MEDICAL TECHNOLOGY LAWS

(MARIA ABIGAIL M. HERNANDEZ, RMT,MPH)

R.A: 5527: PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969

SECTION 1: TITLE
SECTION 2: DEFINITION OF TERMS

Pathologist: A duly registered physician who is specially trained in methods of laboratory medicine, or the
gross and microscopic study and interpretation of issues, secretion and excretions of the human body
and its functions in order to diagnose disease, follow its course, determine the effectivity of treatment.
ascertain cause of death and advance medicine by means of research.

Medical Technologist: A person who engages in the work of medical technology under the supervision of
a pathologist or licensed physician authorized by the Department of Heal in places where there is no
pathologist and who having passed the prescribed course (Bachelor of Science in Medical
Technology/Bachelor of Science in Hygiene) of training and examination is registered under the provision
of this Act.

Medical Laboratory Technicians: A person certified and registered with the Board as qualified to assist a
medical technologist and/or qualified pathologist in the practice of medical technology as defined in this
Act.

SECTION 3: COUNCIL OF MEDICAL TECHNOLOGY EDUCATION, ITS COMPOSITION

Chairman: Director ot Higher Education
Vice Chairman: PRC chairman
Members

SECTION 4: COMPENSATION AND TRAVELLING EXPENSES OF COUNCIL MEMBERS

SECTION 5: FUNCTIONS OF THE COUNCIL OF MEDICAL TECHNOLOGY EDUCATION

-To recommend the minimum required curriculum for the course of medical technology.
-To determine and prescribe the number of students to be allowed to take up the medical technology
course in each school, taking into account the student-instructor ratio and the availability of facilities for
instruction.
-To approve medical technology schools meeting the requirements and recommend closure of those
found to be substandard.
-To require all medical technology schools to submit an annual report, including the total number of
students and instructors, list of facilities available for instruction, a list of their recent graduates and new
admissions, on or before the month of June.
-To inspect. when necessary, the different medical technology schools in the country in order to determine
whether a high standard of education is maintained in said institutions.
-To certify for admission in to an undergraduate internship, student who have satisfactorily completed three
years of the medical technology course or its equivalent and to collect from said student the amount of
five pesos each which money accrue to the operating fund of the Council.
-Formulate and recommend approval of refresher course for applicants who shall have failed the Board
Examination for the third time.
-To promulgate and prescribe and enforce necessary rules and regulations for the proper implementation
of the foregoing functions

SECTION 6: MINIMUM REQUIRED COURSE

-The medical technology course shall be at least four years, including a 12-month satisfactory internship in
accredited laboratories
-The Council is hereby authorized, subject to the approval of the Secretary of Education to change,
remove from or add to the subjects listed above as the needs and demands of progress in the science of
medical technology may require.
SECTION 7: MEDICAL TECHNOLOGY BOARD
Appointed by the President of the Republic of the Philippines upon recommendation of the Professional
Chairman:
Members:
The Chairman and members of the Board shall hold office for three (3) years after appointments or until
their successors shall have been appointed and duly qualified

SECTION B: QUALIFICATIONS OF EXAMINERS

1. A Filipino citizen
2. Of good moral character
3. A qualified Pathologist, or a duly registered medical technologist of the Philippines with the degree of
Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene/Public Health
4. Has been in practice of laboratory medicine or medical technology at least ten years prior to his appointment
5. Not a member of the faculty of any medical technology school for at least two (2) years prior to
appointment or having any pecuniary interest direct or indirect in such institution: Provided, however, That
for the first three years following the approval of this Act, the requirements mentioned in number four (4)
shall be reduced to five years.

SECTION 9: EXECUTIVE OFFICER OF THE BOARD

SECTION 10: COMPENSATION OF MEMBERS OF THE BOARD OF EXAMINERS FOR MEDICAL

TECHNOLOGY

SECTION 11: FUNCTIONS AND DUTIES OF THE BOARD

-Administer the provisions of this Act;
-Administer oaths in connection with the administration of this Act;
-Issue, suspend and revoke certificates of registration for the practice of medical technology and medical
laboratory technician;
-Look into conditions affecting the practice of medical technology in the Philippines and, whenever
necessary, adopt such a measure may be deemed proper for the maintenance of good ethic and
standards in the praclice of medical technology;
-Investigate such violations of this Act or of the rules and regulations issued thereunder as may come to
the knowledge of the Board and, for this purpose issue subpoena and subpoena duces tecum to secure
appearance of witnesses and production of documents in connection with charges presented to the
Board; and
-Draft such rules and regulations as may be necessary to carry out the provisions of this Act: Provided, that
the same shall be issued only after the approval of the President of the Philippines
-To determine the adequacy of the technical staff of all clinical laboratories and blood banks before they
could be licensed with the Department of Health in accordance with R.A. No. 4655 and 1517:
-To prescribe the qualifications and training of medical technologists as to special fields of the profession
and supervise their specialty examination conducted by the professional organization of medical
technologists accredited by the Professional Regulation Commission;
-To classify and prescribe the qualification and training of the technical staff of clinical laboratories as to:
Medical Technology: Medical Technologist: Senior Medical Technologist; Medical Technologist and
Medical Laboratory Technician.

SECTION 12: REMOVAL OF BOARD MEMBERS

-Any member of the Board may be removed by the President of the Philippines for neglect of duty,
incompetency, malpractice or unprofessional, unethical, immoral or dishonorable conduct after having
been given opportunity to defend himself in a proper and administrative investigation
-Provided, that during the process of investigation, the President shall have the power to suspend such
member under investigation and appoint a temporary member in his place.
SECTION 13: ACCREDITATION OF SCHOOLS OF MEDICAL TECHNOLOGY AND OF TRAINING
LABORATORIES
Approval of training laboratories:
Approval of schools for Medical Technology:

SECTION 14: INHIBITION AGAINST THE PRACTICE OF MEDICAL TECHNOLOGY

No person shall practice or offer to practice medical technology as defined in this Act without having
previously obfained a valid certilicate of registration from the Board provided that registration shall not
be required of the following:
1. Duly registered physicians.
2. Medical technologist from other countries called in for consultation or as visiting or exchange
professors to colleges or universities: Provided, they are only practicing the said funetion.
3. Medical technologists in the service of the United States Armed Forces stationed in the Philippines
rendering services as such for members of the said forces only.

SECTION 15 EXAMINATION
-Except as otherwise specifically allowed under the provision of lhis Act, all applicants for registration as
medical fechnologist shall be required to undergo written examination
-Written notices of such examination shall be published in al least three newspapers of national circulation
by the Secretary of lhe Board of least thirty days prior to the date of examination.

SECTION 16: QUALIFICATION FOR EXAMINATION

Every applicant examination under this Act, shall prior to the date thereof, furnish the Board satisfactory
Proof that he or she
1. is in good health and is of good moral character:
2. Has completed a course of at least four (4) years leading to the degree of Bachelor of Science in
Medical Technology or Bachelor of Science in Public Health conferred by a recognized school,
college or university in accordance with this Decree
3.Or having graduated from some other profession and has been actually performing medical
technology for he last five (5) years prior to the date of lhe examinations, if such performance began
prior to June 21. 1969.

SECTION 17: SCOPE OF EXAMINATION

The Board shall prepare the schedule of subjects for examination and to submit the same to the
Commissioner of the Professional Regulation Commission for publication at least thirty (30) days before the
date of examination

SECTION 18: REPORT OF RATING

SECTION 19: RATING IN THE EXAMINATION

In order to pass the examination
1.must obtain a general average of at least seventy-five percent in the written test
2.no rating below fifty percent in any of the major subjects
3. not failed in at least sixty percent of the subjects computed according to their relative weights

SECTION 20: OATH TAKING

SECTION 21: ISSUANCE OF CERTIFICATE OF REGISTRATION
-Every applicant who has satisfactorily passed the required examination for medical technologist shall be
issued a certificate of registration
-No such cerlificate shall be issued to any successful applicant who has not attained the age of twenty-
one (21) years.
-All certificates shall be signed by the members of the Board and by the Commissioner of the Professional
Regulation Commission.
-The Board shall likewise issue a certificate of registration as medical laboratory technician without
examination to any person who show evidence satisfactory to the Board that:
1. He or she passed the civil service examination for medical technician given on March 21, 1964
2.Has finished a two-year college course and has at least one (1) year of experience as medical
laboratory technician. Provided, that for every year of deficiency in college attainment two (2) years
of experience may be substituted
3. An applicant who has at least ten (10) years of experience as medical laboratory technician as of the
date of approval of this Decree regardless of his academic attainment may qualify for registration
without examination
4. Has failed to pass the board examination for medical technology but had obtained a general rating
of at least 70%.

SECTION 22: FEES

SECTION 23: REFUSAL TO ISSUE CERTIFICATE

The Board shall refuse to issue a certificate of registration to any person convicted by the court of
competent jurisdiction of any criminal offense involving moral turpitude, or any person guilly of immoral
or dishonorable conduct, or of unsound mind, or incurable communicable disease, and in such shall be
given to the applicant a written statement setting forth the reason for its action, which statement shall be
incorporated in the record of the Board.

SECTION 24: ADMINISTRATIVE INVESTIGATION-REVOCATION OR SUSPENSION OF

CERTIFICATES
Administralive Investigation shal be conducted by al least Iwo members o the bourd wilh one legal
officer sitting during all gdministrative proceedings.

SECTION 25: APPEAL

-The revocation or suspension of a certificate made by the Board shall be subject to appeal to the Civil
Service Commissioner whose decision shall become final thirty days after its promulgation. unless the
respondent within the same period has appealed to the office of the President of the Philippines

SECTION 26: REINSTATEMENT, REISSUE OR REPLACEMENT OF CERTIFICATE

-The Board may, Upon applicalion and for reason deerned proper and sufficient, reissue any revoked
registration certificale,
-The suspension of a certificate shall be re-issued to the medical technologist concerned upon request
without prejudice to further actions by the Board for violation of the provisions of this Act or conditions
imposed by the Board upon the medical technologist during the period of suspension.

SECTION 27: FOREIGN RECIPROCITY

No foreigner shall be admitted to examination, or be given a certificate of registration or be entilled to
any of the rights and privileges under this Act, unless the country or state of which he is a subject or citizen
permits Filipino Medical Technologist to practice within its temitorial limits on the same as the subject or
citizens of said country or state,

SECTION 28: ROSTER OF MEDICAL TECHNOLOGIST

A roster of Medical Technologist shall be prepared annually by the Secretary of the Board
This roster shall contain the name, address and citizenship of each registered Medical Technologist, date
of registration or issuance of certificate, and other data which in the opinion of the Board are pertinent

SECTION 29: PENAL PROVISIONS

Without prejudice to the pravision of the Medical Act of 1959 as amended relating to illegal practice of
Medicine, the following shall be punished by a fine of not less than two thousand pesos nor more than five
thousand pesos, or imprisonment for not less than six months nor more than two years, or both, in the
discretion of the court:
1. Any person who shall practice Medical Technology in the Philippines without being registered or
exempted from registration in accordance with the provisions of this Act:
2.Any medical technologist, even if duly registered, who shall practice medical technology in the
Philippines without the necessary supervision of a qualified pathologist or physician authorized by the
Department of Health:
3. Any medical technologist who shall knowingly make a fraudulent laboratory report;
4.Any duly registered medical technologist who shall refuse or fail, after due warning by the Board to
display his certificate o registration in the place where he works;
5.Any person presenting or attempting to use as his own, the certificate of registration of another:
6. Any person who shall give any false or fraudulent evidence of any kind to the Board or any member
thereof in obtaining a certificate of registration as Medical Technologist;
7.Any person who shall impersonate any registrant of like or the same name;
8. Any person who shall attempt to use a revoked or suspended certificate of registration;
9. Any person who shall in connection with his name or otherwise, assume, use or advertise any title or
description tending to convey the impression that he is a Medical Technologist without holding a valid
cerlificate of registration;
10. Any person or corporate body who shall allow anyone in his employ who is not a registered medical
technologist/medical laboratory technician to engage in the practice of medical technology or
recommend for appointment anyone to the position of medical technologist/medical laboratory
technician knowing that he is not registered as such.
11. Any person or corporate body who shall violate the rules and regulations of the Board or orders
promulgated by it after having been duly approved and issued by the President of the Philippines
upon recommendation of the Commissioner of Civil Service for the purpose of carrying out the
provisions of this Act.

SECTION 30: SEPARABILITY CLAUSE

SECTION 31: REPEALING CLAUSE

SECTION 32: EFFECTIVITY

Date of effectivity: June 21, 1969
Signed by:. Ferdinand E. Marcos

RA5527 AMENDMENTS
AMMENDMENTS DATE OF APPROVAL SECTIONS AMENDED
RA6138 AUG. 31, 1970 16,21,22
PD 498 JUNE 28, 1974 2,3,4,7,8,11,13,16,17,21,24
RA 1534 JUNE 11, 1978 3,8,13

SENATE BILL 2722: MEDICAL TECHNOLOGY ACT OF 2011

An Act Regulating and Modernizing the practice of Medical Technology (Medical Laboratory Science) in the
Philippines, Repealing for this purpose Republic Act Nos. 5572 and 6132 and Presidential Decree Nos. 498 and
1534 and for other purposes.

Filed on: Feb 8, 2011

Author: Senator Edgardo J. Angara

RA 4688: CLINICAL LABORATORY ACT OF 1966

Also known as the Clinical Laboratory Law
-the act was piut into effect to regulate the operation and maintenance of clinical laboratories and to require their
registration with the DOH, providing penalty for violation thereof and other purposes
-effectivity date: June 18, 1966
Classification of Clinical Laboratories
1. Based on Ownership
2. Based on Function
3. Based on Institutional Character
4. Based on Service Capability

CATEGORIES OF GENERAL LABORATORY

1. Primary
2. Secondary
3. Tertiary
4. Limited service capability

WHO CLASSIFICATION OF LABORATORIES BASED ON BIOSAFETY LEVEL

1. Biosafety Level 1
2. Biosafet Level 2
3. Biosafety Level 3
4. Biosafety Level 4

A.O. NO 49-B SERIES OF 1988

Management of the Clinical Laboratory:
-a certified pathologist is authorized to manage/supervise or be an associate in not more than four clinical
laboratories/blood banks
-a physician may be authorized to head only one hospital laboratory

Laboratory Personnel
-a medical technologist can supervise the work of only two medical laboratory technicians at one time

Reporting
- All laboratory requests shall be considered as consultations between the requesting physicion and the
pathologist of the laboratory. As such shall be considered as consultation reports and shall bear the name
of the Pathologist or his associale.
-No person in clinical laboratory shall issue a report, orally or in wiling whole or portions thereof without a
directive from the palhologist or his aulhorized representalive except in emergencies when the results
may be released as authorized by the pathologist

Recording
-All laboratory requests and reports shall be kept on file for at least one year provided the original report is
on file in the patient's medical records.
-Records of anatomic and forensic pathology should be kept permanently in the laboratory.

Exhibition of Certificate of Approval and License and the Rules and Regulations:
-The license of the clinical laboratory must be placed in a conspicuous place within the laboratory.
-The physician who heads the laboratory must likewise place his certificate of proficiency in the specially.
A copy of the rules and regulation should be readily available for guidance to all staff and personnel in
the laboratory.

A.O. No. 59 Series of 2001

Policies:
-An approved permit to construct and design lay-out of a clinical laboratory shall be secured from the
BHFS prior to submission of an application for Petition to Operate.
-No clinical laboratory shall be constructed unless plans have been approved and construction perrit is
issued by the BHFS.
Requirements and Procedures for Application of Permit to Construct and License to Operate
APPLICATION FOR PERMIT TO CONSTRUCT
-Letter of application to the director of BHFS
-Four (4) sets of sited developmental plans and floor plans approved by an architect and/or engineer
-DTI/SEC registration (for private clinical laboratory)

APPLICATION FOR NEW LICENSE

-A duly notarized application form "Petition to Establish, Operate and Maintain a Clinical Laboratory" shall
be filed by the owner or his duly authorized representative at the BHFS.
-A BRL inspector shall, upon the receipt of the application, inspect within (0 Days_ the establishment
and verify if the applicant has complied with the requirements prescribed in these regulations

APPLICATION FOR RENEWAL OF LICENSE

-A duly notarized application form "Application for Renewal of License to Establish, Operate and Maintain
a Clinical Laboratory" shall be filed by the owner or his duly authorized representative at the respective
CHD.
-Application must be filed within 90 davs before the expiry date of the license.

Terms and Conditions of License

-The license is granted upon compliance with the licensing requirements and is non-transferable.
-any clinical laboratory desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in
writing at least 15 days before actual transfer
-an extension laboratory shall have a separate license

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

R.A. 7719: NATIONAL BLOOD SERVICES ACT OF 1994

An act promoting voluntary blood donation providing for an adequate supply of safe blood, regulating
blood banks, and providing penalties for violation thereof.
Effectivity date: May 5, 1994

Blood Station (BS)

-Advocacy and promotion of voluntary blood donation and healthy lifestyle
-Provision of whole blood and packed red cells
-Storage, issuance, transport and distribution of whole blood and packed red cells
-Compatibility testing of red cell units, if hospital based

Blood Collection Unit (BCU)

-Advocacy and promotion of voluntary blood donation and healthy lifestvle
-Recruitment, retention, and care of voluntary blood donors
-Conduct health education and counseling services
-Collection of blood (mobile or facility-based) from qualified voluntary blood donors
-Transport of blood to BC for testing and processing
-Compatibility testing of red cell units, if hospital-based
BCU/BS
-All services stipulated under BU and BS

Blood Bank (BB)

-Advocacy and promolion of voluntary blood donation and healthy lileslyle
-Storage and issuance of whole blood and blead components obtained from c BE
-The following services shall also be provided:
1.Compalibility testing of red cell units
2.Direct Coomb's Test
3.Red Cell Antibody Screening
4.Investigation of Transfusion Reactions
5. Assist the Hospital Blood Transfusion Committee (HTC) in the conduct of post- transfusion surveillance
(hemovigilance)

R.A. 9288: NEWBORN SCREENING ACT OF 2004

Effectivity date: April 7. 2004

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.

P.D. 223: CREATION OF PROFESSIONAL REGULATION COMMISSION

June 22, 1973
Amendments
PD 657
Ra8981
Composition (Appointed by the President)
Chairperson
Commissioner (2)
Term of Office: 7 years
Qualifications:
1. At least 40 years old
2. With a valid license/COR
3. Familiar with principles and methods of the PRC
4. At least 5 years executive/management experience
5. One commissioner must be a past chairman or member of Professional Regulatory Board

R.A. 11166: Philippine HIV and AIDS Policy Act

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.\
HIV Testing must be made available under the following circumstances:
-If the person is IS to below 18 years of age, consent to voluntary HIV testing shall be obtained
from the child without the need of conseni from a parent or guardian
-Any young person aged below 15 who is pregnant or engaged in high-risk behavior shall be
eligible for HIV testing and counseling, with the assistance o a licensed social worker or health
worker. Consent shall be obtained from the child without the need of consent from parent of
guardian
-Consent to voluntary HIV testing shall be obtained from the child" s parent or legal guardian if
the person is below 15 years of age or is mentally incapacitated.
-In cases when the child's parent or legal guardian cannot be located despite reasonable
efforts, or if the child's parents or legal guardian refuse to give consent, it shall be obtained from
a licensed social worker or health worker, the assent of the minor must also be required prior to
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 E No. 209, otherwise known as
"The FamilyCode of the Philippines"
-As a prerequisite in the donation of blood in compliance with the provisions of the
"OrganDonation Act" (RA 7170) and "National Blood Services Act of 1994" (RA 7719)

Article VI: Confidentiality

Confidential HIV and AIDS information may be released by HIV testing facilities without consent in
the following instances:
-When complying with reportorial requirements of the national active passive surveillance system
of the DOH: Provided, the information related to a person's identity shall remain confidential

-When informing other health workers directly involved in the treatment or care of a PLHIV.
Provided, that such worker shall be required to perform the duty of shared medical confidentiality

- When responding to a subpoena duces tecum and subpoena as testificandum issued by a court
with jurisdiction over a legal proceeding where the main issue is the HIV status of an individual.
Provided, that the confidential medical record, after having been verified for accuracy by the
head of the office or department, shall remain anonymous and shall be properly sealed by its
lawful custodian, hand delivered to the court, and personally opened by the judge: Provided
further, that the judicial proceedings be held in executive session.

Disclosure of HIV-Related Test Results

The result of any test related to HIV Shall be disclosed by the trained service provider who conducls
Prelest and post- est counseling only to the individual who submilled to he test:

The result may be disclosed to eilher of the patient' & parents, legal guardian, or a duly assigned
licensed social worker or health worker only:
-If the patient is below 15 years of age
-An orphan
-Mentally Incapacitated

CURRENT HIV TESTING ALGORITH IN THE PHILIPPINES

-The current HIV Testing diagnosiic algorithm in the Philippines include screening test from referring labs
-A reactive result from the screening test will be sent to SACCL for confirmatory testing, where 2 parallel
screening tests are performed
-A reactive resull on either of these tests will then require Western blot and/or nuclei acid test supplemental
confirmatory test
SUMMARY OF OTHER RELATED LAWS
RA 11223 UNIVERSAL HEALTH CARE FEB 20, 2019
LAW
RA 11215 NATIONAL INTEGRATED FEB 14, 2019
CANCER CONTROL ACT
RA 11166 THE PHILIPPINE HIV AND DEC 20, 2018
AIDS POLICY LAW
RA 10912 CONTINUING JULY 21, 2016
PROFESSIONAL
DEVELOPMENT ACT
RA1517 BLOOD BANKING LAW OF JUNE 16, 1956
THE PHILIPPINES
RA 9165 COMPREHENSIVE JUNE 7, 2002
DANGEROUS DRUGS ACT
RA 10152 MANDATORY INFANTS AND JUNE 21, 2011
CHILDREN HEALTH
IMMUNIZATION ACT
RA 8981 PRC MODERNIZATION ACT DEC 5, 2000
RA 8504 PHILIPPINE AIDS FEB 13, 1998
PREVENTION AND CONTROL
ACT
RA 7170 ORGAN DONATION ACT JANUARY 7, 1992
RA 6969 TOXIC SUBSTANCES, OCTOBER 26, 1990
HAZARDOUS WASTES AND
NUCLEAR WASTES
CONTROL ACT
RA 9482 ANTI-RABIES ACT MAY 25, 2007
RA 7711 HIGHER EDUCATION ACT MAY 18, 1994