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HISTORY OF MT LAWS Ebers Papyrus

MEDICAL TECHNOLOGY • A book for treatment of diseases contains


description of the three stages of hookworm
Ruth Heinemann infection.
• The application of principles of natural, physical
and biological sciences to the performance of
laboratory procedures which aid in the diagnosis Ruth Williams
and treatment of diseases.
• A medical technologist
• Believes that medical technology began from the
medieval period (1096-1438) as supported by the
Anne Fagelson (1961) fact that urinalysis was a fad
• The branch of medicine concerned with the • Early Hindu doctors made the scientific
performance of laboratory determinations and observation that the urine of certain individuals
analysis used in the diagnosis and treatment of attract ants and that such urine has a sweetish
diseases and maintenance of health taste
• QUACKS, calling themselves doctors reaped
fortunes from diagnosing diseases by the
appearance of the urine.
Philippine Medical Technology Act

• An auxiliary branch of laboratory medicine which


deals with the examination of various chemical, Anne Fagelson
microscopic, bacteriologic, and other medical
procedures, technique which will aid the • Prefers to date medical technology from the 14th
physician in the diagnosis, study and treatment of century when a prominent Italian physician at the
disease and in the promotion of health in general. University of Bologna employed one, Alessandra
Giliani to perform tasks now under the domain of
the medical technology
• Unfortunately, this young lady died from a
HISTORY OF MEDICAL TECHNOLOGY
laboratory acquired infection
• In the year 460 B.C. when the Greek physician
Hippocrates also known as the father of medicine
formulated the famous Hippocratic Oath, the Antonie Van Leeuwenhoek (1632-1723)
code of ethics for practicing physicians.
Hippocrates described four “humors” or body • Invented and improved the compound
fluids in man (blood, phlegm, yellow bile and microscope
black bile) • The first to describe red blood cell, to see
• These four humors or body fluids were felt to be protozoa, and to classify bacteria according to
the source of a person’s disposition and disease shape
in ancient times. • Invention of the microscope led to the rapid
progress of microbiology and pathology

Hindu Physician (600 BC)


Marcelo Malphigi (1628-1694)
- Polyuria in diabetes was noted
• Described as the greatest of the early
microscopist
Vivian Herrick • His work on embryology and anatomy definitely
marked him as the “Founder of Pathology”
• Traces the beginning of medical technology back
to 1500 BC when intestinal parasites such as
“taenia” and “ascaris” were mentioned in early Rudolph Virchow
writings.
• One of the youngest medical specialists
• Founded the archives of pathology in Berlin in
1847
1915

Hermann Fehling The state legislature of Pennsylvania enacted a law


acquiring all hospitals and institutions to have an
• Performed the first quantitative test in urine sugar adequate laboratory and to employ a full-time laboratory
in 1848 technician

Middle of 15th Century WORLD WAR 1


• Aniline Dyes were used in staining • It was an impact factor in the growth of clinical
microorganisms laboratory and produced a great demand for
• Bacterial staining and microscopic study on technicians
bacteria were made possible • The demand for technicians in clinical
laboratories continued, so practicing physicians
with knowledge on laboratory works began to
ESTABLISHMENT OF LABORATORIES teach their assistants to do some of the tests for
them

FIRST CHEMICAL LABORATORY


UNIVERSITY OF MINNESOTA
• Established at the University of Michigan by Dr.
Douglas • One of the first schools for training laboratory
• Dr. Douglas pioneered laboratory instruction in workers was established here
this well-equipped laboratory • A course bulletin entitles “Courses in Medical
Technology for Clinical and Laboratory
Technicians” was issued in 1992
1878 • They were the first to offer a degree level program
in 1923
Dr. William H. Welch

• Established another laboratory at the BELLEVUE


HOSPITAL MEDICAL COLLEGE 1931
• He gave the first laboratory course in pathology • Denver Society of Clinical Pathologists were
offered in American Medical School organized

1885 1936
• Dr. Welch became the first professor of pathology • American Board of Pathology established
at John Hopkins University

HISTORY OF MEDICAL TECHNOLOGY IN THE


FIRST CLINICAL LABORATORY PHILIPPINES
• Opened in 1896 at JOHN HOPKINS HOSPITAL
by Dr. William Osler
• In this laboratory, routine examinations were • Medical technology practice was introduced by
carried out, special attention being given to the the 26th Medical Infantry of the 6th US Army
search for malarial parasites in the blood
• A clinical laboratory was also opened at the
University of Pennsylvania in 1896 (William First Clinical Laboratory
Pepper Laboratory)
• Quiricada St. Sta. Cruz, Manila (Manila Public
Health)
• The lab offered training program to high school
graduates as early as February 1944
1943 S.Y. 1957-1958

• The US ARMY left in June - Dr. Antonio Gabriel and Gustavo Reyes of the
• Endorsed it to the National Department of Health Faculty of Pharmacy, University of Sto. Tomas
• The Department rendered the laboratory non- offered medical technology as an elective subject to
functional for sometime 4th and 5th year B.S. Pharmacy students

- Rev. Fr. Lorenzo Rodriguez decided to offer it as a


course because of the popularity of medical
Dr. Pio De Roda technology among pharmacy students
• One of the staffs of the clinical laboratory
• Organized Manila Public Health Laboratory from
the remnants of the deserted laboratory June 17, 1957

October 1, 1945 • Temporary permit was issued by the Department


of Education, for first to third year students
• With Dr. Mariano Icasiano as his assistant and
who was then the Manila City Health Officer
reopened Manila Public Laboratory

POST GRADUATE STUDIES


1947

Dr. Pio De Roda and Dr. Prudencia Sta. Ana


• Offered to BS Medical Technology graduates
• Training of high school graduates to work as MS in Medical Technology
medical technicians
• No period of training was set and no certificates • UST Graduate School
were given • Philippine Women’s University
• Manila Central University

MS in Public Health (one-year, non-thesis degree)


1954
• University of the Philippines
• A 6 months laboratory training with certificate
upon completion was given to the trainees
• Dr. Sta. Ana prepared the syllabus for the training
program June 1960

- The permit for the internship program was issued

Mrs. Willa Hilgert Hedrick

- Founder of Medical Technology Education in the June 14, 1961


Philippines - Full recognition of the 4-year B.S. Medical
- American medical practitioner and missionary of Technology course was given
Seventh Day Adventist Church of the Philippines.

1954
1962
- The first BS degree course in Medical
Technology was offered by the Philippine Union - CEU produced its 1st batch of BSMT graduates
College and manila Sanitarium through the effort of Mrs. Purificacion Sunico-
Suaco and approved by CEU President Carmen
1956 de Luna
- PUC produced its first graduate, Dr. Jesse Umali,
now a successful OB-Gynecologist.
• Many schools followed to offer BS Medical
Technology
• DECS and CHED – 47 colleges and universities
offering the course
University of the Philippines

- Offers a similar course but the degree being


conferred in BS Public Health

July 5, 1962

- Bureau of Education approved the BSMT course


in FEU thru the efforts of Dr. Horacio A. Ylagan
and Dr. Serafin Juliano approved by Dean IM Dr.
Lauro H. Panganiban and Secretary of IM, Dr.
Jesus B. Nolasco

1963

- Produced its 1st batch of BSMT graduates

1982

- SPC offered BSMT course CHED memo #14


series of 2006 (BSMLS)
PHILIPPINE ASSOCIATION OF SCHOOLS OF MEDICAL TECHNOLOGY & PUBLIC HEALTH (PASMETH)

- Is the national organization of all recognized schools of Medical Technology in the Philippines. It was formed in
1970 in the hopes of maintaining the highest standards for Medical Technology/Public Health education and to
foster closer relations among these schools

On May 13, 1970, director Narciso Albarracin appointed Dr. Serafin Juliano and Dr. Gustavo U. Reyes to organize an
association of deans of schools of Medical Technology and Hygiene. The first organizational meeting was held at the
University of Sto. Tomas on June 22, 1970. The first sets of officers were:

President - Dr. Gustavo Reyes

Vice President - Dr. Serafin Juliano

Secretary/Treasurer - Dr. Velia Trinidad

Public Relations Officer - Dr. Faustino Sunico

The first annual meeting was held at the Universitry of Sto. Tomas on May 17,1971. The first set of officers was reelected
for a second term on April 30, 1972. For the school year 1972-1973, the elected officers were:

President - Dr. Gustavo Reyes

Vice President - Dr. Claro Cabrera

Secretary/Treasurer - Dr. Elvira Silva

Public Relations Officer - Dr. Faustino Sunico

Others who served as PASMETH presidents were:

Dr. Ibarra Panopio (1973-1974) Velez College

Dr. Angelita G. Adeva (1974-1977) UST

Dr. Elizabeth M. Del Rio (1977-1980) Martinez Memorial College

Dr. Gustavo Reyes (1980-1981) UST

Dr. Claro D. Cabrera (1981-1982) UST

Dr. Elizabeth M. Del Rio (1982-1983) Martinez Memorial College

Dr. Norma V. Lerma (1983-1984) UST

Dr. Vicencio T. Torres (1984-1985) Univ of Luzon

Prof. Nardito Moraleta (1985-1988) FEU

Dean Norma N. Chang (1988-1995) San Juan de Dios Educ. Foundation Inc

Prof. Rodolfo R. Rabor (1996-2000) UST

Dean Nini F. Lim (2000-2002) PWU

Dean Zenaida C. Cajucom (2002-2010) World Citi Colleges

Dean Mgadalena F. Natividad (2010-2012) FEU

Dean Bernard U. Ebuen (2012-present) Arellano University


It was formally registered with the Securities and Exchange Commission on October 6, 1985 thru the Committee on
Legislation chaired by Mr. Cirilo S. Cajucom with the help of a legal counsel, Atty. Dexter Bihis.

PHILIPPINE ASSOCIATION OF MEDICAL TECHNOLOGISTS (PAMET)

- Is a non-stock, non-profit organization


- It was originally organized on September 15, 1963 by Mr. Crisanto G. Almario at the Public Health Laboratory in
Sta. Cruz, Manila

It has its fist convention and election of officers on September 20,1964 at the FEU wherein Mr. Charlemagne Tamondong
became the first president.

Mr. Crisanto G. Almario

- Father of PAMET

It was incorporated and registered at the Securities and Exchange Commission on October 14, 1969 with Reg. No. 39570
during the presidency of Mr. Nardito D. Moraleta

June 21, 1969

- RA 5527 also known as the Philippine Medical Technology Act was enacted into law

June 22, 1973

- P.D.223 was approved creating the Professional Regulation Commission (PRC).


- PAMET was officially recognized as the only Accredited Professional organization (APO) of registered Medical
Technologists in the Philippines

PAMET is national body with 46 chapters nationwide totaling to more than 12,000 members

PAMET is affiliated with other local professional associations namely Council of Professional Health Associations (COPHA),
Philippine Federation of Professional Associations (PFPA), Council of Health agencies (CHAP) and Philippine Council for
Quality Assurance in Clinical Laboratories (PCQACL).

PAMET PRESIDENT YEAR THEME


Charlemagne T. Tamondong 1963-1967 Emergence of the Profession
Nardito D. Moraleta 1967-1970 Professional Recognition
Felix E. Asprer 1970-1971, 1973-1977 Legislative Agenda
Bernardo T. Tabaosares 1971-1973 Celebration of the Profession
Angelina R. Jose 1973 Career Advocacy
Venerable C.V. Oca 1977-1981 Educational Enhancement
Carmencita P. Acedera 1982-1991 Image Building
Marilyn R. Atienza 1992-1996 Proactivism
Norma N. Chang 1997-2000 International Leadership
Agnes B. Medenilla 2001-2002, 2005-2006 Organizational Dynamism
Shirley F. Cruzada 2003-2004 Interdisciplinary Networking
Leila M. Florento 2007-2013 Global Perspectives
Romeo Joseph J. Ignacio 2013-2015 Golden Celebration
Ronaldo E. Puno 2015-present Empowerment
DAVAO CHAPTER PRESIDENTS

YEAR PRESIDENT
1971 Teresita V. Magpantay - Organized Davao Chapter
- Davao chapter was recognized was recognized
as a chapter of PAMET
1972 Irene C. Padilla
1973 Monina Parreno
1974 Pilar Bullecer
1975-1976 Lolita D. Mamaril - Davao chapter awarded as 1976 Outstanding
Chapter
1977 Edward Flores
1978 Belen Aspera
1979-1980 Jesusa T. Carino
1981 Myrna T. Rodriguez
1982 Eva Fe Abellera
1983 Marita P. De Jesus
1984 Violeta Nano - Teresita Magpantay was awarded Distinguished
Service award
1985 Rosalinda Ebrado
1986 Judy Ann Nengasca
1987-1993 Irene C. Padilla - Irene Padilla was awarded Distinguished
Service award
1994-1995 Belen Aspera - First Mindanao sectoral Conference in Davao
1996-1998 Frederick Barez - 1998 Outstanding Chapter
- Irene Padilla was PRC 1996 Outstanding
Professional in the field of Medical Technology
1999-2002 Zenaida M. Banzon - Davao chapter hosted the National Mid Year
Conference
- 2000 Outstanding Chapter Award
- 2000 First runner-up in Siglahi Awards
(Safeguard)
- Lolita Mamaril was PRC 2000 Outstanding
professional in the filed of MT
- 2001 Outstanding Chapter Award
- 2001 First place – KKK Siglahi awards
- Marita de Jesus was awarded 2001
Distinguished Service Award
2003-2004 Cynthia Dayoan - Hall of Fame award for Outstanding Chapter
2005-2006 Sr. Nina Balbas, RVM
2007-2012 Zenaida Banzon - Hosted the 15th Midyear Conference in Davao
City
MT204 – MTLE

Republic Act 5527: Philippine Medical Technology Act of 1969


An Act requiring the Registration of Medical Technologist, defining their practice, and for other
purposes

AMENDMENTS

 Republic Act 6138


 August 31, 1970
 Sections 16, 21 and 22

 Presidential Decree 498


 June 28, 1974
 Sec. 2, 3, 4, 7, 8, 11, 13, 16, 17, 21 and 29

 Presidential Decree 1534


 June 11, 1978
 Sec. 3, 8, and 13

32 Sections of RA 5527

Section 1: Title
 Philippine Medical Technology Act of 1969
 Approved on June 21, 1969

Section 2: Definition of Terms


 Practice of Medical Technology
 Examination of tissues, secretions and excretions of the human body and body fluids.
 Blood banking procedures
 Parasitologic, mycologic and microbiologic techniques
 Histopathologic & cytotechnology
 Clinical research
 Preparations & standardization of reagents
 Clinical Lab QC
 Collection and preservation of specimen
 Pathologist
 Medical Technologist
 Medical Laboratory Technicians
 Accredited Medical Technology Training Lab.
 Recognized School of MT
 Council of MT
 Board of MT

Section 3: Council of MT Education, Its Composition


 Chair: Director of CHED
 Vice Chair: Chair of PRC
 Members:
 Director of DOH
 Board of MT
 PASMETH (Representative)
 PSP President
 PAMET President

Section 4: Compensation and Traveling Expenses of Council Members


 Chairman – entitled to a 50 pesos per diem
 Members P25/diem
 Chairman and members – entitled to traveling expenses (official duties)

Section 5: Functions of the Council of MT


 Recommend minimum required curriculum
 Prescribe number of students allowed
 Approve MT schools
 Require all MT schools to submit annual report
 Inspect MT schools
 Certify qualified MT Interns
 Formulate & recommend refresher course
 Promulgate & implement policies

Section 6: Minimum Required Course


 CMO No. 14, s. 2006
 CMO Number 08, series of 1998
 CMO Number 27, series of 1998
 MT Internship

Section 7: Med. Tech. Board


 Pathologist
 2 RMTs

Section 8: Qualifications of the Examiners


 Filipino citizen
 Good moral character
 Qualified Patho/RMTs
 Practicing (at least 10 {4} years)
 Not a faculty member for at least 2 years prior to appointment
Section 9: Executive Officer of the Board
 Commissioner of Civil Service
 Conduct the examination
 Secretary of the Board – Secretary of the Board Examiner
 Keep a register of all person’s certificate of registration (COR) (have been granted)

Section 10: Compensation


 Each member of the shall receive
 Sum of P10/applicant examined
 P5/applicant granted a certificate of registration without exam.

Section 11: Functions and Duties of the Board


 Administer the provision of this Act (RA 5527)
 Administer the oaths
 Issue, suspend & revoke certificates of registration for the practice of MT
 Look into conditions affecting the practice of MT
 Investigate such violations of this Act.
 Draft rules and regulations
 Determine the adequacy of the technical staff of all clin, lab & BBs
 Prescribe the qualifications and training of MT staff as to specialty examinations
conducted by the prof. Org. of MTs accredited by PRC.
 Classify & prescribe the qualifications & training of technical staff as to diff. categories.

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


 DepEd (now CHED) approve MT schools (recommendation of the MT Board)
 DOH, through the BRL, shall approve labs for accreditation as training labs for MT
students or post-grad trainees.

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 obtained a valid certificate of registration from the Board
provided that registration shall not be required of the following:
a. Duly registered physicians.
b. 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 function.
c. 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 this Act, all applicants
for registration as medical technologist shall be required to undergo written
examination which shall be given by the Board annually in the greater Manila area,
Cebu and Davao during the month of August or September on such days and places
as the Board may designate. Written notices of such examination shall be published in
at least three newspapers of national circulation by the Secretary of the 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:
A. is in good health and is of good moral character;
B. 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.
C. or having graduated from some other profession and has been actually performing medical
technology for the last five (5) years prior to the date of the examinations, if such performance
began prior to June 21, 1969.

Section 17: Scope of Examination


 The examination questions shall cover the following subjects with their respective weights:
 Clinical Chemistry ……………………………………………………….. 20%
 Microbiology & Parasitology…………………………………………….. 20%
 Hematology ……………………………………………………………….. 20%
 Blood Banking & Serology …………………………………………….... 20%
 Clinical Microscopy (Urinalysis & other body fluids) ………………… 10%
 Histopathologic Techniques, Cytotechnology, Medical Technology
Laws, Related Laws and its implementing rules, and the Code of
Ethics ……………………………………………………………………… 10%

Section 18: Report of Rating


 The Board shall, within one hundred and twenty days after the date of completion of the
examination, report the result thereof to the Commissioner of Civil Service, who shall
submit such result to the President of the Philippines for approval.
 New Policy: 10 days

Section 19: Rating in the Examination


In order to pass the examination, a candidate:
 Must obtain a general average of at least 75% in the written test, with no rating below fifty
percent (50%) in any of the major subjects: Provided, that the candidate has not failed in
at least sixty percent (60%) of the subjects computed according to their relative weights.
 No further examinations, unless and until he shall have completed 12 months refresher
course in an accredited laboratory:
 Provided, that graduate of paramedical profession other than Bachelor of Science in
Medical Technology/ Bachelor of Science in Hygiene admitted to an examination under
the provisions of this Act shall not be given further examinations after his failure to
qualify for the third time.

Section 20: Oath Taking


 All successful examinees shall be required to take a professional oath before the Board of
before any person authorized to administer oath prior to entering upon the practice of
Medical Technology in the Philippines.

Section 21: Issuance of Certificate of Registration


 RMT
 Passed the licensure exam.
 Pay the corresponding fee.
 Display the CR in his workplace at all times.
 Without examination?
RMLT
 He or she passed the civil service examination for Medical Technician given on March 21,
1964; or
 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;
 Provided, further, that 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; or
 Has failed to pass the board examination for Medical Technology but had obtained a
general rating of at least 70%.
 Provided, finally, that a Registered Medical Laboratory Technician when employed in the
government shall have the equivalent civil service eligibility not lower than second grade.

Section 22: Fees


 Exam and registration
 COR without exam
 Lost, destroyed, mutilated certificate.

Section 23: Refusal to Issue Certificate


 Moral turpitude
 Immoral act
 Incurable disease
 Negligence
 Dishonorable conduct
 Unsound mind

Section 24: Administrative Investigation


 Revocation or Suspension of Certificate

Section 25: Appeal


 Can file for an appeal to the Civil Service Commissioner
 Further understand and go back

Section 26: Reinstatement, Reissue or Replacement of Certificate


 The board may reissue any revoked COR for proper and sufficient reason.
 Suspended COR can be reissued upon request

Section 27: Foreign Reciprocity


 Foreigners are not allowed to admit to MT examination or given COR in the PH or any
rights and privileges under this Act.
 Filipino MT can practice in other countries or state that allow them

Section 28: Roster of Medical Technologists


 Prepared annually by the Secretary of the Board.
 Contain the name, address, and citizenship of each registered MT, date of registration or
issuance of certificate, and other data.

Section 29: Penal Provisions


 Any person who shall practice Medical Technology in the Philippines without being
registered or exempted from registration in accordance with the provision of this Act.
 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;
 Any Medical Technologist who shall knowingly make a fraudulent laboratory report;
 Any duly registered Medical Technologist who shall refuse or fail, after due warning by the
Board to display his certificate of registration in the place where he works;
 Any person presenting or attempting to use his own, the certificate of registration of
another.
 False or fraud evidence to obtain a certificate of registration as Medical Technologist;
 Impersonate any registrant of like or the same name.
 Using or advertising any title or description tending to convey the impression that he is a
Medical Technologist without holding a valid certificate of registration;
 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 MT/MLT
knowing that he is not registered.
 Anyone who 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


 All acts, executive orders, rules and regulations, or parts there of inconsistent with the
provisions to any person or circumstances are declared by a court or competent
jurisdiction.

Section 31: Repealing Clause


 All acts, EO, rules and regulations, or part thereof inconsistent with the provision of this act
are hereby repealed. Provided, that nothing in this act shall be construed as repealing or
amending any portion of the RA 2382, RA 4688 and RA 1517

Section 32: Effectivity


 June 21, 1969
REPUBLIC ACT NO. 8981

AN ACT MODERNIZING THE PROFESSIONAL REGULATION COMMISSION, REPEALING FOR


THE PURPOSE PRESIDENTIAL DECREE NUMBERED TWO HUNDRED AND TWENTY-THREE,
ENTITLED "CREATING THE PROFESSIONAL REGULATION COMMISSION AND PRESCRIBING
ITS POWERS AND FUNCTIONS," AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines Congress assembled:

Section 1. Title – This Act shall be called the "PRC Modernization Act of 2000."

Section 2. Statement of Policy – The State recognizes the important role of professionals in nation-
building and, towards this end, promotes the sustained development of a reservoir of professionals
whose competence has been determined by honest and credible licensure examinations and whose
standards of professional service and practice are internationally recognized and considered world-
class brought about the regulatory measures, programs and activities that foster professional growth
and advancement.

Section 3. Professional Regulation Commission – There is hereby created a three-man commission


to be known as the Professional Regulation Commission, hereinafter referred to as the Commission,
which shall be attached to the office of the President for general direction and coordination.

Section 4. Composition – The Commission shall be headed by one (1) full-time Chairperson and two
(2) full-time Commissioners, all to be appointed by the President for a term of seven (7) years without
reappointment to start from the time they assume office. Appointments to a vacancy that occurs before
the expiration of the term of a Commissioner shall cover only the unexpired term of the immediate
predecessor. At the expiration of the Chairperson, the most senior of the Commissioners shall
temporarily assume and perform the duties and functions of the Chairperson until a permanent
Chairperson is appointed by the President.

The Chairperson or Commissioner shall be at least forty (40) years of age, holding a valid certificate
of registration/professional license and a valid professional identification card or a valid certificate of
competency issued by the Commission or a valid professional license issued by any government
agency, familiar with the principles and methods of professional regulation and/or licensing and has
had at least five (5) years of executive or management experience: Provided, That, one (1) of the
Commissioners must be a past Chairperson/member of a Professional Regulatory Board.

Section 5. Exercise of Powers and Functions of the Commission – The Chairperson of the
Commission, and the Commissioners as members thereof shall sit and act as a body to exercise
general administrative, executive and policy-making functions of the Commission. The Commission
shall establish and maintain a high standard of admission to the practice of all professions and at all
times ensure and safeguard the integrity of all licensure examinations.

The Chairperson shall act as the presiding and chief executive officer of the Commission. As presiding
officer, he/she shall preside over the meetings of the Commission sitting as a collegial body. As chief
executive officer of the Commission, he/she shall be responsible for the implementation of the policies
and the programs adopted by the Commission for the general administration of the Commission.
He/she shall perform such other activities which are necessary for the effective exercise of the powers,
functions and responsibilities of the Commission.

Section 6. Compensation and Other Benefits – The Chairperson shall receive compensation and
allowances equivalent to that of a Department Secretary while the Commissioners shall receive
compensation and allowances equivalent to that of an Undersecretary. The Chairperson and the
members of the Commission shall be entitled to retirement benefits provided under Republic Act
Numbered Fifteen Hundred and Sixty Eight, as amended by Republic Act Numbered Three Thousand
Five Hundred and Ninety Five.

Section 7. Powers, Functions and Responsibilities of the Commission – The powers, functions, and
responsibilities of the Commission are as follows:

(a) To administer, implement and enforce the regulatory policies of the national government
with respect to the regulation and licensing of the various professions and occupations under
its jurisdiction including the enhancement and maintenance of professional and occupational
standards and ethics and the enforcement of the rules and regulations relative thereto:

(b) To perform any and all acts, enter into contracts, make such rules and regulations and
issue such orders and other administrative issuance as may be necessary in the execution
and implementation of its functions and the improvement of its services;

(c) To review, revise, and approve resolutions, embodying policies promulgated by the
Professional Regulatory Boards in the exercise of their powers and functions or in
implementing the laws regulating their respective professions and other official actions on non-
ministerial matters within their respective jurisdictions;

(d) To administer and conduct the licensure examinations of the various regulatory boards in
accordance with the rules and regulations promulgated by the Commission; determine and fix
the places and dates of examinations; use publicly or privately owned buildings and facilities
for examination purposes; conduct more than one (1) licensure examination: Provided, That,
when there are two (2) or more examinations given in a year, at least one (1) examinations
shall be held on weekdays (Monday to Friday): Provided, further, That, if only one (1)
examination is given in a year, this shall be held only on weekdays: Provided, finally, That, the
Commission is also authorized to require the completion of a refresher course where the
examinee has failed to pass three (3) times, except as otherwise provided by law; approve the
results of examinations and the release of the same; adopt measures to preserve the integrity
and inviolability of licensure examinations; appoint supervisors and room watchers from
among the employees of the government and/or private individuals with baccalaureate
degrees, who have been trained by the Commission for the purpose and who shall be entitled
to a reasonable daily allowance for every examination day actually attended, to be determined
and fixed by the Commission; publish the list of successful examinees; provide schools,
colleges and universities, public and private, offering courses for licensure examinations, with
copies of sample test questions on examinations recently conducted by the Commission and
copies of the syllabi or terms of specifications of subjects for licensure examinations; and
impose the penalty of suspension or prohibition from taking licensure examinations to any
examinee charged and found guilty of violating the rules and regulations governing the conduct
of licensure examinations promulgated by the Commission;

(e) To admit the successful examinees to the practice of the profession or occupation; cause
the entry of their names on its registry book and computerized database; issue certificates of
registration/professional license, bearing the registrant’s name, picture, and registration
number, signed by all the members of the Board concerned and the Chairperson, with the
official seal of the Board and the Commission affixed thereto which certificate shall be the
authority to practice; and at the option of the professional concerned, ministerially issue the
professional identification card, to be used solely for the purpose of identification, upon
payment of the appropriate amount: Provided, That, marine deck and marine engineer officers
shall also be issued endorsement certificates exclusively by the Commission pursuant to the
1978 and 1995 Standards of Training, Certification and Watch-keeping (STCW) Convention,
to the exclusion of any other government agency, Section 1(2) of Executive Order No. 149,
Series of 1999 and provisions of other existing laws, executive orders, administrative
issuance/regulations to the contrary notwithstanding: Provided, further, That, once a certificate
of registration/professional license, or certificate of competency, in the case of marine deck
and engine officers are issued, this cannot be withdrawn, cancelled, revoked, or suspended
except for just cause as may be provided by law after due notice and hearing;

(f) To have custody of all the records of the various Boards, including examination papers,
minutes of deliberation, records of administrative cases and investigations and examination
results for control and disposition;

(g) To determine and fix the amount of fees to be charged and collected for examination,
registration, registration without examination, professional identification card, certification,
docket, appeal, replacement, accreditation, including surcharges and other fees not specified
under the provisions of Republic Act Numbered Four Hundred Sixty Five as amended by
Republic Act Numbered Sixty Five Hundred and Eleven or to charge and collect reasonable
fees at the rates higher than the rates provided thereunder subject to the approval by the Office
of the President.

(h) To appoint subject to the Civil Service laws, rules, and regulations, officials and employees
of the Commission necessary for the effective performance of its functions and responsibilities;
prescribe their duties and fix their compensation subject to the provisions of Republic Act
Numbered Six Thousand Seven Hundred and Fifty Eight and allowances including other fringe
benefits; and to assign and/or reassign personnel as the exigency of the service requires
subject to the Civil Service laws, rules and regulations; and to organize or reorganize the
structure of the Commission; and create or abolish positions or change the designation of
existing positions in accordance with a staffing pattern prepared by it and approved by the
Office of the President upon the recommendation of the Department of Budget and
Management (DBM) to meet the changing conditions or as the need arises: Provided, That,
such changes shall not affect the employment status of the incumbents, reduce their ranks
and/or salaries nor shall result in their separation from the service;

(i) To submit and recommend to the President of the Philippines the names of
licensed/registered professionals for appointment as members of the various Professional
Regulatory Boards from among those nominated to fill up vacancies pursuant to the provisions
of Executive Order No. 496, Series of 1991;

(j) Upon recommendation of the Professional Regulatory Board concerned, to approve the
registration of and authorize the issuance of a certificate of registration/license and
professional identification card with or without examination to a foreigner who is registered
under the laws of his state or country and whose certificate of registration issued therein has
not been suspended or revoked: Provided, That, the requirements for the registration or
licensing in said foreign state or country are substantially the same as those required and
contemplated by the laws of the Philippines and that the laws of such foreign state or country
allow the citizens of the Philippines to practice the profession on the same basis and grant the
same privileges as those enjoyed by the subjects or citizens of such foreign state or
country: Provided, further, That, the Commission may, upon recommendation of the Board
concerned, authorize the issuance of a certificate of registration/license or a special temporary
permit to foreign professionals who desire to practice their professions in the country under
reciprocity and other international agreements; consultants in foreign-funded, joint venture or
foreign-assisted projects of the government, employees of Philippine or foreign private firms
or institutions pursuant to law, or health professionals engaged in humanitarian mission for a
limited period of time: Provided, finally, That agencies, organizations or individuals whether
public or private, who secure he services of a foreign professional authorized by law to practice
in the Philippines for reasons aforementioned, shall be responsible for securing a special
permit from the Professional Regulation Commission (PRC) and the Department of Labor and
Employment (DOLE), pursuant to PRC and DOLE rules:

(k) To authorize any officer of the Commission to administer oaths:

(l) To supervise foreign nations who are authorized by existing laws to practice their
professions either as holders of a certificate of registration and a professional identification
card or a temporary special permit in the Philippines; to ensue that the terms and conditions
for their practice or of their employment are strictly complied with; to require the hiring or
employing government agency or private entity/institution to secure a temporary special permit
from the concerned Board subject to approval by the Commission and to file a criminal
complaint against the head of the government agency or officers of the said private
entity/institution, who shall be liable under the penalty provided for in the concerned
professional regulatory law or the penalty imposed pursuant to this Act, when the professional
was hired and allowed to practice his/her profession without permit; to file upon due process
request for deportation with the Bureau of Immigration and Deportation (BID); and to supervise
professionals who were former citizens of the Philippines and who had been registered and
issued a certificate of registration and a professional identification card prior to their
naturalization as foreign citizens, who may, while in the country on a visit, sojourn or
permanent residence, practice their profession: Provided, That, prior to the practice of their
profession they shall have first been issued a special permit and updated professional
identification card by the Board concerned subject to approval by the Commission and upon
payment of the permit and annual registration fees;

(m) To monitor the performance of schools in licensure examinations and publish the results
thereof in a newspaper of national circulation;

(n) To adopt and institute a comprehensive rating system for universities, colleges, and training
institutes based on the passing ratio and overall performance of students in board
examinations;

(o) To exercise administrative supervision over the various professional regulatory boards and
its members;

(p) To adopt and promulgate such rules and regulations as may be necessary to effectively
implement policies with respect to the regulation and practice of the professions;

(q) To implement the program for the full computerization of all licensure examinations given
by the various professional regulatory boards including the registration of professionals not
later than the year 2003 and other operations of the Commission;

(r) To investigate and decide administrative matters involving officers and employees under
the jurisdiction of the Commission;

(s) To investigate motu proprio or upon the filing of a verified complaint, any member of the
Professional Regulatory Boards for neglect of duty, incompetence, unprofessional, unethical,
immoral or dishonorable conduct, commission of irregularities in the licensure examinations
which taint or impugn the integrity and authenticity of the results of the said examinations and,
if found guilty, to revoke or suspend their certificates of registration and professional
licenses/identification cards and to recommend to the President of the Philippines their
suspension or removal from office as the case may be;

(t) To issue summons, subpoena and subpoena duces tecum in connection with the
investigation of cases against officials and employees of the Commission and the members of
the Professional Regulatory Boards;

(u) To hold in contempt in erring party or person only upon application with a court of competent
jurisdiction;

(v) To call upon or request any department, instrumentality, office, bureau, institution or agency
of the government including local government units to render such assistance as it may
require, or to coordinate or cooperate in order to carry out, enforce or implement the
professional regulatory policies of the government or any program or activity it may undertake
pursuant to the provisions of this Act;

(w) To initiate an investigation, upon complaint under oath by an aggrieved party, of any
person, whether a private individual or professional, local or foreign, who practices the
regulated profession or occupation without being authorized by law, or without being registered
with and licensed by the concerned regulatory board and issued the corresponding
license/professional identification card or temporary or special permit, or who commits any of
the prohibited acts provided in the regulatory laws of the various professions, which acts are
criminal in nature, and if the evidence so warrants, to forward the records of the case to the
office of the city or provincial prosecutor for the filing of the corresponding information in court
by the lawyers of the legal services of the Commission who may prosecute said case/s upon
being deputized by the Secretary of Justice;

(x) To prepare an annual report of accomplishments on the programs, projects and activities
of the Commission during the year for submission to Congress after the close of its calendar
year and make appropriate recommendations on issues and/or problems affecting the
Commission, the Professional Regulatory Board, and the various professions under its
jurisdiction; and

(y) To perform such other functions and duties as may be necessary to carry out the provisions
of this Act, the various professional regulatory laws, decrees, executive orders and other
administrative issuance.

Section 8. Regional Offices – The Commission is hereby authorized to create regional offices as may
be necessary to carry out their functions mandated under this Act.

Section 9. Powers, Functions and Responsibilities of the Various Professional Regulatory Boards –
The various, professional regulatory boards shall retain the following powers, functions and
responsibilities:

(a) To regulate the practice of the professions in accordance with the provisions of their
respective professional regulatory laws;

(b) To monitor the conditions affecting the practice of the profession or occupation under their
respective jurisdictions and whenever necessary, adopt such measures as may be deemed
proper for the enhancement of the profession or occupation and/or the maintenance of high
professional, ethical and technical standards, and for this purpose the members of the Board
duly authorized by the Commission with deputized employees of the Commission, may
conduct ocular inspection in industrial, mechanical, electrical or chemical plants or
establishments, hospitals, clinics, laboratories, testing facilities, mines and quarries, other
engineering facilities and in the case of schools, in coordination with the Commission on Higher
Education (CHED);

(c) To hear and investigate cases arising from violations of their respective laws, the rules and
regulations promulgated thereunder and their Codes of Ethics and, for this purpose, may issue
summons, subpoena and subpoena duces tecum to alleged violators and/or witnesses to
compel their attendance in such investigations or hearings: Provided, That, the decision of the
Professional Regulatory Board shall, unless appealed to the Commission, become final and
executory after fifteen (15) days from receipt of notice of judgment or decision;

(d) To delegate the hearing or investigation of administrative cases filed before them except
in cases where the issue or question involved strictly concerns the practice of the profession
or occupation, in which case, the hearing shall be presided over by at least one (1) member of
the Board concerned assisted by a Legal or Hearing Officer of the Commission;

(e) To conduct, through the Legal Officers of the Commission, summary proceedings on minor
violations of their respective regulatory laws, violations of the rules and regulations issued by
the boards to implement their respective laws, including violations of the general instructions
to examinees committed by examinees, and render summary judgment thereon which shall,
unless appealed to the Commission, become final and executory after fifteen (15) days from
receipt of notice of judgment or decision;

(f) Subject to final approval by the Commission, to recommend registration without examination
and the issuance of corresponding certificate of registration and professional identification
card;

(g) After due process, to suspend, revoke or reissue, reinstate certificate of registration or
licenses for causes provided by law;

(h) To prepare, adopt and issue the syllabi or tables of specifications of the subjects for
examinations in consultation with the academe; determine and prepare the questions for the
licensure examinations which shall strictly be within the scope of the syllabus or table of
specifications of the subject for examination; score and rate the examination papers with the
name and signature of the Board member concerned appearing thereon and submit the results
in all subjects duly signed by the members of the Board to the Commission within ten (10)
days from the last day of examination unless extended by the Commission for justifiable
cause/s; and subject to the approval by the Commission, determine the appropriate passing
general average rating in an examination if not provided for in the law regulating the profession;
and

(i) To prepare an annual report of accomplishments on programs, projects and activities of the
Board during the year for submission to the Commission after the close of each calendar year
and make appropriate recommendations on issues or problems affecting the profession to the
Commission.

Section 10. Compensation of the Members of the Professional Regulatory Boards – The members of
the Professional Regulatory Boards shall receive compensation equivalent to, at least, two salary
grades lower than the salary grade of the Commissioners: Provided, That the Chairperson of the
Regulatory Board shall receive a monthly compensation of two steps higher than the members of the
Board, and: Provided, further, That they shall be entitled to other allowances and benefits provided
under existing laws.

Section 11. Person to Teach Subjects for Licensure Examination on all Professions – All subjects for
licensure examinations shall be taught by persons who are holders of valid certificates of registration
and valid professional licenses of the profession and who comply with the other requirements of the
CHED.

Section 12. Assistance of Law Enforcement Agency – Any law enforcement agency shall, upon call
or request of the Commission or of any Professional Regulatory Board, render assistance in enforcing
the regulatory law of the profession including the rules and regulations promulgated thereunder by
prosecuting the violators thereof in accordance with law and the rules of court.

Section 13. Appropriations – The amount necessary to carry out the initial implementation of this Act
shall be charged against the current year’s appropriations of the Professional Regulation Commission.
Thereafter, such sums as may be necessary for the continued implementation of this Act shall be
included in the succeeding General Appropriations Act.

Section 14. Authority to Use Income – In addition to the annual appropriations of the Commission
provided under the Annual General Appropriations Act, the Commission is hereby authorized to use
its income not exceeding the amount of Forty-five million pesos (P45,000,000.00) a year for a period
of five (5) years after the effectivity of this Act to implement the program for full computerization of the
operations of the Commission, subject to the usual accounting and auditing requirements.

Section 15. Penalties for Manipulation and Other Corrupt Practices in the Conduct of Professional
Examinations –

(a) Any person who manipulates or rigs licensure examination results, secretly informs or
makes known licensure examination questions prior to the conduct of the examination or
tampers with the grades in professional licensure examinations shall, upon conviction, be
punished by imprisonment of not less than six (6) years and one (1) day to not more than
twelve (12) years or a fine of not less than Fifty thousand pesos (P50,000.00) to not more than
One hundred thousand pesos (P100,000.00) or both such imprisonment and fine at the
discretion of the court.

(b) In case the offender is an officer or employee of the Commission or a member of the
regulatory board, he/she shall be removed from office and shall suffer the penalty of perpetual
absolute disqualification from public office to addition to the penalties prescribed in the
preceding section of this Act;

(c) The penalty of imprisonment ranging from four (4) years and one (1) day to six (6) years or
a fine ranging from Twenty thousand pesos (P20,000.00) to not more than Forty-nine thousand
pesos (P49,000.00), or both imprisonment and fine at the discretion of the court, shall be
imposed upon the accomplices. The penalty of imprisonment ranging from two (2) years and
one (1) day to four (4) years or a fine ranging from Five thousand pesos (P5,000.00) to not
more than Nineteen thousand pesos (P19,000.00), or both imprisonment and fine at the
discretion of the court, shall be imposed upon the accessories.

Section 16. Penalties for Violation of Section 7 – Subparagraph (1) by Heads of Government Agencies
or Officers of Private Entities/Institutions – Any head of a government agency or officer(s) of a private
firm/institution who violates Section 7 – subpar. (1) of this Act shall be punished by imprisonment of
not less than six (6) months and one (1) day to not more than six (6) years, or a fine of not less than
Fifty thousand pesos (P50,000.00) to not more than Five hundred thousand pesos (P500,000.00) or
both at the discretion of the court.

Section 17. Implementing Rules and Regulations – Within ninety (90) days after the approval of this
Act, the Professional Regulation Commission, together with representatives of the various
Professional Regulatory Boards and accredited professional organizations, the DBM, and the CHED
shall prepare and promulgate the necessary rules and regulations needed to implement the provisions
of this Act.

Section 18. Transitory Provisions – The incumbent Commissioner and two (2) incumbent Associate
Commissioners shall serve as Chairperson and Commissioners respectively under the terms for which
they have been appointed without need of new appointments. The incumbent Executive Director shall
likewise serve as Assistant Commissioner without need of new appointment.

Section 19. Separability Clause – If any provision of this Act or the application of such provision to
any person or circumstances is declared invalid or unconstitutional, the remainder of this Act or
application of such provisions to other persons or circumstance shall not be affected by such
declaration.

Section 20. Repealing Clause – Republic Act. No. 546, Presidential Decree No. 223, as amended by
Presidential Decree No. 657, Republic Act No. 5181, and Executive Order No. 266, Series of 1995
are hereby repealed. Section 23 (h) of Republic Act No. 7836, Section 4 (m & s). Section 23 of Republic
Act No. 7920, and Section 29 of Republic Act No. 8050, insofar as it requires completion of the
requirements of the Continuing Professional Education (CPE) as a condition for the renewal of the
license are hereby repealed. All other laws, orders, rules and regulations or resolutions and all part/s
thereof inconsistent with the provisions of this Act are hereby repealed or amended accordingly.

Section 21. Effectivity – This Act shall take effect after fifteen (15) days following its publication in
the Official Gazette or in two (2) newspapers of general circulation, whichever is earlier.

Approved: December 05, 2000

(Sgd.)JOSEPH EJERCITO ESTRADA


President of the Philippines
REPUBLIC ACT No. 4688

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

Be it enacted by the Senate and House of Representatives of the Philippine Congress Assembled:

Section 1. Any person, firm or corporation, operating and maintaining a clinical laboratory in which
body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for
the determination of the presence of pathologic organisms, processes and/or conditions in the persons
or animals from which they were obtained, shall register and secure a license annually at the office of
the Secretary of Health: Provided, That government hospital 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. 1avvphi1

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 Bureau of Research and Laboratories shall be
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. Any person, firm or corporation who violates any provisions of this Act or the rules and
regulations issued thereunder by the Secretary of Health 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 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.

Approved: June 18, 1966.


RA 4688: The Clinical Laboratory Act of 1966 AO No. 2007-0027 (A)
o Exemption of National Tuberculosis
Reference Laboratory and Regional TB Ref
o An act regulating the operation and Labs from licensing
maintenance of Clinical laboratories and o (August 28, 2008)
requiring the registration of the same with the
Department of Health, providing penalty for
the violation thereof and for other purposes.
AO 393-E s. 2000
o Approved: June 18, 1966
o Designation of National Reference
Laboratories (NRL) (2000)
AO No. 2007-0027 o Approved: November 14, 2000

o Revised rules and regulations governing the


registration, operation and maintenance of
clinical laboratories in the Philippines
(August 22, 2007) NRL

Features: RITM
o Classification of laboratories o Mycobacterial diseases
o LTO is applied thru BHFS, renewed every o Parasitic diseases
year o Bacterial enteric diseases
o Exempted from licensing but need to be o Viral exanthems
registered o Mycology
o Non-hospital-based labs can apply for o Enteroviruses
renewal starting October 1 until November o Antimicrobial resistance and emerging
30 filed under CHD/BHFS; hospitals under diseases
the one-shop stop o NRL for confirmatory testing of blood units
o Appeal of decisions made thru the office of
the DOH sec within 10 days upon receipt of
decision SACCL
o Record keeping within 1 year, reports need
to have name of lab, bear name and o HIV/AIDS
signature of RMT and pathologist o Hepatitis
o SY and other STIs

Automatic cancellation of LTO


o Failure to submit duly accomplished form, EAMC
non-payment of fees on expiration dates o Environmental and Occupational Health
o Non-participation in EQAS/EQAP o Toxicology
o Usage of test report of the referral lab o Micronutrient Assay

AO No. 2005-0027 NKTI


o Rules and regulations governing the o Hematology including Immunohematology
regulation of HIV laboratories o Immunopathology
o August 15, 2005 o Anatomic Pathology
LCP
o Chemistry

DM 2009-0086
o Implementation of external quality
assessment program as regulatory
requirement for licensing of clinical
laboratories (February 3, 2009)

Proficiency Testing Areas

o Hematology – primary, secondary and


tertiary
o Clinical chemistry – tertiary clinical labs
o HIV/AIDS, Hepa B&C – all labs with such
tests
o Water proficiency testing – all screening
and confirmatory water testing labs
o Drug proficiency testing – screening and
confirmation DTLs
o Microbiology

AO No. 2007-0027
I. Rationale
II. Objective
- Promulgated to prescribe a revised
minimum standard for clinical
laboratories
III. Scope and Coverage
- 4.1 Applies to all entities performing
the activities and functions
- 4.2 Excludes government
laboratories doing laboratory
examination limited to AFB
microscopy, malaria screening and
cervical cancer screening; declared
as extension of a license government
clinical lab
WEEK 5 A.O. 59 s 2001 PRE-INSPECTION PHASE

1. Goal
OBJECTIVES
a. To coordinate with the health facility to be
1. General visited
o To acquire a broad-based view of the b. To inform the management of the
hospital licensing process purpose of the inspection and their
participation in the activity

2. Specific
o To orient stakeholders on the rules 2. Activities
and requirements involved in hospital
licensing a. Fill up application form
o To clarify issues and enlighten b. Inspection activity agenda
stakeholders on rules and c. Copt of administrative order and other
requirements in hospital licensing related issuances
d. Checklist of documents to be available
during inspection
ACRONYMS

BHFS – Bureau of Health Facilities and services INSPECTION PHASE

CHD – Center for Health Development


CON – Certificate of Need Goal:
PTC – Permit to Construct o To encourage interactive participation of the
key staff in the inspection process
OSS – One-stop Shop
LTO – License to Operate
Activities:
AO – Administrative Order
a. Leadership interview
b. Document review session
DOH WEBSITE c. Tour of the health facility
d. Feedback session

www.doh.gov.ph -> doing business -> licensing ->


BHFS requirements -> hospitals and other health POST-INSPECTION PHASE
facilities

Activities
3 PHASES
a. Regulatory officers collate findings
1. Pre-inspection phase b. The team prepares the report
2. Inspection phase c. The team submits the report together with its
3. Post-inspection phase recommendations to the director of the CHD
d. The CHD director approves or disapproves
the issuance of the LTO
CERTIFICATE OF NEED (CON) Application for PTC

A legal document issued by the CHD regulatory


agency with authority over an area which affirms that
1.Three sets of site development and architectural
a proposed acquisition, expansion or creation of a
floor plans
medical facility falling under that authority is required
to fulfill the needs of a community. o Signed and sealed by an architect
o Showing all areas with appropriate scale,
This certificate is necessary for the construction of
dimensions and labels
medical facility to be issued by the responsible CHD.

2.For new hospitals


Criteria for the establishment of a new general
hospital o CON from the CHD
o Zoning certificate/location clearance from the
City/Municipal Planning and Development
1. Bed to population ration shall not be more Office
than 1 bed per 1000 population (1:1000) o DTI/SEC Registration (for private hospital)
2. Travel time – proposed hospital shall be at o Board registration (for government hospital)
least 1 hour away from the nearest hospital
3. Accessibility – strategically located
4. Integration with Provincial/City strategic plan
for the rationalization of the health care
delivery system based on health needs’ ONE STOP SHOP (OSS)
5. Track record

DOH strategy to harmonize licensure of hospitals, its


Requirements for general hospitals: ancillary and other facilities, such as but not limited
to the following:
o Application form for CON
o Certification from the provincial planning and o Clinical laboratory
development office that the proposed o HIV testing
hospital is part of the duly approved o Drinking water analysis
provincial hospital/health care deliver plan (if o Drug testing
available) o Blood bank, blood collection unit, and blood
station
o Dialysis clinic
Permit to Construct (PTC) o Ambulatory surgical clinic
o Pharmacy
o Medical x-ray facility
A PTC is a pre-requisite for LTO
It is required for: OSS excludes the following:
o Construction of a new hospital or other health o Hospital-based medical facility for overseas
facility workers and seafarers
o Substantial alteration, expansion or o Hospital-based drug abuse treatment and
renovation of an existing hospital or other rehabilitation center
health facility o Facility using radioactive material regulated
o Change in classification’ by the PNRI
o Increase in bed capacity o Performance of kidney transplantation
Application for OSS SCHEDULE OF FEES

Required for all hospitals: a. The applicant, upon filling the application
shall pay at the CHD or DOH cashier
o Hospital documents
b. Fees for the OSS licensure system shall be
o Clinical laboratory
regularly reviewed by the BHFS, BHDT, and
o Pharmacy
BFAD in consultation with the CHDs and
o Radiology
stakeholders
c. All fees, surcharges and discounts shall
follow the current DOH prescribed schedule
CLASSIFICATION OF HOSPITALS
of fees

A. By Function VALIDITY OF LTO


1. General
2. Special o The LTO shall be valid for one year from
January 1 to December 31

B. By service capability
1. Level 1 SANCTIONS
2. Level 2
o 1st violation – written warning
3. Level 3
o Violation involving basic hospital licensing
4. Level 4
requirements

2nd violation – Php 30,000.00


CLASSIFICATION OF CLINICAL LABS 3rd violation – Php 50,000.00
4th violation – suspension or revocation of the
LTO
By service capability
1. General Clinical Lab
a. Primary category
b. Secondary category
c. Tertiary category
d. Limited service

2. Special clinical lab

CLASSIFICATION OF X-RAY FACILITIES

By service capability:
1. Level 1 - < 100 ma
2. Level 2 - > 100 ma special procedures with
contrast
3. Level 3 - > 300 ma with image intensifier
system
REPUBLIC ACT No. 1517

An Act Regulating the Collection, Processing and Sale of Human Blood, and the
Establishment and Operation of Blood Banks and Blood Processing Laboratories

Blood Bank Act

Repealed by Republic Act No. 7719

Be it enacted by the Senate and House of Representatives of the Philippine Congress Assembled:

Section 1. In order to promote public health, it is declared a national policy to prevent trafficking in
human blood and its products and derivatives.

Section 2. As used in this Act:

"Blood" means human blood, processed or unprocessed, and includes its products and derivatives.

"Person" includes corporations, partnerships, associations, and organizations.

"Cost" means the actual purchase price of unprocessed blood and its handling charges, such as
those for its collection, processing, storage, transportation, and sale, and a reasonable allowance for
spoilage.

Section 3. It shall be the unlawful for any person to establish or operate a blood bank or blood
processing laboratory, or to collect or process blood if he is not a licensed physician, or to sell blood
collected from another person, even if authorized by the latter, without first securing a license from
the Department of Health: Provided, That in cases of emergency, blood transfusion shall be allowed
under the responsibility of the attending physician without such license: And Provided, further, That
persons operating blood banks and blood processing laboratories on the date of the approval of this
Act may continue to operate and same if they secure such license within sixty days from the date of
the issuance of the rules and regulations provided for in section five hereof.

No license shall be granted or renewed by the Department of Health for the establishment or
operation of a blood bank or blood processing laboratory unless such bank or laboratory be
established or operated in accordance with accepted scientific standards, is under the
administration, direction and supervision of a licensed and qualified physician, and blood is collected
and/or processed therein by licensed physicians or under their direct supervision and responsibility.

No license shall be granted or renewed by said Department for the collection and/or processing of
blood unless the licensee complies with the requirements hereinabove established for blood banks
and blood processing laboratories.

Section 4. Blood banks and processing laboratories shall be operated on a non-profit basis. Blood
collecting or processing by other blood collectors or processors or by individual physicians shall also
be on a non-profit basis. Blood shall be sold by such banks and laboratories, other blood collectors
or processors, and individual physicians at cost.

Section 5. The Secretary of Health is charged with the responsibility of strictly enforcing this Act,
and shall issue such rules and regulations as may be necessary to carry out its provisions, including
rules and regulations prescribing, from time to time, the maximum ceilings for handling charges of
blood, such as charges for its collection, processing, storage, transportation, and sale, and a
reasonable allowance for spoilage, which shall be considered as part of the cost of blood.

Section 6. Any person who violates any provision of this Act or of the rules and regulations issued
thereunder shall be punished by imprisonment for not less than one month and not more than one
year or by a fine of not less than one hundred pesos and not more than one thousand pesos or by
both such fine and imprisonment in the discretion of the court.

Section 7. This Act shall take effect upon its approval.

Approved: June 16, 1956.


Republic of the Philippines
Congress of the Philippines
Metro Manila

Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty-sixth day of July,
nineteen hundred and ninety-three.

[REPUBLIC ACT NO. 7719]

AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN


ADEQUATE SUPPLY OF SAFE BLOOD, REGULATING BLOOD BANKS, AND
PROVIDING PENALTIES FOR VIOLATION THEREOF

Be it enacted by the Senate and House of Representatives of the Philippines in Congress


assembled:

SECTION 1. Title. – This Act shall be known as the “National Blood Services Act of 1994”.

SEC. 2. Declaration of Policy. – In order to promote public health, it is hereby declared


the policy of the State:

a) to promote and encourage voluntary blood donation by the citizenry and to instill public
consciousness of the principle that blood donation is a humanitarian act;

b) to lay down the legal principle that the provision of blood for transfusion is a
professional medical service and not a sale of a commodity;

c) to provide for adequate, safe, affordable and equitable distribution of supply of blood
and blood products;

d) to inform the public of the need for voluntary blood donation to curb the hazards caused
by the commercial sale of blood;

e) to teach the benefits and rationale of voluntary blood donation in the existing health
subjects of the formal education system in all public and private schools, in the
elementary, high school and college levels as well as the non-formal education system;

f) to mobilize all sectors of the community to participate in mechanisms for voluntary and
non-profit collection of blood;

g) to mandate the Department of Health to establish and organize a National Blood


Transfusion Service Network in order to rationalize and improve the provision of adequate
and safe supply of blood;
h) to provide for adequate assistance to institutions promoting voluntary blood donation
and providing non-profit blood services, either through a system of reimbursement for
costs from patients who can afford to pay, or donations from governmental and non-
governmental entities:

i) to require all blood collection units and blood banks/centers to operate on a non-profit
basis;

j) to establish scientific and professional standards for the operation of blood collection
units and blood banks/centers in the Philippines;

k) to regulate and ensure the safety of all activities related to the collection, storage and
banking of blood; and

l) to require upgrading of blood banks/centers to include preventive services and


education to control spread of blood transfusion transmissible diseases.

SEC. 3. Definitions. –For purposes of this Act, the following terms shall mean:

a) Blood/blood product – refers to human blood, processed or unprocessed and includes


blood components, its products and derivatives;

b) Blood bank/center – a laboratory or institution with the capability to recruit and screen
blood donors, collect, process, store, transport and issue blood for transfusion and
provide information and/ or education on blood transfusion transmissible diseases;

c) Commercial blood bank – a blood bank that exists for profit;

d) Hospital-based blood bank – a blood bank which is located within the premises of a
hospital and which can perform compatibility testing of blood;

e) Blood collection unit – an institution or facility duly authorized by the Department of


Health to recruit and screen donors and collect blood;

f) Voluntary blood donor – one who donates blood on one’s own volition or initiative and
without monetary compensation;

g) Department – the Department of Health;

h) Blood transfusion transmissible diseases – diseases which may be transmitted as a


result of blood transfusion, including AIDS, Hepatitis-B, Malaria and Syphilis;

i) Secretary of Health – the Secretary of Health or any other person to whom the Secretary
delegates the responsibility of carrying out the provisions of this Act; and
j) Walking Blood Donor – an individual included in the list of qualified voluntary blood
donors referred to in Section 4, paragraph (e), who is ready to donate blood when needed
in his/her community.

SEC. 4. Promotion of Voluntary Blood Donation. – In order to ensure adequate supply of


human blood, voluntary blood donation shall be promoted through the following:

a) Public Education. – Through an organized and sustained nationwide public education


campaign by the Department, the Philippine National Red Cross (PNRC) and the
Philippine Blood Coordinating Council (PBCC), as the lead agencies, other government
agencies, local government units (particularly the barangays), non-governmental
organizations, all medical organizations, all public and private hospitals, all health and
health-related institutions, print and broadcast media as well as other sectors. The
Department is hereby authorized to set aside funds and generate financial support for all
sectors involved in the collection and processing of blood from voluntary blood donors
through a system of reimbursement for costs for patients who can afford to pay or from
donations from government and private institutions. Voluntary donors shall likewise be
provided non monetary incentives as may be determined by the Department.

b) Promotion in Schools. – The benefits and rationale of voluntary blood donation shall
be included and given emphasis in health subjects of schools, both public and private, at
the elementary, high school and college levels. The Department of Education, Culture
and Sports shall also require such inclusion in its non-formal education curricula.

c) Professional Education. – The Department, the PBCC, the Philippine Society of


Hematology and Blood Transfusion (PSHBT), the Philippine Society of Pathologists
(PSP), the Philippine Medical Association (PMA), the Philippine Association of Medical
Technologists (PAMET) and the Philippine Nursing Association (PNA) are encouraged to
conduct for their respective members and as part of the continuing medical education,
trainings on the rational use of blood and blood products including the merits of voluntary
blood donation.

d) Establishment of Blood Services Network. – Blood centers shall be strategically


established in every province and city nationwide within the framework of a National Blood
Transfusion Service Network spearheaded by the Department, in coordination with the
PNRC. The collection of blood in various areas in the community, such as schools,
business enterprises, barangays, and military camps shall be promoted.

The Secretary shall set the standards for the scientific and professional establishment
and operation of blood banks/centers and collection units. The Department shall provide
training programs and technical assistance to enable communities, schools, industrial and
business sites, barangays, military camps and local government units to implement their
own voluntary blood donation programs.

e) Walking Blood Donors. – In areas where there may be inadequate blood banking
facilities, the walking blood donor concept shall be encouraged and all government
hospitals, rural-health units, health centers and barangays in these areas shall be
required to keep at all times a list of qualified voluntary blood donors with their specified
blood typing.

SEC. 5. National Voluntary Blood Services Program. – The Department, in cooperation


with the PNRC and PBCC and other government agencies and non-governmental
organizations shall plan and implement a National Voluntary Blood Services Program
(NVBSP) to meet in an evolutionary manner, the needs for blood transfusion in all regions
of the country. Funds for this purpose shall be provided by the Government through the
budgetary allocation of the Department, by the Philippine Charity Sweepstakes Office
(PCSO) with an initial amount of at least Twenty-five million pesos (P25,000,000), by the
Philippine Amusement and Gaming Corporation (PAGCOR) with an initial amount of at
least Twenty-five million pesos (P25,000,000), by the trust liability account of the Duty
Free Shop (Duty Free Philippines) with an initial amount of at least Twenty million pesos
(P20,000,000) and through contributions of other agencies such as civic organizations.

SEC. 6. Upgrading of Services and Facilities. – All blood banks/ centers shall provide
preventive health services such as education and counselling on blood transfusion
transmissible diseases. All government hospitals, including those that have been
devolved, shall be required to establish voluntary blood donation programs and all private
hospitals shall be encouraged to establish voluntary blood donation programs.

The Department, in consultation with the PSHBT and the PSP, shall also establish
guidelines for the rational use of blood and blood products.

SEC. 7. Phase-out of Commercial Blood Banks. – AH commercial blood banks shall be


phased-out over a period of two (2) years after the effectivity of this Act, extendable to a
maximum period of two (2) years by the Secretary.

SEC. 8. Non-Profit Operation. – All blood banks/centers shall operate on a non-profit


basis: Provided, That they may collect service fees not greater than the maximum
prescribed by the Department which shall be limited to the necessary expenses entailed
in collecting and processing of blood. Blood shall be collected from healthy voluntary
donors only.

SEC. 9. Regulation of Blood Sciences. – It shall be unlawful for any person to establish
and operate a blood bank/center unless it is registered and issued a license to operate
by the Department: Provided, That in case of emergencies, blood collection and
transfusion under the responsibility of the attending physician shall be allowed in hospitals
without such license under certain conditions prescribed by the Department. No license
shall be granted or renewed by the Department for the establishment and operation of a
blood bank/ center unless it complies with the standards prescribed by the Department.
Such blood bank/center shall be under the management of a licensed and qualified
physician duly authorized by the Department.
SEC. 10. Importation of Blood Bank Equipment, Blood Bags and Reagents. -Upon the
effectivity of this Act, equipment, blood bags and reagents used for the screening and
testing of donors, collection and processing and storage of blood shall be imported tax-
and duty-free by the PNRC, blood banks and hospitals participating actively in the
National Voluntary Blood Services Program. This provision shall be implemented by the
rules and regulations to be promulgated by the Department in consultation and
coordination with the Department of Finance.

SEC. 11. Rules and Regulations. – The implementation of the provisions of this Act shall
be in accordance with the rules and regulations to be promulgated by the Secretary, within
sixty (60) days from the approval hereof. The existing Revised Rules and Regulations
Governing the Collection, Processing and Provision of Human Blood and the
Establishment and Operation of Blood Banks shall remain in force unless amended or
revised by the Secretary. The rules and regulations shall prescribe from time to time the
maximum ceiling for fees for the provision of blood, including its collection, processing
and storage, professional services and a reasonable allowance for spoilage.

SEC. 12. Penalties. – Upon complaint of any person and after due notice and hearing,
any blood bank/center which shall collect charges and fees greater than the maximum
prescribed by the Department shall have its license suspended or revoked by the
Secretary.

Any person or persons who shall be responsible for the above violation shall suffer the
penalty of imprisonment of not less than one (1) month nor more than six (6) months, or
a fine of not less than Five thousand pesos (P5,000) nor more than Fifty thousand pesos
(P50,000), or both at the discretion of the competent court.

Any person who shall establish and operate a blood bank without securing any license to
operate from the Department or who fails to comply with the standards prescribed by the
Department referred to in Section 9 hereof shall suffer the penalty of imprisonment of not
less than twelve (12) years and one (1) day nor more than twenty (20) years or a fine of
not less than Fifty thousand pesos (P50.000) nor more than Five hundred thousand pesos
(P500,000), or both at the discretion of the competent court.

The Secretary, after due notice and hearing, may impose administrative sanctions such
as, but not limited to, fines, suspension, or revocation of license to operate a blood
bank/center and to recommend the suspension or revocation of the license to practice
the profession when applicable.

The head of the blood bank and the necessary trained personnel under the head’s direct
supervision found responsible for dispensing, transfusing and failing to dispose, within
forty-eight (48) hours, blood which have been proven contaminated with blood transfusion
transmissible diseases shall be imprisoned for ten (10) years. This is without prejudice to
the filing of criminal charges under the Revised Penal Code.
SEC. 13. Separability Clause. – If any provision of this Act is declared invalid, the other
provisions hereof not affected thereby shall remain in force and effect.

SEC. 14. Repealing Clause. – This Act shall supersede Republic Act No. 1517 entitled
“Blood Bank Act.” The provisions of any law, executive order, presidential decree or other
issuances inconsistent with this Act are hereby repealed or modified accordingly.

SEC. 15. Effectivity Clause. – This Act shall take effect after fifteen (15) days following its
publication in the Official Gazette or in two (2) national newspapers of general circulation.

Approved,

(Sgd.) JOSE C. DE VENECIA, JR.


(Sgd.) EDGARDO J. ANGARA
Speaker of the House
President of the Senate
of Representatives

This Act which is a consolidation of Senate Bill No. 1011 and House Bill No. 879 was
finally passed by the Senate and the House of Representatives on April 28, 1994.

(Sgd.) CAMILO L. SABIO


(Sgd.) EDGARDO E. TUMANGAN
Secretary General
Secretary of the Senate
House of Representatives

Approved: MAY 5, 1994

(Sgd.) FIDEL V. RAMOS


President of the Philippines

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