Legal basis, policy, and purpose
- Administrative Order No. 2016-0042 operationalizes decentralization of parts of the DOH-PTC application process to improve efficiency and client responsiveness.
- The order implements a re-centralization strategy under Administrative Order No. 2010-0035 for licensing functions handled by Health Facilities and Services Regulatory Bureau (HFSRB), and then re-decentralizes selected facility licensing functions to DOH Regional Offices.
- The order harmonizes PTC-related issuances for consistent processing of DOH-PTC applications.
- The order’s objective is to decentralize to Regional Offices the DOH-PTC application process for selected health facilities while harmonizing PTC-related issuances.
Definitions and key terms
- “Add-on Services” are health care services beyond the current service capability of a health facility (e.g., Level 1 Hospital add-ons like Hemodialysis Clinic, Intensive Care Unit, Neonatal Intensive Care Unit).
- “Ambulatory Surgical Clinic (ASC)” is a government or privately owned institution organized primarily to provide elective surgical treatment of out-patients whose recovery, under normal and routine circumstances, will not require inpatient care.
- “Applicant” is the natural or juridical person applying for a License to Operate or Certificate of Accreditation of a hospital or other health facility.
- “Certificate of Need (CON)” is a required document prior to issuance of a DOH-PTC for construction of new government and private hospitals.
- “DOH-PTC” is a permit issued by the DOH through HFSRB to an applicant that will establish and operate a hospital or other health facility upon compliance with required documents prior to construction; it is required for substantial alteration, expansion, renovation, increase in the number of beds, or add-on services beyond service capability; and it is a prerequisite for License to Operate.
- “Health Facilities Evaluation and Review Committee (HFERC)” reviews all DOH-PTC applications for compliance with planning and design guidelines for health facilities.
- “HFSRB” is the bureau of DOH in charge of implementation of these rules.
- “Regional Office (RO)” is the regional health office of DOH.
- “Regulation Licensing and Enforcement Division (RLED)” is part of the Regional Office structure involved in processing.
- “Hospital” is primarily devoted to maintenance and operation of health facilities for diagnosis, treatment and care of persons suffering illness, disease, injury, deformity, or needing obstetrical or other surgical, medical and nursing care; it also includes institutions/buildings/places with installed beds, cribs, or bassinets for 24-hour use or longer for patients’ treatment.
- “License to Operate (LTO)” is a formal DOH authority to operate a hospital or other health facility and is a prerequisite for accreditation recognized by DOH.
Scope and coverage of facilities
- The DOH-PTC application guidelines apply to all government and private hospitals and other health facilities applying for a DOH-PTC.
- DOH-PTC is required for the following health facilities:
- Ambulatory Surgical Clinic
- Birthing Home
- Drug Abuse Treatment and Rehabilitation Center (Residential and Non-Residential)
- Drug Testing Laboratory
- Hemodialysis Clinic
- Hospital
- Infirmary
- Medical Facility for Overseas Workers and Seafarers
- Psychiatric Care Facility (Acute-Chronic and Custodial)
- The processing responsibility is allocated between HFSRB and Regional Offices (RLED) depending on facility type and level.
- HFSRB exercises oversight, supervision, and monitoring functions over Regional Offices regarding infrastructure compliance based on approved DOH-PTC for hospitals and ancillary facilities.
Implementation mechanisms and processing assignment
- The processing assignment distinguishes between:
- HFSRB processing for Ambulatory Surgical Clinic, Drug Abuse Treatment and Rehabilitation Center (Residential and Non-Residential), Drug Testing Laboratory (free-standing), Hemodialysis Clinic, Hospital (Levels 2 and 3), Medical Facility for Overseas Workers and Seafarers, and Add-on Services to Level 2 and Level 3 Hospitals.
- Regional Offices processing for Birthing Home, Level 1 and Health Facility Enhancement Program (HFEP) funded Hospitals, Add-on Services to Level 1 Hospitals, Infirmary, and Psychiatric Care Facility (Acute-Chronic and Custodial).
- HFERC is created by the HFSRB and RLED and includes:
- Chairperson: Director IV (HFSRB) or qualified HFSRB personnel/RLED Chief or qualified RLED personnel
- Vice-Chair: any competent HFSRB/RLED personnel
- Members: at minimum Architect/Engineer, Physician, Nurse, and other invited technical experts such as Medical Technologists, Pharmacists, Physicists, etc., as needed.
- Hospitals and other health facilities must be planned and designed according to existing laws and guidelines to ensure safe and secure environments.
- Health facility owners must strictly follow the checklist for review of floor plans.
- HFSRB oversees and monitors RO compliance with infrastructure standards tied to approved DOH-PTC.
DOH-PTC application documents, review, and timelines
- Applicants must submit required documents to HFSRB or RO-RLED before a DOH-PTC is issued, using regular mail, courier, or available online systems.
- Required documents include:
- A duly accomplished DOH-PTC application form for the specific facility (downloadable from the HFSRB website: //hfsrb.doh.gov.ph)
- Proof of ownership, including DTI or SEC Registration with Articles of Incorporation and By-laws; Enabling Act or Board Resolution for government-owned facilities; and Cooperative Development Authority registration with Articles of Cooperation and By-laws
- Three sets of architectural floor plans signed and sealed by an architect and/or engineer; an electronic copy may be submitted by email to hfsrb@doh.gov.ph or through online systems when available
- An Approved CON issued by the Regional Office for new general hospitals
- Upon filing, the applicant must pay the corresponding fee to the DOH Central Office cashier or RO cashier in person, or through postal money order, or other bank-to-bank transactions once the system is operational.
- The HFERC reviews submitted plans and documents for basic requirements and compliance with planning/design prototype plans and technical guidelines.
- Standards for radiology services are the physical plant standards developed by the Center for Device Regulation, Radiation Health and Research.
- Site verification surveys may be conducted by the HFSRB and RO-RLED (One-Stop Shop Inspection Team) as needed.
- Within fifteen (15) working days, HFSRB or RO must:
- approve or disapprove the application;
- inform the applicant of the status (approved or disapproved);
- issue the DOH-PTC signed by the HFSRB Director or Regional Director if approved;
- return documents together with findings if disapproved.
- If disapproved, the applicant may request technical assistance/advisory services from HFSRB or RO and must submit revised documents for re-review without additional payment.
- For the second review, the same timeline applies as in the fifteen (15) working days rule after submission of revised/corrected documents.
- If disapproved again after the second review, the applicant must re-apply and pay another application fee.
Schedule of fees and payment handling
- A non-refundable fee is charged for the DOH-PTC application of a hospital or health facility.
- Fees/checks must be paid to the DOH Central Office cashier or Regional Office cashier in person, or through postal money order, or through bank-to-bank payments once the system is functional.
- Fees, surcharges, and discounts follow the DOH prescribed schedule under:
- Administrative Order No. 2007-0023 (Schedule of Fees for the One-Stop Shop Licensure System for Hospitals)
- Administrative Order No. 2008-0028 (Schedule of Fees for the One-Stop Shop Licensure System for Non-Hospital Based Facilities)
- Administrative Order No. 2007-0001 (Revised Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services and Centers for Health Development)
Validity, compliance violations, and appeals
- A DOH-PTC is valid for one (1) year after approval.
- DOH-PTC compliance must strictly adhere to the terms and conditions in the DOH-PTC (Annex I).
- Facilities that violate any provision of these rules and regulations and related issuances, or commit acts/omissions by personnel operating a hospital or health facility under this Order, are penalized through issuance of a Cease and Desist Order.
- An aggrieved hospital or other health facility may appeal the decision of the HFSRB Director or Regional Director by filing a notice of appeal to the Head of the Office for Health Regulation (OHR) within ten (10) days after receipt of the notice of decision.
- HFSRB or the Regional Office must elevate all pertinent documents and records to the OHR.
- If still contested, the decision of the Head of the OHR may be brought to final appeal to the Secretary of Health, whose decision is absolute and executory.
Transitory enforcement and phase decentralization
- DOH-PTC applications filed at HFSRB before effect of this Order for Infirmary, Level 1 Hospitals, Add-on Services to Level 1 Hospitals, and Psychiatric Care Facility (Acute-Chronic and Custodial) are acted upon by HFSRB.
- Immediately upon approval, the rules apply to hospitals and other health facilities applying for DOH-PTC.
- HFSRB must provide technical assistance and trainings to capacitate RO licensing officers before December 31, 2016.
- RO decentralized functions for review, evaluation, and approval for Infirmary, Level 1 Hospitals, Add-on Services to Level 1 Hospitals, and Psychiatric Care Facility (Acute-Chronic and Custodial) begin January 1, 2017.
- Level 2 and level 3 hospitals and other health facilities are decentralized by phase over a period of three (3) years, based on set criteria evaluating region performance and capacity.
Amendments, repeal, and separability
- Administrative Order No. 2016-0042 amends specified sections of earlier issuances:
- Section V. A. 2. b. of Administrative Order No. 2010-0035
- Section VI. B. of Administrative Order No. 2012-0012
- Section V. A. 5. a. of Administrative Order No. 2014-0036
- Inconsistent or contrary provisions from previous issuances are repealed or modified accordingly.
- If any provision or part of the order is declared unauthorized or rendered invalid by a court or competent authority, the remaining provisions remain valid and in force.