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.
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
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
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