(NAR) VOL. 29 NO. 2/ APRIL - JUNE 18
1. All hospitals and other health facilities must secure a DOH-LTO or DOH- COA, whichever is applicable, and must be compliant at all times with the licensing standards and requirements set forth by HFSRB and FDA.B. Specific Guidelines
2. The Certificate of Need (CON), when applicable, issued by the Regional Office and the Department of Health-Permit to Construct (DOH-PTC), issued by the HFSRB or the RO-RLED, are prerequisites for the issuance of the DOH-LTO or DOH-COA.
3. The guidelines for the OSS implementation shall be strictly followed at the central and the regional levels of the involved DOH regulatory offices.
4. The HFSRB shall be responsible for the initial and renewal of DOH-LTO of levels 2 and 3 general hospitals and specialty hospitals, non-hospital- based MFOWS, non-hospital-based ASCs and non-hospital-based dialysis clinics.
5. The RO-RLED shall be responsible for the initial and renewal of DOH- LTO of birthing homes, infirmaries, and level 1 hospitals and their add-on facilities, for example, dialysis clinic in a level 1 hospital.
6. All applications, whether for initial or renewal, for DOH-LTO or DOH-COA shall be processed through the Online Licensing and Regulatory System (OLRS), once the system is fully functional.
7. The HFSRBRO-RLED and FDA (RFO and CDRRHR) shall assign OSS evaluators for the assessment of all submitted applications and corresponding documentary requirements.
8. At the Central Office, the Director IV, or in his/her absence or unavailability or when delegated, the Director III of HFSRB, shall approve the issuance of the DOH-LTO or DOH-COA of the health facility.
9. At the Regional Office, the Director IV, or in his/her absence or unavailability or when delegated, the Director III of the RO-RLED, shall approve the issuance of the DOH-LTO or DOH-COA of the health facility.
10. A single DOH-LTO or DOH-COA shall be issued to the health facility, and shall include:a) Category of the facility;11. The OSS Licensing System shall be applicable to all health facilities and ancillary services within the hospital premises, except for the following health facilities, which shall require a separate application for DOH-COA:
b) Authorized bed capacity (when applicable);
c) Ancillary services and other regulated health facilities regardless of ownership, beyond the requirement for the category of that particular health facility; and
d) Validity perioda) Medical Facilities for Overseas Workers and Seafarers (MFOWS);12. Sanctions for violations meted out for ancillary services and other health facilities, regardless of ownership, shall be borne by the hospital or health facility where they are located.
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
13. A database of all licensed health facilities under the OSS shall be integrated into the OLRS.
1. Licensing or Accreditation Process - Initial Application (See Annex A* for the Process Flow of Initial Application)2. Renewal of the License or Accreditation (See Annex B* for the Process Flow of Renewal Application)
a) Filing of application for initial DOH-LTO/DOH-COA shall be from the start of the working day of the year to November 15.
b) Initial applicants shall create an account at the OLRS webpage. The user name and password shall be safeguarded by the client, and shall be used to register for all transactions.
c) Once registered, the applicant may log in to access and fill out the application forms. The corresponding fees for the applied health facilities/services shall be shown to guide the client in the computation of fees due to each agency. The applicant shall then encode and/or upload the documentary requirements including scanned copy of the proofs of payment for HFSRB/RO-RLED and FDA.
d) The non-refundable application fee shall be paid to the corresponding regulatory offices: for HFSRB to the DOH cashier, for the RO-RLED to the RO Cashier and for RFO and CDRRHR through FDA cashier or bank payments specified by the FDA. Applicant shall provide proofs of payment, such as scanned copy of the official receipt and deposit slip/on-coll payment slip.
e) The application will not proceed if there are incomplete entries and lacking documentary requirements.
f) Once the application is accepted into the system, the assigned OSS evaluators shall assess the technical correctness of the documentary requirements submitted including proofs of payment. A technically correct application means that the required documents, as specified in the application checklist of HFSRB/RO-RLED and FDA, have been submitted. The timeline from acceptance to approval of application is three (3) days.
g) If the application was evaluated to be technically incorrect, a system generated email will be sent automatically to the applicant, and the status of the application shall appear as “WITH DEFICIENCY”. A STOP-CLOCK shall be observed and the client shall be given thirty (30) days to correct the documentary requirements. Failure to do so shall result in the DISAPPROVAL and forfeiture of payment.
h) If the application was evaluated to be technically correct, HFSRBRO-RLED and FDA shall organize a team of inspectors and shall implement joint inspections of health facilities whose priority are those under the One-Stop Shop Licensing System. From the time of approval of the application, the inspection teams from HFSRB/RO-RLED, RFO and CDRRHR/RFO shall be given twenty (20) days to inspect the facility.
i) Inspection maybe waived by RFO, who shall then automatically issue a Recommendation Letter (RL) for pharmacy and schedule a post licensing inspection. Nevertheless, if deemed necessary, the RFO may conduct an inspection of the pharmacy and shall then transmit the COC online to HFSRB/RO-RLED, if compliant. A copy of the Inspection Report shall be issued to the facility. The list of
facilities found to be non-compliant during the post licensing inspection shall be forwarded to HFSRB/RO-RLED.
j) If found non-compliant during inspection, the inspection team from the concerned offices shall notify the applicant of their deficiencies and the facility shall be given time to comply within the prescribed timeline (maximum of 30 days).
k) The counting of days for the HFSRB/RO-RLED to process the application shall be stopped (“STOP-CLOCK”) until all deficiencies have been complied with.
l) Failure to complete the compliance within the timeline given shall mean disapproval of the application and forfeiture of payment. The client shall then be notified through e-mail, and shall have to re- apply.
m) For compliant health facilities, the following documents shall be transmitted online to HFSRB/RO-RLED:i. For Hospital, Infirmaryn) The assigned OSS evaluators from HFSRB/RO-RLED, after receiving the transmitted RL/COC from RFO, and COC, COR or LTO from CDRRHR/RFO, shall then recommend to the Director IV of HFSRB/RO Director, or in his/her absence or unavailability or when delegated, the Director III of HFSRB/RO, the approval of the issuance of the DOH-LTO or DOH-COA.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 Magnetic Resonance Imaging (MRI) facilities; and LTO for Transportable X-ray Facility and for Therapeutic X-ray Facility Utilizing Medical Linear Accelerator (LINAC) x-ray machinesii. For Birthing Home, ASC, MFOWS, Dialysis Clinic
From RFO: RUCOC for pharmacyFrom CDRRHR/RFO: COC for diagnostic radiology
From RFO: RL/COC for pharmacy
o) The Director IV of HFSRB/RO Director, or in his/her absence or unavailability or when delegated, the Director III of HFSRB/RO, shall approve the issuance of the DOH-LTO or DOH-COA.
p) The system will then generate a hard copy of the DOH-LTO or DOH- COA on a security paper with QR (quick response) code, to be picked up by the applicant or be delivered by courier, depending on the chosen method of delivery.
q) Once licensed, applicant shall be assigned a National Health Facility
Registry Code as its new username and a system generated
password for DOH-LTO/DOH-COA renewal and shall be transmitted via email.
r) The timeline from complete compliance after inspection to the issuance of DOH-LTO/DOH-COA shall be seven (7) days.
s) The timeline for the issuance of the initial DOH-LTO or DOH-COA shall be within thirty (30) days from acceptance of complete application.
t) If due to force majeure or any unforeseen events, the RL/COC/COR/LTO from FDA and DOH-LTO or DOH-COA were not issued within the 30-day period from receipt of the complete application, the DOH-LTO or DOH-COA shall automatically be issued, but a post licensing inspection shall be undertaken by the concerned offices.
a) The renewal period for DOH-LTO or DOH-COA shall be from October 1 to December 15 of the current year. A 10% discount shall be given to those who filed complete renewal applications from October 1 to November 30 of the current year.VI. VALIDITY OF DOH-LTO OR DOH-COA
b) Application to HFSRB/RO-RLED and FDA (RFO and CDRRHR) shall be through the OLRS, using the National Health Facility Registry code assigned to the licensed health facility as username and the system generated password.
c) The timeline for automatic renewal shall be fifteen (15) days from acceptance into the system of the complete application forms, together with the other documentary requirements and the uploaded scanned copy of the proofs of payment for each office, to the issuance of DOH-LTO/DOH-COA.
d) Eligible for automatic renewal:i. facilities with no sanctions, violations or deficiencies;e) Automatic renewal shall only apply to hospitals.
ii. facilities which have corrected/complied to the noted violations at the time of application; and
iii. facilities which submitted/participated in the Online Health
Facility Statistical Reporting System (OHFSRS)
f) The DOH-LTO or DOH-COA of those facilities with sanctions, violations or deficiencies shall be renewed only after serving out their sanction/penalty or corrected their violations, or completed their deficiencies. If compliance was met after the expiration of the DOH- LTO/DOH-COA, the date of validity of the new DOH-LTO/DOH-COA shall start from the date of full compliance.
g) HFSRB shall conduct monitoring visits and FDA (RFO and CDRRHR) may carry out Post Licensing Inspection on those facilities which renewed their DOH-LTO/DOH-COA automatically, and those with previous sanctions or violations.
h) Whenever there are changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, and increase in bed, the health facility shall go through the same process in the issuance of initial DOH-LTO or DOH-COA.
i) Sanctions for late filing of application for renewal of DOH-LTO or DOH-COA shall be in accordance with the existing rules and regulations of the concerned bureau/agency.
a) The DOH-LTO for the hospitals, birthing homes and infirmaries shall be valid for one (1) year.VII. SCHEDULE OF FEES
b) The DOH-LTO for non-hospital-based dialysis clinics and non-hospital-based ambulatory surgical clinics shall be valid for three (3) years.
c) The DOH-COA for the non-hospital-based medical facilities for overseas workers and seafarers shall be valid for three (3) years.
a) The DOH-LTO or DOH-COA fee shall follow the Schedule of Fees currently prescribed by the DOH and FDA.VIII. PENALTY
b) The applicant, upon filing the application, shall pay the corresponding fee to the DOH/RO Cashier and FDA Cashier or any authorized banks for pharmacy and diagnostic radiology and radiation oncology.
1. Implementation of the online licensing system shall be done by phase.XI. REPEALING CLAUSEa. Phase 1 shall start on July 2018, and shall cover:2. The OSS Licensing System shall be implemented even while the online system is being developed and finalized.i. initial DOH-LTO of hospitals (HFSRB)b. Phase 2 shall start on July 2019, and shall cover:
ii. initial DOH-LTO/DOH-COA of other health facilities (HFSRB)i. initial and renewal DOH-LTO of hospitals (HFSRB/selected regional offices)c. Phase 3 (full implementation) shall start on July 2020, and shall cover:
ii. initial and renewal of the DOH-LTO/DOH-COA of other health facilities (HFSRB/selected regional offices)i. initial and renewal of the DOH-LTO/DOH-COA of all health facilities under the OSS Licensing System (HFSRB/all regional offices)
3. The General Guidelines and the Specific Guidelines for Initial and Renewal of DOH-LTO/DOH-COA (Section V. A and B of this A.O.) shall be applicable during the transition period. Submission of documentary requirements including the copy of the proofs of payment to HFSRB/RO-RLEDs shall be in hard copies, while those for FDA shall be in hard copies and soft copies saved in universal serial bus (USB) flash drive. The processing of the complete application forms and documentary requirements shall be done manually.
4. The HFSRB/RO-RLED and FDA shall designate OSS Evaluators who shall assess the completeness and technical correctness of the submitted documents.
5. The same timelines shall be observed for all processes (initial/renewal) as stated in Section V. A and B.