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. Certificate of Need (CON)
A Certificate, issued by CHD for the
proposed construction of a new general
hospital, which ensures that the facility will
be needed at the time of its completion.
The Certificate is issued to an individual or
group intending to build a hospital in order
to meet the needs of a community.
A CON is a required document prior to the
issuance of a DOH-PTC for construction of
a new general hospital .
www.wikipedia
15. 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
16. 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
17. 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
18. 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
19. 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)
20. 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
21. 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
22. Application for OSS
Required for all hospitals:
2. Hospital documents
3. Clinical Laboratory
4. Pharmacy
5. Radiology
AO No. 2007 - 0021
23. 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. Ambulatory Surgical Clinic
AO No. 2007 - 0021
AO No. 2010 - 0035
24. 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
25. 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
26. 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
27. Schedule of Fees
a) The applicant, upon filing the application,
shall pay at CHD or DOH cashier.
b) Fees for the OSS licensure system shall
be regularly reviewed by BHFS and FDA in
consultation with CHDs and stakeholders.
c) All fees, surcharges, and discounts shall
follow the current DOH prescribed
schedule of fees.
AO No. 2007 – 0023
28. 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
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. Updates in Hospital Licensing
“Streamlining of Licensure and
Accreditation of Hospitals”
(A.O. No. 2011 – 0020)
DEPARTMENT OF HEALTH
BUREAU OF HEALTH FACILITIES AND SERVICES
Atty. Nicolas B. Lutero III, CESO III
Director IV
33. Rationale in the Streamlining of
Licensure and Accreditation
of Hospitals
1. Simplification of processes
2. Limited resources available
3. To eliminate duplication in
licensing and accreditation
34. Figure 1. Percent Distribution of DOH
Licensed Hospitals as to Ownership
n = 1,812
4%
DOH-Retained
36%
Government
60% Private
Source: DOH – BHFS 2010
35. Figure 2. Percentage of DOH Licensed
Hospitals with PhilHealth Accreditation
n = 1,812
12%
PhilHealth
Accredited
Non-PhilHealth
Accredited
88% Source: DOH – BHFS and
PHIC, 2010
36. OBJECTIVE
To improve access to quality
health facilities with the
efficient use of limited
government resources and
without compromising the
quality of care
37. Scope and Coverage
Regulatory offices – BHFS,
FDA, CHD, PhilHealth
All government and private
hospitals
38. Acronyms
1. BHFS – Bureau of Health
Facilities and Services
3. CHD – Center for Health
Development
4. FDA – Food and Drug
Administration
39. Strategies
1. To harmonize DOH standards of
safety and PhilHealth core
indicators;
3. To streamline regulatory
processes by recognition of DOH
licensed hospitals as Centers of
Safety without the need for a
separate survey by PhilHealth.
40. Definition of Terms
1. LTO – refers to License to Operate. It is
the formal authorization issued by DOH
through BHFS/CHD to an individual,
partnership, corporation or association to
operate a hospital and/or other health
facility upon compliance with the minimum
standards of safety. It is a pre-requisite
for accreditation of a hospital and/or other
health facility by any accrediting body
recognized by DOH.
41. Definition of Terms
1. Accreditation – a process whereby the
qualifications and capabilities of health
care providers are verified in accordance
with the guidelines, standards and
procedures set by the accrediting body for
the purpose of conferring upon them
certain privileges and assuring that health
care services rendered by these providers
are of the desired and expected quality.
42. Definition of Terms
1. Assessment Tool – the checklist which
prescribes the minimum standards and
requirements for hospital licensure. It is
the tool used by the regulatory officers
to evaluate compliance of a hospital to
DOH requirements. This tool shall also
serve as the Self-Assessment Tool to
be used by hospitals prior to inspection/
monitoring visits by DOH.
43. DOH LICENSE
1. All DOH licensed hospitals shall be
deemed automatically accredited by
PhilHealth as Centers of Safety.
3. Stakeholders shall follow the standards
and requirements prescribed in the
enhanced assessment tool for
licensure of hospitals posted at DOH
website.
44. Philhealth Accreditation
All DOH licensed hospitals shall be
deemed automatically accredited by
PhilHealth as Centers of Safety.
Such hospital shall no longer be
surveyed by PhilHealth as a pre-
requisite for accreditation.
45. PhilHealth Accreditation
Hospitals applying for Center of Quality
and Center of Excellence shall undergo
a separate survey by PhilHealth prior to
granting of the award.
Should they fail to meet the required
scores for the award they applied for, they
shall be downgraded to the appropriate
award or at least as a Center of Safety.
46. Reports to be submitted by
BHFS/CHD
1. Listing of hospitals
Status of LTO of hospitals and hospital
based facilities
Consolidated hospital statistical report
Consolidated report on deficiencies and
violations in licensing requirements of
government and private hospitals
Consolidated report on sanctions, penalties
and complaints against hospitals
47. Information Dissemination
1. Publication of DOH licensed hospitals
annually to provide the public with a
selection of hospital facilities to
choose from.
3. Posting of licensed hospitals at DOH
website upon issuance of LTO.
48. Next Steps
ACTIVITY TIME FRAME
• Conduct training of Regulatory
Officers pursuant to A.O. No. Ongoing up to
2011-0020 re: “Streamlining of October 1,
Licensure and Accreditation of 2012
Hospitals”
1. Formulate and/or revise assessment
Ongoing
tool for licensure of hospitals
1. Sharing of resources between DOH To be
and PhilHealth (e.g. vehicle) discussed
49. Next Steps
ACTIVITY TIME FRAME
1. Implementation of Regulatory
October 2012
Scheme
1. BHFS Information Management Unit
Link with DOH-IMS and PhilHealth
50. BUREAU OF HEALTH FACILITIES AND SERVICES
Contact Number/
Division Chief
Email Address
Standards 6517800 local 2525
Dr. Cynthia R.
Development 7119572 (direct)
Rosuman
Division cyros88@gmail.com
Licensing and 6517800 local 2502-2504
Atty. Rodel C.
Accreditation 7116982 (direct)
Flores (OIC)
Division ledor72@yahoo.com
Quality
6517800 local 2528
Assurance and Dr. Beauty A.
bapalongpalong@yahoo.
Monitoring Palongpalong
com
Division
Administrative Ms. Teresa
6517800 local 2500
Unit Salgado
Streamlining would benefit patients, DOH and PHIC Limited resources available in the implementation of licensing and accreditation requires collaboration between DOH and PHIC to pool resources together to achieve efficiency To address the clamor from the hospital sector for DOH and PHIC to synchronized efforts to eliminate duplication in licensing and accreditation without compromising the quality of care.