Revised OSS Licensing Guidelines DOH 2018

Policy and objective for OSS online licensing

The Order implements a revised One-Stop Shop (OSS) Licensing System to harmonize licensing and accreditation processes.
The OSS system is designed to make licensing timely, easy, and convenient for clients.
DOH regulatory offices must adopt online processing through the Online Licensing and Regulatory System (OLRS).
The Order targets faster and more efficient issuance of DOH-License to Operate (DOH-LTO) and DOH-Certificate of Accreditation (DOH-COA).
The online OSS licensing coverage includes hospitals and other health facilities with ancillary services.

Coverage, offices, and affected facilities

The Order applies to DOH offices involved in enforcement of regulatory standards for all government and private hospitals and other health facilities, namely HFSRB, RO-RLED, and FDA (including RFO and CDRRHR).
The OSS Licensing System applies to health facilities and ancillary services within hospital premises, including multiple regulated ancillary services under one licensing output.
The OSS Licensing System also applies to non-hospital-based MFOWS, Ambulatory Surgical Clinics (ASC), dialysis clinics, infirmaries, and birthing homes.
Facilities that require a separate application for DOH-COA are:
- Medical Facilities for Overseas Workers and Seafarers (MFOWS);
- Drug Abuse Treatment and Rehabilitation Center (DATRC);
- Human Stem Cell and Cell-based or Cellular Therapy Facility; and
- Facilities for Kidney Transplantation.
Ancillary services and other regulated health facilities, regardless of ownership, are included in the single license of the hosting facility through the OSS mechanism, except for facilities requiring separate DOH-COA applications.
Sanctions for violations relating to ancillary services and other health facilities, regardless of ownership, are borne by the hospital or health facility where they are located.

Key definitions and licensing concepts

An Applicant is the natural or juridical person applying for a License to Operate or Certificate of Accreditation of a hospital or any other health facility.
A Certificate of Compliance (COC) is an FDA authorization proving compliance with technical requirements and is a prerequisite for issuance of DOH-LTO.
CDDRRHR refers to the Center for Device Regulation, Radiation Health and Research of the FDA.
A Certificate of Registration is issued by CDRRHR to compliant Magnetic Resonance Imaging (MRI) facilities.
DOH-COA is the formal authorization issued by DOH to an individual, partnership, corporation, or association to operate a health facility for standards such as HIV testing, drug testing, water analysis, medical fitness certification for overseas work applicants, and performance of kidney transplant, including input/structural, process, and outcome/output standards.
DOH-LTO is the formal authority issued by DOH to operate a hospital or other health facility and is a prerequisite for accreditation by DOH-recognized accrediting bodies for Quality Management System (e.g., ISO).
FDA refers to the Food and Drug Administration.
A Health Facility is an institution (stationary or mobile; land-based or otherwise) providing healthcare and related services, including diagnostics, therapeutic, rehabilitative, palliative, and related health care services, except medical radiation facilities and hospital pharmacies.
HFERC is the committee that reviews applications for DOH-Permit to Construct (DOH-PTC) for compliance with planning and design guidelines for health facilities.
HFSRB is the DOH bureau responsible for implementation of these rules and regulations.
A Hospital is a place primarily devoted to maintenance and operation of health facilities for diagnosis, treatment, and care, and includes any institution/building/place with beds, cribs, or bassinets for twenty-four hour use or longer by patients.
Initial Applications include applications by newly constructed health facilities, changes such as change of ownership, transfer of site, increase in bed, and major alterations or renovations.
One-Stop Shop (OSS) Licensing System is the DOH strategy to harmonize licensure of hospitals and their ancillary and other health facilities (including clinical laboratory, HIV testing, drinking water analysis, drug testing; blood bank/collection/unit; dialysis clinic; ambulatory surgical clinic; pharmacy; and medical x-ray facility), while excluding specific facilities currently regulated by specified bodies (including hospital-based MFOWS, hospital-based DATRC, hospital-based stem cell facility, kidney transplantation facilities, and facilities using radioactive material regulated by PNRI), and it also applies to specified non-hospital-based facilities.
A Recommendation Letter (RL) is an FDA authorization/permission granted by RFO and CDRRHR to facilities with waived inspection but compliant documentary requirements; such facilities are subject to Post Licensing Inspection (PLI) prior to issuance of COC.

Mandatory OSS licensing requirements and evaluations

Hospitals and other health facilities must secure the appropriate DOH-LTO or DOH-COA and must comply with licensing standards and requirements of HFSRB and FDA at all times.
Where applicable, the Certificate of Need (CON) and DOH-PTC are prerequisites for issuance of DOH-LTO or DOH-COA.
The OSS implementation guidelines must be followed strictly at both central and regional levels of the involved DOH regulatory offices.
HFSRB is responsible for initial and renewal of DOH-LTO of level 2 and 3 general hospitals and specialty hospitals, non-hospital-based MFOWS, non-hospital-based ASCs, and non-hospital-based dialysis clinics.
RO-RLED is responsible for initial and renewal of DOH-LTO of birthing homes, infirmaries, and level 1 hospitals and their add-on facilities (e.g., dialysis clinic in a level 1 hospital).
All applications for initial or renewal must be processed through OLRS once the system is fully functional.
HFSRB-RO-RLED and FDA (through RFO and CDRRHR) must assign OSS evaluators to assess applications and documentary requirements.
At the central level, the Director IV of HFSRB approves issuance of the DOH-LTO or DOH-COA; in the absence/unavailability/delegation, approval is by the Director III.
At the regional level, the Director IV of RO-RLED approves issuance; in the absence/unavailability/delegation, approval is by the Director III.
A single DOH-LTO or DOH-COA must be issued to the health facility and must include: (a) category of facility; (b) authorized bed capacity when applicable; (c) ancillary services and other regulated health facilities regardless of ownership beyond category requirements; and (d) validity period.
A database of all licensed health facilities under the OSS must be integrated into OLRS.

Initial application online process rules

Initial applications may be filed from the start of the working day of the year until November 15.
Applicants must create an OLRS account, with a user name and password safeguarded by the client for all transactions.
Applicants must log in to fill out application forms, and corresponding fees for each applied health facility/service must be shown for fee computation across agencies.
Applicants must encode and/or upload documentary requirements, including scanned proofs of payment for HFSRB/RO-RLED and FDA.
The application fee is non-refundable and must be paid to the corresponding regulatory offices: HFSRB to the DOH cashier; RO-RLED to the RO cashier; and RFO and CDRRHR through FDA cashier or FDA-specified bank payments.
Applicants must provide proofs of payment such as scanned copies of the official receipt and deposit slip/on-coll payment slip.
The application will not proceed if entries are incomplete or documentary requirements are lacking.
After system acceptance, OSS evaluators assess technical correctness, and a technically correct application exists when all required documents (as in the application checklist of HFSRB/RO-RLED and FDA) are submitted.
The time from acceptance to approval of the application is three (3) days.
If the application is technically incorrect, the system generates an email; the status appears as “WITH DEFICIENCy”, and a STOP-CLOCK applies.
The applicant must be given thirty (30) days to correct documentary requirements after a WITH DEFICIENCY status.
Failure to correct within thirty (30) days results in DISAPPROVAL and forfeiture of payment.
If technically correct, HFSRB/RO-RLED and FDA must organize inspection teams and conduct joint inspections for OSS-priority facilities.
Once the application is approved, inspection teams have twenty (20) days to inspect the facility.
Inspection may be waived by RFO; the RFO then automatically issues a Recommendation Letter (RL) for pharmacy and schedules post licensing inspection.
If deemed necessary, the RFO may inspect the pharmacy and must transmit the COC online to HFSRB/RO-RLED if compliant, and a copy of the Inspection Report must be issued to the facility.
Facilities found non-compliant during post-licensing inspection must have that list forwarded to HFSRB/RO-RLED.
If found non-compliant during inspection, the inspection team must notify the applicant of deficiencies, and the facility must be allowed time to comply within a timeline with a maximum of thirty (30) days.
Days for HFSRB/RO-RLED processing are stopped through a STOP-CLOCK until deficiencies are complied with.
Failure to complete compliance within the given timeline results in disapproval, forfeiture of payment, notification by e-mail, and requirement to re-apply.
For compliant facilities, the required online transmissions to HFSRB/RO-RLED are:
- For Hospital and Infirmary:
  - From CDRRHR/RFO: COC for Levels I, II and III diagnostic x-ray facilities, dental x-ray facilities, interventional and specialized x-ray facilities; Certificate of Registration for MRI facilities; and LTO for Transportable X-ray Facility and for Therapeutic X-ray Facility Utilizing Medical Linear Accelerator (LINAC) x-ray machines.
  - From RFO: RUCOC for pharmacy.
- For Birthing Home, ASC, MFOWS, Dialysis Clinic:
  - From CDRRHR/RFO: COC for diagnostic radiology.
  - From RFO: RL/COC for pharmacy.
After receiving transmitted RL/COC from RFO and COC, COR or LTO from CDRRHR/RFO, assigned OSS evaluators must recommend approval of issuance of the DOH-LTO or DOH-COA to the Director IV (or Director III in delegation) of HFSRB/RO.
The system generates the hard copy DOH-LTO or DOH-COA on security paper with QR (quick response) code, for pickup by the applicant or delivery by courier, depending on the chosen delivery method.
Upon licensing, the applicant is assigned a National Health Facility Registry Code as new username and a system-generated password for DOH-LTO/DOH-COA renewal, transmitted via email.
The timeline from complete compliance after inspection to issuance of DOH-LTO/DOH-COA is seven (7) days.
Issuance of initial DOH-LTO/DOH-COA must occur within thirty (30) days from acceptance of the complete application.
If force majeure or any unforeseen events prevent issuance within the 30-day period from receipt of complete application, DOH-LTO or DOH-COA must automatically be issued, and a post licensing inspection must be undertaken by the concerned offices.

Renewal process, eligibility, and discount

Renewal applications for DOH-LTO or DOH-COA must be filed from October 1 to December 15 of the current year.
A 10% discount is granted to those who file complete renewal applications from October 1 to November 30 of the current year.
Renewal applications must be filed through OLRS using the National Health Facility Registry code as username and the system-generated password.
The timeline for automatic renewal is fifteen (15) days from acceptance into the system of the complete application forms and other documentary requirements, including uploaded scanned proofs of payment for each office.
Automatic renewal applies to:
- Facilities with no sanctions, violations or deficiencies;
- Facilities that have corrected/complied to noted violations at the time of application; and
- Facilities that submitted/participated in the Online Health Facility Statistical Reporting System (OHFSRS).
Automatic renewal applies only to hospitals.
For facilities with sanctions, violations, or deficiencies, renewal occurs only after serving out the sanction/penalty, correcting violations, or completing deficiencies.
If compliance is met after expiration of DOH-LTO/DOH-COA, the validity of the new DOH-LTO/DOH-COA starts from the date of full compliance.
HFSRB must conduct monitoring visits, and FDA (RFO and CDRRHR) may carry out Post Licensing Inspection on automatically renewed facilities and those with previous sanctions or violations.
Whenever there are changes in circumstances (including change of ownership, transfer of site, and increase in bed), the health facility must undergo the same process as initial issuance of DOH-LTO/DOH-COA.
Sanctions for late filing of renewal applications must follow the existing rules and regulations of the concerned bureau/agency.

Validity periods and fee rules

DOH-LTO for hospitals, birthing homes, and infirmaries is valid for one (1) year.
DOH-LTO for non-hospital-based dialysis clinics and non-hospital-based ambulatory surgical clinics is valid for three (3) years.
DOH-COA for non-hospital-based medical facilities for overseas workers and seafarers is valid for three (3) years.
The DOH-LTO or DOH-COA fee follows the Schedule of Fees currently prescribed by DOH and FDA.
Upon filing, applicants must pay corresponding fees to DOH/RO Cashier and FDA Cashier or any authorized banks for pharmacy and diagnostic radiology and radiation oncology.

Penalties and appeal rights

Violations under this OSS licensing implementation are subject to imposable penalties under A.O. No. 2007-0022 titled “Violations under the One-Stop Shop Licensure System for Hospitals,” A.O. No. 2008-0027 titled “One-Stop Shop System for the Regulation of Medical Facilities for Overseas Workers and Seafarers, Non-Hospital-Based Dialysis Clinics and Non-Hospital-Based Ambulatory Surgical Clinics with Ancillary Services,” and related issuances or guidelines.
Any aggrieved hospital or other health facility may file 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.
The decision being appealed is that of the Director IV of HFSRB/RO Director, or in the absence/unavailability/delegation, the Director III of HFSRB/RO, or the FDA Director-General.
All pertinent documents and records must be elevated by HFSRB or RO to OHR upon filing of the notice of appeal.
A decision of the Head of OHR that remains contested may be brought on final appeal to the Secretary of Health, whose decision is final and executory.

Transition, repeals, and separability

Implementation of the online licensing system is done by phase:
- Phase 1 starts on July 2018 and covers:
  - initial DOH-LTO of hospitals (HFSRB);
  - initial DOH-LTO/DOH-COA of other health facilities (HFSRB).
- Phase 2 starts on July 2019 and covers:
  - initial and renewal DOH-LTO of hospitals (HFSRB/selected regional offices);
  - initial and renewal of the DOH-LTO/DOH-COA of other health facilities (HFSRB/selected regional offices).
- Phase 3 (full implementation) starts on July 2020 and covers:
  - initial and renewal DOH-LTO/DOH-COA of all health facilities under the OSS (HFSRB/all regional offices).
The OSS Licensing System applies even while the online system is being developed and finalized.
During transition, the general and specific guidelines under Section V (A and B) apply.
During transition, documentary submission rules require:
- submissions to HFSRB/RO-RLED in hard copies for documentary requirements including copies of proofs of payment;
- submissions for FDA in hard copies and soft copies saved in a USB flash drive.
During transition, processing of complete application forms and documentary requirements is done manually.
HFSRB/RO-RLED and FDA must designate OSS Evaluators to assess completeness and technical correctness during transition.
The same timelines for initial/renewal processes in Section V (A and B) must be observed during the transition period.
The repealing clause revokes A.O. No. 2007-0024 titled “Guidelines for the Licensure of Department of Health Hospitals” and revokes A.O. No. 2008-0027 titled “One- Stop Shop System for the Regulation of Medical Facilities for Overseas Workers and Seafarers, Non-Hospital -Based Dialysis Clinics and Non-Hospital-Based Ambulatory Surgical Clinics with Ancillary Services.”
Inconsistent or contrary provisions from previous issuances are rescinded and modified accordingly.
The separability clause preserves validity of unaffected provisions if any provision or part is declared unconstitutional or invalid by a competent court.