation protection requirements on justification of the practice, dose limitation, and optimization of protection and dose constraints as stated in Section IV Part A of A.O. 149 s. 2004 entitled œBasic Standards on Radiation Protection and Safety Governing the Authorization for the Introduction and Conduct of Practices Involving X-ray Sources in the Philippines  or as revised shall apply.

VII. SAFETY OF X-RAY SOURCES

A. Defense in depth

The requirement for defense in depth as described in DOH Administrative Order No. 149 s. 2004, specifically section IV-A subsection 3.1 shall be established in the radiation oncology facility.

B. Design of the X-ray Facility, Equipment and Sources

The design of the radiation oncology facility, equipment and sources shall comply with the requirements for optimization of radiation protection for medical exposures stated in the DOH A.O. No. 149 s. 2004 section 4-B subsection 1.2.

C. Testing, Commissioning and Operation

Acceptance testing, performance testing and commissioning shall be conducted for all therapeutic radiation emitting equipment including non-radiation emitting equipment/systems which affect safety such as treatment planning systems, etc.

D. Maintenance

1. The licensee shall ensure that adequate preventive and corrective maintenance of the equipment is performed as necessary to ensure that design specifications for radiation protection and safety is retained throughout their useful life.
2. The licensee shall ensure that the preventive and corrective maintenance of the equipment is performed only by qualified maintenance/ service personnel authorized by the equipment manufacturer.
3. Records of preventive and corrective maintenance program shall be kept for reference.
4. The licensee shall ensure that records of removal from and return to clinical service of therapeutic x-ray equipment for maintenance are properly kept.
5. When maintenance of therapeutic x-ray equipment or treatment planning system may affect the accuracy of the physical or clinical dosimetry, tests and measurements shall be performed by or under the supervision of a board certified radiation oncology medical physicist in order to determine if the equipment is operating satisfactorily before it is used in the treatment of patients.

VIII. OCCUPATIONAL EXPOSURE

A. Responsibilities and conditions of service

The requirements and recommendations stated in the IAEA/ILO Safety Guide RS-G-1.1 (Occupational Radiation Protection) and RS-G-1.3 (Assessment of Occupational Exposure due to External Sources of Radiation) or as revised, shall be applicable to radiotherapy practices.

B. The use of dose constraints in radiotherapy

Radiotherapy practice shall be subject to dose constraints in accordance with Section 1.4 Part IV of A.O. 149 s. 2004 and Chapter II of DOH Department Circular No. 323 s. 2004

C. Investigation levels in radiotherapy

Investigation levels shall be established for every task of each staff member in radiotherapy and a review of existing procedures shall be conducted in the event that such levels have been exceeded.

D. Classification of areas

1. All irradiation rooms and radioactive source storage and handling areas in a radiotherapy department are controlled areas. Supervised areas should include all remaining areas in the department except the public area/waiting room.
2. The licensees shall ensure that the specific rules in the designation of controlled and supervised areas, as well as the specific safety provisions and protective measures stated in Chapter IV of the Manual, are implemented.

E. Local rules and supervision

Local rules and supervision as stated in Chapter IV of the Manual shall apply to therapeutic x-ray facilities.

F. Protective equipment and tools

The licensee shall ensure that workers are provided with suitable and adequate personal protective equipment which meet any relevant regulations such as:

1. protective aprons and gloves for use only during work on a simulator or with a superficial x-ray unit
2. a radiation survey meter

G. Individual exposure monitoring

1. The licensee shall ensure that all personnel working in controlled areas are monitored using individual monitoring devices approved by the CDRRHR.
2. The RPO shall ensure that proper use of individual monitoring device is implemented.
3. The personnel dose monitoring period for each monitoring badge shall not exceed 2 (two) months. Replacement of the badge shall be immediate.
4. Individual monitoring devices shall be part of a production batch that underwent calibration traceable to a standard dosimetry laboratory.

H. Investigation and follow-up

1. The licensee shall notify the CDRRHR within twenty-four (24) hours of any cases of overexposure of personnel, abnormal operating conditions, radiological accidents and incidents, and any other unusual event that has the potential to cause exposure in excess of the operational restrictions imposed on the installation.
2. The licensee shall initiate a formal investigation as soon as possible following the event, and a written report shall be prepared concerning its cause, including determination or verification of any dose received, corrective or mitigating actions, instructions or recommendations to avoid recurrence and other information listed in Appendix VI of this AO.
3. The licensee shall submit the written report to the CDRRHR within twenty five (25) days after the occurrence of the events mentioned in item (1).

I. Monitoring the workplace

1. The licensee shall develop programs for initial and continuous monitoring of radiation levels in the workplace.
2. All survey meters used for workplace monitoring shall be calibrated in a standard dosimetry laboratory annually and after any repair done.
3. Initial monitoring shall be conducted by the licensee immediately after the installation of the new therapeutic x-ray equipment.

J. Health surveillance

Medical supervision intended to ensure the initial and continuous fitness of workers for their intended task is provided.

K. Records

The licensee shall maintain and preserve exposure records for each worker. These records shall be made available to the CDRRHR health physics team during the conduct of RPSE.

IX. MEDICAL EXPOSURE

A. General Responsibilities

1. The licensee shall ensure that all responsibilities for medical exposure required in Chapter V of the Manual and in relevant sections of this A.O. are observed and implemented at all times.
2. The licensee shall ensure that there is a written protocol for each of the top ten clinical procedures of the facility.
3. All persons involved in the delivery of medical exposure shall

3.1	follow the applicable rules and procedures for the protection and safety of patients as specified by the licensee
3.2	make sure that the prescription of treatment and the treatment plan shall be made in writing and duly signed by the radiation oncologist prior to initiation of the treatment

B. Justification

1. All therapeutic x-ray exposures shall be justified as required in A.O. 149 s. 2004 entitled œBasic Standards on Radiation Protection and Safety Governing the Authorization for the Introduction and Conduct of Practices Involving X-ray Sources in the Philippines .
2. The licensee should ensure that radiation oncologists follow a justification procedure that is documented and signed. He/she should consider the efficacy, benefits and risks of alternative treatment modalities such as surgery and chemotherapy, either alone or in combination with radiation therapy.
3. Exposure to comforters and care givers shall be in accordance with the dose constraints found in Appendix I of the Manual.

C. Optimization

Licensees shall ensure that all provisions for optimization of therapeutic x-ray exposures as required in Chapter V of the Manual are implemented.

D. Calibration of equipment and x-ray sources

The licensee shall ensure that:

1. the machine output calibration of the equipment and other radiation sources utilized in the practice of radiotherapy are traceable to a standard dosimetry laboratory.
2. the therapeutic x-ray equipment is calibrated using the IAEA Code of Practice for radiotherapy.
3. beam calibrations are carried out at the time of commissioning, after any maintenance procedure that may have an effect on the dosimetry, and at intervals set in this Order.
4. records of beam calibration, measurements and associated calculations are maintained in accordance with the requirements of the CDRRHR for a period of at least two (2) years.
5. the facility implements the latest IAEA Code of Practice for absorbed dose determination in x-ray and electron beams or its equivalent national protocol for radiotherapy.

E. Clinical Dosimetry

Registrants and licensees shall ensure that the following items are determined and documented:

1. For each patient treated with external beam radiotherapy equipment, the maximum and minimum absorbed doses to the planning target volume together with the absorbed dose to a relevant point such as the centre of the target volume, plus the dose to other relevant points selected by the medical practitioner prescribing the treatment; and
2. In all radiotherapeutic treatments, the absorbed doses to relevant organs.

F. Quality Assurance for Medical Exposure

The licensee shall ensure that:

1. A comprehensive quality assurance program for medical exposures is developed and implemented in the facility with the participation of appropriate qualified experts.
2. The quality assurance program includes all the items mentioned in Chapter V of the Manual.
3. Upon the acceptance of new therapeutic x-ray equipment, sufficient physics data are measured during the commissioning to be used for clinical dosimetry in treatment planning.
4. The facility participates in independent national or international postal dose verification program (e. g. IAEA/WHO).

G. Investigation of accidental medical exposure

The licensee shall promptly conduct an investigation of events involving accidental medical exposure and implement the actions required under Chapter V of the Manual. A list of identified causes and contributing factors of accidents in radiotherapy is given in the Manual.

X. PUBLIC EXPOSURE

A. General Responsibilities

1. The licensee shall be responsible for controlling public exposure resulting from radiotherapy practice.
2. Therapeutic x-ray sources shall be properly shielded and secured e.g. located in a locked area, with interlocks functional and keys to the control panel properly secured to prevent unauthorized access or use.
3. Access by members of the public and by other members of the facility staff who may need to be in areas within and near the radiotherapy department shall be considered in designing the shielding and use of facilities.
4. Measures for ensuring the safety and security of therapeutic x-ray sources to control public exposures shall be in accordance with the requirements of the CDRRHR shall be developed and implemented.

B. Control of access of visitors

Rules on the control of access of visitors as stated in Chapter VI of the Manual shall apply to all therapeutic x-ray facilities.

C. Therapeutic x-ray sources that are not in active use

The licensee shall notify the CDRRHR of any intention to transfer, dispose or decommission any therapeutic x-ray equipment that are no longer in use prior to initiating any action.

D. Monitoring of public exposure

1. The requirements for monitoring public exposure in Chapter VI of the Manual shall apply.
2. The licensee shall establish and implement a program for monitoring public exposure from radiotherapy which shall include dose assessment in the surroundings of irradiation rooms for therapeutic x-ray equipment, stability check device storage room and waiting rooms.

XI. POTENTIAL EXPOSURE AND EMERGENCY PLANS

A. Potential exposure

1. The licensee shall prepare a safety assessment applied to all stages of design, construction, and operation of the radiotherapy facility and submit it to the CDRRHR.
2. The safety assessment shall be documented and revised by an independent expert when:

2.1	modifications of the x-ray sources or its facilities are made
2.2	operational experience or information on accidents or errors indicates that the safety assessment should be reviewed
2.3	techniques are modified in such a way that safety may be compromised.

B. Accident Prevention and Mitigation

The rules on accident prevention and mitigation of their consequences stated in Chapter VII of the Manual shall apply to all therapeutic x-ray facilities.

C. Emergency plans

The licensee shall develop emergency response plans based on the events identified by the safety assessment and shall include the following:

1. list of predictable incidents and accidents and measures to deal with them
2. persons responsible to take action with complete information including phone numbers
3. responsibilities of individual personnel in emergency procedures (radiation oncologist, medical physicists, radiotherapy technologists, etc)
4. set of concise instructions posted in a visible area
5. availability of quick access to persons responsible for carrying out emergency response action
6. equipment and tools necessary to carry out the procedures
7. training and periodic rehearsal and recording and reporting system

Emergency procedures should also include:

1. immediate measures to avoid unnecessary radiation doses to patients, staff and public (such as removal of patients from a therapeutic x-ray unit)
2. measures to prevent access of persons to the affected area during the time that the x-ray source exposure is still going on and normal conditions are not yet restored.

XII. ROLES AND RESPONSIBILITIES

1. The CDRRHR of the Food and Drug Administration, Department of Health shall be responsible for the enforcement of this administrative order (A.O.) and other relevant regulatory standards pertaining to the operation of a therapeutic x-ray facility utilizing medical linear accelerators in the Philippines
2. The licensees and employers are the principal parties that are mainly responsible for the application of this A.O.
3. The other parties who shall have subsidiary responsibilities for the application of the regulations are:
   
   1. Radiation protection officer
   2. Assistant Radiation protection officer
   3. Radiation oncologist
   4. Radiation oncology medical physicist
   5. Radiotherapy technologist
   6. Suppliers
   7. Workers
   8. Maintenance Engineer
   9. Ethical Review Committee
   10. Any other party to whom the licensee has delegated specific responsibilities.
       
4. The management/licensee shall develop, implement, maintain and document a radiation protection and safety program commensurate with the nature and extent of the risks associated with the practices in radiation oncology. Necessary resources to comply with this program shall be provided.
5. The management/licensee shall issue a written policy that clearly assigns prime importance to protection and safety in radiotherapy while recognizing that the treatment and well-being of the patient are the prime objectives of medical care.
6. The management/licensee shall be committed to an effective protection and safety policy, particularly at senior level and by clearly demonstrable support for those persons with direct responsibilities for radiation protection.
7. The radiation protection and safety program shall describe and include all, but not limited to, the items stated in Appendix IV of this A.O.
8. A Radiation Protection Committee shall be organized in the facility. The committee shall consist of but shall not be limited to, the radiation protection officer, assistant radiation protection officer, chief radiation oncologist, radiation oncology medical physicist, chief radiotherapy technologist, a maintenance engineer (or any person responsible for coordinating the maintenance of equipment), and an administrator (representing the management/licensee);
9. The licensee shall prepare an annual report indicating the workload of the facility, the radiotherapy procedures/techniques done, data on the manpower, and any accidental exposure of patient, staff or members of the general public, using the form provided. The report shall be submitted to the CDRRHR together with the required renewal documents.
10. The licensee shall ensure that all responsibilities for occupational, medical and public exposure required in this A.O. are observed and implemented at all times.

All administrative orders, rules or regulations inconsistent herewith are hereby repealed, superseded, amended or modified accordingly.

XIV. SEPARABILITY CLAUSE

The provisions of this administrative order are hereby declared to be separable, and in the event anyone or more such provisions are held unconstitutional, the validity of the other provisions shall not be affected.

XV. TRANSITORY PROVISIONS

1. All existing radiotherapy facilities shall be given five (5) years from the effectivity date of this A.O. to comply with the requirements in Section VI.A.4.2 of this AO.
2. All existing radiotherapy facilities shall be given two (2) years from the effectivity date of this A.O. to comply with the requirements in Section VII.B.1.4 of this AO.
3. Facilities that plan to put-up a therapeutic x-ray facility, within the transition period shall satisfy the following manpower requirements for the radiation oncology medical physicist:
   
   

   1.	A minimum of 1 (one) full-time or part-time board certified ROMP shall be employed.
   2.	If the board certified ROMP is employed on a part time basis, an additional full time ROMP shall be employed with the following qualifications:
   	a.	Has a PhD or a Masters degree in Medical Physics;
   	b.	Has undergone structured clinical training in ROMP and has done conventional radiotherapy procedures under the close supervision of a board certified ROMP for a period of at least three (3) months, whether on site or at the board certified ROMP ™s facility, as attested to by a certificate issued by the board certified ROMP. The training shall cover the following activities: treatment planning, dose calculation, tumor localization and simulation, generation of beam data, beam calibration, activities pertaining to radiation protection and safety, and quality control and assurance of all equipment used in radiotherapy including treatment planning system. The training syllabus must be based on the Guidelines issued by the Philippine Board of Medical Physics Section of ROMP and the IAEA clinical training guide for ROMP; and
   	c.	Shall work on site under the supervision of a board certified ROMP for at least two (2) more years, following the Guidelines issued by the Philippine Board of Medical Physics, Section of ROMP. This ROMP may have a visiting consultant status to do review of treatment plans and other activities undertaken until the non-board certified ROMP shall have been certified by the board.
   3.	For existing facilities that plan to upgrade their services to special procedures, an additional board certified ROMP shall be employed on a part-time or full time basis.
   4.	For level 3 and 4 facilities an additional ROMP shall be employed depending on the workload for the IMRT and special procedures.

XVI. EFFECTIVITY

This administrative order shall take effect 15 days following the publication in the Official Gazette or in a newspaper of general circulation.

(SGD) ENRIQUE T. ONA, M.D.
Secretary of Health