Lesson 8

Nature of the Clinical Laboratory

The Clinical Laboratory

The clinical laboratory is an essential component of health institutions. Its main task is to provide
accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and
management of diseases. Seventy percent of all decisions performed by medical doctors are
based on laboratory test results, thus the need for accurate and reliable test results. The clinical
laboratory is also actively involved in research, community outreach programs, surveillance,
infection control in the hospital and community settings, information dissemination, and evaluation
of the applicability of current and innovative diagnostic technologies. Thus, the medical
technologist/clinical laboratory scientist serves as the integral partner of medical doctors and is
an important member of the health care delivery system.
The clinical laboratory is the place where specimens (e.g., blood and other body fluids, tissues,
feces, hair, nails, collected from individuals are processed, analyzed, preserved, and properly
disposed. Clinical laboratories vary according to size, function, and the complexity of tests
performed.
A medical technologist/clinical laboratory scientist plays a very significant role in the performance
of laboratory testing and ensuring the reliability of test results. Assays undertaken in the clinical
laboratory in the past were described as manual, taxing, labor-intensive, and time-consuming.
Currently, with the advent of automation, assays are less laborious, with shortened turnaround
time (TAT). Also, test procedures are ensured to produce more reliable results. In the near future,
there will be more changes in the clinical laboratory. Changes may be due to shifting
demographics, emergence of new and re-emergence of infectious and non-infectious diseases,
demand for a more efficient and effective workflow, and new government institutional policies.
These factors can usher in change in the activities done in the laboratory.

Classifications of Clinical Laboratories

According to Function
1. Clinical Pathology is a clinical laboratory that focuses on the areas of clinical chemistry,
immunohematology and blood banking, medical microbiology, immunology and serology,
hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring, and
endocrinology, among others. It is concerned with the diagnosis and treatment of diseases
performed through laboratory testing of blood and other body fluids.
2. Anatomic Pathology is a clinical laboratory that focuses on the areas of histopathology,
immunohistopathology, cytology, autopsy, and forensic pathology among others. It is concerned
with the diagnosis of diseases through microscopic examination of tissues and organs.
According to Institutional Characteristics
1. An institution-based is a clinical laboratory that operates within the premises or part of an
institution such as a hospital, school, medical clinic, medical facility for overseas workers and
seafarers, birthing home, psychiatric facility, drug rehabilitation center, and others Hospital-based
clinical laboratories are the most common example of institution based laboratories.
2. A free-standing clinical laboratory is not part of an established institution. The most common
example is a free-standing out-patient clinical laboratory.

According to Ownership
1. Government-owned clinical laboratories are owned, wholly or partially, by national or local
government units. Examples are the clinical and anatomical laboratories of DOH-run government
hospitals like the San Lazaro Hospital, Jose R. Reyes Memorial Medical Center, University of the
Philippines Philippine General Hospital and local government run hospital-based clinical
laboratories of the Ospital ng Maynila Medical Center Sta. Ana Hospital, and Bulacan Medical
Center.
2. Privately-owned clinical laboratories are owned, established, and operated by an individual,
corporation, institution, association, or organization. Examples are St. Luke's Medical Center,
Makati Medical Center, and MCU-FDTMF Hospital

According to Service Capability

1. Clinical laboratories under the primary category are licensed to perform basic routine
laboratory testing, namely, routine urinalysis, routine stool examination, routine hematology or
complete blood count that includes hemoglobin, hematocrit, WBC and RBC count. WBC
differential count and qualitative platelet count, blood typing, and Gram staining lif hospital-based).
Equipment requirements are, but not limited to, microscopes, centrifuge, and hematocrit
centrifuge Space requirement is at least 10 square meters.
2. Clinical laboratories secondary category (Hospital and non-hospital-based) are licensed to
perform laboratory tests being done by the primary category clinical laboratories along with routine
clinical chemistry tests like blood glucose concentration blood urea nitrogen, blood uric acid, blood
creatinine, cholesterol determination, qualitative platelet count, and if hospital-based, Gram stain,
KOH mount, crossmatching. A minimum requirement of 20 square meters is needed for the floor
area of this type of laboratory, Personnel requirement depends on the workload. Minimum
equipment requirements are microscopes, centrifuge, Hematocrit centrifuge, semi-automated
chemistry analyzers, autoclave, incubator, and oven.
3. Clinical laboratories under the tertiary category (Hospital and non-hospital based) are licensed
to perform all the laboratory tests performed in the secondary category laboratory plus (1)
immunology and serology (e.g., NSI-Ag for dengue, rapid plasma reagin, Treponema pallidum
particle agglutination tests (2) microbiology, bacteriology, and mycology (e.g., differential staining
techniques, culture and identification of bacteria and fungi from specimens, antimicrobial
susceptibility testing); (3) special clinical chemistry (e.g., clinical enzymology, therapeutic drug
monitoring, markers for certain diseases). (4) special hematology (e.g., bone marrow studies,
special staining for abnormal blood cells, red cell orphology), and (5) immunohematology and
blood banking (e.g., blood donation program, antibody screening and identification, preparation
of blood components).
Tertiary laboratories have a minimum floor area requirement of at least 60 square meters.
Equipment requirements include those seen in secondary category laboratories along with
automated chemistry analyzer, biosafety cabinet class II, serofuge, among others.
4. National Reference Laboratory is a laboratory in a government hospital designated by the
DOH to provide special diagnostic functions and services for certain diseases. These functions
include referral services, provision of confirmatory testing, assistance for research activities,
implementation of External Quality Assurance Programs (EQAP) of the government, resolution of
conflicts regarding test results of different laboratories, and training of medical technologists on
certain specialized procedures that require standardization.

Laws on the Operation, Maintenance, and Registration of Clinical

Laboratories in the Philippines
Republic Act No. 4688
An act regulating the operation and maintenance of clinical laboratories and requiring the
registration of the same with the department of health, providing penalty for the violation
thereof, and for other purposes.
SECTION 1. Any person, firm or corporation, operating and maintaining a clinical laboratory in
which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are
analyzed for the determination of the presence of pathologic organisms, processes and/or
conditions in the persons or animals from which they were obtained, shall register and secure a
license annually at the office of the Secretary of Health: provided, that government hospital
laboratories doing routine or minimum laboratory examinations shall be exempt from the
provisions of this section if their services are extensions of government regional or central
laboratories.
SECTION 2. It shall be unlawful for any person to be professionally in-charge of a registered
clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and
authorized by the Secretary of Health, such authorization to be renewed annually. No license shall
be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical
laboratory unless such laboratory is under the administration, direction and supervision of an
authorized physician, as provided for in the preceding paragraph.
SECTION 3. The Secretary of Health, through the Bureau of Research and Laboratories shall be
charged with the responsibility of strictly enforcing the provisions of this Act and shall be
authorized to issue such rules and regulations as may be necessary to carry out its provisions.
SECTION 4. Any person, firm or corporation who violates any provisions of this Act or the rules
and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment
for not less than one month but not more than one year, or by a fine of not less than one thousand
pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion
of the court.
SECTION 5. If any section or part of this Act shall be adjudged by any court of competent
jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof
SECTION 6. The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby
authorized to be appropriated, out of any funds in the National Treasury not otherwise
appropriated to carry into effect the provisions of this Act.
SECTION 7 All Acts or parts of Acts which are inconsistent with the provisions of this Act are
hereby repealed
SECTION 8. This Act shall take effect upon its approval
Approved, June 18, 1966.

Administrative Order No. 59 s. 2001

Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical
Laboratories in the Philippines
Section 1: Title
This Administrative Order shall be known as the "Rules and Regulations Governing the
Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines."

Section 2: Authority
These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law
consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the
Department of Health, The Department of Health (DOH), through the Bureau of Health Facilities
and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions
under these rules and regulations.
Section 3: Purpose
These rules and regulations are promulgated to protect and promote the health of the people
ensuring availability of clinical laboratories that are properly managed with adequate sources, with
effective and efficient performance through compliance with quality standards.
Section 4: Scope
1. These regulations shall apply to all entities performing the activities and functions of
clinical laboratories which shall include the examination and analysis of any or all samples
of human and other related tissues, fluids, secretions, radioactive, or other materials from
the human body for the determination of the existence of pathogenic organisms,
pathologic processes or conditions in the person from whom such samples are obtained.
 2. These regulations do not include government laboratories doing laboratory examinations
limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening
provided their services are declared as extension of a licensed government clinical
laboratory.

Section 5: Classification of Laboratories

1. Classification by Function
a. Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology,
Parasitology, Mycology, Clinical Microscopy, immunology and Serology,
Immunohematology. Toxicology and Therapeutic Drug Monitoring and other similar
disciplines.
b. Anatomic Pathology - includes Surgical Pathology Immunohistopathology, Cytology,
Autopsy and Forensic Pathology.
2. Classification by Institutional Character
a. Hospital-based laboratory - a laboratory that operates within a hospital
b. Non-hospital-based laboratory - a laboratory that operates on its own
3. Classification by Service Capability
a. Primary - provides the minimum service capabilities such as:
(1) Routine Hematology (Complete Blood Count or CBC)- includes Hemoglobin Mass
Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number
Concentration (WBC count) and Leucocyte Type Number Fraction Differential Count),
Qualitative Platelet Determination
(2) Routine Urinalysis
(3) Routine Fecalysis
(4) Blood Typing - hospital-based
(5) Quantitative Platelet Determination - hospital based
b. Secondary - provides the minimum service capabilities of a primary category and the
following:
(1) Routine Clinical Chemistry – includes Blood Glucose Substance Concentration, Blood
Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine
Concentration, Blood Total Cholesterol Concentration
(2) Crossmatching
c. Tertiary - provides the secondary service capabilities and the following:
(1) Special Chemistry
(2) Special Hematology
(3) Immunology/Serology
(4) Microbiology
Section 6: Policies
1. An approved permit to construct and design layout of a clinical laboratory shall be secured form
the BHFS prior to submission of an application for a Petition to Operate.
2. No clinical laboratory shall be constructed unless plans have been approved and construction
permit issued by the BHFS.
3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on
compliance with the minimum licensing requirements (Annex A).
4. The clinical laboratory shall be organized and managed to provide effective and efficient
laboratory services,
5. The clinical laboratory shall provide adequate and appropriate safety practices for its personnel
and clientele.

Section 7: Requirements and Procedures for Application of Permit to Construct and License to
Operate
1. Application for Permit to Construct
The following are the documents required:
a. Letter of Application to the Director of BHFS
b. Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or
engineer
c. DTI/SEC Registration (for private clinical laboratory)
2. Application for New License
A duly notarized application form "Petition to Establish, Operate and Maintain a Clinical
Laboratory", shall be filed by the owner or his duly authorized representative at the BHFS.
3. Application for renewal of license
A duly notarized application form "Application for Renewal of License to Establish, Operate and
Maintain a Clinical Laboratory" shall be filed by the owner or his duly authorized representative at
the respective CHD.
a. Renewal of License:
Application for renewal of license shall be filed within 90 days before the expiry date
of the license described as follows:
Region Schedule of application for Renewal of License
NCR January to March
1,2,3 & CAR February to April
4,5 & 6 March to May
7,8 & 9 April to June
10,11,12, CARAGA & ARMM May to July

4. Permit and License Fees

a. A non-refundable license fee shall be charged for application for permit to construct, and
for license to operate a government and private clinical laboratory.
b. A non-refundable fee shall be charged for application for renewal of license to operate.
 c. All fees shall be paid to the Cashier of the BHFS/CHD.

d. All fees shall follow the current prescribed schedule of fees of the DOH.
5. Penalties
a. A penalty of one thousand pesos (P1, 000.00) for late renewal shall be charged in addition
to the renewal fee for all categories if the application is filed during the next two (2) months
after expiry date.
b. An application received more than two (2) months after expiry date shall be fined one
hundred pesos (P100.00) for each month thereafter in addition to the P1, 000.00 penalty.
6. Inspection
a. Each license shall make available to the Director of the BHFS/CHD or his duly authorized
representative(s) at any reasonable time, the premises and facilities where the laboratory
examinations are being performed for inspection.
b. Each license shall make available to the Director of the BHFS/CHD or his duly authorized
representative(s) all pertinent records.
c. Clinical laboratories shall be inspected every two (2) years or as necessary.
7. Monitoring
a. All clinical laboratories shall be monitored regularly and records shall be made available
to determine compliance with these rules and regulations
b. The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to
monitor the clinical laboratory at any given time.
c. All clinical laboratories shall make available to the Director of the BHFS or his duly
authorized representative(s) records for monitoring.
8. Issuance of License
The license shall be issued by the Director of the CHD or his authorized representative, if the
application is found to be meritorious.
9. Terms and Conditions of License
a. The license is granted upon compliance with the licensing requirements
b. The license is non-transferable.
c. The owner or authorized representative of any clinical laboratory desiring to transfer a
licensed clinical laboratory to another location shall inform the CHD in writing at least 15
days before actual transfer.
d. The laboratory in its new location shall be subject to re-inspection and shall comply with
the licensing requirements.
e. An extension laboratory shall have a separate license.
f. Any change affecting the substantial conditions of the license to operate a laboratory shall
be reported within 15 days in writing by the person(s) concerned, to the BHFS/ CHD for
notation and approval. Failure to do so will cause the revocation of the license of the
clinical laboratory.
g. The clinical laboratory license must be placed in a conspicuous location area within the
laboratory.
 Section 8: Violations
1. The license to operate a clinical laboratory shall be suspended or revoked by the Secretary of
Health upon violation of R.A. 4688 or the Rules and Regulations issued in pursuance thereto.
2. The following acts committed by the Owner, President, Managers, Board of Trustees/Director,
Pathologist or its personnel are considered violations.
a. Operation of a clinical laboratory without a certified pathologist or without a
registered medical technologist
b. Change of ownership, location, head of laboratory or personnel without informing
the BHFS and/or the CHD
c. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by
the BHFS during reasonable hours
d. Gross negligence e Any act or omission detrimental to the public
3. The Provincial, City and Municipal Health Officers are authorized to report to the CHD and
BHFS the existence of unlicensed clinical laboratories or any private party performing laboratory
examinations without proper license and/or violations to these rules and regulations.
Section 9: Investigation of Charges or Complaints
The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify
if the laboratory concerned or any of its personnel is guilty of the charges
1. If upon investigation, any person is found violating the provision of R.A. 4688, or any of
these rules and regulations, the BHFS/CHD or his duly authorized representative(s) shall
suspend, cancel or revoke for a determined period of time the license, as well as the
authority of the offending person(s), without prejudice to taking the case to judicial authority
for criminal action.
2. Any person who operates a clinical laboratory without the proper license from the
Department of Health shall upon conviction be subject to imprisonment for not less than 1
month but not more I year or a fine of not less than P1,000.00 and not more than P5,000.00
or both at the discretion of the court. Provided, however, that if the offender is a firm or
corporation, the Managing Head and/or owner/s thereof shall be liable to the penalty
imposed herein
3. Any Clinical Laboratory operating without a valid license or whose license has been
revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his
duly authorized representative. The BHFS/CHD may seek the assistance of the law
enforcement agency to enforce the closure of any clinical laboratory.
4. The closure order issued by the DOH shall not be rendered ineffective by any restraining
order and injunction order issued by any court, tribunal or agency or instrumentalities.
Section 10: Modification and Revocation of License
1. A license maybe revoked, suspended or modified in full or in part for any material false
statement by the applicant, or as shown by the record of inspection or for a violation of, or
failure to comply with any of the terms and conditions and provisions of these rules and
regulations.
 2. No license shall be modified, suspended or revoked unless prior notice has been made
and the corresponding investigation conducted except in cases of willful, or repeated
violations hereof, or where public health interest or safety requires otherwise.
Section 11: Repealing Clause
These rules and regulations shall supersede all other previous official issuances hereof.
Section 12: Publication and List of Licensed Clinical Laboratories
A list of licensed clinical laboratories shall be published annually in a newspaper of general
circulation
Section 13: Effectivity
These rules and regulations shall take effect 15 days after its publication in the Official Gazette,
or in a newspaper of general circulation.

ANNEX A
Technical Standards and Minimum Requirements
The clinical laboratory shall be organized to provide effective and efficient laboratory services.
I. STAFFING
1. The clinical laboratory shall be managed by a licensed physician certified by the Philippine
Board of Pathology.
In areas where pathologists are not available, a physician with three (3) months training
on clinical laboratory medicine, quality control and laboratory management, may manage
a primary/secondary category clinical laboratory. The BHFS shall certify such training,
2. The clinical laboratory shall employ qualified and adequately train personnel. Work
assignment shall be consistent with the qualification of the concerned personnel.
a. A clinical laboratory shall have sufficient number of registered medical technologists
proportional to the workload and shall be available at all times during hours of
laboratory operations. For hospital-based clinical laboratory, there shall be at least one
registered medical technologist per shift to cover the laboratory operation.
3. There shall be staff development and appropriate continuing education program available
at all levels of the organization to upgrade the knowledge, attitudes and skills of staff.
II. PHYSICAL FACILITIES
1. The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe.
2. The working space shall be sufficient to accommodate its activities and allow for smooth
and coordinated work flow.
3. There shall be an adequate water supply.
4. The working space for all categories of clinical laboratories (both hospital and non-
hospital-based shall have at least the following measurements
 Category space in sq. m.
Primary 10
Secondary 20
Tertiary 60

III. EQUIPMENT INSTRUMENTS

1. There shall be provisions for sufficient number and types of appropriate equipment
instruments in order to undertake all the activities and laboratory examinations. This
equipment shall comply with safety requirements
2. For other laboratory examinations being performed the appropriate equipment necessary
for performing such procedures shall be made available.

IV. GLASSWARES REAGENTS/SUPPLIES

All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents
and supplies necessary to undertake the required services.
V. WASTE MANAGEMENT
There shall be provisions for adequate and efficient disposal of waste following guidelines of the
Department of Health and the local government copies of which are available in respective CHDs
and DOH BHFS and focal government office.
VI. QUALITY CONTROL PROGRAM
All clinical laboratories shall have a functional Quality Assurance Program
1. Internal Quality Control Program
a. There shall be a documented, continuous competency assessment program for all
laboratory personnel
b. The program shall provide appropriate and standard laboratory methods reagents and
supplies and equipment.
c. There shall be a program for the proper maintenance and monitoring of all equipment.
d. The program shall provide for the use of quality control reference materials
2. External Quality Control Program
a. All clinical laboratories shall participate in an External Quality Assurance Program
given by designated National Reference Laboratories and/or other recognized
reference laboratories
b. A satisfactory performance rating given by a National Reference Laboratory shall be
one of the criteria for the renewal of license
c. Any refusal to participate in an External Quality Assurance Program given by the
designated National Reference Laboratories shall be one of the bases for
suspension/revocation of the license of the laboratory.
VII. REPORTING
Laboratory requests shall be construed as consultation between the requesting physician and the
Pathologist of the laboratory and as such laboratory results shall be released accordingly
1. All laboratory reports on various examinations of specimens shall bear the name of the
registered medical technologist and the Pathologist and duly signed by both.
2. No person in the clinical laboratory shall issue a report, orally or in writing, whole or
portions thereof without a directive from the Pathologist or his authorized associate to the
requesting physician or his authorized representative except in emergency cases when
the results may be released as authorized by the Pathologist
VIII. RECORDING
There shall be a system of accurate recording to ensure quality results.
1. There shall be an adequate and effective system of recording requests and reports of all
specimens submitted and examined.
2. There shall be provisions for filing, storage and accession of all reports.
3. All laboratory records shall be kept on file for at least one (1) year
a. Records of anatomic and forensic pathology shall be kept permanently in the
laboratory.
IX. LABORATORY FEES
The laboratory and professional fees to be charged for laboratory examination shall be at the
prevailing rates.
1. The rates shall be within the range of the usual fees prevailing at the time and the particular
place, taking into consideration the cost of testing and quality control of various laboratory
procedures.
2. Professional services rendered to the patient in the performance of special procedures or
examinations shall be charged separately and not included in the laboratory fees

Sections of the Clinical Laboratory

A clinical laboratory is made up of different sections cohesively and comprehensively performing
different activities and procedures for each specimen collected from patients to produce reliable
test results. At the forefront of these activities are the clinical laboratory personnel, namely the
pathologists, medical technologists/clinical laboratory scientists, medical technicians,
phlebotomists, and other laboratory personnel

Clinical Chemistry
This section is intended for the testing of blood and other body fluids to quantify essential soluble
chemicals including waste products useful for the diagnosis of certain diseases Blood and urine
are the two most common body fluids subjected for analyses in this section Examples of tests
performed in this section are fasting blood sugar FRS, and glycoside hemoglobin (HbAle for the
diagnosis of diabetes, total cholesterol including high and low density lipoproteins HDL and LDL)
triglycerides TAG that can be used for the diagnosis of cardiovascular diseases blood uric acid
(BUA blood urea nitrogen (BUN) creatinine for diagnosis of diseases involving the kidney total
protein T albumin electrolytes leg. Sodium, Potassium Chloride clinical enzymology (eg,
aminotransferase, creatine kinase etc.
In terms of the number of tests performed, this section is considered to be one of the busiest In
majority of tertiary level clinical laboratories, this section is characterized as a state-of-the-art fully
automated facility In some laboratories, hormone in the blood and urine are also measured under
endocrinology Thyroid hormones tests include thyroid stimulating hormone (TSH), T3 and T4
(triodothyronine and thyroxine, respectively); other tests involving estrogen prolactin, and
testosterone Other laboratories also have Toxicology and Drug Testing sections where
therapeutic drug monitoring tests for prohibited drugs are performed.
Internal Quality Assurance 10A) Continuous Quality Improvement (CQA), and participation in
National External Quality Assurance Program (NEQAP) are important activities that medical
technologists perform and are responsible for.

Figure 8.1 Vacutainer tubes used for collecting blood for Hematology, Coagulation Studies,
Clinical Chemistry, Immunohematology, and Serology

Microbiology
This section is subdivided into four sections: bacteriology, mycobacteriology, mycology, and
virology. At present, the work in this section is more focused on the identification of bacteria and
fungi on specimens received. Specimens usually submitted are blood and other body fluids, stool,
tissues, and swabs from different sites in the body.
Tests include the microscopic visualization of microorganisms after staining, isolation, and
identification of bacteria (aerobes and anaerobes) and fungi using varied culture media and
different biochemical tests, and at times, antigen typing, and antibacterial susceptibility testing.
Other activities performed in this section include the preparation of culture media and stains,
quality assurance and control, infection control, and biosafety and proper waste disposal.
Mycobacteriology looks into the identification of mycobacterium (e.g., Mycobacterium
tuberculosis) from the specimens submitted. Although not as automated as clinical chemistry,
automated instruments are available such as those used for blood culture and antimicrobial
susceptibility testing.

Figure 8.2 Culture media used for isolation of bacteria in Bacteriology section

Figure 8.3 Anaerobic glass jar used for the isolation of anaerobic bacteria (e.g., Clostridium
tetani)

Figure 8.4 Biosafety Cabinet 2 in Microbiology section

Hematology and Coagulation Studies
This section deals with the enumeration of cells in the blood and other body fluids (e.g., CSF,
pleural fluid, etc.). The examinations done in this section include complete blood count (CBC),
hemoglobin, hematocrit, WBC differential count, red cell morphology and cell indices, quantitative
platelet count, total cell count and differential count, blood smear preparation, and staining for
other body fluids. Coagulation studies focus on blood testing for the determination of various
coagulation factors.
There are also developments and innovations that contribute to the automation of activities in this
section. Automated hematology analyzers are currently available in the market. Bone marrow
examination using automated analyzers is also conducted in this section.

Figure 8.5 Preparation of blood smear for differential counts.

Figure 8.6 Cellular components of blood

Clinical Microscopy
There are two major areas in this section of the laboratory. The first area is allotted to routine and
other special examinations of urine such as macroscopic examinations to determine color,
transparency, specific gravity, and pH level, and microscopic examinations to detect presence of
abnormal cells and/or parasites as well as to quantify red cells and WBC and other chemicals
found in urine. Examination of other body fluids is also performed in this area. The second area
is assigned to the examination of stool or routine fecalysis. Detection and identification of parasitic
worms and ova are the primary activities in this area.

Figure 8.7 Routine analysis of urine

Figure 8.8 Parasitic ova identified in routine fecalysis

Blood Bank/Immunohematology
Blood typing and compatibility testing are the two main activities performed in this section.
Screening for all antibodies and identification of antibodies as well as the blood components used
for transfusion are also conducted in this section. This section is considered as the most critical
in the clinical laboratory.
In hospital-based clinical laboratories, blood donation activities prompt other activities such as
donor recruitment and screening, bleeding of donor, and post-donation care.
Figure 8.9 Blood bank refrigerator used for storage of blood collected from donors used for blood
transfusion

Figure 8.10 Reagents in Immunohematology for ABO and Rh typing

Figure 8.11 Sample result in ABO and Rh typing

Immunology and Serology

Analyses of serum antibodies in certain infectious agents (primarily viral agents) are performed in
this section. Hepatitis B profile tests, serological tests for syphilis, and tests for hepatitis C and
dengue fever are some examples of antibody screening tests. Similar to Clinical Chemistry and
Hematology sections, automated analyzers are commonly used in this section when performing
different serological tests.

Anatomic Pathology
Section of Histopathology Cytology
Activities performed in this section include tissue (removed surgically as in biopsy and autopsy)
processing, cutting into sections, staining, and preparation for microscopic examination by a
pathologist.

Specialized Sections of the Laboratory

Immunohistochemistry
It is a specialized section of the laboratory that combines anatomical, clinical, and biochemical
techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent
dyes are used to detect presence of antigens in tissue. This is useful in the diagnosis of some
types of cancers by detecting the presence of tumor-specific antigens, oncogenes, and tumor
suppressor genes. It can also be used to assess the responses of patients to cancer therapy as
well as diagnosis of certain neurodegenerative disorders.
Molecular Biology and Biotechnology
One of the exciting developments in medical technology is molecular biology and biotechnology
diagnostics. Primarily using different enzymes and other reagents, DNA and RNA are identified
and sequenced to detect any pathologic conditions/disease processes. The most common
technique currently in use is the polymerase chain reaction (PCR). This technique has contributed
to scientific advancements in laboratory research and is useful for a number of clinical techniques
such as screening genetic indicators of disease and diagnosis of cancer and infectious diseases.

Laboratory Testing Cycle

The laboratory testing cycle encompasses all activities starting from a medical doctor writing a
laboratory request up the time (called the turnaround time [TAT]) the results are generated and
become useful information for the treatment and management of patients. This cycle has three
phases, namely, pre-analytic, analytic, and post-analytic. The pre-analytic phase includes the
receipt of the laboratory request, patient preparation, specimen collection, and proper transport
and processing of specimen to the clinical laboratory. The analytic phase deals with the actual
testing of the submitted/collected specimen. Important consideration should be given to
equipment and instruments used, reagents, and internal quality control program. The post-
analytic phase includes the transmission of test results to the medical doctor for interpretation,
TAT, and application of doctor's recommendations. The diagnosis and treatment are based on
the generated data.

Pre-analytical
phase
Laboratory test
requisition/order
Post Analytic phase
Data
transmission/interpretation Order
reception
Results application
TAT

Patient
Actual preparation
Testing Specimen
collection

Specimen
transport and
processing

Figure 8.12 Laboratory Testing Cycle

Medical technologists/clinical laboratory scientists should have a clear understanding of this
testing cycle in order to prevent erroneous test results. In the pre-analytic phase, variables that
may affect the test results are present in the preparation of the request slip for the patient until
the sample is transported to and processed in the clinical laboratory. Some of the variables that
may cause errors are physiologic factors, diet, medications, alcohol and caffeine intake,
exercise, underlying disease conditions, identification of patients and labeling of specimens,
anticoagulant used, and volume of specimen collected vis-à-vis volume of anticoagulant. The
major sources of variables under the analytic phase are equipment and instruments, quality of
reagents used, and internal quality control program. The post-analytic phase looks into the
control of the variables of TAT and transcription errors (e.g., wrong value used, results given to
the wrong patient),

Quality Assurance in the Clinical Laboratory

Quality assurance (QA) encompasses all activities performed by laboratory personnel to ensure
reliability of test results. It is organized, systematic, well-planned, and regularly done with the
results properly documented and consistently reviewed.
Quality assurance in the clinical laboratory has two major components: Internal Quality Assurance
System (IQAS) and External Quality Assurance System (EQAS), IQAS includes day-to-day
activities that are undertaken in order to control factors or variables that may affect test results.
Regular review and audit of results are done in order to identify weaknesses and consequently
perform corrective actions. EQAS, on the other hand, is a system for checking performance
among clinical laboratories and is facilitated by designated external agencies. The National
Reference Laboratories (NRL) is the DOH-designated EQAS. An unknown sample with known
test results is regularly sent to a clinical laboratory for testing Results are then returned to the
external facility and are compared with the known result This procedure determines the
performance of the laboratory. A certificate of performance is given to the participating clinical
laboratory.
At present, the designated NRL-EQAS are the following:
• National Kidney and Transplant Institute (NKTI) - Hematology and Coagulation Research
Institute of Tropical Medicine (RITM) - Microbiology (identification and antibiotic susceptibility
testing) and Parasitology (identification of ova and quantitation of malaria)
• Lung Center of the Philippines (LCP) - Clinical Chemistry (for testing 10 analytes, namely
glucose, creatinine total protein, albumin, blood urea nitrogen, uric acid, cholesterol, sodium,
potassium, and chloride)

• East Avenue Medical Center (EAMC) - Drugs of abuse (methamphetamine and cannabinoids)
• San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) – Infectious
immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV), hepatitis
C virus (HCV)