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New Born Screening
New Born Screening
Newborn Screening (NBS) is an essential public health and management of several congenital metabolic disorders, which if left untreated, may lead to mental retardation and even death. It is an integral part of routine newborn care in most developed countries for four decades, either as health directive or mandated by law. Early diagnosis and treatment of the disorders can result to normal growth and development of the affected individual.
specifically identified healthcare facility that collects samples for newborn screening of babies, born either within the healthcare facility or elsewhere, and has operational recall/follow up program for newborns with heritable conditions. Newborn Screening Center(NSC) a facility equipped with a newborn screening laboratory that complies with the standards established by the NHIP, and provides all required laboratory tests and recall / follow up programs for newborns with heritable conditions.
Newborn Screening Reference Center (NSRC)- a central facility 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.
NBS in the Philippines began 1996 when group of pediatricians and obstetricians initiated the Philippine Newborn Screening Project in 24 pilot hospital in Metro Manila. The group conducted the research with the following objectives:
NBS OBJECTIVES
a. To determine the local incidence of congenital hypothyroidism (CH), Congenital adrenal hyperplasia (CAH),phenylketonuria (PKU),galactosemia (Gal) and homocystinuria (HCY) and b. To make recommendations for nationwide implementation of the newborn screening
In accordance with the mandate and thrust of ensuring quality life for all Filipinos, the following were undertaken by DOH in the implementation of NBS.
1999 DOH included NBS in their child health 2025 framework . A DOH inter-agency, was created to design a national plan for the nationwide implementation of newborn screening. To disseminate and initiate NBS at the regional level representatives from the 16 Center for Health Development (CHD) offices were designated as regional coordinators and were oriented to NBS in September 1999.
history
January 2000- Issuance of administrative order 1-A s, 2000 entitled Policies on the Nationwide implementation of Newborn Screening.
February of 2001- Creation of an interagency National Technical working group on NBS (NTWG-NBS) . The group was tasked to provide national direction and guidance in the attainment of the project goals stipulated in the DOH Administrative Order 1-A series of 2000.
history
June 2001- Conduct of Strategic Planning Workshop on NBS participated by Private and Public hospitals and other stakeholders. January 2004- Issuance of second department order No. 121, s 2003, entitled Strengthening the implementation of the National Newborn Screening System. PD No. 540 entitled: Declaring first Week of October of each year as the National Newborn Screening Week as declared by Pres. GMA Jan. 20,2004.
history
Last April 7, 2004, Republic Act 9288 known as the Newborn Screening Act of 2004 was enacted to institutionalize NBS in the Philippines.
The Implementing Rules and Regulation of RA 9288 was signed last October 5, 2004.
What Are the highlights of RA 9288 and its implementing rules and regulations and their implications?
Section 5 of RA 9288- Obligation of Health workers to inform about newborn screening among its clients any health practitioner who delivers or assist delivery of a newborn in the Philippines shall prior to delivery, inform patients and legal guardians about the availability and benefits of NBS.
Highlights of RA 9288
Section 6 RA 9288- NBS shall be performed after 24 hours from birth but not later than three days from complete delivery of the newborn. A newborn that may be placed in an intensive care in order to insure survival may be exempted from the 3-day requirement but must be detected by 7 day of age. It shall be a joint responsibility of the parents and the practitioner or other persons delivering the newborn to ensure that NBS is performed.
Highlights of RA 9288
Section 10 of RA 9288 : Defining DOH lead agency. Section 11 of RA 9288: Creation of Advisory Committee on NBS Composition DOH, DILG, NIH, NSRC,CWC,3 representatives( pedia, obgyne, midwife, nurses, family physician, endocrinologist). Section 12 of RA 9288: Establishment of accreditation of NBS.
Highlights of RA 9288
Section 13 of 9288: Establishment of NSRC by NIH which will be responsible for the Quality Assurance of all NBS Center, national testing, database, and case registries,training,technical assistance and continuing education for lab staff of all the NBS center Section 14 of 9288: Quality Assurance all NBS center shall follow the prescribed guidelines of good laboratory proficiency/ practice standards set by NSRC.
HIGHLIGHTS OF RA 9288
Section 16 of RA 9288: PHIC inclusion of NBS in its benefits. Section 19-d of the IRR: DOH will regulate the NBS fee to be charged by the NSC and set the maximum allowable service to be charged by all facilities and collecting NBS samples. Section 14-A of the IRR: Health Facilities as Major stakeholders shall ensure the implementation on NBS and will have the following responsibilities:
Steps
Prenatal visits Home visit All health workers who provide prenatal care and attends to the actual delivery of baby are responsible for informing parents about NBS. Parental Objection: sign a written form of dissent
Specimen collection
Falsely elevated thyroid stimulating hormone (TSH)= false (+) screen for CH b. Falsely elevated 17 hydroxyprogesterone (17-oHP)= false (+) screen for CH c. Falsely low galactose and phenylalanine because of inadequate feeding= false(.) screen for Gal and PKU 2. Samples taken less than 24 hours from birth require repeat screening at 2 weeks of age.
a.
Specimen collection
Sample Collection is done in participating health facilities. Hospitals Health centers Rural health unit Lying-in or birthing facilities NBS samples are collected by trained health workers such as
Physicians Medical technologist Nurses Midwives The heel Prick method Preferred method of collecting blood sample Proper training of practitioner Alternative blood (venous blood) Umbilical blood is not recommended
Transporting NBS
8. Arrange for regular pick-up with courier Ideal time in sending NBS samples Pick up and transport of specimen daily Explore other means of transport DO NOT BATCH NBS SPECIMENS COLLECTED ON SEPARATE DAYS ( Mon-Fri)
Transporting NBS
5. accomplish the courier forms completely 6. Insert the NBS samples, properly sealed 7. Address envelop to: Newborn Screening Center Institute of Human Genetics National Institute of Health University of the Philippines Pedro Gil St., Ermita, Manila
The NSC releases NORMAL results or the NBS Summary through the following:
For Normal NBS results , the NSC releases normal results thru :
Fax or email to NBS Facilities with fax or-Daily b. Courier to those who do not have fax or email-Weekly Hard copies of the results sent through fax and e mail are sent through the courier by the end of the month. The NBS Coordinator is responsible for ensuring the distribution of the individual.
a.
The NBS coordinator is responsible for ensuring the distribution of the individual.
Normal NBS results to the Attending Physician or Health Practitioner who attended the birth of the newborn. When NBS coordinator or attending Physician or both are not available, the result may be given directly to the parents.
The NBS Overall Coordinators should see to it that all babies with positive screen are recalled promptly. The health facility should designate a person in- charge responsible for the recall of patients to ensure that parents or guardians of babies with positive screen are informed immediately. In case both the Attending Physician and NBS Hospital Coordinator are not able to do the recall.
As much as possible, unsatisfactory samples must be detected before the sample is even sent to NSC so that a repeat sample can be collected while the baby is still in the NSF. Comparing the sample with "Simple Spot Check poster can minimize rejects.
Contaminated(water, dirt, beverage) 2. Insufficient blood( not enough to perform the whole newborn screening panel) 3. Sample taken within 48 hours after blood or exchange transfusions. 4. Sample taken when patient is on total parenteral nutrition (TPN) 5. Sample taken when baby was on nothing per Orem (NPO) 6. Early sampling ( baby is less than 24 hour of life) 7. NBS samples received at NSC more than 10 days from date of collection or late transport to laboratory (more than10 days).
1.
In both types of recall, the main purpose is the early confirmation and management of babies whose screening results are positive. Prompt recall of patients with elevated results is critical in saving babies from mental retardation or death. Patients with unfit samples must be recalled immediately. Each disorder has a critical time when it is best to start treatment in order to avoid irreversible consequences.
Responsibilities
Prompt notification of the Attending Physician or health care provider of positive screens/unsatisfactory samples. Immediate notification of parents about the NBS results of their newborn when the attending Physician is not around. Immediate facilitation of repeat blood collection from babies with elevated results or rejected samples
Proper Documentation
An effective recall system, relies on proper documentation of information about all babies born with the jurisdiction Document the following information: complete address of patient contact numbers and address of individuals who can assist in the recall of the patient(ex. Neighbor, barangay captain,bhw, midwives)all efforts made to recall a baby
What to do for patients with positive NBS for one of the Disorders
1.Recall patient Know the health status of the patient, if it is critical, inform the AP about the initial findings and/or suggest referral of the patient to a specialist for immediate management Meet with the parents and explain the NBS results and things that need to be done 2. Facilitate confirmatory testing 3. Check if confirmatory test was done 4.Follow-up results of confirmatory test
If result confirms the condition, refer the patient If result is negative for the condition, inform the NBSC coordinator or attending Physician and close the case.
The NBS Team should do regular monitoring of the patient with positive screen through the attending physician or by direct inquiry of the patient.
Newborn screening sample collection can be done by a physician, a nurse, a midwife or a medical technologists.
Newborn screening is available in participating health institutions(Hospitals,lying-ins, rural health units,local government units, health centers). If the baby is delivered at home, he/she may be brought to the nearest institution offering newborn screening.
Newborn screening results are available within seven working days after the newborn screening samples are received in the NBS laboratory.
A negative screen means that the result of the test indicates extremely low risk of having any of the disorders being screened.
A positive screen means that the baby is at increased risk of having one disorders being screened.
What should be done when the baby is tested positive for any of the disorder?
Babies with positive results should be referred at once to the nearest hospital or specialist for confirmatory testing and possible medical management. The Newborn Screening Center will assist the patients attending physician.
Prepare and send a purchase Order(P.O.) of NBS SpecimenCollection Kit contains the following : filter card, lancet, result form and brochure. Mechanics for preparing P.O. for NBS Specimen Kit a. All orders for the NBS specimen Collection Kit must be in Purchase Order (PO) of the requesting health facility. b. Fax a copy of the approved P.O. to NSC. Send the original copy of the P.O. via courier or mail to:
Newborn Screening Center, Institute of Human Genetics, National Institute of Health, University of the Philippines; Manila, Pedro Gil St. Ermita, Manila
Ordered supplies will be sent by the assigned NSC through preferred courier of the facility together with the sales invoice in triplicate Original Sales Invoice is retained at the receiving health facility and forwarded to its Accounting Department. The duplicate and triplicate copies are sent back to NSC within the same day the order was received.
NRC will only replace for free filter card used for repeat sample collection of patients with positive screening results. Filter cards that were rejected due to contamination, insufficiency, and late transmittal to NSC will not be replaced.
Prepare Advocacy and Promotional Plan for the following: Administrators Professionals/Health Practitioners Expectant parents/guardians/patients
a. b. c.
As soon as the Newborn Screening Reference Center receives the duly accomplishment forms, you will be assigned to a Newborn Screening Center who will send you the Specimen Collection Kit.