‘ONE-STOP SHOP’ LICENSING
| |Republic of the Philippines | |
| |Department of Health | |
| |HEALTH FACILITIES AND SERVICES REGULATORY BUREAU | |
Application for License to Operate a Dialysis Clinic
Name of Dialysis Clinic[1] :
Address of Dialysis Clinic :
No. & Street Barangay
City/ Municipality Province Region
Telephone/ Fax No. :
Medical Director of the
Dialysis Clinic :
Name of Owner :
Chairman of the Board
(If Corporation) :
Classification According to
Ownership : [ ] Government [ ] Private
Number of Hemodialysis : _____________________________________________________________
Stations
|Ancillary and Other Clinical Services: | |
| | |
|[ ] Clinical Laboratory |[ ] Pharmacy |
| [ ] Function | No. of satellite, please specify:_________ |
| [ ] Clinical Pathology | |
| [ ] Anatomic Pathology |[ ] Diagnostic X-ray Services |
| [ ] Service Capability | [ ] Level 1 |
| [ ] Limited | |
| [ ] Primary | |
| [ ] Secondary | |
| [ ] Tertiary | |
| | |
|[ ] HIV Testing Laboratory | |
| | |
|[ ] Laboratory for Drinking Water Analysis | |
| [ ] Bacteriological Analysis | |
| [ ] Chemical Analysis | |
| [ ] Physical Analysis | |
| [ ] Radiological Analysis | |
| | |
Status of Application : [ ] Initial [ ] Renewal
License No.
Date Issued
Expiry Date
Checklist of Application Documents
1) For INITIAL or RENEWAL, please tick (() the appropriate boxes under column B or C and provide necessary documents.
2) Items shaded are not required. However, if there are changes in information upon RENEWAL, please tick (() the appropriate boxes under column C and provide necessary documents.
|A |B |C |
|Documents |Initial |Renewal |
| |Application |Application |
|Required For All Dialysis Clinics | | |
| | | |
|Dialysis Clinic | | |
|Notarized duly accomplished Application for License to Operate a Dialysis Clinic (this form) | | |
|List of Personnel (use ANNEX A) | | |
|Photocopies of the following: | | |
|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 | | |
|Proof of employment of the medical, paramedical and administrative staff | | |
|List of Equipment/ Instrument (use ANNEX B) | | |
|Health Facility Geographic Form (Location Map) | | |
|Photocopy of DOH Permit to Construct | | |
|DTI/ SEC Registration (for private dialysis clinic) OR | | |
|Issuance or Board Resolution (for government dialysis clinic) | | |
|Manual of Operations/ SOP of Dialysis Clinic | | |
|Annual Summary Report of Patients Registered to the Renal Disease Registry (Certificate of Compliance) | | |
|Documented Quality Assurance Program (QAP) of Dialysis Clinic | | |
| | | |
|When Provided by the Dialysis Clinic | | |
| | | |
|Clinical Laboratory | | |
|List of Personnel (use ANNEX A) | | |
|Application as Head of Clinical Laboratory (use ANNEX C) | | |
|Photocopies of the following: | | |
|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 | | |
|Proof of employment of the medical, paramedical and administrative staff | | |
|Current Authority to Practice for government pathologists (AO No. 161 s. 2000) | | |
|List of Equipment/ Instrument (use ANNEX B) | | |
|Quality Manual of the Clinical Laboratory | | |
|Certificate of Participation in External Quality Assurance Program | | |
|Memorandum of Agreement, if not owned by the dialysis clinic | | |
| | | |
|Radiology | | |
|List of Diagnostic Radiology Services (use ANNEX D) | | |
|List of Personnel for Diagnostic Radiology Services (use ANNEX E) | | |
|For diagnostic radiology services, photocopies of the following: | | |
|Proof of qualification of radiologist and radiologic/ x-ray technologist | | |
|Valid PRC ID | | |
|Specialty Board Certificate (for radiologist) | | |
|Certificate of Training | | |
|List of X-ray Machines (use ANNEX F) | | |
|Photocopy of official receipt from PNRI for new film badge subscription for one year | | |
|Photocopy of film badge personal dose evaluation reports within the validity period of the health facility | | |
|license | | |
|Memorandum of Agreement, if not owned by the dialysis clinic | | |
| | | |
|HIV Testing Laboratory | | |
|List of Personnel (use ANNEX A) | | |
|Photocopies of the following: | | |
|Proof of qualification of medical technologist | | |
|Valid PRC ID | | |
|Certificate of Proficiency in HIV Testing | | |
|List of Testing Materials (use ANNEX G) | | |
| | | |
|Pharmacy | | |
|List of Personnel (use ANNEX A) | | |
|Photocopies of the following: | | |
|Proof of qualification of pharmacist | | |
|Valid PRC ID | | |
|Certificate of Training in Licensing of Drug Establishments and Outlets | | |
|List of Products (use ANNEX H) | | |
|Memorandum of Agreement, if not owned by the dialysis clinic | | |
| | | |
|Laboratory for Drinking Water Analysis | | |
|List of Personnel (use ANNEX A) | | |
|Photocopies of the following: | | |
|Proof of qualification of head of the laboratory, analyst and laboratory aide/technician | | |
|Valid PRC ID, if applicable | | |
|PSP Certificate, if applicable | | |
|PAM Registration, if applicable | | |
|Certificate of Training/ Record of Work Experience | | |
|Proof of employment of the analyst and laboratory aide/technician | | |
|List of Parameters for Each Service Capability (use ANNEX I) | | |
|List of Equipment, Reagent, Laboratory Ware and Materials for Specific Test ( fill-up ANNEX J using the | | |
|Drinking Water Analysis Guide posted at the DOH Website) | | |
|Quality Manual for Drinking Water Analysis | | |
| | | |
Acknowledgement
Republic of the Philippines )
City/Municipality of _______________ ) S. S.
I, ____________________________, ____________________________, of legal age, ______________, a resident of __________________________________________________, after having been 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 and to the dialysis clinic’s compliance with all standards and requirements for the Initial/ Renewal of License to Operate a Dialysis Clinic and its ancillary services as set by the Department of Health.
_____________________________
Signature
Before me, this ______ day of ______________, 20____ in the City/ Municipality of _____________________, Philippines, personally appeared the above affiant with Community Tax Certificate No. _________________ 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.
IN WITNESS WHEREOF, I have hereunto set my hands this _________day of _______________, 20___.
NOTARY PUBLIC
My Commission Expires
December 31, 20______
Doc. No. ;
Page No. ;
Book No. ;
Series of 20
[pic]List of Equipment[2]
Name of Health Facility :
Address of Health Facility :
|Brand Name & Model |Serial No. |Quantity |Date of Purchase |
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Use additional sheets when necessary
APPLICATION AS HEAD OF CLINICAL LABORATORY
The Director
Health Facilities and Services Regulatory Bureau/DOH-Regional Office
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[3] Anatomic Pathology | | |
|PBP Clinical Pathology | | |
|PBP Anatomic and Clinical Pathology | | |
|Others: Specify_________ | | |
III. List all clinical laboratories/ HIV-testing laboratory/ blood bank 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
List of Diagnostic Radiology Services
Name of Health Facility :
Address of Health Facility :
Please tick (() appropriate box/es.
Level One includes the following non-contrast x-ray examinations:
| Abdomen | Shoulder girdle |
| Chest for heart and lung | Skull |
| Extremities | Thoracic cage |
| Localization of foreign body | Vertebral column |
| Pelvis | |
Dental x-ray examinations – done with a dedicated x-ray unit equipment such as:
| Panoramic/ Cephalometric | Periapical |
[pic]
List of X-ray Machines
Name of Health Facility :
Address of Health Facility :
|* Type of X-ray Machine |Number of |Brand |Model |Serial No |Diagnostic X-ray Machines |** Location |
| |X-ray | | | | | |
| |machine | | | | | |
| |
|* For Type, indicate whether ** For Location, indicate location of x-ray machine such as : |
|- Radiography (mobile/ stationary) - Radiology Department (Room 1, 2, 3, etc.) |
|- Dental x-ray machine (panoramic/ cephalometric/ periapical) |
|- Transportable |
| |
Use additional sheets when necessary
List of Testing Materials
Name of Health Facility :
Address of Health Facility :
A. Screening Test/s, specify name of kit:
| |EIA | |Lot No. |
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| |PA | |Lot No. |
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B. Supplemental Test/s, specify name of kit:
| |WB | |Lot No. |
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| |IF | |Lot No. |
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| |Others | |Lot No. |
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List of Products
Name of Health Facility :
Address of Health Facility :
|Generic Name |Brand Name |Quantity |Expiry Date |
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Use additional sheets when necessary
[pic]
List of Equipment, Reagent and Laboratory Ware for Laboratory for Drinking Water Analysis[4]
Name of Health Facility :
Address of Health Facility :
|Test/ Method |Equipment |Reagent/ Media |Laboratory Ware and Materials |
| |Brand Name & Model |Serial No. |Quantity |Date of Purchase | | |
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[1] The name of dialysis clinic should match the DTI/ SEC Registration and Mayor’s/ Business Permit.
[2] Equipment should be present, functional, and owned by the health facility applying for license to operate (Dialysis Clinic or Ambulatory Surgical Clinic) or certificate of accreditation (Medical Facility for Overseas Workers and Seafarers).
[3] PBP – Philippine Board of Pathology
[4] Equipment, reagent and laboratory ware should be present, functional, and owned by laboratory applying for accreditation.
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Form-OSS-DC-LTO-A
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12/03/2014
Page 1 of 14
Form-OSS-DC-LTO-A
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Form-OSS-DC-LTO-A
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Home Address
Designation
Name
Civil Status
Form-OSS-DC-LTO-A
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Annex A
Annex A-List of Personnel
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Page 5 of 14
Annex A
Annex B
Annex B- List of Equipment
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Annex C
Form-CL-Head-A
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Annex D
Annex D-List of Diagnostic Radiology Services
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Page 8 of 14
Annex E-List of Personnel for Diagnostic Radiology
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Annex E
Annex F
Annex F-List of X-ray Machines
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Annex G
Annex G-List of Testing Materials
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Annex H
Annex H-List of Products
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Annex I-List of Parameters for Each Service Capability
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Annex I
Annex J
Annex J-List of Equipment, Reagent, and Laboratory Ware for Laboratory for Drinking Water Analysis Revision:01
12/03/2014
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