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 HMOs 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

FACILITIES
1. Hospitals 2. OFW Clinics 3. FS Dialysis Clinics 4. Ambulatory Surgical Clinics

BHFS
Initial Renewal

CHD LREDs
Initial Renewal

Level 2 and 3

Level 1

5. Kidney Transplant Facilities

6. Dental Lab 7. FS Clinical Lab 8. Drinking Water Testing Facilities

REGULATED HEALTH FACILITIES

FACILITIES
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)

BHFS
Initial Renewal

CHD LREDs
Initial Renewal

REGULATED HEALTH FACILITIES

FACILITIES
16. Hospital Blood Bank 17. Hospital Blood Stations 18. HIV Testing Lab

BHFS
Initial Renewal

CHD LREDs
Initial Renewal

Level 3

Level 3

Level 2

Level 2

Level 1

Level 1

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)

BASIS FOR REGULATION

BASIS FOR REGULATION

FACILITIES
1. Ambulatory Surgical Clinic

MANDATE
AO 183 s 2004 (amendment in progress) AO 24 s. 1994 AO 2008-0027 AO 2008-0111 AO 2013-0003 AO 2012-0001 AO 2008-0027 AO 2006-0037 AO 163 s. 2004

REGULATORY INSTRUMENT
License to Operate

2. Dialysis Clinic

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
4. Drug Testing Laboratory

MANDATE

REGULATORY INSTRUMENT

RA 9165 Certificate of Accreditation DDB Resolution (IRR Governing Accreditation of DTLs in the Philippines, as revised) Clearance to Operate Certificate of Accreditation

5. Health Maintenance AO 34 s. 1994 Organization 6. Kidney Transplant Facility AO 2008-0034 AO 81 s. 2003 7. Medical Facility for Overseas Workers and Seafarers RA 10022 AO 2013-0006 AO 2010-0022 AO 2008-0027 AO 2007-0025 AO 181 s. 2004

Certificate of Accreditation

BASIS FOR REGULATION

FACILITIES
8. Newborn Screening Center

MANDATE
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

REGULATORY INSTRUMENT
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

BASIS FOR REGULATION

FACILITIES
11, 12 and 13. Blood Service Facility, Blood Bank and BC 14. Clinical Laboratory

MANDATE
RA 7719 AO 2005-0002 AO 2008-0008

REGULATORY INSTRUMENT
License to Operate

RA s. 4688 License to Operate AO 2007-0027 and 2007A AO 2008-0007 AO 2008-0002 DM 2009-0086 DM 2009-0183 PD 856 RA 9275 AO 2006-0024 AO 2007-0001 DC 2007-0134 AO 2008-0002 Certificate of Accreditation

15. Drinking Water Testing Laboratory

BASIS FOR REGULATION

FACILITIES
16. HIV Testing Laboratory

MANDATE
AO 2005-0027 AO 2005-0027-A AO 2008-0002 RA s. 4226 AO 2012-0012 AO 2011-0020 AO 2010-0081 AO 2008-0021 AO 2007- 0021 AO 2007-0022

REGULATORY INSTRUMENT
Subsumed in the LTO of CL and BB License to Operate

17. Hospital

18. Dental Clinic a. Occupational b. 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

FACILITIES
20 and 21. Birthing Home and Other HFs Category A without beds (e.g. RHUs)

MANDATE
RA s. 4226 AO 2012-0012 AO 2011-0020

REGULATORY INSTRUMENT
License to Operate

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 dont even have pockets

Access to Healthcare

Administrative Order No. 2011 0020

Streamlining of Licensure and Accreditation of Hospitals

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

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 LICENSE
1. 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. 68A s. 1989
Primary Secondary Tertiary (Non-Teaching) Tertiary (Teaching)

AO No. 70A s. 2002

Infirmary First Level Referral Hospital Second Level Referral Hospital Third Level Referral Hospital

AO No. 147 AO No. s. 2004 2005 0029

Infirmary Primary Care Hospital Secondary Care Hospital Tertiary Care Hospital Level 1 Level 2

Level 3

Level 4

Legal Basis for Defining a Hospital Per R.A. 4226

Section 2 Beds or cribs or bassinets for 24 hour use or longer Section 8 Bed space Laboratory OR X-ray Pharmacy OPD DR Isolation Morgue Section 16 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 Primary care General Pediatrics Emergency and Out-patient Services General Obstetrics Non-surgical Gynecology Anesthesia LEVEL 2 LEVEL 3 LEVEL 4 Level 3 plus: Teaching and/or training with at least 1 accredited residency training program for physicians Department of Emergency Medicine

Level 1 plus: Level 2 plus: Specialty Clinical Care with departmentalized clinical services General Dentistry Pharmacy Secondary Clinical Laboratory 1st Level Radiology Provision for ICU

General Medicine Surgery

Tertiary Clinical Laboratory 2nd Level Radiology

Specialized and subspecialized forms of treatment, surgical procedure and intensive care
Rehabilitation Service 3rd Level Radiology

Minor Surgery

INCONSISTENCY OF OLD CLASSIFICATION VS. LAW

CATEGORY

Bed space

OR X

DR

OPD X

Lab X

X-ray X

P X

I M X X

Consistent with Law NO YES YES YES

Level 1 Level 2 Level 3 Level 4

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 and others
A.O. No. 2012 0012 Rule V. B. 1. a., p. 6

Classification of Hospitals
According to Functional Capacity:
A. General Hospital
Provides medical and surgical care to the sick and injured and maternity care and shall have as minimum, the following clinical services: medicine, pediatrics, obstetrics and gynecology, surgery and anesthesia, emergency services, out-patient and ancillary services.

B. Specialty Hospital
Specializes in a particular disease or condition or in one type of patient.
A.O. No. 2012 0012 Rule V. B. 1. b., p. 6

Examples of SPECIALTY HOSPITALS

Particular Disease National Orthopedic Hospital National Center for Mental Health San Lazaro Hospital Particular Organ(s) Lung Center Philippine Heart Center National Kidney and Transplant Institute Particular Group of Patients Philippine Childrens Medical Center National Childrens Hospital Dr. Jose Fabella Memorial Hospital

Classification of Hospitals
According to Trauma Capability: Guidelines formulated by PCS
A. Trauma-Capable Facility
A DOH licensed hospital designated as a trauma center.

B. Trauma-Receiving Facility
A DOH licensed hospital within the trauma service area which receives trauma patients for transport to the point of care or a trauma center.
A.O. No. 2012 0012 Rule V. B. 1. c. 3., p. 8

Classification of General Hospitals

OLD
LEVEL I LEVEL 2 LEVEL 3 LEVEL 4

NEW
RE-CLASSIFY TO OTHER HEALTH FACILITIES LEVEL 1 LEVEL 2 LEVEL 3

GENERAL Clinical Services and Facilities for In-Patients

LEVEL 1 Consulting Specialists in: Medicine Pediatrics OB-GYNE Surgery

LEVEL 2 Level 1 plus all:

LEVEL 3 Level 2 plus all:

Teaching/ training with accredited residency Departmentalized training program in Clinical Services the 4 major clinical services Physical Medicine and Rehabilitation Unit Ambulatory Surgical Clinic Dialysis Clinic

Emergency and OutRespiratory Unit patient Services Isolation Facilities Surgical/ Maternity Facilities Dental Clinic General ICU High Risk Pregnancy Unit NICU

Ancillary Services

Secondary Clinical Tertiary Clinical Laboratory Laboratory

Blood Station 1st Level X-ray Blood Station 2nd Level X-ray with mobile unit

Tertiary lab with histopathology

Blood Bank 3rd Level X-ray

Pharmacy

NEW CLASSIFICATION OF OTHER HEALTH FACILITIES

A Primary Care Facility B C D Specialized OutPatient Facility Dialysis Clinic (DC) Ambulatory Surgical Clinic (ASC) In-Vitro Fertilization (IVF) Centers Custodial Care Diagnostic/ Facility Therapeutic Facility Laboratories: Clinical Lab/ HIV Blood Service Facilities Drug Test Lab NB Screening Lab Water Lab Ionizing Machines as X-ray, CT scan, mammography and others Non-Ionizing Machines as ultrasound, MRI and others Nuclear Medicine

With In-patient Beds: Infirmary/ Dispensary Birthing Home

Without Beds: Medical Outpatient Clinics OFW Clinics Dental Clinics

Psychiatric Care Facility

Drug Abuse Treatment and Rehabilitation Center (DATRC) Sanitarium/ Leprosarium Nursing Home

Radiation Oncology Facility Oncology Center/ Clinic

NEW CLASSIFICATION
HOSPITALS
GENERAL Level 1 Level 2 Level 3 (Teaching/ Training) SPECIALTY

OTHER HEALTH FACILITIES

A. Primary Care Facility B. Custodial Care Facility C. Diagnostic/ Therapeutic Facility D. Specialized OutPatient Facility

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 reclassified 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.

TERTIARY CARE

SECONDARY CARE

PRIMARY CARE

Evaluation Criteria:
1. 2. 3. 4. Responsiveness to health needs Access and equitable health care Relevance to health care needs Health care outcomes

Dr. Margaret Chan

WHO Director General

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.

LEVEL OF CARE

DESCRIPTION Education Prevention Early Detection & Routine Care

FACILITIES AND SERVICES

Bgy. Health Stations, Rural Health Units/ Health Centers, Clinics, Dispensaries Infirmaries (Level 1 Category Hospitals), Community, Municipal & District Hospitals, Birthing Homes, Ambulatory Surgical Clinics

Promotive & Preventive Care

Healthcare System

Primary Care

Secondary Care

Emergency Treatment Critical Care

City, Provincial, Level 1 Category Hospitals

Tertiary Care

Specialized Care Rehabilitation

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

Restorative Care

Intermediate & Follow-Up Care Home Care

Continuing Care

Long Term & Chronic Care Personal Care Hospice Care

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.
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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 dont 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!