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Clinical Lab Form

This document contains an application for a license to operate a general clinical laboratory in the Philippines. It requests information such as the name and address of the laboratory, the head of the laboratory, laboratory classification and ownership details. It also contains a checklist of required documents for an initial or renewal application, including personnel lists, equipment lists, quality manuals and certificates of external quality assurance participation. The applicant must acknowledge and sign the form to attest to the truth and completeness of the information provided.
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0% found this document useful (0 votes)
304 views10 pages

Clinical Lab Form

This document contains an application for a license to operate a general clinical laboratory in the Philippines. It requests information such as the name and address of the laboratory, the head of the laboratory, laboratory classification and ownership details. It also contains a checklist of required documents for an initial or renewal application, including personnel lists, equipment lists, quality manuals and certificates of external quality assurance participation. The applicant must acknowledge and sign the form to attest to the truth and completeness of the information provided.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Republic of the Philippines

Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

APPLICATION FOR LICENSE TO OPERATE A GENERAL CLINICAL LABORATORY

Name of Laboratory :
Address of Laboratory :
No. & Street Barangay

City/ Municipality Province Region


Telephone/ Fax No. :

Head of the Laboratory :

Name of Owner :
Contact Number :

Classification According to

Ownership : [ ] Government [ ] Private

Function : [ ] Clinical Pathology [ ] Anatomic Pathology

Institutional Character : [ ] Institution Based [ ] Freestanding

Service Capability : [ ] Primary [ ] Secondary [ ] Tertiary [ ] Limited

Status of Application : [ ] Initial [ ] Renewal


License No.
Date Issued
Expiry Date

Checklist of Application Documents


Please tick () the appropriate boxes under column B or C. Shaded Items are not required.

A B C
Documents For Initial For Renewal
1. Notarized Application for License to Operate a Clinical Laboratory (this form)
Submit
2. List of Personnel (attached form)
changes only
3. Photocopies of the following:
3.1. Proof of qualification of the medical and paramedical staff
 Valid PRC ID
 Specialty Board Certificate of the medical staff
 Certificate of Training/ Record of Work Experience
3.2. Proof of employment of the medical, paramedical and administrative staff
3.3. Current Authority to Practice for government pathologists (AO No. 161 s. 2000)
Submit
4. List of Equipment/ Instrument (attached Form)
changes only
5. Health Facility Geographic Form (Location Map)
6. SEC/ DTI Registration (for private clinical laboratories) OR
Issuance or Board Resolution (for government clinical laboratories)
Submit
7. Quality Manual of Clinical Laboratory (to be fully implemented by January 2009)
changes only
8. Certificate of Participation in External Quality Assurance Program
Form-GCL-LTO-A
Revision:01
12/03/2014
Page 1 of 5
Acknowledgement

REPUBLIC OF THE PHILIPPINES )


CITY/ MUNICIPALITY OF ANGELES) S.S.

I, __________________________________, _____________, of legal age, ___________ , a resident


Name Civil Status Age
of_______________________________________________________________________________, after having been
Address
sworn in accordance with law hereby depose and say that I am executing this affidavit to attest to the completeness and

truth of the foregoing information and the attached documents required for the Licensure and Regulation of Clinical

Laboratories in the Philippines pursuant to Administrative Order No. 2007-0027 “Revised Rules and Regulations Governing

the Licensure and Regulation of Clinical Laboratories in the Philippines”.

_________________________
Signature

Before me, this ______ day of _________ 2020 in the City__________, Philippines personally appeared the
above affiant with ______________ issued on __________ at _________ , Known to me to be the same
person/s who executed the foregoing instrument and they acknowledge to me that the same is their free act
and deed.

Owner Passport Number Issued at/ on

known to me to be the same person/s who executed the foregoing instrument and they acknowledge to me that the same is

their free act and deed.

IN WITNESS WHEREOF, I have hereunto set my hands this ____day of ________, 2020.

Doc No. ________ NOTARY PUBLIC


Page No. ________ My Commission Expires
Book No. ________ Dec. 31, 20 ____
Series of ______________________

Form-GCL-LTO-A
Revision:01
12/03/2014
Page 2 of 5

APPLICATION AS HEAD OF CLINICAL LABORATORY


The Director
Health Facilities and Services Regulatory Bureau
Department of Health

Sir,

In compliance with the requirements of Republic Act (RA) No. 4688 and Administrative Order
(AO) No. 2007-0027, I have the honor to apply as head of:

______________________________________________________
Name of Clinical Laboratory

____________________________________________________________
Address of Clinical Laboratory

I. Name of Applicant:
Landline No.: Mobile No.:
Address:
II. Education and Training (Use additional sheets if necessary):
Medical School/ Institution:
Inclusive Dates/ Year Graduated:

Specialty Board Date Certified Training Institution


PBP Anatomic Pathology
1

PBP Clinical Pathology


PBP Anatomic and Clinical Pathology

Others: Specify

III. List all clinical laboratories supervised/ headed or associated with:

Name and Address of Clinical Laboratory Working Time Work Schedule


A. As Head
B. As Associate

I hereby certify that the foregoing statements are true. I assume full responsibility that the
operation of the clinical laboratory is in accordance with the Rules and Regulations pursuant
to RA 4688 and AO No. 2007-0027.

____________________________________
Signature over Printed Name

____________
Date

Form-CL-Head-A
Revision:01
12/03/2014

1
PBP – Philippine Board of Pathology
List of Personnel

Name of Laboratory :
Address of Laboratory :

Valid
Name Designation/ Position Highest Educational Attainment PRC Reg. No. Signature
From To

Annex A- List of Personnel


Form-GCL-LTO-A
Revision:01
12/03/2014
Page 4 of 5
List of Equipments, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials


List of Equipments, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials


List of Equipments, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials


List of Equipments, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials


List of Equipments, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials


List of Equipment’s, Reagent, Laboratory Ware and Materials for Specific Test

Name of Laboratory :
Address of Laboratory :

Test / Method Equipment Reagent / Media Laboratory Ware and Materials

Annex B- List of Equipment


Form-GCL-LTO-A
Revision:01
12/03/2014
Page 5 of 5

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