Laboratory Management System

Licensing/Accreditation

Licensing is;
Promoting confidence through Accreditation in order to assure the reliability of the results of laboratory services, clinical
laboratories are regulated in the Philippines.
Started 1965 with the passage of the Clinical Laboratory Law that requires licensing of clinical laboratories by the Bureau
of Research and Laboratories (BRL), Department of Health (DOH) before they can operate. These standards were set for the
various types of laboratory services.

History
1968 - the Philippine Society of Pathologists (PSP) decided to accredit clinical laboratories for Residency Training Program for both
Anatomic and Clinical Pathology.
1988 - the minimum standards of laboratory services were formulated for three categories:
1. Primary category
2. Secondary category
3. 3.Tertiary category
1989 - The DOH mandated the BRL, DOH to set standards for clinical
laboratories performing HIV testing.

1997 - The PSP formulated and submitted standards for the accreditation of clinical laboratories, both hospital and free-standing, for
reimbursement of fees for laboratory services rendered to patients enrolled in the PhilHealth social insurance program.
PhilHealth
Is a government funded Health Care system in the Philippines created in 1995 to create a universal health coverage for
the Philippines.
A tax-exempt, government-owned and government-controlled corporation (GOCC) of the Philippines, and is attached to
the Department of Health.
It states its goal as insuring a sustainable national health insurance program for all.
2010 - it claimed to have achieved "universal" coverage with 86% of the population, although the 2008 National Demographic
Health Survey showed that only 38 percent of respondents were aware of at least one household member being enrolled in
PhilHealth.
This social insurance program provides a means for the healthy to pay for the care of the sick and for those who can afford
medical care to subsidize those who cannot.

2000 - The Philippine Council for Accreditation of Healthcare Organizations (PCAHO) approved the standards for the accreditation of
Hospitals for the provision of quality medical services. Included were the standards for the department of Pathology.

Example of Application Form for Licensing

to Operate a Clinical Laboratory
Joint Commission International Accreditation

Benefits of Joint Commission Accreditation:

1. Helps organize and strengthen patient safety efforts (Patient safety and quality of care issues are at the forefront of
Joint Commission standards and initiatives).
2. Strengthens community confidence in the quality and safety of care, treatment and services (Achieving
accreditation makes a strong statement to the community about an organizations efforts to provide the highest quality
services).

Benefits of Laboratory Accreditation:

The Joint Commission accredits more than 20,000 health care organizations, including approximately 3,000 clinical
laboratories. The Joint Commission is the gold standard in health care accreditation, with 60 years of experience across the
full spectrum of health care settings. Joint Commission accreditation, which is designed to uphold the highest level of patient
care, provides the most comprehensive evaluation process in the industry. After completion, laboratories can proudly display
the Gold Seal of Approval.

Accreditation and/or Certification:

It is a process in which an entity, separate and distinct from the health care organization, usually non-governmental, assesses
the health care organization to determine if it meets a set of standards requirements designed to improve quality of care.
It is a voluntary process provides a visible commitment by an organization to continually ensure a safe environment for its
patients and staff. This accrediting agency (JCI) can help international health care organizations, public health agencies,
health ministries and others to:
Evaluate, b. Improve and c.Demonstrate the quality of patient care in their nations while accommodating specific legal,
religious and cultural factors within a country
JCI - is a division of Joint Commission Resources, Inc., a wholly owned subsidiary of JCAHO. It is the largest accrediting
health care organizations in the US and surveys nearly 20,000 health care programs through a voluntary accreditation
process.
JCAHO and its subsidiary are both not-for-profit U.S. corporations.

The Mission:
To improve the quality of health care in the international community through the provision of worldwide accreditation
services.

Accreditation process is designed to:

create a culture of safety & quality within an organization to continually improve patient care processes and results
improve public trust that the organization is concerned for patient safety and quality of care provide a safe and efficient work
environment that contributes to worker satisfaction
listen to patients and their families, respect their rights, and involve them in the care process as partners
establish collaborative leadership that sets priorities for and continuous leadership for quality and patient safety levels
listen to patients and their families, respect their rights, and involve them in the care process as partners
establish collaborative leadership that sets priorities for and continuous leadership for quality and patient safety levels

Joint Commission International

is an initiative designed in response to the growing demand around the world for standards-based evaluation in health care.
The Joint Commission has been evaluating and accrediting hospital laboratory services since 1979 and freestanding
laboratories since 1995. Today, The Joint Commission accredits about 1,700 organizations providing laboratory services. This
represents almost 2,500 Clinical Laboratory Improvement Amendment (CLIA)-certified laboratories, including freestanding
laboratories, such as reference labs and in vitro fertilization labs, and those connected with other health care organizations
such as hospitals and ambulatory surgical centers

Purpose:
to offer the international community a standards-based ,objective process for the evaluation of health care organizations.

Goal of the Program:

to stimulate demonstration of continuous, sustained improvement in health care organizations through the application of
international consensus standards and indicators.
Brief overview of the JCI Program for Clinical Laboratories
The standards follow the outline and flow of ISO 9001:2000 standards .

The Underlying Philosophy of the Standards:

is based on principles of quality management and continuous quality improvement.
Joint Commission International accreditation is designed to be valid, reliable, and objective.
Based on the analysis of the survey findings, final accreditation decisions will be made by an international accreditation
committee.

The Standards for Accreditation for Clinical Laboratories

(2003) - First published to support a complete, accurate and objective assessment of laboratory processes and management
practices. The clinical laboratories provide essential services for patient assessment and treatment

International Patient Safety Goals (IPSG)

Goals:
1. Identify Patients Correctly
2. Improve Effective Communication
3. Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery
5. Reduce the Risk of Health CareAssociated Infections

Management and Leadership (MGT) Standards

Planning
MGT.1 - The leaders are responsible for laboratory planning.
MGT.1.1- The leaders plan the type and scope of services to be provided after communicating with customers regarding their needs.

Contract and Reference Laboratory Services

MGT.1.2 - The laboratory director and other leaders define the process for selecting and approving contract and reference laboratory
services, including services that provide blood and blood products.

Contract Laboratory Services

MGT.1.2.1 - The laboratory director is responsible for assuring the consistent performance of contract laboratory services.

Reference Laboratory Services

MGT.1.2.2 - The laboratory director is responsible for assuring the consistent performance of reference laboratory services

Resource Planning
MGT.1.3 - The leaders are responsible for providing adequate resources for the provision of planned laboratory services.

Responsibility and Authority

MGT.2 - Responsibilities for administrative direction and clinical direction of the laboratory are defined in writing.

MGT.2.1 - The directorship of the laboratory is effective.

MGT.2.2 - The laboratory director is responsible for requiring practices that respect the needs of patients and other customers.

Communication and Coordination

MGT.3 - Laboratory leaders provide for communication and coordination throughout the laboratory and with outside customers.
MGT.3.1 - Leaders communicate to laboratory staff the priority of meeting the needs of clinicians, patients, and other users of
laboratory services.
MGT.3.2 - Necessary policies are developed for communicating with clinicians who order tests
(Ex. No relaying of result over the phone. Solution LIS)
Quality Management and Improvement Process

Planning and Coordination of the Quality Management and Improvement Program

MGT.4 - Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a quality management and
improvement program.
MGT.4.1 - The laboratorys program for process design and quality measurement, analysis, and improvement is systematic &
addresses the goals of the quality management and improvement system.

Quality Management and Improvement Process

Planning and Coordination of the Quality Management and Improvement Program

The Quality Management and Improvement Systems Components;

1. Methodology used to measure and improve processes
2. Services
3. Systems used for quality control of laboratory testing
4. Other services.

Data Collection for Quality Measurement

MGT.4.2 - The laboratorys leaders identify key measures (indicators) to evaluate clinical and managerial structures, processes and
outcomes.

MGT.4.2.1 - Quality measurement includes those aspects of the following that are selected by leaders:
1) The laboratorys safety and infection control programs
2) The laboratorys quality control programs
3) Pre-analytic processes
4) Post-analytic processes

Pre-analytic processes
a. Patient preparation
b. Specimen quality processes
1. Collection of specimen 3. Preservation of specimen
2. Labeling of specimen 4. Transport of specimen 5. Rejection

c. completeness of requisitions.

Post-analytic processes:
a. efficient transfer of information
b. timeliness of reporting test results
c. adequacy of documentation
d. accuracy of reports

Human Resources
Staff Qualifications
RSM.1.2 - Pathology and clinical laboratory services are directed by one or more qualified professionals.
RSM.1.3 - Supervisory staff and other leaders have the appropriate training and expertise to perform all responsibilities.
RSM.1.4 - The director of the laboratory provides an adequate number of qualified staff.

Staff Orientation and Education

RSM.1.5 - All new staff members are oriented to the organization and the laboratory area(s) where they are assigned, as well as
to their specific job responsibilities.
RSM.1.6 - In-service or other education and training maintain and improve staff competence.