Law Summary
Purpose
- To protect public health by ensuring proper management and operation of x-ray facilities.
- To prevent substandard and improperly managed x-ray operations across various fields such as medicine, dentistry, veterinary science, industry, research, education, and anti-crime work.
Scope and Definitions
- Applicable to all entities establishing, operating, or maintaining x-ray facilities.
- Defines an x-ray facility as any establishment using x-ray devices for irradiation.
- Defines x-ray devices as apparatuses with high vacuum tubes generating x-rays by electron bombardment of metallic targets.
Regulatory Authority
- The Department of Health, through the Bureau of Licensing and Regulation (BLR), issues and monitors x-ray facility licenses.
- The Radiation Health Service (RHS) conducts radiation protection surveys and evaluations and recommends actions.
Classification of X-ray Facilities
- By function: anti-crime, clinical (hospital or free-standing), dental (hospital-based or free-standing), education and training, industrial, research, and veterinary.
- By location: transportable (used inside properly shielded vehicles) and stationary (used within facility premises).
License Requirement
- A valid license from the Department of Health is mandatory to operate any x-ray facility.
- Separate licenses required for hospitals with multiple types of x-ray services and for transportable x-ray units.
Licensing Requirements
- Compliance with Technical Standards issued by the Radiation Health Service and BLR is mandatory.
- Facilities must have a qualified head and staff including a Radiation Safety Officer.
- X-ray equipment must be calibrated and facilities must ensure proper environmental conditions.
Quality Control and Monitoring
- X-radiation workers must use personal radiation dose monitors, and occupational dose records must be maintained.
- Quality control programs are mandatory for improving service quality.
- Immediate reporting to RHS required for equipment malfunction or radiation accidents, including written reports detailing corrective actions.
License Application Procedures
- Application via sworn petition to RHS including identification of key personnel, facility location, equipment details, and statement of business compliance.
- Partnerships and corporations must provide registration documents.
- RHS conducts survey and evaluation within 90 working days of application.
License Fees
- Non-refundable fees based on x-ray machine milliamperage for initial license and renewal.
- Penalties apply for late renewal and operation without a valid license.
Inspection
- Licensees must allow inspection by BLR, RHS, and authorized representatives.
- Health officers must report unlicensed or illegal x-ray operations to DOH.
License Issuance and Terms
- Licenses issued by BLR upon RHS recommendation and Undersecretary approval.
- Licenses are non-transferable.
- Changes affecting license conditions must be reported within 15 days.
Exhibition and Validity
- License and personnel certificates must be displayed conspicuously.
- License valid for one year.
Renewal and Continuity
- Renewal applications filed two months before expiry.
- Expired licenses allow continued operation unless adverse actions have been taken or ordered otherwise.
Publication of Licensed Facilities
- Periodic publication of licensed x-ray facilities by type and category in widely circulated newspapers.
Modification and Revocation
- License terms subject to amendment in line with regulatory changes.
Violations and Sanctions
- Grounds for license suspension or revocation include lack of qualified personnel, non-reporting of changes, refusal to allow inspection, use of non-compliant equipment, inadequate radiation protection, falsification in applications, and operation without license.
- Unlicensed facilities must cease operation immediately, and equipment may be disabled by RHS.
Penalties
- Violations are punishable by a fine up to P500 or imprisonment up to six months under Presidential Decree No. 480.
Investigation of Complaints
- The Undersecretary of Health investigates sworn complaints.
- Upon verification of violations, licenses may be revoked and facilities closed.
- Cases may be referred to judicial authorities for criminal proceedings.
Effectivity
- These rules take effect 15 days after publication in the Official Gazette or a general circulation newspaper.
- Supersede any inconsistent prior issuances.