THE CLINICAL

LABORATORY
INTRODUCTION
 Regulation of Clinical Laboratories in the Philippines is
mandated by RA 4688 aka Clinical Laboratory Law of 1966
 
Department of Health through Bureau of Research and
Laboratory
central governmental agency authorized to regulate the operation
and maintenance of the laboratory
 
Secretary of DOH through the director of BRL
formulate rules and regulations
Administrative and Executive Orders:
AO 201 s. 1973
Revised Rules and Regulations Governing the Registration, Operations and Maintenance
of Clinical Laboratories in the Philippines
AO 290 s. 1976
Amending Section II Subsection A of Administrative Order No. 201, Series of 1973
Concerning Requirements for a Clinical Laboratory
AO 52 s. 1983
AO 49-B s. 1988
EO 102 s. 1999
Redirecting the Functions and Operations of the DOH)
AO 59 s. 2001
Rules and Regulations Governing the Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines)
AO 2007-0027
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines
CLINICAL LABORATORY (AO 2007-0027)
facility where tests are done on specimens form the human body to obtain
information about the health status of a patient for the prevention, diagnosis and
treatment of diseases
Tests include, but are not limited to, the following disciplines:
• clinical chemistry • histopathology
• hematology • cytology
• immunohematology • toxicology
• endocrinology
• microbiology
• molecular biology
• immunology • cytogenetics
• clinical microscopy
CLINICAL LABORATORY (AO 2007-0027)

Other functions: provide consultative advisory services covering all aspects of

laboratory investigations

Facilities that are involved in the pre–analytical processes (collection,

handling or preparation of specimens) or act as a mailing or distribution center
(laboratory network or system)

total testing process includes pre–analytical, analytical and post–analytical

procedures
CLASSIFICATION OF CLINICAL LABORATORIES (AO 2007-0027)
A. Classification by Ownership
1. Government 
operated and maintained, partially or wholly, by the national
government, a local government unit (provincial, city or
municipal), any other political unit or any department, division,
board or agency thereof
2. Private 
owned, established and operated by any individual,
corporation, association or organization
B. Classification by Function

1. Clinical Pathology 
includes Clinical Chemistry, Hematology, Immunohematology,
Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular
Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring and
other similar disciplines

2. Anatomic Pathology 
includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy,
Forensic Pathology and Molecular Pathology
C. Classification by Institutional Character

1. Institution Based 
laboratory that operates within the premises and as part of an institution,
such as but not limited to hospital, medical clinic, school, medical facility
for overseas and seafarers, birthing home, psychiatric facility, drug
rehabilitation center

2. Freestanding 
laboratory that does not form part of any other institution
D. Classification by Service Capability

1. General Clinical Laboratory

(a) Primary Category 
provides the following minimum service capabilities:
(1) Routine Hematology [Complete Blood Count – includes Hemoglobin Mass
Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number
Concentration (White Blood Cell or WBC count) and Leucocyte Number Fraction
(Differential count)
(2) Qualitative Platelet Determination
(3) Routine Urinalysis
(4) Routine Fecalysis
(5) Blood typing – for hospital based
(b) Secondary Category 
provides the minimum service capabilities of a primary category
laboratory plus the following:
(1) Routine Clinical Chemistry –Blood Glucose Substance Concentration,
Blood Urea Nitrogen concentration, Blood Uric Acid Substance
Concentration, Blood Creatinine Concentration, Blood Total Cholesterol
Concentration
(2) Quantitative Platelet Determination
(3) Cross matching – for hospital based
(4) Gram Staining – for hospital based
(5) KOH – for hospital based
(c) Tertiary Category 

provides the minimum service capabilities of a secondary category

laboratory plus the following:
(1) Special Chemistry
(2) Special Hematology, including coagulation procedures
(3) Immunology
(4) Microbiology – culture and sensitivity
*Aerobic and anaerobic (for hospital and non–hospital based)
 (d) Limited Service Capability (institution–based only) 
provides the laboratory tests required for a particular service in
institutions such as but not limited to dialysis centers and social hygiene
clinics

2. Special Clinical Laboratory

laboratory that offers highly specialized laboratory services that are usually
not provided by a general clinical laboratory
LABORATORY DESIGN AND SERVICE MODELS
 Hospital based laboratories have distinct designs and service models
differentiated by their purpose or objectives

TRADITIONAL ‘CLOSED’ LABORATORY

 generally separated into rooms or sections
has discrete sections in hematology, chemistry, microbiology and BB

‘OPEN’ LABORATORY
discrete service is placed in one large room with portable walls that can be
adjusted as needed based on volume
CORE LABORATORY
common type of consolidation has been hematology and chemistry
laboratories
advantages include handling stat requests, improving off-shift workflow and
avoiding chronic staffing problems
 enables a continuous work-flow process that reduces specimen wait times,
ensures accurate and timely electronic reporting of laboratory results and
reduces biohazard exposures for laboratory staff

REGIONAL LABORATORY
specific low-volume or expensive laboratory services currently provided by
more than one regional hospital laboratory, that are consolidated into one
hospital laboratory
NATIONAL REFERENCE LABORATORY

laboratory in a government hospital which has been designated by

the DOH to provide special functions and services for specific disease
areas

functions:
• confirmatory testing
• surveillance
• resolution of conflicting results between or among laboratories
• training
• research
• implementation of EQAS
• evaluation of diagnostic kits and reagents
Department Order No. 393E s. 2000  (November 14, 200)
designation of NRL
POINT-of-CARE
diagnostic testing at or near the site of patient care rather than in the clinical
laboratory
includes bedside testing, outpatient and home care
test is generally limited to a few basic chemistry and hematology test (glucose,
preagnancy test)

STAT LABORATORY
rapid”response laboratory” that is often located in or near an emergency department
or surgical sui
provides critical laboratory tests(HCT and Blood Gases)

LIMITED SERVICE
provide limited routine test (CBC, Blood Chem) and/or specialty services (Fertility
Testing) on stat or non-stat basis
includes downsized hospital laboratories that remain stat and some routine test but
send most work to an-off site core laboratory
CLINICAL LABORATORY
provide physicians and other health care professionals with
information to:
(1) detect disease or predisposition to disease
(2) confirm or reject a diagnosis
(3) establish prognosis;
(4) guide patient management
(5) monitor efficacy of therapy
plays a leading role in education and research, information
technology design and implementation, and quality improvement
To successfully achieve its goal, a lab must use:
(1) expertise
(2) resources
(3) skills
The Concept of Practice of Pathology and Laboratory Medicine
• Laboratory medicine can be viewed as a bridging endeavour that
links basic sciences (biological and physical) with medical
principles.
• This bridging is not complete without the appropriate support
mechanism from the following:
Computes Science  provides necessary equipment, technology and
informatics
Management Techniques  laboratory staff enhances the level of care
provided and economically utilize available resources
Industry  interchange of business transactions between the healthcare
provider and the manufacturer of reagents, supplies and instruments
Activities in Pathology and Laboratory Medicine
 A new and transformed laboratory organization that continuously
promotes and uphold a favourable impact in patient care are
structured into four major activities.

Leadership and Management, Administration

management leads the laboratory to attain its organizational goals and the
administration interprets the policies and translate it into executive activities

Patient Care Services

provides pre-analytical, analytical and post-analytical phases of work in
the laboratory
Education
laboratories assume a significant level of responsibility in educating all
healthcare providers so that utilization and test ordering patterns are
implemented in the best interest of the patient and decision-making at
appropriate cost
laboratories provide training ground for MT interns and externs

Research
 new technologies and procedures are developed and implemented to provide
highest level of patient care
LABORATORY TESTS:

- are an integral part of the workup of any

patient
- constitute up to 80% of a physician's diagnosis
and treatment choice.
Next Topic:

INTRODUCTION TO
MANAGEMENT