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I.    RATIONALE

The Responsible Parenthood and Reproductive Health Act of 2012 (RPRH Act) declares that the State shall guarantee “universal access” to reproductive health care services, methods, devices and supplies with “preferential access” to those identified through the National Household Targeting System for Poverty Reduction (NHTS-PR) and other government measures of identifying marginalization, who are expected to be “voluntary beneficiaries of reproductive health care, services and supplies given for free” (Sec. 2 Declaration of Policy).

According to the latest data from the Philippine Statistics Authority (PSA), there are approximately 16.18 million married women of reproductive age (MWRA, age 15-49) and 0.31 million sexually active unmarried women (SAUW) in the country. Of these women, PSA’s 2013 National Demographic and Health Survey (NDHS 2013) estimates that around 10.62 million have a continuing demand or need for Family Planning (FP). In sum, providing “universal access” to modern FP entails planning, organizing, budgeting for and serving the needs of around 10.62 million women; while ensuring “preferential access” for just the poorest two quintiles (40%) will require serving the needs of 4.25 million women.

In order to provide millions of couples and individuals the means to make their FP decisions a reality, important mechanisms in the RPRH Act must be linked together, scaled up and operationalized. Specifically, the RPRH Act:

• requires the DOH to procure, distribute and monitor the usage of FP supplies for the whole country (Sec. 10. Procurement and Distribution of Family Planning Supplies);
  
  
• requires all accredited public health facilities to provide a full range of modern FP methods (Sec. 7. Access to Family Planning);
  
  
• mandates the DOH in coordination with PhilHealth to facilitate the involvement and participation of NGOs and the private sector in RH care service delivery and in the production, distribution and delivery of quality RH and FP supplies and commodities to make them accessible and affordable to ordinary citizens (Sec. 19. Duties and Responsibilities); and
  
  
• opens up the establishment of Mobile Health Care Service (MHCS) in the form of a van or other means of transportation appropriate to the terrain, to deliver health care goods and services to LGU constituents, more particularly to the poor and needy (Sec. 13. Mobile Health Care Service).

Mechanisms should be in place to ensure that DOH supplies, PhilHealth funds, and contingency funds for emergencies flow systematically and efficiently to support and promote better access to FP services by engaging and collaborating with civil society organizations (CSOs), non-government organizations (NGOs) and private facilities providing RH service and commodities towards standardized quality care and inclusiveness at all levels of health care.

II.    OBJECTIVES

A.    General

To prescribe guidelines and procedures in the certification of Free Standing Private Family Planning Clinics.

B.    Specific

1.    To ensure access of safe and quality modem FP services for all and;
2.    To provide gender sensitive delivery of modern FP services;

III.    SCOPE

This Order shall cover the certification process of private health facilities that provide modern FP services such as contraceptive pills and injectables, natural FP methods, contraceptive implants, intrauterine device (IUD) and no-scalpel vasectomy (NSV) excluding bilateral tubal ligation (BTL) and other surgical procedures (traditional/ incisional vasectomy). Private facilities who wishes to provide BTL and other surgical procedures shall apply for a License to Operate (LTO) to Health Facility and Service Regulation Bureau. Further, this Order pertains to facilities only and does not change or restrict the scope of practice of individual healthcare providers who will still be governed by specific laws, regulations and codes of conduct and ethics of their particular profession. For example, a physician can still prescribe contraceptive pills or provide contraceptive implants or injectables within his/her office or clinic without the need to acquire a Free Standing FP Clinics certification.

IV.    DEFINITION OF TERMS

1.    Certification - refers to the process wherein the DOH RO assesses and evaluates a free standing family planning facility if it has met the standards for quality set in this Order
2.    Electronic Document - refers to information or the representation of information, data, figures, symbols or other modes of written expression, described or however represented, by which a right is established or an obligation extinguished, or by which a fact may be prove and affirmed, which is receive, recorded, transmitted, stored, processed, retrieved or produced electronically.
3.    Electronic Signature - refers to any distinctive mark, characteristic and/or sound in electronic form, representing the identity of a person and attached to or logically associated with the electronic data message or electronic document or any methodology or procedures employed or adopted by a person and executed or adopted by such person with the intention of authenticating or approving an electronic data message or electronic document.
4.    Free Standing Family Planning Clinics - refers to a health facility that provides modern FP services such as contraceptive pills and injectables, natural FP methods, contraceptive implants, intrauterinedevice(IUD) and no-scalpel vasectomy (NSV).

V.    GENERAL GUIDELINES

1.    All DOH certified Free Standing FP Clinics shall be deemed qualified for accreditation by PhilHealth for modern FP procedures allowed under this Order and compensable in primary care facilities without in-patient beds, subject to other requirements and rules of PhilHealth.
2.    All DOH certified Free Standing FP Clinics shall receive FP supplies purchased by the DOH for priority distribution to marginalized couples and individuals, to include, among others, those who are poor, vulnerable, a member of a basic sector or a Geographically Isolated and Depressed Areas (GIDA) resident. The Women’s, Men’s and Children’s Health Development Division (WMCHDD) shall issue separate guidelines on the DOH FP supplies to address, among others, request procedures, volume/allocation of products, reporting and “Not for Resale” requirements and other guidelines as stipulated in the IRR of the RPRH Law.
3.    All Free Standing FP Clinics with denied, suspended or revoked DOH certification are not qualified to receive FP supplies purchased by the DOH until DOH standards and requirements have been fully complied.
4.    Free Standing FP Clinics shall strictly adhere to the principle of informed choice and voluntarism.
5.    Free Standing FP Clinics shall ensure that its healthcare waste management collection, treatment and disposal systems are being implemented in accordance with applicable local ordinances and national regulations.
6.    Free Standing FP Clinics shall clearly indicate its functional capacity by including the words “Family Planning Clinic” in its registered or displayed name.
7.    Free Standing FP Clinics shall not charge any fee for services rendered to marginalized individual or couples who needs reproductive health services and commodities.
8.    Free Standing FP Clinics shall submit the list of PhilHealth accredited members provided FP services to the PhilHealth regional office.
9.    Free Standing FP Clinics shall comply with the standard training requirement for health service providers conducted by DOH accredited training institutions on FP.
10.    Free Standing FP Clinics shall accomplish the FP Form 1, and submit the FP inventory reports, FP monthly and summary reports to its respective local government health units (rural health units/municipal health office/city health office) regularly.
11.    In case of conflicting interpretations or unclear provisions in this Order, actions or decisions should favor greater or easier access to FP services and upholding the reproductive health and rights of women, in compliance with the RPRH Act which mandates that the law “be liberally construed to ensure the provision, delivery and access to reproductive health care services, and to promote, protect and fulfill women’s reproductive health and rights” (Sec. 27. Interpretation Clause).

VI.    SPECIFIC GUIDELINES

A.    The Free Standing Family Planning Clinics should provide the minimum set of services:

1.    Provision of fertility awareness and FP information, promotion and education with IEC materials.
2.    Conduct of Interpersonal communication and counseling (IPCC) services to allow to make a free and informed choice.
3.    Conduct of FP counseling including risk assessment and use of medical eligibility criteria table.
4.    Provision of modern FP methods: pills, injectables, condoms, contraceptive implants, IUDs, no-scalpel vasectomy (NSV), and natural family planning (i.e., modern fertility awareness methods), lactational amenorrhea method (LAM), standard days method (SDM).
5.    Establish a referral or service delivery network within the vicinity of their facilities to provide access to services they are not capable of rendering.
6.    Refer patients seeking BTL, and other surgical procedures (traditional/incisional vasectomy) to DOH licensed level 2 health facilities.
7.    Refer complicated cases of contraceptive implant and IUD removal to the DOH licensed level 2 health facility with trained physician performing such procedures.
8.    Ensure strict compliance with infection control and surveillance practices and initial management and referral of adverse events, if any.
9.    Maintain a non-medical support, proportional to the scale of the facility, such as persons in charge of medical records, logistics management, facility maintenance, sanitation and waste management, and finance and administration.
10.    Conduct risk assessment by history
11.    Manage minor side effects
12.    Conduct routine check-up/follow-up of clients
13.    Follow-up discontinuing FP clients
14.    Conduct regular recording and reporting of services to the DOH

B.    Minimum Required Staff, Instruments, Equipment, Supplies, Records and Documentation for a Free Standing FP Clinics (Annex A)

Every Free Standing FP Clinics shall be organized to provide safe, quality, effective and efficient FP services with priority to those who are poor, marginalized or in vulnerable situations. Private entities operating Free Standing FP Clinics should have at least one (1) trained health service provider on Family Planning and Competency Based Training Level 1 and 2, Progestin Subdermal Implant (PSI) insertion and removal and on NSV, if providing such services. The trained health service providers should have been observed during post training follow up and monitoring as having successfully integrated learnings of the course to their practice. Free Standing FP Clinics should strive to keep the amount of personnel and equipment and size of facilities commensurate to the number of FP clients and consultations.

C.    Certificate of Compliance for a Free Standing FP Clinics (Annex B)

VII.    PROCEDURAL GUIDELINES

A.    Documentation Process

1.    All documents defined in this Order such as application forms, proof of ownership, government registrations, reports, notifications of permits and licenses shall be secured and transmitted in the form of electronic documents with electronic signatures shall have the legal effect, validity or enforceability as any other document or legal writing as mandated by RA 8792 or the Electronic Commerce Act of 2000.
2.    All electronic documents and signatures may be subjected to verification later as to their authenticity, during certification and monitoring visits by the authorized personnel of the DOH.
3.    The use of fake documents or signatures, electronic or otherwise, may result in the suspension or revocation of the certification.

B.    Certification of Free Standing FP Clinics facilities

1.    Checklist

a)    The Checklist shall be made readily available for download using the DOH’s website and through template copies distributed to all DOH ROs FP Program. (See Annex A)
b)    The facility manager together with his/her staff shall accomplish the Checklist to get an initial measure of compliance with set standards. Missing or substandard components of the clinic such as staffing, instruments, equipment, supplies, records, documentation and physical facilities – shall be addressed and complied with by the facility manager. A completely filled-out and fully-compliant to the checklist required before moving to the next step.

2.    Application for Certification

a)    The following documents must be accomplished and submitted to the DOH RO FP Program where the facility is located before a Certification visit can be scheduled:

i.    Duly accomplished Checklist.
ii.    Duly accomplished application form. The form shall be developed and issued by the DOH - WMCHDD.
iii.    Proof of ownership of the facility as stipulated in any one of the following:
?    Private: appropriate registration with an authorized government agency such as the Securities and Exchange Commission (SEC)/ Cooperative Development Authority (CDA) or the Department of Trade and Industry (DTI), including the required organizational articles and by-laws

b)    The DOH RO shall approve or disapprove the scheduling of a Certification Visit. If disapproved, the DOH RO shall return the documents together with their findings and recommendations to the applicant. The applicant shall make the necessary revisions on the documents and shall submit the revised documents to the DOH RO for another review. The applicant shall be entitled to two revisions. Notification of approval or disapproval shall be done within ten (10) working days after receipt of a complete application packet (documents and payment) or revised application packet.
c)    Upon the DOH RO’s approval of the application, a Certification visit shall be scheduled within 30 days.

3.    Certification Visit

a)    A DOH RO Certifying Team of at least two persons from the FP program shall visit the facility during office hours on the scheduled date.
b)    The Certifying Team shall validate the information in the checklist, conduct staff interviews and examination of original documents. At the end of the one-day visit, the team shall rate the facility as 1) compliant; 2) non-compliant; or 3) for further validation.
c)    If the facility is rated “for further validation,” the Certifying Team shall return within 5 days with a third person to reexamine problem areas. The three-person Certifying Team shall then decide to rate the facility as either compliant or non-compliant. This decision shall be final and executory.
d)    The DOH Certifying Team shall submit the List of Certified Free Standing FP Clinics to the PhilHealth Regional Office and copy furnished the WMCHDD, on an annual basis. (See Annex C)
e)    A non-compliant facility may reapply for a Certification Visit after addressing its deficiencies. A waiting period of not less than 30 days and not more than 45 days shall be enforced to provide reasonable time on improvements for compliance. If a facility is rated non-compliant on three consecutive occasions, the waiting period shall be increased to not less than 60 days and not more than 90 days.

4.    Registration and Issuance

a)    Upon receipt of the summary report from the DOH RO FP program, the WMCHDD shall register the various facilities (whether compliant or non-compliant) in a central registry of all Free Standing FP Clinics facilities. Each facility shall be assigned a unique identification number to easily track their certification status.
b)    A compliant facility shall be issued a Certificate of Compliance with Free Standing FP Clinics Standards, signed by the DOH Regional Director and dry sealed for authenticity, which shall remain valid for a period of (3) three years. Before the three-year lapse, the facility shall reapply six (6) months prior to expiration of validity and follow the same procedures described above. The second and subsequent Certification shall be valid for three years

5.    Monitoring

a)    The DOH RO FP program shall from time to time conduct monitoring inspections during office hours using the Checklist based on this Order and other FP regulations such as that on informed choice and voluntarism. The DOH RO may delegate this function to Provincial, City or Municipal Health Offices through written agreements.
b)    Every Free Standing FP Clinics shall ensure that all key staff, pertinent records/documents, supplies/equipment in the facilities are made available to the DOH RO FP Program authorized representatives during monitoring visits.
c)    A Notice of Suspension or Revocation shall be issued within three (3) days for noncompliance with these rules and regulations.
d)    Each DOH RO shall submit a summary of violations on a semi-annual basis to the WMCHDD and copy furnished the PhilHealth’s Regional Office stating among others, the name of the health facility, location, its violation and the course of action taken.

VIII.     INVESTIGATION OF CHARGES AND COMPLAINTS

A.    The DOH Regional Director or his/her authorized representative(s) shall investigate the complaint and verify if the Free Standing FP Clinics concerned or any of its personnel is liable for any documented alleged violation.
B.    The DOH Regional Director or his/her authorized representative(s), after investigation, may suspend, cancel or revoke the Certification of Free Standing FP Clinics found violating any of the provisions of this Order and its related issuances, without prejudice to taking the case to judicial or other authorities such as the Commission on Human Rights as the Gender Ombud.

IX.    APPEAL

The management of a Free Standing FP Clinics aggrieved by the decision of the DOH RO may, within ten (10) days after receipt of notice of decision, file a notice of appeal to the Office of the Secretary of Health. Thereupon, the DOH RO shall promptly certify, file a copy of the decision, including all pertinent documents and transcript of hearings on which the decision is based, and forward to the Office of the Secretary for review. The decision of the Secretary of Health shall be final and executory.

X.    REPEALING CLAUSE

This Order has not been found to contradict any issuance previously filed after the conduct of policy review. Provisions from previous issuances that are inconsistent or contrary to the provisions of this Order are hereby repealed or modified accordingly.

XI.    SEPARABILITY CLAUSE

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

XII.    EFFECTIVITY

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


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