DOH Initiatives on Regulation: New Classification of Hospitals and Other Health Facilities in the Philippines

By:

NILDA B. SILVERA, RN, MPH, DHR

Regulatory Function of the DOH: Constitution DOH Mandate Specific Laws

The

DEPARTMENT OF HEALTH

Lead agency for Health and Healthcar 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 a 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 FACILITI 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 5. Kidney Transplant Facilities

BHFS
Initial Renewal
Level 2 and 3

CHD LREDs
Initial Renewal
Level 1

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
Level 3

CHD LREDs
Initial
Level 3

Renewal

Renewal

Level 2

Level 2

Level 1

Level 1

Hospital LevelHospital Level FS Labs and FS Labs and 2 and 3 2 and 3 Level 1 Level 1 Hospital 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 REGULATIO

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT
License to Operate progress) AO 24 s. 1994 AO 2008-0027 AO 2008-0111 2. Dialysis Clinic AO 2013-0003 License to Operate AO 2012-0001 AO 2008-0027 AO 2006-0037 AO 163 s. 2004

1. Ambulatory Surgical AO 183 s 2004 Clinic (amendment in

3. Drug Abuse Treatment RA 9165 Certificate of Accreditation and Rehabilitation DDB Resolution (IRR Center Governing Accreditation of Drug Treatment and Rehabilitation Centers and Accreditation of Center Personnel)

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT

4. Drug Testing Laboratory RA 9165

Certificate of Accreditation DDB Resolution (IRR Governing Accreditation of DTLs in the Philippines, as revised) Clearance to Operate Certificate of Accreditation 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 RA 10022 Overseas Workers and AO 2013-0006 Seafarers AO 2010-0022

AO 2008-0027 AO 2007-0025 AO 181 s. 2004

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT

8. Newborn Screening RA 9288 and its IRR Certificate of Accreditation Center AO 2008-0026-A AO 2008-0026 DM 2008-0123 DM2008-0044 DM 2008-0020 AO 2008-0002 AO 2007-0001 9. Water Testing Laboratory 10. Dental Laboratory PD 856 AO 2006-0024 Certificate of Accreditation

PD 1542 s. 1978 License to Operate DC 79 s. 1988 AO 28 s 2003 RA 9484 s. 2007 AO 2008-0010 AO 2008-0019

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT
License to Operate

11, 12 and 13. Blood RA 7719 Service Facility, Blood AO 2005-0002 Bank and BC AO 2008-0008 14. Clinical Laboratory

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

15. Drinking Water Testing PD 856 Laboratory RA 9275

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT

16. HIV Testing Laboratory AO 2005-0027 Subsumed in the LTO of CL AO 2005-0027-A and BB AO 2008-0002 17. Hospital RA s. 4226 License to Operate AO 2012-0012 AO 2011-0020 AO 2010-0081 AO 2008-0021 AO 2007- 0021 AO 2007-0022

18. Dental Clinic a. Occupational

AO 3 s 1998 Certificate of Accreditation AO 4 s 1998 b. Private School License to Operate AO 147 s. 2004 AO 2005-0029

19. Psychiatric Care Facility RA 4226

BASIS FOR REGULATION

FACILITIES MANDATE REGULATORY INSTRUMENT

20 and 21. Birthing Home RA s. 4226 License to Operate and Other HFs AO 2012-0012 Category A without AO 2011-0020 beds (e.g. RHUs)

Only those with money (i.e., the rich) can fully pay for out of pocket payments and often the 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 Accreditat of Hospitals

Administrative Order No. 2012 - 0012

New Classification of Hospitals and Oth 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. 68-A AO No. 70-A AO No. 147 AO No. s. 1989 s. 2002 s. 2004 2005 - 0029
Primary Infirmary Infirmary Level 1 Level 2

Primary Care First Level Secondary Referral Hospital Hospital Second Level Secondary Tertiary Referral Hospital Care Hospital (Non-Teaching) Tertiary (Teaching) Third Level Tertiary Care Referral Hospital Hospital

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 Section 16 Bed space Classify hospitals Laboratory as to: OR General or Special X-ray Pharmacy Service Capacity OPD Size or bed capacity DR Training or not Isolation Morgue

All 3 Sections of the Law have to be complie with to be classified as a hospital.

OLD CLASSIFICATION OF HOSPITALS PER DOH A.O. NO. 2005 - 0029

LEVEL 1
Primary care General Medicine General Pediatrics Emergency and Out-patient Services General Obstetrics Non-surgical Gynecology Minor Surgery 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 Specialized and subspecialized forms of treatment, surgical procedure and intensive care Rehabilitation Service

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

3rd Level Radiology

INCONSISTENCY OF OLD CLASSIFICATION VS. LAW

CATEGORY

Bed OR DR OPD Lab X-ray P space

Level 1 Level 2 Level 3 Level 4

Consist with Law ent X X XM NO I YES

YES YES

Therefore, Level 1 does not qualify as a hospital and must be give 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 Emergency and Outpatient Services Isolation Facilities

LEVEL 2
Level 1 plus all: Departmentalized Clinical Services

LEVEL 3
Level 2 plus all: Teaching/ training with accredited residency training program in the 4 major clinical services Physical Medicine and Rehabilitation Unit Ambulatory Surgical Clinic Dialysis Clinic Tertiary lab with histopathology Blood Bank 3rd Level X-ray

Respiratory Unit General ICU

Surgical/ Maternity High Risk Facilities Pregnancy Unit Dental Clinic Ancillary Services NICU Secondary Clinical Tertiary Clinical Laboratory Laboratory Blood Station 1st Level X-ray Pharmacy Blood Station 2nd Level X-ray with mobile unit

NEW CLASSIFICATION OF OTHER HEALTH FACILITIES

A Primary Care Facility
With In-patient Beds: Infirmary/ Dispensary Birthing Home Without Beds: Medical Outpatient Clinics OFW Clinics Dental Clinics

Custodial Care Diagnostic/ Specialized OutFacility Therapeutic Facility Patient 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 Dialysis Clinic (DC) Ambulatory Surgical Clinic (ASC) In-Vitro Fertilization (IVF) Centers Radiation Oncology Facility Oncology Center/ Clinic

Psychiatric Care Facility

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

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

OTHER HEALTH FACILITIES

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

SPECIALTY

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 b 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. Responsiveness to health need 2. Access and equitable health car 3. Relevance to health care needs 4. Health care outcomes

Dr. Margaret Chan

WHO Director General

In matters of health, I believe our world of balance, possibly as never before in h have never had such a sophisticated arse technologies for treating disease an onging life. Yet the gaps in health outco p getting wider.

LEVEL OF CARE

DESCRIPTION Education Prevention Early Detection & Routine Care

FACILITIES AND SERVICES

Promotive & Preventive Care

Bgy. Health Stations, Rural Health Units/ Health Center Clinics, Dispensaries

Primary Care

Infirmaries (Level 1 Categor Hospitals), Community, Municipal & District Hospitals, Birthing Homes, Ambulatory Surgical Clinics City, Provincial, Level 1 Category Hospitals

Secondary Care

Emergency Treatment Critical Care

Tertiary Care

Specialized Care Rehabilitation

National, Regional, Level 2 and 3 Category Hospital, Medical Centers, Teaching/ Training Hospitals

Restorative Care

National, Regional, Level 2 and 3 Category Hospital, Intermediate & Follow-Up Care Medical Centers, Teaching/ Training Hospitals, Rehab Facilities

Home Care

Continuing Care

Long Term & Chronic Care Personal Care Hospice Care

Hospice Care, Custodial & Chronic Care Facilities, Retirement, Institutional Care Facilities

Role of Government

r the health sector and given the economic cri ovides the government the rare opportunity to e needed reforms that would lead to universal care for Filipinos. With the national and local elections, there wil ew set of leaders at the national and local leve overnment may rewrite the rules on health car ovision in the country, consistent with the nstitutional provision that asserts that health ght of every Filipino citizen.
55

Health at the centre of developme

Health is a right. Access to health care is a fundamental entitl Investing in health is investing in human cap Human capital is the foundation of economic productivity. Health is a core concern of developmen

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 Performan

ess --- 1.3 Billion individuals with no access to worldwide ale --- safe, proven and reasonable interventio ching those in need bution --- those with unmet needs are disprop se with lesser means rotection/Safety --- too many are worse off thr ncounters with the health system ystems capabilities --- conventional framework sponses to dealing with complex challenges tisfied patients --- disease rather than custom es, limited patient voice in treatment decision

IntensiveCare

Intermediate Care

We dont care

Need to overcome problems that continue to undermine the contribution nurse make to health and development!

Only those who provid care can in the end change care

behalf of the future generation country..

Maraming Salama