Republic ofthe Philippines beet a, Department of Health Gp atsibe it OFFICE OF THE SECRETARY ‘October 22, 2004 DEPARTMENT CIRCULAR No. __ 333 3. 2004 TO: ‘THE UNDERSECRETARIES, ASST. —_ SECRETARIES, CHD/BUREAU/ SERVICE PROJECT/PROGRAM DIRECTORS, MEDICAL CENTER CHIEFS OF SPECIAL/SPECIALTY HOSPITALS, EXECUTIVE DIRECTOR OF DANGEROUS DRUGS BOARD, PRESIDENT OF THE PHIC AND OTHERS CONCERNED SUBJECT: Rules_and Regulations Implementing Republic_Act No, 9288 Otherwise Known as the “Newborn Screening Act of 2004” ‘Attached for information and guidance, is a copy of the Rules and Regulations Implementing Republic Act No. 9288 otherwise known as the “Newbom Screening Act of 2004.” Dissemination of the information to all concemed is desired. MANUIL M. DAYRIT, MD, MS: Secretary of Health Smoking is hazardous to your healthUpper 10° oTTaEgo TewbuMT screen ane Mus De sparea wom heritable conditions that can lead to mental retardation and death if undetected and untreated. Sec. 3. Objectives - National Comprehensive Newborn Screening System shall aim to: Pagetsec. 4. Definition of Terms — For the purposes of this Act: a) Accreditation - a formal authorization issued by the DOH fo an individual, partnership, corporation or association and to the Newborn Screening Center. It must comply with the mandatory requirements as enumerated in the attached annexes and with the input, process and outcome standards as prescribed in the Manual of Operations for Newborn Screening Center. b) DILG ~refers to the Department of the Interior and Local Government ¢) DOH - refers to the Department of Health, the lead agency in implementing this Act d) Follow-up - refers to the monitoring of a newbom with a heritable condition for the purpose of ensuring that the newbom patient receives the appropriate medicine or dietary préscriptions. €) Health institutions - refer to hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private. {) Healthcare practitioner - refers to physicians, nurses, midwives,g) Health professional societies - refer to the national organizations of recognized health societies in the country. h) Heritable condition - any condition that can result in menial retardation, physical deformity or death if left undetected and untreated and which is usually inherited from the genes of either ‘or both biological parents of the newborn. IRR- refers fo the Implementing Rules and Regulations. j) LGU - refers to the Local Government Unit. k) National Comprehensive Newborn Screening System-Treatment Network - refers to the terliary hospitals equipped to diagnose and manage the confirmed cases. |) NIHP - refers to the National Institutes of Health, Philippines. m)}Newborn - a child from the time of complete delivery to thirty (30)days old. n) Newbom screening (NBS) - the process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing for determining if the newbom has a heritable condition. 0) Newborn Screening Center (NSC)- a facility equipped with a newbom screening laboratory that complies with the standards established by the NIHP, and provides all required taboratory fests and recall/follow-up programs for newborns with heritable conditions. Pp) Newbom Screening Reference Center (NSRC)- central facilly at the NIHP 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 activities in all aspects of the NBS program, oversees content of educational materials, recommends establishment of NSCs and acts as the Secretariat ‘of the Advisory Committee on Newborn Screening.e) Administration of drugs and/or medical surgical management and/or dietary supplementation fo counter adverse effects of the heritable conditions; and f)_ Monitoring and evaluation of the NCNBSS. Sec, 6. Obligation to Inform. Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall, prior to delivery, inform parents or legal guardian of the newborn of the availability, nature and benefits of NBS. Health practitioners shall follow the DOH prescribed guidelines on notification and education relative to the obligation to inform. The DOH, other Governmeni agencies, non-government agencies, professional societies and LGU shall make available appropriate information materials and shall have a system of its distribution. The health practitioner shall maintain documentation in the patient's records that NBS information has been provided Sec 7. Performance of NBS. -NBS shall be performed after iwenty- four (24) hours of life but not later than three (3) days from complete delivery of the newborn. A newbom placed in intensive care in order to ensure survival may be exempted from the three (3)-day requirement but should be tested by seven (7) days of age. @) Compliance to NBS shall be the joint responsibility of the parent(s) /legal guardians and health practitioner or other person delivering the newborn to ensure that NBS is performed; b) Health practitioners shall fully inform their patients’ parents, or legal guardians about the availability, nature, and benefits of NBS; ¢} Collection of samples may be performed by any trained health worker such as physicians, medical technologists, nurses and midwives; d) NBS. specimens shall be properly transported to the accredited NSCs by courier or any other fast and timely mode of transport within twenty four (24) hours following collection of the sample; €) NBS laboratory testing shall be performed by DOH-accredited NSCs. Any laboratory resulls indicating an increased tisk of a heritable disorder (.e. positive testing result) shail be immediately released, within twenty- PagesOTT, nnn Tee SCM TCHS COICeMeo reun———E. Council for the Welfare of Children shall: a) Integrate NBS in the establishment of the system for early identification, prevention, referral and intervention of developmenial disorders and disabilities in early childhood; b) Promote NBS as an integral part of the Early Childhood and Core Development (ECCD) programs implemented at the national and local levels; ¢) Provide avenues in developing innovative advocacy and communication approaches in partnership with civil societies, NGOs and other groups; d) Include NBS-related indicators in the Subaybay Bata and Macro-Monitoring system for children. RULE IV ADVISORY COMMITTEE ON NEWBORN SCREENING. Sec, 15. Advisory Committee on Newborn Screening {ACNBS}. To. ensure sustained inter-agency collaboration, the ACNBS shall be created and made an integral part of the Office of the Secretary of the DOH. Sec. 16. Functions. The ACNBS shall have the following functions: a) Review annually and recommend conditions to be included in the NBS panel of disorders; 6) Review and recommend the standard NBS fee fo be charged by NSCs; ¢) Review the report of the NSRC on the quality assurance of the NSCs; and d) Recommend corrective measures as deemed necessary. Sec. 17. Composition of the Committee. the Committee shall be composed of eight (8) members:equivalent from all hospitals, birthing facilities and other collecting units; f) NSRC shall transfer earmarked funds fo all DOH CHDs or its future equivalent. Sec. 20. PHIC Benefit Package and Other Health Insurance-Related Concerns. a) The PHIC shall include cost of NBS in its benefit package of its members; b} PHIC shall only reimburse NBS tests done in DOH accredited NSCs; ¢) Anewbom shall be considered a dependent of a PHIC member; d) Newborn Screening for disorders included in the NBS panel approved by ACNBS shall be considered nationally accepted screening tests for inborn errors of metabolism and shall be considered as “medically necessary”; e For other health facilities, i.e. lying in and birthing facilities, PHIC shall develop a reimbursement scheme to cover the newboms similar to the benefits of newborns born in the hospital facilities; fj Private insurance = companies, Health = Management Organizations and =community-based health care organizations shall include payment for NBS as a standard benefit to their members. Sec 21. NBS Specimen Collection Kits q) All hospitals, birthing facilities, Rural Health Units, Health Centers and other collecting units throughout the country shall have NBS Specimen Collection Kits at ail times; b) The cost of the NBS Specimen Collection Kits shall be based on the amount prescribed by the ACNBS; ¢) Members of the PHIC may apply for reimbursement of the cost ofd) For indigent members, PHIC shall devise a scheme that shall not entail a cash advance for NBS. SEC 22, Usage of NBS Fees. Guidelines on the usage of funds, as approved by the ACNBS, shall be formulated by the NIHP and DOH. The NBS fee shall be applied to, among others, testing costs, education, sample transport, follow-up and reasonable overhead expenses. To ensure sustainability of the NCNBSS, the NBS fee shall be divided and set aside for the following purpose: a) Ai least four percent (4%) to the DOH - CHDs or its future equivalent for: |. Follow-up service of patients with positive screening result by personnel hired for the NBS unit based ai CHD; Education and other activities directly related to the provision of NBS services; Incentives for RHU collecting health units at least 2 % of the money allocated to the CHD; iv. Staff development of the personnel of the NBS unit based at the CHD, i.e. attendance of training seminars and official meetings of the DOH and the NIHP, v. Capital outlay, ie. vehicle vi. Maintenance and operating expenses of the program Vi. Cost of repeat samples due to insufficient and unsatisfactory samples of patients in their catchment | area b) At least four percent (4%) to the NSC for human resource development and equipment maintenance and upgrading; c) At least four percent (4%) to the NIHP-NSRC for overall supervision, training and continuing education, maintenance of national database, qualify assurance program and monitoring of the national program; and d) The balance for the operational and other expenses of the NSC. yrRULE VI NEWBORN SCREENING CENTERS. Sec. 24, Establishment of Newborn Screening Centers (NSC). a} No NSC shall be allowed to operate unless if has been duly accredited by the DOH based on the standards and procedural guidelines approved by the Committee as enumerated in the attached annexes, which is an integral part of this IRR and the Manual of Operations for NSC formulated by the NSRC; ») The establishment and accreditation of either free-standing or hospital-based NSC shall be phased, It shall take into consideration: strategic and geographical access to the public, data on the number of live births in each of the following areas in relation to the minimum required number of fests run (at least 50,000 samples per annum), the network component including the availability of courier services and the other NCNBSS policies. Initially, there shall be four (4) NSCs to serve the whole country. However additional NSCs shall be established upon the recommendation of the NSRC; d) NSCs shall make available their records to the team, including their financial books to determine compliance with fee structures and other accreditation rules and regulations. Sec. 24, Licensing and Accreditation. a) The DOH through the Bureau of Health Facilities and Services {BHFS) shall include, among others, the provision of NBS services in the licensing requirements for hospitals and birthing facilities; b} PHIC shall include, among others, proof of NBS services in the accreditation of health facilities for quality pediatric services; ¢) The NSC shalll issue proof of NBS services, RULE Vil ESTABLISHMENT OF NEWBORN SCREENING REFERENCE CENTER Sec. 26. Establishment of a Newborn Screening Reference Center (NSRC). The NIHP shall establish a NSRC. It has the following functions: Page 15RULE VIII FINAL PROVISIONS . Sec. 29. Repealing Clause ~ All general and special laws,- decrees, executive orders, proclamations and administrative regulations, or any parts thereof, which ate inconsistent with this Act are hereby repealed or modified accordingly. Sec. 30-.;Separability — If, for any reason, any part of provisions of this Act shall be declared or held fo be unconstitutional or invalid, other provision or provisions hereof which are not affected thereby shall continue to be in full force and effect. Sec 30. Fffectivity — This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation. AL Secretary of Health Page 171.2.9 Receiving specimens on a daily basis five (5) working days per week from courier or other appropriate delivery services 1.2.10 Storing specimens in a manner deemed appropriate 1.2.11 Maintaining detailed documentation logs of testing and follow-up. 2. PERSONNEL 21 2.2 23 24 A licensed physician with at least one (I) year training/ orientation and experience in running a NBS program or three (3) years of equivalent experience in a closely allied situation as approved by the NSRC. A licensed biochemist, chemist, medical technologist. or microbiologist with at least one (1) year of satisfactory training/ orientation in NBS Laboratory Management or three (3) years of experience in related field. Three appropriately licensed scientists (biochemist, chemist, medical technologist or microbiologist) with at least three (3) months of laboratory testing experience in performing the tesis specified or one (1) year of equivalent testing experience in a Clinical taboratory. A licensed nurse with at least three (3) months of experience working/Iraining in NBS or six (6) months of equivalent experience in public health case management program. 3. EQUIPMENT/ INSTRUMENT/ REAGENTS. 31 3.2 33 3.4 3.5 3.6 ‘37 Database system compatible with that of the NSRC. Equipment appropriate for performing analytical testing on died blood spots (3 mm diameter - ~1.5 ul serum) for Congenital Hypothyroidism, Congenital Adrenal Hyperplasia, Phenyiketonuria, Galactosemia and Glucose-6-Phosphate Dehydrogenase deficiency Fume hood necessary for any of the analytical procedures specified Automated puncher capable of cleanly punching 3 mm paper punches Manual paper punch capable of cleanly punching 3 mm paper punches Muliiple pipettor capable of delivering appropriate reagent volumes for any of the procedures specified (ie. generally considered to be volumes of 10 yl, 50 ul or 100 pl) Eppendorf pipettes, if deemed appropriate, calibrated to deliver volumes of 100 yl and 200 yl Pege 193.8 Filter paper collection cards ($8 903) compatible with those designed for use by the NSRC 3.9 Lancets with tip approximately 2.0 mm long sufficient for heel- prick 3.10 Disposal system for hazardous and non-hazardous materials 3.11. Drying rack for horizontal drying of filter paper collection cards 3.12 Storage area of used filter paper cards (a small room with temperature and humidity conirol is preferred) 3.13. Freezer with temperatures maintained between -20 to -10 °C 3.14 Refrigerator capable of maintaining constant temperatures between 48 °C. 4, FACILITY 4.1 Minimum of one hundred (100) square meters working floor area 4.2 Area for blood collection and storage 4.3 _ Five (5) work-benches to run the five (5) tests. Each work bench approximately three (3) ft. long and five (5) ft. wide. 4.4 — Sink for waste disposal 4.8 Source of de-ionized water 4.6 Waste disposal facilities for any hazardous materials generated | |, EE Seen SSS eee