Lesson 8

2. Anatomic Pathology
Nature of the Clinical Laboratory ● is a clinical laboratory that focuses on the areas of
histopathology, immunohistopathology, cytology, autopsy,
The Clinical Laboratory and forensic pathology among others.
● It is concerned with the diagnosis of diseases through
The Clinical laboratory is an essential component of health microscopic examination of tissues and organs.
institutions. ‘
According to Institutional Characteristics
Its main task is to provide accurate and reliable
information to medical doctors for the diagnosis, prognosis, 1. An institution-based
treatment, and management of diseases. Seventy percent ● is a clinical laboratory that operates within the
of all decisions performed by medical doctors are based on premises or part of an institution such as a hospital,
laboratory test results, thus the need for accurate and school, medical clinic, medical facility for overseas
reliable test results. workers and seafarers, birthing home, psychiatric
facility, drug rehabilitation center, and others.
The clinical laboratory is also actively involved in ● Hospital-based clinical laboratories are the most
research, community outreach programs, surveillance, common example of institution-based laboratories.
infection control in the hospital and community settings,
information dissemination, and evaluation of the 2. A free-standing clinical laboratory
applicability of current and innovative diagnostic ● is not part of an established institution. The most
technologies. common example is a free-standing out-patient clinical
laboratory.
Thus, the medical technologist/clinical
laboratory scientist serves as the integral partner of According to Ownership:
medical doctors and is an important member of the health
care delivery system. 1. Government-owned clinical laboratories
● are owned, wholly or partially, by national or local
The clinical laboratory is the place where specimens government units.
(e.g,, blood and other body fluids, tissues, feces, hair, ○ Examples are the clinical and anatomical laboratories
nails) collected from individuals are processed, analyzed, of DOH-run government hospitals like the San Lazaro
preserved, and properly disposed. Hospital, Jose R. Reyes Memorial Medical Center,
University of the Philippines-Philippine General
Clinical laboratories vary according to size, Hospital and local government-run hospital-based
function, and the complexity of tests performed. clinical laboratories of the Ospital ng Maynila Medical
Center, Sta. Ana Hospital, and Bulacan Medical
A medical technologist/clinical laboratory Center.
scientist plays a very significant role in the performance of
laboratory testing and ensuring the reliability of test 2. Privately-owned clinical laboratories
results. ● are owned, established, and operated by an individual,
corporation, institution, association, or organization.
Assays undertaken in the clinical laboratory in the ○ Examples are St. Luke's Medical Center, Makati
past were described as manual, taxing, labor-intensive, and Medical Center, and MCU-FDTMF Hospital.
time-consuming. Currently, with the advent of automation,
assays are. less laborious, with shortened turnaround According to Service Capability
time (TAT). Also, test procedures are ensured to produce
more reliable results. In the near future, there will be more 1. Primary category
changes in the clinical laboratory. ● These clinical laboratories are licensed to perform
basic, routine laboratory testing, namely, routine
Classifications of Clinical Laboratories urinalysis, routine stool examination, routine
hematology or complete blood count that includes
According to Function: hemoglobin, hematocrit, WBC and RBC count, WBC
differential count and qualitative platelet count, blood
1. Clinical Pathology typing, and Gram staining (if hospital-based).
● is a clinical laboratory that focuses on the areas of ● Equipment requirements are, but not limited to,
clinical chemistry, immunohematology and blood microscopes, centrifuge, hematocrit centrifuge. Space
banking, medical microbiology, immunology and requirement is at least 10 square meters.
serology, hematology, parasitology, clinical microscopy,
toxicology, therapeutic drug monitoring, and 2. Secondary category (Hospital and non-hospital-based)
endocrinology, among others. ● Clinical laboratories are licensed to perform laboratory
● It is concerned with the diagnosis and treatment of tests being done by the primary category clinical
diseases performed through laboratory testing of blood laboratories along with routine clinical chemistry
and other body fluids. tests like blood glucose concentration, blood urea
nitrogen, blood uric acid, blood creatinine, cholesterol
 determination, qualitative platelet count, and if Secretary of Health: provided, that government hospital
hospital-based, Gram stain, KOH mount, and laboratories doing routine or minimum laboratory
crossmatching. examinations shall be exempt from the provisions of this
● A minimum requirement of 20 square meters is section if their services are extensions of government
needed for the floor area of this type of laboratory. regional or central laboratories.
● Personnel requirement depends on the workload.
● Minimum equipment requirements are microscopes, SECTION 2. It shall be unlawful for any person to be
centrifuge, Hematocrit centrifuge, semi-automated professionally in-charge of a registered clinical laboratory
chemistry analyzers, autoclave, incubator, and oven. unless he is a licensed physician duly qualified in laboratory
medicine and authorized by the Secretary of Health, such
3. Tertiary category (Hospital and non-hospital-based) authorization to be renewed annually. No license shall be
● Clinical laboratories under the are licensed to perform granted or renewed by the Secretary of Health for the
all the laboratory tests performed in the secondary operation and maintenance of a clinical laboratory unless
category laboratory plus such laboratory is under the administration, direction and
○ (1) immunology and serology (e.g., NS1-Ag for supervision of an authorized physician, as provided for in the
dengue, rapid plasma reagin, Treponema pallidum preceding paragraph.
particle agglutination tests); SECTION 3. The Secretary of Health, through the Bureau of
○ (2) microbiology, bacteriology, and mycology (e.g, Research and Laboratories shall be charged with the
differential staining techniques, culture and responsibility of strictly enforcing the provisions of this Act
identification of bacteria and fungi from specimens, and shall be authorized to issue such rules and regulations
antimicrobial susceptibility testing); as may be necessary to carry out its provisions.
○ (3) special clinical chemistry (e.g, clinical SECTION 4. Any person, firm or corporation who violates
enzymology, therapeutic drug monitoring, markers any provisions of this Act or the rules and regulations issued
for certain diseases); thereunder by the Secretary of Health shall be punished with
○ (4) special hematology (e.g., bone marrow studies, imprisonment for not less than one month but not more than
special staining for abnormal blood cells, red cell one year, or by a fine of not less than one thousand pesos
orphology); and nor more than five thousand pesos, or both such fine and
○ (5) immunohematology and blood banking (e.g., imprisonment, at the discretion of the court.
blood donation program, antibody screening and SECTION 5. If any section or part of this Act shall be
identification, preparation of blood components) adjudged by any court of competent jurisdiction to be invalid,
the judgment shall not affect, impair, or invalidate the
● Tertiary laboratories have a minimum floor area remainder thereof.
requirement of at least 60 square meters. Equipment SECTION 6. The sum of fifty thousand pesos, or so much
requirements include those seen in secondary category thereof as may be necessary, is hereby authorized to be
laboratories along with automated chemistry analyzer, appropriated, out of any funds in the National Treasury not
biosafety cabinet class II, serofuge, among others. otherwise appropriated, to carry into effect the provisions of
this Act.
4. National Reference Laboratory i SECTION 7. All Acts or parts of Acts which are inconsistent
● s a laboratory in a government hospital designated by with the provisions of this Act are hereby repealed.
the DOH to provide special diagnostic functions and SECTION 8. This Act shall take effect upon its approval.
services for certain diseases. Approved, June 18, 1966.
● These functions include referral services, provision of Administrative Order No. 59 s. 2001
confirmatory testing, assistance for research activities, Rules and Regulation Governing the Establishment,
implementation of External Quality Assurance Operation and Maintenance of Clinical Laboratories in the
Programs (EQAP) of the government, resolution of Philippines Section 1: Title
conflicts regarding test results of different laboratories, This Administrative Order shall be known as the "Rules and
and training of medical technologists on certain Regulations Governing the Establishment, Operation and
specialized procedures that require standardization. Maintenance of Clinical Laboratories in the Phlippines."
Section 2: Authority
Laws on the Operation, Maintenance, and Registration of These rules and regulations are issued to implement R.A.
Clinical Laboratories in the Philippines Republic Act No. 4688: Clinical Laboratory Law consistent with E.O. 102
4688 series 1999: Redirecting the Functions and Operations of the
Department of Health. The Department of Health (DOH),
An act regulating the operation and maintenance of clinical through the Bureau of Health Facilities and Services (BHFS)
laboratories and requiring the registration of the same with in the Health Regulation Cluster, shall exercise the regulatory
the department of health, providing penalty for the violation functions under these rules and regulations.
thereof, and for other purposes
SECTION 1. Any person, firm or corporation, operating and Section 3: Purpose
maintaining a clinical laboratory in which body fluids, tissues, These rules and regulations are promulgated to protect and
secretions, excretions and radioactivity from beings or promote the health of the people
animals are analyzed for the determination of the presence by ensuring availability of clinical laboratories that are
of pathologic organisms, processes and/or conditions in the properly managed with adequate
persons or animals from which they were obtained, shall resources, with effective and efficient performance through
register and secure a license annually at the office of the compliance with quality standards.
Section 4: Scope 2. No clinical laboratory shall be constructed unless plans
1. These regulations shall apply to all entities performing the have been approved and construction permit issued by the
activities and functions of clinical laboratories which shall BHFS.
include the examination and analysis of any or all samples of •3. A clinical laboratory shall operate with a valid license
human and other related tissues, fluids, secretions, issued by BHFS/CHD, based on compliance with the
radioactive, or other materials from the human body for the minimum licensing requirements (Annex A).
determination of the existence of pathogenic organisms, 4. The clinical laboratory shall be organized and managed to
pathologic processes or conditions in the person from whom provide effective and efficient laboratory services.
such samples are obtained. 5. The clinical laboratory shall provide adequate and
2. appropriate safety practices for its personnel and clientele.
These regulations do not include government laboratories Section 7: Requirements and Procedures for Application of
doing laboratory examinations limited to acid fast bacilli Permit to Construct and License to Operate
microscopy, malaria screening and cervical cancer 1. Application for Permit to Construct
screening, provided their services are declared as extension The following are the documents required:
of a licensed government clinical laboratory. a. Letter of Application to the Director of BHFS
Section 5: Classification of Laboratories b. Four (4) sets of Site Development Plans and Floor Plans
1. Classification by Function approved by an architect and/or engineer.
a. Clinical Pathology - includes Hematology, Clinical c. DTI/SEC Registration (for private clinical laboratory)
Chemistry, Microbiology, Parasitology, Mycology, Clinical 2. Application for New License
Microscopy, Immunology and Serology, Immunohematology, A duly notarized application form Petition to Establish,
Toxicology and Therapeutic Drug Monitoring and other Operate and Maintain a Clinical Laboratory', shall be filed by
similar disciplines. the owner or his duly authorized representative at the BHES.
Anatomic Pathology - includes Surgical Pathology,
Immunohistopathology, Cytology, Autopsy and Forensic 3. Application for renewal of license
Pathology. Nature of the Clinical Laboratory 125
2. Classification by Institutional Character A duly notarized application form "Application for Renewal of
a. Hospital-based laboratory - a laboratory that operates License to Establish, Operate and Maintain a Clinical
within a hospital Laboratory" shall be filed by the owner or his duly authorized
b. Non-hospital-based laboratory - a laboratory that operates representative at the respective CHD.
on its own a. Renewal of License:
3.. Classification by Service Capability of the license described as follows:
a. Primary - provides the minimum service capabilities such Application for renewal of license shall be filed within 90 days
as: before the expiry date
1) Routine Hematology (Complete Blood Count or CBC) - 4. Permit and License Fees
includes Hemoglobin Mass Concentration, Erythrocyte a. A non-refundable license fee shall be charged for
Volume Fraction (Hematocrit), Leucocyte Number application for permit to construct, and for license to operate
Concentration (WBC count) and Leucocyte Type Number a government and private clinical laboratory.
Fraction (Differential Count), Qualitative Platelet b. A non-refundable fee shall be charged for application for
Determination renewal of license to operate.
(2) Routine Urinalysis c. All fees shall be paid to the Cashier of the BHFS/CHD.
(3) Routine Fecalysis d. All fees shall follow the current prescribed schedule of
(1) Blood Typing - hospital-based fees of the DOH.
(5) Quantitative Platelet Determination - hospital-based 5. Penalties
a. A penalty of one thousand pesos (P1,000.00) for late
b. Secondary - provides the minimum service capabilities of renewal shall be charged in addition to the renewal fee for all
a primary category and the following categories if the application is filed during the next two (2)
(1) months after expiry date.
Routine Clinical Chemistry - includes Blood Glucose b. An application received more than two (2) months after
Substance Concentration, Blood Urea Nitrogen expiry date shall be fined one hundred pesos (P100.00) for
Concentration, Blood Uric Acid Substance Concentration, each month thereafter in addition to the P1,000.00 penalty.
Blood Creatinine Concentration, Blood Total Cholesterol 6. Inspection
Concentration a. Each license shall make available to the Director of the
(2) Crossmatching BHES/CHD or his duly authorized representatives) at any
c. Tertiary - provides the secondary service capabilities and reasonable time, the premises and facilities where the
the following: laboratory examinations are being performed for inspection.
(1) Special Chemistry b. Each license shall make available to the Director of the
(2) Special Hematology BHFS/CHD or his duly authorized representatives) all
(3) Immunology/Serology pertinent records.
(4) Microbiology c. Clinical laboratories shall be inspected every two (2) years
Section 6: Policies or as necessary.
1. An approved permit to construct and design layout of a
clinical laboratory shall be secured form the BHFS prior to 7. Monitoring
submission of an application for a Petition to Operate.
a. All clinical laboratories shall be monitored regularly and person(s), without prejudice to taking the case to judicial
records shall be made available to determine compliance authority for criminal action.
with these rules and regulations. 2. Any person who operates a clinical laboratory without the
b. The Director of the BHFS/CHD or his authorized proper license from the Department of Health shall upon
representative(s) shall be allowed to monitor the clinical conviction be subject to imprisonment for not less than 1
laboratory at any given time. month but not more 1 year or a fine of not less than
c. All clinical laboratories shall make available to the Director P1,000.00 and not more than
of the BHES or his duly authorized representatives) records P5,000.00 or both at the discretion of the court. Provided,
for monitoring. however, that if the offender is a firm or corporation, the
8. Issuance of License Managing Head and/or owner/s thereof shall be liable to the
The license shall be issued by the Director of the CHD or his penalty imposed herein.
authorized representative, if the application is found to be 3. Any Clinical Laboratory operating without a valid license or
meritorious. whose license has been revoked/cancelled shall be
9. Terms and Conditions of License summarily closed upon order issued by the BHFS/CHD or
a. The license is granted upon compliance with the licensing his duly authorized representative. The BHFS/CHD may
requirements. seek the assistance of the law enforcement agency to
b. The license is non-transferable. enforce the closure of any clinical laboratory.
c. The owner or authorized representative of any clinical 4. The closure order issued by the DOH shall not be
laboratory desiring to transfer a licensed clinical laboratory to rendered ineffective by any restraining order and injunction
another location shall inform the CHD in writing at least 15 order issued by any court, tribunal or agency or
days before actual transfer. instrumentalities.
d. The laboratory in its new location shall be subject to Section 10: Modification and Revocation of License
re-inspection and shall comply with the licensing 1. A license maybe revoked, suspended or modified in full or
requirements. in part for any material false statement by the applicant, or as
e. An extension laboratory shall have a separate license. shown by the record of inspection or for a violation of, or
f. Any change affecting the substantial conditions of the failure to comply with any of the terms and conditions and
license to operate a laboratory shall be reported within 15 provisions of these rules and regulations.
days in writing by the person(s) concerned, to the BHFS/ 2. No license shall be modified, suspended or revoked
CHD for notation and approval. Failure to do so will cause unless prior notice has been made and the corresponding
the revocation of the license of the clinical laboratory. investigation conducted except in cases of willful, or
g. repeated violations hereof, or where public health interest or
The clinical laboratory license must be placed in a safety requires otherwise.
conspicuous location/area within the laboratory.
Section 8: Violations Section 11: Repealing Clause
1. The license to operate a clinical laboratory shall be These rules and regulations shall supersede all other
suspended or revoked by the Secretary of Health upon previous official issuances hereof.
violation of R.A. 4688 or the Rules and Regulations issued in Section 12: Publication and List of Licensed Clinical
pursuance thereto. Laboratories
2. The following acts committed by the Owner, President, A list of licensed clinical laboratories shall be published
Managers, Board of Trustees/ Director, Pathologist or its annually in a newspaper of general circulation.
personnel are considered violations. Section 13: Effectivity
a. Operation of a clinical laboratory without a certified These rules and regulations shall take effect 15 days after its
pathologist or without a registered medical technologist publication in the Official Gazette, or in a newspaper of
b. Change of ownership, location, head of laboratory or general circulation.
personnel without informing the BHFS and/or the CHD ANNEX A
Technical Standards and Minimum Requirements
c. Refusal to allow inspection of the clinical laboratory by the The clinical laboratory shall be organized to provide effective
person(s) authorized by the BHFS during reasonable hours and efficient laboratory services.
d. Gross negligence I. STAFFING
e. Any act or omission detrimental to the public 1. The clinical laboratory shall be managed by a licensed
3. The Provincial, City and Municipal Health Officers are physician certified by the Philippine Board of Pathology.
authorized to report to the CHD and BHFS the existence of In areas where pathologists are not available, a physician
unlicensed clinical laboratories or any private party with three (3) months training on clinical laboratory medicine,
performing laboratory examinations without proper license quality control and laboratory management, may manage a
and/or violations to these rules and regulations. primary/secondary category clinical laboratory. The BHFS
Section 9: Investigation of Charges or Complaints shall certify such training.
The BHFS/CHD or his duly authorized representatives) shall 2. The clinical laboratory shall employ qualified and
investigate the complaint and verify if the laboratory adequately train personnel.
concerned or any of its personnel is guilty of the charges. Work assignment shall be consistent with the qualification of
1. If upon investigation, any person is found violating the the concerned personnel.
provision of R.A. 4688, or any of these rules and regulations, a. A clinical laboratory shall have sufficient number of
the BHFS/CHD or his duly authorized representative(s) shall registered medical technologists proportional to the workload
suspend, cancel or revoke for a determined period of time and shall be available at all times during hours of laboratory
the license, as well as the authority of the offending operations. For hospital-based clinical laboratory, there shall
be at least one registered medical technologist per shift to C. Any refusal to participate in an External Quality Assurance
cover the laboratory operation. Program given by the designated National Reference
3. There shall be staff development and appropriate Laboratories shall be one of the bases for
continuing education program available at all levels of the suspension/revocation of the license of the laboratory.
organization to upgrade the knowledge, attitudes and skills of VII. REPORTING
staff. Laboratory requests shall be construed as consultation
II. PHYSICAL FACILITIES between the requesting physician and the Pathologist of the
1. The clinical laboratory shall be well-ventilated, adequately laboratory and as such laboratory results shall be released
lighted, clean and safe. accordingly.
2. The working space shall be sufficient to accommodate its 1. All laboratory reports on various examinations of
activities and allow for smooth and coordinated work flow. specimens shall bear the name of the registered medical
3: There shall be an adequate water supply. technologist and the Pathologist and duly signed by both.
2. No person in the clinical laboratory shall issue a report,
4. The working space for all categories of clinical laboratories orally or in writing, whole or portions thereof without a
(both hospital and non-hospital-based) shall have at least the directive from the Pathologist or his authorized associate to
following measurements: the requesting physician or his authorized representative
Category except in emergency cases when the results may be
space in sq. m. released as authorized by the Pathologist.
Primary VIII. RECORDING
10 There shall be a system of accurate recording to ensure
Secondary quality results.
20 1. There shall be an adequate and effective system of
Tertiary recording requests and reports of all specimens submitted
60 and examined.
III. EQUIPMENT/INSTRUMENTS 2. There shall be provisions for filing, storage and accession
1. There shall be provisions for sufficient number and types of all reports.
of appropriate equipment/instruments in order to undertake 3. All laboratory records shall be kept on file for at least one
all the activities and laboratory examinations. This equipment (1) year.
shall comply with safety requirements. a. Records of anatomic and forensic pathology shall be kept
2. For other laboratory examinations being performed, the permanently in the laboratory.
appropriate equipment necessary for performing such IX. LABORATORY FEES
procedures shall be made available. The laboratory and professional fees to be charged for
IV. GLASSWARES/REAGENTS/SUPPLIES laboratory examination shall be at the prevailing rates.
All categories of clinical laboratories shall provide adequate 1. The rates shall be within the range of the usual fees
and appropriate glassware, reagents and supplies necessary prevailing at the time and the of various laboratory
to undertake the required services. procedures.
V. WASTE MANAGEMENT particular place, taking into consideration the cost of testing
There shall be provisions for adequate and efficient disposal and quality control
of waste following guidelines of the Department of Health 2. Professional services rendered to the patient in the
and the local government. (copies of which are available at performance of special laboratory fee/s.
respective CHDs and DOH-BHFS and local government procedures or examinations shall be charged separately and
offices) not included in the
VI. QUALITY CONTROL PROGRAM
All clinical laboratories shall have a functional Quality Sections of the Clinical Laboratory
Assurance Program
1. Internal Quality Control Program A clinical laboratory is made up of different sections
a. There shall be a documented, continuous competency cohesively and comprehensively performing different
assessment program for all laboratory personnel. activities and procedures for each specimen collected from
b. The program shall provide appropriate and standard patients to produce reliable test results. At the forefront of
laboratory methods, reagents and supplies and equipment. these activities are the clinical laboratory personnel, namely
c. There shall be a program for the proper maintenance and the pathologists, medical technologists/clinical laboratory
monitoring of all equipment. scientists, medical technicians, phlebotomists, and other
d. The program shall provide for the use of quality control laboratory personnel.
reference materials.
2. External Quality Control Program ❖ Clinical Chemistry
a. All clinical laboratories shall participate in an External ➢ This section is intended for the testing of blood and
Quality Assurance Program given by designated National other body fluids to quantify essential soluble
Reference Laboratories and/or other recognized reference chemicals including waste products useful for the
laboratories. diagnosis of certain diseases.Blood and urine are the
b. A satisfactory performance rating given by a National two most common body fluids subjected for analyses in
Reference Laboratory shall be one of the criteria for the this section.
renewal of license. ➢ Vacutainer tubes used for collecting blood for
Hematology, Coagulation Studies, immunohematology,
and Serology
 ➢ Examples of things performed in this section are fasting ❖ Hematology and Coagulation Studies
blood sugar (FBS) and glycosylated hemoglobin ➢ This section deals with the enumeration of cells in the
(HbAIc) for the diagnosis of diabetes; total cholesterol blood and other body fluids (e.g., CSF, pleural fluid,
including high- and low-density lipoproteins (HDL and etc.). The examinations done in this section include
LDL); triglycerides (TAG) that can be used for the complete blood count (CBC), hemoglobin, hematocrit,
diagnosis of cardiovascular diseases; blood uric acid WBC differential count, red cell morphology and cell
(BUA); blood urea nitrogen (BUN); creatinine for indices, quantitative platelet count, total cell count and
diagnosis of diseases involving the kidney; total protein differential count, blood smear preparation, and staining
(TP); albumin; electrolytes (e.g., Sodium, Potassium, for other body fluids. Coagulation studies focus on
Chloride); clinical enzymology (e.g., aminotransferase, blood testing for the determination of various
creatine kinase, etc.). coagulation factors.
➢ In terms of the number of tests performed, this section ➢ Preparation of blood smear for differential counts
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, hormones 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
Clinical Microscopy
tests for prohibited drugs are performed.
There are two major areas in this section of the laboratory.
The first area is allotted to routine and other special
Internal Quality Assurance (IQA), Continuous Quality
examinations of urine such as macroscopic examinations to
Improvement (CQA), and participation in National External
determine color, transparency, specific gravity, and pH level,
Quality Assurance Program (NEQAP) are important activities
and microscopic examinations to detect presence of
that medical technologists perform and are responsible for.
abnormal cells and/or parasites as well as to quantify red
cells and WBC and other chemicals found in urine.
❖ Microbiology
Examination of other body fluids is also performed in this
➢ This section is subdivided into four sections;
area. The second area is assigned to the examination of
bacteriology, mycobacteriology, mycology and
stool or routine fecalysis. Detection and identification of
virology. At present, the work in this section is more
parasitic worms and ova are the primary activities in this
focused on the identification of bacteria and fungi
area.
on specimens received.
➢ Culture media used for isolation of bacteria in
Blood Bank/Immunohematology
Bacteriology section
Blood typing and compatibility testing are the two main
➢ Anaerobic glass jar used for the isolation of anaerobic
activities performed in this section. Screening for all
bacteria
antibodies and identification of antibodies as well as the
➢ Biosafety Cabinet in Microbiology section
blood components used for transfusion are also conducted in
➢ Specimens usually submitted are blood and other body
this section. This section is considered as the most critical in
fluids, stool, tissues, and swabs from different sites in
the clinical laboratory.
the body.
In hospital-based clinical laboratories, blood donation
➢ Tests include the microscopie visualization of
activities prompt other activities such as donor recruitment
microorganisms after staining, isolation, and
and screening, bleeding of donor, and post-donation care.
identification of bacteria (aerobes and anaerobes) and
fungi using varied culture media. and different
Immunology and Serology
biochemical tests, and at times, antigen typing, and
Analyses of serum antibodies in certain infectious agents
antibacterial susceptibility testing.
(primarily viral agents) are performed in this section.
➢ Other activities performed in this section include the
Hepatitis B profile tests, serological tests for syphilis, and
preparation of culture media and stains, quality
tests for hepatitis C and dengue fever are some examples of
assurance and control, infection control, and biosafety
antibody screening tests. Similar to Clinical Chemistry and
and proper waste disposal. Mycobacteriology looks into
Hematology sections, automated analyzers are commonly
the identification of mycobacterium (84 Mycobacterium
used in this section when performing different serological
tuberculosis) from the specimens submitted. Although
tests.
not as automated as clinical chemistry, automated
Anatomic Pathology
instruments are available such as those used for blood
Section of Histopathology/Cytology
culture and antimicrobial susceptibility testing.
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 labeling of specimens, anticoagulant used, and volume of
anatomical, clinical, and biochemical techniques where specimen collected vis-à-vis volume of anticoagulant.
antibodies (monoclonal and polyclonal) bounded to enzymes
and fluorescent dyes are used to detect presence of antigens The major sources of variables under the analytic
in tissue. This is useful in the diagnosis of some types of phase are equipment and instruments, quality of reagents
cancers by detecting the presence of tumor-specific used, and internal quality control program.
antigens, oncogenes, and tumor suppressor genes. It can
also be used to assess the responses of patients to cancer The post-analytic phase looks into the control of
therapy as well as diagnosis of certain neurodegenerative the variables of TAT and transcription errors {e.g., wrong
disorders. value used, results given to the wrong patient).
Molecular Biology and Biotechnology
One of the exciting developments in medical technology is Quality Assurance in the Clinical Laboratory
molecular biology and biotechnology diagnostics. Primarily
using different enzymes and other reagents, DNA and RNA Quality assurance (QA) encompasses all activities
are identified and sequenced to detect any pathologic performed by laboratory personnel to ensure reliability of
conditions/disease processes. test results. It is organized, systematic, well-planned, and
The most common technique currently in use is the regularly done with the results properly documented and
polymerase chain reaction (PCR). This technique has consistently reviewed.
contributed to scientific advancements in laboratory research
and is useful for a number of clinical techniques such as Quality assurance in the clinical laboratory has two
screening genetic indicators of disease and diagnosis of major components:
cancer and infectious diseases.
1. Internal Quality Assurance System (IQAS) and
Laboratory Testing Cycle 2. External Quality Assurance System (EQAS).

The laboratory testing cycle encompasses all activities IQAS

starting from a medical doctor writing a laboratory request includes day-to-day activities that are undertaken
up to the time (called the turnaround time (TAT]) the results in order to control factors or variables that may affect test
are generated and become useful information for the results. Regular review and audit of results are done in
treatment and management of patients. order to identify weaknesses and consequently perform
corrective actions.
This cycle has three phases, namely, pre-analytic, analytic,
and post-analytic. EQAS,
on the other hand, is a system for S checking
The pre-analytic: performance among clinical laboratories and is
This phase includes the receipt of the laboratory facilitated by designated external agencies.
request, patient preparation, specimen collection, and
proper transport and processing of specimen to the The National Reference Laboratories (NRL) is the
clinical laboratory. DOH-designated EQAS.

The analytic phase An unknown sample with known test results is

deals with the actual testing of the regularly sent to a clinical laboratory for testing.
submitted/collected specimen. Results are then returned to the external facility and are
Important consideration should be given to compared with the known result.
equipment and instruments used, reagents, and internal
quality control program. This proceduré determines the performance of the
laboratory. A certificate of performance is given to the
The post-analytic phase participating clinical laboratory.
includes the transmission of test results to the
medical doctor for interpretation, TAT, and application of At present, the designated NRL-EQAS are the following:
doctor's recommendations. The diagnosis and treatment are
based on the generated data. National Kidney and Transplant Institute (NKTI) -
Hematology and Coagulation
Medical technologists/clinical laboratory scientists
should have a clear understanding of this testing cycle Research Institute of Tropical Medicine (RITM) -
in order to prevent erroneous test results. Microbiology identification and antibiotic susceptibility
testing) and Parasitology (identification of ova and
In the pre-analytic phase, variables that may affect quantitation of malaria)
the test results are present in the preparation of the request
slip for the patient until the sample is transported to and Lung Center of the Philippines (LCP) - Clinical Chemistry
processed in the clinical laboratory. Some of the variables (for testing 10 analytes, namely glucose, creatinine, total
that may cause errors are physiologic factors, diet, protein, albumin, blood urea nitrogen, uric acid, cholesterol,
medications, alcohol and caffeine intake, exercise, sodium, potassium, and chloride)
underlying disease conditions, identification of patients and cannabinoids)
East Avenue Medical Center (EAMC) - Drugs of abuse
(methamphetamine and

San Lazaro Hospital STD-AIDS Cooperative Center

Laboratory (SACCL) - Infectious immunology hepatitis B
surface antigen (HBsAg), human immunodeficiency virus
(HIV), hepatitis C virus (HCV)

Key points

• The clinical laboratory is an essential component of health

institutions. Its main task is to provide accurate and realistic
information to medical doctors for the diagnosis, prognosis,
and treatment of diseases.
• 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 results.
• Quality assurance (QA) encompasses all activities
performed by laboratory personnel to ensure reliability of test
results.