Republic of the Philippines

Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR ACCREDITATION OF DRUG TESTING LABORATORY

I. FACILITY INFORMATION

Name of Laboratory : RUGENE N. BERATO WELL LABORATORY DIAGNOSTIC CENTER

Complete Address : J. SAAVEDRA ST. TORIL
No. & Street Barangay
DAVAO CITY DAVAO DEL SUR REGION XI
City/Municipality Province Region
09434600629 welllaboratorydiagnosticcenter@gmail.com
Contact Number : E-mail Address
Name of Owner/Corporation : RUGENE N. BERATO

Name of Head of Laboratory : DR. EDMUNDO J. VISITACION, JR.

Application for: Initial New Existing with change/s. Specify

Renewal Accreditation No.: ___________________
Expiry Date: _______________________

Classification: Ownership: Government Private

Institutional Character: Institution-based Free-standing
Service Capability: Screening Confirmatory

II. TECHNICAL REQUIREMENTS Inspection Monitoring

Instruction: In the appropriate box, place a check mark (√) if the drug testing laboratory is compliant or x
mark (X) if it is not compliant.
STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
A. PERSONNEL
Every DTL shall have an adequate number of
qualified, trained, and competent staff to ensure
efficient and effective delivery of services.
ORGANIZATIONAL CHART
The organizational chart shall be clearly structured
indicating the name and designation of all personnel
with corresponding picture.
HEAD OF THE LABORATORY
Ø For SDTL
Free-standing
r Clinical Pathologist
r Physician trained in Laboratory
Management
r Chemist
Institution-based
r Clinical Pathologist/Trained Physician
r Chemist
r Medical Technologist
r Pharmacist
r Chemical Engineer

CERTIFIED TRUE AND CORRECT BY:

DOH-DTL-AT
GIEZABEL B. ABEDES Revision:03

Analyst/Medical Technologist 06/23/2015

Page 1 of 8
 STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
Ø For CDTL
r Clinical Pathologist
r Chemist
ANALYST
r Chemist
r Medical Technologist
r Pharmacist
r Chemical Engineer
201 FILES (All records should be within the laboratory
premises)
Ø HEAD OF LABORATORY
Name: ___________________________
r Resume
r PRC ID (Valid)
r PRC Board Certificate
r Written & notarized employment
contract/appointment as head of lab.
r For Clinical Pathologist, certificate from
Philippine Society of Pathologist
r For Non-Pathologist, Certificate of
Laboratory Management for DTL
conducted by DOH
Certificate No. _______________
r Job description (detailed description of
tasks, responsibilities and accounta-
bilities)
r Complete, updated and notarized list of
DTLs handled to include each address
and work schedule
For CDTL only:
r 2 years of active laboratory experience
in analytical toxicology
r If chemist, master’s degree in
chemistry/Biochemistry/other fields of
chemistry
Ø ANALYST
r Resume
r PRC ID (Valid)
r PRC Board Certificate
r Written & notarized employment
contract/appointment as analyst
r Certificate of training for SDTL conducted
by DOH
Certificate No. _______________
r Certificate of training for CDTL conducted
by DOH
Certificate No. _______________
r Job description (detailed description of
tasks, responsibilities & accountabilities)
Ø AUTHORIZED SPECIMEN COLLECTOR
(ASC) *Applicable for SDTL only
r Resume
r Written & notarized employment
contract/appointment as ASC
r Certificate of training conducted by the
Laboratory signed by HOL
r Job description (detailed description of
tasks, responsibilities & accountabilities)
CERTIFIED TRUE AND CORRECT BY:

GIEZABEL B. ABEDES DOH-DTL-AT

Revision:03
Analyst/Medical Technologist 06/23/2015
Page 2 of 8
 STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
Ø HEALTH STATUS
r Medical/Health Certificate (valid)
r Annual drug test report conducted by
another accredited DTL
WORK SCHEDULE
Ø Monthly schedule of duties and assignment
posted within the laboratory
B. PHYSICAL FACILITIES
The laboratory has adequate space for conduct of
its activities.
Ø FLOOR AREA

SCREENING LABORATORY
v FREE-STANDING
r Approved PTC (for new facility)
r Floor Area (20 sq.m.)

v INSTITUTION-BASED
r Working Area of Secondary/Tertiary
Clinical Lab. (designated area
Exclusive for drug testing)

CONFIRMATORY LABORATORY
r Floor Area (60 sq.m.)
r Stock Room
r Instrumentation Room

A laboratory of whatever category shall have within

its premises the following:
0 Receiving Area (can accommodates at least 5
clients at a given time)
• Suggestion box for Client’s Feedback
0 Toilet Facility
Ø POSTED IN CONSPICUOUS AREA
r For SDTL, poster detailing the process
flow of drug testing
r Vision, mission and objectives
r Organizational Chart
r Local Permits
r Licenses and Certificates of personnel
r NO SMOKING Signage
Ø SPECIMEN COLLECTION AREA (SDTL)
r Waterless urinal
r Handwashing Facility
0 Outside the toilet
0 Within, provided with partition
0 With free flowing water
supply from the faucet

Ø WORKING AREA
r At least 10sq.m. for free standing SDTL
r At least 30sq.m. for Confirmatory Lab.
r Sink (with countertop and faucet with
adequate water supply
r Functional exhaust fan
r Electric fan/air conditioner unit may be
used for improved ventilation
Ø PERIODIC SIGNAGE PER AREA
CERTIFIED TRUE AND CORRECT BY:

GIEZABEL B. ABEDES DOH-DTL-AT

Revision:03
Analyst/Medical Technologist 06/23/2015
Page 3 of 8
 STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
Ø WASTE MANAGEMENT AND
HOUSEKEEPING
r Solid Waste – Practice of waste
Segregation
r Liquid Waste
§ Proper disposal of urine specimen
§ Proper disposal of used and
expired reagents either by
neutralization, delay to decay or
through the drainage system
(Applicable for CDTL only)
r Housekeeping
§ Facility is kept clean, safe and
odor-free
§ There should be a program for
pest and vermin control
§ Supplies are kept and secured

Ø PROGRAM FOR THE PROPER

MAINTENANCE AND MONITORING OF
PHYSICAL PLANT AND FACILITIES

C. EQUIPMENT, SUPPLIES AND FIXTURES

r Schedule of preventive maintenance of
equipment
r Inventory relative to the workload and procurement
receipts of supplies
Ø REFRIGERATOR/FREEZER
r Properly maintained & functional, strictly for
urine specimen
r Laboratory thermometer inside
refrigerator/freezer (non-mercurial)
r Daily monitoring temperature record posted
on the unit
Ø INFORMATION TECHNOLOGY
REQUIREMENTS
§ Windows XP operating system
§ 1.5 GHz processor
§ 4GB HDD
§ ISP 128Kbps CIR
§ Fingerprint Biometric Scanning Device
§ Webcam (For SDTL only)
§ Megamatcher License Dangle
§ Ink or Laser printer
§ DOH-IDTOMIS
Ø SUPPLIES
r Specimen Container (For SDTL only)
- 60ml polyethylene, wide mouth with
screw cap
r Plastic Bag (For SDTL only)
- Transparent, self-sealing/sealable and
leak proof, capable of containing the
specimen & pertinent documents
(CCF)
r Gloves - disposable

CERTIFIED TRUE AND CORRECT BY:

GIEZABEL B. ABEDES
Analyst/Medical Technologist
DOH-DTL-AT
Revision:03
06/23/2015
Page 4 of 8
 STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
Ø FIXTURES
r Cabinet
- With lock to secure and store
records & supplies
r Tables/Chairs/Bench
- Tables and chairs allotted for
personnel
- Chairs/bench that can accommodate
at least 5 clients at the same time
D. STANDARD OPERATING PROCEDURES
The DTL shall have a Manual of Standard Operating
Procedures containing documented policies,
protocols, guidelines in the operation and
maintenance of the laboratory.
• Administrative Policies and Procedures
Ø Vision, Mission and Objectives (should be
in accordance with RA 9165 ”Comprehensive
Dangerous Drug Act of 2002”)
Ø Policy for hiring, orientation and
promotion for all levels of personnel
Ø Duties and Responsibilities of personnel
Ø Continuing Education/Training Program
for Staff
Ø Policy for discipline, suspension,
demotion and termination of all
personnel at all levels
Ø Procedures for handling complaints and
laboratory accidents
Ø Quality Plan
A written program/plan of management to assure
competence, integrity of drug testing
Ø Policy for waste management and
housekeeping
Ø Policy for equipment maintenance and
repair
• Technical Policies and Procedures
Ø Specimen Collection/ Sampling
(within the laboratory)
Ø Receiving, Accessioning and
Releasing of Specimen
Ø Specimen Rejection/ Cancellation
Ø Referral to Confirmatory Laboratory
when positive results was obtained
Ø Remote Collection
Ø Reagents, Standards and Controls
Ø Analytical Procedure
Ø Mechanism of Reporting Results
Ø Procedure for Security and
Confidentiality of Records, Supplies and
Specimen
Ø Storage and Disposal of Specimen
*For CDTL, include storage and disposal of
chemicals
Ø Internal Quality Assurance Program
Ø External Quality Assurance Program
Ø Good Laboratory Practice
CERTIFIED TRUE AND CORRECT BY:

GIEZABEL B. ABEDES
Analyst/Medical Technologist DOH-DTL-AT
Revision:03
06/23/2015
Page 5 of 8
 STANDARDS AND REQUIREMENTS INSPECTION MONITORING REMARKS
E. RECORDS/FILES
Ø Systematic filing and safekeeping of records
For SDTL
r Laboratory file copy of results with corresponding
attached test kit membrane (For Renewal)
r File of letters of request for confirmatory drug test
received by CDTL/with attached copy of receipt
from courier (For Renewal)
r File of submitted MFR through IDTOMIS (For
Renewal)
r Memorandum of Agreement with Confirmatory
Drug Testing Laboratory
Name of CDTL: __________________________

Ø FORMS (For SDTL)

For renewal, completely and properly filled-
out.
o Custody and Control Form (CCF)
o Consent Form
Ø LOGBOOKS
Properly labeled. For renewal, with updated
entries
o Remote Collection
o Receiving, Accessioning (For SDTL
and Releasing only)
o Confirmatory Test
o Test Results
o Quality Control Results
o Equipment Preventive Maintenance
o Storage and Disposal of Specimen
o Visitor’s Logbook
F. QUALITY IMPROVEMENT ACTIVITIES
The drug testing laboratory shall practice Quality
Assurance Program (QAP) and Continuous Quality
Improvement (CQI) reviewed periodically.
• Client Satisfaction Survey (e.g. comments,
feedback)
• Records of complaints and laboratory
accidents
• Corrective Actions Taken (For renewal)
• Management/staff meetings conducted at
least twice a year (with minutes of meetings)
– For Renewal
Ø EXTERNAL QUALITY ASSURANCE
PROGRAM (For Renewal of Accreditation)
r Application for proficiency test
r Record of receipt of samples for EQAS from
NRL
r Logbook/Record of PT Results
r Certificate of PT
r Record of corrective action taken when
evaluation of performance is below
satisfactory

CERTIFIED TRUE AND CORRECT BY:

GIEZABEL B. ABEDES
Analyst/Medical Technologist
DOH-DTL-AT
Revision:03
06/23/2015
Page 6 of 8
 Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Health Facility:

Date of Inspection:

RECOMMENDATIONS:

A. For Licensing Process:

[ ] For issuance of Certificate of Accreditation as Drug Testing Laboratory

Classification:
Validity from to

[ ] Issuance depends upon compliance to the recommendations given and submission of the
following within from the date of inspection:

[ ] Non-Issuance : Specify

Inspected by:

Name Position/Designation Signature

Received by:

Signature
Name
Position/Designation
Date

DOH-DTL-AT
Revision:03
06/23/2015
Page 7 of 8
 Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Health Facility:

Date of Monitoring:

RECOMMENDATIONS:

B. For Monitoring Process:

[ ] Issuance of Notice of Violation

[ ] Non-issuance of Notice of Violation

[ ] Others (Specify)

Monitored by:

Name Position/Designation Signature

Received by:

Signature
Name
Position/Designation
Date

DOH-DTL-AT
Revision:03
06/23/2015
Page 8 of 8