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(NAR) VOL. III NO. 4 / OCTOBER - DECEMBER 1992

[ DOH ADMINISTRATIVE ORDER NO. 124 S. 92, June 01, 1992 ]

RULES AND REGULATIONS GOVERNING THE ESTABLISHMENT, OPERATION AND MAINTENANCE OF AN X-RAY FACILITY IN THE PHILIPPINES



SECTION 1. Title — These rules shall be known as the “Rules and Regulations Governing the Establishment, Operation and Maintenance of X-ray Facility in the Philippines”.

SECTION 2. Authority — These rules and regulations are issued pursuant to P.D. 480 (Creation of the Radiation Health Office in the Department of Health) as amended by P.D. 1372 and consistent with E.O. 119 (Reorganization Act of the Ministry of Health) dated January 30, 1987.

SECTION 3. Purpose — These rules and regulations are promulgated to protect the health of the people by preventing the operation of substandard, improperly managed, and inadequately supported facilities using x-ray devices in medicine, dentistry, veterinary science, industry, research, education, anti-crime work, and other areas.

SECTION 4. Scope — These rules and regulations apply to all entities establishing, operating, or maintaining x-ray facilities. An x-ray facility is an establishment in which an x-ray device is intentionally used for irradiation. 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 5. Regulatory Authority — The Department of Health, through the Bureau of Licensing and Regulation (BLR) in the Office for Standards and Regulation, shall issue and monitor all licenses to establish, operate, and maintain x-ray facilities. The Radiation Health Service (RHS) in the Office for Hospital and Facility Services shall undertake radiation protection survey and evaluation of all x-ray facilities and shall recommend appropriate action to the Bureau of Licensing and Regulation.

SECTION 6. Classification of X-ray Facilities:

6.1 According to functions, x-ray facilities shall be classified as follows:
  1. Anti-crime x-ray facility — a facility using x-ray devices for prevention, detection, and abatement or prosecution of public nuisances and crimes.

  2. Clinical x-ray facility — a facility using x-ray devices for diagnosis or treatment of human diseases. This facility is either a hospital or a free-standing (non-hospital) facility. A hospital x-ray facility operates within a hospital; a free-standing x-ray facility operates on its own or is a part of an institution other than a hospital.

  3. Dental x-ray facility — a facility using x-ray devices for diagnosis of human dental diseases. This facility is either hospital-based or a free-standing one.

  4. Education and training x-ray facility — a facility using x-ray devices for teaching and training purposes.

  5. Industrial x-ray facility — a facility using x-ray devices for industrial applications.

  6. Research x-ray facility — a facility using x-ray devices for research and development work.

  7. Veterinary x-ray facility — a facility using x-ray devices for diagnosis of animal diseases.
6.2 According to location of services, x-ray facilities shall be classified as follows:
  1. Transportable X-ray Facility — an x-ray facility whose x-ray device can be transported and is used inside a vehicle that is properly shielded.

  2. Stationary X-ray Facility — an x-ray facility where all the x-ray devices are used only within the premises of the facility.
SECTION 7. License Required

7.1 License — a license is a formal authorization issued by the Department of Health to a person, association, partnership, or corporation to operate and maintain an x-ray facility.

7.2 No x-ray facility may operate without a valid license issued by the Department of Health.

7.3 Separate Licenses — a hospital with radiographic, computed tomography and radiotherapy facilities shall have separate x-ray licenses for each one. A transportable x-ray facility shall also have a separate x-ray license. A hospital with both clinical and dental x-ray equipment shall have separate x-ray licenses for each one.

SECTION 8. Licensing Requirements

8.1 All x-ray facilities shall be required to demonstrate compliance with the Technical Standards as a requirement to licensing. The Technical Standards are the requirements formulated by the Radiation Health Service and issued in the form of Bureau Administrative Orders by the BLR for control of radiation hazards from x-ray devices.
  1. Head of the Facility — The head is that person with qualifications indicated in the appropriate Bureau Administrative Order who assumes technical and administrative supervision and control of the activities in the x-ray facility.

  2. Personnel — Every x-ray facility is required to be staffed by qualified x-radiation workers. An x-radiation worker is a person who by reason of his profession, trade, or occupation uses any x-ray device or is directly involved in such activity or operation in which an x-ray device is used and who may be exposed to x-rays as a result of being directly involved in such activity or operation. Every x-ray facility shall have a Radiation Safety Officer who must himself be an x-radiation worker.

  3. X-ray Equipment/Device and Accessories — Every x-ray facility shall have calibrated and safe x-ray device and adequate accessories to be used in protecting an individual and the public from the hazards of x-rays.

  4. Physical Plant — Every x-ray facility is required to be well ventilated, well lit, clean, and safe with space sufficient to accommodate its activities.
8.2 The Radiation Health Service shall evaluate compliance with the Technical Standards.

SECTION 9. Quality Control and Monitoring

9.1 All x-radiation workers shall be provided with personal radiation dose monitors. A personal radiation dose monitor is a device that measures the radiation dose absorbed by the individual x-radiation worker. A record of occupational radiation doses received by these workers shall be kept.

9.2 A quality control program shall be established in all x-ray facilities. A quality control program is the overall system of activities the purpose of which is to provide better quality products of services.

9.3 In case of an equipment malfunction or any accident which may cause unwarranted radiation exposure of patients, staff members or others from the public, the Radiation Health Service must immediately be notified by the licensee. A written report must be sent to the Bureau of Licensing and Regulation by the licensee. The report must include information on action taken by the licensee to solve the problem or to contain the effects of the accident.

SECTION 10. Basic Licensing Requirements

10.1 Any person, firm or corporation desiring to establish or operate and maintain an x-ray facility shall submit to the Radiation Health Service a sworn petition/application, on the prescribed form, containing, among others, the following data:
  1. Name, citizenship, and domicile of the head of the X-ray facility.

  2. Place, municipality and province where it is to be established.

  3. Name of establishment.

  4. Name, citizenship, and domicile of the owner of the facility.

  5. Names and qualifications of the x-radiation workers.

  6. Brand, model, serial numbers, maximum mA and kVp of the x-ray machine.

  7. Type of x-ray examinations to be performed.

  8. Statement duly notarized that applicant has complied with all business requirements under other existing laws or ordinances that are necessary in pursuance of the activity for which a license is herein applied for.
10.2 If the applicant is a partnership or corporation, it must be duly registered under existing laws and a copy of its registration papers must be attached to the corresponding license application.

SECTION 11. Application for Issuance of License

11.1 Application shall be made by the owner or his duly authorized representative using the appropriate prescribed form for x-ray license application. Each application shall be signed by the applicant or a person duly authorized to act for and in his behalf. Application shall be filed with the RHS.

11.2 Upon receipt of said application, a health physics team of the RHS shall undertake within ninety (90) working days a radiation protection survey and evaluation of the facility and the work thereat.

11.3 Any material false statement in the application or failure to comply with requirements shall serve as basis for the RHS Director to recommend to the BLR Director the non-issuance/non-renewal of an x-ray license.

SECTION 12. License Fees

12.1 The non-refundable fee listed in section 12.2 shall be charged for every application for issuance/renewal of a license to establish, operate and maintain any x-ray facility both government and private.

12.2 All fees shall be payable to the Department of Health in accordance with the following schedule:

a.  Initial License Fees:
P400.00/Unit — X-ray devices with milliamperage of 100 mA and less.

P550.00/Unit — Units with milliamperage greater than 100 mA up to 300 mA.

P700.00/Unit — Units with milliamperage greater than 300 mA up to 500 mA.

P850.00/Unit — Units with milliamperage greater than 500 mA up to 700 mA.

P1000.00/Unit — Units with milliamperage greater than 700 mA.
b.  Renewal Fees:
P200.00/Unit — X-ray devices with milliamperage of 100 mA and less.

P275.00/Unit — Units with milliamperage greater than 100 mA up to 300 mA.

P350.00/Unit — Units with milliamperage greater than 300 mA up to 500 mA.

P425.00/Unit — Units with milliamperage greater than 500 mA up to 700 mA.

P500.00/Unit — Units with milliamperage greater than 700 mA.
12.3 A penalty of 50% surcharge shall be charged for late renewal in addition to the renewal fee for all categories if the application is filed during the first three (3) months after the license expiry date.

12.4 After the third month unrenewed licenses shall be considered lapsed, and a new license shall be applied for without prejudice, however, to the provision of Section 18.2. If the facility still operates despite a lapsed license, the penalties for operation without a license shall apply.

SECTION 13. Inspection

13.1 Each licensee shall give the BLR Director or the RHS Director or his duly authorized representative reasonable time to do a survey and evaluation of the facility and the work thereat.

13.2 Each licensee shall make available for inspection by the BLR Director and the RHS Director or his duly authorized representative, records kept by him pursuant to these regulations.

13.3 The BLR Director or the RHS Director or their authorized representatives may be assisted by experts from professional associations in such inspection.

13.4 Directors of Regional Health Offices, Provincial Health Officers, and City and Municipal Health Officers shall report the existence of unlicensed x-ray facilities or any private party performing x-ray examinations without proper permit or license and/or violations of these rules to the Bureau of Licensing and Regulation or Radiation Health Service of the Department of Health.

SECTION 14. Issuance of License

14.1 The license shall be issued by the BLR upon recommendation of the RHS Director and the same shall be approved by the Undersecretary of Health for Standards and Regulation if application is found to be meritorious and the license fees duly paid; otherwise the license shall be disapproved.

SECTION 15. Terms and Conditions of License

15.1 The license as herein granted as well as any right under the license shall not be assigned or otherwise transferred directly or indirectly to any other party.

15.2 Any change affecting the conditions of the license to operate the facility shall be reported in writing within 15 days to the BLR and the RHS for notation and approval. Failure to do so will justify the revocation of the license of the x-ray facility.

SECTION 16. Exhibition of License, Certificate of Proficiency and the Rules and Regulations — The license of the x-ray facility must be placed in a conspicuous place within the facility. The physician who heads the facility and the x-ray/radiologic technologist/s must likewise display their certificate of proficiency in the specialty. A copy of the rules and regulation shall be readily available for guidance of all staff and personnel in the x-ray facility.

SECTION 17. Expiration — The license herein granted shall expire one year after the date of issuance.

SECTION 18. Renewal

18.1 Application for renewal of license shall be filed with the RHS two (2) months before the expiry date. Expiry dates of licenses shall be determined on a regional basis by the BLR. Application shall be processed by the BLR upon the recommendation of the Director of the RHS.

18.2 X-ray facilities can continue operation even if the license has expired provided that no previous adverse action has been taken thereon or unless otherwise ordered by the Under-secretary of Health for Standards and Regulation to cease operation.

SECTION 19. Publication of List of Licensed X-ray Facilities — A list of licensed x-ray facilities according to type and category shall be published periodically in a newspaper of leading circulation and shall be made available to any interested person, agency or organization for legitimate purposes.

SECTION 20. Modification and Revocation of License — The terms and conditions of each license shall be subject to amendment or modification to conform to the amendments to these regulations, as the Secretary of Health may deem necessary.

SECTION 21. Violations

21.1 The license to operate an x-ray facility may be suspended or revoked by the Undersecretary of Health for Standards and Regulations upon violation of any provision of P.D. 480, P.D. 1372, E.O. 119, this Administrative Order, and the appropriate Bureau Administrative Order issued in pursuance thereof or upon the commission of the following acts by the persons owning or operating an x-ray facility and the persons under their authority.

  21.1.1
Operation of an x-ray facility without the required qualified personnel.
   
  21.1.2.
Change of ownership, location, or personnel without informing the BLR.
   
  21.1.3.
Any change affecting the substantial conditions of the license to operate the x-ray facility that is not reported to the BLR.
   
  21.1.4.
Refusal to allow inspection of the facility by the persons authorized by the RHS Director or the BLR Director during reasonable hours.
   
  21.1.5.
Use of equipment which fails to comply with the appropriate standards as specified in the Bureau Administrative Order.
   
  21.1.6
Operation without providing adequate radiation protection to workers, patient, and members of the general public.
   
  21.1.7
Operation without the necessary accessories as specified in the regulations.
   
  21.1.8
Falsification or any untrue statement in the submitted x-ray license application and other supporting document as may be required.

21.2 An x-ray facility found to be operating without a license shall immediately cease operation. The RHS health physics team upon the order of the Undersecretary of Health for Standards and Regulations shall incapacitate the x-ray device by detaching one high tension wire connection and by sealing it with an RHS seal to ensure non-operation of the machine. The RHS seal shall not be broken and the high tension wire connector can only be re-attached by authorized DOH personnel upon approval of the Undersecretary of Health for Standards and Regulations.

SECTION 22. Penalty — As provided for in the penalty clause of Presidential Decree No. 480, any person or institution who shall violate these rules and regulations shall upon conviction pay a fine of P500.00 or suffer imprisonment for a period not exceeding six (6) months.

SECTION 23. Investigation of Charges of Complaints — Upon the filing of a complaint or charges duly sworn to by any person, interested party or corporation, against an x-ray facility or any of its personnel to the effect that provisions of these rules and regulations are being violated, the Undersecretary of Health for Standards and Regulations or his duly authorized representative/s shall investigate the complaints or charges and verify if the facility concerned or any of its personnel is guilty of the charges. If upon investigation, a person or persons are found violating any of the provision of these regulations, the Undersecretary of Health for Standards and regulations shall cancel or revoke the license of the x-ray facility and the authority of the offending person/s, or order the closure of the facility, without prejudice to taking the case to judicial authorities for criminal action.

SECTION 24. Effectivity — These rules and regulations shall take effect 15 days after its publication in the Official Gazette or in a newspaper of general circulation and shall supersede all issuances inconsistent therewith.

Adopted: 1 June 1992

(SGD.) ANTONIO O. PERIQUET, M.D.
Secretary of Health
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