Republic Act No.

8981
lectures, subject matter meeting, non-degree
 The PRC Modernization Act of 2000 training/lectures, scientific meetings, modules
 Approved: December 5, 2000 o CPD providers – refers to a natural or judicial person
o Professional – person registered and licensed to
Section 4 – Composition practice a regulated profession in the Philippines
Commission shall be headed by
 1 full-time chairperson
PD 657
 2 part-time commissioners
7 year term  Amending section 5 of PD 223
Requirements:  Aprroved: February 19, 1975
 At least 40 years old
 Holding a valid certificated of registration/professional EO No. 200
license and a valid professional identification card or a
valid certificate of competency issued by PRC  Providing For the Publication of Laws
 At least 5 years of executive or management  Approved: June 18, 1987
experience  Approved by: Pres. Corazon I. Aquino
 Must be past Chairperson/member of a PRC Board
Section 6 – Compensation and Other Benefits
Republic Act No. 4688
 Entitled to a retirement benefits provided under RA
1568  An act regulating the operation and maintenance of clinical
Chairperson: receives compensation and allowances equivalent laboratories and requiring the registration of the same
to a Department of Secretary with the department of health, providing penalty for the
Commissioners: receives compensation and allowances violation thereof, and for Other Purposes
equivalent to an Undersecretary Approved: June 18, 1966
 48000 with 500 pesos
 Associate commissioner: 36000 with 750 pesos Republic Act No. 7719
9 years of term except the 1st  National Blood Service Act of 1994
Two associate commissioner  Approved: May 5, 1994
1st: 6 years  Approved by: Pres. Fidel V. Ramos
2nd: 3 years
Section 3 – Definitions
PD 223 o Blood/Blood Product – refers to human blood,
processed or unprocessed and includes blood
 Creating the Personal Regulation Commissioner and components, its products and derivatives
Prescribing its Power and Function o Blood Bank/center – a laboratory or institution with the
 Approved: June 23 1973 capability to recruit and screen blood donors, collect,
 Approved by: President Ferdinand Marcos process, store, transport and issue blood for
transfusion and provide information and/or education
Republic Act No. 10912 on blood transfusion transmissible diseases
o Commercial blood –bank blood bank exist for profit
 Continuing Professional Development Act of 2016 o Hospital based blood bank – a blood bank which is
 Approved: July 21, 2016 located within the premises of a hospital and which can
 Approved by: Benigno S. Aquino III perform compatibility testing of blood
o Blood collection unit – an institution or facility duly
PRC license authorized by the Department of Health to recruit and
 3 years expiration screen donors and collect blood
 Renewal of registration must be processed 3 o Voluntary blood donor – one who donates blood on
months before the expiration date one’s own volition or initiative and without monetary
 Req: 15 CPD units (from workshops and seminars) compensation
o CPD – refers to the inuclation of advanced knowledge, o Blood transfusion transmissible diseases – may be
skills and ethical values in a post- licensure transmitted as a result of blood transfusion, including
specialization or in inter- or multidisciplinary field of AIDS, Hepatitis B, Malaria and Syphilis
study o Walking Blood Donor – an individual included in the list
o CPD credit unit – refers to the value of an amount of of qualified voluntary blood donors, referred to section
learning that can be transferred to a qualification 4, who is ready to donate blood when needed in
o CPD council – refers to the body created to promote his/her community
and ensure the continuous improvement of
professionals
o CPD programs – a set of learning activities accredited
by the council such as seminars, workshops, technical
Section 12 – Penalties the test and the person on whom the test is conducted to
 Any blood bank/center which shall collect charges and match the test results with the identifying number or symbol.
fees greater than the maximum prescribed by the o "Compulsory HIV Testing" — refers to HIV testing imposed
Department shall have its license suspended or revoked upon a person attended or characterized by the lack of or
by the Secretary vitiated consent, use of physical force, intimidation or any
 Imprisonment: 1 month to 6 months form of compulsion.
 Fine: 5,000 to 50,000 o Contact tracing — refers to the method of finding and
counselling the sexual partner(s) of a person who has been
 Any person who established and operate a blood bank diagnosed as having sexually transmitted disease.
without securing any license to operate or who fails to o "Human Immunodeficiency Virus (HIV)" — refers to the
comply with the standards prescribed virus which causes AIDS.
 Imprisonment: 12 years and 1 day to 20 years o "HIV/AIDS Monitoring" — refers to the documentation and
 Fine: 50,000 to 500,000 analysis of the number of HIV/AIDS infections and the
 The head of the blood bank and the necessary trained pattern of its spread.
personnel under the head’s direct supervision found o "HIV/AIDS Prevention and Control" — refers to measures
responsible for dispensing, transfusing and failing to aimed at protecting non-infected from contracting HIV and
dispose within 48 hours, blood which may have been minimizing the impact of the condition of persons living
proven contaminated with blood transfusion with HIV.
transmissible diseases o "HIV-positive" — refers to the presence of HIV infection as
 Imprisonment: 10 years documented by the presence of HIV or HIV antibodies in the
sample being tested.
Republic Act No. 1517 o "HIV-negative" — denotes the absence of HIV or HIV
antibodies upon HIV testing.
 An act regulating the collection, processing and sale of o "HIV Testing" — refers to any laboratory procedure done on
human blood, and the establishment and operation of an individual to determine the presence or absence of HIV
blood banks and blood processing laboratories infection.
 Repealed by RA 7719 o "HIV Transmission" — refers to the transfer of HIV from one
 Approved: June 16 1956 infected person to an uninfected individual, most commonly
through sexual intercourse, blood transfusion, sharing of
Section 2 intravenous needles and during pregnancy.
 Blood – human blood, processed or unprocessed, o "High-Risk Behavior" — refers to a person's frequent
includes it products and derivatives involvement in certain activities which increase the risk of
 Person – includes corporations, partnerships, transmitting or acquiring HIV.
associates and organizations o "Informed Consent" — refers to the voluntary agreement of
 Cost – the actual purchase of unprocessed blood and a person to undergo or be subjected to a procedure based
its handling charges, such as for its collection, on full information, whether such permission is written,
processing, storage, transportation, and sale, and a conveyed verbally, or expressed indirectly.
reasonable allowance for spoilage o "Medical Confidentiality" — refers to the relationship of
trust and confidence created or existing between a patient
Republic Act No. 8504 or a person with HIV and his attending physician, consulting
medical specialist, nurse, medical technologist and all other
 An act promulgating policies and prescribing measures for health workers or personnel involved in any counselling,
the prevention and control of HIV/AIDS in the Philippines, testing or professional care of the former; it also applies to
instituting a nationwide HIV/AIDS information and any person who, in any official capacity, has acquired or may
educational program, establishing a comprehensive have acquired such confidential information.
HIV/AIDS monitoring system, strengthening the Philippine o "Person with HIV" — refers to an individual whose HIV test
national council and for other purposes indicates, directly or indirectly, that he/she is infected with
 Philippine AIDS Prevention and Control Act of 1998 HIV.
 Approved: February 13 1998 o "Pre-Test Counselling" — refers to the process of providing
an individual information on the biomedical aspects of
Section 3 – Definition of Terms HIV/AIDS and emotional support to any psychological
o Acquired Immune Deficiency Syndrome (AIDS)" — a implications of undergoing HIV testing and the test result
condition characterized by a combination of signs and itself before he/she is subjected to the test.
symptoms, caused by HIV contracted from another person o "Post-Test Counselling" — refers to the process of providing
and which attacks and weakens the body's immune system, risk-reduction information and emotional support to a
making the afflicted individual susceptible to other life- person who submitted to HIV testing at the time that the
threatening infections. test result is released.
o "Anonymous Testing" — refers to an HIV testing procedure o "Prophylactic" — refers to any agent or device used to
whereby the individual being tested does not reveal his/her prevent the transmission of a disease
true identity. An identifying number or symbol is used to o "Sexually Transmitted Diseases" — refers to any disease
substitute for the name and allows the laboratory conducting that may be acquired or passed on through sexual contact.
 o "Voluntary HIV Testing" — refers to HIV testing done on an  It is a diagnostic testing at or near the site of
individual who, after having undergone pre-test counselling, patient care rather than in the clinical lab.
willingly submits himself/herself to such test. 16. Routine tests – the basic, commonly requested tests in
o "Window Period" — refers to the period of time, usually the lab, the results of which are not required to be
lasting from two weeks to six (6) months during which an released immediately upon completion.
infected individual will test "negative" upon HIV testing but 17. Satellite Testing Site – any testing site that performs lab
can actually transmit the infection exams under the administrative control of a licensed
lab, but performed outside the physical confines of that
Article 3 Section 15 – Consent as a requisite for HIV testing lab.
a. A person volunteers or freely agrees to donate his/her 18. STAT tests – tests done on urgent cases
blood, organ, or tissue for transfusion, transplantation,
or research Classification of Clinical Laboratories
b. A person has executed a legacy in accordance with
section 3 of RA no. 7170 or Organ Donation Act of 1991 By ownership
a. Government – operated and maintained partially or
wholly, by the national government, a local
AO 2007-0027 government unit (provincial, city or municipal) or any
other political unit or any department, division, board
 Revised rule and regulations governing the licensure and or agency thereof
regulation of clinical laboratories in the Philippines b. Private – owned, established and operated by any
 Approved: August 22, 2007 individual, corporation, association or organization
By Function
Definition of Terms a. Clinical Pathology – includes clinical chemistry,
1. Applicant – A natural or juridicial person who intends to hematology, immunohematology, microbiology,
operate a clinical laboratory immunology, clinical microscopy, endocrinology,
2. Bureau of Health facilities and Services – Acronym : molecular biology, toxicology and therapeutic drug
BHFS monitoring and other similar discipline
3. Center for Health Development –Acronym : CHD b. Anatomic Pathology – includes surgical pathology,
4. Clinical Laboratory – facility where tests are done on immunohistopathology, cytology, autopsy, forensic
specimens from the human body to obtain information pathology and molecular pathology
about the health status of a patient for the prevention, By Institutional Character
diagnosis and treatment of diseases. a. Institution based – a laboratory that operates within
5. Critical Values – Panic values originally described in by the premises and as part of an institution, such as but
Lundberg as " life threatening" not limited to a hospital, medical clinic, school, medical
6. External Quality Assesment Program – Acronym : EQAP facility for overseas workers and seafarers, birthing
 program where participating laboratories are given homes, psychiatric facility, drug rehabilitation center
unknown samples for analysis b. Free standing – a laboratory that does not form part of
7. Inspection Tool – the checklist used by the regulatory any other institution
officers during inspection visits By Service Capability
8. Institution – A corporate body or establishment 1. General Clinical Laboratory
organized for and educational, medical , charitable, or a. Primary Category
similar purpose  Routine Hematology
9. License – the individual, agency, partnership or  Qualitative Platelet Determination
corporation to whom the license is issued.  Routine Urinalysis
10. License to Operate – Acronym : LTO  Routine Fecalysis
 Also refers to the license  Blood-typing (hospital based)
11. Mobile Clinical Laboratory – A laboratory testing unit b. Secondary Category
that moves from testing site to another testing site, or  Routine Clinical Chemistry
has a temporary testing location  Quantitative Platelet Determination
12. Monitoring Examination – Tests done in series of  Cross - matching
patients as a guide for treatment or follow up of their  Gram staining
condition  KOH (Hospital based)
13. National Reference Laboratory –Acronym : NRL c. Tertiary Category
 Laboratory in a government hospital which had  Special Chemistry
been designed by the DOH to provide special  Special Hematology
functions and services for specific disease areas  Immunology
14. Physician's Office Laboratory – ACRONYM : POL  Microbiology
 It is an individual doctor's office / clinic wherein  Hospital based – aerobic and anaerobic
lab exams are performed  Non hospital based – aerobic or
15. Point of Care Testing –Acronym : POCT anaerobic
d. Limited Service Capability – for institution-based only
 - Provides the laboratory test required for a o Hematology – 3,500
particular service in institutions such as but not
limited to dialysis centers and social hygiene 5. Lung Center of the Philippines (LCP)
clinics  Biochemistry
2. Special Clinical Laboratory – offers highly specialized Price
laboratory services that are usually not provided by a o Clinical Chemistry – 8,000
general clinical laboratory

Penalty
 Laboratory without proper license from DOH
 Imprisonment – not less than 1 month
 Fine – 1,000 – 5,000

DM no. 2009-0086
 Implementation of external quality assessment
program as a regulatory requirement for licensing of
clinical laboratories
 Approved: February 3, 2009
 Amended (2009-086-A): September 26, 2013
 Amended (2009-086-B): September 8, 2014

National Reference Laboratories

1. Research Institute for Tropical Medicine (RITM)
 Dengue
 Influenza
 tuberculosis and other mycobacteria
 malaria and other parasites
 bacterial enteric diseases
 Measles and other viral exanthems
 Mycology
 Enteroviruses
 Antimicrobial resistance and emerging disease
 Confirmatory testing of blood units
Prices:
o Bacteriology, Parasitology, TB – 7,500
o Bacteriology, Parasitology, or TB – 7,500
o Parasitology, TB – 4,200
o Parasitology or TB – 4,200

2. San Lazaro Hospital (SLH)

 HIV/AIDS
 Hepatitis
 Syphilis
 Other STDs
Price
o Serology – 3,500

3. East Avenue Medical Center (EAMC)

 Environmental and occupational health
 Toxicology
 Micronutrient assay
Price:
o Drugtest or toxicology – 1,000

4. National Kidney and Transplant Institute (NKTI)

 Hematology
 Immunohemathology
 Immunopathology
 Anatomic pathology
Price