QuestionsQuestions (ADMINISTRATIVE ORDER NO. 2018-0016)
It is a DOH administrative issuance revising the guidelines for implementing the One-Stop Shop (OSS) Licensing System using the Online Licensing and Regulatory System (OLRS). Its purpose is to harmonize and streamline the processing of DOH-LTO and DOH-COA, reduce delays caused by separate processes (e.g., FDA location, different payment modes, inspection schedules), and make licensing more timely, easy, and convenient in line with the President’s directive to streamline government processes.
The Order applies to DOH offices involved in enforcement of regulatory standards: HFSRB, RO-RLED, and the FDA (including its RFO and CDRRHR). It covers hospitals and certain other health facilities with ancillary services, including non-hospital-based MFOWS, non-hospital-based ASCs, non-hospital-based dialysis clinics, infirmaries, and birthing homes.
Applicant is the natural or juridical person applying for a License to Operate (DOH-LTO) or Certificate of Accreditation (DOH-COA) of a hospital or any other health facility. The AO’s definitions of DOH-COA indicate that accreditation may be sought by an individual, partnership, corporation, or association.
The Certificate of Need (CON), when applicable, and the DOH-Permit to Construct (DOH-PTC) are prerequisites for the issuance of DOH-LTO or DOH-COA.
HFSRB is responsible for the initial and renewal of DOH-LTO of Level 2 and Level 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, including their add-on facilities (e.g., a dialysis clinic in a Level 1 hospital).
All applications (initial or renewal) for DOH-LTO or DOH-COA must be processed through OLRS once fully functional.
A single license/certificate is issued for the facility. It includes: (1) category of the facility; (2) authorized bed capacity when applicable; (3) ancillary services and other regulated health facilities regardless of ownership beyond the requirement for that facility category; and (4) validity period.
Facilities requiring separate application for DOH-COA are: (a) Medical Facilities for Overseas Workers and Seafarers (MFOWS); (b) Drug Abuse Treatment and Rehabilitation Center (DATRC); (c) Human Stem Cell and Cell-based or Cellular Therapy Facility; and (d) facilities for Kidney Transplantation.
From acceptance to approval of a technically correct application: 3 days. If technically incorrect: the status becomes “WITH DEFICIENCIES,” a STOP-CLOCK is observed, and the facility has 30 days to correct deficiencies; otherwise disapproval and forfeiture of payment result. After approval, inspectors have 20 days to inspect the facility.
It stops the counting of days for HFSRB/RO-RLED to process the application until the applicant complies with deficiencies. Thus, timelines for processing are suspended during the compliance period.
For hospitals/infirmaries, CDRRHR/RFO transmits COCs for 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 Therapeutic X-ray Facility utilizing LINAC. For pharmacy, RFO transmits RUCOC. For birthing homes/ASCs/MFOWS/dialysis clinics, CDRRHR/RFO transmits COC for diagnostic radiology and RFO transmits RL/COC for pharmacy.
After complete compliance after inspection, issuance of DOH-LTO/DOH-COA is within 7 days. The issuance of the initial DOH-LTO/DOH-COA is within 30 days from acceptance of a complete application.
Renewal period is from October 1 to December 15 of the current year, with a 10% discount for complete renewal applications filed from October 1 to November 30. Automatic renewal is allowed only for hospitals and is eligible for facilities with no sanctions/violations/deficiencies, facilities that corrected noted violations at the time of application, and facilities that submitted/participated in the Online Health Facility Statistical Reporting System (OHFSRS).
DOH-LTO for hospitals, birthing homes, and infirmaries is valid for 1 year. DOH-LTO for non-hospital-based dialysis clinics and non-hospital-based ASCs is valid for 3 years. DOH-COA for non-hospital-based MFOWS is valid for 3 years.
Any aggrieved hospital/health facility may file a notice of appeal within 10 days after receipt of the notice of decision to the Head of the Office for Health Regulation (OHR). Records are elevated by HFSRB/RO to OHR. If still contested, a final appeal may be brought to the Secretary of Health, whose decision is final and executory.
Phase 1 starts July 2018 covering initial DOH-LTO of hospitals (HFSRB) and initial DOH-LTO/DOH-COA of other health facilities (HFSRB). Phase 2 starts July 2019 covering initial/renewal DOH-LTO of hospitals (HFSRB/selected regional offices) and initial/renewal DOH-LTO/DOH-COA of other health facilities (HFSRB/selected regional offices). Phase 3 starts July 2020 covering initial and renewal DOH-LTO/DOH-COA of all facilities under OSS in HFSRB/all regional offices. Even while the online system is being developed, OSS guidelines still apply; documentary requirements are submitted in hard copies (FDA includes soft copies saved in a USB), and processing of complete forms/document requirements is done manually.