I.    RATIONALE/BACKGROUND

Administrative Order (A.O.) No. 2007-0021, known as, œHarmonization and Streamlining of the Licensure System for Hospitals  was issued on June 6, 2007, to harmonize and streamline the systems and processes that will make health regulation more rational and client responsive. The One-Stop Shop (OSS) Licensing System was adopted, and entailed transaction with one regulatory office  in  the  Department  of  Health  (DOH),  a  unified  inspection  team,  and issuance of a single license for hospitals which covered their ancillary services and other health facilities/services. The application of the OSS Licensing System expanded to include non-institution based health facilities with ancillary services, such as Medical Facilities for Overseas Workers and Seafarers (MFOWS), Ambulatory Surgical Clinics (ASC), Dialysis Clinics, based on A.O. No. 2008- 0027, known as œOne-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. 

Recent changes, such as the passage of Republic Act. No. 9711 or the Food and Drug Administration (FDA) Act of 2009, necessitated transfer of the then DOH Bureau of Health Devices and Technology (BHDT) to Alabang, Muntinlupa, when it became the FDA-Center for Device Regulation, Radiation Health and Research (CDRRHR). Consequently, the filing of application and payment of fees for radiation facilities are now received at the FDA main office. Moreover, the varied modes of payment (direct to DOH Central/Regional Cashier, online bank payments), the separate schedules for inspection, and the different processing timelines being followed by the concerned regulatory offices are no longer in consonance with the OSS Licensing System, and contributed further to the delay in the issuance of the DOH-License to Operate (DOH-LTO) or DOH- Certificate of Accreditation (DOH-COA).

Cognizant of the situation and the need for a more efficient and harmonized system in the issuance of DOH-LTO and DOH-COA, the OSS Licensing System is to be adopted once again. As a refinement to the current regulatory scheme and to create more impact by making the licensing process timely, easy and convenient to the clients, the concerned regulatory offices shall accept and process applications online through the Online Licensing and Regulatory System (OLRS). Furthermore, this is in support of the President ™s directive to streamline all government processes including regulation.

The implementation of the OSS Online Licensing System shall also cover the other  health  facilities  with  ancillary  services,  such  as  non-hospital-based MFOWS, non-hospital-based ASCs, non-hospital-based Dialysis Clinics, Infirmaries and Birthing Homes.

II.   OBJECTIVE

This Order sets the revised guidelines in the implementation of the One-Stop Shop Licensing System using the Online Licensing and Regulatory System (OLRS) for the licensure of hospitals and licensure and accreditation of other health facilities with ancillary services.

III.  SCOPE

This Order shall apply to the following DOH offices involved in the enforcement of regulatory standards in all government and private hospitals and other health facilities namely: the Health Facilities and Services Regulatory Bureau (HFSRB), the Regional Office-Regulatory, Licensing and Enforcement Division  (RO-RLED)  and  the  Food  and  Drug  Administration  (FDA),  which involves the Regional Field Office (RFO) and the Center for Device Regulation, Radiation Health and Research (CDRRHR).

IV.  DEFINITION OF TERMS AND ACRONYMS

1. Applicant - the natural or juridical person who is applying for a License to Operate or Certificate of Accreditation of a hospital or any other health facility
   
   
2. Certificate  of  Compliance  (COC)  -  a  form  of  authorization/permission granted by the Food and Drug Administration which serves as proof of the facility ™s compliance to the set technical requirements. It is a prerequisite for the issuance of the Department of Health-License to Operate.
   
   
3. CDRR - refers to the Center for Drug Regulation and Research of the FDA
   
   
4. CDRRHR - refers to the Center for Device Regulation, Radiation Health and Research of the FDA
   
   
5. Certificate of Registration - refers to the certificate issued by CDRRHR to compliant Magnetic Resonance Imaging (MRI) facilities
   
   
6. DOH - refers to the Department of Health
   
   
7. Department of Health-Certificate of Accreditation (DOH-COA) - refers to the formal authorization issued by DOH to an individual, partnership, corporation or association to operate a health facility. It refers to compliance to standards set for a particular purpose such as, but not limited to, HIV testing, drug testing, water analysis, issuance of medical fitness certification to overseas work applicants, and performance of kidney transplant. These standards cover input/structural, process and outcome/output standards.
   
   
8. Department of Health-License to Operate (DOH-LTO) - a formal authority issued  by  DOH  to  an  individual,  agency,  partnership  or  corporation  to operate a hospital or other health facility. It is a prerequisite for accreditation of a health facility (regulated by HFSRB) by any DOH-recognized accrediting body for Quality Management System, such as International Organization for Standardization (ISO).
   
   
9. FDA - refers to the Food and Drug Administration
   
   
10. Health Facility - refers to institution, whether stationary or mobile, land based or otherwise, that provides healthcare and other health-related establishment which provides diagnostics, therapeutic, rehabilitative, palliative and/or related health care services except medical radiation facilities and hospital pharmacies.
    
    
11. Health Facility Evaluation and Review Committee (HFERC) - refers to the committee that reviews all applications for Department of Health-Permit to Construct (DOH-PTC) with respect to compliance with the guidelines in planning and design of health facilities.
    
    
12. Health Facilities and Services Regulatory Bureau (HFSRB) - the Bureau of DOH in charge with the implementation of these rules and regulations.
    
    
13. Hospital - a place devoted primarily to the maintenance and operation of health facilities for the diagnosis, treatment and care of individuals suffering from illness, disease, injury or deformity or in need of obstetrical or other surgical, medical and nursing care. It shall also be construed as any institution, building or place where there are installed beds, cribs or bassinets for twenty-four hour use or longer by patients in the treatment of diseases.
    
    
14. Initial  Applications  -  refer  to  applications  by  newly  constructed  health facilities, changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, and increase in bed and major alterations or renovations.
    
    
15. One-Stop Shop (OSS) Licensing System - a strategy of the DOH to harmonize the licensure of hospitals, their ancillary and other health facilities including, but not limited to, the clinical laboratory, HIV testing, drinking water analysis and drug testing; blood bank, blood collection unit and blood station; dialysis  clinic;  ambulatory  surgical  clinic;  pharmacy;  and  medical  x-ray facility; but excluding hospital-based Medical Facilities for Overseas Workers and Seafarers (MFOWS), hospital-based Drug Abuse Treatment and Rehabilitation Center, hospital-based Stem Cell Facility, facilities for kidney transplantation, and facility using radioactive material that are currently regulated by the Philippine Nuclear Research Institute (PNRI). The OSS shall also apply to non-hospital-based Medical Facilities for Overseas Workers  and  Seafarers,  non-hospital-based Ambulatory  Surgical  Clinics, non-hospital-based Dialysis Clinics, Infirmaries and Birthing Homes.
    
    
16. Recommendation Letter (RL) - a form of authorization/permission granted by the RFO and CDRRHR of the Food and Drug Administration to facilities with waived  inspection  but  have  proven  compliance  to  documentary requirements. These facilities shall be subject to Post Licensing Inspection (PLI) prior to the issuance of the Certificate of Compliance.
    
    
17. 1 RFO - refers to the Regional Field Office of the FDA.
    
    
18. RO-RLED - Regional Office-Regulation Licensing and Enforcement Division

V.   IMPLEMENTING MECHANISMS

A.   General Guidelines

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.

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;
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 period

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:

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

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.

13. A  database  of  all  licensed  health  facilities  under  the  OSS  shall  be integrated into the OLRS.

B.   Specific Guidelines

1.   Licensing or Accreditation Process - Initial Application (See Annex A* for the Process Flow of Initial 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 œWITH 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 ( œSTOP-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, 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 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 machines
From RFO: RUCOC for pharmacy

ii.   For Birthing Home, ASC, MFOWS, Dialysis Clinic

From CDRRHR/RFO: COC for diagnostic radiology
From RFO: RL/COC for pharmacy

n)    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.

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.

2.   Renewal of the License or Accreditation (See Annex B*  for the Process Flow of Renewal Application)

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.

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;
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)

e)    Automatic renewal shall only apply to hospitals.

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.

VI.  VALIDITY OF DOH-LTO OR DOH-COA

a)   The DOH-LTO for the hospitals, birthing homes and infirmaries shall be valid for one (1) year.
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.

VII. SCHEDULE OF FEES

a)   The DOH-LTO or DOH-COA fee shall follow the Schedule of Fees currently prescribed by the DOH and FDA.
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.

VIII. PENALTY

Imposable penalties for violations hereof shall be in accordance with A.O. No. 2007-0022 titled œViolations under the One-Stop Shop Licensure System for Hospitals , A.O. No. 2008-0027 known as œOne-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.

IX.  APPEAL

Any hospital or other health facility aggrieved by the decision of the Director IV of HFSRB/RO Director, or in his/her absence or unavailability or when delegated, the Director III of HFSRB/RO, or FDA Director-General may, within ten (10) days after receipt of the notice of decision file a notice of appeal to the Head of the Office for Health Regulation (OHR). All pertinent documents and records of the applicant shall then be elevated by the HFSRB or RO to the OHR. The decision of the Head of the OHR if still contested maybe brought on a final appeal to the Secretary of Health whose decision shall be final and executory.

X.   TRANSITORY PROVISIONS

1.    Implementation of the online licensing system shall be done by phase.

a.   Phase 1 shall start on July 2018, and shall cover:

i.    initial DOH-LTO of hospitals (HFSRB)
ii.    initial DOH-LTO/DOH-COA of other health facilities (HFSRB)

b.   Phase 2 shall start on July 2019, and shall cover:

i.    initial and renewal DOH-LTO of hospitals (HFSRB/selected regional offices)
ii.    initial  and  renewal  of  the  DOH-LTO/DOH-COA  of  other  health facilities (HFSRB/selected regional offices)

c.   Phase 3 (full implementation) shall start on July 2020, and shall cover:

i.    initial and renewal of the DOH-LTO/DOH-COA of all health facilities under the OSS Licensing System (HFSRB/all regional offices)

2.    The OSS Licensing System shall be implemented even while the online system is being developed and finalized.

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.

XI.  REPEALING CLAUSE

This repeals/revokes A.O. No. 2007-0024 known as Guidelines for the Licensure of Department of Health Hospitals and 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.

Provisions from previous issuances that are inconsistent or contrary to the provisions of this Order are hereby rescinded and modified accordingly.

XII. SEPARABILITY CLAUSE

In the event that any provision or part of this Order is declared unconstitutional or null and void or rendered invalid by any court of law of competent authority, those provisions not affected by such declaration shall remain valid and effective.

XIII. EFFECTIVITY

This Order shall take effect fifteen (15) days after its approval and publication in the official gazette or two (2) newspapers of general circulation.