Office of The Secretary: Administrative Order NO. 2012
Office of The Secretary: Administrative Order NO. 2012
Office of The Secretary: Administrative Order NO. 2012
Department of Health
OFFICE OF THE SECRETARY
JUL 18 2012
ADMINISTRATIVE ORDER
NO. 2012 - _O_O_l-~~--
I. RATIONALE/ BACKGROUND
i Thus, a new classification of hospitals and other health facilities becomes inevitable in
1; compliance with statutory requirements and the emergence of new health facilities. The move
J 0, aims to upgrade the services offered in health facilities and come up with a more
~ 8 ~ homogeneous category for health facilities with similar services. The new classification of
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health facilities will simplify licensing systems and processes and make the regulatory
scheme more effective and efficient.
Related issuances such as, but not limited to, the following, may no longer be relevant
and realistic especially on the aspects of manpower and equipment, to wit, Administrative
Order (A.O.) No. 70-A s. 2002 entitled "Revised Rules and Regulations Governing the
Registration, Licensure and Operation of Hospitals and Other Health Facilities in the
Philippines", A.O. No. 147 s. 2004 and A.O. No. 2005 - 0029, which are Amendments to
A.O. No. 70-A s. 2002. Thus, this Order rescinds the foregoing issuances in line with the
objective of health regulatory reforms to ensure access to safe, quality and affordable health
facilities and services.
II. OBJECTIVE
These rules and regulations are promulgated to protect and promote the health of the
public by ensuring a minimum quality of service rendered by hospitals and other regulated
health facilities and to assure the safety of patients and personnel.
III.SCOPE
These rules and regulations shall apply to all government and private hospitals and
other health facilities.
For purposes of this Order, the succeeding terms and acronyms shall be defined as
follows:
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fitness certification to overseas work applicants, and performance of kidney
transplant. These standards cover input/structural, process and outcome/output
standards.
9. 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.
10. Dental Section/Clinic - a section/clinic in a hospital or non-hospital based
facility with standard dental equipment, instruments and supplies plus all the
anesthetic and sterilization apparatus. A dentist, duly licensed by the
Professional Regulation Commission (PRC), is the head of the section/clinic
capable of providing dental services such as, but not limited to, oral
examination, preventive, curative and rehabilitative services.
11. Department of Health (DOH)
12. Department of Health-Permit to Construct (DOH-PTC) - a permit issued by
DOH through BHFS to an applicant who will establish and operate a hospital or
other health facility, upon compliance with required documents set forth in this
Order prior to the actual construction of the subject facility. A DOH-PTC is also
required for hospitals and other health facilities with substantial alteration,
expansion, renovation, or increase in the number of beds. It is a prerequisite for
LTO.
13. Department/Departmentalized - administrative units in a hospital with a clearly
articulated mission that includes education, research and clinical service in the
field of medicine. Each clinical department shall meet the membership
requirements of the concerned specialty/subspecialty society recognized by the
Philippine Medical Association.
14. License to Operate (LTO) - a formal authority issued by DOH to an individual,
agency, partnership or corporation to operate a hospital or other health facility.
It is a prerequisite for accreditation of a health facility (regulated by BHFS) by
any accrediting body recognized by DOH.
15. Hospital - a place devoted primarily to the maintenance and operation of health
facilities for the diagnosis, treatment and care of individuals suffering from
illness, disease, injury or deformity or in need of obstetrical or other surgical,
medical and nursing care. It shall also be construed as any institution, building
or place where there are installed beds, cribs or bassinets for twenty-four hour
use or longer by patients in the treatment of diseases.
16. High Risk Pregnancy Unit (HRPU) - a unit in the hospital where women are
confined, with complications arising from pregnancy, whose treatment requires
constant supervision or further investigation and assessment. The unit is
operated by a staff of experts such as, but not limited to, perinatologists,
obstetricians, pediatricians, with the assistance, as needed, of other specialists.
It is a fully equipped obstetric ICU that can handle high risk cases and with a
corresponding high risk neonatal ICU (NICU) to handle high risk neonates.
17. Intensive Care Unit (ICU) - a hospital unit in which patients requiring close
monitoring, continuous attention and intensive/critical care are kept. An ICU
contains highly technical monitoring devices and equipment and is staffed by
personnel trained to deliver critical care.
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18. In-Patient Hospital Beds - all hospital beds which are regularly maintained and
staffed for the accommodation and full time care of a succession of in-patients.
These beds are immediately available for the care of admitted patients who stay
for a minimum of twenty-four hours in the hospital. It is situated in wards, or a
part of the hospital where continuous medical care for in-patients is provided. It
includes beds, occupied and unoccupied, in all general hospitals and specialty
hospitals. It refers to counts of 'available beds'. Counts of hospital beds exclude
cots for neonates, day care beds, provisional and temporary beds, beds in
storerooms, beds for special purposes such as delivery tables, surgical tables,
post-operative recovery beds, emergency room beds, dialysis beds, beds for
same day care, beds in nursing and residential care facilities and beds under the
sub-classification of other health facilities.
19. Medical Center - a hospital staffed and equipped to care for many patients and
for a large number of kinds of diseases and dysfunctions using modem
technology.
20. Neonatal Intensive Care Unit (NICU) - a hospital unit containing a variety of
mechanical devices and special equipment for the management and care of
premature/preterm and seriously ill newborns. The unit is staffed by a team of
neonatologists, other pediatric subspecialists, and nurses who are highly trained
in the management of medical and surgical conditions of the newborn.
21. New Hospital - refers to a newly built or constructed hospital.
22. One-Stop Shop (OSS) - a strategy employed by DOH to harmonize the
licensure of hospitals and other health facilities including, but not limited to,
their ancillary and support services.
23. Philippine Health Insurance Corporation (PhilHealth)
24. Physical Medicine and Rehabilitation Unit - a unit in the hospital headed by a
physiatrist, concerned with the maximal restoration or development of physical,
psychological, social, occupational and vocational functions in persons whose
abilities have been limited by disease, trauma, congenital disorders or pain to
enable people to achieve their maximum functional abilities. Physical Medicine
and Rehabilitation involves the diagnosis, evaluation, and management of
persons of all ages with physical and/or cognitive impairment and disability.
25. Philippine Nuclear and Research Institute (PNRI) - an agency under the
Department of Science and Technology that was created by virtue of R.A. 2067
to promote the peaceful uses of atomic energy and promulgate rules and
regulations to ensure the safe use and application of radioactive materials in the
different fields of application.
26. Respiratory Therapy Unit - a unit in the hospital or other health facility with the
necessary equipment needed for the provision of respiratory care. It is headed by
a duly licensed physician and staffed by personnel trained in the treatment and
care of patients with cardio-pulmonary disorders.
27. Sentinel Event - an unexpected occurrence involving death or serious physical
or psychological injury, or the risk thereof, not related to the natural course of
the patient's illness or underlying condition. The phrase 'or the risk thereof
includes any process variation for which a recurrence would carry a significant
chance of a serious adverse outcome. Examples are, but not limited to, the
following: suicide, rape, unanticipated death of a full-term infant, discharge of
an infant to the wrong family, hemolytic transfusion reaction involving
administration of blood or blood products having major blood group
incompatibilities, surgery on the wrong patient or wrong body part, unintended
retention of a foreign object in a patient after surgery or other procedure, near .../
miss, medication errors. Sentinel events signal the need for immediate \ <J1--.
investigation and response. '\
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28. Trauma-Capable Facility - a DOH licensed hospital equipped to provide
comprehensive emergency medical services to patients suffering from traumatic
injuries. It is able to handle any level of severity of trauma and has a trauma
surgeon on-site 24/7 and an operating room ready at all times for trauma cases.
29. Trauma-Receiving Facility - a DOH licensed hospital equipped to evaluate,
treat, and transport severely injured people to appropriate trauma capable
hospitals.
V. IMPLEMENTING MECHANISMS
A. GENERAL GUIDELINES
2. All hospitals shall provide basic hospital functions such as, but not limited to,
acute medical and surgical services, anesthesia services, emergency and
outpatient services, nursing service, dental service, with common diagnostic and
support units as pathology, radiology, and pharmacy.
3. All hospitals and other health facilities shall adhere and ensure strict compliance
to infection control and surveillance practices.
4. All hospitals and other health facilities shall have non-medical support such as,
but not limited to, administrative and finance section, medical records section,
information management, dietary (for in-patients) services, facility management
and maintenance, waste management and security services.
5. All hospitals and other health facilities shall establish a referral network within
the vicinity of their facilities to provide for services where they are not capable
to render.
6. The name of the institution shall be compatible with the functional capacity of
the health facility. All health facilities regulated by DOH applying for
Securities and Exchange Commission (SEC) and/or Department of Trade and
Industry (DTI) registration shall undergo clearance from BHFS. [Example: A
clinic cannot be called a medical center under these rules and regulations.}
7. Health facility owners shall strictly follow the standards, criteria and
requirements prescribed in the Assessment Tool for licensure or accreditation of
health facilities subject to the provisions of Rule IX hereof.
8. All DOH licensed hospitals shall follow A.O. No. 2011 - 0020 on "Streamlining
of Licensure and Accreditation of Hospitals", A.O. No. 2007 - 0021 regarding
"Harmonization and Streamlining of the Licensure System for Hospitals", this
Order and other policy guidelines and/or related issuances.
9. All DOH licensed non-hospital based health facilities subject to the provisions
of other Administrative Orders shall follow the appropriate health facility
issuance, this Order and other policy guidelines and/or related issuances. ~
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B. SPECIFIC GUIDELINES
1. CLASSIFICATION OF HOSPITALS
a. ACCORDING TO OWNERSHIP
a. Clinical Services
1. Family Medicine;
2. Pediatrics;
3. Internal Medicine;
4. Obstetrics and Gynecology;
5. Surgery;
b. Emergency Services;
c. Outpatient Services;
d. Ancillary and Support Services such as, clinical laboratory, imaging
facility and pharmacy.
1. General Hospital
a. Level 1
A Level 1 hospital shall have as minimum the services stipulated
under Rule V. B. 1. b. 1. of this Order, including, but not limited to,
the following:
b. Level 2
A Level 2 hospital shall have as minimum, all of Level 1 capacity,
including, but not limited to, the following:
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4. Provision for NICU;
5. Provision for HRPU;
6. Provision for respiratory therapy services;
7. A DOH licensed tertiary clinical laboratory;
8. A DOH licensed level 2 imaging facility with mobile x-ray inside
the institution and with capability for contrast examinations.
c. Level 3
A Level 3 hospital shall have as minimum, all of Level 2 capacity,
including, but not limited to, the following:
1. With In-patient beds - a short stay facility where a short (average of one
to three days) length of time is spent by patients before discharge.
Examples are, but not limited to, the following:
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a. Infirmary;
b. Birthing Home - a homelike facility that provides maternity service
on pre-natal and post-natal care, normal spontaneous delivery, and
care of newborn babies. Staff shall be trained in Essential
Intrapartum and Newborn Care (EINC) in accordance with DOH
A.O. No. 2009 - 0025 entitled "Adopting Policies and Guidelines on
Essential Newborn Care" and Basic Emergency Obstetrics and
Newborn Care (BEmONC) in accordance with DOH A.O. No. 2011
- 0014 regarding "Guidelines on the Certification of Health Facilities
with Basic Emergency Obstetrics and Newborn Care". Birthing
facilities shall comply with licensing requirements (Annex C) and
planning and design guidelines/ Reference Plan (Annex D) of DOH.
1. Laboratory Facility, such as, but not limited to, the following:
a. Clinical Laboratory;
b. Human Immunodeficiency Virus (HIV) Testing Laboratory;
c. Blood Service Facility;
d. Drug Testing Laboratory;
e. Newborn Screening Laboratory;
f. Laboratory for Drinking Water Analysis.
2. Radiologic Facility, such as, but not limited to, the following:
a. Ionizing Machines as X-Ray, CT scan, mammography and others.
b. Non-Ionizing Machines as MRI, ultrasound and others.
3. Nuclear Medicine Facility - a facility, presently regulated by PNRI,
j
embracing all applications of radioactive materials in diagnosis, \(
treatment or in medical research, with the exception of the use of sealed G. J\
radiation sources in radiotherapy. ,-
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d. Category D: Specialized Out-Patient Facility - a facility with highly
competent and trained staff that performs highly specialized procedures on
an out-patient basis. Examples are, but not limited to, the following:
1. Dialysis Clinic;
2. Ambulatory Surgical Clinic;
3. In-Vitro Fertilization Center;
4. Stem Cell Facility;
5. Oncology Chemotherapeutic Center/Clinic;
6. Radiation Oncology Facility;
7. Physical Medicine and Rehabilitation Center/Clinic.
Table 1. Summary of the New Classification of Hospitals and Other Health Facilities
NEW CLASSIFICATION
OTHER HEALTH
HOSPITALS
FACILITIES
GENERAL A. Primary Care Facility
• Level 1
■ Level2 B. Custodial Care Facility
• Level3
(Teaching/ C. Diagnostic/ Therapeutic
Training) Facility
D. Specialized Out-Patient
SPECIALTY
Facility
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Table 3. New Classification of Other Health Facilities
3. STANDARDS
Every health facility shall be organized to provide safe, quality, effective and
efficient services for patients.
a. PERSONNEL
Every health facility shall have an adequate number of qualified, trained and
competent staff to ensure efficient and effective delivery of quality services.
1. Every health facility shall have a duly licensed physician to oversee the
clinical/ medical operations of the health facility.
2. The staff composition, particularly the Medical, Allied Medical,
Nursing, Administrative and Finance Sections of the hospital, shall
depend on the workload and the services being provided and other
personnel qualifications as may be required by DOH.
3. There shall be staff development and continuing education program at all
levels of organization to upgrade the knowledge, attitude and skills of
staff.
b. PHYSICAL FACILITIES
Every health facility shall have physical facilities with adequate areas to
safely, effectively and efficiently provide health services to patients as well
as members of the public as necessary.
1. Every health facility shall comply with the applicable local and national
regulations for the construction, renovation, maintenance and repair of
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the health facility. \ (
2. Every health facility shall provide enough space for the conduct of its.
activities depending on its workload and the services being given. (
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3. Every health facility shall have an approved DOH-PTC in accordance
with the planning and design guidelines prepared by DOH.
Every health facility shall have available and operational equipment and
instruments consistent with the services it will provide.
1. Every health facility shall be adequately equipped based on the level and
complexity of healthcare it provides.
2. There shall be a program for calibration, preventive maintenance and
repair of equipment.
3. There shall be a contingency plan in case of equipment breakdown and
malfunction.
d. SERVICE DELIVERY
Every health facility shall ensure that the services delivered to patients
comply with the standard quality embodied in the Assessment Tool for
licensure/accreditation of health facilities, other policy guidelines and/or
related issuances.
Every health facility shall establish and maintain a system for continuous
quality improvement activities.
f. INFORMATION MANAGEMENT )
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1. Contents of Medical Records
Each patient record shall be kept confidential and shall contain sufficient
information to identify the patient and to justify the diagnosis and
treatment. Current medical records shall contain, but are not limited to,
the following:
a. Summary or face sheet with patient identification data, diagnosis,
physician's name and phone number, family member to be contacted
in case of emergency and phone number, patient's address and phone
number, date of admission;
b. Doctor's orders. Standing orders shall be up-to-date.
c. Informed consent;
d. Problem list;
e. Clinical and graphic record of patient's vital signs;
f. Personal history and physical examination records;
g. Newborn record and physical maturity rating, whenever warranted;
h. Doctor's progress notes;
1. Medication and/or treatment record;
J. Laboratory and x-ray reports;
k. Operative and anesthesia records;
1. Dietary assessment;
m. Nurse's progress notes;
n. Records of transfer/referral of patient to another physician or health
facility;
o. Inpatient referral/ consultation notes of other physicians
p. Final Diagnosis;
q. Discharge summary;
r. Clinical Abstract;
s. Advance Directive, whenever available.
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3. Records Management
a. There shall be documented policies and procedures on access to and
confidentiality of patient's information. Likewise, the right of the
patient to obtain records of treatment and other relevant medical
information shall be observed.
b. Retention and disposal of medical records and other relevant
information whether paper-based or electronic media shall be in
accordance with the standards promulgated by DOH or by competent
authorities for such purposes.
g. ENVIRONMENTAL MANAGEMENT
Every health facility shall ensure that the environment is safe for its patients
and staff including members of the public as necessary and that the
following measures and/or safeguards shall be observed.
1. There shall be well ventilated, lighted, clean, safe and functional areas
based on the services provided.
2. There shall be a program of proper maintenance and monitoring of
physical facilities.
3. Water supply for all purposes shall be adequate in volume and pressure.
Likewise, safe and potable water shall be available at all times.
4. There shall be procedures for the proper disposal of infectious wastes
and toxic and hazardous substances in accordance with R.A. 6969
known as "Toxic and Hazardous Substances and Nuclear Wastes Act"
and other related policy guidelines and/or issuances.
a. Each health facility shall establish and implement a system for
proper solid waste management which shall be in accordance with
the revised DOH Manual on Health Care Waste Management and
Environmental Management Bureau - Department of Environment
and Natural Resources (EMB-DENR) environmental laws,
particularly R.A. 9003 "Ecological Solid Waste Management Act"
and the Environmental Sanitation Code and other pertinent policy
guidelines and/or issuances.
b. Each health facility shall establish and implement a system for
proper liquid waste management which shall be in accordance with
the revised DOH Manual on Health Care Waste Management and
other EMB-DENR policy guidelines and/or issuances.
5. There shall be a "no smoking policy" and that the same shall be strictly
enforced.
6. There shall be a contingency plan in case of accidents and emergencies
following the guidelines stipulated in DOH A.O. No. 2004 - 0168
known as "National Policy on Health Emergencies and Disasters".
1. The applicant c.an acquire the prescribed application form for CON to establish a
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new general hospital at BHFS/CHD or at DOH website www.doh.gov.ph
2. The applicant shall submit the duly accomplished application form at CHD
which has jurisdiction over the proposed hospital. t· A
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3. The applicant shall submit a Certification from the Provincial Planning and
Development Office that the proposed hospital is part of the duly approved
Provincial Hospital/ Health Care Delivery Plan.
4. Each CHD evaluates, approves or disapproves CON in accordance with A.O.
No. 2006 - 0004 regarding "Guidelines for the Issuance of Certificate of Need
to Establish a New General Hospital", its amendments, other policy guidelines
and/or related issuances.
1. Applicants can acquire the prescribed application form for LTO at BHFS or
CHD or at DOH website www.doh.gov.ph.
2. The duly accomplished form together with the necessary attachments such as, )
but not limited to, list of personnel, list of equipment and other relevant records
shall be submitted to BHFS/CHD, as the case maybe. \ (_
3. Each CHD shall issue the initial LTO of other health facilities under Category A JJ \
- Primary Care Facility with in-patient beds. f '\I
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4. All hospitals shall follow OSS Licensure System for Hospitals under A.O. No.
2007 - 0021 known as "Harmonization and Streamlining of the Regulatory
Processes", A.O. No. 2010-0035 about "Re-centralization of the Issuances of
Permit to Construct (PTC) for All Levels of Hospitals, License to Operate
(LTO) for All New Hospitals and Renewal of LTO for Levels 3 and 4
Hospitals", A.O. No. 2011 - 0020 entitled "Streamlining of Licensure and
Accreditation of Hospitals", its related issuances and this Order.
1. Each CHD shall renew LTO of Level 1 hospitals following OSS Licensure
System for Hospitals and renew LTO of other health facilities under Category A
- Primary Care Facility with in-patient beds.
2. The Bureau of Health Facilities and Services 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.
3. The duly accomplished application form together with the necessary
attachments including the annual hospital statistical report, and whenever
applicable, proposed floor plan with cost estimate and corresponding budgetary
allocation and other relevant records, shall be submitted to BHFS/CHD, as the
case maybe.
4. The License to Operate a hospital shall be cancelled automatically without
notice upon failure to submit a duly accomplished application form and failure
to pay the proper fee on or before the expiration date stated on its license.
Hence, the hospital shall apply for initial/new LTO.
E. INSPECTION
1. The Bureau of Health Facilities and Services or CHD, as the case may be, shall
conduct licensure inspections utilizing the Assessment Tool for
licensure/accreditation of health facilities within reasonable time and during
office hours.
2. The applicant shall ensure that all key staff, pertinent records, premises and
facilities are made available to BHFS/CHD Director and/or his authorized
representative(s) during inspection visits.
F. MONITORING
t
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VII. SCHEDULE OF FEES
VIII.VALIDITY OF LTO
The License to Operate a hospital shall be valid for one (1) year following OSS
Licensure System for hospitals. The License to Operate/Accreditation of other health
facilities covered by other Administrative Orders shall follow the specific issuance(s) of the
health facility under evaluation.
IX. VIOLATIONS
Facilities found violating any provision of these rules and regulations and its related
issuances, and/or commission/omission of acts by personnel operating a hospital or health
facility under this Order shall be penalized and/or its LTO suspended or revoked. The
guidelines on violations shall be in accordance with A.O. No. 2007 - 0022 entitled
"Violations Under the One-Stop Shop Licensure System for Hospitals", its related issuances,
other relevant policy guidelines and this Order.
A. The Bureau of Health Facilities and Services or the Director of CHD and/or his
authorized representative(s) shall investigate the complaint and verify if the hospital
or other health facility concerned or any of its personnel is liable for an alleged
violation.
B. The Bureau of Health Facilities and Services or the Director of CHD and/or his
authorized representative(s), after investigation, may suspend, cancel or revoke
LTO of licensees found violating the provisions of this Order and its related
issuances, without prejudice to taking the case to judicial authority for criminal
action.
XI. PENALTY
The imposable penalty for violations hereof shall be in accordance with A.O. No. 2007
- 0022 on "Violations Under the One-Stop Shop Licensure System for Hospitals" and A.O.
2008 - 0028 known as "Violations Under the One-Stop Shop Licensure System for Non-
Hospital Based Facilities ... ", its related issuances and this Order.
XII. APPEAL )
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file a notice of appeal to the Office of the Secretary of Health. Thereupon, BHFS shall
promptly certify and file a copy of the decision, including all documents and transcript of
hearings on which the decision is based, with the Office of the Secretary for review. The
decision of the Secretary of Health shall be final and executory.
A. These rules and regulations, upon approval, shall be enforced on New Hospitals
applying for LTO.
C. Existing Level 1 health facilities which cannot comply with the provisions stated in
Sections 2, 8 and 16 of Republic Act 4226 shall, upon approval of this Order, be re-
classified to 'Other Health Facilities'.
This Order rescinds A.O. No. 2005 - 0029, A.O. No. 147 s. 2004 and A.O. No. 70-A s.
2002. Provisions from previous issuances that are inconsistent or contrary to the provisions
of this Order are hereby repealed and modified accordingly.
In the event that any provision or part of this Order is declared unauthorized or rendered
invalid by any court of law or competent authority, those provisions not affected by such
declaration shall remain valid and in force.
XVI. EFFECTIVITY
This Order shall take effect fifteen (15) days after its approval and publication in a
newspaper of general circulation.
ENRJQUE~D.
Secretary of Health
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