RULES AND REGULATIONS
IMPLEMENTING REPUBLIC ACT No. 9288 OTHERWISE KNOWN AS THE “NEWBORN SCREENING
ACT OF 2004”
The following Rules and Regulations are hereby promulgated to implement the Republic Act No. 9288 otherwise known as “Newborn Screening Act of 2004”, an act promulgating a comprehensive policy and a national system for ensuring newborn screening.
RULE I
POLICY AND APPLICATION
Section
1
Purpose
These implementing Rules and Regulations
shall provide the concerned national government agencies, local government
units and other public institutions, non–government organizations, people’s
organizations and private institutions with guidelines for the implementation
of a comprehensive national policy institutionalizing the newborn screening
system to ensure that every baby born in the Philippine is offered the
opportunity to undergo newborn screening.
Section2
Declaration
of Policy
It is the policy of the State to protect
and promote the right to health of the people, including the rights of children
to survival and full and healthy development as normal individuals. In pursuit
of such policy, the State shall institutionalize a National Newborn Screening
System that is comprehensive, integrative and sustainable, and will facilitate
at the national and local levels, collaboration among government and non–government
agencies, the private sector, families and communities, professional health
organizations, academic institutions, and non–governmental organizations. The
National Comprehensive Newborn Screening System shall ensure that every baby
born in the Philippines is offered the opportunity to undergo newborn screening
and thus be spared from heritable conditions that can lead to mental
retardation and death if undetected and untreated.
Section
3
Objectives
National
Comprehensive Newborn Screening System shall aim to:
a. Ensure
that every newborn has access to newborn screening for certain heritable
conditions that can result in mental retardation, serious health complications
or death if left undetected and untreated;
b. Establish
and integrate a sustainable newborn screening system within the public health
delivery system;
c. Ensure
that al health practitioners are aware of the advantages of newborn screening
and of their respective responsibilities in offering newborns the opportunity
to undergo newborn screening; and
d. 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 disability and death through
newborn screening.
Section
4
Definition
of Terms
For the purposes of this Act:
a. Accreditation
– a formal authorization issued by the DOH to 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
c. DOH
– refers to the Department of Health, the lead
agency in implementing this Act
d. Follow–up
– refers to the monitoring of a newborn with a heritable condition for the
purpose of ensuring that the newborn patient receives the appropriate medicine
or dietary prescriptions.
e. Health
institutions – refer to hospitals, health infirmaries,
health centers, lying – in centers or puericulture centers with obstetrical and
pediatric services, whether public or private.
f. Healthcare
practitioner – refers to physicians, nurses, midwives,
nursing aides and traditional birth attendants.
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 mental
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.
i. IRR
– refers to the Implementing Rules and Regulations.
j. LGU
– refers to the Local Government Unit.
k. National
Comprehensive Newborn Screening System – Treatment Network
– refers to the tertiary hospitals equipped to diagnose and manage the
confirmed cases.
l. NIHP
– refers to the National Institute of Health,
Philippines.
m. Newborn –
a child from the time of complete delivery to thirty (30) days old.
n. Newborn
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 newborn has a heritable condition.
o. Newborn
Screening Center (NSC) – a facility equipped
with a newborn screening laboratory that complies with the standards
established by the NIHP, and provides all required laboratory tests and
recall/follow–up programs for newborns with heritable conditions.
p. Newborn
Screening Reference Center (NSRC) – 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.
q. Newborn
Screening Specimen Collection Kit – materials
needed in collecting NBS samples namely filter collection card, lancet,
information materials, etc. which can be procured at the NSC.
r. Parent
Education – the various means of providing parents
or legal guardians information about NBS.
s. Participating
Health Institutions – health institutions
offering newborn screening services such as, but not limited to, motivation of
parents, collection of blood sample and recall.
t. PHIC
– refers to the Philippine Health Insurance
Corporation
u. Recall
– a procedure for locating a newborn with a positive screening results from a
possible heritable condition for purposes of providing that newborn with
appropriate laboratory testing to confirm the diagnosis and, as appropriate, to
provide treatment.
v. Treatment
– provision of prompt, appropriate and adequate
medicine, medical and surgical management or dietary prescription to a newborn
for purposes of treating or mitigating the adverse health consequences of a
heritable condition.
w. UP
– refers to the University of the Philippines
RULE II
NATIONAL COMPREHENSIVE
NEWBORN SCREENING SYSTEM
Section
5
National
Comprehensive Newborn Screening System (NCNBSS)
NCNBSS
shall refer to a NBS system that includes, but is not limited to
a. Education
of relevant stakeholders;
b. Collection,
transport, biochemical screening, and reporting on result of blood samples
taken from newborns;
c. Tracking
and confirmatory testing to ensure the accuracy of screening results;
d. Clinical
evaluation and biochemical/medical confirmation of follow–up test results;
e. Administration
of drugs and/or medical surgical management and/or dietary supplementation to
counter adverse effects of the heritable conditions; and
f. Monitoring
and evaluation of the NCNBSS.
Section
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 the parents or legal guardian of the newborn of the
availability, nature and benefit of NBS. Health practitioner shall follow the
DOH prescribed guidelines on notification and education relative to the
obligation to inform. The DOH, other government agencies, non–government
agencies, professional societies and LGU shall have a system of its
distribution. The health practitioner shall maintain documentation in the
patient’s records that NBS information has been provided.
Section
7
Performance
of NBS
NBS shall be performed after twenty hours
of life but not later than three days form complete delivery of the newborn. A
newborn placed in intensive care in order to ensure survival may be exempted
from the three day requirement but should be tested by seven days of age.
a. 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 patient’s parents, or legal guardians
about the availability, nature and benefits of NBS;
c. Collection
of samples may be performed by any trained health workers such as physician, medical technologists, nurses and midwives;
d. NBS
specimen 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;
e. NBS
laboratory testing shall be performed by DOH–accredited NSCs.
Any laboratory results indicating an
increased risk of a heritable disorder (i.e. positive testing result shall be
immediately released, within twenty–four hours, so that confirmatory testing
can be performed as provided in Section 8.
Negative screens shall be released seven
working days after receipt at the NSC.
Section
8
Recall
A newborn with a positive result shall be
located and recalled for confirmatory testing as soon as possible.
a. A
newborn identified at high risk (positive screening result) for a heritable
disorder shall be recalled immediately to confirm the diagnosis. The Municipal
Health Office, City Health Office, Provincial Health Office and District Health
Office shall be involved in the recall process;
b. The
NSC shall notify the participating health institution about the immediate
recall of the newborn with a positive screening result. Every collecting health
facility shall designate a person or office responsible in the recall of the
newborn;
c. The
NSCH shall likewise inform the designated person of the CHD or its equivalent
to assist in the immediate recall of newborn with positive screen;
d. The
attending health practitioner shall assist the participating health institution
in locating and recalling the patient;
e. Once
located, the newborn with confirmed diagnosis shall be referred for treatment
and management to a duly licensed physician or a medical specialist such as but
not limited to, neonatologist, pediatric endocrinologist and geneticist. Prompt
management of newborns with positive screen is essential to prevent the
debilitating consequences or death of the newborn;
f. Once
contacted, the parents with assistance of the respective LGU shall have the
primary responsibility to ensure that their newborn receive appropriate
confirmatory testing as soon as possible.
Section
9
Referral
and Management of Positive Cases
a. The
total management of patient with confirmed diagnosis shall be referred to the
NCNBSS Treatment Network;
b. All
NCNBSS Treatment Network shall follow the DOH–approved clinical protocol in the
management of patients diagnosed in any of the disorders included in the
newborn screening panel.
Section
10
Monitoring
of patients
Monitoring and follow up of patients
confirmed to have the disorders shall be done regularly by the attending
physician, appropriate subspecialist or Rural Health Unit (RHU).
Report forms about the status of the
patients shall be accomplished by the attending physicians to be submitted to
the NSCs.
Section
11
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
mental retardation or death of undiagnosed heritable conditions. A copy of this
refusal documentation shall be made part of the newborn’s medical record and refusal
shall be indicated in the national NBS database.
Section
12
Continuing
Education, Re–education and Training of Health Personnel
To ensure awareness of all health
personnel, the DOH, LGUs, and the academe with the assistance of the NIHP and
other government agencies, professional societies and non– government
organization shall:
a. Conduct
continuing information, education, re–education and training program for health
personnel on the rationale, benefits, procedures of NBS;
b. Disseminate
information materials on NBS at least annually to all health personnel involved
in maternal and pediatric care;
c. Integrate
information in existing education programs for medical and paramedical
professionals.
RULE III
IMPLEMENTATION
Section
13
Lead
Agency
The DOH shall be the lead agency for
implementing the NCNBSS. DOH shall have the following responsibilities:
a. Fully
utilize the efforts and resources of various offices within the DOH, NIHP, PHIC
and health facilities, concerned health personnel and workers to implement the
NCNBSS;
b. Establish
the Advisory Committee on Newborn Screening (ACNBS);
c. Coordinate
with the Department of the Interior and Local Government for implementation of
the NCNBSS;
d. Coordinate
with the NSRC for the accreditation of NSC and preparation of defined testing
protocols and quality assurance programs;
e. Coordinate
with all health professionals societies in an advocacy campaigns on behalf of
the comprehensive NBS system;
f. Integrate
NBS in the current health care delivery system. NBS shall be an integral part
of all public health programs. It should be a routine procedure for newborns in
public and private health, hospital and birthing facilities;
g. Ensure
that a network for the prompt recall of positive cases is established in
collaboration with LGUs, government agencies and other Non Government
Organizations;
h. Ensure
that a network of facilities for referral and management of all positive cases
is established;
i. Formulate protocols in
the referral and management of the positive cases in collaboration with the
Philippine Society for Pediatric Metabolism and Endocrinology and the IHG–NIHP;
j. Develop referral centers
and identify referral teams in strategic areas for referral and management of
patients with any of the disorders;
k. Ensure
inter–agency collaboration through inclusion of NBS in the agenda of existing
committees on children’s health and welfare. In such venues, the following
agencies shall be represented: DOH, NIHP, DILG and other relevant health
professional organizations;
l. Ensure quality and
sustainability of NBS system through the establishment of NSRC as well as its
attendant requisites.
Section
14
Major
Stakeholders
To ensure implementation of NCNBSS, the
agencies/organization identified below shall have the following
responsibilities:
A. Health
Facilities, i.e. Hospitals, birthing facilities, rural health units and health
centers
a. Integrate
NBS in its delivery of health services;
b. Serve
as collecting health facility for NBS;
c. Coordinate
with a duly accredited NSC;
d. Ensure
that adequate and sustained NBS services such as information, education,
communication, screening, recall and management of identified cases are being
provided in the hospital;
e. Establish
a NBS Team that will be responsible for the following: collection of samples,
sending of samples to accredited NSC, prompt recall of positive patients,
referral and management of patients;
f. Establish
an appropriate financial system that will ensure effective and efficient
collection of fees and payment of NBS services to the NSC;
g. Conduct
orientation and/or training of hospital staff on NBS;
h. Monitor
and evaluate the implementation of NBS within in the institution;
i. Define creative
financial packages to make NBS accessible particularly among the economically
deprived populace.
B. Department
of the Interior and Local Government shall:
a. Encourage
LGUs to implement R.A. 9288, “The Newborn Screening Act of 2004” and extend
total cooperation in the implementation of the said law;
b. Assist
the DOH in the monitoring and evaluation of the program implementation.
C.
Local
Government Units shall:
a. Develop
capabilities of health workers;
b. Issue
local ordinances and resolutions that integrate NBS in the delivery of health
delivery system;
c. Ensure
that adequate and sustained NBS services such as information, education,
communication, screening, recall and follow–up are being provided in all LGU
Health facilities (Rural Health Unit / City Health Unit, Lying–ins, City /
Municipal / District / Provincial Hospitals);
d. Establish
a functional case management referral system with strategically accessible
NCNSS treatment network;
e. Establish
coordination and networking among concerned agencies in NBS implementation;
f. Monitor
and evaluate the newborn screening implementation in their localities;
g. Explore/encourage
creative financial packages to make NBS accessible particularly among the
economically deprived populace;
h. Perform
other roles and responsibilities as deemed necessary for the implementation of
this Act.
D. Academe,
Health Professional Societies, National Organizations of Health Professionals
shall:
a. Ensure
that all its members are aware of the significance of NBS to their clients,
their families and the society at large;
b. Define
mechanism that will ensure and monitor that its member are doing their
obligations to inform parents about the significance of NBS;
c. Recommend
the inclusion of NBS as part of the curricula of all allied health professions;
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 developmental disorders and disabilities in early
childhood;
b. Promote
NBS as an integral part of the Early Childhood and Care Development (ECCD)
programs implemented at the national and local levels;
c. 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
Section
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.
Section
16
Functions
The ACNBS shall have the following
functions:
a. Review
annually and recommend conditions to be included in the NBS panel of disorders;
b. Review
and recommend the standard NBS fee to be charged by NSCs;
c. Review
the report at the NSRC on the quality assurance of the NSCs; and
d. Recommend
corrective measure as deemed necessary.
Section
17
Composition
of the Committee
The Committee shall be composed of eight
members:
a. Secretary
of Health, who shall act as Chairperson;
b. Executive
Director of the NIHP, who shall act as Vice Chairperson;
c. Undersecretary
of the DILG;
d. Executive
Director of the Council for the Welfare of Children;
e. Director
of the NSRC; and
f. Three
(3) representatives appointed by the Secretary of Health who shall either be a
pediatrician, obstetrician, endocrinologist, family physician, nurse or
midwife, from either the public or private sector. The three (3)
representatives shall be appointed for a term of three (3) years, subject to
their being reappointed for additional three year periods for each extension.
Section
18
Meetings
The ACNBS shall meet at least twice a year.
The NIHP shall serve as the Secretariat of the Committee.
RULE V
NEWBORN SCREENING FEES
Section
19
Newborn
Screening Fees
a. Expenses
for the NBS tests shall be the responsibility of the parents/guardians of the
newborn;
b. The
government and private health facilities are highly encouraged to develop a
scheme providing partial or full subsidy depending on the financial capability
of the parents;
c. A
standard NBS fee covering all program costs shall be implemented by all NSCs as
approved by the ACNBS. A payment schedule shall also be imposed on all
participating health institutions so that the NSC may stay financially solvent;
d. A
health facility may collect a reasonable fee for the collection of samples,
which shall not be greater than the maximum allowable service fee prescribed by
DOH.
e. NSRC
shall collect the percentage of the NBS fees earmarked for the DOH – Centers
for Health Development (CHD) or its future equivalent from all hospitals,
birthing facilities and other collecting units;
f. NSRC
shall transfer earmarked funds to all DOH CHDs or its future equivalent.
Section
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;
c. A
newborn 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 newborns similar to the benefits of
newborns born in the hospital facilities;
f. Private
insurance companies, Health Management Organizations and community–based
health care organizations shall include payment for NBS as a standard benefit
to their members.
Section
21
NBS
Specimen Collection Kits
a. All
hospitals, birthing facilities, Rural Health Units, Health Centers and other
collecting units throughout the country shall have NBS Specimen Collection Kits
at all times;
b. The
cost of the NBS Specimen Collection Kits shall be based on the amount
prescribed by the ACNBS;
c. Members
of the PHIC may apply for reimbursement of the cost of NBS Specimen Collection
Kits;
d. For
indigent members, PHIC shall devise a scheme that shall not entail a cash
advance for NBS.
Section
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. At
least four percent (4%) to the DOH–CHDs or its future equivalent for:
1. Follow–up
service of patients with positive screening result by personnel hired for the
NBS unit based at CHD;
2. Education
and other activities directly related to the provision of NBS services;
3. Incentives
for RHU collecting health units at least 2% of the money allocated to the CHD;
4. Staff
development of the personnel of the NBS units based at the CHD, i.e. attendance
of training seminars and official meetings of the DOH and the NHIP,
5. Capital
outlay, i.e. vehicle
6. Maintenance
and operating expenses of the program
7. 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, quality assurance
program and monitoring of the national program; and
d. The
balance for the operational and other expenses of the NSC.
RULE VI
NEWBORN SCREENING
CENTERS
Section
23
Establishment
of Newborn Screening Centers (NSC)
a. No
NSC shall be allowed to operate unless it 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;
b. 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 tests 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;
c. 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.
Section
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 requirement 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;
c. The
NSC shall issue proof of NBS services
RULE VII
ESTABLISHMENT OF NEWBORN
SCREENING REFERENCE CENTER
Section
25
Establishment
of a Newborn Screening Reference Center (NSRC)
The NIHP shall establish a NSRC. It has the
following functions:
a. Be
responsible for the national testing database and case registries, training,
technical assistance and continuing education for laboratory staffs in the all
NSCs;
b. Define
the testing and follow–up protocols for NSCs;
c. Maintain
an external laboratory proficiency–testing program;
d. Oversee
the national testing database and case registries;
e. Report
to the DOH the NSCs found violating these rules and regulations and those
performing and providing NBS procedures and services without any DOH
accreditation;
f. Participate
in consultation and evaluation activities initiated by BHFS in relation to the
NSRC and the NSCs performance and in improving implementation of these rules
and regulations.
Section
26
Quality
Assurance
All NSC’s shall strictly follow the
prescribed guidelines of good laboratory practices. The NSRC shall be
responsible for drafting and ensuring good laboratory practice standards for
NSCs, including establishing an external laboratory proficiency testing and
certification program. It shall also act as the principal repository of
technical information relating to the NBS standards and practices, and shall
provide technical assistance to the NSCs needing such assistance.
Section
27
Database
a. All
NSCs shall coordinate with the NSRC for consolidation of patient databases;
b. The
NSRC shall maintain a national database of patients tested and a registry for
each condition;
c. The
NSRC shall submit reports semi–annually or more frequently as the need arises
to the ACNBS and the DOH on the status of the relevant health information
derived from the database.
NSRC shall prepare a plan for long–term
outcome evaluation of NBS utilizing the cases registries. The plan shall be
developed within one (1) year of passage of this Act in consultation with the
ACNBS. Implementation of this plan shall become a responsibility of the ACNBS.
RULE VIII
FINAL PROVISIONS
Section
28
Repealing
Clause
All general and special laws, decrees,
executive orders, proclamations and administrative regulations, or any parts
thereof, which are inconsistent with this Act are hereby repealed or modified
accordingly.
Section
29
Separability
If, for any reason, any part of provision
of this Act shall be declared or held to be unconstitutional or invalid, other
provision or provisions hereof which are not affected thereby shall continue to
be in full force and effect.
Section
30
Effectivity
This Act shall take effect fifteen (15)
days after its publication in at least two (2) newspapers of general
circulation.
MANUEL
M. DAYRIT, MD, MSc.
Secretary
of Health
ANNEX 1
MANDATORY ACCREDITATION
REQUIREMENTS FOR NSCs
1. SERVICE
CAPABILITY
a. Testing
Capability
(1) Analyzing
a minimum of one hundred and fifty (150) samples a day utilizing testing
methods approved by the NSRC
(2) Testing
for the following disorders included in the NBS package currently approved by
the ACNBS for NBS:
a. Congenital
Adrenal Hyperplasia (CAH)
b. Congenital
Hypothyroidism (CH)
c. Phenylketonuria
(PKU)
d. Galactosemia
(GAL)
e. Glucose–6–Phosphate
Dehydrogenase Deficiency (G6PD)
(3) Interpreting
and reporting test results for each disorder based on pre–determined
analytical ranges and expected norms
b. Administrative
and Network Capability:
(1) Providing
the necessary NBS Specimen Collection Kits (filter collection card, lancets,
information materials, etc) to all health facilities within its coverage.
(2) Releasing
results of all analytical testing for all samples received from health
facilities within its coverage.
(3) Informing
NBS coordinators of health facilities of patients whose results are positive or
unsatisfactory at the same time of initial screening.
(4) Monitoring
and referring patients with abnormal results to NCNSS treatment network.
(5) Coordinating
with government and non–government agencies for the establishment of a network
for NBS recall and follow up.
(6) Establishing
and maintaining databases of patients screened, analytical results and follow
up outcome
(7) Providing
required information from databases to NSRC via computerized linkages
(8) Transporting
samples from the health facilities to the NSC
(9) Receiving
specimens on a daily basis five working days per week from courier or other appropriate
delivery services
(10) Storing specimens in a
manner deemed appropriate
(11) Maintaining detailed
documentation logs of testing and follow up.
2. PERSONNEL
a. A
licensed physician with at least one year training/orientation and experience
in running a NBS program or three years equivalent experience in a closely
allied situation as approved by the NSRC.
b. A
licensed biochemist, chemist, medical technologist
or microbiologist with at least one year of satisfactory training/orientation
in NBS Laboratory Management or three years of experience in related field.
c. Three
licensed scientist (biochemist, chemist, medical
technologist or microbiologist) with at least three months of laboratory
testing experience in performing the tests specified or one year equivalent
testing experience in a clinical laboratory.
d. A
licensed nurse with at least three months of experience working/training in NBS
or six months of equivalent experience in a public health case management
program.
3. EQUIPMENT
/ INSTRUMENT / REAGENTS
a. Database
system compatible with that of the NSRC
b. Equipment
appropriate for performing analytical testing on dried blood spots (3mm
diameter – 1.5 µL serum) for Congenital Hypothyroidism, Congenital Adrenal
Hyperplasia, Phenylketonuria, Galactosemia and Glucose–6–Phosphate
Dehydrogenase deficiency
c. Fume
hood necessary for any of the analytical procedures specified
d. Automated
puncher capable of cleanly punching 3 mm paper punches
e. Manual
paper punch capable of cleanly punching 3 mm paper punches
f. Multiple
pipettor capable of delivering appropriate reagent volumes for any of the
procedures specified (i.e., generally considered to be volumes of 10 ml, 50 ml
or 100 ml)
g. Eppendorf
pipettes, if deemed appropriate, calibrated to deliver volumes of 100 ml and
200 ml
h. Filter
paper collection cards (S&S 903) compatible with those designed for use by
the NSRC
i. Lancets with tip
approximately 2.0 mm long sufficient for heel–prick
j. Disposal system for
hazardous and non–hazardous materials
k. Drying
rack for horizontal drying of filter paper collection cards
l. Storage area of used
filter paper cards (a small room with temperature and humidity control is
preferred)
m. Freezer
with temperatures maintained between –20 to –10oC
n. Refrigerator
capable of maintaining constant temperatures between 4 – 8oC.
4. FACILITY
a. Minimum
of one hundred square meters working floor area
b. Area
for blood collection and storage
c. Five
work benches to run the five tests. Each work bench approximately three feet
long and five feet wide.
d. Sink
for wasted disposal
e. Source
of de–ionized water
f. Waste
disposal facilities for any hazardous materials generated
GUIDELINES IN THE
APPLICATION FOR ACCREDITATION
A Certificate of Accreditation shall be
granted in accordance with the prescribed accreditation requirements and on the
bases of specific conditions and limitations. The accreditation as herein
granted as well as any right under the accreditation cannot be assigned or
otherwise transferred directly or indirectly to any party. A separate
accreditation shall be required for all NSC or branches maintained in separate
premises. Violation of this IRR, its Manual of Operation for NSC and other
related issuances shall be a ground for suspension or revocation of the
accreditation.
1. PROCEDURES
FOR APPLICATION OF ACCREDITATION
a. Applicant
requests for relevant information and prescribed forms from the BHFS on the
proposed NSC, in person, or through mail, e–mail, fax transmittal or the
internet.
b. Applicant
accomplishes required documents and submits them in person or through mail to
the BHFS.
Documentary Requirements:
Initial Accreditation:
(1) BHFS–NSC Form No. 1–01:
Application for DOH Accreditation as a NSC
(2) List of personnel
involved in NBS, indicating names, positions, job description, PRC license
number and relevant training
(3) List of equipment /
instrument / reagents for NBS if available Letter of Intent signifying
willingness to:
· Comply with the
prescribed Technical and Administrative Manual of Operations for NBS, and
· Participate in Quality
Assurance Program
Renewal of
Accreditation:
BHFS–NSC
Form No. 2–01: Application for Renewal of DOH Accreditation as a NSC
(1) List of Personnel
involved with NBS, indicating names, positions, job description, PRC license
number and relevant training
(2) List of equipment /
instrument / reagents for NBS
(3) List of NBS procedures
performed, services offered and statistical accomplishment report for the past
three years
(4) Copy of the NSCs
Technical and Administrative Manual of Procedures for NBS.
(5) Documentation of Quality
Assurance Program implementation
c. BHFS
together with NSRC evaluates application based on the selection criteria that
includes the pre–identified regional areas for NSCs that includes the pre–identified regional areas for NSCs to serve and compliance with documentary
requirements.
d. BHFS
informs the applicant of the result of evaluation. If favorable, applicant for
initial accreditation is informed to set–up the facility for an ocular
inspection and payment of the prescribed accreditation fees to the Cashier of
the DOH, in cash or through postal money order.
e. BHFS
and NSRC conduct ocular inspection in accordance with NSC technical
requirements.
f. The
BHFS and NSRC recommend approval or disapproval upon inspection.
g. The
Director of the BHFS signs approval or disapproval of application for
accreditation
If approved,
the BHFS registers the health facility as NSC and issues the corresponding
certificate of accreditation to the applicant.
If disapproved,
the BHFS sends the findings, recommendations to the applicant who makes the
necessary alterations and/or corrections within fifteen days from the time of
inspection. The applicant then requests the BHFS for another inspection.
Failure to make necessary corrections of deficiencies within fifteen days after
due notice, results to forfeiture of application and accreditation fee.
2. VALIDITY
AND EXPIRATION
a. The
Certificate of Accreditation shall have a validity period of three years
subject to periodic monitoring.
b. Application
for renewal of accreditation no filed within thirty days after expiration shall
be treated as a new application.
No comments:
Post a Comment