THE CLINICAL LABORATORY AND ITS LAW  All procedures in processing sample should be

Classification of clinical laboratories in the Philippines done in biosafety cabinet with a gas-tight
-Clinical laboratories in the Philippines can be classified aerosol generation chamber.
based on ownership, function, institutional character  Access to the laboratory is controlled to prevent
and service capacity. potentially infectious aerosols from escaping to
Classification based on ownership: the environment
 Government owned Biosafety level 4:
 Private  Laboratories handle extremely dangerous and
Classification based on function: exotic agents that can be transmitted thru air,
 Clinical pathology function have no available vaccine or therapeutic cure,
 Anatomical pathology function and are under Risk group 4 classification.
Classification based on institutional character:  The personnel working under BSL 4 laboratories
 Institutional-based clinical laboratory are required to wear fully-body, air-supplied
 Free-standing positive-pressure suits.
Classification based on service capacity:  Provided with a specialized ventilation and
 Primary waste management system
 Secondary  Facility operates in a separate building
 Tertiary
RISK AGENT RISK DECRIPTION EXAMPLES
WHO classification of laboratories based on biosafety GROUP
level RG-1 Agents that are not Bacillus
 WHO recognizes four levels of laboratories associated with diseases subtilis, E. coli
depending on their biosafety capacity: in healthy adult K12, Adeno-
Biosafety level 1 associated
 Personnel who work in laboratory should wear virus (AAV)
their PPE RG-2 Agents that are associated S. aureus,
 Special containment systems are not required with human diseases that Salmonella sp.,
for this type of a laboratory are rarely serious and for Herpes simplex
 Personnel are supervised by a scientist with a which preventive or viruses,
previous training in microbiology or related therapeutic interventions Adenovirus
fields are often available
 Laboratories that fall under this classification RG-3 Agents that are associated M.
include those that handle organism which are with serious or lethal tubercolosis,
considered as Risk Group 1 human disease that are Bacillus
Biosafety level 2: rarely serious and for anthacis, HIV
 These laboratories handle broad spectrum of which preventive or
moderate-risk agents or Risk group organism therapeutic interventions
 The personnel working in this type of laboratory are may be available
normally process human-derived specimens
such as blood, body fluids, tissue and human RG-4 Agents that are likely to Ebola virus,
cell lines which the organism causing the cause serious or lethal Marburg virus,
disease in unknown. human diseases for which Lassa virus
 Aside from wearing PPE, the personnel have preventive or therapeutic
secondary barriers such as sink, waste inventions are not usually
decontamination facilities (such as: autoclave) available
to reduce the transmission of biohazard waste,
and a biohazard cabinet Biosafety cabinet:
Biosafety level 3:  enclosed, ventilated laboratory workspace
 Handle Risk Group 3 organism that are areas designed to protect the user and
considered indigenous or exotic agents with the surrounding environment from pathogens
potential to be transmitted thru respiratory  All exhaust air is HEPA filtered to remove
routes and can cause severe or fatal infection hazardous agents such as viruses and bacteria.
 Class I: Pertinent laws
 provides protection for the user and Republic act No. 4688
surrounding environment, but no protection for (Clinical labotarory act of 1966)
the sample being manipulated  Approved on June 18, 1966
 Biosafety level 1  AN ACT REGULATING THE OPERATION AND
Class II MAINTENANCE OF CLINICAL LABORATORIES
 provides protection for the user, environment AND REQUIRING THE REGISTRATION OF THE
and sample SAME WITH THE DEPARTMENT OF HEALTH,
 Vertical laminar flow recirculating air cabinet PROVIDING PENALTY FOR THE VIOLATION
 divided into four types: A1, A2, B1 and B2 THEREOF, AND FOR OTHER PURPOSES
 Biosafety level 2 and 3 SECTION 1: Any person, firm or corporation, operating
Class III and maintaining a clinical laboratory in which body
 also known as glove boxes, provides maximum fluids, tissues, secretions, excretions and radioactivity
protection; the enclosure is gas-tight, and all from beings or animals are analyzed for the
materials enter and leave through a dunk tank determination of the presence of pathologic organisms,
or double-door autoclave processes and/or conditions in the persons or animals
 The exhaust air is treated with either double from which they were obtained, shall register and
HEPA filtration or HEPA filtration and secure a license annually at the office of the Secretary
incineration of Health: provided, that government hospital
 Biosafety level 4 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. 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
Requirements for equipment/instruments Bureau of Research and Laboratories shall be charged
with the responsibility of strictly
PRIMARY CATEGORY SECONDARY TERTIARY CATEGORY enforcing the provisions of this Act and
CATEGORY shall be authorized to issue such rules
• Clinical Centrifuge • All those in • All those in and regulations as may be necessary to
• Hemocytometer Primary secondary category carry out its provisions.
• Microhematocrit Category • Incubator SECTION 4: Any person, firm or
centrifuge • Refrigerator • Balance corporation who violates any
• Microscope w/ oil • Photometer • Rotator provisions of this Act or the rules and
immersion objective • Water bath • Serofuge regulations issued thereunder by the
• Hemoglobinometer • timer • Autoclave Secretary of Health shall be punished
• Different blood cell • Drying oven with imprisonment for not less than
counter • Biosafety cabinet 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
mush 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.
Commentaries on selected administrative orders and
P.D.
 Eight (8) articles are incorporated in R.A 4688
 Provisions need to comply with the rules and
regulations enforced by the Secretary of Health
 Any person, firm, or company that desires to
supervise a clinical lab must meet the
qualification set by the secretary of health
 The sum of 50000 pesos is appropriated in
carrying into effect the provision of this act
Administrative Order No. 201,. S. 1973
 Approved by Dr. Clemente Gatmaitan consists
of 24 sections
 Issued for the purpose of governing the rules
and regulations on registration, operation
Section 1: Purpose
Section 2: applies to any person, firm or corporation
operating and maintaining clinical laboratories involved
in the analysis of human body fluids, excretion,
secretions and pathological tissues
Section 3: Basic licensure requirements
-desiring to establish or operate and maintain a clinical
laboratory shall submit to the Secretary of Health, thru
the Bureau of Research and Laboratories
(1) The name, citizenship and domicile of the head of
the laboratory;
(2) The place, municipality and province where it is to
be established;
(3) The name of establishment
(4) The name, citizenship and domicile of the owner
(5) Scope and nature of work to be undertaken (see
Section 11–c)
(6) Statement that applicant has complied with all
business requirements under other existing laws or
ordinances that are necessary in pursuance of the
activity for which a license is herein applied for
(7) A tax clearance for the preceding year
Section 4: License fees
-one hundred pesos shall be charged for every license
issued to open and operate a clinical laboratory,
payable to the Bureau of Research and Laboratories
Section 5 and 6: person or persons qualified to manage
and supervise a clinical laboratory
Section 7: Terminologies
Section 8,9,10,11: discuss the facilities and floor area
requirement of a clinical lab
Section 12 & 13: laboratory examination reports are
considered consultation between the patient and the
person working in the laboratory
-the prescribe rate of laboratory fee should be charge
by the clinical laboratory
Section 14 &15: required fees and publicity
-Only the name of the laboratory, address, telephone
number of the laboratory, pathologists and assistants
and field of work covered by the licensure shall appear
on the letterhead and other information media
Section 16: Exhibition of Certificate of Approval and
license and rules and regulations
Section 17 & 18: Expiration and Renewal of license
-Each specific license shall expire on the last day of
December of the year stated therein, including the
authorization given to the Head, Director or Physician–
in–charge of the clinical laboratory
-The Bureau of Research and Laboratories shall process
applications for license or renewal
Section 19: Inspection
-It shall be the duty of the Secretary of Health or his
representative to conduct periodical inspection of
clinical laboratories
Section 20: Quality Control Test
-The Director of the Bureau of Research and
Laboratories or his representative is hereby authorized
to conduct such quality control tests .
Section 21-Modification and Revocation of Licenses
Section 22: Investigation of Charges or Complaint
Section 23: Violations
Section 24: Effectivity
A.O No. 290, S.1976
 AMENDING SECTION II SUBSECTION A OF
ADMINISTRATIVE ORDER NO. 201, SERIES OF
1973 CONCERNING REQUIREMENTS FOR A
CLINICAL LABORATORY
 Also include certain provisions about
pathologist
Administrative Order No. 59, S 2001
-implements provisions regarding the rules and
regulations on the operation, maintenance and
establishment of clinical lab in the Philippines
Section 1: Title:
-“Rules and regulations governing the establishment,
operation and maintenance of Clinical Laboratories in -exempted NTRL and Regional TB Reference
the Philippines” laboratories performing TB culture from securing a
Section: 2: Authority license to operate as clinical laboratory provided they
-Redirecting the Functions and Operations of the have adhered to the standards and requirements of
Department of Health. The Department of Health National Reference Laboratories
(DOH), through the Bureau of Health Facilities and
Services (BHFS) in the Health Regulation Cluster, shall Department Memorandum Order No. 2009-0086
exercise the regulatory functions under these rules and -prescribes rules and regulations regarding
regulations. implementation of internal and external quality control
Section 3: Purpose programs
Section 4: Scope  Internal QC: inputs, processes and outputs of
Section 5: Classification of laboratories the laboratory
Section 6: Policies  External QCAP: requires a clinical lab to
Section 7: Requirements and Procedures for application participate in the National External Assessment
of Permit to Construct and License to Operate Program (NEAP)
-within 90 days before expiry date -This order consists of 12 sections
-The license shall be issued by the Director of
the CHD or his authorized representative  Department Order No. 393, s. 2000:
Section 8: Violations -the designated reference laboratories are the
- license to operate a clinical laboratory shall be ff:
suspended or revoked by the Secretary of Health upon
Research Institute for • National reference lab
violation of R.A. 4688
Tropical Medicine for dengue, influenza,
Section 9: Investigation of Charges or Complaint
TB, malaria and other
Section 10: Modification and Revocation of License
parasites, enteric
Section 11: Repealing Clause
disease, measles ,
Section 12: Publication and List of Licensed Clinical
enterovirus
Laboratories
San Lazaro Hospital • National reference lab
Section 13: Effectivity
for HIV/ AIDS, hepatitis,
syphilis and other STIs
A.O no. 48, S 2003
CLASSIFICATION OF CLINICAL LABORATORIES BASED East Avenue Medical • National reference lab
ON INSTITUTIONAL CHARACTER Center for environmental and
 Hospital–based laboratory – a laboratory that occupational health,
operates within hospital toxicology and
 Non–hospital based laboratory – a laboratory micronutrients
that operate its own National Kidney and • National reference lab
 Institution–based laboratory – a laboratory that Transplant Institute for hematology
operates within the premises and operates as including
part of an institution immunohematology,
 Freestanding laboratory – a laboratory that immunopathology and
operates outside the premises of an institution anatomic patho
and operates independently. Lung Center of the • National reference lab
Philippines for biochemistry
A.O no 2007-0027
 Revised Rules and Regulations Governing the Department Memorandum Order No. 2009-0086A
Licensure and Regulation of Clinical  Requires a clinical lab to participate in National
Laboratories in the Philippines External Quality Assessment Scheme (NEQAS)
 Starting 2013 and upon filling of the application
A.O no 2007-0027A of renewal of the license to operate for 2014,
 Amendment to Administrative Order No. 2007- the NEQAS Certificate of Proficiency Testing is a
0027 “Revised Rules and Regulations Governing initial requirement for the issuance of license to
the Licensure and Regulation of Clinical operate clinical lab.
Laboratories in the Philippines”