Administrative Order No. 2012 - 0021

October 12, 2012

ADMINISTRATIVE ORDER

No. 2012 – 0021

NATIONAL FRAMEWORK OF THE NATIONAL HEALTH LABORATORY NETWORK

I.     BACKGROUND      

The health laboratory is an integral part of the overall health care delivery system. The practice of public health, medicine and surgery over the years has become more complex and had increased the demands placed on the laboratories. The laboratories are often the major source of data in the rapid recognition and prevention of the spread of communicable diseases. They produce critical and relevant information for patient care and treatment, epidemiology and surveillance. Hence, to optimize their utilization, the health laboratories shall be organized into a coordinated laboratory network.

After the establishment of the Republic of the Philippines in 1946, public health laboratories were created at the regional and provincial levels. These laboratories were placed under the supervision and control of the Bureau of Research and Laboratories (BRL). When the regional health laboratories were integrated into the Regional Hospitals or Medical Centers in the 1970’s and the provincial health laboratories integrated into the Provincial hospitals in the 1980’s, the BRL lost administrative authority and control over these laboratories. However, an Administrative Order was issued forming a network of laboratories at various levels in the Department of Health with the BRL exercising technical supervision over the network.

When provincial and district hospitals were devolved to the provincial governments and rural health units and other peripheral health services devolved to the municipal governments, the in 1990’s, the health laboratory network ceased to exist. In 2000, by virtue of E.O. 102, “Redirecting the Functions and Operations of the Department of Health,” the BRL was abolished and its personnel were deployed to hospital laboratories in the DOH. On one hand, technical supervision and coordination of health laboratories disappeared and DOH no longer articulated and implemented a comprehensive and coherent national laboratory policy.

With the loss of the Central Public Health Laboratory, some functions of the BRL were transferred to the six (6) designated National Reference Laboratories (NRLs) for specific disease areas. These NRLs are the National Kidney and Transplant Institute (NKTI), Lung Center of the Philippines (LCP), Research Institute for Tropical Medicine (RITM), East Avenue Medical Center (EAMC), STD – AIDS Central Cooperative Laboratory (SACCL) – San Lazaro Hospital and the Philippine Heart Center (PHC).

However, since adequate resources were not provided, the newly–designated NRLs were unable in varying degrees to carry out their mandates. And since they are still in the process of fully operationalizing and strengthening their capabilities, the mechanism for networking and collaboration from their level down to the municipal / rural level has not yet been established. Furthermore, mechanisms for referral of samples, information / data flow, feedback and consultation have to be developed and strengthened.

In 2010, the WHO – WPRO transmitted a document entitled “Asia Pacific Strategy for the Strengthening of Health Laboratories” which had been approved in the 2009 Western Pacific Regional Committee Meeting. Pursuant to the DOH’s commitment, a Task Force LABNET was tasked to formulate a Strategic Plan for the National Health Laboratory Network (NHLN). This provided the opportunity to realize a vision to establish a functional National Health Laboratory Network.

This Administrative Order is issued to articulate the National Framework for the National Health Laboratory Network that will support the achievement of quality service and accessible health facilities which is one of the strategies of Universal Health Care (Kalusugan Pangkalahatan). The National Framework shall provide a road map or direction for strengthening and promoting the institutional and operational capacities of the health laboratories that will help improve their diagnostic, surveillance and monitoring capabilities. This will be achieved by the implementation of the Strategic Plan for the NHLN.

II.    OBJECTIVES

The objective of this Order shall comprise of the following:

General:

To provide a National Framework for the organization of all government and private hospitals at all levels into a functional National Health Laboratory Network. Further, it shall provide guidance for the implementation of Strategic Plan of the National Health Laboratory Network.

Specific:

1. To establish national standards of laboratory services at all levels.

2. To institutionalize a Quality Management System in laboratory services to ensure high standards of performance and outcomes.

3. To obtain the commitment and support of the national and local governments for the organization and operation of efficient and sustainable laboratory services.

4. To define the ethical values in laboratory practice, including patient confidentiality, adherence to codes of professional ethics and ethical norms for human research.

5. To encourage research for the improvement of the technical and management aspects of laboratory services and

6. To establish efficient and operational laboratory networks and referral mechanisms at the national, regional, provincial and peripheral levels of the health services.

III.  SCOPE

This National Framework of NHLN shall apply nationwide to all health and clinical laboratories at all levels, government and private, which are licensed or accredited by the DOH. All agencies (public and private, including donors) supporting the operation and management of health and clinical laboratories shall also be governed by this Order.

IV.   DEFINITION OF TERMS

1. Clinical Laboratory – a facility where tests are done on specimen from the human body to obtain information about health status of patient for the prevention, diagnosis and treatment of diseases.

2. Health Laboratory – a facility in which tests are done on specimens from the human body, animals and other sources to obtain information about the status of health of a person or community or about factors or conditions that are related to health.

3. Quality Assurance – is a set of planned and systematic activities to provide confidence that a laboratory / organization fulfill the requirements for quality.

4.  National External Quality Assessment Survey (NEQAS) – is a quality assurance activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of test results of laboratories. The participating laboratories are given unknown samples for analysis and they are rated based on the closeness of their results to the pre – determined value or the reference value.

5. Standards in Quality Management System – are developmental standards formulated and adopted by the DOH which covers all aspects of laboratory operations and services to ensure quality performance and test results.

6. Levels of Laboratories – pertain to the hierarchy of laboratories based on the administrative levels of government and required functions and service capabilities.

V.     GENERAL GUIDELINES

1. The Department of Health states the policy that both government and private laboratories shall provide laboratory services at each level of health services, i.e., national, regional, provincial, city and municipal levels in support of public health and clinical programs of the national and local governments and private sector.

2. All the clinical and health laboratories are organized into the National Health Laboratory Network to serve the laboratory requirements of the country. Health laboratories are established at various levels, i.e., national, regional, provincial, city and peripheral levels.

3. To ensure quality, take advantage of economies of scale and provide efficient operations, the service capabilities at various levels differ. The simpler procedures are done at the lower levels while the more complex procedures are done at the national and regional levels.

4. All health laboratories shall be guided by the following legislative and administrative standards:

a. WHO “Asia Pacific Strategy for the Strengthening of Health Laboratories”

b. Strategic Plan for New and Emerging Diseases

c. Republic Act 4688 – Clinical Laboratory Act (May 19, 1966) – an act regulating the operation and maintenance of clinical laboratories

d. DOH Administrative Order No. 2007 – 0027 (August 22, 2007) – Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

e. DOH Department Order No. 393–E series 2000 – designation of five (5) National Reference Laboratories (NRLs) to undertake the functions of the Bureau of Research and Laboratories (BRL)

f.  DOH Department Order No. 2009 – 5148 – Amended to D.O. No. 393 – E series of 2000 designating the Philippine Heart Center as the National Reference Laboratory in Anatomic Pathology for Cardiac Diseases

g. DOH Department Order No. 698 series 2004 – designation of DOH Hospitals according to Hierarchy of Referral Centers for SARS and other emerging and re–emerging Infectious Diseases.

5. The clinical laboratories shall subscribe to NHLN Concepts and Policies which require that:

a. Quality Laboratory services deliver timely, reliable and effective health interventions through guaranteed package of services at each level and their accessibility.

b. A well–performing laboratory workforce works in ways that are responsive, effective and efficient in achieving high quality results through staff development, national workforce policies and Standards in Quality Management System.

c. Good financing ensures availability and adequacy of funds and resources to maintain and sustain the operations through budget allocation, national financial policies, local and foreign grants and Public Private Partnership (PPP).

d. Good leadership and governance require dedicated key health officials, technical experts / consultants and laboratory managers who develop and implement strategic plans, policies and programs for the benefit of the health laboratory system through health sector policies, regulation – licensing and accreditation and National External Quality Assessment Surveys (NEQAS).

e. Rational use of laboratory services assures the efficient utilization of resources.

f.  Maintenance of safe laboratory services ensures safe environment for laboratory workers and protects the community from bio risks.

g. A formal system of referral of specimens and reporting of results is established among the various health laboratories. Networking includes consultation meetings at all levels in which issues, problems and needs are discussed, best practices, reagents, other resources shared, administrative issuances and other directives disseminated and exchange of data.

VI.   SPECIFIC GUIDELINES

A.  Constituting NHLN

1. In the context of the National Framework of the NHLN, a National Strategic Plan has been formulated and shall be integrated into the National Health Plan. Strategic Plan shall provide the guidelines for the strengthening of the health laboratory services and relationship among health laboratories at different levels.

2. For the efficient and effective operation of the NHLN, a National Unit for Health Laboratories (NUHL) shall be created under the National Center for Health Facility Development (NCHFD) to be supervised by one or more Pathologists and staffed by highly qualified and competent Medical Technologists.

The NUHL shall have the following functions:

a. Facilitate the development of the National Strategic Plan for the Health Laboratory Network and formulate and implement the essential action plans, policies and programs.

b. Ensure implementation of standards in the delivery of services (i.e. licensing and accreditation in collaboration with the Bureau of Health Facilities and Services (BHFS), Food and Drug Administration (FDA), Center for Health Development (CHD) – DOH and participation in External Quality Assessment Surveys (EQAS), both national and international.

c. Monitor the compliance of clinical laboratories with Quality Management System.

d. Provide technical supervision of the National Reference Laboratories, DOH national and regional laboratories and indirectly, other government laboratories at the local levels.

e. Coordinate training of laboratory staff of government and private laboratories.

f.  Supervise the evaluation of laboratory equipment, reagents, reagent kits and supplies by the NRLs for regulatory purposes.

g. Standardize laboratory methods and develop standards and reference control materials in coordination with the NRLs.

3. A National Technical Working Group (TWG) for the National Strategic Plan shall assist the NUHL in implementing the Strategic Plan in the regions, provinces, cities and peripheral levels.

The functions of the TWG shall be:

a. Provide assistance to the NUHL in the implementation of the National Strategic Plan for the NHLN/national action plans to include coordination and field activities.

b. Serve as lecturer/resource person in the conduct of training, consultative meetings, monitoring and assessment of clinical laboratories.

c. Develop and formulate policies, standards, operational guidelines, strategies, action plans for the implementation of the National Strategic Plan.

d. Assist in the development of Laboratory Action Plans for the implementation of the national action plans and strategic plan.

e. Provide technical assistance to clinical laboratories in the implementation of the Laboratory Action Plans.

4. The Chairpersons and members of the different committees under the National Technical Working Group shall be Pathologists and Medical Technologists who have the technical expertise and experience on laboratory work and operations, management and collaboration and on quality system. Other experts in specialized areas such as financial management, management of national health programs shall be invited as resource persons.

The National Technical Working Group shall be headed by an Overall Chairman and composed of the chairs of the following nine committees:

a.   Committee on Strategic Planning and Financing

b.   Committee on Laboratory Facilities and Safety

c.   Committee on Training

d.   Committee on Rational Use of Laboratory Services/Research and Ethics

e.   Committee on Information Management

f.    Committee on National Reference Laboratories

g.   Committee on Quality Assurance

h.   Committee on Laboratory Network

i.    Committee on National Health Programs

5. With the comprehensive tasks to be undertaken by the National Unit for Health Laboratories, a National Advisory Council shall be created to be headed by the NCHFD Director and composed of the Heads/Representatives of selected DOH Offices, government organizations and professional societies/associations.

Functions of the National Advisory Council:

a. Review and recommend for approval policies and guidelines, program development strategies and action plans in their capacity as adviser to the NUHL and National Technical Working Group.

b. Provide technical advice and guidance in developing a road map for the improvement, strengthening, provision and delivery of quality services to the general public.

6. For the technical counterpart in the regions, a Regional Team shall be organized to be composed of the Head/Pathologist of the Laboratory of the DOH Regional Medical Center or Hospital as Head, a Senior Medical Technologist and a representative from the Center for Health Development of the DOH as members of the team. Other Pathologists and Senior Medical Technologists shall be recruited as resource persons.

The Regional Team shall have the following functions:

a. Collaborate with the NUHL and TWC in the implementation of the national action plans in the area of responsibility through the development and implementation of Laboratory Action Plans of government and private laboratories participating.

b. Conduct advocacy campaign, orientation seminar on the National Strategic Plan, National Action Plans and Laboratory Action Plans and social mobilization activities.

c. Establish linkage with local health and hospital officials pertaining to program support and funding of the Laboratory Action Plans.

d. Conduct training of laboratory staff in developing and implementing Laboratory Action Plans.

B. Roles and Responsibilities of Other Units/Entities

1. National Center for Health Facility Development (NCHFD), Department of Health

a. Supervise the NUHL in the implementation and assessment of the National Action Plans and Laboratory Action Plans for the participating Laboratories.

b. Coordinate all activities pertaining to the National Strategic Plan for NHLN.

c. Transmit reports of project implementation for submission to the DOH Management

2.  National Reference Laboratories (NRLs)

a. Provide laboratory referral services, e.g. for confirmatory testing, surveillance and research.

b. Administer the National External Quality Assessment Survey (NEQAS) to assess the quality of performance and test results of clinical laboratories.

c. Conduct training to upgrade knowledge and skill of laboratory personnel.

d. Evaluate diagnostic kits and reagents in collaboration with the Food and Drug Administration.

3. Local Government Units (LGU)

a. Pursue targeted quality improvement strategies through provision of appropriate resources.

b. Ensure effective implementation of the annual plan of laboratories under them.

c. Provide adequate resources for the capacity building and operation of health laboratories under their jurisdiction.

4. Government Hospital and other Health Laboratories under DOH and LGUs

a. Join the Laboratory Network in their province and region.

b. Ensure that the staff of their laboratories is trained in Laboratory Action Plan.

c. Provide support to the implementation of the Laboratory Action Plan.

d. Obtain funding assistance from local government, DOH, national and international donors.

5. Health and Clinical Laboratories under other National Government Agencies

a. Establish linkage with the DOH for the effective and efficient implementation of standards and guidelines on laboratory networking.

b. Serve as member of the committee created to carry out specific /specialized activities of the project.

c. Pursue and sustain quality improvement activities through provision of resources, training and appropriate collaborative mechanism.

6. Private Hospital and Free–standing Clinical Laboratories

a. Establish linkages with the DOH for the effective and efficient implementation of standards on laboratory networking.

b. Pursue and sustain quality improvement activities through provision of resources, training and appropriate collaborative mechanism.

C. Sustaining and Coordinating Mechanisms

1. A registry of all licensed clinical laboratories in the Philippines shall be maintained by the National Unit for Health Laboratories (NUHL) at the NCHFD. The Regional Teams shall keep an updated list of clinical laboratories in coordination with the Center for Health Development.

2. A network of clinical laboratories shall be established at the national, regional, provincial and municipal levels.

3. A formal system of coordination for the referral of specimens and communication shall be developed among the various health laboratories. This is to ensure that all health laboratories work harmoniously in an effective, practical and functional way.

4. The National Technical Working Group for the National Strategic Plan and the Regional Teams shall submit reports to the Director of NCHFD through the NUHL.

5. The DOH shall provide resources for the implementation of Philippine National Health Laboratory Network (NHLN). The National Center for Health Facility Development, National Center for Disease Prevention and Control and National Epidemiology Center shall likewise allocate funds for specific laboratory programs/test activities.

6. The Local Government Units and governing bodies of laboratories in the private sector and under the National Government Agencies shall allocate funds or their own laboratories in support of this strategic plan. Public – private partnership shall also be utilized whenever appropriate.

7. Collaborative links with funding agencies, foreign and local, shall be strengthened to assist in implementing and sustaining the project.

D.  Critical Milestones and Timelines

1. The Technical Working Group for the National Strategic Plan for National Health Laboratory Network shall formulate and implement an Annual Action Plans for the Strategies of the National Strategic Plan for a five year period – 2012 to 2016 aimed at the delivery of equitable, accessible, sustainable and quality laboratory services.

2. The Annual National Action Plans shall include activities and strategies for the development of new services, standards and protocols, systems and procedures that will enhance and upgrade capabilities and networking mechanisms as follows:

a. Develop and operationalize a network of clinical laboratories for the national, regional, provincial/city, municipal and peripheral levels. This shall include network design, guidelines and protocols.

b. Develop service capabilities of clinical laboratories at every level.

c. Formulate Standards for the service capabilities to include requirements for equipment and manpower.

d. Develop appropriate laboratory design and physical infrastructure for each level of laboratory.

e. Promote rational use of laboratory services.

f.  Develop system of referrals from the peripheral levels to the National Reference Laboratories.

g. Create awareness on the importance of laboratory health care through summit, lay forum, tri media information drive.

h. Design method of utilizing laboratory data base for public health programs.

i.  Ensure maintenance of safe laboratory services by implementing the National Standards on Laboratory Biosafety and Biosecurity.

j.  Strengthen Information Management by promoting Laboratory Information System (LIS)

k. Formulate a plan on the development and implementation of a “LIS Links” project

l.  Ensure quality assurance of laboratory services through implementation of Standards on Quality Management System, participation in national and international quality assessment surveys (EQAS) and accreditation in ISO 15189

m.Enhance research capabilities of laboratories

n. Promote and practice code of ethics through advocacy and communication (web based communication).

3. These strategies and activities shall be incorporated in Laboratory Action Plan for every clinical laboratory participating in the implementation of the Strategic Plan for NHLN. The methodology for the formulation and implementation of the Laboratory Action Plan is as follows:

a.  Initial assessment of clinical laboratory on degree of compliance with standards

b. Train clinical laboratory staff in formulating its Laboratory Action Plan

c. Assist in implementation and monitoring of the Laboratory Action Plan

d. Conduct 2^nd assessment of clinical laboratory on degree of compliance with standards

e. Report to Management of Laboratory, NUHL and NCHFD

4. In support of these planned activities, consultative meetings, committee activities, training/workshops/orientation seminars, assessment/on – site visits of laboratories, advocacy campaign, consultation with technical experts and coordination with DOH and other concerned offices/organizations and funding agencies shall be conducted.

E. Monitoring and Evaluation

1. The DOH, through the National Center for Health Facility Development, shall issue guidelines and provide technical support to monitor and evaluate the implementation of the national strategic plans / action plans for clinical laboratories.

2. The National Advisory Council shall convene regularly to review the reports on program implementation, monitoring and assessment. Appropriate interventions/modifications shall be implemented to ensure appropriateness of the strategies and approaches used.

VII.  REPEALING CLAUSE OR SEPARABILITY 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

This order shall take effect immediately.

ENRIQUE T. ONA, MD, FPCS, FACS

Secretary of Health