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SIXTEENTH CONGRESS OF THE REPUBLIC 
OF THE PHILIPPINES 
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First Regular Session 
SENATE 
Senate Bill No. 545 
"13 
JUL -8 118:51 
INTRODUCED BY SEN. JINGGOY EJERCITO ESTRADA 
EXPLANATORY NOTE 
The Constitution, Article XIII, Section 11 provides that 
"The State shall adopt an integrated and comprehensive 
approach to health development, which shall endeavor to make 
essential goods, health and other social seNices available to the 
people at affordable cost. There shall be priority for the needs of 
the underprivileged sick, elderly, disabled, women, and children. 
The State shall endeavor to provide free medical care to paupers." 
The Administrative Code, Title 9, Section 2 provides that: 
"The Department (of Health) shall be primarily responsib~e 
for the formulation, planning, implementation, and coordination of 
policies and programs in the field of health. The primary function M 
the Department is the promotion, protection, preseNation, or 
restoration of the health of the people through provision and 
delivery of health seNices and through the regulation and 
encouragement of health goods and seNices. " 
Health care providers have the responsibility of giving the care and 
services needed to restore the well-being of patients. However, despite their 
expertise, health care providers also commit medical mistakes and medication-
related errol's to the prejUdice Of tne patients. ThUs, to redUce these mistakes, 
this bill seeks to: 
1) promote the identification, evaluation, and reporting of medical errors; 
2) raise standards and expectations for improvement in patient safety; 
3) reduce deaths, serious injuries, and other medical errors through the 
implementation of safe practices at the delivery level; 
4) develop error reduction systems with legal protections to support the 
collection of information under such systems; 
5) extend existing confidentiality and peer review protections to the reports 
relating to medical errors that are reported under such systems that are 
developed for safety and quality improvement purposes; and 


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6) provide for the establishment of systems of information collection, 
analysis, and dissemination to enhance the knowledge base concerning 
patient safety. 
Considering the foregoing, immediate passage of this bill is earnestly 
solicited. 
GOY EJERCITO ESTRADA 
Senator 


SIXTEENTH CONGRESS OF THE REPUBLIC 
OJ; THE PHILIPPINES 
First Regular Session 
SENATE 
Senate Bill No. 
545 
) 
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"13 
JUL -8 AS 51 
INTRODUCED BY SEN. JINGGOY EJERCITO ESTRADA 
AN ACT 
TO REDUCE MEDICAL MISTAKES AND MEDICATION-RELATED ERRORS 
Be it enacted by the Senate and House of Representatives of the Philippines in 
Gongress assembled: 
SECTION 1. Short Title. - The Act shall be known as the "Patient Safety 
and lirrors Reduction Act". 
I 
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SEC. 2. Declaration of Policy. - The State shall adopt an integrated and 
comprehensive approach to health development. 
SEC. 3. Definition of Term. - As used in this Act: 
1) "Adverse Event" means, with respect to the patient of a provider of 
services, an untoward incident, therapeutic misadventure, or iatrogenic 
injury associated with the provision of health care items and services by a 
health care provider or provider of 
2) services; 
3) "Center" means the Center for Quality Improvement and Patient Safety 
established under Section 4; 
4) "Close Call" means, with respect to the patient of a provider of services, 
any event or situation that -
a) but for chance or a timely intervention, could have resulted in an 
accident, injury, or illness; and 
b) is directly associated with the provision of health care items and 
services by a provider of services; 
5) "Expert Organization" means a third party acting on behalf of or in 
m:mjuRctioR with, a previder of services te cellect infeFmation aBout, OF 
evaluate, a medical event; 
6) "Health Care Oversight Agency" means an agency, entity, or person, 
including employees and agents thereof, that performs or oversees the 


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performance of any activities necessary to ensure the safety of the health 
care system, 
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7) "Health Care Provider" means any person furnishing any medical or other 
health care services, or under the authority of, a provider of services 
described in the next paragraph; 
8) "Provider of Services" means a hospital, skilled nursing facility, 
comprehensive outpatient rehabilitation facility, home health agency, renal 
dialysis facility, ambulatory surgical center, or hospice program, and any 
other entity specified in regulations promulgated by the Secretary; 
9) "Public Health Authority" means an agency or authority of the Republic of 
the Philippines that is responsible for public health matters as part of its 
mandate; 
10)"Medical Event" means, with respect to the patient of a provider of 
services, any sentinel event, or close call; 
11 )"Medical Event Analysis Entity" means an entity certified under Section 
S(A); 
12)"Root Cause Analysis" means -
(a) 
In General - The term "root cause analysis" means a 
process for identifying the basic or contributing causal 
factors that underlie variation in performance associated 
with adverse events or close calls that -
(i) 
has the characteristics described in subparagraph (b); 
(ii) 
includes participation by the leadership of the organization 
and individuals most closely involved in the processes and 
systems under review; 
(iii) 
is internally consistent; and 
(iv) 
includes the consideration of relevant literature. 
(b) Characteristics -
The characterisctics subparagraph inclpde the 
following: ' 
I 
(i) 
The analysis is interdisciplinary in nature and involves 
those individuals who are responsible for administering 
the reporting systems. 
(ii) 
The analysis focuses primarily on systems and processes 
rather than individual performance. 
(iii) 
The analysis focuses primarily on systems and process 
and all contributing factors involved. 
(iv) 
The analysis identifies changes that could be made in 
systems and processes, through either redesign or 
development of new processes or systems that would 
improve performance and reduce the risk of adverse 
events or close calls. 


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13)"Sentinel Event" means, with respect to the patient of a provider of 
services, an unexpected occurrence that -
(a) involves death or serious physical or psychological injury 
(including loss of a limb); and 
(b) is directly associated with the provision of health care items and 
services by a provider. 
14)"Secretary" means the Secretary of Health. 
SEC. 4. Research to Improve the Quality and Safety of Patient Care. -
(A) In General - To improve the quality and safety of patient care, the Secretary 
shall-
1) conduct and support research, evaluations and training, I support 
demonstration projects, provide technical assistance, and devellop and 
support partnerships that will identify and determine the causes of medical 
errors and other threats to the quality and safety of patient care; 
2) develop or identify and evaluate interventions and strategies for 
preventing or reducing medical errors and threats to the quality and safety 
of patient care; 
3) develop, in conjunction with experts in the field, reporting requirements to 
provide consistency throughout the errors reporting system; 
4) develop approaches for the clinical management of complications from 
medical errors; and 
5) establish mechanisms for the rapid dissemination of interventions and 
strategies developed under this section for which there is scientific 
evidence of effectiveness. 
(8) Center for Quality Improvement and Patient Safety -
1) Establishment. - There shall be established a center to be known as the 
Center for Quality Improvement and Patient Safety to assist the Secretary in 
carrying out the requirements of subsection (A). 
2) Mission. - The Center shall -
(a) provide national leadership for research and other initiatives to 
improve the quality and safety of patient care; 
(b) develop public-private sector partnerships to improve the quality 
and safety of patient care; and 
(c) serve as a national resource for research and learning from 
medical errors. 
(3) Duties.-


(a) In General - In carrying out this section, the Secretary acting 
through the Center, 
shalJ consult and develop partnerships, as 
appropriate, with all segments of the health care industry, including health 
care practitioners and patients, those who manage health care facilities, 
systems and plans, peer review organizations, health care purchasers and 
policymakers, and other users of health care research. 
(b) Required Duties - In addition to the broad responsibilities that 
the Secretary may assign to the Center for research and related activities 
that are designed to improve the quality of health care, the Secretary shall 
ensure that the Center-
(i) builds scientific knowledge and understanding of the 
causes of medical errors in all health care settings and 
identifies or develops and validates effective interventions 
and strategies to reduce errors and· improve the safety and 
quality of patient care; 
(ii) promotes public and private sector research on patient 
safety by-
(Ua) identifjfying promising opportunities for preventing 
or reducing medical errors; and 
(iib) tracking the progress made in addressing the 
highest priority research questions with respect to 
patient safety. 
(iii) facilitates the development of volantary national 
patient safety goals by convening all segments of 
health care industry and tracks the progress made in 
meeting those goals; 
(iv) develops national patient safety data for inclusion 
in the annual report on the quality of health care; , 
(v) strengthens the ability of the Republic of the 
Philippines to learn from medical errors by-
(va) developing the necessary tools and 
advancing the scientific techniques for analysis 
of errors; 
(vb) 
providing 
technical 
assistance 
as 
appropriate to reporting systems; and 
(vc) entering into contracts to receive and 
analyze aggregate data from public and private 
sector reporting systems; 
(vi)supports 
dissemination 
and 
communication 
activities 
to 
improve 
patient 
safety, 
including 
the 
development of tools and methods for educating consumers 
about patient safety; and 


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(vii) undertakes other activities that the Secretary 
determines are necessary to enable the Center to fulfills its 
mission, 
(c) Limitation. - Aggregate data gathered for the purposes described in this 
section shall not include specific patient, health care provider, or provider of 
service identifiers. 
(C) Learning from Medical Errors. -
(1) In General. - To enhance the ability of the health care community in the 
Republic of the Philippines to learn from medical errors and close crlls, the 
Secretary shall -
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, 
(a) understanding regarding medical error reporting systems; 
(b) carry o\.lt activities to increase scientific knowledge and (b) carry out 
activities to advance scientific knowledge regarding the tools and techniques for 
analyzing medical errors and determining their root causes; 
(c) carry out activities in partnership with experts in the field to increase 
the capacity of the health care community to analyze patient safety data; 
d) develop a confidential national safety database of medical errors 
reports; 
(e) conduct and support research, using the database developed under 
subparagraph (d), into the causes and potential intervention to decrease the 
incidence of medical errors and close calls; and 
(f) ensure that information contained in the national database under 
subparagraph (d) does not include specific patient, health care provider, or 
provider of service identifiers. 
(2) National Patient Safety Database. - The Secretary shall, in accordance with 
paragraph (C)(1)(d), establish a confidential national safety database (to be 
known as the National Patient Safety Database) of reports of medical errors and 
close calls that can be used only for research to improve the quality and safety of 
patient care. In developing and managing the National Patient Safety Database, 
the Secretary shall-
a) ensure that the database can only be used for its intended purpose; 
b) ensure that the database is as comprehensive as possible by aggregating 
data from public and private sector patient safety reporting systems; 
c) research on the most common medical errors and close calls, their 
causes, and potential interventions to reduce medical errors and improve 
the quality and safety of patient care; 
d) report findings based on the data in the database, to clinicians, in?ividuals 
who manage health care facilities, systems, and plans, patients, and other 
individuals who can act appropriately to improve patient safety; and 
e) develop a rapid response capacity to provide alerts when specific health 
care practices pose an imminent threat to patients or health care workers. 


(3) Confidentially and Peer Review Protections - Notwithstanding any other 
provision of law any information (including any data, reports, records, 
memoranda, analyses, statements, and other communications) developed by or 
on behalf of a health care provider or provider of services with respect to a 
medical event, that is contained in the National Patient Safety Database shall be 
confidential in accordance with Section 8. 
(4) Patient Safety Reporting Systems. - The Secretary shall identify public and 
private sector patient safety reporting systems and build scientific knowledge and 
understanding regarding the most effective -
(a) components of patients safety reporting systems; 
(b) incentives intended to increase the rate of error reporting; . 
(c) approaches for undertaking root cause analysis; 
(d) ways to provide meaningful information to patients, consumers, and 
purchasers that will enhance their understanding of patient safety issues. 
(5) Training. - The Secretary shall support training initiatives to build the capacity 
of the health care community to analyze patient safety date and to act on that 
data to improve patient safety. 
(D) Evaluation. - The Secretary shall recommend strategies for measuring and 
evaluating the national progress made in implementing safe practices and 
standards identified by the Center through the research and analysis required 
under sUbsection (8) and through the voluntary reporting system established 
under subsection (C). 
I 
(E) Implementation. - In Implementing strategies to carry out the functions 
described in subsections (8), (C), and (D), the Secretary may contract with public 
or private entities on a national or local level with appropriate expertise. 
SEC. 5 . Medical Event Analysis Entities. -
(A) In General. - The Secretary, based on information collected under Section 
4(C), shall provide for the certification of entities to collect and analyze 
information on medical errors, and to collaborate with health care providers of 
services in collecting information about, or evaluating, certain medical events. 
(8) Compatibility of Collected Data - To ensure that data reported to the National 
Patient Safety Database under Section (4)(2) concerning medical errors and 
close calls are comparable and useful on an analytic basis, the Secretary shall 
require that the entities described in subsection (C) follow the recommendations 
regarding a common set of core measures for reporting that are developed by 
the National Forum for Health Care Quality Measurement and Reporting, or other 
voluntary private standard setting organization that is designated by the 
Secretary taking into account existing measurement systems and in conjunction 
with experts in the field. 
(C) Duties of Certified Entities. -
(1) In General. - An entity that is certified under subsection (A) shall collect 
and analyze information, consistent with the requirement of subsection (8), 
provided to the entity under Section 6(A) to improve patient safety. 


(2) Information to be Reported to the Entity - A medical event analysis 
entity shall, on a periodic and in a duly prescribed format submit to the Secretary 
a report that contains -
(a) a description of the medical events that were reported to the 
entity during the period covered under the report; 
(b) a description of any corrective action taken by providers of 
services with respect to such medical events or any other 
measures that are necessary to prevent similar events from 
occurring in the future; 
(c) a description of the systemic changes that entities have 
identified, through an analysis of the medical events included in the report, 
as being needed to improve patient safety. 
(3) Collaboration. - A medical event analysis entity that is collaborating 
with a health care provider or provider of services to address close calls and 
adverse events may, at the request of the health care provider or provider of 
services -
(a) provide expertise in the development of root cause analyses and 
corrective action plan relating to such close calls and adverse events; or 
(b)collaborate with such provider of services to identify on-going risk 
reduction activities that may enhance patient safety. 
(D) Confidentially and Peer Review Protections. - Notwithstanding any other 
provision of law, any information (including any data, reports, records, 
memoranda, analyses, statements, and other communications) collected by a 
medical events analysis entity or developed by or on behalf of such an entity 
under this part shall be confidential in accordance with Section 7. 
(E) Termination and Renewal. -
(1) In General. - The certification of an entity under this section shall 
terminate after three (3) years from the date on which such certification was 
provided. Such certification may renewed at the discretion of the Secretary. 
(2) Noncompliance. - The Secretary may terminate the certification of a 
medical event analysis entity if he determines that such entity has failed to 
comply with this section. 
(F) Implementation. - In implementing strategies to carry out the functions 
described in subsection (C), the Secretary may contract with public or private 
entities on a national or local level with appropriate expertise. 
: 
SEC. 6. Provider of Services Systems for Reporting Medical Events -
(A) Internal Medical Event Reporting Systems - Each provider of services that 
elects to participate in a medical error reporting system under this part shall -
(1) establish a systems for - -
(a) identifying, collecting information about, and evaluating medical 
events that occur with respect to a patient in the care of the provider of 


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services or a practitioner employed by the provider of services, that may 
include-
(i) 
the provision of a medically coherent description of 
each so identified; 
(ii) 
the provision of a clear and thorough accounting of the 
results of the investigation of such event under the 
system; and 
(iii) a description of all corrective measures taken in response 
to the event; and 
(b) determining appropriate follow-up actions to be taken with 
respect to such events; 
(2) establish policies and procedures with respect to when and to whom 
such events are to be reported; 
(3) take appropriate follow-up action with respect to such events; and 
(4) submit to the appropriate medical event analysis entity information that 
contains descriptions of the medical events identified under paragraph (I)~A). 
(8) Promoting Identification, Evaluation, and Reporting of Certain I Medical 
Events. -
(1) In General. - Notwithstanding any other provIsIon of law, any 
information (including any data, reports, records, memoranda, analyses, 
statements, and other communications) developed by or on behalf of a provider 
of services with respect to a medical event pursuant to a system established 
under subsection (A) shall be privileged in accordance with Section 7. 
(2) Rules of Construction. - Nothing in this subsection shall be construed 
as prohibiting -
(a) disclosure of a patient's medical record to the patient; 
(b) a health care oversight agency or a public health authority from 
requiring a provider of services to transfer information to the agency or 
authority to the extent required by law; or 
(c) such an agency or authority from disclosing information 
transferred by a provider of services to the public in a form that does not 
identify or permit the identification on the health care provider or provider 
of services or patient. 
SEC. 7. Confidentiality. -
(A) Confidentially and Peer Review Protections - Notwithstanding any other 
provision of law-
(1) Any information (including any data, reports, records, memoranda, 
analyses, statements, and other communications) developed by or on behalf of a 
health care provider or provider of services with respect to a medical event, that 
is contained in the National Patient Safety Database, collected- by a medical 


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L 
event analysis entity, or developed by or on behalf of such an entity, or c10llected 
by a health care provider or provider or services for use under systems that are 
developed for safety and quality improvement purposes under this part-
I 
(a) shall be privileged, strictly confidential, and may not be disclosed by 
any other person to which such information is transferred without the 
authorization of the health care provider or provider of services; and 
(b)shall-
1) be protected from disclosure by civil, criminal, or administrative 
subpoena; 
2) not be subject to discovery or otherwise discoverable in connection 
with a civil, criminal, or administrative proceeding; and 
3) not be admissible as evidence in any civil, criminal, or 
administrative proceeding; 
4) Without regard to whether such information is held by the provider 
or by another person to which such information was transferred; 
(2) the transfer of any such information by a provider of services to a health care 
oversight agency, an expert organization, a medical event analysis entity, or a 
public health authority, shall not be treated as a waiver of any privilege or 
protection established under paragraph (I) or established under the law. 
(8) Penalty. - It shall be unlawful for any person to disclose any 
information described in subsection (A) other than for the purposes provided in 
such paragraph, and any person violating the provisions of this section shall, 
upon conviction, be fined for not more than One Hundred Thousand 
Pesos(P100,OOO.OO), and imprisoned for not more than six (6) months, or both. 
(C) Application of Provisions. - The protections provided under SUbsection 
(A) and the penalty provided for under subsection (8) shall apply to any 
information (including any data, reports, memoranda, analyses, statements, and 
other communications) collected or developed pursuant to research including 
demonstration projects, with respect to medical error reporting supported by the 
Secretary under this part. 
SEC. 8. Appropriations. - To carry out the provisions of this Pict, such 
amount as many be necessary is hereby authorized to be appropriated from the 
National Treasury. Thereafter, the amount necessary for the continuous 
operation of the Act shall be included in the annual appropriation of the 
Department of Health. 
SEC. 9. Separability Clause. - If any proviSion or part hereof, is held 
invalid or unconstitutional, the remainder of the law or the provision not otherwise 
affected shall remain valid and subsisting. 
SEC. 10. Repealing Clause. - Any law, presidential decree or issuance, 
executive order, letter of instruction. administrative order, rule or regulation 
contrary to or inconsistent with the provisions of this Act is hereby repealed, 
modified, or amended accordingly. 


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SEC. 11. Effectivity Clause. - This Act shall take effect fifteen (15) days 
after its publication in at least two (2) newspapers of general circulation. 
Approved, 
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