Authority and legal basis
- Section 2 provides that these rules are issued to implement Republic Act No. 4226, the Hospital Licensure Act.
- Section 2 also directs consistency with Executive Order No. 102, which redirects the functions and operations of the Department of Health.
Policy and purpose
- These rules are promulgated to protect and promote the health of the people.
- Section 3 requires ensuring the right to quality health service appropriate to the level of care through regulation of hospitals and other health facilities.
Coverage and key definitions
- The rules apply to all government and private hospitals and other health facilities (Section 4).
- A hospital is defined as a health facility for the diagnosis, treatment and care of individuals suffering from deformity, disease, illness or injury, or in need of surgical, obstetrical, medical or nursing care.
- A hospital is an institution with installed bassinets or beds for 24-hour use or longer for patients, including management of abnormal physical and mental conditions and maternity cases (Section 6).
Hospital and facility classification
- Section 7 requires classification of hospitals and other health facilities by:
- Government vs Private (Section 7.1).
- General vs Special (Section 7.2).
- Service capability (Section 7.3).
- A Government hospital is operated and maintained partially or wholly by the national, provincial, city or municipal government, or other political unit, or by any department/division/board/agency thereof (Section 7.1.1).
- A Private hospital is privately owned, established, and operated with funds through donation, principal, investment, or other means, by any individual, corporation, association, or organization (Section 7.1.2).
- A General hospital provides services for all types of deformity, disease, illness or injury (Section 7.2.1).
- A Special hospital is primarily engaged in the provision of specific clinical care and management (Section 7.2.2).
- Service capability categories include:
- Primary Care: non-departmentalized hospital providing clinical care and management on prevalent diseases; includes general medicine, pediatrics, obstetrics and gynecology, surgery and anesthesia; provides administrative/ancillary services (clinical laboratory, radiology, pharmacy); provides nursing care for patients requiring intermediate, moderate and partial category of supervised care for 24 hours or longer (Section 7.3.1).
- Secondary Care: departmentalized hospital providing clinical care and management on prevalent diseases plus particular forms of treatment, surgical procedures and intensive care; includes Primary Care clinical services plus specialty clinical care; provides nursing care including total and intensive skilled care (Section 7.3.2).
- Tertiary Care: teaching and training hospital providing clinical care and management on prevalent diseases plus specialized and sub-specialized forms of treatment, surgical procedures and intensive care; includes Secondary Care clinical services plus sub-specialty clinical care; provides nursing care including continuous and highly specialized critical care (Section 7.3.3).
- Infirmary: provides emergency treatment and care; provides clinical care and management to mothers and newborn babies (Section 7.3.4).
- Birthing Home: provides maternity service on pre-natal and post-natal care, normal spontaneous delivery, and care of newborn babies (Section 7.3.5).
- Acute-Chronic Psychiatric Care Facility: provides medical service, nursing care, pharmacological treatment and psychosocial intervention for mentally ill patients (Section 7.3.6).
- Custodial Psychiatric Care Facility: provides long-term care including basic human services such as food and shelter to chronic mentally ill patients (Section 7.3.7).
Regulatory agency and what licensing authorizes
- Section 5 designates the Department of Health through the Bureau of Health Facilities and Services in the Office for Health Regulation as the principal agency for implementation and enforcement.
- A License is defined as a formal authorization issued by the Department of Health through the Bureau of Health Facilities and Services or the Center for Health Development, as the case may be.
- A License authorizes an individual, partnership, corporation or association to operate a hospital and other health facilities (Section 8).
- Section 8 states that the License is a prerequisite for accreditation of a hospital and other health facilities by any accrediting body recognized by the Department of Health.
- All hospitals and other health facilities are required to comply with licensing requirements (Section 9).
Licensing requirements and approvals
- Planning and design must comply with prescribed guidelines formulated by the Department of Health through the Bureau of Health Facilities and Services, after consultation and public hearings with affected organizations/associations/stakeholders (Section 9.1).
- Management of service capability, personnel, equipment, and physical plant must conform to prescribed guidelines formulated by the Department of Health through the Bureau of Health Facilities and Services, after consultation and public hearings (Section 9.2).
- Construction and major works must be implemented under specified compliance documents and approvals:
- Floor plans prepared by a duly licensed Architect and/or Civil Engineer and approved by the Bureau of Health Facilities and Services (Section 9.3.1).
- Architectural and engineering drawings (based on approved floor plans), specifications, building permit and fire safety permit prepared by a duly licensed Architect and/or Civil Engineer and approved by the Office of the Building Official and the Bureau of Fire Protection in the locality (Section 9.3.2).
- Prescribed health guidelines formulated by the Department of Health through the Bureau of Health Facilities and Services, after consultation and public hearings (Section 9.3.3).
- The Bureau of Health Facilities and Services (or the Center for Health Development, as applicable) evaluates licensing compliance using criteria including:
- Service Capability (administrative, clinical, ancillary and other services) (Section 9.4.1).
- Personnel (qualified and trained professionals and non-professionals) (Section 9.4.2).
- Equipment/Instrument (tools to perform required services) (Section 9.4.3).
- Physical Plant (well ventilated, lighted, clean, safe and functional structure sufficient for activities) (Section 9.4.4).
- Other analogous factors approved by the Department of Health (Section 9.4.5).
Permit to Construct and initial License to Operate
- Permit to Construct is required for:
- construction of a new hospital/other health facility,
- substantial alteration,
- expansion or renovation of an existing hospital/other health facility,
- change in classification, or
- increase in bed capacity.
- The Permit to Construct is a prerequisite for a license to operate (Section 10.1).
- Hospitals providing maternity service on pre-natal and post-natal care, normal spontaneous delivery, and care of newborn are exempted from securing the Permit to Construct (Section 10.1).
- The required documents for a Permit to Construct include:
- Letter of Application to the Director of the Center for Health Development (Section 10.1.1.1).
- Letter of Endorsement to the Director of the Bureau of Health Facilities and Services (Section 10.1.1.2).
- Form No. 1-01: Notarized Application for Permit to Construct (Section 10.1.1.3).
- Four (4) Sets of Site Development Plans and Floor Plans signed and sealed by an Architect and/or Engineer (Section 10.1.1.4).
- Environmental Compliance Certificate from the DENR Environmental Management Bureau-Regional Office (for hospitals only) (Section 10.1.1.5).
- Waste Management Plan (Section 10.1.1.6).
- Other documents required by the Bureau of Health Facilities and Services (Section 10.1.1.7).
- For construction or change in classification, additional required documents include:
- Feasibility Study (Section 10.1.1.8).
- Zoning Certificate or Location Clearance from the City/Municipal Planning and Development Office (Section 10.1.1.9).
- DTI/SEC Registration (for private hospital/other health facility) (Section 10.1.1.10).
- Enabling Act (for national government hospital/other health facility) (Section 10.1.1.11).
- Approved Sanggunian Resolution (for local government hospital/other health facility) (Section 10.1.1.12).
- Building Permit from the Office of the Building Official in the locality (Section 10.1.1.13).
- Fire Safety Permit from the Bureau of Fire Protection in the locality (Section 10.1.1.14).
- Other documents required by the Bureau of Health Facilities and Services (Section 10.1.1.15).
- Permit to Construct procedures:
- Applicants request relevant information and the prescribed form from the Bureau of Health Facilities and Services or the Center for Health Development in person or through mail, email or Internet (Section 10.1.2.1).
- Applicants accomplish required documents and submit them to the Center for Health Development for endorsement to the Bureau of Health Facilities and Services (Section 10.1.2.2).
- The Bureau reviews documents and approves or disapproves issuance (Section 10.1.2.3).
- If disapproved, documents and findings/recommendations are returned; applicants revise and submit revised documents for another review (Section 10.1.2.4).
- If approved, the Bureau issues the permit; applicants pay the corresponding fee to the Cashier of the Department of Health in person or through postal money order (Section 10.1.2.5).
- License to Operate is required for operation and is secured after construction and completion (Section 10.2).
- Required documents for initial License to Operate include:
- Letter of Application and Request for Inspection to the Director of the Center for Health Development (Section 10.2.1.1).
- Letter of Endorsement to the Bureau of Health Facilities and Services (Section 10.2.1.2).
- Form No. 2-01: Notarized Application for Registration and Issuance of License to Operate (Section 10.2.1.3).
- Notarized List of Personnel (Section 10.2.1.4).
- List of Equipment/Instrument (Section 10.2.1.5).
- Photo Album of the Exterior and Interior (Section 10.2.1.6).
- Certificate of Occupancy from the Office of the Building Official (Section 10.2.1.7).
- Fire Safety Inspection Certificate from the Bureau of Fire Protection (Section 10.2.1.8).
- Sanitary Certificate from the Local Health Office (Section 10.2.1.9).
- Other documents required by the Bureau of Health Facilities and Services (Section 10.2.1.10).
- Initial License to Operate procedures:
- Applicants request relevant information and forms from the Bureau or the Center in person or through mail, email or internet (Section 10.2.2.1).
- Applicants submit completed documents to the Center for endorsement to the Bureau; upon filing, applicants pay corresponding fees for registration and license with the Cashier of the Center for Health Development in person or through postal money order (Section 10.2.2.2).
- The Bureau conducts an ocular inspection in accordance with licensing requirements (Section 10.2.2.3).
- The Bureau approves or disapproves issuance (Section 10.2.2.4).
- If disapproved, findings and recommendations are sent; the applicant may move for reconsideration; if denied, the applicant may appeal to the Office of the Secretary in accordance with Section 22 (Section 10.2.2.5).
- If approved, the Bureau registers the hospital/health facility and issues the initial License to Operate (Section 10.2.2.6).
- Health Facility Establishment Review Committee:
- The Bureau creates a committee for effective action on applications for Permit to Construct for non-exempt facilities (Section 10.3).
- The committee reviews applications for compliance with licensing requirements and planning/design guidelines (Section 10.3.1).
- The committee meets once a week or when necessary and includes specified roles and professionals from the Bureau (Section 10.3.2).
- Health Facility Licensing Team(s):
- The Bureau creates licensing team(s) for effective action on applications for initial License to Operate (Section 10.4).
- Licensing teams inspect compliance with licensing requirements, planning/design guidelines, and management of service capability, personnel, equipment, and physical plant (Section 10.4.1).
- Team composition includes specified roles and professionals from the Bureau (Section 10.4.2).
- The Bureau, through an appropriate Memorandum of Agreement with the largest non-stock, non-profit hospital association, allows the association’s duly authorized representative as a third party observer accompanying the licensing team during inspections (Section 10.4.3).
Renewal of License to Operate
- License to Operate is automatically renewed every year upon:
- filing an Application for Renewal of License to Operate ninety (90) days before expiry with the Center for Health Development under whose territorial jurisdiction the hospital/health facility is located; and
- payment of the renewal fee (Section 11.1).
- Required renewal documents include:
- Letter of Application to the Center Director (Section 11.2.1.1).
- Form No. 2-01: Application for Renewal of License to Operate (Section 11.2.1.2).
- A Sworn Statement that the hospital/health facility complied with all requirements of applicable laws, rules and regulations and that submitted documents are true and correct insofar as the applicant is concerned/knowledgeable (Section 11.2.1.3).
- Renewal procedures:
- Applicants request forms from the Center in person or through mail, email or Internet (Section 11.3.1).
- Applicants submit the documents to the Center; upon filing, they pay corresponding renewal fees to the Cashier of the Center for Health Development in person or through postal money order (Section 11.3.2).
- Upon proof of payment, the Center issues the Renewal of License to Operate (Section 11.3.3).
- The Center must submit a quarterly report to the Bureau listing hospital/health facility name, location, type of application, and scope of work (Section 11.4).
- During the transition period, processing and renewal responsibilities are allocated by category:
- Centers process and renew licenses for Birthing Home, Acute-Chronic Psychiatric Care Facility, Custodial Psychiatric Care Facility, Infirmary, or Primary Care Hospital (Section 11.5).
- The Bureau processes and renews licenses for Secondary Care Hospital or Tertiary Care Hospital (Section 11.5).
Inspection, monitoring, and technical assistance
- All hospitals and other health facilities must be inspected regularly, and their records must be made available to determine compliance (Section 12.1).
- The Bureau or the Center may inspect at any given time and without prior notice (Section 12.2).
- Hospitals and other health facilities must make records available for inspection and examination (Section 12.3).
- The Director of the Center for Health Development and the Chief of the Provincial/City/Municipal Health Office must report unlicensed hospitals and violations to the Bureau (Section 12.4).
- All hospitals and other health facilities must be monitored regularly, and their records must be made available to determine compliance (Section 13.1).
- The Bureau may monitor at any given time and without prior notice (Section 13.2).
- Hospitals must make records available for monitoring/examination (Section 13.3).
- The Bureau must develop capability of Centers for enforcement of these rules and regulations (Section 14.1).
- The Bureau must provide technical assistance and advisory services to Centers, Local Government Units, and private institutions on compliance with licensing requirements (Section 14.2).
Fees, licensing terms, and operational conditions
- A non-refundable fee is charged for:
- Application for Permit to Construct,
- Application for Registration and Issuance of License to Operate, or
- Application for Renewal of License to Operate (Section 15.1).
- Fees must be paid to the Cashier of the Bureau or Center, as applicable (Section 15.2).
- Fees follow the Department of Health’s current prescribed schedule of fees (Section 15.3).
- No License to Operate for applicable non-exempt hospitals/health facilities may be issued without the appropriate Permit to Construct secured prior to:
- construction, alteration, expansion, renovation, increase in bed capacity, or
- issuance of license for operation of clinical laboratory, radiology and pharmacy (Section 16.1).
- A Permit to Construct is lapsed and the fee paid is forfeited when work does not commence within three hundred sixty-five (365) days from issuance date or is abandoned during the period specified (Section 16.2).
- An initial License to Operate is granted based on prescribed licensing requirements and may be subject to specific conditions and limitations established during inspection (Section 16.3).
- A License to Operate not renewed for two (2) consecutive years is treated as lapsed and the registration is cancelled; a new Application for Registration and Issuance of License to Operate is required before operation continues (Section 16.4).
- The License to Operate and any right under it cannot be assigned or transferred directly or indirectly to any party without the written consent of the Director of the Bureau of Health Facilities and Services (Section 16.5).
- The Bureau must be notified of any change in management, name or ownership without disrupting operation; if change causes disruption or if there is transfer of location, a new application for permit to construct, registration and issuance of License to Operate is required (Section 16.6).
- Failure to report in writing within fifteen (15) days of any substantial change in the condition of the License to Operate is a basis for suspension or revocation (Section 16.7).
- A separate License to Operate is required for hospitals/health facilities or branches in separate premises under the same management; no separate license is required for separate buildings in the same premises (Section 16.8).
- The License to Operate must be placed in an area readily seen by the public and a copy of rules and regulations must be readily available for personnel guidance (Section 16.9).
- The License to Operate automatically expires on the date of the anniversary of its issuance (Section 16.10).
Violations, investigation, suspension/revocation, and closure
- Violations of Republic Act No. 4226 and/or these rules include the following acts by any individual, corporation, association, or organization operating a hospital/health facility, or persons under their authority, with hospital personnel deemed “personnel” for these rules purposes (Section 17).
- Prohibited acts include:
- making substantial alteration or renovation without a Permit to Construct (Section 17.1),
- making any material false statement in the application (Section 17.2),
- making fraudulent, unscrupulous, or false claims or misrepresentations in the Sworn Statement for Renewal (Section 17.3),
- changing location, management, name or ownership without written consent of the Bureau (Section 17.4),
- refusing to allow inspection by the Bureau or Center (Section 17.5),
- refusing to allow monitoring by the Bureau (Section 17.6),
- failing to make required corrections after due notice (Section 17.7).
- Investigation and hearing:
- Upon filing of charges/complaints, the Bureau with assistance of the concerned Center investigates and verifies whether the facility or its personnel is guilty (Section 18).
- If found violating, the Director may suspend for a definite or indefinite period or revoke the license (Section 18).
- For government hospital personnel, they are subject to appropriate disciplinary/administrative action under Civil Service Rules (Section 18).
- For personnel who are professionals under the Professional Regulation Commission, a finding of guilt is treated as a formal complaint filed immediately with the relevant Professional Regulatory Board; this is without prejudice to judicial action (Section 18).
- Suspension/revocation procedure:
- The Director suspends or revokes a License to Operate (initial or renewed) upon violation of Republic Act No. 4226 and/or these rules.
- The Bureau notifies the facility/personnel by registered mail stating reasons for denial/suspension/revocation (Section 19).
- Closure:
- The Bureau must immediately close all hospitals and other health facilities that operate without a License to Operate.
- The Bureau may seek assistance of any government agency to enforce closure (Section 20).
Criminal penalty for operating without licensing
- Any individual or responsible officer who establishes, operates, conducts, manages, or maintains a hospital/health facility without first securing the necessary Permit to Construct and/or License to Operate, or who violates any provision of Republic Act No. 4226 and/or these rules, commits a misdemeanor (Section 21).
- Upon conviction:
- fine is not more than five hundred pesos (P500.00) for the first offense,
- fine is not more than one thousand pesos (P1,000.00) for each subsequent offense (Section 21).
- Operating for each day after the first conviction is treated as a subsequent offense (Section 21).
Appeals and finality
- A facility and/or its personnel aggrieved by a decision of the Bureau may file a notice of appeal with the Office of the Secretary within thirty (30) days after receipt of notice, and must serve a copy to the Bureau (Section 22).
- The Bureau must promptly certify and forward to the Office of the Secretary a copy of the decision including all documents and transcript(s) of hearings for review (Section 22).
- If the licensee is refused or has its license suspended or revoked, it is entitled to an administrative hearing conducted by the Secretary of Health and his two (2) undersecretaries to determine justifiability (Section 22).
- The licensee may resort to courts as in other cases provided by law, and the Office of the Secretary’s decision is final and executory (Section 22).
Publication and repealing provisions
- The Bureau publishes periodically and makes available to the public a list of licensed hospitals and other health facilities according to classification (Section 23).
- The guidelines attached to Administrative Order No. 70-A, series of 2002 are withdrawn.
- All previous rules and regulations and other administrative issuances with inconsistent provisions are amended, modified, superseded, repealed, and/or revoked (Section 24).
Transition period and interim licensing rules
- Within one (1) month from effectivity, the Department of Health through the Bureau forms a committee to initiate, study, formulate, and draft the prescribed guidelines; consultation with affected organizations/stakeholders and public hearings are required (Section 25).
- The committee completes its study and prepares the draft prescribed guidelines within four (4) months from constitution; the draft is submitted to and approved by the Secretary of Health (Section 25).
- During the transition period, the absence of prescribed guidelines does not defer issuance of:
- the Permit to Construct,
- initial License to Operate, or
- Renewal of License to Operate (Section 25).
- The Center for Health Development must prepare resources to execute renewal of licenses of all existing licensed hospitals and other health facilities within one (1) year from effectivity (Section 25).
- During the interim period, Centers renew licenses for Birthing Home, Acute-Chronic Psychiatric Care Facility, Custodial Psychiatric Care Facility, Infirmary, or Primary Care Hospital, while the Bureau renews Secondary Care Hospital or Tertiary Care Hospital (Section 25).
- Birthing Home, Acute Chronic Psychiatric Care Facility, and Custodial Psychiatric Care Facility follow interim licensing requirements through referenced annex licensing requirements (Annex 1, Annex 2, and Annex 3) until the prescribed guidelines are promulgated (Section 25).