September 19,
2012
ADMINISTRATIVE
ORDER
No. 2012 –
0017
GUIDELINES ON THE USE, RETENTION AND
STORAGE OF RESIDUAL DRIED BLOOD SPOTS FROM NEWBORN SCREENING
I. RATIONALE
The introduction of Newborn Screening (NBS) in the
Philippines in 1996 and the enactment of the Newborn Screening Act in 2004 are
significant milestones in the Philippine health sector. Since then, the National
Comprehensive Newborn Screening System has been developed and in the course of
its implementation has collected over 2.5 million filter cards containing
residual dried blood spots (DBS) currently in storage at various Newborn
Screening Centers. These residual DBS obtained from newborn screening have generated
interest here and around the world as objects of public health research.
Likewise, maintenance costs and space requirements of these residual DBS have
risen. In this light, this Administrative Order is being issued.
II. OBJECTIVE
To set the guidelines for the retention, storage and
use of residual DBS and to ensure that the confidentiality and privacy
interests attached to the residual DBS are taken into consideration.
III. SCOPE AND COVERAGE
This Administrative Order applies to all implementers
of the Newborn Screening Program, both public and private, research and
academic institutions.
IV. DEFINITION OF TERMS
1. Residual Dried Blood Spots (DBS) refers to the dried blood spot materials
remaining after samples for newborn screening have been punched out.
2. Newborn Screening Data Card refers to the portion of the filter card
that contains all the identifying and demographic data of the patient
accompanying the dried blood specimens.
3. Newborn Screening Reference Center (NSRC) refers to the central facility at the
National Institute of Health that defines testing and follow–up protocols,
maintains an external laboratory proficiency 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 Newborn Screening.
4. R.A. 9288: Newborn Screening Act of 2004 refers to the act
promulgating a comprehensive policy and a national system for ensuring newborn
screening.
5. R.A. 9470: National Archives of the Philippines Act of 2007
refers to the policy that enforces proper management, control and regulation of
record disposition in all government offices/institutions.
6. Records Disposition Schedule refers to the document prepared and
submitted by the Newborn Screening Reference Center for the National Archives
that governs the disposition of all records of the National Comprehensive
Newborn Screening System.
V. POLICIES AND PROCEDURES
A. General
Guidelines
1. All
residual DBS shall be stored as long as possible and may be retrieved for non–screening purposes
2. All
newborn screening data shall be secured to protect the privacy of the newborn
and its family
3. Should
the need arise, all residual DBS and data cards shall be disposed of so that
the confidentiality of information is assured
4. Residual
DBS should be available for screening–related and non–screening purposes
B. Specific
Guidelines
1. Storage
of Residual DBS and Data Cards
(a) All
residual DBS shall be placed under the custody of the Newborn Screening
Reference Center (NSRC) at the University of the Philippines – National
Institute of Health
(b) Residual
DBS, with a unique laboratory identification number, shall be stored in a
secure and centralized storage facility. Residual blood spots shall be stored
in a low humidity environment at 4oC or lower
(c) All
samples shall be stored as long as possible, subject to space limitations and
the NSRC’s policy on disposal
(d) Upon
receipt, all Newborn Screening Data Cards shall be encoded, verified, and the
data maintained in a highly secure database
2. Retention
of Newborn Screening Data
(a) Multiple
(electronic) copies of stored data shall be maintained
(b) Stored
data shall include all information contained on the Newborn Screening Data Card
and newborn screening results
(c) The
NSRC shall conduct periodic reviews of its computing practices to help ensure
that the information collected will remain accessible and readable in the
future. The review may address computing issues including data storage, backup,
retrieval and management, technological obsolescence, vendor lock–in, data
formats and standards, and security
3. Disposal
of Residual DBS and Newborn Screening Data Cards
(a) Residual
DBS are classified as non–infectious materials (Classification of Infectious
Substances, Dangerous Good Regulation, International Air Transport Association,
2010).
(b) When
the need arises, destruction (and/or disposal) of the residual DBS shall be
conducted in an appropriate manner according to the Health Care Waste
Management Manual of the DOH and approved by the National Archives of the
Philippines.
(c) Newborn
screening data cards shall be destroyed by shredding after encoding and
scanning of the data cards in accordance with the approved Records Disposition
Schedule by the National Archives of the Philippines.
4. Screening
and Non–screening uses of Residual DBS
(a) A
Special Committee on the use of Residual DBS (henceforth abbreviated as
“Special Committee”) shall be created to ensure the appropriate use of the
samples.
The primary task of the Special Committee is to
evaluate the relevance of the proposed research requests and to assess the
capacity of the researcher/requesting body to care for the residual specimens.
(b) The
Chair of the Special Committee will be a designate representative of the
Secretary of the Department of Health.
(c) The
Special Committee shall prioritize requests that benefit the patient or his/her
family and address public health risks.
(d) Requests
for the purposes of litigation, criminal investigation, insurance, and
employment shall not be approved.
(e) Use of
residual DBS for Newborn Screening Purposes
(1) Screening–related
uses refer to the use of the blood spots for newborn screening and the
processes associated with it such as test refinement, treatment efficacy
studies, new test validation, and result verification.
(2) Screening–related
uses shall not require approval of the Special Committee prior to use of
residual specimens. It is the responsibility of the NSRC to maintain patient
confidentiality and ensure that specimens remain in the custody of NSRC.
(f) Use of
Residual DBS for Non–screening purposes
(1) Potential
use of the samples include, but are not limited to, the following:
i. Patient/Family
Studies
ii. Public
Health Research
(2) All
requests for the use of residual DBS for non–screening uses shall go through
the Special Committee and the NIH Technical Review Board and ethics review by
the UPM Research Ethics Board
(3) In
patient/family studies, it may be beneficial that the samples be re–linked to
the individual from which the sample was taken. This process shall require
consent of the source individuals or their legal guardians, in case of minors.
(4) For
purposes of public health research, all samples released must be de–identified. Only samples permitted for research will be released. Only samples
permitted for research will be released. Any request deemed by the Special
Committee and the UPM Research Ethics Board to be consent–requiring shall not
be approved. A return or destruction process must be approved as part of the
request.
(5) Researchers
must submit the following documentation to the Special Committee prior to the
review of the request
i. Credentials
of all requesting investigators
ii. Capsule
proposal which includes the purpose and anticipated benefits of the study
(6) Upon
approval of the capsule proposal, the requesting party is asked to prepare a
full proposal for technical review by the NIH Technical Review Board, ethics
review by the UPM Research Ethics Board and final approval of the Special
Committee.
(7) All
costs incurred in the retrieval, preparation, and processing of the request and
sample shall be shouldered by the requesting party. The proceeds shall go to
the NSRC for the maintenance of the storage facility.
These guidelines shall be reviewed periodically by
NCDPC–DOH.
VI. REPEALING CLAUSE
All issuance that are inconsistent with the provision
of this Order are hereby repealed/rescinded
VII. EFFECTIVITY
This Order shall take effect fifteen (15) days after
its approval and publication in the Official Gazette or newspaper of general
circulation.
ENRIQUE T. ONA, M.D.,F.P.C.S.,F.A.C.S.
Secretary of Health
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