JIYAH MAE B.

VILLACERAN, RMT
 LEARNING OBJECTIVES
oDiscuss the different sections of the
laboratory and the tests done in each
oCompare and contrast the different types of
clinical laboratories
oIdentify the salient points of the laws
governing the establishment, operation, and
maintenance of clinical laboratories in the
Philippines
oDiscuss the importance of quality assurance
in the clinical laboratory.
 o An essential component of health institutions

o Main task: Provide accurate and reliable

information to medical doctors for the
diagnosis, prognosis, treatment, and
Clinical management of diseases. (70% of all decisions
Laboratory performed by medical doctors are based in
laboratory test results)

o Place where specimens that are collected from

individuals are processed, analyzed, preserved,
and properly disposed.

o Vary according to size, function, and the

complexity of tests performed.
 o Actively involved in:
➢ Research
➢ Community outreach programs
➢ Surveillance
Clinical ➢ Infection control in the hospital and community settings
Laboratory ➢ Information dissemination
➢ Evaluation of the applicability of current and innovative
diagnostic technologies

o Medical technologist/Clinical Lab scientist

➢ serves as the integral partner of medical doctors
➢ important member of the health care delivery system
➢ plays a very significant role in the performance of laboratory
testing and ensuring reliability of test results
 PAST CURRENT FUTURE
o Assays o With the advent o Changes may be
undertaken in the of automation, due to shifting
Clinical assays are less demographics,
laboratory were laborious, with emergence of
Clinical described as shortened new and re-
Laboratory manual, taxing, turnaround time emergence of
labor-intensive, (TAT) infectious and
and time- o Test procedures non-infectious
consuming are ensured to diseases, demand
produce more for a more
reliable results efficient and
effective
workflow, and
new government
institutional
policies
 1. According to Function
o Clinical Pathology
o Anatomic Pathology
2. According to Institutional
Characteristics
Classifications o Institution-based
of Clinical o Free-standing
Laboratories 3. According to ownership
o Government-owned
o Privately-owned
4. According to Service Capability
o Primary category
o Secondary category
o Tertiary category
o National Reference Laboratory
 1. According to Function

• Clinical Pathology (blood and other body fluids)

- the branch of pathology dealing with the disease and disease
processes by means of chemical microscopic, and serologic
examinations.
Classifications - focuses on the areas of clinical chemistry, immunohematology,
of Clinical and blood banking, medical microbiology, immunology and
serology, hematology, parasitology, clinical microscopy,
Laboratories toxicology, therapeutic drug monitoring (TDM), and
endocrinology

• Anatomic Pathology (tissues and organs)

- the branch of pathology dealing with the morphologic changes in
the tissues, both gross and microscopic
- focuses on the areas of histopathology, immunohistopathology,
cytology, autopsy, and forensic pathology among others
 2. According to institutional characteristics

• Institution-based/Hospital laboratory
- a clinical laboratory that operates within the
premises of an institution, such as a hospital, school,
Classifications medical clinic, medical facility for OFW and seafarers,
of Clinical birthing home, psychiatric facility, drug rehabilitation
Laboratories centers and others
- Ex.: VCMC, UCMed, CHH

• Free-standing laboratory/Non-hospital laboratory

- a clinical laboratory that is not part of an established
institution.
- Free-standing out-patient clinical laboratory (most
common example)
- Ex.: Hi-Precision, CUPSI, Stanford
 3. According to Ownership

• Government-owned
- clinical laboratories that are owned, wholly or partially,
Classifications by national or LGU hospitals. (provincial, city, or
municipal)
of Clinical - Ex.: San Lazaro Hospital, Vicente Sotto Memorial Medical
Laboratories Center (VSMMC), Cebu City Medical Center (CCMC)

• Privately-owned
- clinical laboratories that are established and operated
by any individual, corporation, association or
organization.
- Ex.: St. Luke’s Medical Center, University of Cebu
Medical Center (UCMed), Chong Hua Hospital (CHH)
 4. According to Service Capability
Primary Secondary Tertiary
category/Primary category/Secondary category/Tertiary
Laboratory Laboratory Laboratory

Classifications ✓ Traditional ✓ Conventional lab w/ ✓ Sophisticated

laboratory partially/Semi- laboratory w/ fully
of Clinical ✓ Routine laboratory automate automated machine
Laboratories examinations instruments ✓ Complete laboratory
✓ Space requirement: ✓ Hospital- compromising eight
10 sq. m. based/School-based sections
✓ Space requirement: ✓ Training ground for
20 sq. m. interns
✓ Site for scientific
research
✓ Space requirement:
60 sq. m.
 4. According to Service Capability
Primary Secondary Tertiary
category/Primary category/Secondary category/Tertiary
Laboratory Laboratory Laboratory
✓ Service capabilities: ✓ Service capabilities: ✓ Service capabilities:
• Routine UA, Routine SE, • Services in 1° lab + • Perform all lab tests
GS, BLT, Routine Routine Chem tests performed in the 2°
Classifications Hematolgy (CBC, Hct, (bld glucose conc, lab + IS test (DFT,
of Clinical WBC cnt, Diff cnt, BUN, BUA, Crea, Chole Syphilis tests),
Qualitative plt det), GS, KOH mount, Microbiology (culture
Laboratories determination) BLT, and Cx matching and identification of
✓ Equipment required: ✓ Equipment required: bacteria and fungi),
• Microscopes, • Equipment used in 1° special Chem tests
centrifuge, hct lab + semi-automated (TDM, clinical
centrifuge, chem analyzers, enzymology), special
hemacytometers autoclave, incubator, Hema (BM studies,
oven Special staining for
abnormal cells), BB
(bld donation, Ab
screening and ID)
✓ Equipment required:
• Equipment used in 2°
lab + automated chem
analyzers, BSC class II
 4. According to Service Capability

• National Reference Laboratory

- a laboratory in a government hospital designated
Classifications by the DOH to provide special diagnostic functions
of Clinical and services for certain diseases.
Laboratories - Functions include referral services, provision of
confirmatory testing, assistance for research
activities, implementation of External Quality
Assurance Programs (EQAP), resolution of conflicts
regarding test results of different laboratories, and
training of medical technologists on certain
specialized procedures that require standardization.
 • R.A 4688
- an act regulating the operation and maintenance of
clinical laboratories and requiring the registration of the
same with the DOH, providing penalty for the violation
Laws on the thereof, and for other purposes.
Operation,
Maintenance, - Section 2: a licensed physician duly qualified in a
and Registration laboratory medicine and authorized by the Secretary of
of Clinical Health must administer, direct, and supervise a Clinical
Laboratories in laboratory; such authorization must be renewed
the Philippines annually.

- Section 3: 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
 R.A. 4688 (cont)
- Section 4: any person, firm or corporation who
violates any provision of this Act shall be punished
Laws on the with imprisonment for not less than 1 month but
Operation, not more than 1 year, or by a fine of not less than
Maintenance, 1000 pesos nor more than 5000 pesos or both
and Registration such fine and imprisonment, at the discretion of
of Clinical the court.
Laboratories in
the Philippines - Section 8: Effectivity (June 18, 1966)
 • AO No. 59 s. 2001
- Rules and Regulation Governing the Establishment,
Operation and Maintenance of Clinical Laboratories in
the Philippines
Laws on the
Operation, - Section 1: (Title) Rules and Regulations Governing
Maintenance, the Establishment, Operation and Maintenance of
and Registration Clinical Laboratories in the Philippines
of Clinical - Section 2: (Authority)
Laboratories in - Section 3: (Purpose)
the Philippines
- Section 4: (Scope)
- Section 5: (Classification of Laboratories)
- Section 6: (Policies)
- Section 7: (Requirements and Procedures for
Application of Permit)
 AO No. 59 s. 2001(Cont)
• Section 8: (Violations)
• Section 9: (Investigation of Charges or Complaints)
Laws on the
Operation, • Section 10: (Modification and Revocation of License)
Maintenance, • Section 11: (Repealing Clause)
and Registration
of Clinical • Section 12: (Publication and List of Licensed Clinical
Laboratories in Laboratories)
the Philippines • Section 13: (Effectivity) it was adopted on Nov. 19,
2001
 I. Staffing
II. Physical Facilities
III. Equipment/Instruments
ANNEX A
(Technical IV. Glasswares/Reagents/Supplies
standards and
Minimum V. Waste Management
requirements)
VI. Quality Control Program
VII. Reporting
VIII. Recording
IX. Laboratory Fees
 I. Staffing
• Licensed Physician
– manages the Clinical laboratory; must be certified by the
Philippine Board of Pathology
ANNEX A - in areas where pathologists are not available, a physician
with three (3) months training on clinical laboratory
(Technical medicine, quality control and laboratory management, may
standards and manage a primary/secondary category clinical laboratory.
Minimum • Registered Medical Technologist/Staffs
requirements)
- must be qualified and adequately trained
- a clinical laboratory shall have sufficient number of RMTs
proportional to the workload and be available at all time
during hours of laboratory operations.
- for hospital-based lab, there shall be at least one (1) RMT
per shift to cover the lab operation.
 II. Physical Facilities
• The Clinical Laboratory shall be well-
ventilated, adequately lighted, clean and
safe.
ANNEX A
(Technical • The working space shall be sufficient to
standards and accommodate its activities and allow for
Minimum smooth and coordinated work flow.
requirements) • There shall be an adequate water supply
• Working space requirements for all
categories of clinical laboratories:
• Primary – 10 sq. m.
• Secondary – 20 sq. m.
• Tertiary – 60 sq. m.
 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
ANNEX A
• For other laboratory examinations being performed, the
(Technical appropriate equipment necessary for performing such
standards and procedures shall be made available.
Minimum IV. Glasswares/Reagents/Supplies
requirements)
• 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.
 VI. Quality Control Program
Internal Quality Control Program External Quality Control Program
✓ Intralab QC ✓ Interlab QC
✓ It involves the analyses of control ✓ It involves the proficiency testing
samples together with the patient programs that periodically provide
ANNEX A specimens. samples of unknown concentrations to
✓ It is important for the daily monitoring participating clinical laboratories
(Technical of accuracy and precision of analytical ✓ It is important in maintaining long-term
standards and methods. accuracy of the clinical methods
✓ It allows identification of analytic errors ✓ It is also used to determine state-of-the
Minimum within a one-week cycle. art interlaboratory performance.
requirements) ✓ The program shall provide for the use of ✓ All clinical laboratories shall participate
quality control reference material in an EQAP given by designated National
Reference Laboratory (NRL). A
satisfactory rating given by the NRL is
one of the criteria for renewal of license
of the laboratory
✓ Refusal to participate in an EQAP shall
be one of the bases for
suspension/revocation of the laboratory
license.
 VII. Reporting
• All lab reports on various examinations of specimens shall bear
the name of the registered medical technologist and the
Pathologist and duly signed by both.
• No person in the clinical laboratory shall issue a report, orally
ANNEX A or in writing, whole or portions thereof without a directive from
(Technical the Pathologist or his authorized associate to the requesting
physician or his authorized representative except in emergency
standards and cases when the results may be released as authorized by the
Minimum Pathologist.
requirements) VIII. Recording
• 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 lab 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 rates shall be within the range of the
usual fees prevailing at the time and the
ANNEX A particular place, taking into consideration the
(Technical cost of testing and quality control of various
standards and lab procedures
Minimum
requirements) • Professional services rendered to the patient
in the performance of special procedures or
examinations shall be charged separately and
not included in the lab fee/s (ex. Extraction
fees, Home-service fees)
 • Clinical Chemistry
• Microbiology
• Hematology and Coagulation studies
• Clinical Microscopy
Sections of the
Clinical • Blood bank/Immunohematology
Laboratory
• Immunology and Serology
• Anatomic Pathology
✓Histopathology/Cytology
• Specialized sections of the laboratory
✓Immunohistochemistry
✓Molecular Biology and Biotechnology
 Clinical Chemistry
• This section is intended for the testing of blood
and other body fluids to quantify essential
soluble chemicals including waste products
Sections of the useful for the diagnosis of certain diseases
Clinical • Blood and urine are the two most common body
Laboratory fluids subjected for analysis in this section
• This sections is considered to be one of the
busiest in terms of the number of tests
performed
• In majority of tertiary clinical laboratories, this
sections is characterized as a state-of-the-art,
fully automated facility.
 Microbiology
• This section is subdivided into four (4)
sections: Bacteriology,
Mycobacteriology, Mycology, and
Sections of the Virology
Clinical
Laboratory • The work in this section is more
focused on the identification of
bacteria and fungi on specimens
• Specimens usually submitted are
blood and other body fluids, stool,
tissues, and swabs from different sites
in the body
 Microbiology
• Anaerobic glass jar used for
isolation of anaerobic bacteria
• McIntosh and Filde’s jar
Sections of the • Anaerobiasis – an anaerobic
culture method used to grow
Clinical anaerobes from a clinical spx.
Laboratory • Catalyst: Hydrogen + O2 = H2O;
palladium coated alumina
pellets (most common)
• Indicator: methylene blue
(colorless- anaerobic, blue –
exposed to O2)
• Gas pak: pellets of sodium
borhydride, cobalt Cl, citric
acid, Sodium bicarbonate;
generates hydrogen and CO2 in
presence of
water
 Hematology and Coagulation
studies
• This section deals with the
enumeration of cells in the blood
Sections of the
Clinical
and other body fluids
Laboratory • Automated hematology analyzers
are currently available in the
market
• BM examination using automated
analyzers is also conducted in this
section
 Hematology

Sections of the
Clinical
Laboratory
 Clinical Microscopy
• 2 major areas:
• First area
➢Allotted to routine and other special
Sections of the examinations of urine (macroscopic
Clinical
Laboratory
to microscopic examination)

• Second area
➢Assigned to the examination of stool
or routine fecalysis (detection and
identification of parasitic worms and
ova)
 Clinical Microscopy

Sections of the
Clinical
Laboratory
 Blood Bank/Immunohematology
• 2 main activities performed in this sections:
✓Blood typing
✓Compatibility testing
Sections of the
Clinical • This section is considered as the most
Laboratory 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
✓Post-donation care
 Blood Bank/Immunohematology
ABO Blood typing

Sections of the
Clinical
Laboratory
 Blood
Bank/Immunohematology
2 types of blood typing
Sections of the Reverse/Back typing
Clinical - Antibodies are being determined
Laboratory - sample: Serum
- reagents: A1 cells and B cells
Forward/antigen typing
- antigens are being detected
- sample: whole blood
- reagents: Anti-A, Anti-B, Anti-D
 Antigen vs. antibody

Sections of the
Clinical
Laboratory
 Forward typing – presence of antigen; absence of
antibody

Sections of the
Clinical
Laboratory
 Reverse typing – presence of antibody; absence of
antigen

Sections of the
Clinical
Laboratory
 Sample pictures

Sections of the
Clinical
Laboratory
 Sample pictures

Sections of the
Clinical
Laboratory
 Immunology and Serology
• Where the analyses of serum antibodies
in certain infectious agents are
Sections of the performed
Clinical
Laboratory • Similar to Clinical Chemistry and
Hematology sections, automated
analyzers are commonly used in this
section when performing different
serological tests
 Histopathology/Cytology
(Anatomic pathology)
Sections of the
•Where surgically removed
Clinical
Laboratory
tissue such as biopsy and
autopsy processing id being
done
•Tissues processed are being
examined by the pathologist
 Specialized sections of the laboratory
• Immunohistochemistry
- combines anatomical, clinical, and biochemical
techniques where antibodies bounded to enzymes
and fluorescent dyes are used to detect presence
Sections of the of antigens in tissues
Clinical - useful in the diagnosis of some types of cancers
Laboratory as well as assess patient responses to cancer
therapy

• Molecular Biology and Biotechnology

- PCR (Polymerase Chain Reaction)
= most common technique currently in use
= useful for a number of clinical techniques
 Tests performed in each section
Clinical Chemistry FBS, HbA1c, Lipid profile, BUA, BUN,
Creatinine, TP, Albumin, Electrolytes,
Clinical enzymology, Thyroid panel, TDM,
etc.
Hematology CBC, hgb and hct determination, WBC
Sections of the differential count, bld smear prep,
quantitative plt cnt, etc.
Clinical
Microbiology Microscopic visualization of
Laboratory microorganisms after staining, isolation,
and identification of bacteria and fungi in
varied culture media, different biochemical
tests, culture media prep, etc.

Clinical Microscopy Routine testing of UA and Stool

Blood bank Donor recruitment and screening, bleeding
of donor, post-donation care

Immunology and serology Hep B profile tests, serological test for

syphilis, tests for dengue fever, etc

Histopathology/Cytology Tissue processing, biopsy staining, etc

 Laboratory Testing Cycle

Sections of the
Clinical
Laboratory
 Quality Assurance in the Clinical Laboratory
• QA (Quality Assurance) – encompasses all
activities performed by laboratory personnel to
ensure reliability of test results; it is organized,
systematic, well-planned, and regularly done
Sections of the with the results properly documented and
Clinical consistently reviewed.
Laboratory • 2 major components:
✓IQAS (Internal Quality Assurance System)
- day-to-day activities that are undertaken in order to
control factors/variables that may affect test results
✓EQAS (External Quality Assurance System)
- system for checking performance among clinical
laboratories and is facilitated by designated external
agencies
 National reference laboratories
(NRL)
• is the DOH-designated EQAS
Sections of the
• Sends unknowns samples to clinical
Clinical laboratories for testing. Results are then
Laboratory returned to the external facility and are
compared with the known result.
(Proficiency testing)
• This procedure will determine the
performance of the laboratory. A
certificate of performance is given to the
participating clinical laboratory
 Designated NRL-EQAS, at present:

Sections of the
Clinical
Laboratory