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Date Filed: 05 January 2017

I.    RATIONALE/BACKGROUND

The issuance of Administrative Order (A.O.) No. 2010-0035 entitled “Recentralization of the Issuances of Permit to Construct (PTC) for All Levels of Hospitals, License to Operate (LTO) for All New Hospitals and Renewal of LTO for Levels Three (3) and Four (4) Hospitals”, authorized the re-centralization of the licensing and regulatory functions to the Health Facilities and Services Regulatory Bureau (HFSRB).

In the said A.O., the following regulatory functions were assigned to HFSRB: a) issuance of PTC for all levels of hospitals; b) issuance of LTO for all new hospitals; c) any change in the LTO of existing hospitals; and d) renewal of LTO for Level 3 and Level 4 hospitals. Based on the same A.O., the Regional Offices shall continue with their regulatory functions of renewing the LTO of Levels 1 and 2 hospitals.

With the issuance of A.O. No. 2012-0012 entitled “Rules and Regulations Governing the New Classification of Hospitals and other Health Facilities in the Philippines”, the processing of DOH-PTC applications for all new hospitals and other health facilities remained solely in the jurisdiction of HFSRB. Upon review and evaluation of its implementation, such set-up along with the increase in the volume of applications has led the HFSRB to adopt a strategy in order to make the process of application for DOH-PTC more efficient, rational and client responsive.

In this regard, regulatory functions for selected health facilities shall be decentralized to the Regional Offices. This decentralization is in support of the presidential directive to streamline all government processes including regulation.

Furthermore, this Order shall serve as the guidelines for the processing of all DOH-PTC applications for both HFSRB and the Regional Offices.

II.    OBJECTIVE

These rules and regulations are promulgated to decentralize to the Regional Offices the DOH-PTC application process for selected health facilities and to harmonize all PTC related issuances.

III.    SCOPE

These rules and regulations shall apply to all government and private hospitals and other health facilities applying for a DOH-PTC.

IV.    DEFINITION OF TERMS AND ACRONYMS

1.    Add-on Services - health care services which are beyond the current service capability of health facility (ex. Level 1 Hospital with add-on services like Hemodialysis Clinic, Intensive Care Unit, Neonatal Intensive Care Unit, etc.)
2.    Ambulatory Surgical Clinic (ASC) - a government or privately owned institution which is primarily organized, constructed, renovated or otherwise established for the purpose of providing elective surgical treatment of out-patients whose recovery, under normal and routine circumstances, will not require inpatient care
3.    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
4.    Birthing Home - a health facility that provides maternity service on prenatal and postnatal care, normal spontaneous delivery and care of newborn babies
5.    Certificate of Need (CON) - a required document prior to the issuance of a DOH-PTC for construction of new government and private hospital.
6.    Checklist for Review of Floor Plans - the checklist for the planning and designing of health facilities to comply with the minimum standards and requirements
7.    Department of Health (DOH)
8.    Department of Health-Permit to Construct (DOH-PTC) - a permit issued by DOH through HFSRB to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents set forth in this Order prior to the actual construction of the said facility. A DOH-PTC is also required for hospitals and other health facilities with substantial alteration, expansion, renovation, increase in the number of beds or for additional services (add-ons) beyond their service capability. It is a prerequisite for License to Operate.
9.    Drug Abuse Treatment and Rehabilitation Center (DATRC) - a health facility that provides diagnosis, treatment and management of drug dependents utilizing any of the accepted modalities such as multidisciplinary team approach, therapeutic community approach, and/or spiritual services towards the rehabilitation of a drug dependent. A DA TRC according to service capability can be categorized as a Residential Treatment and Rehabilitation Center (In-patient Center) or as a Non-residential Treatment and Rehabilitation Center (Out-patient Center).
10.    Residential Treatment and Rehabilitation Center (In-patient Center) - a health facility that provides comprehensive rehabilitation services utilizing, among others, any of the accepted modalities: multidisciplinary team approach, therapeutic community approach, and/or spiritual services towards the rehabilitation of a drug dependent.
11.    Non-residential Treatment and Rehabilitation Center (Out-patient Center) - a health facility that provides diagnosis, treatment and management of drug dependents on an outpatient basis. It may be a drop-in/walk-in center or any other facility with consultation and counseling on addiction as the main services provided, or may be an aftercare service facility. From time to time, it may provide temporary shelter for patients in crisis for not more than twenty four (24) hours.
12.    Drug Testing Laboratory (DTL) - refers to a private or government diagnostic facility that performs a laboratory examination of human biological specimen for identification of dangerous drugs
13.    Health Facility - a building or physical structure providing health care services
14.    Health Facilities Evaluation and Review Committee (HFERC) - refers to the committee that reviews all applications for PTC with respect to compliance with the guidelines in planning and design of health facilities
15.    Health Facilities and Services Regulatory Bureau (HFSRB) - the Bureau of DOH in charge with the implementation of these rules and regulations
16.    Hemodialysis Clinic - a health facility doing medical procedures whereby the patient’s blood is delivered by a machine to a dialyzer (filter) to remove metabolic waste and restore fluid and electrolyte balance
17.    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
18.    Infirmary - a health facility that provides emergency treatment and care to the sick and injured, as well as clinical care and management to mothers and newborn babies
19.    License to Operate (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 by any accrediting body recognized by DOH.
20.    Medical Facility for Overseas Workers and Seafarers (MFOWS) - a health facility that conducts pre-employment medical examinations prior to deployment of land based overseas work applicant or seafarers for domestic/overseas employment to determine whether he/she is physically and mentally fit to work
21.    Psychiatric Care Facility - a health facility that provides medical service, nursing care, pharmacological treatment and psychosocial intervention, including basic human services like food and shelter, for mentally ill patients. It can be categorized as an Acute-Chronic Psychiatric Care Facility or as a Custodial Psychiatric Care Facility.
22.    Acute-Chronic Psychiatric Care Facility - a health facility that provides medical service, nursing care, pharmacological treatment and psychosocial intervention, including basic human services like food and shelter, for mentally ill patients.
23.    Custodial Psychiatric Care Facility - a health facility that provides long-term care, including basic human services like food and shelter, for mentally ill patients.
24.    Regional Office (RO) - the regional health office of DOH
25.    Regulation Licensing and Enforcement Division (RLED)

V.    IMPLEMENTING MECHANISMS

A.    GENERAL GUIDELINES

1.    The application for the DOH-PTC are required for the following health facilities:

a.    Ambulatory Surgical Clinic
b.    Birthing Home
c.    Drug Abuse Treatment and Rehabilitation Center (Residential and Non-Residential)
d.    Drug Testing Laboratory
e.    Hemodialysis Clinic
f.    Hospital
g.    Infirmary
h.    Medical Facility for Overseas Workers and Seafarers
i.    Psychiatric Care Facility (Acute-Chronic and Custodial)

2.    The processing of application for DOH-PTC shall be as follows:

HFSRB	Regional Offices – RLED
a. Ambulatory Surgical Clinic b. Drug Abuse Treatment and Rehabilitation Center (Residential and Non-Residential) c. Drug Testing Laboratory (free- standing) d. Hemodialysis Clinic e. Hospital (Levels 2 and 3) f. Medical Facility for Overseas Workers and Seafarers g. Add-on Services to Level 2 and Level 3 Hospitals	a. Birthing Home b. Level! and Health Facility Enhancement Program (HFEP) funded Hospitals c. Add-on Services to Level 1 Hospitals d. Infirmary e. Psychiatric Care Facility (Acute-Chronic and Custodial)'

3.    The HFSRB and RLED shall create a Health Facilities Evaluation and Review Committee (HFERC) composed of the following:

a.    Chairperson - Director IV ( HFSRB) or may be assigned to any qualified HFSRB personnel/RLED Chief (RO) or may be assigned to any qualified RLED personnel
b.    Vice-Chair - any competent HFSRB/RLED personnel may be assigned
c.    Members at a minimum shall include the following:

i.    Architect/Engineer
ii.    Physician
iii.    Nurse
iv.    Other technical experts such as Medical Technologists, Pharmacists, Physicists, etc. may be invited to assist in the evaluation of the DOH-PTC application as needed.

4.    Hospitals and other health facilities shall be planned and designed in accordance to existing laws and guidelines to ensure a safe and secure environment for patients, staff and the public.

5.    Health facility owners shall strictly follow the checklist for review of floor plans.

6.    The HFSRB shall exercise oversight, supervisory and monitoring functions over the ROs with regards to infrastructure compliance of facilities based on the approved DOH-PTC of hospitals, their ancillary and other facilities.

B.    PROCEDURAL GUIDELINES (See Annex A for the Process Flow of DOH-PTC Application)

1.    The following are the required documents to be accomplished and submitted either through regular mail, courier or whenever available through online systems to HFSRB or RO-RLED before a DOH-PTC can be issued to an applicant.

a)    Duly accomplished application form for the specific facility (downloadable from the HFSRB website: https://hfsrb.doh.gov.ph)
b)    Proof of ownership

i.    Department of Trade and Industry (DTI) or Securities and Exchange Commission (SEC) Registration with Articles of Incorporation and By-laws;
ii.    Enabling Act or Board Resolution (for government owned);
iii.    Cooperative Development Authority Registration with Articles of Cooperation and By-laws;

c)    Three sets of architectural floor plans signed and sealed by an architect and/or engineer. An electronic copy of the same may be submitted through email (hfsrb@doh.gov.ph) or whenever available through online systems;
d)    Approved CON issued by the Regional Office (for new general hospitals).

2.    The architectural floor plans should conform to the prescribed planning and design guidelines, and checklist for specific health facility. Refer to the following Annexes:

a.    Annex B: Planning and Design Guidelines for Hospitals and Other Health Facilities
b.    Annex C: Planning and Design Guidelines for Birthing Home
c.    Annex D: Planning and Design Guidelines for DATRC (Residential and Non-Residential)
d.    Annex E: Planning and Design Guidelines for DTL
e.    Annex F: Planning and Design Guidelines for Hemodialysis Clinic
f.    Annex G: Planning and Design Guidelines for MFOWS
g.    Annex H: Checklist for Review of Floor Plans

i.    H-I: Ambulatory Surgical Clinic
ii.    H-2: Birthing Home
iii.    H-3a: Residential Drug Abuse Treatment and Rehabilitation Center (In-patient)
iv.    H-3b: Non-Residential Drug Abuse Treatment and Rehabilitation Center (Out-patient)
v.    H-4: Drug Testing Laboratory
vi.    H-5: Hemodialysis Clinic
vii.    H-6a: Level 1 Hospital
viii.    H-6b: Level 2 Hospital
ix.    H-6c: Level 3 Hospital
x.    H-7: Infirmary
xi.    H-8: Medical Facility for Overseas Workers and Seafarers
xii.    H-9a: Acute-Chronic Psychiatric Care Facility
xiii.    H-9b: Custodial Psychiatric Care Facility
h.    Annex I: Terms and Conditions of DOH-PTC

3.    Upon filing of application, the applicant shall pay the corresponding fee to DOH Central Office cashier or RO cashier in person or through postal money order or through other means as bank to bank transactions once the system becomes operational.

4.    The HFERC shall review and evaluate the submitted plans and documents of the proposed hospital with respect to basic requirements and with the prescribed prototype planes) and technical guidelines in the planning and design of a hospital and other health facility.

5.    Standards for the physical plant developed by the Center for Device Regulation, Radiation Health and Research shall be applied for the Radiology Services of hospitals and other health facilities.

6.    The HFSRB and RO-RLED (One-Stop Shop Inspection Team) may do site verification surveys as needed.

7.    Within fifteen (15) working days, the HFSRB or RO shall approve or disapprove the application for a DOH-PTC; inform the applicant of the status of their application whether approved or disapproved; issue the DOH-PTC duly signed by the HFSRB Director or the Regional Director for approved applications; and return the documents together with the findings to the applicant if the application is disapproved.

8.    Applicants whose application for a DOH-PTC has been disapproved may avail of technical assistance/advisory services from HFSRB or RO. The applicant shall make the necessary revisions on the documents and shall submit the revised documents to HFSRB or RO for another review without additional payment. The same timeline will apply for the second review (see V.B.6) upon submission of the revised/corrected documents.

9.    If after the second review, the application for DOH-PTC has been disapproved, the applicant shall have to re-apply and pay another application fee.

VI.    SCHEDULE OF FEES

A.    A non-refundable fee shall be charged for the application of DOH-PTC of a hospital or health facility.
B.    All fees/checks shall be paid to the DOH Central Office cashier or Regional Office cashier in person or through postal money order or through bank to bank payments as soon as the system becomes functional.
C.    All fees, surcharges and discounts shall follow the current DOH prescribed schedule of fees in A.O. No. 2007-0023 regarding “Schedule of Fees for the One-Stop Shop Licensure System for Hospitals”, A.O. No. 2008-0028 “Schedule of Fees for the One-Stop Shop Licensure System for Non-Hospital Based Facilities ... “ and A.O. No. 2007-0001 “Revised Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services and Centers for Health Development. ..”

VII.    VALIDITY OF DOH-PTC

The DOH-PTC shall be valid for one (1) year after approval and shall strictly adhere to the terms and conditions found in the DOH-PTC. (See Annex I)

VIII.      VIOLATIONS

Facilities found violating any provision of these rules and regulations and its related issuances, and/or commission/omission of acts by personnel operating a hospital or health facility under this Order shall be penalized through the issuance of a Cease and Desist Order.

IX.    APPEAL

Any hospital or other health facility aggrieved by the decision of the HFSRB Director or Regional Director 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 appellant shall then be elevated by HFSRB or the Regional Office 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 absolute and executory.

X.    TRANSITORY PROVISIONS

A.    All DOH-PTC applications for Infirmary, Level 1 Hospitals, Add-on Services to Level 1 Hospitals and Psychiatric Care Facility (Acute-Chronic and Custodial) filed at HFSRB before the enactment of this Order shall still be acted upon by HFSRB.
B.    These rules and regulations, upon approval, shall be immediately enforced on hospitals and other health facilities applying for DOH-PTC.
C.    All technical assistance and trainings to capacitate the Licensing Officers of the ROs shall be provided by HFSRB before December 31, 2016.
D.    The Regional Offices shall assume its full decentralized functions for the review, evaluation and approval of the DOH-PTC application for Infirmary, Level 1 Hospitals, Add-on Services to Level 1 Hospitals and Psychiatric Care Facility (Acute-Chronic and Custodial) by January 1, 2017.
E.    Level 2 and level 3 hospitals and other health facilities will be decentralized by phase over a period of three (3) years, and shall be based on set criteria, to evaluate the performance and capacity of the region.

XI.    REPEALING CLAUSE

This order amends the sections of the following issuances:

A.    Section V. A. 2. b. of A.O. No. 2010-0035 entitled “Recentralization of the Issuances of Permit to Construct (PTC) for All Levels of Hospitals, License to Operate (LTO) for All New Hospitals and Renewal of LTO for Levels Three (3) and Four (4) Hospitals”
B.    Section VI. B. of A.O. No. 2012-0012 entitled “Rules and Regulations Governing the New Classification of Hospitals and Other Health Facilities in the Philippines”
C.    Section V. A. 5. a. of A.O. No. 2014-0036 entitled “Supplemental Guidelines to Administrative Order 2012-0012 to Strengthen the Role of the Bureau of Health Facilities and Services (BHFS) and DOH Regional Offices (ROs) in Licensing of Hospitals and Other Health Facilities.”

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

XII.    SEPARABILITY CLAUSE

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

XIII.     EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation.


(SGD) PAULYN JEAN B. ROSELL-UBIAL, MD, MPH, CESO II
Secretary of Health