MTPMLSP111 – PRINCIPLES OF

MEDICAL LABORATORY SCIENCE

LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

LESSON 8: NATURE OF THE CLINICAL LABORATORY o Evaluation of the applicability of current and
innovative diagnostic technologies
➢ Medical Technologist / Clinical Laboratory Scientist
OUTLINE o Significant role in the performance of lab testing and
ensuring the reliability of test results
8.1 The Clinical Laboratory
o Integral partner of medical doctors & important
8.2 Classification of Clinical Laboratories
member of the health care delivery system
8.2.1 According to Function
8.2.2 According to Institutional Characteristics
8.2.3 According to Ownership
8.2 CLASSIFICATIONS OF CLINICAL LABORATORIES
8.2.4 According to Service Capability
8.3 Laws on the Operation, Maintenance, and Registration of
Clinical Laboratories in the Philippines 1. According to Function
8.3.1 Republic Act No. 4688 2. According to Institutional Characteristics
8.3.2 Administrative Order No. 59 Series of 2001
3. According to Ownership
8.3.3 Annex A
4. According to Service Capability
8.4 Sections of the Clinical Laboratory
8.4.1 Clinical Chemistry
8.4.2 Microbiology
8.2.1 ACCORDING TO FUNCTION
8.4.3 Hematology and Coagulation Studies
8.4.4 Clinical Microscopy
8.4.5 Blood Bank/Immunohematology 1. Clinical Pathology
8.4.6 Immunology and Serology
➢ Focuses on the areas of:
8.5 Anatomic Pathology
o Clinical Chemistry
8.5.1 Section of Histopathology/Cytology
8.6 Specialized Sections of the Laboratory o Immunohematology and Blood Banking
8.6.1 Immunohistochemistry o Medical Microbiology
8.6.2 Molecular Biology and Biotechnology o Immunology and Serology
8.7 Laboratory Testing Cycle o Hematology
8.8 Quality Assurance in the Clinical Laboratory o Parasitology
o Clinical Microscopy
o Toxicology
8.1 THE CLINICAL LABORATORY o Therapeutic Drug Monitoring
o Endocrinology
➢ Concerned with the diagnosis and treatment of
Clinical Laboratory
diseases performed through lab testing of blood and
➢ Place where specimens (blood, and other bodily fluids, other body fluids
tissues, feces, hair, nails) collected from individuals are 2. Anatomic Pathology
processed, analyzed, preserved, and properly disposed ➢ Focuses on the areas of:
➢ Varies according to size, function, and the complexity of tests o Histopathology
performed o Immunohistopathology
➢ Essential component of health institutions o Cytology
➢ Main task: provide accurate and reliable info to doctors for the o Autopsy
diagnosis, prognosis, treatment, and management of diseases o Forensic Pathology
➢ 70% of decisions performed by MDs are based on lab test ➢ Concerned with the diagnosis of diseases through
results microscopic examination of tissues and organs
➢ Actively involved in:
o Research
o Community outreach programs 8.2.2 ACCORDING TO INSTITUTIONAL CHARACTERISTICS
o Surveillance
o Infection control in hospital and community settings 1. Institution-Based
o Information dissemination ➢ Operates within the premises of part of an institution:
o Hospital

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

o School o Centrifuge
o Medical clinic o Hematocrit centrifuge
o Medical facility for overseas workers and ➢ Space requirement – at least 10 sq m
seafarers 2. Secondary Category (Hospital and Non-Hospital-Based)
o Birthing home ➢ Licensed to perform lab tests being done by the
o Psychiatric facility primary category, along with routine clinical chemistry
o Drug rehab center tests:
➢ Most common: hospital-based clinical labs o Blood glucose concentration
2. Free-Standing o Blood urea nitrogen
➢ Not part of an established institution o Blood uric acid
➢ Most common: free-standing out-patient clinical lab o Blood creatinine
o Cholesterol determination
o Qualitative platelet count
8.2.3 ACCORDING TO OWNERSHIP o Gram-stain (hospital-based)
o KOH mount (hospital-based)
o Crossmatching (hospital-based)
1. Government-Owned
➢ Personnel requirement – depends on the workload
➢ Owned, wholly or partially by national or local
➢ Minimum equipment requirements:
government units
o Microscopes
➢ Examples:
o Centrifuge
o San Lazaro Hospital
o Hematocrit centrifuge
o Jose R. Reyes Memorial Medical Center
o Semi-automated chemistry analyzers
o UP-Philippine General Hospital
o Autoclave
o Ospital ng Maynila Medical Center
o Incubator
o Sta. Ana Hospital
o Oven
o Bulacan Medical Center
➢ Minimum space requirement – 20 sq m
2. Privately-Owned
3. Tertiary Category (Hospital and Non-Hospital-Based)
➢ Owned, established, and operated by an individual,
➢ Licensed to perform all the lab tests performed in the
corporation, institution, association, or organization
secondary category plus:
➢ Examples:
o Immunology and serology (NS1-AG for
o St. Luke’s Medical Center
dengue, rapid plasma regain, Treponema
o Makati Medical Center
pallidum particle agglutination tests)
o MCU-FDTMF Hospital
o Microbiology, bacteriology, and mycology
(differential staining techniques, culture and
8.2.4 ACCORDING TO SERVICE CAPABILITY identification of bacteria and fungi from
specimens, antimicrobial susceptibility testing)
o Special clinical chemistry (clinical enzymology,
1. Primary Category therapeutic drug monitoring, markers for
➢ Licensed to perform basic, routine lab testing: certain diseases)
o Routine urinalysis o Special hematology (bone marrow studies,
o Routine stool examination special staining for abnormal blood cells, red
o Routine hematology cell morphology)
o Complete blood count: o Immunohematology and blood banking (blood
▪ Hemoglobin donation program, antibody screening and
▪ Hematocrit identification, preparation of blood
▪ WBC and RBC count components)
▪ Qualitative platelet count ➢ Equipment requirements:
▪ Blood typing o Secondary category
▪ Gram staining (hospital-based) o Automated chemistry analyzer
➢ Equipment requirements (not limited): o Biosafety cabinet class II
o Microscopes o Serofuge

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER
VERDE, E.J. | 1MT03
➢ Minimum space requirement – 60 sq m
4. National Reference Laboratory
➢ Laboratory in a government hospital designated by the
DOH to provide special diagnostic functions and
services for certain diseases
➢ Functions:
o Referral services
o Provision of confirmatory testing
o Assistance for research activities
o Implementation of External Quality Assurance
Programs (EQAP) of the government
o Resolution of conflicts regarding test results of
diff labs
o Training of medtechs on certain specialized
procedure that require standardization
8.3 LAWS ON THE OPERATION, MAINTENANCE, AND
REGISTRATION OF CLINICAL LABORATORIES IN THE
PHILIPPINES
8.3.1 REPUBLIC ACT NO. 4688
Republic Act No. 4688 – Clinical Laboratory Act
➢ 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
➢ Approved on June 18, 1966
➢ Signed by Ferdinand E. Marcos
➢ Promulgated for the purpose of preventing the operation and
maintenance of substandard, improperly managed and
poorly-equipped clinical laboratories
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 the 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.
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TRINITY UNIVERSITY OF ASIA
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.
8.3.2 ADMINISTRATIVE ORDER NO. 59 S. 2001
Administrative Order No. 59 Series of 2001 – Rules and Regulation
Governing the Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines
Section 1: Title
“Rules and Regulation 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 consistent with E.O. 102 s. 1999: Redirecting
the Functions and Operations of the DOH. The 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.
 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

Section 3: Purpose o Leucocyte Number

To protect and promote health of people by ensuring availability of Concentration (WBC Count)
clinical laboratory that are PROPERLY MANAGED with adequate o Leucocyte Type Number
resources, with effective and efficient performance through Fraction (Differential Count)
compliance with quality standards. o Qualitative Platelet
Determination
Section 4: Scope ➢ Routine Urinalysis
➢ Routine Fecalysis
1. Regulations shall apply to all entities performing the activities ➢ Blood Typing – hospital-based
and functions of clinical lab which shall include the ➢ Quantitative platelet determination
examination and analysis of any or all samples of human and – hospital-based
other related tissues, fluids, secretions, excretions, radioactive 2. Secondary ➢ Provides the minimum service
of other materials form the human body for the determination capabilities of the primary
of the existence of pathogenic organisms, pathologic category and the ff:
processes/conditions in the person from whom such samples ➢ Routine Clinical Chemistry
o Blood Glucose Substance
are obtained.
Concentration
2. Regulations DO NOT INCLUDE GOVERNMENT
o Blood Urea Nitrogen
LABORATORY during lab examinations limited to acid fast Concentration
bacilli microscopy, malaria screening and cervical cancer o Blood Uric Acid Substance
screening, provided their services are declared as extension of Concentration
a licensed government clinical laboratory. o Blood Creatine
Concentration
Section 5: Classification of Laboratories o Blood Total Cholesterol
Concentration
BY FUNCTION
➢ Crossmatching
1. Clinical ➢ Hematology
3. Tertiary ➢ Provides the secondary service
Pathology ➢ Clinical Chemistry
capabilities and the following:
➢ Microbiology
➢ Special Chemistry
➢ Parasitology
➢ Special Hematology
➢ Mycology
➢ Immunology / Serology
➢ Clinical Microscopy
➢ Microbiology
➢ Immunology and Serology
➢ Immunohematology
➢ Blood Banking Section 6: Policies
➢ Lab Endocrinology
➢ Toxicology and Therapeutic Drug 1. An approved permit to construct and design lay-out of a
Monitoring and clinical laboratory shall be secured from BHFS prior to
➢ Other similar disciplines submission of an application for a Petition to Operate.
2. Anatomic ➢ Serological Pathology 2. No clinical laboratory shall be constructed unless plans have
Pathology ➢ Immunohistopathology
been approved and construction permit issued by the BHFS.
➢ Cytology
3. A clinical laboratory shall operate with a valid license issued by
➢ Autopsy and
➢ Forensic Pathology BHFS/CHD, based on compliance with the minimum licensing
BY INSTITUTIONAL CHARACTER requirements (annex A)
1. Hospital-Based ➢ Operates within the hospital 4. The clinical laboratory shall be organized and managed to
2. Non-Hospital- ➢ Operates on its own provide effective and efficient laboratory services.
Based 5. The clinical laboratory shall provide adequate and appropriate
BY SERVICE CAPABILITIES safety practices for its personnel and clientele.
1. Primary ➢ Routine Hematology (CBC)
o Hemoglobin Mass Section 7: Requirements and Procedures for Application of Permit
Concentration to Construct and License to Operate
o Erythrocyte Volume Fraction
1. Application for Permit to Construct
(Hematocrit)
The following are the documents required:

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

a. Letter of Application to the Director of BHFS the laboratory examinations are being performed for
b. Four (4) sets of Site Development Plans and floor inspection.
Plans approved by an architect and/or b. Each license shall make available to the Director of the
engineer. BHFS/CHD or his duly authorized representative(s) all
c. DTI/SEC Registration (for private clinical laboratory) pertinent records.
2. Application for New License c. Clinical laboratories shall be inspected every two (2)
A duly notarized application form “Petition to Establish, years or as necessary.
Operate, and Maintain a Clinical Laboratory” (Annex B), 7. Monitoring
shall be filed by the owner or his duly authorized a. All clinical laboratories shall be monitored regularly and
representative at the BHFS. records shall be made available to determine compliance
3. Application for Renewal of License with these rules and regulations.
A duly notarized application form “Application for b. The Director of the BHFS/CHD or his authorized
Renewal of License to Establish, Operate and Maintain a representative(s) shall be allowed to monitor the clinical
clinical Laboratory” (Annex C), shall be filed by the owner laboratory at any given time.
or his duly authorized representative at the respective c. All clinical laboratories shall make available to the
CHD. Director of the BHFS or his duly authorized
a. Renewal of License: representative(s) records for monitoring.
Application for renewal of license shall be filled within 8. Issuance of License
90 days before the expiry date of the license The license shall be issued by the Director of the CHD or
described as follows: his authorized representative, if the application is found to
SCHEDULE OF APPLICATION FOR be meritorious.
REGION
RENEWAL OF LICENSE 9. Terms and Conditions of License
NCR January to March a. The license is granted upon compliance with the
1, 2, 3, & CAR February to April licensing requirements.
4, 5, & 6 March to May b. The license is non-transferable.
7, 8, & 9 April to June c. The owner or authorized representative of any clinical
10, 11, 12, CARAGA & laboratory desiring to transfer a licensed clinical
May to July
ARMM 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-
4. Permit and License Fees
inspection and shall comply with the licensing
a. A non-refundable license fee shall be charged for
requirements.
application for permit to construct, and for license to
e. An extension laboratory shall have a separate license.
operate a government and private clinical laboratory.
f. Any change affecting the substantial conditions of the
b. A non-refundable fee shall be charged for application for
license to operate a laboratory shall be reported within 15
renewal of license to operate.
days in writing by the person(s) concerned, to the
c. All fees shall be paid to the cashier of the BHFS/CHD.
BHFS/CHD for notation and approval.
d. All fees shall follow the current prescribed schedules of
Failure to do so will cause the revocation of the license of
fees of the DOH.
the clinical laboratory.
5. Penalties
g. The clinical laboratory license must be placed in a
a. A penalty of one thousand pesos (P1, 000.00) for late
conspicuous location/area within the laboratory.
renewal shall be charged in addition to the renewal fee
for all categories if the application is filed during the next Section 8: Violations
two (2) months after expiry date.
b. An application received more than two (2) months after 1. The License to operate a clinical laboratory shall be suspended
expiry date shall be fined one hundred pesos (P100.00) or revoked by the Secretary of Health upon violation of R.A.
for each month thereafter in addition to the p1, 000.00 4688 or the Rules and Regulations issued in pursuance
penalty. thereto.
6. Inspection 2. The following acts committed by the Owner, President,
a. Each license shall make available to the Director of the Managers, Board of Trustees/Director, Pathologist or its
BHFS/CHD or his duly authorized representative(s) at personnel are considered violations.
any reasonable time, the premises and facilities where

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER
VERDE, E.J. | 1MT03
a. Operation of a clinical laboratory without a certified
pathologist or without a registered medical
technologist.
b. Change of ownership, location, and 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 & 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
provisions 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 than 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 a corporation, the Managing Head
and/or owner/s thereof shall be liable to the penalty
imprisoned 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.
Section 10: Modification and Revocation of License
1. A license maybe revoked, suspended or modified in full or
in part for any materially false statement by the applicant,
or as shown by the record of inspection or for a violation
of, or failure to comply any of the terms and conditions
and provisions of these rules and regulations.
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TRINITY UNIVERSITY OF ASIA
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 Cause
These rules and regulation shall supersede ail other previous official
issuances hereof.
Section 12: Publication of 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.
8.3.3 ANNEX
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 a 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 trained 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
operation. For the hospital-based clinical
laboratory, there shall be at least one registered
medical technologist per shift to cover the
laboratory operation.
 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER
VERDE, E.J. | 1MT03
3. There shall be staff development and appropriate
continuing education program available at all levels
of organization to upgrade the knowledge, attitudes
and skill 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 glass wares, 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.
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, reagent 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.
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TRINITY UNIVERSITY OF ASIA
2. External Quality Control Program
a. All clinical laboratories shall participate in an
External Quality Assurance Program given by
designated National Reference Laboratory
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 constructed 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
singed 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 a
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
 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

laboratory fee/s. 8.4.2 MICROBIOLOGY

8.4 SECTIONS OF THE CLINICAL LABORATORY Microbiology

➢ Four sections:
8.4.1 CLINICAL CHEMISTRY o Bacteriology
o Mycobacteriology
o Mycology
Clinical Chemistry o Virology
➢ Identification of bacteria and fungi on specimens received
➢ Intended for the testing of blood and other body fluids to
➢ Specimens:
quantify soluble chemicals including waste products useful for
o Blood
the diagnosis of certain diseases
o Body fluids
o Blood and urine – most common body fluids
o Stool
subjected for analyses in this section
o Tissues
➢ Examples of tests:
o Swabs from diff sites in the body
o Fasting blood sugar
➢ Tests:
o Glycosylated hemoglobin (HbA1c) – diagnosis of
o Microscopic visualization of microorganisms after
diabetes
staining, isolation, and identification of bacteria
o Total cholesterol – high- and low-density
(aerobes and anaerobes) and fungi using varied
lipoproteins (HDL and LDL)
culture media and different biochemical tests and at
o Triglycerides (TAG) – diagnosis of cardiovascular
times, antigen typing, and antibacterial susceptibility
diseases
testing
o Blood uric acid (BUA)
o Preparation of culture media and stains
o Blood urea nitrogen (BUN)
o Quality assurance and control
o Creatinine – diagnosis of diseases in the kidney
o Infection control
o Total protein (TP)
o Biosafety and proper waste disposal
o Albumin
➢ Mycobacteriology – identification of mycobacterium
o Electrolytes (sodium, potassium, chloride)
o Clinical enzymology (aminotransferase, creatine
kinase) 8.4.3 HEMATOLOGY AND COAGULATION STUDIES
➢ One of the busiest sections
➢ Characterized as a state-of-the-art, fully automated facility in
majority of tertiary-level clinical laboratories ➢ Enumeration of cells in the blood and other body fluids (CSF,
➢ Endocrinology (in some labs) pleural fluid, etc.)
o Blood and urine are also measured ➢ Examinations:
➢ Thyroid hormone tests: o Complete blood count
o Thyroid-stimulating hormone (TSH) o Hemoglobin
o T3 and T4 (triiodothyronine and thyroxine) o Hematocrit
o Estrogen, prolactin, and testosterone o WBC differential count
o Other labs: toxicology and drug testing sections o Red cell morphology and cell indices
➢ Internal Quality Assurance (IQA) & National External Quality o Quantitative platelet count
Assurance Program (NEQAP) o Total cell count and differential count
o Important activities that medtechs perform o Blood smear preparation
o Staining for other body fluids
➢ Coagulation studies – focus on blood testing for the
determination of various coagulation factors
➢ Automation of activities:
o Bone marrow examination
o Automated hematology analyzers

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

8.4.4 CLINICAL MICROSCOPY ➢ Automated analyzers are commonly used

Clinical Microscopy 8.5 ANATOMIC PATHOLOGY

➢ Two major areas:

1. Routine and other special examinations of urine 8.5.1 SECTION OF HISTOPATHOLOGY/CYTOLOGY
o Macroscopic examinations
▪ Determine color, transparency, specific
gravity, and pH level Histopathology / Cytology
o Microscopic examinations
➢ Activities:
▪ Presence of abnormal cells and/or
o Tissue processing
parasites, quantify red cells and WBC
o Cutting into sections
and other chemicals found in urine
o Staining
o Examinations of other body fluids
o Preparation for microscopic examination by a
2. Examination of stool or routine fecalysis
pathologist
o Detection and identification of parasitic worms
and ova
8.6 SPECIALIZED SECTIONS OF THE LABORATORY

8.4.5 BLOOD BANK/IMMUNOHEMATOLOGY

8.6.1 IMMUNOHISTOCHEMISTRY

Blood Bank / Immunohematology

Immunohistochemistry
➢ Two main activities:
o Blood typing ➢ Combines anatomical, clinical, and biochemical techniques
o Compatibility testing where:
➢ Other activities: o Antibodies (monoclonal and polyclonal) are bounded
o Screening for all antibodies to enzymes
o Identification of antibodies and blood components o Fluorescent dyes – used to detect presence of
for transfusion antigens in tissue
➢ Most critical section in the lab ➢ Useful in the diagnosis of some types of cancers by detecting
➢ Hospital-based: the presence of tumor-specific antigens, oncogenes, and
o Blood donation activities: tumor suppressor genes
▪ Donor recruitment and screening ➢ Can also be used to assess the responses of patients to
▪ Bleeding of donor cancer therapy as well as diagnosis of certain
▪ Post-donation care neurodegenerative disorders

8.4.6 IMMUNOLOGY AND SEROLOGY 8.6.2 MOLECULAR BIOLOGY AND BIOTECHNOLOGY

Immunology and Serology Molecular Biology and Biotechnology

➢ Activities: ➢ Using different enzymes and other reagents, DNA and RNA
o Analyses of serum antibodies in certain infectious are identified and sequenced to detect any pathologic
agents (primarily viral agents) conditions/disease processes
➢ Examples of antibody screening tests: ➢ Most common technique:
o Hepatitis B profile tests o Polymerase chain reaction (PCR)
o Serological tests for syphilis
o Tests for Hepatitis C
o Dengue fever

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 MTPMLSP111 – PRINCIPLES OF
MEDICAL LABORATORY SCIENCE
LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA
VERDE, E.J. | 1MT03

8.7 LABORATORY TESTING CYCLE o Transcription errors

Laboratory Testing Cycle 8.8 QUALITY ASSURANCE IN THE CLINICAL LABORATORY

➢ All activities starting from a medical doctor writing a laboratory

request up to the time (turnaround time) the results are Quality Assurance
generated and become useful information for the treatment
and management of patients ➢ Encompasses all activities performed by laboratory personnel
➢ Three phases: to ensure reliability of test results
1. Pre-analytic ➢ Organized, systematic, well-planned, and regularly done with
➢ Receipt of the lab request the results properly documented and consistently reviewed
➢ Patient preparation ➢ Two major components:
➢ Specimen collection o Internal Quality Assurance System (IQAS)
➢ Proper transport and processing of specimen ▪ Day-to-day activities undertaken in order
to the clinical lab to control factors or variables that may
2. Analytic affect test results
➢ Actual testing of the specimen ▪ Regular review and audit of results to
➢ Equipment and instruments used, reagents, identify weaknesses and consequently
and internal quality control program perform corrective actions
3. Post-analytic o External Quality Assurance System (EQAS)
➢ Transmission of test results ▪ System for checking performance among
➢ Interpretation clinical labs
➢ Turnaround time ▪ Facilitated by designated external agencies
➢ Application of doctor’s recommendation ▪ National Reference Laboratories (NRL) –
➢ Diagnosis and treatment – based on the generated data DOH-designated EQAS

Pre-Analytic Phase Designated NRL-EQAS:

➢ Variables that may affect test results: ➢ National Kidney and Transplant Institute (NKTI) – Hematology
o Preparation of the request slip for the patient and Coagulation
o Physiologic factors ➢ Research Institute of Tropical Medicine (RITM) – Microbiology
o Diet (identification and antibiotic susceptibility testing) and
o Medications Parasitology (identification of ova and quantitation of malaria)
o Alcohol and caffeine intake ➢ Lung Center of the Philippines (LCP) – Clinical Chemistry (for
o Exercise testing 10 analytes: glucose, creatinine, total protein, albumin,
o Underlying disease conditions blood urea nitrogen, uric acid, cholesterol, sodium, potassium,
o Identification of patients and labeling of specimens and chloride)
o Anticoagulant used ➢ East Avenue Medical Center (EAMC) – Drugs of abuse
o Volume of specimen collected vis-à-vis volume of (methamphetamine and cannabinoids)
anticoagulant ➢ San Lazaro Hospital STD-AIDS Cooperative Center
Laboratory (SACCL) – Infectious immunology hepatitis B
Analytic Phase surface antigen (HBsAg), human immunodeficiency virus
(HIV), hepatitis C virus (HCV)
➢ Variables:
o Equipment and instruments
o Quality of reagents used and internal quality control
program

Post-Analytic Phase

➢ Variables:
o TAT

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