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ORDINANCE NO. 2019-069

AN ORDINANCE INSTITUTIONALIZING A COMPREHENSIVE NEWBORN SCREEENING SYSTEM IN THE CITY OF NAGA AND ENHANCING THE IMPLEMENTATION OF EXPANDED NEWBORN SCREENING PROGRAM, APPROPRIATING FUNDS THEREFOR, AND FOR OTHER PURPOSES:-

Author: Hon. Jose C. Rañola, M.D.

EXPLANATORY NOTE

Republic Act 9288, otherwise known as the New Born Screening Act of 2004, provides for the implementation of a comprehensive National Policy institutionalizing the Newborn Screening program to ensure that every baby born in the Philippines is offered the opportunity to undergo Newborn Screening;

The Department of Health (DOH) Advisory Committee on Newborn Screening (ACNBS) has approved the implementation of the Expanded Newborn Screening through the DOH AO 2014-0045 on November 19, 2014 Section V 5 of said order mandates both public and private health facilities to offer and provide expanded newborn screening services together with the regular test as an option to parents;

The Newborn Screening program in the Philippines currently includes screening of six disorders namely: 1) Congenital Hypothyroidism (CH), 2) Congenital Adrenal Hyperplasia (CAH), 3) Phenylketonuria (PKU), 4) Glucose-6-Phospate Dehydrogenase Deficiency (G6PD), 5) Galactosemia (GAL), and 6) Maple Syrup Urine Disease (MSUD). The Expanded Newborn Screening (ENBS) will include more screening to disorders such as Hemoglobinopathies and additional metabolic disorders namely: 1) Organic Acid Disorders, 2) Fatty Acid Oxidation Disorders, and 3) Amino Acid Disorders;

The NBS program is an offshoot of the study “Enhancing Case Detection of Selected Inherited Disorders through Expanded Newborn Screening” at the UP Manila NIH showing the data of newborn screened through the California Newborn Screening Program (CNSP) from 2005 to 2009. It revealed that serious disorders which are not included in the existing program of the country;

NOW, THEREFORE, based on the premises considered,

BE IT ORDAINED, by the Sangguniang Panlungsod of Naga in session assembled that:

SECTION 1. Title. This ordinance shall be known as “An Ordinance Institutionalizing a Comprehensive Newborn Screening System in the City of Naga and enhancing the implementation of the Expanded Newborn Screening Program, Appropriating Funds Therefor, and for other Purposes”.

SECTION 2. Declaration of Policy. It is hereby declared as the policy of the City Government of Naga to adopt adequate measures to promote the Newborn Screening System within its jurisdiction and to ensure the right of the newborn baby to have an opportunity to undergo newborn screening and thus be spared from the heritable conditions that can lead to mental retardation and death if undetected and untreated.

SECTION 3. Objectives. This ordinance is enacted with the following objectives:

1. To ensure the people with proper information on the nature and benefits of Newborn Screening in the life of every newborn baby;

2. To ensure that parents recognize the rights of every children to survival and full and healthy development as individual;

3. To protect every newborn baby from certain heritable conditions that can result in mental retardation and death if left undetected and untreated through Newborn Screening.

SECTION 4. Definition of Terms. For the purpose of this Ordinance, the following terms shall mean:

1. Comprehensive Newborn Screening is a newborn screening system that includes, but is not limited to education of relevant stakeholders; collection and biochemical screening of blood samples taken from newborn; tracking and confirmatory testing to ensure the accuracy of the screening results, drugs and medical/surgical management and dietary supplementation to address the heritable condition; and evaluation activities to assess long term outcome, patient compliance and quality assurance.

2. Recall means a procedure for locating a newborn with a heritable condition for purposes of providing the newborn with appropriate laboratory to confirm the diagnosis and, as appropriate, provide treatment.

3. Treatment means provision of prompt, appropriate and adequate medicines, medical, surgical management or dietary prescription to a newborn for the purposes of treating or mitigating the adverse health consequences of the heritable condition.

4. Follow-up means the monitoring of a newborn with a heritable condition for the purpose of ensuring that newborn patient complies fully with the medicines and dietary prescriptions.

5. Health institutions refers to hospitals, infirmaries, health centers, lying-in centers or puericulture center with obstetrical and pediatric services whether public or private.

6. Health practitioners refers to physicians, nurse, midwives, nursing aides, medical technologist and traditional birth attendants.

7. Heritable conditions means any condition that result in mental retardation, physical deformity or death if left undetected and untreated and which is usually inherited from the genes of either both biological parents of the newborn.

8. UP Manila NIH refers to the University of the Philippines Manila National Institute of Health.

9. Newborn means a child from the time of complete delivery to 30 days old.

10. Newborn Screening is the process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing for the determining if the newborn has heritable conditions.

11. Expanded Newborn Screening means expanded screening which will include 22 more disorders from the six disorders, such as Hemoglobinopathies and additional metabolic disorders.

12. Newborn Screening Center refers to a facility equipped with a newborn screening laboratory that complies with the standards established by the NIH and provides all required laboratory test and recall/follow up programs for newborn with heritable conditions.

13. Newborn Screening Reference Center refers to the central facility at the NIH that defines testing and follow up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training in all aspects of the program, oversees content of educational materials, and acts as secretariat of the Advisory Committee on Newborn Screening.

14. Parent Education refers to various means of providing parents/legal guardians information about newborn screening.

SECTION 5. Scope. This ordinance shall cover all hospitals, infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services within the jurisdiction of the City of Naga except to private hospitals, health infirmaries, health centers, lying-in centers, puericulture centers which is directly monitored by the Department of Health.

SECTION 6. Performance of Newborn Screening. Newborn Screening shall be performed immediately after 24 hours from birth but not later than 3 days after delivery. A newborn placed in an intensive care in order to ensure survival may be exempted from the 3 days requirement but must be tested within 7 days of age.

It shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that Newborn Screening is performed.

SECTION 7. Quality Samples. Health institutions must maintain an acceptable number of unfit and unsatisfactory samples (less than 0.05% of the total samples) to maximize the use of available resources and prevent the prolonging of screening time, thereby, putting the newborn at risk from the effects of the NBS disorders if present.

SECTION 8. Refusal to be Tested. A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions. A copy of this refusal shall be made part of newborn’s medical record and refusal shall be indicated in the National Screening Database.

SECTION 9. Program Management. The City Health Office shall integrate the Newborn Screening Program as part of the regular services being delivered. As such it will continue to identify funding sources during the succeeding years after the approval of this ordinance.

SECTION 10. Duties and Functions of the City Health Officer. Unless otherwise provided by law, the City Health Officer shall have the following functions:

1. To implement, monitor, supervise, and evaluate the newborn screening implementation in all hospitals situated with jurisdiction of the City of Naga.

2. To establish a functional Case Management Referral System with strategically National Comprehensive Newborn Screening System Treatment Network (NCNBSS)

3. To create a program for purposes of information, education, communication, screening and recall on the Newborn Screening System; and

4. Establish rules and regulation related to the implementation of this ordinance.

SECTION 11. The City Mayor. It shall be the responsibility of the City Mayor, through the City Health Officer, to monitor and evaluate the implementation of the Newborn Screening System and to perform other roles and responsibilities as may be deemed necessary for the effective implementation of this ordinance.

SECTION 12. The Sangguniang Panlungsod. The office of the Sangguniang Panlungsod shall enact local ordinances and resolutions integrating the Newborn Screening System in health delivery and shall encourage creative financial packages to make Newborn Screening accessible to the most economically-deprived populace. Unless otherwise provided by law, no collection of Newborn Screening Test fees shall be collected more than the maximum standard imposed by the Department of Health.

SECTION 13. Birth Deliveries. All birth deliveries within the jurisdiction of the City of Naga shall be required to perform a newborn screening test on every newborn baby without prejudice to the provision of Section 7, Chapter 1 of this Ordinance.

SECTION 14. Recall. Birthing facilities situated within the city shall establish a recall system for purposes of locating a newborn with a possible heritable condition to provide the newborn with appropriate laboratory testing to confirm the diagnosis and, as appropriate, provide treatment. The City Recall Team shall be created through this ordinance and will be composed of:

City NBS Recall Team:

1. Office of the Mayor through the City Health Officer

2. NBS Coordinator

3. Health Worker (Midwife/Nurse) assigned to the area where the patient resides

4. City Social Welfare and Development Officer

5. Bgy. Official of the area where the patient resides

The NBS Recall Team shall have the following functions:

a) Facilitate/assist in the coordination of the recall of the screened positive newborn;

b) Provide assistance (financial/logistics) for laboratory, transportation and other expenses incurred in the confirmatory testing of the patient;

c) Referral to social institutions of indigent client;

d) Maintain close coordination with the Newborn Screening Center and DOH Regional Office for the recall of screened positive newborns;

e) Assist in the referral to specialist or if not feasible co-management with specialist via phone or electronic mail (email);

f) Help in the transport of the client to a higher-level facility (specialty hospitals/tertiary hospitals) for appropriate management. Patient should be accompanied by licensed health professional during the transport period;

g) Ensure that patient being recalled have been given information about the disorder, undergone confirmatory testing, and received appropriate management;

h) Provide report about the results of the recall including actions taken to Newborn Screening Center.

i) Assistance to newborn screening patients includes but is not limited to transportation expenses, meals, medicines, laboratory fees, and nutritional supplementation.

SECTION 15. Monitoring of Confirmed NBS Patient. Monitoring and follow-up of patients confirmed to have disorders shall be done regularly by the attending physician, appropriate subspecialist, or the City Health Office. Report forms about the status of the patients shall be accomplished by the attending physicians to be submitted to the NSCS.

SECTION 16. Newborn Screening Fee. Government health facilities such as hospitals and lying-in centers are authorized to collect fee/cost for the performance of the Newborn Screening test the amount of Five Hundred Fifty Pesos (Php550.00) for the regular 6 test and One Thousand Five Hundred Pesos (Php1,500.00) and an allowable maximum  service fee of Fifty Pesos (Php50.00) which shall not be more than the prescribed amount imposed by the Department of Health.

SECTION 17. Appropriation. The cost for the purchase of the newborn screening kits and other related expenses for the newborn screening services shall be charged against the City Health Office and the City Hospital, chargeable against the 20% City Development Fund, PhilHealth Capitation Fund, and other existing appropriation which can be aligned for this purpose.

The City Health Office shall integrate the Newborn Screening Program as part of the regular services being delivered.

As such it will continue to identify funding sources during the succeeding years after the approval of this ordinance.

SECTION 18. Sanction. Except in private hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services where the management and monitoring is under the Department of Health, refusal to provide the Newborn Screening services to the newborn babies in City Hospital, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services within the jurisdiction of this city shall be dealt administratively for comment of judge.

SECTION 19. Separability Clause. If, for any reason or reasons, any part of the provisions of this Ordinance shall be declared null and void by the court having jurisdiction, the other portions thereof shall remain legal and valid and in full effect.

SECTION 20. Effectivity. This Ordinance shall take effect upon its approval and fifteen (15) days after publication in a newspaper of general circulation.

ENACTED: September 10, 2019

WE HEREBY CERTIFY to the correctness of the foregoing ordinance.

GIL A. DE LA TORRE
Secretary to the Sangguniang Panlungsod

CECILIA B. VELUZ-DE ASIS
City Vice Mayor & Presiding Officer

APPROVED:

NELSON S. LEGACION
City Mayor