Unit 4: NATURE OF THE CLINICAL LABORATORY

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 doctors are based on
laboratory test results, thus the need for accurate and reliable results. The clinical laboratory is
also actively involved in research, community outreach programs, surveillance, and infection
control in the hospital and community settings, information and evaluation of the applicability of
current and innovative diagnostic technologies. Thus, the medical technologist/clinical
laboratory scientist serves as the integral er 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, sues,
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.
At the end of this unit, students will be able to:
1. Discuss the history of medical technology on a global context.
2. Discuss the history of medical technology in the United States.
3. Discuss the history of medical technology in the Philippines.
4. Identify important personalities that played a significant role in the progress of medical
technology profession.
5. Discuss the historical milestones in Medical Technology.

Clinical Laboratory
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 doctors
are based on laboratory test results, thus the need for accurate and reliable results. The clinical
laboratory is also actively involved in research, community outreach programs, surveillance, and
infection control in the hospital and community settings, information and evaluation of the
applicability of current and innovative diagnostic technologies. Thus, the medical
technologist/clinical laboratory scientist serves as the integral er 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,
sues, 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 over 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 (if hospital-
based). Equipment requirements are, but not limited to, microscopes, centrifuge, 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, and 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, semiautomated 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., NS1-Ag for rapid plasma reagin, Treponema pallidum particle
agglutination tests); 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
monitoring, markers for certain diseases); (4) special hematology (e.g., bone marrow studies,
special staining for abnormal blood cells, red cell morphology); and immunohematology and
blood banking (e.g.. blood donation program, antibody 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
authorized by the Secretary of Health, such authorization to be renewed annually. No lice 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 s be
charged with the responsibility of strictly enforcing the provisions of this Act and shall 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 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 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 related tissue, 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
• Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology, Parasitology,
Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology,
Toxicology and Therapeutic Drug Monitoring and other similar disciplines.
• Anatomic Pathology - includes Surgical Pathology, Immunohistopathology, Cytology, O
Autopsy and Forensic Pathology. 2. Classification by Institutional Character

2. Classification by Institutional Character

• Hospital-based laboratory - a laboratory that operates within a hospital
• Non-hospital-based laboratory - a laboratory that operates on its own

3. Classification by Service Capability

 • 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

• Secondary - provides the minimum service capabilities of a primary category and

following: (1) Routine Clinical Chemistry - includes Blood Glucose Substance Concentra
Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood
Creatinine Concentration, Blood Total Cholesterol Concentration (2) Crossmatching

• 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:
• Letter of Application to the Director of BHFS
• Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or
engineer.
 • 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:
• 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 non-refundable license fee shall be charged for application for permit to construct, and
for license to operate a government and private clinical laboratory.
• A non-refundable fee shall be charged for application for renewal of license to operate.
• All fees shall be paid to the Cashier of the BHFS/CHD. Cud. All fees shall follow the current
prescribed schedule of fees of the DOH.

5. Penalties
1. 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.

2. 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 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 allow 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

• The license is granted upon compliance with the licensing requirements.
• The license is non-transferable.
• 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.
• 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.
• 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.
• 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.
• Operation of a clinical laboratory without a certified pathologist or without a registered
medical technologist
• Change of ownership, location, head of laboratory or personnel without informing the
BHFS and/or the CHD
• Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the
BHFS during reasonable hours
 • Gross negligence
• 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 1 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
circulation.

Section 13: Effectivity

These rules and regulations shall take effect 15 days after its publication in the Official c.
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.
a. 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.
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

• The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe.
• The working space shall be sufficient to accommodate its activities and allow for smooth
and coordinated work flow.
• There shall be an adequate water supply.
• The working space for all categories of clinical laboratories (both hospital and non-
hospital-based) shall have at least the following measurements:
Primary 10 sqm
Secondary 20
Tertiary 60

III. EQUIPMENT/INSTRUMENTS
• 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.
 • 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 at respective
CHDs and DOH-BHFS and local government offices)

VI. QUALITY CONTROL PROGRAM

All clinical laboratories shall have a functional Quality Assurance Program

1. Internal Quality Control Program

• There shall be a documented, continuous competency assessment program for all
laboratory personnel.
• The program shall provide appropriate and standard laboratory methods, reagents and
supplies and equipment.
• There shall be a program for the proper maintenance and monitoring of all equipment.
• The program shall provide for the use of quality control reference materials.

2. External Quality Control Program

• All clinical laboratories shall participate in an External Quality Assurance Program given
by designated National Reference Laboratories and/or other recognized reference
laboratories.
• A satisfactory performance rating given by a National Reference Laboratory shall be one
of the criteria for the renewal of license.
• Any refusal to participate in an External Quality Assurance Program the designated
National Reference Laboratories shall be one of the suspension/revocation of the license
of the laboratory.

VII. REPORTING
• Laboratory requests shall be construed as consultation between the physician and the
Pathologist of the laboratory and as such laboratory results released accordingly.
• All laboratory reports on various examinations of specimens shall bear the sign of the
registered medical technologist and the Pathologist and duly sign both.
• No person in the clinical laboratory shall issue a report, orally or in writing whole or
portions thereof without a directive from the Pathologist 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.
• There shall be an adequate and effective system of recording requests and reports of all
specimens submitted and examined.
• There shall be provisions for filing, storage and accession of all reports.
• 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.
• The rates shall be within the range of the usual fees prevailing at the time and the place,
taking into consideration the cost of testing and quality control of various laboratory
procedures.
• Professional services rendered to the patient in the performance of special procedures or
examinations shall be charged separately and not included in the laboratory fee/s.

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 namely
the pathologists, medical technologists/clinical laboratory scientists, 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 (FBS) and glycosylated hemoglobin
(HbA1c) 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 (TP); albumin; electrolytes (e.g., Sodium,
Potassium, Chloride); clinical enzymology (e.g., aminotransferase, creatinine 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 (IQA), Continuous Quality Improvement (CQA), and
participation in National External Quality Assurance Program (NEQAP) are important activities
that medical technologists perform and are responsible for.

Microbiology
This section is subdivided into four sections: bacteriology, mycobacteriology, myco 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.

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
globin, hematocrit, WBC differential count, red cell morphology and cell indices, quantitative
platelet count, total cell count and differential count, blood smear preparation, 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.

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

Blood Bank/Immunohematology
Blood typing and compatibility testing are the two main activities performed in this ion.
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.

Immunology and Serology

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

Anatomic Pathology
Section of Histopathology/Cytology
Activities performed in this section include tissue (removed surgically as in bi and autopsy)
processing, cutting into sections, staining, and preparation for micro 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 to 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,
transport and processing of specimen to the clinical laboratory. The analytic phase the actual
testing of the submitted/collected specimen. Important consideration should be given to
equipment and instruments used, reagents, and internal quality control. 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.
 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 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 checking performance among
clinical laboratories and is facilitated by designated a agencies. The National Reference
Laboratories (NRL) is the DOH-designated FOA unknown sample with known test results is
regularly sent to a clinical laboratory for to Results are then returned to the external facility and
are compared with the known This procedure determines the performance of the laboratory. A
certificate of performance 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 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)