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Hospital Licensing Process

“Rules and Requirements Explained”




       DEPARTMENT OF HEALTH
BUREAU OF HEALTH FACILITIES AND SERVICES
        Atty. Nicolas B. Lutero III, CESO III
                    Director IV
Objectives
1. General
    To acquire a broad-based view of the hospital
    licensing process.
2. Specific
    To orient stakeholders on the rules and
      requirements involved in hospital licensing;
    To     clarify    issues   and      enlighten
      stakeholders on rules and requirements in
      hospital licensing.
Acronyms
1. BHFS – Bureau of Health Facilities
     and Services
2.   CHD     –    Center    for   Health
   Development
3. CON – Certificate of Need
4. PTC – Permit to Construct
5. OSS – One-Stop Shop
6. LTO – License to Operate
7. AO – Administrative Order
DOH Website
          www.doh.gov.ph

          Doing Business

             Licensing

        BHFS Requirements

Hospitals and Other Health Facilities
The process has 3 phases:

1. Pre-inspection Phase
2. Inspection Phase
3. Post-inspection Phase
Pre-inspection Phase
1. Goal:
  a) To coordinate with the health
     facility to be visited;
  b) To inform the management of the
     purpose of the inspection and
     their participation in the activity.
Pre-inspection Phase
2. Activities:
  a) Fill up application form
  b) Inspection activity agenda
  c) Copy of Administrative Order
     and other related issuances
  d) Checklist of documents to be
     available during inspection
Inspection Phase

Goal:
 To encourage interactive
 participation of the key staff
 in the inspection process.
Inspection Phase
Activities:
b)Leadership interview
c)Document review session
d)Tour of the health facility
e)Feedback session
Post-inspection Phase

Goal:
 To make a decision on the extent
 to which the health facility is able
 to meet the minimum licensing
 requirements.
Post-inspection Phase
Activities:
b)Regulatory officers collate findings.
c) The team prepares the report.
d)The team submits the report together
   with its recommendations to the director
   of the CHD.
e)The CHD director approves or
   disapproves the issuance of the LTO.
Process Flow
   CHD
Secretariat



              NO        Health
Documents               facility
 complete               owner

       YES


CHD cashier        Pre-inspection Phase
Process Flow
                 Head of the licensing
                    team at CHD
  Additional
requirements
                      Inspection          MD, RN, RMT,
                                         FDRO, HEALTH
     Non-compliance   proper plus          PHYSICIST,
                                           ENGINEER
                       feedback

                           Compliance


               CHD director approves
                 issuance of LTO          Inspection and
                                          Post-inspection
                                              Phases
Hospital Licensing Process

      STANDARDS                   BHFS/              FEEDBACK
                                   CHD             Review of accomplished
   Legislative Acts
   Rules & Regulations           DOH               forms (application,
                                                    inspection, evaluation)
   Technical Requirements
                                                   Monitoring reports
   Administrative SOPs
                                                   Oral reports
   Manuals
                                                   Written reports
                                                   Complaints
                                                   Consultation meetings
                                                   Hospital performance
   INPUT                 PROCESS
                                                    OUTPUT
 Manpower               Application        Accomplished forms(application,
 Forms                  Payment of fees     inspection, evaluation forms)
 Office/ furniture      Processing         Certificate of Need
 Clerical support       Inspection         Permit to Construct
 Travel fund            Evaluation         Hospital license
                         Action             Reports
                         Education          Enlightened hospital staff
Certificate of Need (CON)
A legal document issued by the CHD
 regulatory agency with authority over an
 area which affirms that a proposed
 acquisition, expansion or creation of a
 medical facility falling under that authority
 is required to fulfill the needs of a
 community.
This certificate is necessary for the
 construction of a medical facility to be
 issued by the responsible CHD.
                                 www.wikipedia
CON
Criteria for the establishment of a new
  general hospital:
2.Bed to population ratio shall not be
  more than 1 bed per 1,000 population
  (1:1,000);
3.Travel time – proposed hospital shall
  be at least 1 hour away from the
  nearest existing hospital;
4.Accessibility – strategically located;
                             AO No. 2006 - 0004
CON

Criteria for the establishment of a new
 general hospital:
3.Integration   with    Provincial/          City
  Strategic Plan for the Rationalization of
  the Health Care Delivery System Based
  on Health Needs;
4.Track record.             AO No. 2006 – 0004
                                AO No. 2006 – 0004 A
                                AO No. 2006 – 0004 B
                                AO No. 2006 – 0029
CON
Requirements for general hospitals:
 Application form for CON
 Certification  from the Provincial
  Planning and Development Office that
  the proposed hospital is part of the
  duly approved Provincial Hospital/
  Health Care Delivery Plan (if available)

                              AO No. 2006 - 0004
Permit to Construct (PTC)
A PTC is a pre-requisite for LTO.
It is required for:
     Construction of a new hospital or other
      health facility;
     Substantial alteration, expansion or
      renovation of an existing hospital or
      other health facility;
     Change in classification
     Increase in bed capacity  Republic Act 4226
                                   AO No. 147 s. 2004
Application for PTC

1. Three sets of site development & architectural floor plans:
   a) Signed and sealed by an architect
   b) Showing all areas with appropriate scale, dimensions,
      and labels
2. For new hospitals:
   a) CON from the CHD
   b) Zoning certificate/ location clearance from the City/
      Municipal Planning and Development Office
   c) DTI/ SEC Registration (for private hospital)
   d) Board Resolution (for government hospital)
One-Stop Shop (OSS)
DOH strategy to harmonize licensure of hospitals, its
  ancillary and other facilities, such as but not limited to,
  the following:
    Clinical laboratory;
    HIV testing;
    Drinking water analysis;
    Drug testing;
    Blood bank, blood collection unit, and blood station;
    Dialysis clinic;
    Ambulatory surgical clinic;
    Pharmacy;
    Medical x-ray facility.
                                          AO No. 2007 – 0021
OSS Exclusion
OSS excludes the following:
   Hospital-based medical facility for
    overseas workers and seafarers;
   Hospital-based drug abuse treatment
    and rehabilitation center;
   Facility using radioactive material
    regulated by the PNRI;
   Performance of kidney transplantation.
                             AO No. 2007 – 0021
Application for OSS

Required for all hospitals:
2. Hospital documents
3. Clinical Laboratory
4. Pharmacy
5. Radiology

                     AO No. 2007 - 0021
OSS
When provided by the hospital :
2. Dialysis Clinic
3. Blood Station/ Blood Collection Unit
4. Blood Bank
5. HIV Testing Laboratory
6. Laboratory for Drinking Water Analysis
7. Drug Testing Laboratory
8. Ambulatory Surgical Clinic
9. Birthing home or CEmOC
                                AO No. 2007 - 0021
Classification of Hospitals
 A. By function
    1. General
    2. Special
 B. By service capability
    1. Level 1
    2. Level 2
    3. Level 3
    4. Level 4
                        AO No. 2005 - 0029
Classification of Clinical Labs
By service capability
 1. General Clinical Lab
     a. Primary Category
     b. Secondary Category
     c. Tertiary Category
     d. Limited Service
 2. Special Clinical Lab
                        AO No. 2007 - 0027
                        DM No. 2009 - 0086
Classification of X-ray Facilities
By service capability:
 1. Level 1 – < 100 ma
 2. Level 2 – > 100 ma
     special procedures with contrast
 3. Level 3 – > 300 ma with image
     intensifier system
     (e.g. interventional radiology)
                             AO No. 35 s. 1994
Schedule of Fees
a) The applicant, upon filing the application,
  shall pay at the CHD or DOH cashier.
b) Fees for the OSS licensure system shall
  be regularly reviewed by the BHFS, BHDT,
  and BFAD in consultation with the CHDs
  and stakeholders.
c) All fees, surcharges, and discounts shall
  follow the current DOH prescribed
  schedule of fees.
                               AO No. 2007 – 0023
Validity of LTO


The LTO shall be valid for one
 year from January 1 to
 December 31.

                    AO No. 2007 – 0021

                    Republic Act 4226
Sanctions

• 1st violation – written warning
• Violations involving basic hospital
  licensing requirements:
   2nd violation – Php 30,000.00
   3rd violation – Php 50,000.00

                            AO No. 2007 - 0022
Sanctions

1. Violations involving facilities/     services    not
   required for hospital licensure:
               2nd violation – Php 20,000.00
      Every subsequent violation – additional 20%
       of the previous fine
4. Fine imposition procedures:
      Fines should be paid within 10 working days
       after receipt of the official notice.
      A surcharge of 3% shall be imposed for each
       month of delay in payment.     AO No. 2007 - 0022
Sanctions

Violations involving basic hospital
  licensing requirements:
   4th violation – suspension or
    revocation of the LTO
                        AO No. 2007 - 0022
ISSUES/ CONCERNS

     cyros_2005@yahoo.com.ph
    711-95-72, 743-83-01 loc 2525
   Standards Development Division
Bureau of Health Facilities and Services
         Department of Health
BHFS
 Division         Contact          Landline
                  person
 Standards
Development      Dr. Cynthia   743-8301 loc 2525;
  Division       Rosuman           711-9572
Licensing and
Accreditation   Dr. Mercedes 743-8301 loc 2502 –
   Division         Palma      2504; 711-6982

Monitoring &
Surveillance
                 Dr. Beauty    743-8301 loc 2528
  Division      Palongpalong
Related Issuances
     Health Facility                  AO
     Dialysis Clinic          AO No. 163 s. 2004
   Blood Station/ Blood       AO No. 2008 – 0008
      Collection Unit
      Blood Bank              AO No. 2008 – 0008
 HIV Testing Laboratory       AO No. 2005 – 0027
 Laboratory for Drinking      AO NO. 2006 – 0024
     Water Analysis
Drug Testing Laboratory      IRR revised July 11, 2003
Ambulatory Surgical Clinic    AO No. 183 s. 2004
Birthing Home or CEmOC        AO No. 2007 – 0039

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Hospital licensing process_up_cph[1]

  • 1. Hospital Licensing Process “Rules and Requirements Explained” DEPARTMENT OF HEALTH BUREAU OF HEALTH FACILITIES AND SERVICES Atty. Nicolas B. Lutero III, CESO III Director IV
  • 2. Objectives 1. General To acquire a broad-based view of the hospital licensing process. 2. Specific  To orient stakeholders on the rules and requirements involved in hospital licensing;  To clarify issues and enlighten stakeholders on rules and requirements in hospital licensing.
  • 3. Acronyms 1. BHFS – Bureau of Health Facilities and Services 2. CHD – Center for Health Development 3. CON – Certificate of Need 4. PTC – Permit to Construct 5. OSS – One-Stop Shop 6. LTO – License to Operate 7. AO – Administrative Order
  • 4. DOH Website www.doh.gov.ph Doing Business Licensing BHFS Requirements Hospitals and Other Health Facilities
  • 5. The process has 3 phases: 1. Pre-inspection Phase 2. Inspection Phase 3. Post-inspection Phase
  • 6. Pre-inspection Phase 1. Goal: a) To coordinate with the health facility to be visited; b) To inform the management of the purpose of the inspection and their participation in the activity.
  • 7. Pre-inspection Phase 2. Activities: a) Fill up application form b) Inspection activity agenda c) Copy of Administrative Order and other related issuances d) Checklist of documents to be available during inspection
  • 8. Inspection Phase Goal: To encourage interactive participation of the key staff in the inspection process.
  • 9. Inspection Phase Activities: b)Leadership interview c)Document review session d)Tour of the health facility e)Feedback session
  • 10. Post-inspection Phase Goal: To make a decision on the extent to which the health facility is able to meet the minimum licensing requirements.
  • 11. Post-inspection Phase Activities: b)Regulatory officers collate findings. c) The team prepares the report. d)The team submits the report together with its recommendations to the director of the CHD. e)The CHD director approves or disapproves the issuance of the LTO.
  • 12. Process Flow CHD Secretariat NO Health Documents facility complete owner YES CHD cashier Pre-inspection Phase
  • 13. Process Flow Head of the licensing team at CHD Additional requirements Inspection MD, RN, RMT, FDRO, HEALTH Non-compliance proper plus PHYSICIST, ENGINEER feedback Compliance CHD director approves issuance of LTO Inspection and Post-inspection Phases
  • 14. Hospital Licensing Process STANDARDS BHFS/ FEEDBACK CHD  Review of accomplished  Legislative Acts  Rules & Regulations DOH forms (application, inspection, evaluation)  Technical Requirements  Monitoring reports  Administrative SOPs  Oral reports  Manuals  Written reports  Complaints  Consultation meetings  Hospital performance INPUT PROCESS OUTPUT  Manpower  Application  Accomplished forms(application,  Forms  Payment of fees inspection, evaluation forms)  Office/ furniture  Processing  Certificate of Need  Clerical support  Inspection  Permit to Construct  Travel fund  Evaluation  Hospital license  Action  Reports  Education  Enlightened hospital staff
  • 15. Certificate of Need (CON) A legal document issued by the CHD regulatory agency with authority over an area which affirms that a proposed acquisition, expansion or creation of a medical facility falling under that authority is required to fulfill the needs of a community. This certificate is necessary for the construction of a medical facility to be issued by the responsible CHD. www.wikipedia
  • 16. CON Criteria for the establishment of a new general hospital: 2.Bed to population ratio shall not be more than 1 bed per 1,000 population (1:1,000); 3.Travel time – proposed hospital shall be at least 1 hour away from the nearest existing hospital; 4.Accessibility – strategically located; AO No. 2006 - 0004
  • 17. CON Criteria for the establishment of a new general hospital: 3.Integration with Provincial/ City Strategic Plan for the Rationalization of the Health Care Delivery System Based on Health Needs; 4.Track record. AO No. 2006 – 0004 AO No. 2006 – 0004 A AO No. 2006 – 0004 B AO No. 2006 – 0029
  • 18. CON Requirements for general hospitals:  Application form for CON  Certification from the Provincial Planning and Development Office that the proposed hospital is part of the duly approved Provincial Hospital/ Health Care Delivery Plan (if available) AO No. 2006 - 0004
  • 19. Permit to Construct (PTC) A PTC is a pre-requisite for LTO. It is required for:  Construction of a new hospital or other health facility;  Substantial alteration, expansion or renovation of an existing hospital or other health facility;  Change in classification  Increase in bed capacity Republic Act 4226 AO No. 147 s. 2004
  • 20. Application for PTC 1. Three sets of site development & architectural floor plans: a) Signed and sealed by an architect b) Showing all areas with appropriate scale, dimensions, and labels 2. For new hospitals: a) CON from the CHD b) Zoning certificate/ location clearance from the City/ Municipal Planning and Development Office c) DTI/ SEC Registration (for private hospital) d) Board Resolution (for government hospital)
  • 21. One-Stop Shop (OSS) DOH strategy to harmonize licensure of hospitals, its ancillary and other facilities, such as but not limited to, the following:  Clinical laboratory;  HIV testing;  Drinking water analysis;  Drug testing;  Blood bank, blood collection unit, and blood station;  Dialysis clinic;  Ambulatory surgical clinic;  Pharmacy;  Medical x-ray facility. AO No. 2007 – 0021
  • 22. OSS Exclusion OSS excludes the following:  Hospital-based medical facility for overseas workers and seafarers;  Hospital-based drug abuse treatment and rehabilitation center;  Facility using radioactive material regulated by the PNRI;  Performance of kidney transplantation. AO No. 2007 – 0021
  • 23. Application for OSS Required for all hospitals: 2. Hospital documents 3. Clinical Laboratory 4. Pharmacy 5. Radiology AO No. 2007 - 0021
  • 24. OSS When provided by the hospital : 2. Dialysis Clinic 3. Blood Station/ Blood Collection Unit 4. Blood Bank 5. HIV Testing Laboratory 6. Laboratory for Drinking Water Analysis 7. Drug Testing Laboratory 8. Ambulatory Surgical Clinic 9. Birthing home or CEmOC AO No. 2007 - 0021
  • 25. Classification of Hospitals A. By function 1. General 2. Special B. By service capability 1. Level 1 2. Level 2 3. Level 3 4. Level 4 AO No. 2005 - 0029
  • 26. Classification of Clinical Labs By service capability 1. General Clinical Lab a. Primary Category b. Secondary Category c. Tertiary Category d. Limited Service 2. Special Clinical Lab AO No. 2007 - 0027 DM No. 2009 - 0086
  • 27. Classification of X-ray Facilities By service capability: 1. Level 1 – < 100 ma 2. Level 2 – > 100 ma special procedures with contrast 3. Level 3 – > 300 ma with image intensifier system (e.g. interventional radiology) AO No. 35 s. 1994
  • 28. Schedule of Fees a) The applicant, upon filing the application, shall pay at the CHD or DOH cashier. b) Fees for the OSS licensure system shall be regularly reviewed by the BHFS, BHDT, and BFAD in consultation with the CHDs and stakeholders. c) All fees, surcharges, and discounts shall follow the current DOH prescribed schedule of fees. AO No. 2007 – 0023
  • 29. Validity of LTO The LTO shall be valid for one year from January 1 to December 31. AO No. 2007 – 0021 Republic Act 4226
  • 30. Sanctions • 1st violation – written warning • Violations involving basic hospital licensing requirements:  2nd violation – Php 30,000.00  3rd violation – Php 50,000.00 AO No. 2007 - 0022
  • 31. Sanctions 1. Violations involving facilities/ services not required for hospital licensure:  2nd violation – Php 20,000.00  Every subsequent violation – additional 20% of the previous fine 4. Fine imposition procedures:  Fines should be paid within 10 working days after receipt of the official notice.  A surcharge of 3% shall be imposed for each month of delay in payment. AO No. 2007 - 0022
  • 32. Sanctions Violations involving basic hospital licensing requirements:  4th violation – suspension or revocation of the LTO AO No. 2007 - 0022
  • 33. ISSUES/ CONCERNS cyros_2005@yahoo.com.ph 711-95-72, 743-83-01 loc 2525 Standards Development Division Bureau of Health Facilities and Services Department of Health
  • 34. BHFS Division Contact Landline person Standards Development Dr. Cynthia 743-8301 loc 2525; Division Rosuman 711-9572 Licensing and Accreditation Dr. Mercedes 743-8301 loc 2502 – Division Palma 2504; 711-6982 Monitoring & Surveillance Dr. Beauty 743-8301 loc 2528 Division Palongpalong
  • 35.
  • 36. Related Issuances Health Facility AO Dialysis Clinic AO No. 163 s. 2004 Blood Station/ Blood AO No. 2008 – 0008 Collection Unit Blood Bank AO No. 2008 – 0008 HIV Testing Laboratory AO No. 2005 – 0027 Laboratory for Drinking AO NO. 2006 – 0024 Water Analysis Drug Testing Laboratory IRR revised July 11, 2003 Ambulatory Surgical Clinic AO No. 183 s. 2004 Birthing Home or CEmOC AO No. 2007 – 0039