Law Summary
Objective
- Establish revised guidelines for implementing the OSS Licensing System using OLRS for licensing hospitals and accrediting health facilities with ancillary services.
Scope
- Applies to DOH offices enforcing regulatory standards: Health Facilities and Services Regulatory Bureau (HFSRB), Regional Office-Regulatory, Licensing and Enforcement Division (RO-RLED), and the FDA (Regional Field Office and CDRRHR).
Key Definitions and Acronyms
- Applicant: Person applying for License to Operate (LTO) or Certificate of Accreditation (COA).
- Certificate of Compliance (COC): FDA-issued proof of compliance, prerequisite for DOH-LTO.
- DOH-LTO: Formal license to operate granted by DOH.
- DOH-COA: Authorization for operation compliance with special standards for specific services.
- OSS Licensing System: DOH strategy to unify licensing for hospitals, ancillary services, excluding certain specialized hospital-based facilities.
- Others include definitions for FDA, CDRRHR, RFO, HFSRB, HFERC, hospitals, facilities, and various certificates and permits.
General Implementing Mechanisms
- All health facilities must secure and maintain DOH-LTO or DOH-COA.
- Certificate of Need (CON) and Permit to Construct (PTC) are prerequisites.
- Strict adherence to OSS guidelines at central and regional DOH levels.
- HFSRB handles initial and renewal licensing for most hospitals and non-hospital based facilities; RO-RLED handles birthing homes, infirmaries, level 1 hospitals.
- Applications processed through OLRS with assigned OSS evaluators.
- Final issuance approved by Director IV or delegated Director III of HFSRB/RO-RLED.
- Single license covers facility category, bed capacity, ancillary services, and validity period.
- Certain specialized facilities require separate COA applications.
- Sanctions for ancillary service violations borne by hosting hospital/facility.
- Integration of licensed facilities into OLRS database.
Specific Guidelines: Initial Licensing Process
- Filing period: start of year to November 15.
- Applicants register and file online with scanned document submissions and payment proofs.
- Non-refundable application fees paid to corresponding offices.
- Applications assessed for technical completeness; deficient applications receive 30-day correction period or face disapproval and forfeiture.
- Joint inspection teams conduct on-site inspections within 20 days after approval.
- FDA RFO may waive inspection and issue Recommendation Letters; post-licensing inspection required.
- Non-compliance during inspection allows up to 30 days for correction; otherwise, disapproval and forfeiture.
- Upon compliance, relevant certificates transmitted online for final approval.
- DOH-LTO/COA issued on security paper with QR code, delivered by pickup or courier.
- Validity assigned a National Health Facility Registry Code for renewals.
- Timelines: 3 days for evaluation; up to 30 days total from complete application to issuance.
- Automatic issuance if delays occur, subject to post licensing inspection.
Specific Guidelines: Renewal Process
- Renewal period: October 1 to December 15 with a 10% discount for early renewal.
- Renewals submitted via OLRS with facility registry credentials.
- Automatic renewal within 15 days for compliant hospitals with no sanctions and participation in statistical reporting.
- Facilities with sanctions or violations renew only after full compliance.
- Monitoring visits and post licensing inspections continue post renewal.
- Changes in facility circumstances require initial application process.
- Penalties for late renewal under existing rules.
Validity of Licenses
- Hospitals, birthing homes, infirmaries: valid for one year.
- Non-hospital dialysis clinics and ambulatory surgical clinics: valid for three years.
- Non-hospital MFOWS COA valid for three years.
Schedule of Fees
- Fees follow rates prescribed by DOH and FDA.
- Fees paid upon application filing to designated cashiers or authorized banks.
Penalties
- Violations subject to penalties pursuant to prior administrative orders and related issuances governing OSS licensing.
Appeal Process
- Applicants aggrieved by licensing decisions have 10 days to appeal to the Head of the Office for Health Regulation (OHR).
- Further appeal possible to Secretary of Health whose decision is final.
Transitory Provisions
- Phased OLRS implementation:
- Phase 1 (July 2018): Initial DOH-LTO/COA for hospitals and other health facilities.
- Phase 2 (July 2019): Initial and renewal licensing for select regions.
- Phase 3 (July 2020): Full nationwide implementation.
- OSS licensing continues manually during system development.
- Hard and soft copy submissions required; timelines observed as in final rules.
Repealing Clause
- Repeals previous Orders Nos. 2007-0024 and 2008-0027 and conflicting provisions.
Separability Clause
- Invalidity of any part does not affect remaining provisions.
Effectivity
- Order effective 15 days after publication in the official gazette or newspapers of general circulation.