THIRTEENTH CONGRESS OF THE REPUBLIC ) 
4 JUN 30 PI :?9 
OF THE PHILIPPINES 
1 
First Regular Session 
1 
S E N A  
S. B. No. 
Introduced by Senator Luisa “Lo?’ P. Ejercito Estrada 
EXPLANATORY NOTE 
The Constitution, Article 13, 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 services 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 shall be primarily responsible for the 
formulation, planning, impfernentation, and coordination of 
policies and programs in the field of health. The primary function 
of the Department is the promotion, protection, preservation, or 
restoration of the health of the people through provision and 
delivery of health services and through the regulation and 
encouragement of health goods and services. ’’ 
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 errors to the prejudice of 
the patients. Thus, to reduce these mistakes, this bill seeks to: 
(1) 
(2) 
(3) 
(4) 
(5) 
promote the identification, evaluation, and reporting of medical errors; 
raise standards and expectations for improvement in patient safety; 
reduce deaths, serious injuries, and other medical errors through the 
implementation of safe practices at the delivery level; 
develop error reduction systems with legal protections to support the 
collection of information under such systems; 
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 
(6) 
provide for the establishment of systems of information collection, 
analysis, and dissemination to enhance the knowledge base concerning 
patient safety. 
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Considering the foregoing, immediate passage of this bill is earnestly solicited. 
LUISA “LOI” fl EJERCFTO ESTRADA 
Senator 


THIR’EENTH CONGRESS OF THE REPUBLIC ) 
OF THE PHILIPPTNES 
1 
First Regular Session 
1 
S E N  
S. El. No. 
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~ 
Introduced by Senator Luisa “Loi” P. 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 Congress 
assembled: 
SECTION 1. Short Title. - Thk Act shall be known its the “Patient Safety and 
Errors Reduction Act.” 
SECTION 2. Declaration of Policy. - The State shall adopt an integrated and 
comprehensive approach to health development. 
SECTION 3. DeJinition 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 services; 
”Center” means the Center for Quality Improvement and Patient 
Safety established under Section 4; 
”Close Call” means, with respect to the patient of a provider of 
services, any event or situation that - 
(a) 
I 
(2) 
‘
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 I 
(3) 
but for chance or a timely intervention, could have resulted 
in an accident, injury, or illness; and 
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(b) 
is directly associated with the provision of health care items 
and services by a provider of services; 
“Expert Organization’9 means a third party acting on behalf of or in 
conjunction with, a provider of services to collect information 
about, or evaluate, a medical event; 
“Health Care Oversight Agency’’ means an agency, entity, or 
person, including employees and agents thereof, that performs or 
oversees the performance of any activities necessary to ensure the 
safety of the health care system, 
“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; 
“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; 
“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; 
“Medical Event” means, with respect to the patient of a provider of 
services, any sentinel event, or close call; 
“Medical Event Analysis Entity” means an entity certified under 
Section S(A); 
“Root Cause Analysis” means - 
(a) 
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I 
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In General - The term “root cause analysis” means a 
process for identifjring the basic or contributing causal 
factors that underlie variation in performance associated 
with adverse events or close calls that - 
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(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) 
Characteristics - The characteristics described in this 
includes the consideration of relevant literature. 
(b) 
subparagraph include the foilowing: 
(i) 
The analysis is interdisciplinary in nature and 
involves those individuals who are responsible for 
administering the reporting systems. 
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(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. 
The anaiysis identifies changes that could be made 
(iv) 
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. 
(12) 
"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. 
(13) 
"Secretary" means the Secretary of Health. 
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SECTION 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, 
support 
demonstration 
projects, 
provide 
technical 
assistance, and develop 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 identifjr 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. 
(B) 
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; 
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(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, shall 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 t4at . 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; 
promotes public and private sector research 
on patient safety by- 
(ii) 
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(iia) identifjkig 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 voluntary 
national patient safety goals by convening a1 
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; 
strengthens the ability of the Republic of the 
Philippines to learn fiom medical errors 
by- 
(va) developing the necessary tools and 
advancing the scientific techniques for 
(v) 
analysis of errors; 
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(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 
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methods for educating consumers about 
patient safety; and 
(vii) 
undertakes other activities that the Secretary 
determines are necessary to enable the 
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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 calls, the Secretary shall - 
(a) 
understanding regarding medical error reporting systems; 
carry out 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) 
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. 
develop a contidential national safety database of medical 
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(2) 
National Patient Safety Database. - The Secretary shall, in 
accordance with paragraph (C)( l)(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) 
purpose; 
(b) 
ensure that the database is as comprehensive as possible by 
aggregating data fiom public and private sector patient safety 
reporting systems; 
ensure that the database can only be used for its intended 
(c) 
conduct and support 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, individuals 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, 
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that is contained in the National Patient Safety Database shall be 
confidential in accordance with Section 8. 
Patient Safety Reporting Systems. - The Secretary shall identifjr 
public and private sector patient safety reporting systems and build 
scientific knowledge and understanding regarding the most 
effective - 
(4) 
(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. 
I 
(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. 
@) 
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 (B) and through the voluntary reporting system 
established under subsection (C). 
Implementation. - In Implementing strategies to carry out the hnctions 
described in subsections (B), (C), and (D), the Secretary may contract with 
public or private entities on a national or local level with appropriate 
expertise. 
(E) 
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SECTION 5 . Medical Eve@ 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. 
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. 
Duties of Certified Entities. - 
(1) 
(B) 
(C) 
In General. - An entity that is certified under subsection 
(A) shall collect and analyze information, consistent with 
the requirement of subsection (B), provided to the entity 
under Section 6(A) to improve patient safety. 
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; 
(2) 
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(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; 
and 
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 
(c) 
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) 
.. . 
I 
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 
identi@ on-going risk reduction activities that may enhance 
patient safety. 
@) 
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 afier three (3) years from the date on 
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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. 
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. 
SECTION 6. Provider of SeWices 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) 
identifjring, collecting information about, and 
evaluating medical events that occur with respect to a 
patient in the care of the provider of services or a 
practitioner employed by the provider of services, that may 
include- 
I
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,
 
(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 
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 . 
(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). 
(El) Promoting Identification, Evaluation, and Reporting of Certain 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. 
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(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 &om disclosing information tranderred by a 
provider of services to the public in a form that does not identifl or permit the 
identification on the health care provider or provider of services or patient. 
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SECTION 7. Confidentiality. - 
(A)Confidentially and Peer Review Protections - Notwithstanding any other 
.
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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 
event analysis entity, or developed by or on behalf of such an entity, or 
collected 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- 
(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) sha11- 
(0 
(ii) 
(iii) 
be protected from disclosure by civil, criminal, or 
administrative subpoena; 
not be subject to discovery or otherwise discoverable in 
konnection with a civil, criminal, or administrative 
proceeding; and 
not be admissible as evidence in any civil, criminal, or 
administrative proceeding; 
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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 
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public health authority, shall not be treated as a waiver of any privilege or 
protection established under paragraph (I) or established under the law. 
(B) 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(P100,000.00), and imprisoned for not more 
than six (6) months, or both. 
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(C) Application of Provisions. - The protectioqs provided under subsection (A) 
and the penalty provided for under subsection (B) 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. 
SECTION 8. Appropriations. - To carry out the provisions of this Act, such 
amount as many be necessary is hereby authorized to be appropriated fiom 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. 
SECTION 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. 
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SECTION 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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SECTION 1 1. Effectbity Clause. - This Act shall take effect .fifteen (15) days 
aRer its publication in at least two (2) newspapers of general circulation. 
Approved, 
GVL/slee billsI violet/patient safety and errors reduction 
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