BOARD REGULATION No. 8
Series of 2007
AMENDING BOARD REGULATION
No. 2 SERIES OF 2003 ENTITLED “IMPLEMENTING RULES
AND REGULATIONS GOVERNING ACCREDITATION OF DRUG
TESTING LABORATORIES IN THE PHILIPPINES”
WHEREAS, Section 39 of
Republic Act 9165, also known as the Comprehensive Dangerous Drugs Act of
2002”, mandates the Department of Health (DOH) to “license and accredit drug
testing centers in each province and city in order to assure their capacity,
competence, integrity and stability to conduct the laboratory examinations and
tests”;
WHEREAS, the Drug Testing
Operations Management and Information Systems (DTOMIS) was adopted by the DOH
and approved by the DDB to gather data on the drug testing laboratories (DTLs)
nationwide and monitor and regulated them;
WHEREAS, the DTOMIS was
originally designed as an interim information technology solution, utilizing
the existing hardware infrastructure of the DOH to address the need for a
system to manage drug testing activities for several government agency end –
beneficiaries;
WHEREAS, the National
Computer Center (NCC) endorsed and released funding for the continuing upgrade
of the hardware and software infrastructure development for the DTOMIS;
WHEREAS, there is a need
to utilize new technologies recently made available in the Philippines to
preserve the integrity and quality of laboratory examinations;
WHEREFORE, be it RESOLVED,
as it is hereby RESOLVED, to amend the Dangerous Drugs Board (DDB) Regulation
No. 2, series of 2003, as hereunder provided:
Section 1
Section 3 Definition of
Terms of DDB Regulation No. 2, series of 2003, is hereby amended by inserting
the definition of the word “Board” between the definition of the phrase “Applications
Service Provider” and the definition of the word “Bureau,” as follows:
“Board”
refers to the Dangerous Drugs Board created under Section 77, Article IX of RA
9165.
Section 2
Section 6, sub–paragraph
5.1 (Information Technology Requirements) of DDB Regulation No. 2, series of
2003, is hereby amended, such that the provision shall now read as follows:
5.1 The
laboratory shall maintain a set of information technology (IT) equipment
Whose specification shall conform to the
minimum requirement set by the
DOH as the need arises and after due
consultation with the stakeholders.
New IT equipment requirements shall be
disseminated through a DOH
memorandum circular which shall be posted in
the DOH website.
Section 3
Section 6,
sub–paragraph 5.2 (Information Technology Requirements) of DDB Regulation No.
2, series of 2003, is hereby amended, such that the provision shall now read as
follows:
5.2 The
laboratory shall have access to and utilize the Integrated Drug Testing
Operations Management Information System
(IDTOMIS), which is the
Application Service Provider (ASP) approved
and maintained by the DOH.
Section 4
Section 6,
sub–paragraph 5.3 (Information Technology Requirements) of DDB Regulation No.
2, series of 2003, is hereby amended, such that the provision shall now read as
follows:
5.3 Collected
subscription fees for the IT Provider shall be used as follows:
5.3.1 Two–thirds
(2/3) or 66.67% of the collected fees shall be used to
maintain the IDTOMIS and shoulder
confirmatory test requests of
Screening drug testing
laboratories subject to the guidelines approved
by the Board and the DOH; and
5.3.2 One–third
(1/3) or 33.33% of the collected fees shall be used to fund
drug abuse prevention and control
programs, projects and activities
of the Board, subject to the
guidelines approved by the Board.
Section 5
Section 6, paragraph 14
(Urine Specimen Collection: Handling and Disposal) of DDB Regulation No. 2,
series of 2003, is hereby amended, such that the entire paragraph shall now
read as follows:
14. Urine
Specimen Collection: Handling and Disposal
The laboratory shall follow the
DOH–prescribed guidelines in the collection,
handling and disposal of urine specimens.
Universal precaution shall be
observed at all times.
14.1 Clients
and analysts shall be required to submit fingerprints for every
drug testing transaction
following the DTOMIS Manual as adopted by
the board.
14.2 Laboratories
shall use waterless urinals to prevent dilution and
tampering of specimen.
14.3 Confirmatory
laboratories shall comply with the procedures
prescribed in the Quality Manual
for Confirmatory Drug Testing
Laboratories as adopted by the
Board.
Section 6
Section 9 (Procedural
Guidelines for Accreditation) of DDB Regulation No. 2, series of 2003, is
hereby amended, such that the entire section shall now read as follows:
Section 9
Procedural Guidelines for Accreditation
1. The applicant shall submit the
following documents before an initial certificate of accreditation shall be
issued:
1.1 DOH Prescribed Application Form –
filled either at the Bureau of CHD
1.2 DTI/SEC Registration (for private
laboratory) or Enabling Act (for national government laboratory) or Approved
Board Resolution (for local government laboratory)
1.3 One (1) set of Floor Plan showing
specific location of equipment and work areas required, appropriately
dimensioned, properly identified and completely labeled, and signed by an
architect or engineer.
1.4 List of personnel, notarized,
including Xerox copies of current PRC identification cards and certificates of
training
1.5 List of Equipment with
specifications
1.6 Contract of Lease (if facility is
rented)
1.7 Procedure Manual
1.8 Chain of Custody Form
1.9 Facility Tax Identification
Number
2. The following requirements shall
be submitted within the first six (6) months of operation after issuance of the
initial certificate of accreditation:
2.1
Documentation of Quality Control Program (for screening laboratory)
2.2
Certification of Quality Standard System from a DOH–recognized certifying
body (for confirmatory laboratory)
3. The applicant shall observe the
following procedures for application for initial certificate of accreditation:
3.1
The applicant requests for relevant information and prescribed form from the
Bureau or CHD under whose jurisdiction the
proposed laboratory is located
either in person or through mail, email or
internet.
3.2 The applicant accomplishes
required documents and submits them to the
Bureau
or CHD. Upon filing of application, the applicant pays the corresponding fees
to the Cashier of the Bureau or CHD either in person, through postal money
order or directly to the accredited collecting bank of the DOH.
3.3 The Bureau or CHD conducts survey
on site to determine compliance with standards and technical requirements of
accreditation.
3.4 The Bureau approves or
disapproves the issuance of certificate of accreditation.
3.4.1
If approved, the Bureau registers the laboratory and issues an initial
certificate of accreditation to the applicant upon deposit of twenty thousand
pesos (P20,000) cash bond.
3.4.2
If disapproved, the Bureau sends the findings and recommendations to
the applicant for compliance.
3.5 If the laboratory has not been
approved for accreditation, it may submit an
Appeal
to the Secretary of Health or designated authority within fifteen (15) days
from the receipt of the official denial of application.
4. Hospital–based laboratories shall
be licensed as part of the hospital through the One–stop–Shop Licensure for
Hospitals and are not required to obtain a separate accreditation.
Section 7
Section 13 (Renewal of
Certificate of Accreditation) of DDB Resolution No. 2, series of 2003, is
hereby amended, such that the entire section now read as follows:
Section 13
Renewal of Certificate of Accreditation
1. Application for renewal of
accreditation shall be filed ninety (90) days before the expiry date to the
Bureau or CHD under whose jurisdiction the laboratory is located.
2. The applicant shall submit the
following documents before renewal certificate of accreditation shall be
issued.
2.1 Notarized: Application for
renewal of Certificate of Accreditation
2.2 List of Personnel
2.3 List of Equipment / Instruments
2.4 Current certificate of
Accreditation
2.5 Documentation of Chain of Custody
2.6 Facility Tax Identification
Number
2.7 Current certification for Quality
Standards Systems – for confirmatory laboratory (renewed yearly)
2.8 Documentation /contract for
confirmation of screened positive specimens
2.9 Currently Proficiency Test Result
(renewed yearly)
3. The applicant shall observe the
following procedure for renewal of certificate of accreditation:
3.1 The applicant requests for
relevant information and prescribed form from the Bureau or CHD under whose jurisdiction
the proposed laboratory is located either in person or through mail, email or
internet.
3.2 The applicant accomplishes
required documents and submits them to the Bureau or CHD. Upon filing of
application, the applicant pays the corresponding fees for renewal to the
Cashier of the Bureau or CHD either in person, through postal money order or
directly to the accredited collecting bank of the DOH.
3.3 The Bureau or CHD conducts a
survey to determine compliance with standards/requirements.
3.4 The Bureau approves or
disapproves the issuance of certification of accreditation.
3.4.1
If approved, the Bureau renews the certificate of accreditation to the
applicant.
3.4.2
If disapproved, the Bureau sends the findings and recommendations to
the applicant for compliance. The applicant requests the Bureau for another
survey.
3.5 If a laboratory has not been
approved for renewal, it may submit an appeal to the Secretary of Health or
designated authority within fifteen (15) days from the receipt of the official
denial of application
Section 8
Section 16 (Violations)
of DDB Regulation No. 2, series of 2003, is hereby amended by adding the
following sub–paragraphs after sub–paragraph 9:
10. Refusal to perform tests on submitted specimens for
screening or confirmation
11.
Failure to follow the prescribed flow of activities described in the IDTOMIS
Manual and Quality Manual for
Confirmatory Drug Testing Laboratories as
Adopted by the Board
Section 9
This Regulation shall take
effect fifteen (15) days after its publication in two (2) newspapers of general
circulation and after its registration with the Office of the National
Administrative Register (ONAR), UP Law Center, Quezon City.
ADOPTED and APPROVED this
11th day of December in the year of our Lord, 2007 in Quezon City.
Secretary ANSELMO S.
AVENIDO, JR.
Chairman, Dangerous
Drugs Board
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