Law Summary
Scope of Application
- These regulations apply to all ambulatory surgical clinics, both government and private.
- Covers clinics that are either freestanding or physically situated within hospital premises but owned separately.
- For hospital-based ASCs, compliance is assessed during hospital license inspections.
Key Definitions
- Ambulatory Surgical Clinic (ASC): Facilities organized primarily to provide elective outpatient surgical treatments that do not require inpatient recovery.
- Ambulatory Surgical Services: Elective surgical procedures ranging from minor to major, performed under any anesthesia type, with same-day patient discharge.
- BHFS: Bureau of Health Facilities and Services, DOH body responsible for licensing and regulation.
- License to Operate: Official DOH authorization to operate an ASC upon meeting prescribed standards.
- Licensee: The entity or individual holding the operating license.
Classification of ASCs
- By Ownership:
- Government: Operated wholly or partly by government entities.
- Private: Operated by individuals, corporations, or associations with private funding.
- By Surgical Specialty Services Offered.
Standards and Technical Requirements
- Governance must promote coordinated, planned, patient-centered service delivery.
- Medical records management ensuring confidentiality, accuracy, and accessibility.
- Human resource management aligned with good employment practices.
- Continuous quality improvement systems.
- Qualified and sufficient personnel allocation.
- Adequate and maintained surgical equipment and instruments.
- Appropriate physical environment ensuring patient privacy, safety, and sufficient space.
- Safe handling, storage, and disposal of wastes in conformity with DOH guidelines and applicable laws.
- Memorandum of Agreement with at least one hospital capable of secondary care for inpatient referrals.
License to Operate (LTO) Provisions
- License issued only after meeting all prescribed requirements; non-transferable and non-assignable.
- Must specify clinic name, address, licensee, license number, and permitted services.
- License renewal applications allowed ninety (90) days before expiration; failure to renew within thirty (30) days post-expiration mandates cessation of operations.
- Permanent and distinctive clinic naming required; name changes require prior BHFS approval.
- Notification of management or ownership changes without operational disruption must be given; disruptions or relocations require new licenses.
- Separate licenses required for distinct premises under the same management.
- License documents must be visibly posted and regulatory guidelines available on-site.
Implementing Authorities and Coordination
- BHFS: Manages licensing, enforcement, suspension, and revocation of licenses.
- Center for Health Development (CHD): Reports illegal ASC operations in their jurisdiction.
- Philippine Health Insurance Corporation (PhilHealth): Accredits facilities, conducts utilization reviews, and supports regulatory compliance.
- BHFS and PhilHealth collaborate regularly to synchronize ASC regulation and accreditation mechanisms.
Licensing Procedures
- Permit to Construct (PTC): Pre-requisite for LTO including submission of documents (application form, endorsements, registration, architectural plans).
- PTC approval/disapproval communicated within thirty (30) days; non-action defaults to approval.
- Application for LTO: Submission of comprehensive documentation including MOA with hospitals, fire safety certificates, surgical operation lists, personnel and equipment lists, quality assurance programs.
- Surveys and inspections conducted by BHFS, with technical input from Philippine College of Surgeons.
- Approval or denial communicated; non-action within sixty (60) days results in deemed approval.
Monitoring and Compliance
- BHFS and CHD authorized to perform on-site inspections anytime.
- ASCs required to provide access to relevant records and documents during monitoring.
License Validity
- License to operate an ASC is valid for three (3) years.
Penalties and Enforcement
- BHFS may suspend or revoke licenses after due process if violations occur.
- Operations without valid licenses shall be closed immediately and fined between PHP 10,000 to PHP 50,000.
Investigation and Preventive Suspension
- BHFS investigates complaints or acts motu proprio.
- Preventive suspension allowed for up to sixty (60) days pending resolution.
Appeal Process
- Licensees are entitled to a fair hearing before suspension or revocation.
- BHFS must notify licensee of grounds via registered mail or personal service.
- Licensees can request hearings within ten (10) days; hearings scheduled at least thirty (30) days thereafter.
- BHFS issues findings and conclusions post-hearing; decisions become final after thirty (30) days unless appealed to DOH Secretary.
- Additional time for appeal may be granted by BHFS discretion.
Separability and Repealing Clause
- Invalidity of any provision does not affect the remainder of the regulations.
- These rules supersede all inconsistent previous administrative orders.
Moratorium for Existing ASCs
- ASCs operating prior to promulgation have one (1) year to comply and apply for licenses.
- Failure to apply results in immediate closure.
Effectivity
- Regulations take effect fifteen (15) days after publication in the Official Gazette or in widely circulated newspapers.