(M) L3.2: RA 9288 - Newborn Screening Act of 2004 Flashcards
What is the full title of RA 9288?
An Act Promulgating a Comprehensive Policy and a National System for Ensuring Newborn Screening
The Act ensures the rights of children to _______ and full and healthy ________ as normal individuals
Survival; Development
The state shall institutionalize a national newborn screening system that is what?
Clue: 3 adjectives
- Comprehensive
- Integrative
- Sustainable
The state shall facilitate collaboration among who at the national and local levels?
Government and non-government agencies
The newborn screening system shall ensure that every baby born in the Philippines will be spared from heritable conditions that can lead to what?
Mental retardation and death
Objectives of RA 9288:
To ensure that every newborn has access to newborn screening for certain heritable conditions that can result in ________ if left undetected and untreated
Mental retardation, serious health complications, or death
Objectives of RA 9288:
To establish and integrate a sustainable newborn screening system within the ________
Public health delivery system
Objectives of RA 9288:
To ensure that all ________ are aware of the advantages of newborn screening and of their respective responsibilities in offering newborns the opportunity to undergo it
Health practitioners
Objectives of RA 9288:
To ensure that parents recognize their responsibility in promoting their child’s right to health and full development, within the context of responsible parenthood, by protecting their child from preventable causes of ________ through newborn screening
Disability and Death
What section talks about the objectives of RA 9288?
Section 3
Definition of Terms:
A system that includes the ff.:
- education of relevant stakeholders
- collection and biochemical screening of blood samples from newborns
- tracking and confirmatory testing to ensure accuracy
- clinical evaluation and biochemical/medical confirmation of test results
- drug and medical/surgical management
- evaluation activities to address heritable conditions
- evaluation activities to assess long-term outcomes
- patient compliance and quality assurance
Comprehensive Newborn Screening System
Definition of Terms:
Monitoring of a newborn with a heritable condition for the purpose of ensuring that they fully comply with the medicine or dietary prescriptions
Follow-up
Follow-ups for newborns ensure that the patient fully complies with the medicine or _________
Dietary prescriptions
Definition of Terms:
Means hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services whether public or private
Health institutions
T or F: Health institutions refer to only public hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services
False (private as well)
Definition of Terms:
Means physicians, nurses, midwives, nursing aides, and traditional birth attendees
Healthcare practitioner
T or F: Healthcare practitioners refer to doctors and nurses in the hospital only
False (includes midwives, nursing aides, and traditional birth attendants)
Definition of Terms:
Refers to any condition that can result to mental retardation, physical deformity, or death if left undetected and untreated and which is usually inherited from the genes of either or both parents
Heritable condition
T or F: Heritable conditions result to mental deformity and physical retardation
False (mental retardation and physical deformity)
T or F: Heritable conditions can come from either or both parents
True
T or F: Heritable conditions have only been found to come from the mothers
False (can be either or both parents)
What does NIH mean?
National Institute of Health
It is referred to as a “newborn” from the time of complete delivery to how many days old?
30 days
Definition of Terms:
The process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing for the determination of a heritable condition
Newborn Screening
Definition of Terms:
A facility equipped with a NBS laboratory that complies with the standards established by the NIH and provides all required lab tests and recall/follow-up programs for newborns with heritable conditions
Newborn Screening Center
Definition of Terms:
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 activities in all aspects of the program, oversees content of educational materials, and acts as the Secretariat of the Advisory Committee on NBS
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
A facility equipped with a NBS laboratory
NBS Center
NBS Center or NBS Reference Center (lifted from the manual)?
Complies with the standards established by the NIH
NBS Center
NBS Center or NBS Reference Center (lifted from the manual)?
Provides all required lab tests and recall/follow-up programs for newborns with heritable conditions
NBS Center
NBS Center or NBS Reference Center (lifted from the manual)?
The central facility at the NIH that defines testing and follow-up protocols
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
Maintains an external laboratory proficiency testing program
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
Oversees the national testing database and case registries
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
Assists in training activities in all aspects of the program
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
Oversees content of educational materials
NBS Reference Center
NBS Center or NBS Reference Center (lifted from the manual)?
Acts as the Secretariat of the Advisory Committee on Newborn Screening
NBS Reference Center
The NBS Reference Center acts as the _________ on Newborn Screening
Secretariat of the Advisory Committee
Definition of Terms:
The various means of providing the parents/legal guardians information about newborn screening
Parent Education
Definition of Terms:
Procedure for locating a newborn with a possible heritable condition for purposes of providing them with appropriate laboratory tests to confirm the diagnosis and provide treatment
Recall
Recall is a procedure that locates a newborn with a possible _________
Heritable condition
Definition of Terms:
The provision of prompt, appropriate, and adequate medicine; medical, and surgical management or dietary prescription for the purpose of treating or mitigating adverse health consequences of the heritable condition
Treatment
It is imperative to health practitioners to inform the soon to be parents the importance of what?
Newborn Screening
T or F: Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall inform the parents/legal guardians of the availability, nature, and benefits of newborn screening after delivery
False (prior to delivery)
T or F: The health practitioner who delivered the newborn is the only one authorized to inform the parents/legal guardians of the NBS
False (also those who have assisted)
Appropriate notification and education regarding the obligation to inform the parents/guardians about NBS shall be the responsibility of what?
DOH
What section states that “appropriate notification and education regarding the obligation to inform the parents/guardians about NBS shall be the responsibility of DOH”?
Section 5
In the case of a complete delivery, when should the NBS be performed?
After 24 hours of life but not later than 3 days from delivery date
T or F: Babies classified under complete delivery shall undergo NBS within the first 24 hours of life
False (AFTER 24 hours)
For babies placed in the ICU/NICU, when should the NBS be performed?
Within 7 days from delivery
Give the appropriate timeframe wherein babies can undergo NBS for those with a complete delivery vs. those that were sent to the NICU
Complete delivery - after 24 hours of life but not more than 3 days
NICU baby - within 7 days
A baby who underwent complete delivery shall be subjected to NBS after how many hours of life?
24 hours
A baby who underwent complete delivery shall be subjected to NBS not exceeding how many days?
3 days
Which type of patient is exempted from the requirement to undergo NBS within the first 3 days?
Those sent to the NICU
Whose JOINT responsibility is it to ensure that NBS is performed on the patient?
The parents and the practitioner/other person who delivered the newborn
An appropriate informational brochure for parents to assist in fulfilling the responsibility to have their children undergo NBS shall be made available by what?
DOH
“When should NBS be performed?” falls under what section?
Section 6
A parent or legal guardian may refuse testing on the grounds of ________
Religious Beliefs
Parents/guardians who refuse to test their newborns shall acknowledge that their refusal places their newborn at risk for undiagnosed heritable conditions in what form?
In writing
A copy of the document acknowledging the refusal for NBS shall be made part of the newborn’s _______
Medical Record
Refusal to test shall be indicated in the national newborn screening _______
Database
T or F: Consenting to NBS shall appear in the newborn screening database
False (refusal)
T or F: The original NBS refusal document shall be made part of the newborn’s medical record
False (a copy)
“Refusal to be tested” is under what section?
Section 7
What are the 2 governing bodies of the newborn screening programs in the country?
DOH and NIH
T or F: The NIH shall be the lead agency in implementing this Act with assistance from the DOH
False (reverse)
The DOH shall be assisted in implementing this act by the NIH and what other organizations?
- Other government agencies
- Professional societies
- Non-governmental organizations
T or F: The DOH shall conduct continuing information, education, re-education, and training programs for parents on the rationale, benefits, and procedures of newborn screening
False (health personnel)
The DOH shall disseminate information materials on newborn screening at least how many times a year to all health personnel involved in maternal and pediatric care?
Annually (once a year)
What shall the DOH disseminate annually to all health personnel involved in maternal and pediatric care?
Information materials on NBS
“Continuing information, education, re-education, and training programs for health personnel” fall under what section?
Section 8
What 2 agencies require health institutions to provide newborn screening services as a condition for licensure or accreditation?
DOH and PHIC
DOH and PHIC requires health institutions to provide newborn screening services as a condition for what?
Licensure or accreditation
“Licensing and accreditation” fall under what section?
Section 9
Who shall ensure that NBS Centers are strategically located in order to be accessible to the relevant public?
DOH
Who shall provide services that comply with the standards approved by the Committee upon the recommendation of the NIH?
NBS Center
The DOH shall provide services that comply with the standards approved by the _______
Committee
The DOH shall provide services that comply with the standards approved by the Committee upon the recommendation of the ______
NIH
No NBS Center shall be allowed to operate unless it has been duly accredited by who?
DOH
Every NBS Center shall have a certified ______ performing all tests included in the program
Laboratory
Every NBS Center shall have recall/follow up programs for infants found _______ for any and all of the heritable conditions
Positive
Every NBS Center shall have ________ programs for infants found positive for any and all of the heritable conditions
Recall/Follow-up
Every NBS Center shall be supervised and staffed by _________ who have been duly qualified by the NIH
Trained personnel
Every NBS Center shall be supervised and staffed by trained personnel who have been duly qualified by the _____
NIH
T or F: Every NBS Center shall be supervised and staffed by trained personnel who have been duly qualified by the DOH
False (NIH)
Every NBS Center shall submit to periodic announced or unannounced _______ by the Reference Center in order to evaluate and ensure quality performance
Inspections
Every NBS Center shall submit to periodic announced or unannounced inspections by the ________ in order to evaluate and ensure quality performance
Reference Center
“Establishment of accreditation of NBS Centers” falls under what section?
Section 12
Who shall establish a Newborn Screening Reference Center?
NIH
T or F: The DOH shall establish a NBS Reference Center which shall be responsible for the national testing database and case registries, training, technical assistance, and continuing education for laboratory staff in all NBS Centers
False (NIH)
The NIH shall establish a _________ which shall be responsible for the national testing database and case registries, training, technical assistance, and continuing education for laboratory staff in all NBS Centers
NBS Reference Center
“Establishment of a NBS Reference Center” falls under what section?
Section 13
DOH, NIH, both, or neither?
The lead agency in implementing this Act
DOH
DOH, NIH, both, or neither?
Conduct continuing information, education, re-education and training programs for health personnel on the rationale, benefits, and procedures of newborn screening
Both
DOH, NIH, both, or neither?
Disseminate information materials on newborn screening at least annually to all health personnel involved in maternal and pediatric care
Both
DOH, NIH, both, or neither?
Requires health institutions to provide newborn screening services as a condition for licensure or accreditation
Neither (it’s DOH and PHIC)
DOH, NIH, both, or neither?
Shall ensure that Newborn Screening Centers are strategically located in order to be accessible to the relevant public
DOH
DOH, NIH, both, or neither?
This agency shall recommend services that comply with the standards approved by the Committee
NIH
DOH, NIH, both, or neither?
This agency shall approve of the standards to be followed in providing NBS services
Neither (Committee)
DOH, NIH, both, or neither?
No NBS Center shall be allowed to operate unless duly accredited by this entity
DOH
DOH, NIH, both, or neither?
NBS Reference Centers shall be established by this entity
NIH
DOH, NIH, both, or neither?
NBS Reference Centers are the central facilities at this agency
NIH
DOH, NIH, both, or neither?
Every NBS Center shall be supervised and staffed by trained personnel who have been duly qualified by this entity
NIH
DOH, NIH, both, or neither?
This shall have a certified laboratory performing all tests included in the newborn screening program
Neither (an NBS Center)
DOH, NIH, both, or neither?
This shall have a recall/follow up program for infants found positive for any and all of the heritable conditions
Neither (an NBS Center)
DOH, NIH, both, or neither?
This shall be supervised and staffed by trained personnel who have been duly qualified
Neither (an NBS Center)
DOH, NIH, both, or neither?
This shall submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality performance
Neither (an NBS Center)
DOH, NIH, both, or neither?
Shall establish a Newborn Screening Reference Center, which shall be responsible for the national testing database and case registries, training, technical assistance, and continuing education for laboratory staff in all Newborn Screening Centers
NIH
This AO provides for the “Revised Guidelines on the Implementation of the Expanded Newborn Screening Program”
AO 52 s. 2020
What is the title of AO 52 s. 2020?
“Revised Guidelines on the Implementation of the Expanded Newborn Screening Program”
AO 52 s. 2020 shall apply to all DOH Centers for what?
Health Development (CHD)
Aside from NBS Centers and NBS Reference Centers, where does AO 52 s. 2020 also apply to?
Clue: There’s 4 specific ones
- All DOH-CHDs
- The Ministry of Health (MOH) of the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM)
- Institute of Human Genetics
- Newborn Screening Facilities (NSFs)
+ all other agencies/stakeholders concerned in the implementation of the program
T or F: NBS Centers and NBS Reference Centers fall under the scope of AO 52 s. 2020
True
T or F: The Department of Health of BARMM falls under the scope of AO 52 s. 2020
False (MINISTRY of health)
T or F: DOH-CHDs fall under the scope of AO 52 s. 2020
True
T or F: The Institute of Newborn Genetics falls under the scope of AO 52 s. 2020
False (Human Genetics)
T or F: NBS Facilities fall under the scope of AO 52 s. 2020
True
How many disorders in the expanded newborn screening panel are included?
28 (and more)
Use this as a reviewer for the types of disorders included in NBS in the manual
- hemoglobinopathies
- amino acid disorders
- organic acidurias
- disorders of fatty acid oxidation
- disorders of carbohydrate metabolism
- disorders of biotin metabolism
- cystic fibrosis
- endocrine disorders
2 AOs were repealed/rescinded with AO 52 s. 2020, what are those?
- AO 45 s. 2014
- AO 45 s. 2014-A