11-Nature of TheClinicalLaboratory

ANNEX A
TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS
I. STAFFING
1. The Clinical Laboratory shall be managed by a licensed physician

certified by the Philippine Board of Pathology.
2. Shall employ qualified and adequately train personnel. Work assignment shall
be consistent with the qualification of the concerned personnel.
3. There shall be staff development and appropriate continuing education

program available at all levels of organization to upgrade the knowledge, attitudes
and skills of staff.
II. PHYSICAL FACILITIES
1. The clinical laboratory shall be well–ventilated,
adequately lighted, clean and safe.
2. The working space shall be sufficient to accommodate
its activities and allow for smooth and coordinated work
flow.
3. There shall be an adequate water supply.
CATEGORY SPACE IN SQ.M
Primary 10 4. The working space for all

categories of clinical laboratories
shall have at least the following
Secondary 20 measurements:
Tertiary 60
III. EQUIPMENT/INSTRUMENTS
1. There shall be provisions for sufficient number and types of appropriate

equipment/instruments in order to undertake all the activities and laboratory examinations.
This equipment shall comply with safety requirements.
2. For other laboratory examinations being performed, the appropriate equipment necessary for
performing such procedures shall be made available.
IV. GLASSWARES/ REAGENTS/SUPPLIES
All categories of clinical laboratories shall provide adequate and appropriate

glassware, reagents and supplies necessary to undertake the required services.
V. WASTE MANAGEMENT
There shall be provisions for adequate and efficient disposal of waste following
guidelines of the Department of Health and the local government.
a. There shall be a
documented, continuous
VI. QUALITY CONTROL 1. Internal Quality
competency assessment
PROGRAM Control Program
program for all laboratory
personnel.
b. The program shall c. There shall be a

d. The program shall
provide appropriate and program for the proper
provide for the use of
standard laboratory maintenance and
quality control reference
methods, reagents & monitoring of all
materials.
supplies and equipment. equipment.
2. External
Quality Control
Program
Any refusal to participate in

All clinical laboratories shall
A satisfactory performance an External Quality Assurance
participate in an External
rating given by a National Program given by the
Quality Assurance Program
designated National
given by designated National Reference Laboratory shall Reference Laboratories shall
Reference Laboratories be one of the criteria for be one of the bases for
and/or other recognized the renewal of license. suspension/revocation of the
reference laboratories.
license of the laboratory
VII. REPORTING
1. All laboratory reports on various examinations of specimens shall bear the name
of the registered medical technologists and the Pathologist and duly signed by
both.
2. No person in the clinical laboratory shall issue a report, orally or in writing,

whole or portions, thereof without a directive from the Pathologist or his
authorized associate to the requesting physician or his authorized representative
except in emergency cases when the results may be released as authorized by the
Pathologist.
VIII. RECORDING
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__________.
IX. LABORATORY FEES
1. The rates shall be within the range of the usual fees
prevailing at the time and the particular place
2. Professional services rendered to the patient in the
performance of special procedures or examinations shall
be charged separately and not included in the laboratory
fee/s
Sections of the
TEST FUNCTION Clinical Laboratory
FBS. HbA1c Diagnosis of diabetes
Trigylcerides, Total Lipid Profile
Cholesterol, HDL and LDL Clinical Chemistry
– Testing of blood and other body
fluids to quantify essential
ALT, AST, TP, Albumin Liver Function Test soluble chemicals
BUA, BUN, Creatinine Kidney Function test – Blood and urine are the two
most common body fluids
Others Electrolytes, Clinical
enzymology subjected for analyses in this
section
Microbiology
– Bacteriology, parasitology,
mycology, virology
– Specimen submitted: blood and
other body fluids, stool, tissues,
and swabs
– Automated instruments are
available such as those used for
blood culture and antimicrobial
susceptibility testing
Hematology and Coagulation Studies
Specimen submitted: blood and other body fluids

(CSF, pleural fluid, etc.)
Automated hematology analyzers are currently

available in the market.
Bone marrow examination using automated

analyzers is also conducted in this section
Clinical Microscopy
– Specimen submitted: stool, urine and other body fluids
Two major areas:

1st: macroscopic examination (determination of color, transparency,
specific gravity and pH level), microscopic examination (detection of
the presence of abnormal cells and/or parasites and to quantify red
cells and WBC and other chemicals found in urine).
2nd: examination of stool or routine fecalysis
Blood Bank/ Immunohematology
- Considered to be most critical in the clinical laboratory
- Blood typing and compatibility testing are two main
activities performed
- Blood Donation Activities  donor recruitment and
screening, bleeding of donor and post donation
Immunology and Serology
Analysis of serum antibodies in certain infectious agents

(primarily viral agents) are performed in this section
Histopathology/Cytology
Tissue processing, cutting into sections, staining and

preparation for microscopic examination by pathologist
Laboratory
Testing Cycle
Quality Assurance in
Clinical Laboratory
Internal Quality Assurance External Quality Assurance

System System – It is organized, systematic, well
• Day-to-day activities that • A system for checking planned, and regularly done
are undertaken in order to performance among with the results properly
control factors or variables clinical laboratories and is
that may affect test facilitated by designated documented and consistently
results. external agencies. viewed.
• NRL is the DOH
designated EQAS Two major components:
National Kidney and Transplant Institute (NKTI)- Hematology and
Coagulation
Research Institute of Tropical Medicine (RITM)- Microbiology

(identification and antibiotic susceptibility testing) and Parasitology
(identification of ova and quantitation of malaria)
NRL-EQAS:
Lung Center of the Philippines (LCP)- Clinical Chemistry (for testing 10
analytes, namely glucose, creatinine, total protein, albumin, blood urea
nitrogen, uric acid cholesterol, sodium, potassium, and chloride.)
East Avenue Medical Center (EAMC)- Drugs of Abuse

(methamphetamine and cannabinoids)
San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL)-

infectious immunology hepatitis B surface antigen (HBsAg), Human
immunodeficiency virus (HIV), Hepatitis C virus (HCV)

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ANNEX A

TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS

1. The Clinical Laboratory shall be managed by a licensed physician

3. There shall be staff development and appropriate continuing education

Primary 10 4. The working space for all

1. There shall be provisions for sufficient number and types of appropriate

All categories of clinical laboratories shall provide adequate and appropriate

b. The program shall c. There shall be a

Any refusal to participate in

2. No person in the clinical laboratory shall issue a report, orally or in writing,

1. There shall be an adequate and effective system of recording

2. There shall be provisions for filing, storage and accession of all

3. All laboratory records shall be kept on file for at

Specimen submitted: blood and other body fluids

Automated hematology analyzers are currently

Bone marrow examination using automated

Two major areas:

Analysis of serum antibodies in certain infectious agents

Tissue processing, cutting into sections, staining and

Internal Quality Assurance External Quality Assurance

Research Institute of Tropical Medicine (RITM)- Microbiology

East Avenue Medical Center (EAMC)- Drugs of Abuse

San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL)-

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