DOH Initiatives on Regulation: New Classification of Hospitals and Other Health Facilities in the Philippines By: NILDA B. SILVERA, RN, MPH, DHRD
Oct 24, 2015
DOH Initiatives on
Regulation:
New Classification
of Hospitals and
Other Health
Facilities in the
Philippines
By: NILDA B. SILVERA, RN, MPH, DHRD
Regulatory Function of the DOH:
• Constitution
• DOH Mandate
• Specific Laws
The DEPARTMENT OF HEALTH as:
Lead agency for Health and Healthcare
Services:
As mandated by law to protect, promote and
maintain the health of the Filipinos
As an influential leader of the health sector
As it continues to provide
guidelines, policies, standards and state of the art
in health and healthcare
What is Regulation?
• A process or activity in which government requires or prescribes certain activities or behavior on the part of individuals and institutions through a continuing administrative process.
• A prescription by the government that must be complied with by the intended individuals and firms.
- Howlett and Ramesh
What is Regulation?
• The use of the coercive power of the state to change the behavior of or to impose constraints on organization and individuals.
• Includes the full range of legal instruments (laws, decrees, orders, codes, administrative rules, guidelines), whether issued by the government or by non-governmental bodies to which the government has delegated regulatory power
- Roberts et.al
Purposes of Regulation
• Establish basic conditions for market
exchange
• Enhance equity
• Correct market failures
• Correct unacceptable market results
Regulatory Approaches in the Health Sector
• Regulating capacity
• Regulating prices
• Regulating quality
• Regulating market structure and levels of service
• Regulating entitlements
BUREAU OF HEALTH FACILITIES AND SERVICES
GENERAL FUNCTIONS
1. Sets standards and guidelines for regulation of various health facilities and services
2. Disseminates regulatory policies and standards for information and compliance
3. Issues permits to construct, license to operate, certificates of accreditation, SEC endorsement as to name of health facility, certification of BHFS regulated health facilities for foreign travel purposes (DFA requirement), authentication of PEME certificates for OCWs and clearance to operate HMO’s
4. Ensures sustainability of health facilities compliance with regulatory standards through monitoring and quality assurance
4. Provides consultation and advisory services to stakeholders
5. Develops and conducts research relative to the regulation of health facilities and services
REGULATED HEALTH FACILITIES
REGULATED HEALTH FACILITIES
FACILITIESBHFS CHD LREDs
Initial Renewal Initial Renewal
1. Hospitals √ √Level 2 and 3
√Level 1
2. OFW Clinics √ √3. FS Dialysis Clinics √ √4. Ambulatory Surgical
Clinics√ √
5. Kidney Transplant Facilities
√ √
6. Dental Lab √ √7. FS Clinical Lab √ √8. Drinking Water
Testing Facilities √ √
FACILITIESBHFS CHD LREDs
Initial Renewal Initial Renewal
9. Drug Testing Lab √ √10. DATRC √ √11. Acute/Chronic Psych Care
and Custodial Care Facility√ √
12. Dental Clinics - Private Schools & Occupational Establishments (For policy review)
√ √
13. Stem Cell Facilities (IRR for finalization)
√ √
14. FS Blood Centers (govt. and PRC)
√ √
15. BCU (govt. and PRC) √ √
REGULATED HEALTH FACILITIES
16. Hospital Blood Bank √Level 3
√Level 3
17. Hospital Blood Stations √Level 2
√Level 2
√Level 1
√Level 1
18. HIV Testing Lab √Hospital Level
2 and 3
√Hospital Level
2 and 3
√FS Labs and
Level 1 Hospital
√FS Labs and
Level 1 Hospital
19. Newborn Screening Centers
√ √
20. Birthing Homes (IRR for finalization)
√ √
21. Other HFs Category A without beds (e.g. RHUs)(IRR for finalization)
√ √
REGULATED HEALTH FACILITIES
FACILITIESBHFS CHD LREDs
Initial Renewal Initial Renewal
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORYINSTRUMENT
1. Ambulatory Surgical Clinic
• AO 183 s 2004 (amendment in progress)
• AO 24 s. 1994• AO 2008-0027• AO 2008-0111
License to Operate
2. Dialysis Clinic • AO 2013-0003• AO 2012-0001• AO 2008-0027• AO 2006-0037• AO 163 s. 2004
License to Operate
3. Drug Abuse Treatment and Rehabilitation Center
• RA 9165• DDB Resolution (IRR
Governing Accreditation of Drug Treatment and Rehabilitation Centers and Accreditation of Center Personnel)
Certificate of Accreditation
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORYINSTRUMENT
4. Drug Testing Laboratory • RA 9165• DDB Resolution (IRR
Governing Accreditation of DTLs in the Philippines, as revised)
Certificate of Accreditation
5. Health MaintenanceOrganization
6. Kidney Transplant Facility
7. Medical Facility for Overseas Workers and Seafarers
• AO 34 s. 1994
• AO 2008-0034• AO 81 s. 2003
• RA 10022• AO 2013-0006• AO 2010-0022• AO 2008-0027• AO 2007-0025• AO 181 s. 2004
Clearance to Operate
Certificate of Accreditation
Certificate of Accreditation
BASIS FOR REGULATION
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORYINSTRUMENT
8. Newborn Screening Center
• RA 9288 and its IRR• AO 2008-0026-A• AO 2008-0026• DM 2008-0123• DM2008-0044• DM 2008-0020• AO 2008-0002• AO 2007-0001
Certificate of Accreditation
9. Water Testing Laboratory
10. Dental Laboratory
• PD 856• AO 2006-0024
• PD 1542 s. 1978• DC 79 s. 1988• AO 28 s 2003• RA 9484 s. 2007• AO 2008-0010• AO 2008-0019
Certificate of Accreditation
License to Operate
FACILITIES MANDATE REGULATORYINSTRUMENT
11, 12 and 13. Blood Service Facility, Blood Bank and BC
• RA 7719• AO 2005-0002• AO 2008-0008
License to Operate
14. Clinical Laboratory • RA s. 4688• AO 2007-0027 and 2007A• AO 2008-0007• AO 2008-0002• DM 2009-0086• DM 2009-0183
License to Operate
15. Drinking Water Testing Laboratory
• PD 856• RA 9275• AO 2006-0024• AO 2007-0001• DC 2007-0134• AO 2008-0002
Certificate of Accreditation
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORYINSTRUMENT
16. HIV Testing Laboratory • AO 2005-0027• AO 2005-0027-A• AO 2008-0002
Subsumed in the LTO of CL and BB
17. Hospital • RA s. 4226• AO 2012-0012• AO 2011-0020• AO 2010-0081• AO 2008-0021• AO 2007- 0021• AO 2007-0022
License to Operate
18. Dental Clinica. Occupationalb. Private School
• AO 3 s 1998• AO 4 s 1998
Certificate of Accreditation
19. Psychiatric Care Facility • RA 4226• AO 147 s. 2004• AO 2005-0029
License to Operate
BASIS FOR REGULATION
20 and 21. Birthing Home and Other HFs Category A without beds (e.g. RHUs)
• RA s. 4226• AO 2012-0012• AO 2011-0020
License to Operate
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORYINSTRUMENT
Only those with money (i.e., the rich) can fully pay for out of pocket payments and often they
have generous health insurance
The near-poor and the lower middle classes can become impoverished to meet out of pocket
payments for health care.
The very poor don’t even have pockets
Access to Healthcare
Administrative Order
No. 2012 – 0012
“New Classification of Hospitals and Other
Health Facilities”
Administrative Order
No. 2011 – 0020
“Streamlining of Licensure and Accreditation
of Hospitals”
Administrative Order
No. 2011 – 0020
“Streamlining of Licensure and
Accreditation of Hospitals”
Department of Health
Bureau of Health Facilities and Services
OBJECTIVE
To improve access to quality
health facilities with the
efficient use of limited
government resources and
without compromising the
quality of care
Scope and Coverage
Regulatory offices – BHFS,
FDA, CHD, PhilHealth
All government and private
hospitals
DOH LICENSE1. All DOH licensed hospitals shall be
deemed automatically accredited by
PhilHealth as Centers of Safety.
(Basic Participation per Philhealth
Circular No. 54)
2. Stakeholders shall comply with the
standards and requirements
prescribed in the enhanced
assessment tool for licensure of
hospitals posted at DOH website.
Administrative Order
No. 2012 – 0012
“New Classification of Hospitals and
Other Health Facilities”
Department of Health
Bureau of Health Facilities and Services
EVOLUTION OF HOSPITAL NOMENCLATURE
AO No. 68–A
s. 1989
AO No. 70–A
s. 2002
AO No. 147
s. 2004
AO No.
2005 – 0029
Primary Infirmary Infirmary Level 1
SecondaryFirst Level
Referral Hospital
Primary Care
HospitalLevel 2
Tertiary
(Non-Teaching)
Second Level
Referral Hospital
Secondary
Care HospitalLevel 3
Tertiary
(Teaching)
Third Level
Referral Hospital
Tertiary Care
HospitalLevel 4
Legal Basis for Defining a Hospital Per
R.A. 4226Section 2 Section 8 Section 16
Beds or
cribs or
bassinets
for 24 hour
use or
longer
Bed space
Laboratory
OR
X-ray
Pharmacy
OPD
DR
Isolation
Morgue
Classify hospitals
as to:
General or Special
Service Capacity
Size or bed capacity
Training or not
All 3 Sections of the Law have to be complied
with to be classified as a hospital.
OLD CLASSIFICATION OF HOSPITALS
PER DOH A.O. NO. 2005 – 0029
LEVEL 1 LEVEL 2 LEVEL 3 LEVEL 4
Primary care Level 1 plus: Level 2 plus: Level 3 plus:
General Medicine Surgery Specialty Clinical
Care with
departmentalized
clinical services
Teaching and/or training
with at least 1 accredited
residency training
program for physicians
General
Pediatrics
AnesthesiaEmergency and
Out-patient
ServicesGeneral Dentistry
Department of
Emergency Medicine
General
ObstetricsPharmacy Provision for ICU
Specialized and sub-
specialized forms of
treatment, surgical
procedure and intensive
careNon-surgical
Gynecology
Secondary
Clinical
Laboratory
Tertiary Clinical
Laboratory
Rehabilitation Service
Minor Surgery1st Level
Radiology
2nd Level
Radiology3rd Level Radiology
INCONSISTENCY OF OLD CLASSIFICATION VS. LAW
CATEGORYBed
spaceOR DR OPD Lab X-ray P I M
Consistent
with Law
Level 1 ✓ X ✓ X X X X X X NO
Level 2 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ YES
Level 3✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
YES
Level 4✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
YES
Therefore, Level 1 does not qualify as a hospital and must be given
a different category for licensure purposes.
Classification of Hospitals
According to Ownership:
A. Government
Created by law. May be under DOH, DND,DOJ, PNP, LGU, SUCs, GOCC and others
B. Private
May be a single proprietorship, partnership,corporation, cooperative, foundation,religious, non-government organization andothers
A.O. No. 2012 – 0012 Rule V. B. 1. a., p. 6
Classification of Hospitals
According to Functional Capacity:
A. General HospitalProvides medical and surgical care to the sick andinjured and maternity care and shall have asminimum, the following clinical services: medicine,pediatrics, obstetrics and gynecology, surgery andanesthesia, emergency services, out-patient andancillary services.
B. Specialty HospitalSpecializes in a particular disease or condition or inone type of patient.
A.O. No. 2012 – 0012 Rule V. B. 1. b., p.
6
Examples of SPECIALTY HOSPITALS
Particular
Disease
Particular
Organ(s)
Particular Group
of Patients
National
Orthopedic
Hospital
Lung CenterPhilippine Children’s
Medical Center
National Center
for Mental Health
Philippine Heart
Center
National Children’s
Hospital
San Lazaro
Hospital
National Kidney
and Transplant
Institute
Dr. Jose Fabella
Memorial Hospital
Classification of Hospitals
According to Trauma Capability:
Guidelines formulated by PCS
A. Trauma-Capable FacilityA DOH licensed hospital designated as a traumacenter.
B. Trauma-Receiving FacilityA DOH licensed hospital within the trauma servicearea which receives trauma patients for transportto the point of care or a trauma center.
A.O. No. 2012 – 0012 Rule V. B. 1. c. 3., p.
8
OLD NEW
LEVEL I
RE-CLASSIFY TO
OTHER HEALTH
FACILITIES
LEVEL 2 LEVEL 1
LEVEL 3 LEVEL 2
LEVEL 4 LEVEL 3
Classification of General
Hospitals
GENERAL LEVEL 1 LEVEL 2 LEVEL 3
Clinical
Services
and
Facilities for
In-Patients
Consulting
Specialists in:
Medicine
Pediatrics
OB-GYNE
Surgery
Level 1 plus all: Level 2 plus all:
Departmentalized
Clinical Services
Teaching/ training with
accredited residency
training program in
the 4 major clinical
services
Emergency and Out-
patient ServicesRespiratory Unit Physical Medicine and
Rehabilitation UnitIsolation Facilities General ICU
Surgical/ Maternity
Facilities
High Risk
Pregnancy Unit
Ambulatory Surgical
Clinic
Dental Clinic NICU Dialysis Clinic
Ancillary
Services
Secondary Clinical
Laboratory
Tertiary Clinical
Laboratory
Tertiary lab with
histopathology
Blood Station Blood Station Blood Bank
1st Level X-ray2nd Level X-ray
with mobile unit3rd Level X-ray
Pharmacy
NEW CLASSIFICATION OF OTHER HEALTH FACILITIES
A B C D
Primary Care
Facility
Custodial Care
Facility
Diagnostic/
Therapeutic Facility
Specialized Out-
Patient Facility
With In-patient
Beds:
Infirmary/
Dispensary
Birthing Home
Psychiatric
Care Facility
Laboratories:
Clinical Lab/ HIV
Blood Service
Facilities
Drug Test Lab
NB Screening Lab
Water Lab
Dialysis Clinic
(DC)
Ambulatory
Surgical Clinic
(ASC)
Without Beds:
Medical Out-
patient Clinics
OFW Clinics
Dental Clinics
Drug Abuse
Treatment and
Rehabilitation
Center
(DATRC)
Ionizing Machines as
X-ray, CT scan,
mammography and
others
In-Vitro
Fertilization (IVF)
Centers
Sanitarium/
Leprosarium
Non-Ionizing Machines
as ultrasound, MRI and
others
Radiation
Oncology Facility
Nursing Home Nuclear MedicineOncology Center/
Clinic
HOSPITALSOTHER HEALTH
FACILITIES
GENERAL
Level 1
Level 2
Level 3
(Teaching/
Training)
A. Primary Care Facility
B. Custodial Care
Facility
C. Diagnostic/
Therapeutic Facility
SPECIALTYD. Specialized Out-
Patient Facility
NEW CLASSIFICATION
Implementing Mechanisms
The name of the institution shall be
compatible with the functional capacity
of the health facility. All health facilities
regulated by DOH applying for SEC
and/or DTI registration shall undergo
clearance from BHFS.
Example: A clinic cannot be called a
medical center.
A.O. No. 2012 – 0012 Rule V. A. 6 p. 5
Implementing Mechanisms
Every health facility shall
have a duly licensed
physician to oversee the
clinical/ medical operations
of the health facility.
A.O. No. 2012 – 0012 Rule V. B. 3. a. p. 11
Implementing Mechanisms
Applications for DOH-PTC of New
Hospitals having at least 100 beds
shall require the approval of the
Secretary of Health. The foregoing is
not limited to New Hospitals but covers
other health facilities as may be
required by the Secretary of Health.
A.O. No. 2012 – 0012 Rule VI. B. 6 p. 15
INITIAL LTO
Each CHD shall issue the
initial LTO of other health
facilities under Category A –
Primary Care Facility with
in-patient beds.
A.O. No. 2012 – 0012 Rule VI. C. 3. p. 15
INITIAL LTO
BHFS shall issue LTO of all
new hospitals and other
health facilities covered by
other DOH issuances.
A.O. No. 2012 – 0012 Rule VI. C. 3. p. 15
RENEWAL OF LTO
Each CHD shall renew LTO of
Level 1 hospitals and renew
LTO of other health facilities
under Category A – Primary
Care Facility with in-patient
beds.
A.O. No. 2012 – 0012 Rule VI. D. 1. p. 16
RENEWAL OF LTO
BHFS shall renew LTO of Level 2
and Level 3 hospitals following
OSS licensure system for hospitals
and renew LTO/accreditation of
health facilities covered by other
DOH issuances.
A.O. No. 2012 – 0012 Rule VI. D. 2. p. 16
TRANSITORY PROVISIONS
1. These rules and regulations shall be
enforced on New Hospitals applying for
LTO.
2. Hospitals categorized as Level 2, 3, 4,
applying for renewal of LTO shall be
given a grace period of 3 years to attain
full compliance with these rules and
regulations.
A.O. No. 2012 – 0012 Rule XIII. p. 18
3. Existing Level 1 health facilities
which cannot comply with the
provisions stated in Sections 2, 8
and 16 of R.A. 4226, shall be re-
classified to ‘Other Health Facilities’.
A.O. No. 2012 – 0012 Rule XIII. p. 18
CERTIFICATE OF NEED
SPECIFIC GUIDELINES
The requirement for a Certificate of Need (CON) shall only apply to proposed new government general hospitals.
Private individuals or corporations who shall establish new general hospitals shall no longer be required to secure a Certificate of Need (CON) from the Center for Health Development.
Proposed new private general hospitals should have at least one hundred (100) beds.
SECONDARY CARE
PRIMARY CARE
TERTIARY CARE
Evaluation Criteria:
1. Responsiveness to health needs
2. Access and equitable health care
3. Relevance to health care needs
4. Health care outcomes
“In matters of health, I believe our world is
out of balance, possibly as never before in history.
We have never had such a sophisticated arsenal
of technologies for treating disease and
prolonging life. Yet the gaps in health outcomes
keep getting wider.”
Dr. Margaret Chan
WHO Director General
Hea
lth
care
Syst
em
Promotive &
Preventive Care
Primary Care
Secondary Care
Tertiary Care
Restorative Care
Continuing Care
Prevention
Early Detection &
Routine Care
Emergency Treatment
Education
Critical Care
Specialized Care
Intermediate & Follow-Up Care
Rehabilitation
Home Care
Long Term & Chronic Care
Personal Care
Hospice Care
Bgy. Health Stations, Rural
Health Units/ Health Centers,
Clinics, Dispensaries
Infirmaries (Level 1 Category
Hospitals), Community,
Municipal & District
Hospitals, Birthing Homes,
Ambulatory Surgical Clinics
City, Provincial, Level 1
Category Hospitals
National, Regional, Level 2
and 3 Category Hospital,
Medical Centers, Teaching/
Training Hospitals
National, Regional, Level 2
and 3 Category Hospital,
Medical Centers, Teaching/
Training Hospitals, Rehab
Facilities
Hospice Care, Custodial &
Chronic Care Facilities,
Retirement, Institutional
Care Facilities
LEVEL OF CARE DESCRIPTION FACILITIES AND SERVICES
Role of Government
For the health sector and given the economic crisis
provides the government the rare opportunity to push
the needed reforms that would lead to universal health
care for Filipinos.
With the national and local elections, there will be a
new set of leaders at the national and local levels. The
government may rewrite the rules on health care
provision in the country, consistent with the
constitutional provision that asserts that health is a
right of every Filipino citizen.
55
Health at the centre of development
Health is a right.
Access to health care is a fundamental entitlement.
Investing in health is investing in human capital.
Human capital is the foundation of economic
productivity.
Health is a core concern of development.
Nurse
Leader
Transformational Leader
System Thinker
“Successful transformational leaders
focus on the whole system rather than on
only one particular part of the system.”
Challenges in Health System Performance
Access --- 1.3 Billion individuals with no access to health care worldwide
Scale --- safe, proven and reasonable interventions not reaching those in need
Distribution --- those with unmet needs are disproportionate to those with lesser means
Protection/Safety --- too many are worse off through encounters with the health system
Systems capabilities --- conventional frameworks and responses to dealing with complex challenges
Dissatisfied patients --- disease rather than customer driven services, limited patient voice in treatment decisions
IntensiveCare
Intermediate Care
We don’t care
Need to overcome
problems that
continue to
undermine the
contribution nurses
make to health and
development!
“Only those who provide
care can in the end
change care”
In behalf of the future generation of this
country…..
Maraming Salamat!