Title
Regulations for X-ray Facilities in the Philippines
Law
Doh Administrative Order No. 124 S. 92
Decision Date
Jun 1, 1992
DOH Administrative Order No. 1992-0124 establishes rules and regulations to protect public health by ensuring proper management and support of X-ray facilities, with violations resulting in license revocation and potential closure of the facility.
rules and regulations
establishment
operation

Legal basis, policy, and intent

  • These rules are issued pursuant to Presidential Decree No. 480, as amended by Presidential Decree No. 1372, and are consistent with Executive Order No. 119 (dated January 30, 1987). (Section 2)
  • The rules protect public health by preventing the operation of substandard, improperly managed, and inadequately supported facilities using x-ray devices. (Section 3)
  • The rules cover the full range of x-ray uses in medicine, dentistry, veterinary science, industry, research, education, anti-crime work, and other areas. (Section 3)

Definitions and facility scope

  • An x-ray facility is an establishment in which an x-ray device is intentionally used for irradiation. (Section 4)
  • An x-ray device is an apparatus equipped with a high vacuum tube that produces x-rays by bombarding a target (usually metallic) with fast-moving electrons. (Section 4)
  • The rules apply to all entities that establish, operate, or maintain x-ray facilities. (Section 4)

Types and locations of x-ray facilities

  • Anti-crime x-ray facilities use x-ray devices for prevention, detection, and abatement or prosecution of public nuisances and crimes. (Section 6.1)
  • Clinical x-ray facilities use x-ray devices for diagnosis or treatment of human diseases and are either hospital-based or free-standing (non-hospital) facilities. (Section 6.1)
  • Dental x-ray facilities use x-ray devices for diagnosis of human dental diseases and are either hospital-based or free-standing. (Section 6.1)
  • Education and training x-ray facilities use x-ray devices for teaching and training purposes. (Section 6.1)
  • Industrial x-ray facilities use x-ray devices for industrial applications. (Section 6.1)
  • Research x-ray facilities use x-ray devices for research and development work. (Section 6.1)
  • Veterinary x-ray facilities use x-ray devices for diagnosis of animal diseases. (Section 6.1)
  • By service location, a transportable x-ray facility uses an x-ray device inside a properly shielded vehicle. (Section 6.2)
  • A stationary x-ray facility uses all x-ray devices only within the premises of the facility. (Section 6.2)

Regulatory agencies and licensing

  • The Department of Health (DOH) issues and monitors all licenses to establish, operate, and maintain x-ray facilities. (Section 5)
  • Licensing authority is assigned to the Bureau of Licensing and Regulation (BLR) in the Office for Standards and Regulation. (Section 5)
  • The Radiation Health Service (RHS) in the Office for Hospital and Facility Services conducts radiation protection survey and evaluation of x-ray facilities and recommends appropriate action to the BLR. (Section 5)
  • A license is a formal authorization issued by the DOH to a person, association, partnership, or corporation to operate and maintain an x-ray facility. (Section 7.1)
  • No x-ray facility may operate without a valid license issued by the DOH. (Section 7.2)

Separate licenses, personnel, and technical compliance

  • A hospital with radiographic, computed tomography and radiotherapy facilities must have separate x-ray licenses for each. (Section 7.3)
  • A transportable x-ray facility must have a separate x-ray license. (Section 7.3)
  • A hospital with both clinical and dental x-ray equipment must have separate x-ray licenses for each. (Section 7.3)
  • All x-ray facilities must demonstrate compliance with Technical Standards as a requirement to licensing. (Section 8.1)
  • The Technical Standards are requirements formulated by the Radiation Health Service and issued as Bureau Administrative Orders by the BLR for control of radiation hazards from x-ray devices. (Section 8.1)
  • The head of the facility is the person whose qualifications are indicated in the appropriate Bureau Administrative Order and who assumes technical and administrative supervision and control. (Section 8.1)
  • Each x-ray facility must be staffed by qualified x-radiation workers. (Section 8.1)
  • An x-radiation worker is a person who, by profession/trade/occupation, uses any x-ray device or is directly involved in activities where an x-ray device is used and who may be exposed to x-rays due to direct involvement. (Section 8.1)
  • Each x-ray facility must have a Radiation Safety Officer, and that officer must himself be an x-radiation worker. (Section 8.1)
  • Each x-ray facility must have calibrated and safe x-ray equipment/device and adequate accessories to protect individuals and the public from x-ray hazards. (Section 8.1)
  • Each x-ray facility must be well ventilated, well lit, clean, and safe, with space sufficient for its activities. (Section 8.1)
  • The Radiation Health Service evaluates compliance with the Technical Standards. (Section 8.2)

Quality control, dose monitoring, and incident reporting

  • All x-radiation workers must be provided with personal radiation dose monitors that measure radiation dose absorbed by the individual worker. (Section 9.1)
  • Records of occupational radiation doses received by these workers must be kept. (Section 9.1)
  • Every x-ray facility must establish a quality control program—an overall system of activities intended to provide better quality products of services. (Section 9.2)
  • The Radiation Health Service must be immediately notified by the licensee upon equipment malfunction or any accident that may cause unwarranted radiation exposure of patients, staff, or members of the public. (Section 9.3)
  • The licensee must send a written report to the BLR describing the information and including the action taken to solve the problem or contain the effects of the accident. (Section 9.3)

Licensing application process and survey timeline

  • A person, firm, or corporation desiring to establish or operate and maintain an x-ray facility must submit to the RHS a sworn petition/application on the prescribed form. (Section 10.1)
  • The application must include: (Section 10.1)
    • Name, citizenship, and domicile of the head of the x-ray facility.
    • Place, municipality, and province where the facility will be established.
    • Name of the establishment.
    • Name, citizenship, and domicile of the owner of the facility.
    • Names and qualifications of the x-radiation workers.
    • Brand, model, serial numbers, maximum mA and kVp of the x-ray machine.
    • Type of x-ray examinations to be performed.
    • A duly notarized statement that the applicant complied with all business requirements under other existing laws or ordinances necessary for the licensed activity.
  • Partnerships or corporations must be duly registered under existing laws, and a copy of registration papers must be attached to the license application. (Section 10.2)
  • Applications must be made by the owner or a duly authorized representative using the appropriate prescribed form. (Section 11.1)
  • Each application must be signed by the applicant or a person duly authorized to act. (Section 11.1)
  • Applications must be filed with the RHS. (Section 11.1)
  • Upon receipt, the RHS health physics team must conduct a radiation protection survey and evaluation within ninety (90) working days. (Section 11.2)
  • Any material false statement in the application, or any failure to comply with requirements, must serve as basis for the RHS Director to recommend the non-issuance/non-renewal of an x-ray license. (Section 11.3)

License fees, surcharges, and lapsed licenses

  • A non-refundable fee applies to every application for issuance/renewal of a license to establish, operate, and maintain an x-ray facility for both government and private facilities. (Section 12.1)
  • Fees are payable to the DOH under the schedule below. (Section 12.2)
  • Initial License Fees per unit: (Section 12.2)
    • P400.00 for x-ray devices with milliamperage of 100 mA and less.
    • P550.00 for units with milliamperage of greater than 100 mA up to 300 mA.
    • P700.00 for units with milliamperage of greater than 300 mA up to 500 mA.
    • P850.00 for units with milliamperage of greater than 500 mA up to 700 mA.
    • P1000.00 for units with milliamperage of greater than 700 mA.
  • Renewal Fees per unit: (Section 12.2)
    • P200.00 for x-ray devices with milliamperage of 100 mA and less.
    • P275.00 for units with milliamperage of greater than 100 mA up to 300 mA.
    • P350.00 for units with milliamperage of greater than 300 mA up to 500 mA.
    • P425.00 for units with milliamperage of greater than 500 mA up to 700 mA.
    • P500.00 for units with milliamperage of greater than 700 mA.
  • A 50% surcharge applies for late renewal in addition to the renewal fee if the application is filed during the first three (3) months after the license expiry date. (Section 12.3)
  • After the third month, unrenewed licenses are considered lapsed, and a new license application is required without prejudice to Section 18.2. (Section 12.4)
  • If the facility still operates despite a lapsed license, the penalties for operation without a license apply. (Section 12.4)

Inspections, issuance approval, and license conditions

  • Each licensee must give the BLR Director or the RHS Director (or their authorized representative) reasonable time for a survey and evaluation. (Section 13.1)
  • Each licensee must make available for inspection the records kept under the regulations. (Section 13.2)
  • The BLR Director or RHS Director may be assisted by experts from professional associations during inspections. (Section 13.3)
  • Regional health and local health officers must report the existence of unlicensed x-ray facilities or private parties performing x-ray examinations without proper permit or license and/or violations of these rules to the BLR or RHS. (Section 13.4)
  • The BLR issues the license upon recommendation of the RHS Director and approval by the Undersecretary of Health for Standards and Regulation, if the application is meritorious and license fees are duly paid; otherwise the license is disapproved. (Section 14.1)
  • The license and any right under the license cannot be assigned or transferred directly or indirectly to any other party. (Section 15.1)
  • Any change affecting the conditions of the license must be reported in writing within 15 days to the BLR and the RHS for notation and approval; failure justifies revocation of the license. (Section 15.2)

Display requirements, expiration, and renewal rules

  • The x-ray facility license must be placed in a conspicuous place within the facility. (Section 16)
  • The physician who heads the facility and the x-ray/radiologic technologist(s) must display their certificate of proficiency in the specialty. (Section 16)
  • A copy of the rules and regulations must be readily available for staff and personnel guidance. (Section 16)
  • A license expires one year after the date of issuance. (Section 17)
  • Renewal application must be filed with the RHS two (2) months before the expiry date. (Section 18.1)
  • Expiry dates are determined on a regional basis by the BLR, and the BLR processes renewal upon recommendation of the RHS Director. (Section 18.1)
  • An x-ray facility may continue operation even if the license has expired when no previous adverse action has been taken, unless otherwise ordered by the Under-secretary of Health for Standards and Regulation to cease operation. (Section 18.2)

Publication, modifications, and revocation framework

  • The BLR publishes a periodic list of licensed x-ray facilities by type and category in a newspaper of leading circulation and makes the list available to any interested person, agency, or organization for legitimate purposes. (Section 19)
  • The Secretary of Health may amend or modify the terms and conditions of each license to conform to amendments to these regulations. (Section 20)
  • License suspension or revocation is governed by the violations framework under Section 21. (Sections 20 and 21)

Prohibited acts, closure, suspension, and revocation

  • The Undersecretary of Health for Standards and Regulations may suspend or revoke the operating license upon violation of Presidential Decree No. 480, Presidential Decree No. 1372, Executive Order No. 119, this Administrative Order, the appropriate Bureau Administrative Order issued pursuant to those laws, or upon commission of the enumerated acts. (Section 21.1)
  • Prohibited acts that trigger suspension or revocation include: (Section 21.1)
    • Operation without required qualified personnel. (Section 21.1.1)
    • Change of ownership, location, or personnel without informing the BLR. (Section 21.1.2)
    • Any change affecting substantial conditions of the license not reported to the BLR. (Section 21.1.3)
    • Refusal to allow inspection during reasonable hours by authorized RHS Director or BLR Director representatives. (Section 21.1.4)
    • Use of equipment that fails to comply with standards specified in the appropriate Bureau Administrative Order. (Section 21.1.5)
    • Operation without adequate radiation protection to workers, patients, and members of the general public. (Section 21.1.6)
    • Operation without necessary accessories specified in the regulations. (Section 21.1.7)
    • Falsification or any untrue statement in the submitted license application and other required supporting documents. (Section 21.1.8)
  • If an x-ray facility is operating without a license, it must immediately cease operation. (Section 21.2)
  • The RHS health physics team must incapacitate the x-ray device by detaching one high tension wire connection and sealing it with an RHS seal to ensure non-operation. (Section 21.2)
  • The RHS seal must not be broken, and the high tension wire connector can only be reattached by authorized DOH personnel upon approval of the Undersecretary of Health for Standards and Regulations. (Section 21.2)

Criminal penalties and investigation of complaints

  • Violations are punishable by the penalty clause of Presidential Decree No. 480: a fine of P500.00 or imprisonment of up to six (6) months upon conviction. (Section 22)
  • Upon filing of a complaint or charges duly sworn by any person, interested party, or corporation against an x-ray facility or its personnel alleging violations, the Undersecretary of Health for Standards and Regulations (or authorized representative) must investigate and verify whether the facility or personnel are guilty of the charges. (Section 23)
  • If the investigation finds violations, the Undersecretary must cancel or revoke the facility’s license and the authority of the offending persons, or order closure of the facility, without prejudice to taking the case to judicial authorities for criminal action. (Section 23)

Effectivity and supersession

  • These rules take effect 15 days after publication in the Official Gazette or a newspaper of general circulation. (Section 24)
  • These rules supersede all issuances inconsistent with them. (Section 24)

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