FAR EASTERN UNIVERSITY- MANILA

Institute of Health Sciences and Nursing

Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

MEDICAL TECHNOLOGY LAWS AND BIOETHICS

REPUBLIC ACT 5527 AND ITS AMMENDMENTS

Republic Act No. 5527 “PHILIPPINE MEICAL TECHNOLOGY ACT OF 1969”

 JUNE 21, 1969

 Signed: Pres. Ferdinand Marcos
o Sen. Gil Puyat
 Medical Technology became profession and professionals.
 USA recognizes MT as professionals as evidenced by it move to place all MT- US migrants under the:
o From 6th preference category (skilled workers) to 3rd (professionals).

AMMENDMENTS ON RA 5527

 RA 6138
o AUGUST 31, 1970
o An act to amend certain sections of RA No. 5527, known as the Philippine Medical Technology Act of
1969
o Section 16: Qualification for Examination
 Added: good health, good moral character, graduated BS Medical Technology or BS Public
Health and Hygiene.
o Section 21: Issuance of Certificate of Registration
 Board passers can receive CoR  21 years of age to be issued.
o Section 22: Fees
 Presidential Decree 498
o June 28, 1974
 Sections 2, 3, 4,7,8,11,13,16,17,21,29
 Presidential Decree 1534
o June 11, 1970
 Sections 3: Council of Medical Technology Education, Its Composition
 Section 8: Qualification of Examiner
 Section 13: Accreditation of Schools of Medical Technology and of Training Laboratory

RA 5527 AMENDMENTS DATE OF APPROVAL SECTIONS AMENDED

RA 6138 08/31/1970 16,21,22
PD 498 06/28/1974 2, 3, 4,7,8,11,13,16,17,21,24
PD1534 06/11/1978 3, 8, 13

MEDICAL TECHNOLOGY LAWS OF 2011

 February 28, 2011

 An Act Regulating and Modernizing the Practice of Medical Technology (Medical Laboratory Science) in
the Philippines.
o Repealing for this purpose: REPUBLIC ACT NOS. 5527 AND 6138 AND PRESIDENTIAL DECREE NOS.
498 AND 1534, and for other purposes.
 House Bill No. 4032
o Cong. Janette Garin (Iloilo)
 Senate Bill No. 2722
o Sen. Eduardo Angara
 Phlebotomy Exam: September
 Medical Technology Exam: May/November
o March/August
 FAR EASTERN UNIVERSITY- MANILA
Institute of Health Sciences and Nursing
Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

Republic Act No. 4688: “CLINICAL LABORATORY ACT OF 1966”

 JUNE 18, 1966

 Also known as Clinical Laboratory Law.
 An act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the
Department of Health, Providing penalty for the violation thereof, and for other purposes.
 AO and EO issued in relation to RA 4688:
o AO 201 s. 1973
o AO 290 s. 1976
o AO 52 s. 1983
o AO 49-B s. 1988
o EO 102 s. 1999 (Redirecting the functions and operations of the DOH)
o AO 59 s. 2001 (Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical
laboratories in the Philippines)
o AO 27 s. 2007 (Revised rules and regulations Governing the Licensure and Regulation of Clinical Laboratories in the
Philippines).

ADMINISTRATIVE ORDER NO.59 SERIES OF 2001

SECTION 5:

 Classification of Clinical Laboratories

o Based on Ownership
o Based on Function
o Based on Institutional Character
o Based on Service Capability

Classification of Laboratories

 By function
o Clinical Pathology- specializes in chemistry, clinical microscopy, microbiologic, immunologic, and hematologic
procedures. Also included are the practices of cytogenetics, toxicology, and therapeutic drug monitoring.
o Anatomic Pathology- diagnosis or confirmation of disease through cellular differentiation in surgical pathology,
cytology, autopsy examination and forensic pathology.

*A pathologist may specialize in either anatomic pathology or clinical pathology or both

 By institutional Character
o Hospital-based lab/ institution based- a laboratory that operates within the premises and as part of an institution,
such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing
home, psychiatric facility, drug rehabilitation center.
o Non-hospital-based lab/ freestanding-a laboratory that does not form part of any other institution.
 By ownership
o Government- operated and maintained, partially or wholly, by the national government, a local government unit
(provincial, city or municipal), any other political unit or any department, division, board, or agency.
o Privately owned, established, and operated by any individual, corporation, association, or organization.

By service capability

 General clinical laboratory

o Primary category
o Secondary category
o Tertiary Category
o Limited-Service Capability
 Mobile Clinical Laboratory
o laboratory testing unit that moves from testing site to another testing site or has a temporary testing location. It shall
have a base laboratory.
 Satellite Testing site
o Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory but
performed outside the physical confines of the laboratory.
 FAR EASTERN UNIVERSITY- MANILA
Institute of Health Sciences and Nursing
Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

WHO CLASSIFICATION OF LABORATORIES BASED ON BIOSAFETY LEVEL

 Biosafety Level 1
 Biosafety Level 2
 Biosafety Level 3
 Biosafety Level 4

PHYSICAL FACILITIES
 Primary= 10 sq.m.
 Secondary= 20 sq.m.
 Tertiary= 60 sq.m
o (To include a separate, enclosed and adequately ventilated room for Microbiology)

ADMINISTRATIVE ORDER NO. 49-B SERIES OF 1988

 Management of the Clinical Laboratory

o A certified pathologist is authorized to manage/supervise or be an associate in not more than four clinical
laboratories/blood banks.
o a physician may be authorized to head only one hospital laboratory.

Department Memorandum Order No. 2009-0086

 Rules and regulations regarding the implementation of internal and external quality control programs as the requirements
for licensing of clinical laboratories in which a clinical laboratory is required to have a Quality Assurance Program.
Department Memorandum Order No. 2009-0086-A
 Requires a clinical laboratory to participate in the National External Quality Assessment Scheme administered by the
designated NRLS.

Republic Act No. 10912 “CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016”

 JULY 21, 2016

 Amendment:
o PRC Resolution No. 2019-1146
 February 7, 2019
 PRC amend parts of its resolution 1032 series of 2017 or the Implementing Rules and Regulations (IRR)
of the CPD Act of 2016.
o CPD Credit Units: value of an amount of learning achieved from formal, informal, non-formal learning.

Republic Act No. 7719: NATIONAL BLOOD SERVICES ACT OF 1994

 MAY 5, 1994
 An act promoting voluntary blood donation providing for an adequate supply of safe blood, regulating blood banks, and
providing penalties for violation thereof.
 Approved by: Fidel V. Ramos

***Blood Donor’s Week: shall be held annually on the 2nd week of July.

REPUBLIC ACT NO. 1517: BLOOD BANKING LAW OF THE PHILIPPINES

o JUNE 12, 1956

o Repealed by RA 7719
o An act regulating the collection, processing and sale of human blood, and the establishment and operation of blood
banks and blood processing laboratories.

Administrative Order no. 2008-0008: Rules and regulations Governing the regulation of Blood Services Facilities
 FAR EASTERN UNIVERSITY- MANILA
Institute of Health Sciences and Nursing
Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

REPUBLIC ACT NO. 8504: PHILIPPINE AIDS PREVENTION AND CONTROL ACT OF 1998

 FEBRUARY 13, 1998

 An act promulgating policies and prescribing measures for the prevention and control of HIV/ AIDS in the Philippines,
instituting a nationwide HIV/AIDS information and educational program, establishing a comprehensive HIV/AIDS monitoring
system, strengthening the Philippine National AIDS council, and for other purposes.
 Pres. Fidel V. Ramos
o ARTICLE I: Education and Information
o ARTICLE II: Safe Practices and Procedures
o ARTICLE III: Testing and Counseling
o ARTICLE IV: Health and Support Services
o ARTICLE V: Monitoring
o ARTICLE VI: Confidentiality
o ARTICLE VII: Discriminatory Acts and Policies
o ARTICLE VIII: The Philippine AIDS Council

Republic Act No. 11166: PHILIPPINE HIV AND AIDS POLICY ACT

 DECEMBER 20, 2018

 Article IV: Screening, Testing and Counseling As a policy , the State shall encourage voluntary HIV testing. Written consent
from the person taking the test must be obtained before HIV testing.

Compulsory HIV Testing shall be allowed only in the following instances:

 When it is necessary to test a person charged with any of the offenses punishable under Articles 264 and 266 on
serious and slight physical injuries, Articles 335 and 338 on rape and simple seduction both of The Revised Penal
Code (RA 3815) and The Anti-Rape Law of 1997 (RA 8553)
 When it is necessary to resolve relevant issues under EO No. 209, otherwise known as "The Family Code of the Philippines."
 As a prerequisite in the donation of blood in compliance with the provisions of the "Organ Donation Act" (RA 7170) and
"National Blood Services Act of 1994" (RA 7719)

Republic Act No. 9165: COMPREHENSIVE DANGEROUS ACT OF 2002

 JUNE 7, 2022
 An act instituting the Comprehensive Dangerous Drugs Act of 2002,
 Repealing RA 6425, aka Dangerous Drugs Act of 1972, as amended, providing funds, therefor, and for other purposes.
o MARCH 30, 1972
 consistent with EO 102 s. 1999 “Redirecting the Functions and Operations of the Department of Health.”

SECTION 5:
Client/ Donor of Drug Testing Laboratories
 Mandatory drug testing
o Applicants for driver’s license
 Repealed by section 19 of RA 10586 (Anti-Drunk and Drugged Driving Act of 2013)
o Applicants for firearm’s license
o Officers and members of the military, police, and other law enforcers.
o Persons charged before the prosecutor’s office with a criminal offense having an imposable penalty of imprisonment
of not less than 6 years and 1 day.
o Candidates for public office whether appointed or elected both in the national or local government.
o Persons apprehended or arrested for violating the provisions of this act.
 Random Drug testing
o Students of secondary and tertiary schools
o Officers and employees of public and private offices whether domestic or overseas
 FAR EASTERN UNIVERSITY- MANILA
Institute of Health Sciences and Nursing
Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

Republic Act No. 9288: NEWBORN SCREENING ACT OF 2004

 APRIL 7, 2004
 An Act promulgating a comprehensive policy and a national system for ensuring newborn screening.
 President Gloria Macapagal Arroyo

PERFORMANCE OF NEWBORN SCREENING

 Newborn screening shall be performed after 24 hours of life but not later than three days from complete delivery of the
newborn.
 A newborn that must be placed in intensive care in order to ensure survival may be exempted from the
 3-day requirement but must be tested by seven days of age.
NEWBORN SCREENING TESTS
1. Congenital Hypothyroidism
2.Congenital Adrenal Hyperplasia
3. Galactosemia
4.Phenylketonuria
5.G6PD Deficiency
6.Maple Syrup Urine Disease-Most common inborn error

DOH Memo 2012-0154 (May 15, 2012): inclusion of MUD in Newborn Screening since it is the most common lEM in the Philippines.

 Implementing Rules and Regulations: OCTOBER 5, 2014

PRESIDENTIAL DECREE 223: CREATION OF PROFESSIONAL REGULATION COMISSION

 June 22, 1973

 AMENDMENTS
o PD 657
o RA 8981

Republic Act No. 8981 “PRC MODERNIZATION ACT OF 2000

 DECEMBER 5, 2000
 An act modernizing the PRC, repealing for the purpose Presidential Decree No. 223, entitled “Creating the Professional
Regulation Commission and Prescribing its Powers and Functions,” and for other purposes.

Republic Act No. 7722: HIGHER EDUCATION ACT OF 1994

 MAY 18, 1994

 An act creating the Commission on Higher Education, Appropriating Funds therefore and for other purposes.
 CMO 14 s 2006
o Policies, standards, and Guidelines for MT Education
 CMO 6 s 2008
o Guidelines for the accreditation of Clinical Laboratories Involved in the training of MT/MLS Interns.
 CMO 13 s 2017
o Latest CMO for MT Education (for K-12 students)

Republic Act No. 7170: ORGAN DONATION ACT OF 1991

 JANUARY 7, 1992
 An act authorizing the legacy or donation of all or part of a human body after death for specified purposes.
 FAR EASTERN UNIVERSITY- MANILA
Institute of Health Sciences and Nursing
Department of Medical Technology
Medical Technology Assessment Program I
JIHRUS MENDOZA | MEDICAL TECHNOLOGY INTERN

Presidential Decree 865: CHAPTER II: WATER SUPPLY

SUMMARY OF MEDICAL TECHNOLOGY LAWS

LAW Date Approved: Amendments
RA 7170 ORGAN DONATION ACT January 7, 1992
RA 8504 PHILIPPNE AIDS PREVENTION & CONTROL ACT February 13, 1998
RA 11215 NATIONAL INTEGRATED CANCER CONTROL ACT February 14, 2019
RA 11223 UNIVERSAL HEALTH CARE LAW February 20, 2019
Senate Bill 2722 MEDICAL TECHNOLOGY LAW OF 2011 February 28, 2011
RA 6425 DANGEROUS DRUGS ACT OF 1972 March 30, 1972 Repealing RA 9165
DOH MEMO. 2012-0154:
RA 9288 NEWBORN SCREENING ACT OF 2004 April 7, 2004 MAY 5, 2012
IRR: October 5, 2014
RA 7719 NATIONAL BLOOD SERVICES ACT OF1994 May 5, 1994
RA 7711 HIGHER EDUCATION ACT May 18, 1194
RA 9482 ANTI-RABIES ACT May 25, 2007
RA 9165 COMPREHENSIVE DANGEROUS DRUGS ACT June 7, 2002 RA 6425: March 30, 1972
RA 1517 BLOOD BANKING LAW OF THE PHILIPPINES June 12, 1956
RA 4688 CLINICAL LABORATORY ACT OF 1966 June 18, 1986
MANDATORY INFANTS AND CHILDREN HEALTH
RA 10152 June 21, 2011
IMMUNIZATION ACT
RA6138: 08/31/70
RA 5527 PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969 June 21, 1969 PD 498: 06/28/1974
PD 1534: 06/11/1978
RA 10912 CONTINUING PROFESSIONAL DEVELOPMENT ACT July 21, 2016
PRC Resolution No. 2019-
1146: February 7, 2019
TOXIC SUBSTANCES, HAZARDOUS WASTES AND
RA 6969 October 16, 1990
NUCLEAR WASTES CONTROL ACT
RA 8981 PRC MODERNIZATION ACT December 5, 2000
RA 11166 THE PHILIPPINE HIV AND AIDS POLICY LAW December 18, 2018