PMLS-1 According to Institutional Characteristics

TOPIC • Institution-based
o Operates within the premises or part
SUB-TOPIC
of an institution.
SUB-SUB-TOPIC ▪ Hospital
▪ School
▪ Medical Clinic
The Clinical Laboratory ▪ Medical Facility for overseas
workers and sea farers
• To provide accurate and reliable ▪ Birthing home
information to medical doctors for the ▪ Psychiatric facility
diagnosis, prognosis, treatment, and ▪ Drug rehabilitation center
management of disease. ▪ Hospital-based clinical
• The place where specimens (e.g., blood and laboratories
other body fluids, tissues, feces, hair, nails) • Free-standing
collected from individuals are processed, o Not part of an established institution
analyzed, preserved, and properly disposed. ▪ Free-standing out-patient
Classifications of Clinical Laboratories clinical laboratory

According to Function According to Ownership

• Clinical Pathology • Government-owned

o Focuses on the areas of: o Owned, wholly or partially by
▪ Clinical Chemistry national or LGUs.
▪ Immunohematology and • Privately-owned
Blood Banking o Owned, established, and operated by
▪ Medical Microbiology an individual, corporation,
▪ Immunology and Serology institution, association or
▪ Hematology organization.
▪ Parasitology According to Service Capability
▪ Clinical Microscopy
▪ Toxicology • Primary Category
▪ Therapeutic Drug Monitoring o Licensed to perform basic routine
▪ Endocrinology laboratory testing, such as:
o Concerned with the diagnosis and • Routine urinalysis
treatment of diseases performed • Routine stool
through laboratory testing of blood examination
and other body fluids. • Routine hematology
• Anatomic Pathology or CBC
o Focuses on the areas of: • Blood-typing
▪ Histopathology • Gram staining (if
▪ Immunohistopathology hospital-based)
▪ Cytology ▪ Microscope
▪ Autopsy ▪ Centrifuge
▪ Forensic pathology ▪ Hematocrit Centrifuge
o It is concerned with the diagnosis of ▪ 10 sqm
diseases through microscopic
examination of tissues and organs.

• Secondary Category
o Licensed to perform laboratory tests
being done by the primary category.
o Routine clinical Chemistry tests
(glucose, BUN, BUA, crea, and
cholesterol)
o Gram stain
o KOH count
o Crossmatching (if hospital-based)
o Microscope
o Centrifuge
o Hematocrit Centrifuge
o Semi-automated chemistry analyzers
o Autoclave
o Incubator
o Oven
o 20 sqm
• Tertiary Category
o Licenses to perform laboratory tests
being done by the secondary
category laboratory
o Immunology and Serology
o Microbiology, Bacteriology, and
Mycology
o Special Clinical Chemistry
o Special Hematology
o Immunohematology and Blood
Banking
o 60 sqm
o Equipment seen in secondary
laboratory + automated chemistry
analyzer, biosafety cabinet class II,
serofuge.
• National Reference Laboratory
o Laboratory in a government hospital
designed by the DOH to provide
special diagnostic functions and
services for certain diseases
o Referral services, provision of
confirmatory testing, assistance for
research activities
o Implementation of External Quality
Assurance Programs (EQAP)
Laws on the Operation, Maintenance, and
Registration of Clinical Laboratories in the
Philippines
RA 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
thereof, and for Other Purposes.
• Section 1
o “Shall register and secure a license
annually.”
• Section 2
o “Licensed Physician”, should be in
charge of a registered clinical
laboratory.
• Section 3
o “Secretary of Health”, 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
o Persons who violates this act 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 7
o All acts or parts of acts which are
inconsistent with the provisions of
this act are hereby repealed.
• Section 8
o This Act shall take effect upon its
approval.
Approved: June 18, 1966
 Administrative Order No. 59 series 2001 o Section 10 = Modification and
Revocation of License
• Rules and regulation governing the
establishment, operation and maintenance of
clinical laboratories in the Philippines.
o Section 1 = Title
o Section 2 = Authority
o Section 3 = Purpose
o Section 4 = Scope
o Section 5 = Classification of
Laboratories
1. Classification by Function
2. Classification by Institutional
Character
3. Classification by Service
Capability
o Section 6 = Policies
o Section 7 = Requirements and
Procedures for Application of Permit
to Construct and License to Operate
1. Application for Permit to
Construct
2. Application for New License
3. Application for Renewal of
License
a) Renewal of License:

4. Permit and Licenses Fees

5. Penalties
6. Inspection
a) Every two years
7. Monitoring
8. Issuance of License
9. Terms and Conditions of
License
o Section 8 = Violations
o Section 9 = Investigation of Charges
or Complaints