Legal Authority
- Implements Republic Act No. 4226 (Hospital Licensure Act).
- Consistent with Executive Order No. 102 regarding Department of Health operations.
Purpose of the Rules
- Protect and promote public health.
- Ensure right to quality health services appropriate to healthcare level.
- Regulate hospitals and other health facilities accordingly.
Scope of Application
- Applies to all government and private hospitals and health facilities in the Philippines.
Regulatory Agency
- Department of Health (DOH) through Bureau of Health Facilities and Services (BHFS), Office for Health Regulation, is the principal implementing and enforcing body.
Definitions
- Hospital: Facility for diagnosis, treatment, and care needing 24-hour bed use, covering deformities, diseases, injuries, surgical, obstetrical, medical, or nursing care.
Classification of Hospitals and Health Facilities
- By Ownership:
- Government: Operated by national or local government entities.
- Private: Owned and operated with private funding.
- By Service Type:
- General: Services for all deformities, diseases, injuries.
- Special: Focused on specific clinical care.
- By Service Capability:
- Primary Care: Non-departmentalized; basic prevalent clinical services and care.
- Secondary Care: Departmentalized; includes specialty clinical care, surgical, intensive care.
- Tertiary Care: Teaching hospital offering specialized and sub-specialized care and training.
- Infirmary: Emergency care, maternal and newborn care.
- Birthing Home: Maternity services, normal delivery, newborn care.
- Acute-Chronic Psychiatric Care Facility: Medical, nursing, pharmacological, psychosocial care for mental illness.
- Custodial Psychiatric Care Facility: Long-term custodial care for chronic mentally ill.
Licensing - Definition and Purpose
- Formal authorization issued by DOH to operate.
- Prerequisite for accreditation by recognized accrediting bodies.
Licensing Requirements
- Compliance with planning, design, management, personnel, equipment, and physical plant guidelines developed by DOH through BHFS.
- Construction and alteration require approved architectural and engineering plans.
- BHFS or Center for Health Development evaluates compliance with:
- Service capability
- Personnel qualifications
- Equipment adequacy
- Physical plant standards
- Other evolving criteria.
Procedures for Permits and Licenses
- Permit to Construct:
- Required before construction, alteration, expansion, change of classification, or bed capacity increase.
- Exception: Existing facilities providing maternity and newborn care.
- Submission of multiple documents including applications, plans, and environmental compliance.
- Review, possible revision, and approval process.
- License to Operate:
- Acquired after construction and completion.
- Requires application, inspections, and submission of various documents.
- Procedures involve inspection by licensing teams and approval or disapproval with options for reconsideration and appeal.
Organizational Bodies
- Health Facility Establishment Review Committee:
- Reviews applications for Permit to Construct.
- Composed of multidisciplinary professionals.
- Health Facility Licensing Teams:
- Conduct licensing inspections.
- Include professionals in medicine, engineering, nursing, pharmacy, and biology.
- Third-party observation allowed through hospital associations.
License Renewal
- Annual automatic renewal upon application and fee payment ninety days before expiration.
- Required documents include application form and sworn compliance statement.
- Procedures managed by Center for Health Development; quarterly reporting to BHFS.
- Transition period provisions clarify roles between BHFS and Centers for Health Development for various hospital types.
Inspection and Monitoring
- Regular and unannounced inspections and monitoring by BHFS or Centers for Health Development.
- Facilities must provide records and allow access.
- Reporting of illegal or unlicensed operations mandatory.
Technical Assistance
- BHFS to build capacity of Centers for Health Development.
- Provides advisory services to local government units and private entities.
Fees
- Non-refundable fees charged for all permit and license applications and renewals.
- Payment processed through designated DOH cashiers.
- Fees conform to DOH schedules.
Terms and Conditions of Licensing
- No License to Operate without prior appropriate Permit to Construct for applicable facilities.
- Permit to Construct lapses if work not started within 365 days.
- License validity and cancellation rules for non-renewal or changes in management/name/ownership.
- License non-transferability without BHFS consent.
- Separate licenses for separate premises but not for separate buildings on same premises.
- Public display of License to Operate required.
Violations
- Include unpermitted renovations, false statements, unauthorized changes, refusal of inspections or monitoring, and failure to correct deficiencies.
- Personnel providing medical services deemed hospital staff for regulatory purposes.
Complaint, Investigation, and Hearings
- Bureau of Health Facilities and Services investigates complaints.
- Disciplinary actions for violations include suspension, revocation of license, and referral to Professional Regulatory Boards or disciplinary authorities.
- Judicial actions remain available.
Suspension, Revocation, and Closure
- BHFS Director empowered to suspend or revoke licenses for violations.
- Facilities without valid licenses subject to immediate closure with possible government assistance.
Penalties
- Operating without required permits or licenses constitutes misdemeanor.
- Fines: P500 for first offense; P1,000 for subsequent offenses.
- Each day of continued unauthorized operation is a separate offense.
Appeal Process
- Decisions by BHFS may be appealed to the Secretary of Health within 30 days.
- Administrative hearings conducted for license refusals, suspensions, or revocations.
- Secretary of Health decisions are final and executory.
Publication of Licensed Facilities
- Periodic publication and public availability of licensed hospitals and health facilities by classification.
Repealing Clause
- Withdrawal of previous related guidelines and amendment or repeal of inconsistent rules.
Transition Period
- Committee formation within one month for drafting licensing guidelines.
- Public consultations and approval to be completed within four months.
- Interim guidelines apply to new facility types not covered in prior orders.
- Transitional management roles assigned between BHFS and Centers for Health Development.
Effectivity
- Rules become effective upon approval and publication in a newspaper of general circulation.