Administrative Order No. 2008 - 0023

July 30, 2008

ADMINISTRATIVE ORDER

No. 2008 – 0023

NATIONAL POLICY ON PATIENT SAFETY

I.     RATIONALE

Patient Safety is defined as “the prevention of harm to patients thru the prevention, avoidance, and amelioration of risk, adverse outcomes or injuries stemming from the processes of health care.” It is the degree to which the risk of an intervention and risk in the care environment are reduced for a patient and other persons, including health care providers.

In 18 May 2002, the 55^th World Health Assembly (WHA) recognized the need to promote patient safety as a fundamental principle of all health systems. Member states were urged to pay closest possible attention to the problem of patient safety and establish or strengthen science–based systems necessary for improving patient’s safety and the quality of health care, including the monitoring of drugs, medical equipment and technology.

In response to the call of the World Health Assembly, the Philippines is reinforcing and institutionalizing the implementation of quality assurance where patient safety is regarded as one of the key dimensions of quality care. It is critical in the development of systems to improve health outcomes in the FOURmula One for Health. The country however, need to consolidate the gains of these efforts, strengthen a nation–wide reporting system of adverse events, and institute a mechanism that would encourage disclosures about said events. Likewise, there is a dire need to encourage more research into patient safety, epidemiological studies of risk factors, effective protective interventions, assessment of associated cost of damage and protection.

In line with the objectives of FOURmula One for Health; to secure more better and sustained financing for Health, assure the quality and affordability of health goods and services; ensure access to and availability of essential and basic health packages and improve performance of the health system, the Department of Health and the Philippine Health Insurance Corporation (PHIC) affirm its commitment to patient safety policies and objectives thru the DOH mandate, the FOURmula (F1) One for Health, and thru the Philippine Health Insurance Corporation (PHIC) Benchbook to adopt the fifty–fifth World Health Assembly’s resolution in formulating guidelines for the implementation of a Patient Safety Program.

II.    GOAL AND OBJECTIVES

Goal:

To ensure that patient safety is institutionalized as a fundamental principle of the

health care delivery system in improving health outcomes.

Objectives:

1. To establish a comprehensive patient safety program in all levels of the health care delivery system thru effective governance.

2. To develop the critical capacity of the health care workers in the health facilities for the implementation of standards, guidelines, systems, training programs, relative to patient safety.

3. To sustain and continuously improve mechanisms that nurtures a culture of safety thru appropriate strategies.

III.  COVERAGE AND SCOPE

This policy shall apply to all government and private health care facilities providing preventive, promotive, curative and rehabilitative care.

IV.    DEFINITION OF TERMS

A. Adverse Events – an untoward, undesirable and usually unanticipated event such as death of a patient, an employee or a visitor in a health care organization. It is an injury caused by medical management rather than by the underlying condition or the patient. Incident such as patient falls or improper administration of medications are also considered adverse events even if there is no permanent effect on the patient.

B. Culture of Safety – an integrated pattern of individual and organizational behavior, based on shared beliefs and values that continuously seek to minimize patient harm that may result from the process of care delivery.

C. Latent Failure – an error precipitated as a consequence of management and organizational processes that poses the greatest danger to complex systems. Latent failures cannot be foreseen but, if detected, they can be corrected before they contribute to mishaps.

D. Near Miss or “close call” – an event or situation that could have resulted in an accident, injury or illness, but did not, either by chance or timely intervention. It is a serious error or mishap that has the potential to cause as adverse event but fails to do so because of chance or because it is intercepted. It is also called potential adverse event.

E. No Blame Culture – a non–punitive voluntary reporting of adverse events.

F. Patient Safety Solution – any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the process of health care.

G. Risk – is any exposure to a harmful event. It is directly related to hazard and vulnerability and, inversely, to capacity.

H. Risk Management – clinical and administrative activities undertaken to identify , evaluate, and reduce the risk of injury to patients, staff and visitors and the risk of loss to the organization itself.

I.  Root Cause Analysis – a process for identifying the basic causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.

J. Safety Assessment – refers to the identification of sources or routine and reasonably foreseeable potential harm, injury or accident, to estimate the probability and magnitude of such potential harm and to assess the quality and extent of the required protection and safety measures to be done.

K. Sentinel Event – an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. It is any process variation for which recurrence would carry a significant chance of serious adverse outcome (PHIC Benchbook). Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called sentinel because they signal the need for immediate investigation and response.

V.   GENERAL POLICY STATEMENTS

A. The establishment and maintenance of a culture of patient safety in an organization is the responsibility of its leadership.

B. Enabling/support mechanisms/strategies be in place to ensure patient safety in the health facilities:

C. The implementation of the Patient Safety Program for all facilities shall be anchored on both DOH licensing and PHIC accreditation standards.

D. The key priority areas in patient safety include but not limited to proper patient identification, assurance of blood safety, safe clinical and surgical procedures, provision and maintenance of safe quality drugs and technology, strengthening of infection control standards, maintenance of the environment of care of standards and energy / waste management standards.

VI.  IMPLEMENTING MECHANISM

A. CONCEPTUAL FRAMEWORK OF THE PATIENT SAFETY PROGRAM

The F1 framework aims to integrate patient safety into the Continuing Quality Improvement (CQI) Program in health facilities and further align with the objectives of the DOH sectoral reforms. (Annex A)

B. KEY ELEMENTS OF A PATIENT SAFETY PROGRAM

1. Leadership

Leadership and political commitment are essential at the health facility level where patient safety becomes an integral component of quality care. The leadership shall address strategic priorities for institutional development, its culture and infrastructure, engage its various stakeholders, communicate and build awareness. It shall track or measure performance over time, provide support to the staff, patients and their families affected by medical errors thru time, provide support to the staff, patients and their families affected by medical errors thru system – wide activities that can be aligned and re – designed for improvement and reliability and if feasible, appropriately linked to an incentive scheme. Regulatory oversight shall be strengthened to enhance compliance to a culture of safety and quality standards thru licensing and accreditation.

2. Institutional Development

Approaches to institutionalize patient safety and quality in the health facilities will have to consider financial and human resource; facility and equipment management; strengthen management responsibility, authority and competency; formulate the standards of what is expected from health providers; communicate; provide training; enforce the standards that comes with the policies and give the patients a voice through a feedback system or a patient satisfaction survey.

3. Reporting System

The National Patient Safety Committee shall develop and institutionalize a proactive reporting and learning system that requires its leadership to encourage reporting of events, in such a way that it will create a protected environment that encourages the systematic surfacing and reporting of serious events which aims to promote error reduction. The primary purpose of the reporting system is to learn from experience.

4. Feedback and Communication

A systematic evaluation, performance feedback and benchmarking mechanism to communicate leadership responses to the reports shall be established to demonstrate commitment to patient safety and ensure continuous improvement of patient safety. An annual assessment of the effectiveness of the activities of the Patient Safety Program and identification of priorities shall include assessment of the organization’s culture of patient safety including employees’ willingness to report errors, review, analyze and act upon aggregated findings and identify opportunities for improvement.

5. Adverse Event Prevention and Risk Management

Adverse even prevention shall involve a system of proactive risk reduction strategies thru patient risk assessment, patient feedback survey, health technology assessment and a safety assessment code. A safety checklist may be developed. Risk analysis and management shall be in place to prevent harm resulting from adverse events, sentinel events, latent failures, near miss or “close calls.”

Data on patient dose estimates for diagnostic and interventional x – ray procedures including nuclear medicine diagnostic exams shall be made available to the patients and/or to their companions. Accidental medical exposures for radiation therapy patients and misadministration of radio – pharmaceuticals for nuclear medicines shall be recorded and data made available upon request.

Guidelines shall be developed for the gradual phase–out of equipment, devices and products that may pose unsafe care (e.g. mercury containing devices, equipment or products and those that contain di–2–ethylhexyl phthalate (DHEP) released from polyvinyl chloride or PVC medical devices).

6. Disclosure of Reported Serious Events

The Reporting System shall ensure confidentiality of individual cases. The events can be made available to the public through disclosure of results or investigations, summary reports or annual repots that summarize events and actions taken.

7. Professional Development

Training and supervision of the health care staff to improve their decision and clinical judgment is imperative. It is necessary to instill standard norms of behavior of courtesy, promptness and efficiency among the health care workers and improve the quality of service given to patients.

Appropriate incentives shall be developed to include awards and recognition.

8. Patient Centered Care and Empowerment of Consumers

Patient must be at the center of patient safety initiatives and must be partners in all aspects of the process. Patient – centered care and patient safety is a national priority and a core agenda to improve quality care in all health facilities to protect patients from faulty systems.

Patient empowerment shall be ensured by respecting their rights, providing them unbiased information to make decisions, involving them in their own care, and institutionalizing a feedback mechanism.

C. ENABLING /SUPPORT MECHANISM

1. Policy Development

Policies, guidelines and procedures shall be developed to institutionalize patient safety at various levels of health care facilities, to provide a supportive environment that promote and protect patient safety practices and to sustain a high level of commitment in its implementation across the health system.

2. Institutional/Organizational Mechanism

Operational arrangement shall be developed thru an effective, efficient and responsive patient safety program management system, with clear lines of authority and responsibility and a functional mechanism for recording, reporting and data management in an integrate coordinated systems approach.

3. Capacity Building

Professional development of health staff shall be assured, for the health

workers to be knowledgeable and possess the necessary skills to implement the policies that contribute to a supportive environment for patient safety. It is the responsibility of the leadership in the health facilities and professional organizations to provide continuing education in order to achieve the goals of patient safety.

4. Research and Development

The DOH shall pursue research activities conducted for public policy purposes relating to patient safety and subject to independent peer review. Researches or studies shall be disseminated through various methods such as seminars, journal publications and newsletters.

5. Advocacy and Social Marketing

The ultimate objective is to instill social consciousness and conscience among decision makers and government/private chief executives on patient safety initiatives.

6. Inter–Agency Collaboration Network

The patient safety program management shall be linked at the national, regional and LGU levels to include all the relevant stakeholders in both the government and the private sector in a broad based network for technical cooperation.

7. Consumer Empowerment

All concerned stakeholders shall continuously provide information and conduct dissemination campaign as strategies to raise the level of awareness that will enable patients to make unbiased, informed choices and allow for their active involvement in their own care thru behavior change communication.

8. Monitoring and Evaluation

Monitoring activities shall ensure compliance to the policies and guidelines on patient safety. The results of monitoring and evaluation shall lay the groundwork for generating technical inputs to further policy development, standards and guidelines formulation and the provision of technical assistance. Self–evaluation shall be regarded as an essential part of actions to improve protocols and procedures and monitor the attainment of objectives.

D. FUNCTIONAL ROLES

1. Health care facilities /providers shall institutionalize a patient safety program to ensure operational enabling/support mechanisms/strategies in place.

2. The DOH shall create a National Patient Safety Committee tasked to provide the over–all management of the Patient Safety Program duly supported by a National Technical Working Group (NTWG). It shall develop the policies, standards, operational guidelines, strategies and targets and provide technical assistance relative to program implementation.

3. The DOH – CHD shall develop the organizational capacity, provide technical assistance, conduct assessment and monitoring, and facilitate the reporting system in both the government and private health facilities.

4. The PHIC Benchbook on Safe Practice & Environment shall be institutionalized based on the indicators developed for standards on patient and staff safety, infection control, equipment/supplies and energy/waste management.

5. LGUs/ILHZ shall provide support to health care facilities under their administrative and technical supervision.

6. Developmental Partners (such as but not limited to civic society/professional organizations, academe, multi/bilateral organizations) shall provide technical assistance, systems development, funding support, research and development.

7. Communities shall actively participate in care decisions and provide feedback for continuing improvement.

E. MONITORING AND EVALUATION SYSTEM

The Department of Health shall institutionalize an effective and efficient monitoring and evaluation system that will link all patient safety initiatives.

F. FUNDING MECHANISM

The health facilities shall allocate budget for the activities of the Patient Safety Program to be included in their respective annual budget.

VII.  REPEALING CLAUSE

The provisions of previous Orders and other related issuances inconsistent or contrary to the provisions of this Administrative Order are hereby revised, modified, repealed or rescinded accordingly. All other provisions of existing issuances which are not affected by this Order shall remain valid and in effect.

VIII. EFFECTIVITY CLAUSE

This Order shall take effect immediately.

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health