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Licensing/Accreditation Requirements

 

 

I.  BUREAU OF FOOD AND DRUGS                                                                          

  1. Registration Requirements

         

                                                                                                             
II. BUREAU OF HEALTH DEVICES AND TECHNOLOGY

    1.   X-ray Facilities

1.1   Application Form
 1.2  Checklist of Requirements
1.3  Documents to be Submitted

Administrative Order

    

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III. BUREAU OF HEALTH FACILITIES AND SERVICES     

  • LAWS  
  1. Republic Act No 4226 "Hospital Licensure Act of 1965"      
  2. Republic Act No. 4688 "Clinical Laboratory Act of 1966"
  3. Republic Act No. 9165 "Comprehensive Dangerous Act of 2003"  
  4. Republic Act No. 9288 "   An Act Promulgating A Comprehensive Policy and a National System for Ensuring Newborn Screening"       
  • ISSUANCES

DEPARTMENT CIRCULAR

1. Department Circular No. 2004-0134 "Permits Issued by Other National Government Agencies and by Local Government Units
ADMINISTRATIVE ORDER
1. Administrative Order No. 2007-0004-A   "Amendment to Administrative Order No. 2006-0004: Guidelines for the Issuance of Certificate of Need to Establish a New Hospital"
2. Administrative Order No. 2007-0001   "Revised Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services and Centers for Health Development in Relation to the Regulation of Health Facilities and Services and Validity Period of License to Operate, Accreditation, Authority to Operate, and Clearance to Operate for Certain Health Facilities and Services"
3. Administrative Order No. 2006-0037 "Amendment To Administrative Order No. 163 s. 2004; Rules And Regulations Governing The Registration, Licensure And Operation of Dialysis Clinics in the Philippiines"
4. Administrative Order No. 2006-0036 "Schedule of Fees for Certain Services Rendered by the Centers for Health Development in Relation to Presidential Decree No. 856 Code on Sanitation in the Philippines"
5. Administrative Order No. 2006-0024 "Rules and Regulations Governing the Accreditation of Laboratories for Drinking Water Analysis"
6. Administrative Order No. 2006-0004 "Guidelines for the Issuance of Certificate of Need to Establish a New Hospital"
7. Administrative Order No. 0029, s, 2005 Amendment to Administrative Order No. 147, s. 2004
8. Administrative Order No. 183 s. 2004 "Rules and Regulations Governing the Licensure and Regulation of Ambulatory Surgical Clinics"
9. Administrative Order No. 181 s. 2004 "Revised Rules and Regulations governing Accreditation of Medical Facilities for Overseas Workers and Seafarers"
10. Administrative Order No. 163 s. 2004 Revised Rules and Regulations Governing Registration, Licensure and Operation of Dialysis Clinics in the Philippines
11. Administrative Order No. 147 s. 2004 "Amending Administrative Order No. 70-A, series 2002 re: Revised Rules and Regulations Governing the Registration, Licensure and Operation of Hospitals and Other Health Facilities in the Philippines"
12. Administrative Order No. 114 s. 2003 "Suspension of the Implementation of Administrative Order NO. 70-A, s. 2002"
13. Administrative Order No. 105 s. 2003 "Revised Rules and Regulations Governing the Registration and Licensure of Dental Laboratories in the Philippines"
14. Administrative Order No. 101-A, s. 2003 "Rules and Regulations Governing Authorization of Blood Collection Unit and Blood Station"
15. Administrative Order No. 81, s. 2003 "Rules and Regulations Governing Accreditation of Hospitals Engaged in the Conduct of Kidney Transplantation"
16. Administrative Order No. 48 s. 2003 "Classification of Clinical Laboratories Based on Institutional Character"
17. Administrative Order No. 28, s.2003 "Revised Rules and Regulations Governing the Registration and Licensure of Dental Laboratories in the Philippines"
18. Administrative Order No. 1, s. 2003 "Operational Guidelines in the Conduct of Pre-Employment Medical Examination of Overseas Workers and Seafarers"
19. Administrative Order No. 127, s. 2002 "Amendment to Administrative Order No. 70-A, s. 2002 "Revised Rules and Regulations Governing the Registration, Licensure and Operation of Hospitals and Other Health Facilities in the Philippines" 
20. Administrative Order No. 118, s. 2002   "Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services"
21. Administrative Order No. 102, s. 2002 "Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services"
22. Administrative Order No. 70-A, s. 2002 "Revised Rules and Regulations Governing the Regulation, Licensure and Operation of Hospitals and Other Health Facilities in the Philippines."
23. Administrative Order No. 59, s. 2001 "Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines."

BUREAU MEMORANDUM/CIRCULAR
1. Bureau Memorandum No. 1, 2006 "Clarifications on the Implementation of Admin Order No. 2006-0004"
2. Bureau Circular No. 002, s. 2005 "Licensure Standards for Birthing Homes"
3 Bureau Circular No. 003, s.2005 "Licensure Standards for Psychiatric Care Facilities"
4. Bureau Circular No. 10, s. 2004 Performance of Immunology/Serology by Secondary Clinical Laboratories
5. Bureau Circular No. 5,  s. 2003 "Certificate of Qualification to Hold a Laboratory Position as Licensing Requirement"
6. Bureau Circular No. 4, s. 2003 "Transfer of Drug Testing Laboratory, When Considered As Renewal Application"
7.. Bureau Circular No. 3,  s. 2003 "Moratorium on the Issuance of Permit to Construct and License to Operate Free Standing Clinical Laboratories Nationwide"
7. Bureau Circular No. 2,  s. 2003 "Amendment on the Issuance of License to Operate/Accreditation of a New Drug Testing Laboratory" 
8. Bureau Memorandum No. 1,  s. 2003 "Extension of Validity of License to Operate/Accreditation Issued by the DDB/LTO"
9. Bureau Memorandum No. 5,  s. 2002  "Exemption from Permit to Construct for Existing Health Facilities Providing Maternity Service"
10. Bureau Memorandum No. 3,  s. 2002 "Clarification Regarding Administrative Order No. 59  s. 2001"
11. Bureau Memorandum No. 2,  s. 2002 "Effectivity of Administrative Order No. 70-A  s. 2002"
10. Bureau Memorandum No. 1,  s. 2002 "Necessary Permits as Requirements for Issuance of License and Renewal of License"

DEPARTMENT MEMORANDUM
1. Department Memorandum No. 2006-0026 "Dissemination of Administrative Order No. 2005-0029 and other Administrative Issuances Related to the Regulation of Health Services
2. Department Memorandum No. 117 s. 2004 "Licensure Standards for Hospitals and Infirmaries and their Implementing Guidelines"
3. Department Memorandum 148 s. 2003 "Clarification on Physical Plant Requirements of Clinical Laboratories"
4. Department Memorandum 51-A s. 2003 "Changes in the Licensing Requirements for First, Second and Third Level Referral Hospitals, and Infirmary"
5. Department Memorandum No. 37-A  s. 2003 "Headship of the Clinical Laboratory and Number of Laboratories a Pathologist Can Handle"
6. Department Memorandum No. 145 s. 2002 "Changes in the Licensing Requirements for First Level Referral Hospital, Second Level Referral Hospital, Third Level Referral Hospital, and Infirmary"
7. Department Memorandum No. 2006-0102 Laboratory Containment of Wild Poliovirus National Inventory Questionnaire ( Laboratory Downloadable Forms)

IMPLEMENTING RULES AND REGULATIONS

  1. Rules and Regulations Implementing Republic Act No. 9288 Otherwise Known As The "Newborn Screening Act of 2004"

  2. Implementing Rules and Regulations Governing Accreditation of Drug Testing Laboratories in the Philippines (As Revised)

  3. Implementing Rules and Regulations Governing Accreditation of Drug Abuse Treatment and Rehabilitation Centers and Accreditation of Center Personnel
 
  • REQUIREMENTS
  1. Clinical Laboratory

1.1   Application for Permit to Construct
1.2   Checklist for Review of Floor Plans
1.3   Licensing Requirements
1.4   Petition to Establish, Operate and Maintain a Clinical Laboratory
1.5   Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory
1.6  Inspection Tool
1.7  National Laboratory Inventory for Wild Poliovirus Infectious and/or Potentially Infectious Materials
1.8  Laboratory Inventory Form

  1. Hospital and other Health Facilities

2.1  Classification of Hospitals and other Health Facilities
2.2 Application Form for Certificate of Need for General Hospitals
2.3  Evaluation Tool - CON
2.4  Evaluation Tool - CON for concurrent application 

2.5  Licensing Requirements

2.5.1  Level 1
2.5.2  Level 2
2.5.3  Level 3
2.5.4  Level 4
2.5.5  Birthing Home
2.5.6  Acute - Chronic Psychiatric Care Facility
2.5.7 Custodial Psychiatric Care Facility

2.6  Guidelines in the Planning & Design of a Hospital and other Health Facilities
2.7 Application for Permit to Construct

2.8 Checklist for Review of Floor Plans

2.8.1  Level 1
2.8.2  Level 2
2.8.3  Level 3
2.8.4  Level 4
 2.8.5  Birthing Home
2.8.6  Acute-Chronic Psychiatric Care Facility
2.8.7  Custodial Psychiatric Care Facility
2.8.9  Comments

2.9  Application for License to Operate a Hospital or Other Health Facility
2.10 Assessment Tool (For Facility Owners)

2.10.1 Level 1
2.10.2 Level 2
2.10.3 Level 3
2.10.4 Level 4
2.10.5 Birthing Home
2.10.6 Acute-Chronic Psychiatric Care Facility
2.10.7 Custodial Psychiatric Care Facility

2.11  Inspection Tool

2.11.1  Level 1
2.11.2  Level 2
2.11.3  Level 3
2.11.4  Level 4
 2.11.5  Birthing Home
2.11.6  Acute-Chronic Psychiatric Care Facility
2.11.7  Custodial Psychiatric Care Facility 

2.12  Summary of Evaluation
2.13 Annual Statistical Report
2.14  Implementing Guidelines on the Licensure Standards for Hospitals and Infirmaries for Regulatory Officers
    3.  Kidney Transplantation Facility

         3.1  Application for Accreditation
         3.2   Checklist for Accreditation

  1. Drug Testing Laboratory

4.1  Application for Accreditation of Drug Testing Laboratory
4.2 Assessment Tool (For Facility Owners)
4.3 Checklist for Accreditation (For Regulatory Officers)

  1. Medical Facilities for Overseas Workers and Seafarers


5.1  Application for Permit to Construct
5.2  Checklist for Review of Floor Plans
5.3  Checklist for Accreditation (Inspection/Monitoring)
5.4  Application for Accreditation
  1. Health Maintenance Organizations (HMO)


6.1  Requirements for Initial Clearance to Operate HMO
6.2  Requirements for Renewal of Clearance to Operate HMO
 6.3  Application Form (initial/renewal)
  1. Dental Laboratory


7.1  Application Form
7.2  Inspection Tool
  1. Licensed Dialysis Clinics


8.1  Licensing Requirements
8.2  Application for Permit to Construct a Dialysis Clinic
8.3  Checklist for Review of Floor Plans
8.4  Application for License to Operate a Dialysis Clinic
8.5  Assessment Tool (For Facility Owners)
8.6  Inspection Tool (For Regulatory Officers)

  1. Ambulatory Surgical Clinics


9.1  Application for Permit to Construct
9.2 Checklist for Review of Floor Plans
9.3  Application for License to Operate
9.4  Inspection Tool
      9.4.1  Part I and II (for all Ambulatory Surgical Clinics)
      9.4.2  Part III
               9.4.2.1  Colorectal Surgery
               9.4.2.2  General Surgery
               9.4.2.3  Opthalmologic Surgery
               9.4.2.4  Orthopedic Surgery
               9.4.2.5  Otolaryngologic Surgery
               9.4.2.6  Pediatric Surgery
               9.4.2.7  Plastic and Reconstructive Surgery
               9.4.2.8  Reproductive Health Surgery
               9.4.2.9  Thoracic Surgery
               9.4.2.10 Urologic Surgery
      9.5.3  Part IV  
  1. Blood Bank


10.1  Application Form for Initial
10.2  Application Form for Renewal
  1. HIV


11.1  Application Form for Initial
11.2  Application Form for Renewal 
  1. Training Laboratories


12.1 Application Form for Renewal
  1. Laboratory for Drinking Water Analysis

13.1  Application for Accreditation of Laboratory For Drinking Water Analysis
13.2  Assessment Tool for Accreditation
13.3  Checklist for Accreditation
13.4  Annexes
  1. Application for Examination as Registered/Licensed Masseurs
  1. Application for Examination as Registered/Licensed Embalmer

  16.   Drug Abuse Treatment and Rehabilitation Center (DATRC)

16.1 Application for Certificate of Accreditation of a Drug Abuse Treatment and        Rehabilitation Center

16.2 Checklist for Accreditation of Residential Drug Abuse Treatment and Rehabilitation
       Center (DATRC)

16.3 Checklist for Accreditation of Non-Residential Drug Abuse Treatment and        Rehabilitation Center (DATRC)
  17.   Newborn Screening Center

          17.1 Checklist for Accreditation of  Newborn Screening Center
          17.2 Application for Accreditation as a Newborn Screening Center