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 FACILITIES 1. Hospitals 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
BHFS
CHD LREDs
Initial
Renewal
√
√
√
Level 2 and 3
Level 1
√ √ √
√ √ √
√
√
Initial
√ √ √
Renewal
√ √ √
REGULATED HEALTH FACILITIES FACILITIES 9. Drug Testing Lab 10. DATRC 11. Acute/Chronic Psych Care and Custodial Care Facility
BHFS
CHD LREDs
Initial
Renewal
√ √ √
√ √
Renewal
√
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)
Initial
√
√
√
√
REGULATED HEALTH FACILITIES FACILITIES
BHFS
CHD LREDs Initial
Renewal
√
√
√
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
√
√
20. Birthing Homes (IRR for finalization)
√
√
21. Other HFs Category A without beds (e.g. RHUs) (IRR for finalization)
√
√
16. Hospital Blood Bank 17. Hospital Blood Stations 18. HIV Testing Lab
19. Newborn Screening Centers
Initial
Renewal
√
√
Level 3
Level 3
√
BASIS FOR REGULATION
BASIS FOR REGULATION FACILITIES
MANDATE
REGULATORY INSTRUMENT
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
• • • • •
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)
AO 2013-0003 AO 2012-0001 AO 2008-0027 AO 2006-0037 AO 163 s. 2004
Certificate of Accreditation
BASIS FOR REGULATION FACILITIES 4. Drug Testing Laboratory
MANDATE
• RA 9165 Certificate of Accreditation • DDB Resolution (IRR Governing Accreditation of DTLs in the Philippines, as revised)
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
REGULATORY INSTRUMENT
• • • • • •
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 FACILITIES
MANDATE
REGULATORY INSTRUMENT
8. Newborn Screening Center
• • • • • • • •
9. Water Testing Laboratory
• PD 856 • AO 2006-0024
Certificate of Accreditation
10. Dental Laboratory
• • • • • •
License to Operate
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
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
BASIS FOR REGULATION FACILITIES
MANDATE
REGULATORY INSTRUMENT
11, 12 and 13. Blood Service Facility, Blood Bank and BC
• RA 7719 • AO 2005-0002 • 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
15. Drinking Water Testing Laboratory
• • • • • •
PD 856 RA 9275 AO 2006-0024 AO 2007-0001 DC 2007-0134 AO 2008-0002
License to Operate
Certificate of Accreditation
BASIS FOR REGULATION FACILITIES
MANDATE
REGULATORY INSTRUMENT
16. HIV Testing Laboratory
• AO 2005-0027 • AO 2005-0027-A • AO 2008-0002
Subsumed in the LTO of CL and BB
17. Hospital
• • • • • • •
License to Operate
18. Dental Clinic a. Occupational b. Private School
• AO 3 s 1998 • AO 4 s 1998
RA s. 4226 AO 2012-0012 AO 2011-0020 AO 2010-0081 AO 2008-0021 AO 2007- 0021 AO 2007-0022
19. Psychiatric Care Facility • RA 4226 • AO 147 s. 2004 • AO 2005-0029
Certificate of Accreditation
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 don’t 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. 68–A s. 1989
AO No. 70–A s. 2002
AO No. 147 AO No. s. 2004 2005 – 0029
Primary
Infirmary
Infirmary
Level 1
Secondary
First Level Referral Hospital
Primary Care Hospital
Level 2
Tertiary (Non-Teaching)
Second Level Referral Hospital
Secondary Care Hospital
Level 3
Tertiary (Teaching)
Third Level Referral Hospital
Tertiary Care Hospital
Level 4
Legal Basis for Defining a Hospital Per R.A. 4226 Section 2
Section 8
Beds or cribs or bassinets for 24 hour use or longer
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
LEVEL 2
Level 1 plus: Level 2 plus:
General Medicine Surgery General Pediatrics Emergency and Out-patient Services
LEVEL 3
Anesthesia
Level 3 plus:
Specialty Clinical Care with departmentalized clinical services
Teaching and/or training with at least 1 accredited residency training program for physicians
General Dentistry
Department of Emergency Medicine
General Obstetrics
Pharmacy
Provision for ICU
Non-surgical Gynecology
Secondary Clinical Laboratory
Tertiary Clinical Laboratory
1st Level Radiology
2nd Level Radiology
Minor Surgery
LEVEL 4
Specialized and subspecialized forms of treatment, surgical procedure and intensive care Rehabilitation Service 3rd Level Radiology
INCONSISTENCY OF OLD CLASSIFICATION VS. LAW CATEGORY
Bed space
OR
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 Level 4
YES 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 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
Particular Organ(s)
Particular Group of Patients
National Orthopedic Hospital
Lung Center
Philippine 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 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
NEW
LEVEL 2
RE-CLASSIFY TO OTHER HEALTH FACILITIES LEVEL 1
LEVEL 3
LEVEL 2
LEVEL 4
LEVEL 3
LEVEL I
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 2 plus all:
Teaching/ training with accredited residency Departmentalized training program in Clinical Services the 4 major clinical services
Emergency and OutRespiratory Unit patient Services
Ancillary Services
LEVEL 3
Physical Medicine and Rehabilitation Unit
Isolation Facilities
General ICU
Surgical/ Maternity Facilities
High Risk Pregnancy Unit
Ambulatory Surgical Clinic
Dental Clinic
NICU
Dialysis Clinic
Secondary Clinical Tertiary Clinical Laboratory Laboratory
Tertiary lab with histopathology
Blood Station
Blood Station
Blood Bank
1st
2nd Level X-ray with mobile unit
3rd Level X-ray
Level X-ray
Pharmacy
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
B
C
Custodial Care Diagnostic/ Facility Therapeutic Facility
Psychiatric Care Facility
Laboratories: Clinical Lab/ HIV Blood Service Facilities Drug Test Lab NB Screening Lab Water Lab
D Specialized OutPatient Facility Dialysis Clinic (DC) Ambulatory Surgical Clinic (ASC)
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 Medicine
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.”
Healthcare System
LEVEL OF CARE
DESCRIPTION
Promotive & Preventive Care
Education
Primary Care
Secondary Care
Tertiary Care
Prevention Early Detection & Routine Care
Emergency Treatment Critical Care
Specialized 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
City, Provincial, Level 1 Category Hospitals
National, Regional, Level 2 and 3 Category Hospital, Medical Centers, Teaching/ Training Hospitals
Rehabilitation
Restorative Care
Intermediate & Follow-Up Care Home Care
Continuing Care
Long Term & Chronic Care Personal Care Hospice Care
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
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!
