AO 2020-0047: Licensure of Primary Care Facilities in the Philippines

a é. Republic ofthe Philippines Department of Health | OFFICE OF THE SECRETARY ADMINISTRATIVE ORDER SEP 362020 No. 2020 — 0047 SUBJECT: Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines I. RATIONALE/BACKGROUND Section 27.b of the Universal Health Care (UHC) Act or Republic Act (RA) No. 11223 states that, “The DOHshall institute a licensing and regulatory system for stand-alone health facilities, including those providing ambulatory and primary care services, and other modes ofhealth service provision.” The Department of Health (DOH), through the Health Facilities and Services Regulatory Bureau (HFSRB) and Center for Health Development Regulation Licensing and Enforcement Divisions (CHD-RLEDs), already regulates stand-alone health facilities providing ambulatory services such as birthing homes, infirmaries, medical facilities for overseas workers and seafarers, ambulatory surgical clinics, and hemodialysisclinics. Aslisted in the 2020 National Health Facility Registry, there are 2,592 rural health units (RHUs) classified as primary care facilities (PCFs) and are currently not being regulated by DOH. These PCFs shall deliver initial-contact, accessible, continuous, comprehensive and coordinated care to the communities they serve, as envisioned in the _ UHC Act. Thus, to fulfill the UHC goals in ensuring that only safe and quality primary care services are being delivered to every Filipino, PCFs will now be regulated and henceforth must comply with the licensing standards and requirements in this Order. I. OBJECTIVE This Order aims to set the guidelines and the minimum standards and requirements for licensing primary care facilities. Hit. SCOPE This Order shall apply to all government andprivate primary care facilities, and not to the outpatient departments ofhospitals and infirmaries that deliver primary care services. ian rs _ CIV. "DEFINITION OF TERMS

• AL Applicant — the natural or juridical person who is applying for a License to PH. PET PPP Lae Hd? ers 4 BS og Be Rca 2 fi FURIEGSU WAY | ad f
  -~perate or Certificate of Accreditation of a hospital or any other health facility. cyHh 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1 1113¢ 4Bey ee Line: 7 1-9502; 711-9503 Fax: 743-1829 e URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph #18 2UAN a4

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B. Assessment Tool — the checklist which prescribes the minimum standards and requirements for licensure or accreditation of health facilities. C. Department of Health-License to Operate (DOH-LTO) — a formal authority issued by DOHto an individual, agency, partnership or corporation to operate a hospital or other health facility. D. 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 prior to the actual construction ofthe said facility. A DOH-PTCis also required for hospitals and other health facilities with substantial alteration, expansion, renovation, increase in the numberof beds, transfer of site, or for additional services (add- ons) beyondtheir service capability. It is a prerequisite for License to Operate. E. Health Facilities — refers to facilities or institutions, whether stationary or mobile, land based or otherwise, that provides any of the following services: diagnostics, therapeutic, rehabilitative, and other health care services except medical radiationfacilities and hospital-based or stand-alone pharmacies. F. Individual-based health services ~ refer to services which can be accessed within a health facility or remotely that can be definitively traced back to one (1) recipient, has limited effect at a population level and does not alter the underlying cause of illness such as ambulatory and inpatient care, medicines, laboratory tests and procedures, among others (RA 11223). _ G. Initial Applications — refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, and i increase in bed and major alterations or renovations. H. 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 OSSshall 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. | .

I. Population-based health services — refer to interventions such as health promotion, disease surveillance, and vector control which have population groups as recipients (RA 11223). J. Primary Care — refers to initial-contact, accessible, continuous, comprehensive | and coordinated care that is accessible at the time of need including a range of -77~~ “"-_ services for all presenting conditions, and the ability to coordinateee “ so ~ sree . | CERTIFIED TRUECOPY; t 1 a fs , : yf . .

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other health care providers in the health care delivery system, when necessary. (RA 11223) K. Primary Care Facility (PCF) — refers to the institution that primarily delivers primary care services which shall be licensed or registered by the DOH (RA 11223 IRR). | L. Primary Care Provider Network (PCPN) — refers to a coordinated group of public, private, or mixed primary care providers, which serve as the foundation of a Health Care Provider Network (HCPN). M. Primary Care Worker —refers to health care worker, who may be a health . professional or community health worker/volunteer, certified by DOH to provide primary care services (RA 11223 IRR). GENERAL GUIDELINES A. All Primary Care Facilities (PCFs) shall secure a DOH-LTO and must be compliantat all times with the licensing standards and requirements set forth by HFSRB and FDA. B. PCFs under the same management, but operating in separate premises, shall secure separate DOH-LTOs. C. A PCFcaneither be government-owned or privately-owned. It can be a rural health unit, urban health center, private medical clinic, among others. D. All government PCFs shall provide both individual-based and population-based primary care services. E. All private PCFs shall provide individual-based primary care services, based on the guidelines set forth by DOH and PhilHealth. F, All PCFs shall follow the guidelines for individual and population based services set by DOH and Philhealth. G. PCEFsshall provide medical consultations and minor surgical services within their premises and shall not be allowed to outsource these services. H. Ancillary services of a PCFshall include the following: ~ 1. Clinical laboratory 2. Diagnostic radiologic services 3. Pharmacy | 4. Birthing services

§. Dental services 6. Ambulance service (Type 1) I. Ancillary services shall comply with licensing standards set by DOH and/or — FDA, as applicable. ee _ J. f-. If the ancillary services are owned by the PCF and located within its premises / “such as, Clinical laboratory, pharmacy, birthing services, diagnosticwp3 |

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services, dental services, and ambulance service, the guidelines for the OSS implementation based on AO No. 2018-0016,titled “Revised Guidelines in the Implementation of the One-Stop Shop Licensing System” shall be strictly followed at the Center for Health Development — Regulatory Licensing and Enforcement Divisions (CHD-RLEDs). K. — If ancillary services are outsourced and located either within or outside the premises of the PCF, a valid Memorandum of Agreement (MOA) with DOH- or FDA-licensed facilities, as applicable, shall be required. L. ‘If the PCF and the ancillary services (located outside the premises of the PCF), have the same owner,a valid MOAc orits equivalent shall still be required. M. Barangay Health Stations (BHS) shall be under the supervision of their respective rural health units/urban health centers and shall not secure their own DOH-LTO. N.— All applications, whether for initial or renewal, shall be processed manually or through the Online Licensing and Regulatory System (OLRS), «once the system iS fully functional. O. PCFs shall strictly follow the standards, criteria and requirements prescribed in the AssessmentTool for Licensing of Primary Care Facilities (ANNEX B). VI. SPECIFIC GUIDELINES A. Licensing Standards PCFsshall 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 owners of PCFs priorto inspection or monitoring visits by the CHD-RLEDs. C. Asingle DOH-LTOshallbeissued to the PCF, and shall include:

1. Category of health facility;
2. Ownership; and
3. Validity period D. Every PCF maybe monitored by CHD-RLEDs. E. PCF shall have a contingency plan in case of suspension or revocation of the DOH or FDA LTO ofany ofits ancillary services, whether located within or

• outside its premises. ~77-" F.° .. PCFs shall have a Manual of Operations, which shall include, but not limited to, ce cence eae eee ge pn arenes men enemas meta ome | -a -. the standard operating procedures being implementedin the facility, the H ~~ a a“
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guidelines and Manualof Procedures for primary care services, once available; and copies of relevant laws and DOH issuances. G. PCFs shall use only FDA registered drugs and/or devices. VII. PROCEDURAL GUIDELINES A. Application for DOH-PTC 1. A DOH-PTCshall be required for construction of new PCFs and for renovation or expansionof existing PCFs. 2. A completely filled out application form for DOH-PTC, whether manual or online, shall be submitted to the respective CHD-RLED. 3. The procedural guidelines for the processing of DOH-PTC shall be in- accordance with Administrative Order (AO) No. 2016-0042, also known as, “Guidelines in the Application for Department of Health Permit to Construct (DOH-PTC).” — B. Application For DOH-LTO

A completely filled out application form for DOH-LTO, whether manual or online, shall be submitted to the respective CHD-RLED. 2. All applications, whether for initial or renewal, shall be processed manually or through the OLRS, once the system is fully functional. 3. The licensing process, both forinitial and renewal of DOH-LTO, shall be in accordance ‘with AO No. -2018-0016, also known as, “Revised Guidelines ' iin the Implementation of the One-Stop Shop Licensing System.” — | 4, For ancillary services owned and located within the premises of the PCF, the following documents shall be transmitted to CHD-RLED by the following releasing offices either manually or through the OLRS, once the system is fully functional: __. Releasing Office | Document Food and Drug

Administration
Certificate
of
Compliance
for
Center
for
Device
Regulation
diagnostic radiology

Radiation Health Research (FDA- | | CDRRHR)/ FDA Regional Field Office (FDA-RFO) | FDA Regional Field Office Recommendation Letter/ mo Certificate of Compliance for pharmacy sy AA 5 4

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C. Validity of DOH-LTO The DOH-LTO of PCFshall be valid for three (3) years. Renewal of DOH- LTO shall follow the annual cut-off dates as prescribed in AO No. 2019- 0004, titled “Guidelines on the Annual Cut-off Dates for Receipt of Complete Applications for Regulatory Authorizations Issued by the Department of Health.” D. Fees 1. The DOH-LTOfee shall follow the schedule of fees prescribed by DOH. 2. The applicant, upon filing the application, shall pay the corresponding fee to the CHD Cashier. VU. VIGLATIONS AND SANCTIONS A. — Any violations relative to the existing laws, rules and regulations of PCF and its ancillary services shall be subjected to the corresponding sanctions stated in their respective existing laws, rules and regulations, and this Order. The sanctions shall be borne by the PCF, regardless of location and ownership. B. The following shall be considered as a violation of PCF: 1. Noncompliance to any of the licensing standards indicated in the Assessment Tool for Licensing of Primary Care Facilities (ANNEX B) beyond the compliance period provided by CHD-RLED. 2. Noncompliance of an ancillary service, regardless of location and ownership, beyond the compliance period provided by CHD-RLED or FDA. However, if the PCF has more than one (1) outsourced clinical laboratory, diagnostic radiologic services, pharmacy, birthing services, _ dental services, and ambulance service (Type 1), with a valid MOA,the PCF will not be sanctioned if at least one ancillary facility of the appropriate category is fully compliant with existing rules and regulations. _ | 7 , C. The following sanctions shall be imposed on PCFs found with violations: 1. For violation to any of the licensing standards indicated in the Assessment Tool for Licensing of Primary Care Facilities (ANNEX B) beyond the compliance period provided by CHD-RLED: : Numberof Incidence Sanction First Offense Written Warning _ Second Offense _ Thirty thousand pesos a oe a ‘(Php 30,000) Third Offense | Fifty thousand pesos (Php50,000) Fourth Offense . : _ Suspension ofthirty days cee Te eo , OT _. (30 days) or revocation of LTO aise cpenere eens — me , pen | a a 6 ' bot a [RED Sen, Dyers fect Bo sore prey restive, Bop eee oo. ~ Te. . : bof eR bh Bop AG foe % GAe bg Fi PEPE F . : s 3 pope fo he The hoa PUR Ve phen i 7 HE Ye . . : . PRG GAP Pa ER Got TAD OR ak fier ¥ PObee bX 0 tle tee bogNes ee NEB bi i . : . : . i

. . : i iy AM . oe . : : get . 3 nf : . , 4 ; F f . . . . . fi FAS . . | i

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For noncompliance of an ancillary service, regardless of location and ownership, beyond the compliance period provided by CHD-RLEDor FDA: Numberof Incidence . Sanction First Offense , Written Warning Second Offense Twenty thousand pesos (Php 20,000) Third Offense Additional twenty percent (20%) 7 : of the previousfine Fourth Offense and onwards Suspension ofthirty days (30 days) or revocation of LTO D. The PCFs or the ancillary service/s shall be cleared of its violation after complying with the necessary corrective actions and the prescribed sanction. IX. APPEAL Any PCF aggrieved by the decision of the Director IV of CHD, orin his/her absence or unavailability or when delegated, the Director II] of CHD, may, within ten (10) days after receipt of the notice of decision file a notice of appeal to the Secretary of Health, whose decision shall be absolute and executory. All pertinent documents and records of the applicant shall then be elevated bythe CHD. 4 X. TRANSITORY oROVISIONS A. The requirement for DOH-PTCshall be waived for existing and operating PCFs prior to the effectivity of this Order. In lieu ofthis requirement, an as-built plan shall be submitted to theCHD-RLED. B. The application fee for DOH-LTO and DOH-PTC for PCF shall be waived until a new schedule offees 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 oftheir 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-LTOshall be given a grace period until October 1, 2023, to attain full compliance with the licensing standards set forth by this Order. XI. REPEALING CLAUSE _ . Provisions from previous issuances that are inconsistent or contrary to th provisions of this Order are hereby rescinded and modified accordingly. SP UE? dE oo fs , So .

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XII. SEPARABILITY CLAUSE In the events 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. XI. EFFECTIVITY This order shali take effect fifteen (15) days after publication in the Official Gazette or in a newspaper of general circulation. Copies of this Order shall be filed with the U.P. Law Center pursuant .to Book VU, Chapter 2, Sec. 3 of E.O, 292. Secrétary of Health (oR, EPRey eype spe 33 tee Tey mop fe pa P Ob ue ‘ oe : i gm iw fet ano, Teh pe Be Vi Lebb tb ea

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II. Ill. A.O. No. 2020- 0047 ANNEX A Republic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU LICENSING STANDARDS FOR PRIMARYCARE FACILITIES PERSONNEL There shall be an adequate numberof qualified, trained and competentstaffto ensure efficient and effective delivery of quality primary care services. A. Every PCFshall have a duly licensed physician, as head ofthe facility, to oversee the clinical and administrative operations of the health facility. B. For rural health units and urban health centers, the head ofthe 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 andcertification prescribed by DOHas a primary care worker. E. There shall be staff development and continuing education program atall levels of organization to upgrade the knowledge, attitude and skills ofstaff. 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 ofits activities depending onits workload and the services being provided, as stated in the Checklist for Review of Floor Plans for Primary Care Facility (ANNEX C). C. Have an approved DOH- Permit to Construct (DOH-PTC)in accordance with the planning and design guidelines prepared by DOH (ANNEX C). EQUIPMENT AND INSTRUMENTS Every PCFshall 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 servicesit 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 matron,{J Pagel of4

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IV. SERVICE DELIVERY Every PCFshall ensure that the services being delivered to patients comply with the standards in the Assessment Tool for Licensing of PCF (ANNEXB)andotherrelated 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. Ambulanceservice (Type 1) E. Ancillary services may be outsourced and located outside the premises ofPCF, 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: Complete blood count with platelet count Urinalysis Fecalysis Fecal occult bloodtest Lipid profile (total cholesterol, HDL, LDL,triglycerides) Fasting blood sugar Oral glucose tolerancetest Pap smear 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 ofits 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/orits participation in the primary care provider network. K. PCFsthat provide primary care services through digital technologies for health and mobile health services, shall adhere to the existing orae CO RPNAYMAS WN Page 2 of 4

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telemedicine guidelines issued by DOH Knowledge Management and Information Technology Service (KMITS). V. QUALITY IMPROVEMENT(QI) ACTIVITIES Every PCFshall establish and maintain a system for continuous quality improvement activities. A. Each PCFshall 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 ofpatient’s results, in adherence to Republic Act (RA) No. 10173 also known as the “Data Privacy Act of 2012” and RA No. 11332 also knownas 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 Resourcesfor 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 recordsof: Minutes of the Meeting Attendance logbook 201 Personnel Staff files Reports of DOH inspection and monitoring activities Preventive and corrective maintenance of equipment . 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 such7 ANP WN ] Page 3 of 4

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Vil. ENVIRONMENTAL MANAGEMENT PCFshall ensure that the environmentis safe for its patients and staff, including the general public. A. B. OO There shall be a program of proper maintenance and monitoring of physical facilities. 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. There shall be a “No smokingpolicy”and that the sameshall be strictly enforced. There shall be a contingency plan in case of accidents and emergencies. Page 4 of 4 |

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A.O. No. 2020 - 0047 ANNEX B Republic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU ASSESSMENT TOOL FOR LICENSING A PRIMARY CARE FACILITY INSTRUCTIONS: I. 2. vee To properly fill-out this tool, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF DOCUMENTS, OBSERVATIONSand VALIDATION offindings. If the corresponding items are present, available or adequate, place (/) on each of the appropriate spaces under the FINDINGS column orspace provided alongside each corresponding item. If not, put an (X) instead. The REMARKS column shall document relevant observations. | Makesureto fill-in the blanks with the needed information. Do not leave any items blank. The Team Leader shall ensure that all team members write down their printed names, designation and affix their signatures and indicate the date of inspection/monitoring, all at the last page ofthe tool. The Team Leader shall makesure that the Head ofthe facility or, when not available, the next most senior or responsible officer likewise affix his/her signature on the same aforementioned pages, to signify that the inspection/monitoring results were discussed during the exit conference and a duplicate copy also received. GENERAL INFORMATION: Name of Primary Care Facility: Address: (Number andStreet) (Barangay/District) (Municipality/City) (Province/Region) Telephone/Fax No. E-mail Address: Initial: Renewal: Existing License No: Date Issued: Expiry Date: Name of Owner or Governing Body (if corporation): Nameof Head of Primary Care Facility: Classification: Ownership: ___ Government __ Private DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 1 of 17

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ath de PART I. SERVICE CAPABILITY, PERSONNEL AND PHYSICAL PLANT L PATIENT RIGHTS AND ORGANIZATION ETHICS —ee ae . | 2 Standard: Organizational Policies and procedures| which respectand‘support patients’ rights to | ~ qualitycareand their responsibilities inthat care. 1. Informed consent is obtained from patients prior to Document Review e All patient charts have signed consent for procedures procedures. (example: minor surgery, immunization). 2. Policies which| Observe identify and e Posted patients’ rights in address patients’ conspicuous places. rights and responsibilities are documented. TL. PATIENT CARE | 5 PosStandard: ‘The organization informsthecommunityaboutthesservices.sitit providesand the hours _ of their availability._ 3. Clinical services are appropriate to patients' needs and the former's availability is consistent with the organization's service capability and role in the Observe : e List of services and schedule of operation posted in a conspicuous area. e DOHLTO(updated, valid and original) posted in a conspicuous area. community. 4. Population-based Document Review Primary Care|

Written policies and procedures Services based on DOH8 issued (Government PCFs guidelines: only) e Health promotion Epidemiologic surveillance Health protection (vector control, environmental health, occupational safety, and food safety measures) e Emergency preparedness and response 5. Individual-based Primary Care Services Document Review

Written policies and procedures based on DOH guidelines and Manualof Procedures: Maternal and Newborn Care Family Planning Services Nutrition Services Dental Services (may be outsourced and/or located Ly fi) DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 2 of 17

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outside PCF through a valid MOA. Outsourced dental services shall comply with the licensing standardsin this Assessment Tool) Referral services* to: o Community-based Rehabilitation Services (example: physical therapy, occupational therapy, speech therapy) o Developmental and mental health evaluation o Substance abuse services *May be provided by PCF 6. Minor Surgeries Document Review Written policies and procedures in conducting minor surgical procedures: Suturing of superficial lacerations Services (Government PCFs only) e Circumcision e Incision and Drainage e Debridement e Excision of small cysts 7. Administrative Document Review Written policies and procedures on: Issuance of certificates (medical certification, death certification, and medico- legal certification) Sanitation inspection and issuance of sanitary permit 8. Supervisory Services Document Review Written policies and procedures on: Patient navigation in its primary care__ provider network Supervision of barangay health stations (Government PCFsonly) Supervision of health workers (Government PCFs only) Standard: Theorganization uniquely identifies all patients and creates a t specific patientr record for each patient that is readily accessible to authorized personnel. _ — ne | 9. Ail patients are correctly identified by their patient—_ records. An appropriate Document Review The contents of patient's records are the following: Doctor's order Det DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 3 of 17

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history and physical examination is performed on every patient. The history includes present_ illness, past medical, family, social and personal history. Informed if applicable e Complete history and physical examination (may use SOAP method for follow-up check- ups) e Medication and/or treatment record e Dental records (May be stored separately if dental facility is outsourced and located outside the PCF) e Laboratory and X-ray reports, if any e Record ofreferral or transfer of patient to other facility/service/doctor including notes Consent, __ Standard: Thecare planaddresses patient's relevant clinical needs. 10. Coordinated plan of care with goals. Document Review e Proofof implementation of adopted/developedprotocols, and DOHapproved CPGs, once available. TL. LEADERSHIP AND MANAGEMENT| | vs | : : Standard: The PCF’s management team 1 provides leadership,:acts

accordingto the organization’ Ss. ~ policies andhas overall responsibilityfofor the © organization’ s s Operation, and the quality of its services | ‘and its resources ~ 28 . ee eeee eeee oe Be oe 11. Organizational Structure/Chart Observe e Observeif the organizational structure/chart is posted in conspicuous area. 12.The organization and its services develop their vision and mission. Document Review e® Written vision and mission Observe e Posted vision and mission in a conspicuous area 14.Evaluation and monitoring activities to assess management and organizational performance (Required for government- owned PCFs. Recommended only for privately- owned PCFEs.) Document Review e Accomplishment reports or other annual reports, as applicable. DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 4 of 17

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-outcomes. :Iv. HUMAN RESOURCE MANAGEMENT oe Standard: Workload is monitoredandappropriate guidelinescconsulted to ensure that | _ appropriate staffnumbersandskill mix areavailable to achieve desired patient and organizational 15. The organization documents and follows policies and procedures for hiring and credentialing of its staff. Document Review | e Policies and procedures for hiring and credentialing of staff Interview e Administrative Officer or Head of PCF Standard: Thereare relevant activities related to orientation ofnew ersonnel. 16. New personnel, new graduates and external contractors- are adequately supervised by qualibed staff Document Review e Documentation of orientation conducted Standard: Thereshall bean adequate numberof qualified, trained and competent staff to ensure | “efficientandeffective delivery of quality primarycare services. es | The staff ‘composition andnumber/ratio shall depend onthe workload. and services being provided, - _ adjusted based on applicable workload assessment tools set by DOH. __ 17.Physician (Full time) Document Review e Proof of qualifications o Resume oPRCID andCertificate o Primary Care Worker Certificate o Proofof relevant trainings o Proof of Employment/Appointment 18. Nurse (Full Time) Document Review e Proofof qualifications o Resume oPRCID andCertificate o Primary Care Worker Certificate o Proofof relevant trainings o Proofof Employment/Appointment 19. Midwife (Full Time) Document Review e§=6 Proof of qualifications o Resume oPRC ID andCertificate o Primary Care Worker Certificate o Proof of relevant trainings We ( DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 5 of 17

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o Proof of Employment/Appointment 20. Dentist Document Review e= Proofof qualifications o Resume oPRC ID andCertificate o Proofof Employment/Appointment, if applicable o Valid Memorandum of Agreement (MOA),if outsourced 21. Sanitation Inspector (Government PCFs only) Document Review e §=Proof of qualifications o Resume OPRC ID andCertificate o Proofof Employment/Appointment 22. Information Technology Officer *may be allowed to handle two administrative roles at a time Document Review e= Proof of qualifications o Resume o Proof of Employment/Appointment 23. Records Officer *may be allowed to handle two administrative roles at a time Document Review e §=©Proof of qualifications o Resume oO Medical Records Management Training Certificate oICD-10 Training Certificate o Proofof Employment/Appointment 24. Administrative Officer *may be allowed to handle two administrative roles at a time Document Review e Proof of qualifications o Resume o Proofof Employment/Appointment 25. Utility Worker Document Review e Proofof qualifications o Resume o Proofof Employment/Appointment V. INFORMATION MANAGEMENT

Standard: Relevant, accurate, quantitative and qualitative ¢ data 2are collected and used iinatimely and efficient mannerfor delivery of patient care and management of services _f f£ fu DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 6 of 17

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26. Records are stored, retained and disposed of in accordance with the guidelines set by National Archives of Document Review ¢ Logbookson record storage, retention and disposal Observe e Proper storage of records the Philippines (NAP)
27. The organization| Document Review defines data sets, data e Policies and procedures on generation, collection record storage, safekeeping and aggregation and maintenance, retention methods and the and disposal. qualified staff who are involved in each stage. Standard: Clinical records arereadily accessibleto facilitate patient care, are kept confidential and safe,and comply with all relevant statutory requirements and codes of practice. ~
28. Patient records documenting any previous care can be quickly retrieved for review, updating and concurrent use. Observe e Patient records are easily retrievable within 10-15 minutes 29.The organization has policies and procedures, and devotes resources, including infrastructure, to protect records and patient charts against loss, destruction, tampering and unauthorized access or use. Only authorized individuals make entries in the patient records Document Review e Logbooks for borrowing and retrieval of records Observe e Access to records
29. Validated Electronic Medical Records Observe e EMRimplementation includes, but is not limited to, primary care benefits, maternal and neonatal deaths, injury, and confirmed cases of diagnosis
30. National Database of Human Resources for Health Document Review e Proof of submission of data to NDHRHIS He DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 7 of 17

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‘Information System ) (NDHRHIS) VILSAFE PRACTICE AND ENVIRONMENT | | Standard: The organization plansasafeaca effectiveenvironmentofcare consistent t with its _mission, services, and with laws and regulations~ 32. An incident reporting system identifies potential harms, evaluates causal and contributing factors for the necessary corrective and reventive action Document Review e Recordofincident reports 33. Presence of a managementplan, policies and procedures addressing safety Document Review e Managementplan, policies and procedures on safety e Proof of implementation of the following: e Fire drill conducted in the past 12 months e Earthquake drill conducted in the past 12 months 34. Building Maintenance Program is in place ensuring facilities are in state of good repair Document Review e Routine program of work for preventive maintenance and record of corrective maintenance are available 35. Policies and procedures for the safe and efficient use of medical equipment according to specifications are documented and implemented. Document Review e Presence of operating manuals of the medical equipment e Preventive and corrective maintenance logbook and plan for replacement 37. A coordinated security arrangement in the organization assures protection of patients and staff Document Review e Designation of person in charge ofsecurity. Interview e Ask the personnel in charge of security what the policies on security are. Observe e Security measures ee DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 8 of 17

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Standard: ‘Emergency light and/orpowersu supply,water and ventilation systemsaareprovided for, irin _keeping with relevant statutory requirements and codes of practice. _ 38. Generator, emergency light, water system, adequate ventilation or air conditioning Document Review: e Bacterial water analysis done every 6 months. e Proof of corrective measures done for failed bacterial water analysis. e Preventive and corrective maintenance logbooks of generator, emergencylight, ventilation and conditioning Observe: e Test if faucets and water closets are working e Functional emergency lights and generators 39, Non-medical equipmentare regularly maintained with plan for replacement according to expected life span or when no longer serviceable Document Review: e Records of preventive and corrective maintenance and plan for replacement 40. Operating manuals of non- medical equipment Document Review: e Operating manuals of equipment, generators,air conditioners and other non- medical equipment Standard:The handling, | collection anddisposal,

~ requirements and code of practice of waste conform with relevant statutory 41. Policies and procedures on Waste Disposal Management Document Review: e Issuances — laws, memos, guidelines on waste segregation, collection, treatment and disposal e Contracts with service providers, waste handlers or disposal contractors(if applicable) Observe: e Location of waste holding area e Segregation of waste (use of color coded garbageplastic and/or bins) fl AAT DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 9 of 17

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Properlabelling of waste receptacles Proper management of temporary storage areas prior to hauling for disposal _ Standard: An interdisciplinary irinfection, control | program¢ensures s the Prevention 2and control of _ infection inall services. oe Coa See ee 42. Infection Document Review Prevention and e IPC Manual Control (IPC) Program 43. Policies and Document Review procedures on e Policies and procedures on cleaning, cleaning, disinfecting, disinfecting, drying, drying, packaging and packaging and sterilizing of equipment, sterilizing of instruments and supplies equipment, instruments and supplies.Standard: The organization uses a a coordinated| system-wide approachtto reduce therisksof BS ‘healthcare- associated infections. 44. “Organization takes steps to prevent and control outbreaks of healthcare associated infections. Document Review Observe Validate PCF policies on infection control such as use of PPEs, isolation precautions and hand washing. Written policies and procedures in accordance with DOH issuances. Use of gloves, surgical masks, etc., as needed Sinks or lavatories or designated areas for hand washing or dispenser for sanitizers Ask a PCFstaff to demonstrate hand washing. 45. There are programs for prevention and treatment of needle stick injuries, and policies and procedures for the safe disposal of used needles are Document Review Reports of needle stick injuries Interview Askstaff their policies on needle stick injury Observe 4 AEE DOH-PCF-LTO-AT-Annex B Revision:00 3 09/30/2020 Page 10 of 17

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documented and e Use of PPEs in doing minor monitored surgeries, handling patients with infectious diseasesetc. Standard:Whenneeded, theorganization reportsinformationaboutinfections to personnel and ] publichealth agencies. ee ee ee | 46. Policies and Document Review procedures in e Copies of reports submitted reporting notifiable to PIDSR and other diseases (Refer to AO applicable DOH recording No. 2008-0009 and and notification systems. AO No. 2020-0013). | VIL. IMPROVING PERFORMANCE.

Be ho oo : as“e

• Standard: Theorganization has.a planned systematic organization- wide e approach,to process: __ design and performance measurement, assessment and improvement. : a7.Continuous Document Review Quality Improvement e CQIplan and proof of (CQIT) Program implementation Interview e Ask abouttheir activities on CQI.
• Standard:The.organization. Brovides;better. care serviceasa result. of continuousquality: “@improvement activities EUS E See : fe cos

48. Customer Document Review satisfaction survey e Domains of the survey form used. e Survey results and how complaints/comments are acted upon. VII PHYSICAL PLANT. sy
49. Entrances and Observe exits are clearly and e Posted entrance and exit prominently marked, signs. free of any e Entrances and exits are obstruction and accessible and free from any readily accessible. obstruction Note: Exit signs should be luminous or illuminated and prominently marked. There should be exit signs in major areas ofthe hospital and all doors leading to the outside. (Reference: RA 6541 Building Code ofthe Philippines)
50. Directional signs| Observe are prominently e Directional signs are posted to help locate prominently posted. service areas within the organization. Nn .Ate DOH-PCF-LTO-AT-Annex q B Revision:00 09/30/2020 Page 11 of 17

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51. Rampsfor patients with special needsare available, clearly and prominently marked and free of any obstruction. Observe @ Rampsfor patients with special needs. © Prominently marked o Free from obstruction DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 12 of 17

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PART IT. EQUIPMENT AND INSTRUMENTS nctional _ MEDICAL EQUIPMENT AND INSTRUMENTSINPCF Autoclave, 20 L BP apparatus, non-mercurial, with adult and pediatric cuffs Cervical Inspection Set/Vaginal Speculum Set Small size Medium size Large size Dressing set (minor surgical set) Surgical scissors straight Surgical scissors curved Bandage scissors Pick up (ovum) forceps Mosquito forceps Tissue forceps with teeth Tissue forceps without teeth Suture removal scissors EENT Diagnostic Set Ophthalmoscope Otoscope Emergency light Examining light Examining table Footstool Instrument table IV stand Nebulizer Neurohammer Non-mercurial thermometer Salter scale Safety/Sharps collector box Snellen’s Chart, Visual Acuity Chart Stethoscope Zet DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 13 of 17

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Weighing scale with height measuring stick, adult Weighingscale, infant Wheelchair Wheeled stretcher Vaccine carrier with cold dog Vaccine carrier thermometer Vaccine refri gerator -DENTAL EQUIPMENT AND INSTRUMENTS ~ ‘(OutsourcedHoxialseservice.locatedoutside PCF shall stillbe pe Inspectedandcomplywiththefollowing licensing requirements) Autoclave, 20 L Dental Unit and chair with compressor and complete accessories, with high and low speed hand pieces Dental prophylaxis instrument set: Universal scaler, non-magnetic hollow handle Peri Curette, non-magnetic hollow handle Periodontal probe Gracey curette, set of 6 different tips, non-magnetic hollow handle Dental instruments: mouth mirror, cotton plier, explorer, spoon excavator(1 set) Basic Dental Surgery Set Extraction forcep, #16 with cross serration (for better grip) Ergonomic for better comfort designed instrument Extraction forcep, #17 Extraction forcep, #18L Extraction forcep, #18R Extraction forcep, #44 Extraction forcep, #69 Extraction forcep, #150 Extraction forcep, #151 Pedoforcep, #150 Pedoforcep, #151 Pedo forcep, #17S Pedo forcep, #16S Pedo forcep, #18R Pedo forcep, #18L Aspirating syringe (2), stainless steel, with locking mechanism LA Aa DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 14 of 17

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q¢ Minnesota retractor, stainless steel Bonefile, stainless steel Dental instrument cabinet Instrument table Sterilizing unit, table top Sharp waste e disposal unit “NON-MEDICAL EQUIPMENT AND INSTRUMENTS ——™” Computer/laptop with internet connection (mobile data, Ethernet) Printer Mobile phone/cellphone Fire extinguisher Standby generatorset DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 15 of 17

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Republic of the Philippines Departmentof Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Nameof Primary Care Facility: Date of Inspection: RECOMMENDATIONS: A. For Licensing Process [ ] For Issuance of License To Operate as PRIMARY CARE FACILITY Validity from to [ Issuance depends upon compliance to the recommendations given and submission ofthe following within days from the date of inspection [ Non-issuance. Specify reason/s: Inspected by: Printed name Signature Position/Designation Received by: Signature: Printed Name: Position/Designation: Date: DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Rage 16 of 17

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Republic of the Philippines Departmentof Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Name of Primary Care Facility: Date of Monitoring: RECOMMENDATIONS: B. For Monitoring Process [ ] Issuance ofNotice of Violation [ | Non-issuance ofNotice of Violation [ Others. Specify: Monitored by: Printed name Signature. Position/Designation Received by: Signature: Printed Name: Position/Designation: Date: DOH-PCF-LTO-AT-Annex B Revision:00 09/30/2020 Page 17 of 17

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Republic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU ANNEX —- C1 A.O. 2020- 0047 PLANNING AND DESIGN GUIDELINES FOR PRIMARY CAREFACILITY 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 processof 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 meansof 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 andrepairofits facilities.
2. Space Requirements 2.1 The PCFshall 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. / DOH-PDG-PTC-PCF Revision:00 09/30/2020 Page 1 of 7

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2.2 PCF shall provide have the following zones,if applicable: 2.2.1 2.2.2 2.2.3 2.2.4 General Administrative Services and Public Areas: Clinical Services Area: Ancillary Services Area; Support Services Area. 2.3 The General Administrative and Public Areas shall be comprised of the following spaces: 2.3.1. 2.3.2. 2.3.3. Main Lobby, provided with: 2.3.1.1 2.3.1.2 2.3.1.3 2.3.1.4 A Reception and information counter or desk. 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, andalike. 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. Conveniently accessible wheelchair storage. 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 2.3.2.2 A separate toilet for the staff, Provision of one (1) toilet for every fifteen (15) personnel shall be applied. Other spaces for staff such as conference room, staff pantry and the like, are optional. Sufficient Storage for Records and Supplies. 2.4 The Clinical Services Area shall be composedof the following spaces: 2.4.1 Physician Office(s)/ Consultation Room(s); Lp / i DOH-PDG-PTC-PCF i Revision:00 : 09/30/2020 : Page 2 of 7

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2.4.2 2.4.3 Medical Examination Room, which shall have a minimum floor area of 7.43 square meters per examination table / bed, exclusive of ante-room andtoilet (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. 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 counteror shelf for writing shall be provided. A space for handwashing shall be provided. 2.5 The Ancillary Services Area(s) shall be composedof the following spaces: 2.5.1 2.9.2 2.5.3 2.5.4 2.5.5 Clinical Laboratory, which shall be composed ofthe following: 2.5.1.1 Extraction Area, separate from the Clinical work area; 2.5.1.2 Clinical Work Area with Sink (minimum of 20.00 square metersin floor area); 2.9.1.3 A Pathologist Area ( may be a separate room or be a part of the Clinical Work Area); 2.5.1.4 Access to Toilet and waiting area. Diagnostic Radiology Facility. The Medical X-ray Facility (Chest X-ray for Heart and Lungs) shall meet the requirements set by the FDA-CDRRHR, and shall comprise of the following spaces: 2.5.2.1 X-ray room (with a minimum width of 2.50 m. and minimum length of 3.00 m as required by the DOH-CDRRHR), and a control booth and dressing area; | 2.5.2.2 Darkroom (with a minimum dimension of 2.00 m by 1.50 m as , required by the DOH-CDRRHR); 2.5.2.3 Film Reading Room andFilm file Storage; 2.5.2.4 Accessto Toilet and waiting area; 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 of the Guidelines in the Application for the DOH- Permit-to-Construct (PTC)). Pharmacy, with a minimum floor area offifteen (15) square meters, provided with work counter andsink. Dental Clinic. Provide at least 8.63 square meters per dental chair that includes space for one (1) dental chair, space for movement of person, and space for passage of equipment. yMf ( DOH-PDG-PTC-PCF Revision:00 09/30/2020 Page 3 of 7

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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. . Functional Requirements 3.1 3.2 3.3 3.4 3.5 3.6 3.7 The different areas of the PCF shall be functionally related to each other. 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. There shall be a rampforclinical and ancillary services located on the upperfloor(if any). The Reception and information counter or desk shall be located in such a manner thatit 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. The waiting area shall be planned in such a waythatit is easily accessible from the main entry and located adjacent to the Reception and information counter or desk. Furthermore, the waiting are shall have a pleasing environment for the clients and patients and shall be adequately spaced and provided with appropriate furniture. The office, shall be located adjacent to the lobby and both shall be located nearthe main entrance of the PCF. 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. / : DOH-PDG-PTC-PCF ? Revision:00 : 09/30/2020 i: Page 4of7

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3.8 The General Administrative Service and Public Areas namely the Lobby, The Office, and Records Storage shall be planned contiguous to one anotheras 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 waythat they are accessible to both clients and staff but concealed from the direct view or zoned awayfrom the rest of the major areas of the PCFfor aesthetic purposes. These rooms maybe clustered in a service zone or perhapslocated at corridor ends. 3.14 Sputum Collection Area shall be located in an open air environment away from the main flow of patients andstaff in the facility, but should be not too far away from the point where the patient can deliver the soutum sample, and shall be provided with partitions on both side for privacy and lavatory/sink for handwashing. . Specific Technical Requirements 4.1 Fire Safety. 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 spaceto 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 Patient Movement. 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. ah q DOH-PDG-PTC-PCF Revision:00 09/30/2020 Page 5 of 7

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4.3 4.4 4.5 4.6 4.7 Lighting. The entire facility shall be well-lighted for the comfort of patients andstaffs. 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 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. Water Supply. 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 makeit 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. Flooring. Floor finishes to be used for various rooms and areas of the PCF shall be readily cleanable and appropriately wear-resistant. Floors subjectto traffic while wet (i.e. entrance porch andtoilet facilities) shall have a non-slip surface. Walls and Partitions. All walls of the Clinical Laboratory 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 Center for Device Regulation, Radiation Health and Research (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 concaveat the base of the wall towards the floor to create a seamless finish to prevent the accumulation of dirt and dust. /4f ) ? DOH-PDG-PTC-PCF : Revision:00 i 09/30/2020 i Page 6 of 7

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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 notlimited 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 andancillary services rooms is recommended, if applicable. The recommended door width of rooms of the PCF that will accommodate patients for consultation, examination, and treatment purposesshall be at least but notlimited 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 windowsfor natural light and cross ventilation of natural air especially during routine decontamination or cleaning, provided that such windowsshall be at least 1.60 meters from the finished floor up to the windowsill 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 Codeof the Philippines. d) 1999 National Plumbing Codeof 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. 4% Edition. Departmentof 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.ad DOH-PDG-PTC-PCF Revision:00 09/30/2020 Page 7 of 7

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Republic of the Philippines Departmentof Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Annex C2 A.O. No. 2020- CHECKLIST FOR REVIEW OF FLOOR PLANS PRIMARY CARE FACILITY (PCF) Nameof Health Facility: Address: Date: Review: 1° gnd 3 1. PHYSICAL PLANT 1.1 General Administrative Services and Public areas 1.1.1 Lobby 1.1.1.1 Waiting Area / Multi-purpose Area (commensurate 1.4 m? per pax) 1.1.1.2 Reception and Information Counter / Desk 1.1.1.3 Toilet (Separate for Male and Female, PWD-accessible) 1.1.2 Office 1.1.3 Staff Toilet 1.1.4 Staff Areas / Conference Room (Optional) 1.1.5 Records Storage Area /Room 1.1.6 Supply Storage Area / Room 1.2 Clinical Services 1.2.1 Minor Surgical Room with Lavatory/Sink (min. of 12 m?in floor area) 1.2.2 Physician Office / Consultation Room/Area 1.2.3 Examination Room with Lavatory/Sink 1.3 Ancillary Services 1.3.1 Birthing Area* 1.3.1.1. Birthing Room (commensurate 10.5 m? per birthing table) 1.3.1.2. Ward (commensurate 7.43 m? per bed) 1.3.1.3. Clean-up and Sterilization Room 1.3.1.4. Scrub-up Area 1.3.1.5. Toilet 1.3.2 Clinical Laboratory* 1.3.2.1. Clinical Work Area with Lavatory/Sink (min. of 20 m?in floor area) 1.3.2.1. Pathologist Area 1.3.2.2. Extraction Area 1.3.2.3. Accessto Toilet 1.3.2.4. Reception / Waiting area 1.3.3 Radiology (Chest X-ray for Heart and Lungs) * 1.3.3.1. X-Ray Room with Control Booth and Dressing Area 1.3.3.2. Dark Room 1.3.3.3. Film Reading Room and Film File Storage 1.3.3.4. Access to Toilet 1.3.4 Pharmacy* with work counter and sink (min. of 15.00 m?in floor area) 1.3.5 Dental Clinic* with Lavatory/Sink (commensurate 8.26 m? per dental chair) 1.3.6 Parking Area for Ambulance / Patient Transport Vehicle 1.4 Support Services 1.3.7| Waste Holding Area / Room 1.3.8 Janitor’s Closet / Maintenance and housekeeping Area / room 1.3.9 Sputum Collection Area with Lavatory/Sink

• When the services are outsourced and/or located outside the premises of the PCF, these areas are not required. However, a contract of service or Memorandum of Agreement A) with a service provider should be secured as a prerequisite for License to Operate (LTO). — | PCF-PTC-CR i Revision:00 ? 09/30/2020 : Page 1 of 3 TEEPEEPEPETTEEEEPPPEEP EPP S ©

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Note: Forancillary services (regulated health facility) outsourced and/or located outside the premisesofthe PCF, please refer to their respective Checklist for Review of Floor plans in the DOH-AO 2016-0042 or the “Guidelines in the Application for DOH-Permit-to-Construct(PTC)” 2. PLANNING AND DESIGN 2.1 Floor plans properly identified and completely labelled. 2.2 Conforms to the applicable codes as part of professional service. 2.2.1 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. 2.2.2 Minimum of two (2) exits of the above types, as remote from each otherfor eachfloor of the building. 2.2.3. Exits terminate directly at an open public space to the outside of the building. 2.2.4 The plans shall conform to the provisions of Batas Pambansa (BP) 344 — — Accessibility Law. 2.2.5 Provision of Ramp for wheelchair access with a clear width of 1.2 meters and minimum slope of 1:12 (Rampis provided at the entranceif it is not at the same level with the inside, and if clinical and ancillary services are located on the upperfloor). 2.3 Meets prescribed functional programs: 2.3.1. Main entrance of the PCF directly accessible from public road. 2.3.2. Ramp or elevatorfor clinical and ancillary services located on the upperfloor (if any). 2.3.3. Provide sufficient area for the office based on the number and the workflow of the staff. 2.3.4. Main lobby and Business Office located near the main entrance of the PCF. 2.3.5. Minor operating room, Birthing Room”, Clinical Laboratory* and Radiology* shall be located and arrangedto prevent non-related traffic through the room. ll|| COMMENTS: i: PCF-PTC-CR ? Revision:00 ? 09/30/2020 : Page 2 of 3

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Republic of the Philippines Departmentof Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Nameof Health Facility: Address: Date: COMMENTS: HEALTH FACILITIES EVALUATION AND REVIEW COMMITTEE (HFERC) [ ] Approved [ ] Disapproved Chairperson, HFERC Vice-Chairperson, HEERC Member Member Member Member Member Member PCF-PTC-CR Revision:00 09/30/2020 Page 3 of 3

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ANNEX C-3a AO 2020- 7600 AOVUOLS Sdu003Y < VauV NOILOSTION WALAGS OL | ! f i | it fo ‘007 | oor 008k Oe tI | 00g6 m1 !|i SHEET NO. 1 OF 4 REVISION 0.0 09/30/2020 | PREPARED BY: HFSRB-SDD elt MARIA ROSARIO SING | - VERGEIRE, MD, MPH, CESO IV HEALTH REGULATION TEAM, DEPARTMENT OF HEA | APPROVED BY: GROSS FLOOR AREA: 72.2 m? (9.5 m x 7.6 m) x FOR AMBULANCE/ PTV

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, ANNEX C-3b ee AQ 2020- Lp500800B00 ctoOOgp ITOgeeID -3000 | : | | — Brennen emer mente ee etme mati oe teins ot emt oe ateat sam tte at Renate Ge Se emntne OE eRe Ae mens ie en ota neHt MeN =et . 7000.fp 3000. eeea en een oe cnn ate ee eee tft -ae| 3 exnttton ve | 3| 5 PeAss 8 L. a o. “DENTAL | | ite 3 egetinie. g | | ig Se ' Bao_/ / | i ia =< | } | <Teocfesoo oe CLINICAL OFFICE/ | Pp o LABORATORY / ig 3! o Bis 20.00 m? Lt = = we wo Dat nie é rl a P (| 3 TO SPUTUM : g 3| COLLECTION AREA g & Ig 4 FIRE EXIT “lf 4 || [i 9

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