Amendment to A.O. No. 2020-0047 Entitled "Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines"

September 6, 2021

DOH ADMINISTRATIVE ORDER NO. 2020-0047-A

 

Administrative Order (AO) No. 2020-0047, titled "Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines" was issued last September 30, 2020, and took effect on October 30, 2020. To be licensed are all government and private primary care facilities, which are the rural health units (RHU), urban health centers (UHCs) and private medical clinics.

In 2021, the National Health Facility Registry (NHFR) listed 2,592 government-owned primary care facilities (PCF), with indeterminate number of private medical clinics. As of July 5, 2021, there is only one (1) DOH-licensed primary care facility. The most common reason for the low rate of filing of application for DOH-LTO a PCF based on stakeholders meetings organized by Center for Health Development (CHD)-Regulation, Licensing and Enforcement Division (RLEDs), is the difficulty in complying with all the minimum licensing requirements for PCF, particularly the ancillary services. The stakeholders are requesting for extension of implementation of the licensing standards. Furthermore, based on the discussions during the said stakeholders meeting, some of the licensing standards on personnel and physical plant needs to be updated and clarified, details of which are in the revised Annexes.

Thus, the following provisions are being amended:

xxx xxx xxx

Under Section VI. SPECIFIC GUIDELINES

A. Licensing Standards

PCFs shall follow the standards, criteria and requirements prescribed in the Licensing Standards for Primary Care Facilities (ANNEX A).

B. Assessment Tool

An Assessment Tool for Licensing of Primary Care Facilities (ANNEX B) shall be used by regulatory officers and other stakeholders to evaluate compliance of PCFs to DOH standards and technical requirements for safety. This particular tool shall also serve as the Self-Assessment Tool to be used by the owners of the PCFs prior to inspection or monitoring visits by the CHD-RLEDs.

xxx xxx xxx

The aforementioned provisions are hereby amended as follows:

xxx xxx xxx

A. Licensing Standards

PCFs shall follow the standards, criteria and requirements prescribed in the Licensing Standards for Primary Care Facilities (ANNEX A. Rev. 01).

B. Assessment Tool

An Assessment Tool for Licensing of Primary Care Facilities (ANNEX B. Rev. 01) shall be used by regulatory officers and other stakeholders to evaluate compliance of PCFs to DOH standards and technical requirements for safety. This particular tool shall also serve as the Self-Assessment Tool to be used by the owners of the PCFs prior to inspection or monitoring visits by the CHD-RLEDs.

xxx xxx xxx

X. TRANSITORY PROVISIONS

A. The requirement for DOH-PTC shall be waived for existing and operating PCFs prior to the effectivity of this Order. In lieu of this requirement, an as-built plan shall be submitted to the CHD-RLED.

B. The application fee for DOH-LTO and DOH-PTC for PCF shall be waived until a new schedule of fees is issued by DOH.

C. Existing PCFs which cannot completely comply with the licensing standards of ambulance service based on A.O. No. 2018-0001, also known as "Revised Rules and Regulations Governing the Licensure of Ambulances and Ambulance Service Providers," during initial application of DOH-LTO shall be given a grace period until October 1, 2022. A DOH-registered Patient Transport Vehicle shall serve as the transportation service of the PCF while complying with the licensing standards of their ambulance service.

D. Furthermore, existing PCFs which cannot completely comply with the required dental equipment and instruments in Annex B of this Order during initial application of DOH-LTO shall be given a grace period until October 1, 2023, to attain full compliance with the licensing standards set forth by this Order.

xxx xxx xxx

The following transitory provisions shall be added:

xxx xxx xxx

E. Existing PCFs which cannot comply with the licensing standards of birthing facility based on Annex-C of AO No. 2012-0012 and clinical standards based on AO No. 2021-0037, titled "New Rules and Regulations Governing the Regulation of Clinical Laboratories, during initial application of DOH-LTO shall be given a grace period until October 1, 2022.

F. Lastly, existing PCFs which cannot comply with the licensing standards of FDA for pharmacy and/or radiologic services, during initial application of DOH-LTO shall both be given a grace period until October 1, 2025 2023.

The schedule of deadline for compliance with all licensing standards of each ancillary service is summarized below:

 

Ancillary Service	End of Moratorium
Birthing Service	October 1, 2022
Ambulance Service
Clinical Laboratory Service
Dental Service	October 1, 2023
Pharmacy
Radiologic Service

 

G. Existing PCFs shall submit a duly notarized Memorandum of Undertaking (MOU) to their respective CHD-RLEDs, expressing their commitment to completely comply with all the licensing standards of the ancillary services within the specified period provided.

H. The DOH-LTO of PCFs shall indicate which ancillary services are already complied with and which have outstanding MOUs.

I. CHD-RLEDs shall monitor progress of compliance of licensed PCFs with MOU. PCFs that are found to be noncompliant with the licensing standards of ancillary services, as stated in their MOU, may issue a suspension of DOH-LTO a PCF. The sanction shall be lifted upon complete compliance with the required ancillary services within the compliance period provided by CHD-RLED.

xxx xxx xxx

All other provisions of A.O. No. 2020-0047 shall remain in effect and provisions/issuances inconsistent or contrary to this Order are hereby rescinded or modified accordingly.

This Order shall take effect fifteen (15) days after publication in the Official Gazette or in a newspaper of general circulation and upon filing three (3) certified copies to the University of the Philippines Law Center.

(SGD.) FRANCISCO T. DUQUE III, MD, MScSecretary of Health

ANNEX A

Rev. 01

HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Licensing Standards for Primary Care Facilities

I. PERSONNEL

There shall be an adequate number of qualified, trained and competent staff to ensure efficient and effective delivery of quality primary care services.

A. Every PCF shall have a duly licensed physician, as head of the facility, to oversee the clinical and administrative operations of the health facility.

B. For rural health units and urban health centers, the head of the facility shall also oversee the clinical and administrative operations of barangay health stations within their jurisdiction.

C. The minimum staffing standards such as staff composition and number/ratio shall be set by DOH. Adjustments in the staffing pattern shall depend on the workload and services being provided, using applicable workload assessment tools.

D. The staff must be competent and shall have the appropriate learning and development interventions and certification prescribed by DOH as a primary care worker.

E. There shall be staff development and continuing education program at all levels of organization to upgrade the knowledge, attitude and skills of staff.

II. PHYSICAL FACILITIES

Every PCF shall have physical facilities with adequate and appropriate areas to safely, effectively, and efficiently provide health services to patients. As such, it shall:

A. Conform to applicable national and local regulations for the construction, renovation, maintenance and repair of the same.

B. Conform to the required space for the conduct of its activities depending on its workload and the services being provided, as stated in the Checklist for Review of Floor Plans for Primary Care Facility (ANNEX C2. Rev. 01).

C. Have an approved DOH-Permit to Construct (DOH-PTC) in accordance with the planning and design guidelines prepared by DOH (ANNEX C1. Rev. 01).

III. EQUIPMENT AND INSTRUMENTS

Every PCF shall have available and operational equipment, instruments, materials and supplies consistent with the services it will provide. As such, it shall:

A. Adequately equipped based on the primary care services it provides.

B. Have an updated inventory, program for calibration, preventive maintenance and repair of equipment.

C. Have a contingency plan in case of equipment breakdown and malfunction.

IV. SERVICE DELIVERY

Every PCF shall ensure that the services being delivered to patients comply with the standards in the Assessment Tool for Licensing of PCF (ANNEX B. Rev. 01) and other related relevant issuances.

A. Primary care services, both individual- and population-based, shall be defined and set into guidelines by DOH and PhilHealth.

B. All government PCFs shall provide both individual-based and population-based primary care services.

C. All private PCFs shall provide individual-based primary care services.

D. Ancillary services of PCF include the following:

1. Clinical laboratory

2. Diagnostic radiologic services

3. Pharmacy

4. Birthing services

5. Dental services

6. Ambulance service (Type 1)

E. Ancillary services may be outsourced and located outside the premises of PCF, through a valid Memorandum of Agreement with DOH or FDA-licensed health facilities or services within the primary care provider network.

F. Clinical laboratory services, either provided within the PCF or outsourced from one or more DOH-licensed clinical laboratories, shall include the following:

1. Complete blood count with platelet count

2. Urinalysis

3. Fecalysis

4. Fecal occult blood test

5. Lipid profile (total cholesterol, HDL, LDL, triglycerides)

6. Fasting blood sugar

7. Oral glucose tolerance test

8. Pap smear

9. Creatinine

10. Blood typing

11. Screening for hepatitis B, syphilis, and HIV

12. Sputum microscopy or Nucleic acid amplification test

13. Dengue rapid test

G. In DOH-identified endemic areas, additional appropriate diagnostic test/s shall be provided, either within the PCF or outsourced from one or more DOH-licensed clinical laboratories (example: Kato Katz Schistosomiasis, Malaria smear, Filaria smear, slit-skin smear, and rapid plasma reagin for Syphilis).

H. Every PCF shall have documented administrative Standard Operating Procedures (SOP) for the provision of its services.

I. Every PCF shall have documented technical policies and procedures for individual-based and/or population-based primary care services, based on policies, guidelines, and Manual of Procedures issued by DOH and PhilHealth.

J. Every PCF shall have documented policies and procedures on the establishment and/or its participation in the primary care provider network.

K. PCFs that provide primary care services through digital technologies for health and mobile health services, shall adhere to the existing or subsequent telemedicine guidelines issued by DOH Knowledge Management and Information Technology Service (KMITS).

V. QUALITY IMPROVEMENT (QI) ACTIVITIES

Every PCF shall establish and maintain a system for continuous quality improvement activities.

A. Each PCF shall have policies and procedures on Quality Assurance Program (QAP) and continuous quality improvement.

B. The Quality Assurance Program shall have a written plan and its implementation shall be continuous with period reviews.

VI. INFORMATION MANAGEMENT

Every PCF shall maintain a system of communication, recording and reporting and releasing of patient's results, in adherence to Republic Act (RA) No. 10173 also known as the "Data Privacy Act of 2012" and RA No. 11332 also known as the "Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act."

A. Medical Records

B. Validated Electronic Medical Records (EMR)

C. Proof of submission of data to National Database of Human Resources for Health Information System (NDHRHIS)

D. Technical records/logbooks of:

1. Sentinel/adverse events

2. Navigation, coordination and referrals of patients through the Primary Care Provider Network and Health Care Provider Network

E. Administrative records of:

1. Minutes of the Meeting

2. Attendance logbook

3. 201 Personnel Staff files

4. Reports of DOH inspection and monitoring activities

5. Preventive and corrective maintenance of equipment

6. Maintenance and monitoring of health facility

F. Records Management

1. There shall be documented policies and procedures on access to and confidentiality of patient's information. Likewise, the right of the patient to obtain records of treatment and other relevant medical information shall be observed.

2. Retention and disposal of medical records and other relevant information whether paper-based or electronic media shall be in accordance with the standards promulgated by DOH or by competent authorities for such purposes.

VII. ENVIRONMENTAL MANAGEMENT

PCF shall ensure that the environment is safe for its patients and staff, including the general public.

A. There shall be a program of proper maintenance and monitoring of physical facilities.

B. There shall be procedures for the proper disposal of infectious wastes and toxic and hazardous substances in accordance with RA 6969, also known as "Toxic and Hazardous Substances and Nuclear Wastes Act" and other related policy guidelines and/or issuances.

C. There shall be a "No smoking policy" and that the same shall be strictly enforced.

D. There shall be a contingency plan in case of accidents and emergencies.

ANNEX B

Assessment Tool for Licensing a Primary Care Facility

ANNEX C1

Planning and Design Guidelines for Primary Care Facility

This Planning and Design Guidelines applies to all new construction and renovation of primary care facilities (PCF) as defined and classified under this Administrative Order. The following provisions and requirements shall be applied in the planning and design process of the construction, addition, alteration and renovation of a PCF.

1. General Requirements:

1.1 Location. The Primary Care Facility (PCF) shall be situated in an area or location that is conveniently accessible both to clients and staff via available means of public transportation.

1.2 Access. Separation and access shall be maintained, regardless the classification of PCF and whether the PCF is freestanding or is part of another facility. Building entrance should be at grade level, clearly marked, and located so that patients need not go through other activity areas. Design shall preclude unrelated traffic within the facility.

1.3 Privacy. The design shall ensure appropriate levels of patient audible and visual privacy and dignity throughout the care process, from the interviews, examinations, treatment, counselling and other testing procedures and related activities.

1.4 Parking. A PCF shall provide a minimum of one (1) parking space for every one hundred (100) square meters of gross floor area (GFA) and the fraction thereof. Aside from this, the PCF shall also provide a designated parking slot for an ambulance and/or patient transport vehicle.

1.5 The PCF shall conform to all applicable local and national regulation for the construction, renovation, maintenance and repair of its facilities.

2. Space Requirements

2.1 The PCF shall have adequate space or area provided for its various space/room requirements in order to attain the effective and efficient operation of its activities and functions.

2.2 PCF shall have the following zones, if applicable:

2.2.1 General Administrative Services and Public Areas;

2.2.2 Clinical Services Area;

2.2.3 Ancillary Services Area;

2.2.4 Support Services Area.

2.3 The General Administrative and Public Areas shall be comprised of the following spaces:

2.3.1. Main Lobby, provided with:

2.3.1.1 A Reception and information counter or desk.

2.3.1.2 Sufficient waiting area for clients, an area of 1.4 square meters shall be allocated per person. Consideration should be given to special needs of specific patient groups, such as of person with disabilities (PWD), infants, pregnant women, etc., such as dedicated seats for PWD, presence of ramps in the entrance, handrails, diaper changing and breastfeeding room, and alike.

2.3.1.3 Conveniently accessible toilet for the public. Provision of one (1) toilet for every eight (8) patient shall be applied. A separate toilet for male and female is preferred, and shall be PWD-accessible.

2.3.1.4 Conveniently accessible wheelchair area.

2.3.2. Office for Staff. General or individual office(s) for the staff, business transactions, and clerical and administrative functions shall be provided, with sufficient space for the staff and the activity involved therein, to attain effective and efficient operation of its activities and function.

2.3.2.1 A separate toilet for the staff, Provision of one (1) toilet for every fifteen (15) personnel shall be applied, preferably segregated by sexes.

2.3.2.2 Other spaces for staff such as conference room, staff pantry and the like, are optional.

2.3.3. Sufficient Storage for Records and Supplies.

2.4 The Clinical Services Area shall be composed of the following spaces:

2.4.1 Physician Office(s)/Consultation Room(s);

2.4.2 Medical Examination Room, which shall have a minimum floor area of 7.43 square meters per examination table/bed, exclusive of ante-room and toilet (if any). Room arrangement should permit of at least 850 mm clearance at the side and foot of the examination table/bed. A space for handwashing and a counter/shelf space for writing shall be provided.

2.4.3 Minor surgical room shall have a minimum floor area of twelve (12) square meters, excluding vestibule and toilet (if any). The minimum room dimension shall be three (3) meters. A hand washing station and a counter or shelf for writing shall be provided. A space for handwashing shall be provided.

2.5 The Ancillary Services Area(s) shall be composed of the following spaces:

2.5.1 Primary General Clinical Laboratory (must comply with the physical plant requirements provided in the Annexes D1 and D2 of Administrative Order No. 2021-0037 titled New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines).

2.5.2 Diagnostic Radiology Facility. The Medical X-ray Facility (at least Chest X-ray for Heart and Lungs) shall meet the requirements set by the Food and Drug Administration (FDA)-Center for Device Regulation, Radiation Health and Research (CDRRHR).

2.5.3 Birthing Facility (must comply with the requirements provided in the Annex C-Planning and Design Guidelines for Birthing Home of Administrative Order No. 2016-0042 titled Guidelines in the Application for the DOH-Permit-to-Construct (PTC)).

2.5.4 Pharmacy, provided with work counter and sink, shall meet the requirements set by the FDA-Center for Drug Regulation and Research (CDRR).

2.5.5 Dental Clinic. Provide at least 8.63 square meters per dental unit that includes space for one (1) dental chair, space for movement of person, and space for passage of equipment.

2.5.6 Designated Parking Area for Ambulance and/or Patient Transport Vehicle.

2.6 The Support Services Area(s) shall be composed of the following spaces:

2.6.1 Waste Holding Room/Area, for temporary and sanitary storage of segregated waste which includes infectious waste such as contaminated sharps and needles and non-infectious waste or general waste;

2.6.2 Janitor's Closet, with slop sink and housekeeping cabinet;

2.6.3 Designated Sputum Collection Area (for government-owned PCFs).

3. Functional Requirements

3.1 The different areas of the PCF shall be functionally related to each other.

3.2 Main entrance of the PCF directly accessible from public road and should be located at ground level with sufficient ramps compliant to BP 344 (with a clear width of 1.2 meters and minimum slope of 1:12) to accommodate person with disabilities (PWD) and groups with special needs.

3.3 A multi-level ramp or elevator for clinical and ancillary services located on the upper floor (if any) is recommended.

3.4 The Reception and information counter or desk shall be located in such a manner that it will afford visual control of the main entry to the PCF. Its layout shall allow the staff to see and acknowledge incoming clients/patients and at the same time facilitate their transaction activities.

3.5 The waiting area shall be planned in such a way that it is easily accessible from the main entry and located adjacent to the Reception and information counter or desk. Furthermore, the waiting area shall have a pleasing environment for the clients and patients and shall be adequately spaced and provided with appropriate furniture.

3.6 The office, shall be located adjacent to the lobby and both shall be located near the main entrance of the PCF.

3.7 The design and planning of the PCF shall also consider important factors such as medical equipment to be accommodated (especially those of the diagnostic radiological and clinical laboratory facilities), proper office/clinic layout/s which include/s furniture, fixtures and equipment, provision of client-friendly transaction windows and counter where necessary, comfortable seats for waiting and appropriate signage.

3.8 The General Administrative Service and Public Areas namely the Lobby, The Office, and Records Storage shall be planned contiguous to one another as they are closely related in terms of function, providing easy accessibility between these areas.

3.9 The Consultation and Examination Rooms shall be planned adjacent or easily accessible from the main lobby.

3.10 The Minor Surgical Room and Birthing Room shall be located away from the main traffic and access shall be limited to authorized personnel and patient only.

3.11 The Ancillary Zone for diagnostic services, namely the Clinical Laboratory and Medical X-ray Facility, shall also be planned contiguous or adjacent to one another. Appropriate waiting areas for these rooms should be provided.

3.12 Ancillary Services Areas shall be located and arranged to prevent non-related traffic through the room.

3.13 Support Service areas shall be planned in such a way that they are accessible to both clients and staff but concealed from the direct view or zoned away from the rest of the major areas of the PCF for aesthetic purposes. These rooms may be clustered in a service zone or perhaps located at corridor ends.

3.14 Sputum Collection Area shall be located in an open air environment away from the main flow of patients and staff in the facility, but should be not too far away from the point where the patient can deliver the sputum sample, and shall be provided with partition on both sides for privacy and lavatory/sink for handwashing.

4. Specific Technical Requirements

4.1 FireSafety. The PCF shall conform to the Division 11 of Chapter 2 and applicable provisions of the 2019 Revised Implementing Rules and Regulations (IRR) of Republic Act (RA) 9514 or the Fire Code of the Philippines. There shall be a minimum of two (2) exits, as remote from each other for each floor of the building, which terminates directly at an open public space to the outside of the building. Exits shall be restricted to the following permissible types: Doors leading directly outside the building; stairs and smoke-proof enclosures, ramps, horizontal exits and exit passageways.

4.2 PatientMovement. The recommended minimum width for public corridor for PCF shall be at least but not limited to 1.80 meters or six (6) feet. Wider corridors shall be provided if waiting areas along the corridor will be accommodated. Width of service corridors may be reduced to 1.20 meters. Rooms shall be properly labelled and identified for ease of way finding.

4.3 Lighting. The entire facility shall be well-lighted for the comfort of patients and staffs.

4.4 Ventilation. There shall be provision of natural ventilation (if applicable) for comfortable environment of patient and staff. Nonetheless, the facility may opt for artificial ventilation if natural ventilation is not possible. Areas requiring a controlled environment, such as the laboratory, diagnostic radiological facility and areas handling temperature sensitive supplies and equipment, shall be artificially ventilated to attain specific Heating, Ventilation and Air Conditioning (HVAC) requirements.

In compliance with the Building Code requirements, floor to ceiling height of all rooms of the PCF shall be at least but not limited to 2.40 meters for artificially ventilated rooms and 2.70 meters for naturally ventilated rooms. However, for radiographic and other rooms containing tall and ceiling-mounted equipment, the ceiling shall be of sufficient height in order to accommodate the equipment and/or fixtures.

4.5 WaterSupply. A water supply from an approved public water supply system whenever available shall be provided. However, other sources may be tapped provided that the water supply has under gone thorough treatment to make it safe for human consumption. Water tank shall also be installed if it necessary just to ensure that the water supply required for the efficient function of the facility is maintained.

4.6 Flooring. Floor finishes to be used for various rooms and areas of the PCF shall be readily cleanable and appropriately wear-resistant. Floors subject to traffic while wet (i.e., entrance porch and toilet facilities) shall have a non-slip surface.

4.7 Walls and Partitions. All walls of the primary care facility in general shall be structurally sound, safe, and sturdy with minimum fire resistant rating as prescribed by the Fire Code of the Philippines for this type of occupancy. Wall finishes shall be washable and in the proximity of plumbing fixtures shall be smooth and moisture resistant.

The outlying walls housing the examination rooms, minor surgical room, diagnostic radiological facility (with special enclosures as specified by the FDA-CDRRHR), Clinical Working Area of the Clinical Laboratory, Birthing Facility and toilet facilities shall be constructed from floor to ceiling to ensure a safe and secured environment with audio and visual privacy for patients undergoing procedures.

The interior walls enclosing the clinical services areas shall concave at the base of the wall towards the floor to create a seamless finish to prevent the accumulation of dirt and dust.

Cubicle curtains and draperies if used for the PCF shall be non-combustible or flame-retardant.

4.8 Doors. The minimum clear opening for the main door for the PCF shall be at least but not limited to 0.90 meters to easily accommodate patients regardless of the type of movement. Installing vision panels to control doors and doors leading to clinical and ancillary services rooms is recommended, if applicable.

The recommended door width of rooms of the PCF that will accommodate patients for consultation, examination, and treatment purposes shall be at least but not limited to 860 millimeters for convenient access of both users and equipment.

Windows. The minor surgical room and birthing room (if birthing facility is on-site) may have windows for natural light and cross ventilation of natural air especially during routine decontamination or cleaning, provided that such windows shall be at least 1.60 meters from the finished floor up to the window sill to ensure privacy.

5. References

A. Relevant Laws and Standards

a) Batas Pambansa Blg. 344. An Act to Enhance the Mobility of Disabled Persons.

b) Presidential Decree (PD) 1096. The National Building Code with its revised Implementing Rules and Regulations.

c) 2019 Revised Implementing Rules and Regulations of RA 9514 Fire Code of the Philippines.

d) 1999 National Plumbing Code of the Philippines of the RA 1378 or the Plumbing Law.

B. DOH Issuances and Manuals

a) A.O. 2016-0042 — Guidelines in the Application for Department of Health Permit to Construct (PTC). Department of Health. Manila. 2016.

b) Manual on Healthcare Waste Management. 4th Edition. Department of Health. 2020.

C. Books and Publication

a) Guidelines for Design and Construction of Hospital and Health Care Facilities. American Institute of Architects. 2001.

b) De Chiara, Joseph. (2001). Time-Saver Standards for Building Types (4th edition). McGraw-Hill Book Company.

c) Fajardo (2002). Planning and Designers Handbook, Second Edition. Quezon City. 5138 Merchandising.

ANNEX C2

Checklist for Review of Floor Plans Primary Care Facility (PCF)