• •

Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

JUL 19 2010
ADMINISTRATIVE ORDER
No. 2010- 00~4-

SUBJECT: Requirement of Permit to Construct in the Establishment

of Free-standing Screening Drug Testing Laboratories
Nationwide

I. BACKGROUND AND RATIONALE :

Pursuant to Republic Act 9165 otherwise known as the "Comprehensive

Dangerous Drugs Act of 2002" and its Implementing Rules and Regulations (IRR) and as
specified in the Manual of Operations for Drug Testing Laboratories in the Philippines, the
Department of Health (DOH) is mandated to oversee and monitor the integration,
coordination and supervision of all drug rehabilitation, intervention, after-care and follow-
up programs, projects and activities as well as the establishment, operation, maintenance
J

and management of privately-owned drug treatment rehabilitation centers and drug

testing networks and laboratories throughout the country, in coordination with other
government agencies. Moreover, the responsibility of the DOH, through its principal
regulatory office, the Bureau of Health Facilities.and Services (BHFS) is to accredit drug
testing laboratories in order to assure quality, competence and integrity in the conduct of
drug testing.

The East Avenue Medical Center (EAMC) is designated by the Secretary of Health
as the National Reference Laboratory (NRL) for Environmental and Occupational Health,
Toxicology and Micronutrient Assay. The NRL in coordination with the BHFS shall assure
the competence, integrity and stability of drug testing centers nationwide.

Furthermore, the BHFS is mandated to formulate and establish the standards for
regulation of hospitals, clinics and other health facilities and to enforce standards that
shall be the basis of issuance of license/accreditation of a facility. In accordance with this
r:nandate, the BHFS shall undertake the following tasks :

1. Develop policies and guidelines on the establishment, operation and

monitoring of drug testing laboratories ;
2. Conduct accreditation of all private and government drug testing
laboratories ; ~

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila • Trunk Line 743-83-01 Direct Line: 711-9501 J}...; , .
Fax: 743-1829; 743-1786 • URL: http://www.doh.gov.ph; e-mail: osec@doh.gov.ph ~
 • •
3. Conduct training of DOH regulatory officers ;
4. Conduct research and development on drug testing and other related
activities.

In pursuit of the said mandate, specifically on the accreditation of Drug Testing

Laboratories (or DTL's) nationwide, the BHFS will officially prescribe the requirement of
DOH Permit to Construct (or DOH-PTC) for all new applications including transfer of site
and change in ownership in the establishment of freestanding Screening Drug Testing
Laboratories (SDTL}, both government and privately owned, in a countrywide coverage.
In addition, the BHFS sh~l officially require the said application for a DOH-PTC and its
subsequent approval as a prerequisite prior to the application for accreditation by the
freestanding SDTL. Concurrent to this, the BHFS is also authorized to set fees and
charges by just and reasonable rates to cover th~ cost of services rendered and partly to
support and to sustain the needed reforms in health regulation.

Lastly, in consonance with the above specific tasks such as conduct of research
and development on drug testing and other related activities among others, the BHFS has
embarked on the development of prototype plants for a freestanding SDTL with the
accompanying technical guidelines and specifications.

II. OBJECTIVE:

As stated in the DOH Manual of Operations for Drug Testing Laboratories in the
Philippines, the general objectives include the following :

1. Standardize the procedure of drug testing services in the Philippines among all
stakeholders ;
2. Implement quality assurance program in drug testing laboratorie~ nationwide.

Consistent with the above objectives and in pursuit of the licensing function of the
BHFS, the primary objective of this Order is to formally impose the requirement of DOH-
Permit To Construct (DOH-PTC) for all new applications including transfer of site, lapsed
accreditation and change in ownership in the establishment of free-standing Screening
Drug Testing Laboratories (SDTL), government and privately owned, on a nationwide
scope. Through this DOH-PTC requirement, the BHFS will be able to screen, review and
evaluate new applications for the subject facility with the end goal of permitting only those
that will sufficiently comply with the established standards and guidelines together with
the other statutory requirements.

As part of its technical assistance, the BHFS shall prescribe prototype plants for a
freestanding SDTL facility with technical guidelines and specifications for the general
information, guidance and compliance of prospective applicants.

Through the above objectives, the BHFS aims to assure the physical acceptability,
functional planning and standard design of all approved new applicants of free-standing
SDTL including the quality service that they shall eventually render to their clientele.
 • •
Ill. SCOPE and COVERAGE :

This Order shall be applicable to all government and privately-owned freestanding

SDTL's in the Philippines that will apply for New Application with the purpose of
establishing, operating and maintaining a free-standing Screening Drug Testing
Laboratory including those freestanding SDTL's with lapsed accreditation and with
change of ownership.

IV. DEFINITION OF TERMS :

Accreditation: refers to the formal authorization issued by the DOH to an individual,

partnership, corporation or association which has complied · with all licensing
requirements (inpuUstructural standards) and accreditation requirements (process
standards and outcome/outpuUimpact standards) as prescribed in the Manual of
Operations for Drug Testing Laboratories issued by the DOH.

Applicant : refers to the owner or president of a freestanding Screening Drug Testing

Laboratory that is applying for the issuance of a DOH-Permit To Construct and
subsequently a Certificate of Accreditation.

BHFS : refers to the Bureau of Health Facilities and Services that shall exercise the
regulatory function.

CDA: refers to Cooperative Development Authority.

CHD : refers to the Centers for Health Development under the Department of Health that
are located in the various regions of the country.

DTI : refers to Department of Trade and Industry.

DOH : refers to the Department of Health.

DOH Permit to Construct (or DOH - PTC) : refers to the authority issued by the DOH-
BHFS to an Applicant who will establish and operate a freestanding Screening Drug
Testing Laboratory upon compliance with required documents set forth in this Order prior
to the actual construction of the subject facility.

Freestanding : refers to an adjective that means standing alone, independent, not

attached to any health facility regulated by the DOH.

Drug Testing Laboratory : refers to a private or government diagnostic facility that

performs a laboratory examination of human biological specimen for identification of
dangerous drugs.

New application : refers to all initial applications including transfer of site, change of
ownership and lapsed accreditation.
 • •
Screening Drug Test : refers to the test used to differentiate a non-reactive specimen
from one that requires further testing for drugs or drug metabolites.

SDTL: refers to Screening Drug Testing Laboratory.

SEC : refers to Securities and Exchange Commission.

V. GUIDELINES :

A. GENERAL GUIDELINES :

1. A DOH-PTC shall be required for the construction of all new freestanding SDTL.

2. All applicants prior to the submission of an Application for Accreditation must first
secure an approved DOH-PTC from the BHFS. No accreditation shall be issued
without the approved DOH-PTC.

3. All freestanding SDTL's shall conform with the prescribed requirements for the
standardized physical plant set-up ·and design specifications provided in . the
Prototype Floor Plants for freestanding SDTL duly prepared and approved by the
BHFS (refer to ANNEXES "A", "B" and "C").

4. A non-refundable fee shall be charged for the Application for a DOH-PTC for all
new applicants of freestanding SDTL, either government or private (refer to item
VI. Schedule of Fees).

5. A DOH-PTC shall be considered lapsed and the fee paid shall be forfeited when
the work authorized by the permit does not commence within ninety (90) calenaar
days from date of issuance or is abandoned during the period specified.

B. PROCEDURAL GUIDELINES :

1. Required Documents for Application of DOH-PTC:

The following are the required documents to be accomplished and/or submitted

before a DOH-PTC can be issued to an Applicant of freestanding SDTL :

a. Duly accomplished Application Form ;

b. Proof of Ownership :

DTI registration ;
SEC registration with Articles of Incorporation and By-laws ;
Enabling Act/Board Resolution (for Government) ;
Cooperative Development Authority (CDA) registration with Articles
of Cooperation and By-laws.

Page4of6 \if
/
 • •
c. Three (3) Sets of Architectural Floor Plans with Location Map. (Note:
Minimum scale for floor plans shall be 1:100 m showing complete areas,
labels and dimensions. All plans shall be signed and sealed by an
Architect or Engineer) ; .

2. Procedures for Application for DOH Permit To Construct (DOH-PTC) :

a. The Applicant shall secure a copy of the prescribed Application Form

for the DOH-PTC from the BHFS or CHD that has jurisdiction over the
proposed freestanding SDTL, or through the DOH website
(www.doh.gov.ph).

b. The Applicant accomplishes the said form together with the necessary
attachments then formally submits to the BHFS. Upon filing of application,
the Applicant pays the corresponding fee to the Cashier of the DOH in
person, or through postal money order.

c. The BHFS, through the Health Facility Establishment Review Committee (or
HFERC) shall review and evaluate the submitted plans and documents of
the subject facility with respect to basic requirements and with the
prescribed prototype plants and technical guidelines in the planning and
design of a freestanding SDTL. Then, the BHFS approves or disapproves
the issuance of a DOH-PTC.

d. If disapproved, the BHFS returns the documents, together with their findings
and recommendations to the Applicant. The Applicant makes the necessary
revisions on the documents. The Applicant submits the revised documents
to the BHFS for another reyiew. The Applicant is entitled to only one
revision.

e. If approved, the BHFS issues a DOH-PTC to the Applicant.

VI. SCHEDULE OF FEES :

1. A non-refundable fee of one thousand (P1 ,000.00) pesos only or as

prescribed by the DOH in its future issuances shall be charged for the
Application for a DOH-PTC for freestanding SDTL either government or
privately owned.

2. All checks shall be paid to the order of DOH in person or through postal
money order or through online payment, if available, as the case may be.

Page5of6 ~~
t
 • •
VII. APPEAL :

The decision of the HFERC may be appealed to the Office of the Director of BHFS
within ten (1 0) days after receipt of the notice of the decision. The decision otthe BHFS
Director is final and executory.

VIII. REPEALING CLAUSE:

Provisions from previous issuances that are inconsistent or contrary to the

provisions of this Order are hereby rescinded and modified accordingly.

IX. SEPARABILITY CLAUSE :

In the event that any provision or part of this Order be declared unauthorized or
rendered invalid by any court of law or competent authority, those provisions not affected
by such declaration shall remain valid and effective.

X. EFFECTIVITY
This Order shall take effect fifteen (15) days after its approval and publication in a
newspaper of general circulation.

7;r;JL_
ENRIQUE T. ONA, MD
Secretary of Health

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila • Trunk Line 743-83-01 Direct Line: 711-9501
Fax: 743-1829; 743-1786 • URL: http://www.doh.gov.ph; e-mail: osec@doh.gov.pb
'
.,
.
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• Republic of the Philippines

Department of Health
Bureau of Health Facilities and Services
•
Bldg. 15, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila, 1003 Manila
Trunk Line: 743-8301; Direct Line: 711-6982; Fax: 781-4179
URL: http://www.doh.gov.ph; e-mail: bhfs@co.doh.gov.ph

Application for DOH Permit to Construct of Free-Standing

Screening Drug Testing Laboratory

Name of Laboratory'
Address of the Laboratory
No. & Street Barangay

City/ Municipality Province Region

Telephone/ Fax No.

Name of Owner
Contact Person
Contact No.

DIRECTIONS: Put a check (v'') mark on the appropriate box.

Classification according to
Ownership [ 1 Government

[ 1 Private
Type of Application
[ 1 New Construction

[ 1 Transfer of Site From

To

[ 1 Change of Ownership From :

To

{ ] Lapsed Accreditation
Date Expired:
Documents attached herewith·
1. Duly Accomplished Application Form (this form)
2. Application Fee of P1 000.00
3. Three (3) sets of Architectural Floor Plans with Location Map.
(Note: Minimum scale for floor plans shall be 1:100 m showing complete areas,
labels and dimensions. All plans shall be signed and sealed by an architect or
engineer).
4. DTI/SEC Registration including Articles of Incorporation and By-Laws
5. Enabling Act/Board Resolution (for government)
6. Cooperative Development Authority (CDA) registration with Articles of
Cooperation and By-laws
'The name of Laboratory should match DTI/SEC Registration and Mayor's/Business Permit

I hereby declare that this Application has been accomplished by the undersigned and that the
foregoing information and attached documents required for the DOH Permit to Construct are true and
correct.

Signature over Printed Name of Owner/

Head of Agency/President of Company

Date: _ _ _ _ _ _ _ _ _ __
 4.00
LEGEND :
$ 0

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ROOM LABELS I NOTES
LINE OF ROOF ABOVE
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RAMP FACILITY SLOPE: 1:12
1.00 3.00
~ HANDWASHING FACILITY
~ (LAVATORY IN COUNTER)

(7\ FLOOR PLAN (Ql SINK IN COUNTER

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SCALE 1:80 METERS
GRAPHICAL SCALE :
0 1 2 5M. 0 1 ojCOMPUTER,PRINTER,BIOMETRICS
AND WEBCAM EQUIPMENT
~
TOTAL FLR. AREA: 20.00 SQ. MTS. ):
Republic of the Philippines
DEPARTMENT OF HEALTH
TITLE OF HEALTH FACILITY PROJECT SHEET CONTENTS SHEET NO. :2
BUREAU OF HEALTH
A-J :2
FACILITIES & SERVICES PROTOTYPE FREE-STANDING DRUG TESTING
BUILDING NO. 15, San Lazaro Compound
Rizat Avenue, Sta. Cruz, Manila
SCREENING LABORATORY SCHEMATIC FLOOR PLAN· SCHEME 1 DRAWN BY:

RBR, JR.
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LEGEND
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DETAIL OF PASS-THRU &BIOMETRICS COUNTERIS I I •

SCALE 1: 25METERS

GRAPHICAL SCALE :
0 0.50 1.00 2.00 MTS.

Republic of the Philippines TITLE OF HEALTH FACILITY PROJECT SHEET CONTENTS SHEET NO.
DEPARTMENT OF HEALTH
BUREAU OF HEALTH A-2
FACILITIES & SERVICES PROTOTYPE FREE-STANDING SCREENING DRAWN BY:
DRUG TESTING LABORATORY DETAIL OF PASS-THRU & BIOMETRICS COUNTERIS
BUILDING NO. 15. San Lazaro Compound
Rizal Avenue, Sta. Cruz, Manna RBR.,JR.

I
 -"·

CLINICAL WORKING AREA

RECEPTION AND
CLIENTS WAITING AREA •

SPECIMEN COLLECTION
AREA

Republic of the PhRippines TITLE OF HEALTH FAC ILITY PROJECT SHEET CONTENTS
DEPARTMENT OF HEAL1H
BUREAU OF HEALTH
FACILITIES &SERVICES PROTOTYPE FREE-STANDING SCREENING
DRUG TESTING LABORATORY ISOMETRIC DRAWING· LEFT SIDE VIEW
BUILDING NO. 15, San Lazaro Compound
Rizal Avenue, Sta. Cruz, Manila
 ~~

CLINICAL WORKING AREA

•
SPECIMEN COLLECTION
AREA

RECEPTION AND
CLIENTS WAITING AREA
...
•
Republic of the Philippines TITLE OF HEALTH FAC ILITY PROJECT SHEET CONTENTS
DEPARTMENT OF HEALTH
BUREAU OF HEALTH
FACILITIES &SERVICES PROTOTYPE FREE-STANDING SCREENING
ISOMETRIC DRAWING- RIGHT SIDE VIEW
DRUG TESTING LABORATORY
BUILDING NO. 15, San Lazaro Compound
Rizal Avenue, Sta. Cruz~ Mar:Uia
. ._.:
•'
.. '

• •• ANNE X "B"

Republic of the Philippines

Department of Health
BUREAU OF HEALTH FACILITIES AND SERVICES
Bldg. 15, San Lazaro Compound, Sta. Cruz, Manila .
Trunk Line 743-83-01 Direct Line: 711-6982; Fax: 781-4179

Title of Health Facility Project: PROPOSED FREE-STANDING SCREENING

DRUG TESTING LABORATORY

Subject : TECHNICAL GUIDELINES AND DESIGN SPECIFICATIONS

• Walls and Partitions :

1. All walls and partitions (whether concrete, steel or wood) shall be

structurally sound, safe and made of sturdy permanent materials.

• Finishes:

2. All floorings shall be provided with vinyl, ceramic tiles or its equivalent and
shall be well-maintained.

3. Work counters shall be provided with glazed tiles or smooth laminated

finish or its equivalent. Stainless steel sink or lavatory preferably with
gooseneck spout shall be provided.

4. Countertop walls or wainscoting shall be provided with glazed tiles or

smooth laminated finish or its equivalent with at least 400 mm (or 16")
high.

5. Specimen collection area shall be provided with unglazed tiles for flooring
and glazed tiles finish for walls with height of at least 1.22 mts. (or 4"-0")
from finish floor line to the top of wall tiles. When there is no window
opening for natural ventilation, exhaust fan shall be provided in order to
promote air circulation.

6. The exterior fa9ade, interior walls and ceilings of the laboratory facility
shall be painted (preferably with anti-bacterial paint for interior walls of the ~­
laboratory working area) for aesthetic purposes and shall be properly
maintained at all times. · · ·
.. ,.
T
• •
• Room Ventilation :

7. For proper ventilation, floor to ceiling height of the laboratory facility shall
be at least 2.40 mts. (or 8'-0") high. Moreover, the rooms may be provided
with air-conditioning unit/s in order to achieve a comfortable and clean-
environment.

8. Working counter area shall be provided with either ceiling or wall mounted
exhaust fan of at least 10" diameter fan blade.

• Utilities (Electrical and Plumbing) :

9. All areas shall be well-lighted by providing fluorescent lamp/s or approved

equivalent with no exposed or dangling electrical wires. Also, convenience
outlets shall be amply provided within the facility.

10. For sanitation purposes, continuous supply of water shall be made

available at all times in both working and hand washing areas.

• Others:

11. Working area shall be provided with the required counters namely: 1) pass-
thru counter for receiving of specimenls and releasing of results and 2)
counter with pass-thru opening and glass panel for biometrics and picture
taking purposes.

12.Access to a regular toilet facility (provided with standard water closet and
lavatory including continuous supply of water), aside from the specimen
collection area, shall be provided for staff, clients and visitors' use.

Approved by :

ATLI~O{S . LUTERO Ill, CESO Ill

Director IV, DOH- HFS
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LABORATORY
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(11.00 SQ. MTS.)

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DOUBLE-WALL PARTITION
', WI LIGHT STEEL FRAMING
OR WOODEN FRAME;
ADOPT DOOR HEIGHT ; ·

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HALLWAY l..~~~-~--__j ENTRY

•
¢ 1.30_ cfx$ 3.20 ¢
SCHEMATIC FLOOR PLAN
SCALE 1:50 METERS

GRAPHICAL SCALE : 5 MTS

TOTAL FLR. AREA : 22.50 SQ. MTS.
0 1 kw/ffi'/////ft//////////////// /1 NOTE: SCHEME APPLICABLE TO RENTABLE UNIT ))
W/7///////jW/U//ffhf
Repubic of lhe Philippines TITLE OF HEALTH FACILITY PROJECT SHEET CONTENT 2
DEPARTMENT OF HEALTH
BUREAU OF HEALTH
PROTOTYPE FREE-STANDING SCHEMATIC FLOOR PLAN- SCHEME 2
z
FACILITIES & SERVICES
BUILDING NO. 15, San Lazaro Compound SCREENING DRUG TESTING LABORATORY (WITH TOILET FOR STAFF USE ONLY) m
Rizal Avenue. Sla. Cruz, Manila
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......
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 •

•
Republic of the Phiippines TITLE OF HEALTH FAC IUTY PROJECT SHEET CONTENTS
DEPARTMENT OF HEALTH
BUREAU OF HEALTH
FACILITIES &SERVICES PROTOTYPE FREE-STANDING SCREENING INTERIOR PERSPECTIVE • RECEPTION AREA
BUILDING NO. 15, San Lazaro Compound
DRUG TESTING LABORATORY (SCHEMATIC FLOOR PLAN N0.1)
Rizal Avenue, Sta. Cruz, Manila
 •

•
Republic of lhe Pf11ippines TITLE OF HEALTH FAC ILITY PROJECT SHEET CONTENTS
DEPARTMENT OF HEALTH
BUREAU OF HEALTH
FACILITIES &SERVICES PROTOTYPE FREE-STANDING SCREENING INTERIOR PERSPECTIVE ·WORKING AREA
BUILDING NO. 15, San Lazaro Compound DRUG TESTING LABORATORY (SCHEMATIC FLOOR PLAN N0.1)
Rizal Avenue, Sta. Cn.a, Manila