(1) History of the Medical Laboratory Science

Definition of terms:

Medical Technology

 Heinemann- the application of the principles of natural, physical and biological

science to the performance of laboratory procedures which aid in the diagnosis
and treatment of disease.
 Fagelson- branch of medicine concerned with the performance of lab
determinations and analyses used the diagnosis and treatment of disease and
the maintenance of health.
 Walters- the health profession concerned with performing lab analyses in view of
obtaining information necessary in the diagnosis and treatment of disease as well
as in the maintenance of good health.
 RA 5527- auxiliary branch of laboratory medicine which deals with the
examination of tissues, secretion and excretion of the human body and body
fluids by various electronic, chemical, microscopic and other medical laboratory
procedures/techniques either manual or automated.

Clinical Laboratories:

 Facilities that performed chemical and microscopic examination of various body

fluids like blood and tissues.
=can be found in:
o Government hospitals
o Private hospitals
o Non-hospitals

Pathologist:

 Director of clinical laboratory = speciality in pathology as certified by PBP

 Pathology
o Practice of medicine which contributes to diagnosis, prognosis and
treatment of disease
 2 areas
o Anatomic= Autopsy and biopsy
o Clinical = chemical, microbiological, hematologic procedures

Medical Technologist:

 Baccalaureate degree in a college or university recognized by CHED

  Clinical internship in a training lab that is accredited by BHFS
 Passed the licensure exam
 Medical detectives

Employment opportunities:

 Medical technologists; specialists; clinical laboratory supervisors; chief med tech,

laboratory owners
 Research: industrial; medical
 Instructors/professors in the academe
 Employment abroad
 Pre-medicine course

Personal traits:

 Physical stamina
 Good eyesight/normal color vision
 Manual dexterity
 Good intellect
 Aptitude for the biological sciences
 Caring attitude
 Good communication skills
 Ability to relate well to others

History of Medical Technology as a Profession

Prehistoric times:

 400 B.C- diagnosis of disease greatly depends on the mere observation of the
clinical symptoms of the patient’s palpation and auscultation
 Health care problems were solved through superstitious practice, magical or
religious beliefs or the used of herbs
 Ancient Egypt
o Imhotep- provided hundreds of remedies for numerous affliction ranging
from crocodile bites to constipations
 Ancient Greece
o Aesculapius- temples of healing precursors of the first hospitals
 Rome
o Galen- viewed diagnosis of diseases as a fine art

Ancient times:
  460 B.C
o Greek Physician- Hippocrates (Father of Medicine)
o Formulate the Hippocratic Oath, the code of ethics for practicing
physicians.
o Describe four “humors” or body fluids in man:
 Blood, phlegm, yellow bile, black bile
 Urine Analysis
o Astrology, superstition and folk-lore often influenced ancient physician in
making diagnoses, but they made credible observation about urine
o Passed down from ancient times as the oldest of laboratory procedure
 Chinese
o Practiced immunization by inhaling powder made from smallpox scrabs to
develop immunity to the disease
 Roman
o Developed lab. Tools such as scalpels, forceps, specula, and surgical
needles which are still used today
 Polyuria of diabetes was noted in ancient times
o Condition fluids or body urinates more than the normal range
o Defined frequent of passage of large volume of urine 3 liters a day
 600 B.C
o Hindu physician recorded the sweet taste of diabetic urine
o Another physician noted in 1674, that urine in diabetes had taste similar to
honey

The Middle Ages

 1550 B.C
o Vivian Herrick
 Traces the beginning of medical technology when intestinal
parasites such as Taenia and Ascaris were first identified
 Elbers Papyrus
o Believe that medical technology began when a book for the treatment of
disease published; book contained the description of the three stages of
hookworm infection and the disease it could produce to human.
 Ruth Williams
o Historian of the profession
o Medical technology began from the medieval period (1096-1438) as
supported by the fact that urinalysis was a fad.
 14th century
o Anne Fagelson
  believe that medical technology started when a prominent Italian
doctor at the University of Bologna employed Alessandra Giliani to
perform different tasks in the laboratory.
 1632
o Anton van Leeuwenhoek
 Invented and improved the compound microscope (1632)
 He was the first to describe red blood cells, to see protozoa, and to
classify bacteria according to shape.
 Around 1628-1694
o Malphigi- greatest of the early microscopist; his contributions to
embryology and anatomy made him known as the “Father of Pathology”
 Discovery of the different dyes such as aniline dyes used in staining
microorganisms was in the mid-15th century
 1815- Physicians started to recognize the use of lab findings using cadavers to
elucidate the causes of the diseases; it was first introduced by Karl Von Humbeldt
 Spread to Greece, Japan, Turkey, US and England
 1844
 M. Ruth Williams- University of Michigan opened the first chemistry laboratory and
began giving laboratory instruction
 Rudolph Virchow (1847)
o Founded the archives of pathology in Berlin
 Hermann Von Fehling ( 1848)
o Perfomed the first quantitative test for sugar
 Dr. William Burdou Sunderson (1878)
o Initiated used of lab. Animals for experiments as part of the means of
diagnose disease
 Dr. William Occan (1800)
o Collected data by using lab procedures to diagnose his patients
 Blood letting
o Curing most afflictions
o Bled with leeches by cutting a blood vessel
o Practice ended and stud y of blood and its cellular element began

Progress 1600-1900:

o 1625- development of microscope described

o 1673- functional fundamental; (microscope) become available
o 1837- pioneering course in medical microscopy was first taught in Paris
o 1850- Aniline dyes used throughout the lab. Then and today were
developed
 1878
 o Dr. William H. Welsh
o Father of American Pathology
o Set up first pathology laboratory in America at Bellevue Hospital
 1896
o First clinical laboratory was opened a 12 foot by 12 foot room equipped at
cost of 50$ at John Hopkins Hospital (Dr. William Osler.)
o Operated in hospitals at Boston, New York and Philadelphia
 From 1886 and the years that followed, many clinical laboratories were
established in the different parts of the United States. This caused an increase in
the demand for appropriately trained lab. Technicians
 Dr. James C. Todd and Arthur H. Sanford (1908)
o “manual of Clinical Diagnosis)
o Revised Title: Diagnosis and Management by Laboratory Methods
o Later editions: Editors: Henry and Davidson
 George Papaniculao- described the Pap’s staining teachnique
 First world war: biological stains used to demonstrate disease- causing bacteria
become a very important commodity

1900 to present:

o A census at the turn of the century indicated that 100 technicians were
employed in the United States. All were men but not all were medically
technicians
 WW1 (1914-1918)
o Was an important factor in the growth of the clinical laboratory with a
demand for medical personnel in the military as well as civilian hospitals,
both men and women were receiving medical training
 1915
o The state of Pennsylvania passed a law that required all hospitals be
equipped with adequate laboratories employing trained technicians
 1920
o The census recorded 35000 technicians, over half were now women
 Always a need for appropriately trained medical personnel, an ad in the AMA
Journal from 1920 read, “ Wanted: A physicians technician to take change of a
well-established laboratory must be able to do all kinds of laboratory work”
 1922
o 3000 U.S hospitals indicated they had established a department for the
clinical laboratory
 1921-1922
 o First formal laboratory course was established at Woman’s Medical School
and Woman’s Hospital in Philadelphia in and recorded in the files of the
Registry of Medical Technologies
 1922
o The American Society of Clinical Pathologist, ASCP was organized
 The University of Minnesota is credited with the first degree program in Medical
Technology, established prior to 1925. It has admission requirement equivalent to
those of B.A and B.A degree
 1926
o American College of Surgeon’s accreditation standards decreed that all
hospitals have a clinical laboratory under the direction of a physicians,
preferably a pathologist
 1928
o ASCP- created the Board of Registry (BOR) to certify individual lab.
Technicians and later the Board of School for the accreditation of
educational programs. After the exam they are referred as Medical
technologist identified by the acronym “MT (ASCP)
 1933
o New organization was formed the American Society of Clinical Laboratory
Technicians (ASCLT)
o Renamed: American Society of Medical Technologists (ASMT)
 1936
o American Board of Pathologists was established
 1937
o Blood banking became a practical procedure among American hospitals
 1940
o US required a 2 year college education and a 12 month actual training in
the laboratory for practice
 1950
 A standard curriculum was formalized (4 years B.S degree)
 Post WWII
o A growing complexity of laboratory test
o Discovery of chromatography by TSWETT
o Performed of CC tests from manual to the used of spectrophotometer
 1952
o Gas liquid chromatography developed by Martin and James
 1953
o Immunoelectrophoresis ( Graber and Williams)
 1957
o Continuous flow Automatic Analyser (Leonard Skeggs)
  1960
o First studies in the US on 131 insulin in plasma ( Berson-yallow)
o Cytogenetics was developed
o Discovery of the Philadelphia chromosomes (Nowell and Hungerford)
 1965
o Uncovered the major histocompatibility complex (HLA system) (Dausett, et
al.)
 1969
o Computerization in clinical laboratories
 1975
o Introduced hybridoma technology and breakthrough in immunochemistry
and immunology leading to the discovery of tumor markers ( Kohler and
Milstein)

(2) History of Medical Technology in the Philippines

26th Medical Laboratory of the 6th US Army:

 Located in Quiricada Sta. Cruz Manila

 Now known as Public Health Laboratory
 Was left by the 6th US Army in June 1945
 Endorsed to the National Department of Health

February 1944:

 Training of High school graduate to work as laboratory technicians

Reorganization of the Laboratory:

 By Dr. Pio deroda assisted by Dr. Mariano Icasiano (who was then the Manila
City Health Officer)
 Renamed: Manila Public Health Laboratory

Training of Laboratory Workers:

 1947
 By Dr. Pio de Roda in collaboration with Dr. Prudencia Sta Ana
 The training was ineffective because:
o Trainees were never motivated
o No program was supposed to last for a definite period
o No certificates were issued

Formalizing the training of Laboratory Workers:

  1954
 Training began using the syllabus prepared by Dr. Sta. Ana and it lasted for six
months
 Dr, Briones later joined the two Dr. deRoda anf Dr. Sta.Ana

Formal medical technology education in in the Philippines:

1954

 Philippines Union College of Baesa Caloocan, Rizal offered the first four-year BS
Medical Technology course thru Manila Sanitarium and Hospital

1956

 Dr. Jesse Umali first Graduate of BS Medical Technology at PUC (Philippine

Union College)

1957-1858

 4th and 5th year BS Pharmacy students took medical technology as an elective
under Dr. Antonio Gabriel and Gustavo Reyes at UST
 Rev. Fr. Lorenzo Rodrigues
o Decided to offer medical technology as a course
 June 17, 1957
 Temporary permit was issued for 1st to 3rd year by the Department of Education

1960-1961

 June 1960
o Permit the internship program issued to UST
 June 14, 1961
o Full recognized of the 4 year BS medical technology course of UST

1962

 CEU, Mrs. Purification Sunico- Sauco undertook a feasibility study for the offering
of the BS Med Tech, Granted permisiion by the University President, Carmen de
Luna
 1962- first batch at CEU graduated
 July 05, 1962- the Bureau of Education approved the program of BS medical
Technology of IM under Dr. Horacio A Ylagan and Dr. Serafin Juliano thru the
authority of Dr. Lauro H. Panganiban (Dean, Im) and Dr. jesus Nolasco (
Secretary, IM)
PASMETH, INC. – Current Dean Bernard U Ebuen

 National organization of recognized schools

 Organized by Dr. Serafin Juliano and Dr. Gustavo U reyes as appointed by
Director Narcisso Albaraccin
 Formed on May 13, 1970
 To maintain the highest standard of MT/PH education to foster closer relations
among these schools

PASMETH Accomplishments:

 CPE for MT faculty

 Preparation of standard curriculum for BS MT schools
 Preparation od std course syllabi for professional subjects in MT
 Scholarship grants for MT students
 Community outreach projects
 Recognition of graduates of BSMT (PASMTH Gold Medal for Excellence Award)
 Accreditation as CPE provider

One of CPD provider is PAMET: current president of PAMET is Romel Saceda

 National organization of all registered MT

 Organized by Mr. Crisanto Almario (Father of PAMET)
 Organized on Sept. 15, 1963

PAMET Accomplishment:

 Recognition as a profession
 Approval of RA 5527
 Registration of PAMET with International Association of Medical Laboratory
Technologists (IAMLT) on May 28, 1970
 Proclamation of the 3rd week of sapt. As Philippine MT. Week
 Upgrading the MT profession by raising the prof. code number from 20 to 30
 Medical missions
 Closer coordination with other professional organization in the health care
delivery system
 Scholarship
 Wider affiliation with international association

The PAMET Presidents:

1. Mr. Charlemagne Tamondong

2. Mr. Nardito Moraleta
 3. Mr. Felix Asprer
4. Mr. Bernardo Tabaosares
5. Ms. Angelina Jose
6. Ms. Venerable Oca
7. Ms. Carmencita Acedera
8. Mrs. Marilyn Atienza
9. Dean Norma Chang
10. Ms. Agnes Medenilla
11. Ms. Shirley Cruzada
12. Ms. Leila Florento
13. Mr. Ronaldo E. Puno

(3) Philippine medical technology act of 1969 (RA 5527)

 Approval: June 21, 1066

 Medtech tech Us immigrants
o 8th preference (skilled workers) to 3rd preference (professional)

Amendments:

 RA 6138: August 31, 1970

 Effectivity was retroactive as of June 21, 1969
 Revised section:
o Section 16: qualification for examination
o Section 21: issuance of COR
o Section 22: fees
 PD 498: June 28, 1974
o Section 2: definition of terms (practice of MT and Medical laboratory
technician)
o Section 3: council of Mt education, composition
o Section 4: compensation and traveling expenses of the council
o Section 7: MT board
o Section 8: qualification of examiners
o Section 11: functions and duties of the board
o Section 13: accreditation of schools of medical technology and the
training laboratories
o Section 16: qualification for examination
o Section 17: the scope of examination
o Section 21: issuance of certificate of registration
o Section 29: penal provisions
  PD 1534: June 11, 1978
o Section 3: council of MT education, its composition
o Section 8: qualification of examiners
o Section 13: accreditation of school of MT and of training laboratories

Section 1: Title:

 This act may also be cited as the “ Philippine Medical Technology Act of 1969”

Section 2: Definition of Terms:

 A. practice of Medical Technology:

o A person shall be deemed to be in the practice of medical technology
within the meaning this act, who shall for a fee, salary or other
compensation or reward pain or given directly or indirectly through
another, renders any of the following professional services for the purpose
of aiding the physician in the diagnosis, study and treatment of diseases
and in the promotion of health in general
o Examination of tissues, secretions and excretion of the human body and
body fluids by various electronic, chemical microscopic, bacteriologic,
hematologic, serologic, immunologic, nuclear and other laboratory
procedures and techniques either manual or automated.
o Blood banking procedures and techniques
o Parasitologic, mycologic and microbiologic procedure and technique
o Histopathologic and cytotechnology; provided that nothing in this
paragraph shall inhibit a duly registered medical laboratory technician from
performing histopathologic techniques and procedures
o Clinical research involving patients or human beings requiring the use of
and/ or application of medical technology knowledge and procedures
o Preparations and standardization of reagents, standards, stains and
others, provided such reagents, standards, stains and others are
exclusively for the use of their laboratory
o Clinical laboratory quality control
o Collection and preservation of specimen; provided that any person who
has passed the corresponding Board examination for the practice of a
profession already regulated by existing law, shall not be subject to the
provisions of the last four preceding paragraphs if the performance of such
acts or services is merely incidental to his prefession
 B. Pathologist
 o A duly registered physician whonis specially trained in methods of
laboratory medicine, of the gross and microscopic study and interpretstion
of tissues, secretion and excretions of the human body and its functions in
order to diagnose diseases, follow its course, determine the effectivity of
treatment, ascertion cause of death and advance medicine of research
 C. Medical Technologies
o A person who engages in the work of medical technology under the
supervision of a pathologist of licensed physician authorized by the
Department of Health in places wher there is no pathologist
o Passed the prescribed course (BSMT, BSH) of training examination and
registered under the provision of this act
 D. Medical laboratory technicians
o Certified and registered by the board
o Assists a medical technologist and or pathologist
 E. Accredited Medical Technology Training Laboratory
o Clinical laboratory, offices, agency, clinic, hospital or sanitarium
o Most approved by the Department of Education
o Approved by DOH or its authorized agency
 F. recognized School of Medical Technology
o School, university or college that offers BSMT
o Approved by DOE
 G. Council
o The council of medical technology education
 H. Board
o The board of examiners for MT established under this Act.

Section 3: Council of medical Technology, it’s Composition:

 Chairman: director of higher education

 Vice chairman: chairman of the professional regulation commission
 Members:
o Director of BRL of DOH
o The chairman and the 2 members of the board
o A representative of the deans of PASMETH
o President of PSP
o President of PAMET

Section 4: Compensation and Travelling Expenses of Council Members:

 Php 50.00 per item for every meeting actually attended for the chairman
 Php 25.00 per diem for member
  They are also entitled to travelling expenses in connection with their official
duties

Section 5: Functions of the Council of Medical Technology Education:

 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
o Students- instructor ratio
o Check the facilities of school
 Approved School offering BSMT and to recommended closure
 require all MT schools to submit an annual report on or before the month of
June
o total number of students and instructors
o list of facilities
o list of recent graduates
 to inspect the diff. schools of MT
 to certify for admission into an undergraduate internship
o Php 5.00 is collected from every applicant
 Formulate and recommend approval of refresher course
 Prescribe and enforce necessary rules and regulations for the proper
implementation of the foregoing functions

Section 6: Minimum Required Course:

 3 years academic and 12 months internship

 CMO 12 section 2017

Section 7: Board of Examiners for Medical technology:

 Under PRC
 Composition
o Chairman: pathologist (marylene a. cabarza)
o 2 members: RMT’s (marylene ateinza and marian n. tandig)
o mary
 appointed by the president of the Philippines
 hold 3 years of office after appointment
o in case of death, disability or removal, the successor shall serve only the
balance of his term

Section 8: Qualifications of Examiners:

  a Filipino citizen
 good moral character
 qualified pathologist or RMT
 has been in practice of laboratory medicine or medical technology for at least 10
years prior to his/her appointment
o may be reduced to 5 years
 not a member of the faculty of any medical technology school for at least 2 years
prior to his/her appointment

Section 10: Compensation of Members of the Board of Examiners:

 Php 10.00- for each applicant examined

 Php 5.00- for each applicant granted a certificate of registration without
examination

Section 11: Function and Duties of the Board:

 Administer the provisions of this act

 Administer oaths
 Issue, suspend, revoke certificate of registration
 Look into conditions affecting the practice of medical technology
 Investigate violations of this act
 Draft rules and regulations as may be necessary to carry out the provisions of
this act
 To determine the adequacy of the technical staff of all clinical laboratories and
blood banks before licensing
 To prescribe the qualifications and training of medical technologists as to special
fields
o Supervise their specialty examination
 To classify and prescribe the qualification and training of the technical staff
clinical laboratories
o senior medical technologist
o Medical technologist
o Medical laboratory technician

Section 12: Removal of Board Members:

 Reasons for removal

 Board member is removed by the president after given due process
 The president shall also appoint a temporary member during his investigation
and suspension
Section 13: Accreditation of Schools of Medical Technology and of Training
Laboratories

 THE BOARD OF Medical Technology shall recommend to DOE the approval of

schools offering BSMT
 The DOH through the BRL shall approve of laboratories for accreditation as
training laboratories for MT students or post-graduate trainees
 Requirements:
 Posses qualified personnels
 Properly equipped for CC, Microbio, Sero, Para, Hema, BB,CM and histopath
 The scope of activities should offer sufficient training

Section 14: Inhibition against the Practice of Medical Technology:

 A valid certificate of registration is needed to practice medical teachnology

 Exemptions:
o Duly registered physicians
o MT’s from other countries
 For consultation purpose
 Visiting or exchange professors to college and universities
 Mt’s in the services of USAF
 Should render services only to their members

Section 15: Examination:

 Board exam
o Give 2x a year: march and September
o Covid: January, march and September
 Location and lay is specified by the board
 Written notices shall be published in at least 3 national newspaper by the
secretary of the board 30 days prior to the date of exam

Section 16: Qualification of Examination:

 In good health
 Of good moral character
 Completed the course of BSMT of BSPH
 Graduated from some other profession
o Performing medical technology for the last 5 years prior to the date of
examination if such performance began prior to June 21, 1969

Section 17: Scope of Examination:

  Clinical chemistry -20%
 Microbiology and Parasitology- 20%
 Hematology- 20%
 Blood Banking and Serology- 20%
 Clinical microscopy (urinalysis and other body fluids)- 10%
 Histopathologic techniques, cytotechnology, med tech laws and its implementing
rules, and code of ethics- 10%
 The board
o Prepares the schedule of exam and submit to the commissioners of PRC
for publication at least 30 days prior the exam.
o May change, add to or remove from the list of subjects or weights above
as progress in the science of Medical Technology may require
 Should be approved by the PRC and be published three months
before exam
o The board shall compute the general average of an examinee according
to the above- mentioned relative weights of each subject

Section 18: Report of Rating:

 The board will report the result of the examination to the commissioner of Civil
Service within 120 days
 The commissioner of the civil service will in turn report it to the president of the
Philippines for approval

Section 19: Ratings in the Examination:

 A general average of 75% must be obtained in the written test

 No rating below 50% in any of the major subject
 No failure in at least 60% of the subject compound according to their relatives
weights
 Failure of 3x = 12 months refresher course an accredited lab
 If a person is graduate of another paramedical course, no further exams will be
given after failing for the third time

Section 20:Oath Taking:

 Oath should be taken

 Before the 16oard
 Before any person authorized to administer oath

Section 21:Issuance of Certificate of Registration:

  The certificate of registration should always be displayed in his/her place
of work
 A certificate of registration shall be given to every successful examinee
o Signed by the board
o Php 115.00
 The board may also issue a certificate of registration w/out examination to
persons who have been graduated with BSMT/BSPH in the Philippines or in
other country (standard should be the same with ours)
o Provide that
 They have in been in practice for 3 years before June 21, 1969
 The board may also provide certificate of registration to any person
graduate from any profession
o Provided that they have been practicing medical technology for the
past 8 years
 Prior to June 21, 1969
 For Medical Technicians:
o No examination
o Pay Php 50.00
o A certificate of registration may be issued to them if:
 passed the civil service examination for medical technician
given March 21, 1964
 has finished a 2 year collage course
 1 year of experience as medical laboratory technician
 For every years of deficiency in college attainment, 2
years of experience may be substituted
 A medical technician who has been practiced for 10 years
regardless of his educational attainment may qualify for
registration without examination

Section 22: Fees:

 50.00 per applicant for each certificate of registration issued

 25.00 for certificate lost
 20.00 for certificate destroyed or multilated
o Pay to the disbursing office of the CSC
o Money will be used for the expenses ad compensation of the board

Section 23: Refusal to Issue Certificate:

 If convicted by the court of any criminal offenses involving moral turpitude

 Guilty of immoral or dishonourable conduct
  Of unsound mind
 Incurable communicable disease
 A letter will be given to the applicant stating the reason for refusal

Section 24: Administrative Investigation:

 Investigation shall be conducted by at least two members of the board with one
legal officer sitting during all administrative proceedings
 Revocation of certificates
o Right of respondents
 Entitled to be represented by counsel or be heard in person
 Have a speedy and public hearing
 To confront and cross-examine witnesses against him or her
 To all other rights guaranteed by the constitution
 Sanction:
o Reprimand or penalty
o Revoke of license
o Suspend- should not be more than 2 years
 The certificate of registration should be surrendered within 30 days after the
decision become final
o Perpetual disqualification if not
 The suspension shall run from the date off suspension
 Reason of revocation or suspension
o Unprofessional conduct
o Malpractice
o Incompetency
o Serious ignorance
o Grow negligence in the practice of medical teachnology
o For causes enumerated in section 29 of this act

Section 25: Appeal:

 Appeal are made to the civil service commissioner

o Their decision become final after 30 days
o The respondent can appeal to the office of the President of the Philippine
within the same period

Section 26: Reinstatement, Reissue, or Replace of Certificates:

 For proper and sufficient reasons, the board may reissue an revoked registration
 The suspension of a certificate shall be re-issued to the medical technologist
concerned upon request without prejudice to further actions
Section 27: Foreign Reciprocity:

 Foreigners cannot take the Philippines board exam

 Foreigners will not be issued certificate of registration
 Foreigners are not entitled to the rights and privileges under this Act
 Unless
o His country permits the same privileges to a Filipino Medical Technologist

Section 28: Roster of Medical Technologists:

 The roster is prepared by the secretary of the board

 It contains the Med Tech’s:
o Name
o Address
o Citizenships of each registered Medical Technologist
o Date of registration or issuance of certificate
o Other pertinent data
 Copies are sent to each medical technologist listed to it
 It is open to the public, private or governmental, upon request
 It is one file in the following offices:
o Offices of the president
o Department of health offices
 Department heads
 All bureau
 Offices
 Instrumentalities

Section 29: Penal Provisions:

 A fine of not less than two thousand pesos nor or 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 is given to the following:
o Unregistered Med tech or exempted from registration in accordance to the
provisions of this act
o A med tech not supervised by a pathologist or physician authorized by the
DOH
 A med tech who makes false report
 A med tech who refuses to display his certificate of registration in the place
where he works
o Warning is given by the board
 Any person using the COR of another
  Any person who shall give any false evidence of any kind to the board or any
member thereof in obtaining a certificate of registration as Medical Technologist
 Any person who shall impersonate any registrant or like or the same name
 Any person who shall attempt to use a revoked or suspended certificate of
registration
 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 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 medical
technologist/medical laboratory technician knowing that he is not registered as
such


Section 30: Separability Clause:

 All acts, executive, rules and regulations, or parts thereof inconsistent with the
provisions to any persons or circumstances is declare invalid by a court of
competent jurisdiction, the remainder of this Act of the application of such
provisions to other persons or circumstances shall not be affected by such
declaration.

Section 31: Repealing Clause:

 All acts, executive, rules and regulations, or parts thereof inconsistent with the
provisions of this Act are hereby repealed. Provided, however that nothing in this
act shall be construed as repealing or amending any portion of the Medical Act of
1959 (R.A 2382, as amended by R.A 4224), the Clinical Laboratory Act of 1966
(R.A 4688), and the Blood Banking Law of 1956 (R.A 15170

Section 32: Effectivity:

 This Act shall take effect upon its approval

 Approved: June 21, 1969

(4) RA 4688: CLINICAL LABORATORY LAW

TITLE:
  “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 Therefore and for other Purposes”

RA 4688:

 Approved: June 18, 1966

o Promulgated for the purpose of preventing the operation and
maintenance of substandard, improperly managed and poorly
equipped clinical laboratories
 Clinical laboratory law

Primary Purpose of Clinical Laboratories:

 To determine the character and quantity of the various chemical substances

in the blood and other body fluids, tissues, secretion and excretions
 To assist the different substances of secretion and excretion of the human
body

A.0 No. 59 s. 2001: A.0 No. 2007- 0027(Rules and Regulations Governing the
Establishment, Operation and Maintenance of Clinical Laboratories in the
Philippines):

Section 1: Title:

 “ Rules and Regulations Governing the Establishment, Operation and

Maintenance of Clinical Laboratories in the Philippines”

A.O. No. 2007- 007:

 “Revised Rules and Regulations Governing the Licensure and Regulation of

Clinical laboratories in the Philippines”
o To make sure the laboratory to release accurate and precise result
 Approved: August 22, 2007
 Updates the minimum standards and technical requirements for clinical
laboratories
o Ensures accuracy and precision of Laboratory examination sin order to
safeguard public health and safety

Section 2: Authority:

 Issued to implement R.A. 4688: Clinical Laboratory law

 Consisted with E.O. 102 s. 1999: Redirecting the functions and operations of the
DOH
  The DOH, thru the BHFS in the Health Regulation Cluster, shall exercise the
regulatory functions under these rules and regulations

Section 3: Purpose:

 To protect and promote the health of the people

o By ensuring the availability of clinical laboratories
o Properly managed (Clinical laboratories) with adequate resource
(Primary, Secondary and Tertiary Laboratories)
o Effective and efficient performance thru compliance with quality standards
(Quality control and Quality assurance program)

Section 4: Scopes:

 All entitles (all individuals, agencies, partnerships or corporations that operate

clinical laboratories in the Philippines) performing the activities and functions of
Clinical laboratories
o Examination and analysis of
 Any or all samples of human and other related tissues
 Fluids
 Secretions
 Excretions
 Radioactive
 Other materials from the human body
o For
 Prevention, diagnosis and treatment of diseases
 Promotion of personal and public health
o Exemptions
 Government clinical laboratories doing microscopy work only for
specific DOH programs
 Malaria screening
 Acid fast bacilli microscopy
 Tests for STI’s
 Cervical cancer screening using PAP’s smears
o Their services are declared as extension of a licensed
government clinical laboratory

Definition of Terms:

 Applicant- person who intends to operate a clinical laboratory

 BHFS – Bureau of Health Facilities and Services
o To set minimum standard
 o To disseminate the regulation
 CHD
 Clinical laboratory
o A facility where test are done
o To obtain information about the health of a person
o Tests include: CC (urinalysis) , hema, Immunohema. Microbio,
immunology, CM, Histopath, cytology, toxicology, endocrinology,
molecular biology and cytogenetics
o Other function of the clinical lab
 Advisory services covering all aspect of laboratory investigation
(includes interpretation of results and advice on further
investigation)
o Total testing process;
 Pre-analytical
 Analytical
 Post-analytical
o Critical values
 Panic values
 “life- threatening” (lundberg)
 Corrective actions should be taken
o DOH
o EQAP
 Lab are given unknown samples and are processed the usual way
o Inspection tools
 Checklist used by regulatory officers
 To evaluate compliance to the minimum standards and technical
requirements
o Institutions
 Corporate body or establishment for an educational, medical,
charitable, or similar purpose
o License
 Issued by the DOH upon compliance with the requirements for
setting up a clinical lab
o Licensee
 To whom the license is issued
o LTO
 License to operate
o Mobile clinical laboratory
 Lab testing unit
 Moves from one testing site to another or has temporary testing site
  Should have a base laboratory
o Monitoring examinations
 Tests done in series
 Guide for treatment or follow-up of their condition
o NRL –national reference laboratory – government laboratory
 Designated by the DOH
 Government laboratory
 Functions include:
 Confirmatory testing
 Surveillance
 Resolution of conflicting results between or among
laboratories
 Training
 Research
 Implementation of EQAS
 Evaluation of diagnostic kits and reagents
o POL
 Physician’s Office Laboratory
 An individual doctor’s office/ clinical wherein lab examination are
performed
o POCT
 Point of care testing
 Diagnostic testing at or near the site of patient care
 Include:
 Bedsides testing
 Outpatient
 Home care
o Routine test
 Basic tests
 Follow the usual procedure and system in the laboratory
o Satellite testing site
 Testing site outside the physical confines of the lab
 Under administration control of the lab
o STAT tests ( sta’tim = immediately)
 Done on urgent cases
 Results are released immediately (w/in 1 hour)

Section 5: Classification of Laboratories:

 Classification by Ownership
o Government
 o Private
 Classification by function
o Clinical pathology
 CC, hema, immunohema, micro, immunology, CM, endocrinology,
mole bio, cytogenetics, toxicology, therapeutic drug monitoring
o Anatomic pathology
 Surgical, immunohisto, cytology, autopsy, forensic, molecular
 Classification by institutional character
o Institution based- operatres witihin the premises and as part of an
institution
 Hospitals, medical clinic, schools, medical facility for OFW’s and
seafarers, birthing home, psychiatric facility
o Freestanding- does not form part of any institution
 Classification by service capability
o General clinical laboratory
o Special clinical laboratory

 General clinical laboratory

o Primary category minimum service capability
 Routine Hematology- cbc, h/h, wbc ct (leulocytes number fraction),
Diff ct (leukocyte type nu,ber fraction
 Qualitative platelet determination
 Routine urinalysis
 Routine fecalysis
 Blood typing ( for hosp based)
 Secondary- primary lab +
o Routine clinical chemistry- blood glucose substance concentration
o BUN, BUA, creatinine, total chole
o Quantitative platelet determination
o Cross matching
o Gram staining KOH
 FOR HOSPITAL BASSED
 Tertiary lab- primary + secondary lab
o Special chemistry
o Special hematology +coagulation procedures
o Immunology
o Microbiology –CNS
 Aerobic and anaerobic (for hosp- based)
 Aerobic and anaerobic (for non- hosp- based )
 Clinical lab may go beyond minimum services capability provided that
 o With proper staff, equipment’s, reagent, supplies additional service should
be listed in the LTO
 Limited service capability (for institution based only)
o Lab test for a particular service in the institution
 Example: dialysis and social hygiene
 Special clinical laboratory
o Offers a highly specialized lab service not offered by a general clinical
laboratory

VI: Guidelines:

 General guidelines
o LTO is issued only to those who can comply with requirements (by BHFS)
o Clinical laboratories for teaching and research is exempted from
requirements but is required to register with BHFS
o Special clinical laboratories
 Assisted reproduction technology laboratories
 Molecular and cellular technology
 Molecular pathology
 Molecular biology
 Forensic pathology
 Anatomic pathology laboratories
 Required to register with the BHFS w/o being licensed
o NRL’s within clinical laboratories in hospitals shall be covered by clinical
laboratory’s license
o Independent NRL’s shall register with the BHFS
 Provided
 They are accredited or certified by an international
accrediting or certifying body
 CDC of USA
 WHO
 Local accrediting or certifying body recognized by DOH
o POL’s are required to register of
 They issue laboratory results
 They perform more than monitoring examinations
 They cater not only to the physicians own patients
o POCT
 Under management and supervision of the licensed clinical
laboratory of the respective hospital

Specific Guidelines:
 Standards- all CL’s should be organized quality, effective and efficient lab service
 A. human resource
o Pathologist- head of lab
 Either clinical or anatomic and certified by PBP
 Have a administrative and technical supervision of activities
 Supervision is according to standards set by the PSP
 With adequate number of med tech’s with documented trainings
 With staff development and continuing education
 B. Equipment
o Available and operational equipment
o Calibration, preventive maintenance and repair program
o A contingency plant in case of equipment breakdown
 C. Glassware, reagents and supplies
o Should be made available always
o With inventory control
o Stored under the required conditions
 D. Administrative procedures
o Written policies and procedures
 For provision of lab services
 For operation and maintenance of the lab
 E. Technical Procedures
o Documented technical procedures in each section of the lab
o Ensures quality of lab results
 F. Quality Assurance program
o Internal Quality Assurance Program
 Internal quality control program for technical procedures
 Internal quality assurance program for inputs, processes and
outputs
 Continuous quality improvement program covering all aspects of
lab performance
o External Quality Assurance Program
 Administered by NRL- local or international
 Approved by DOH
 G. Communication and Records
o There should be procedures for:
 Receipt and performance of routine and STAT requests
 Reporting of results of routine and STAT including impact values
that would impact on patient care
  Reports should include: names and signature of pathologist (
accountable for results) and med tech ( performed the
exam); E- signature are accepted
 The reporting of workload, QC, inventory control, work schedule
and assignment
 Reporting and analysis of incidents, adverse events and handling
complaints
o Retention of lab records shall be in accordance to the standards
promulgated by the DOH
 G. Physical Facilities/ Work Environment
o Conform to all applicable local and national regulations for the
constructions, renovation, maintenance and repair
o Conform to the required space
o Well ventilated, lighted, clean safe and functional areas
o Maintenance and monitoring of physical plant and facilities
o Proper disposal of waste and hazardous substances
o Biosafety and biosecurity
 H. Referral of examinations outside of the Clinical lab
o Memorandum of Agreement- for assurance of the quality of services
rendered by the outside lab

Licence to Operate:

 Issued in the name of the licensee

o Non transferable
o Not valid other than the premise stated in the license
 Valid for a year
o Expires on the date set by CHD
o Expiry is seen on the face of the license
 For non-hospital based lab
o Name of clinical lab
o Name/s of the owner or operator
o Head of the lab
o Service capability
o Period of validity
o License number
o Location wherein in the laboratory procedures are to be performed
 LTO should be displayed at all times for non-hospital based lab
 For hospital based lab
o One-stop-shop licensure for hospitals
o They are licensed as part of the hospitals
 o No need for a separate license
 HIV and Drinking water analysis
o Should be indicated in the LTO as service capability
 A satellite lab within the same compound as the central lab shall have only one
LTO
 A satellite lab outside the premised of the central lab shall have a separate LTO
 Mobile clinical lab is licensed as part of the main lab and permitted to collect
specimens only
o Operate within 100 km radius from its main lab
 Changes should be reported to the concerned CHD within 2 weeks
o Should be in writing, signed by licensee and submitted to the concerned
CHD for natation
 Reason for suspension, revocation and suspension of modification in full and part
o Material false statement of the applicant
o Failure to comply with any of the terms and conditions and provision of
these rules and regulations

Procedural Guidelines:

 A. registration for special clinical laboratories, NRL’s, Research and Teaching

laboratories
o Get application form from BHFS, CHD, DOH website
o Submit to the BHFS OR CHD
o Pay non-refundable application fee for certificate of registration upon
submission of accomplished form and documentary requirements
o BHFS will evaluate and accept application based on due execution of
forms and completeness of attachments
 B. Procedure for application for initial/ Renewal of LTO
o Get application form from BHFS, CHD, DOH website
o Submit to the CHD
o Play non-refundable application fee
o CHD will conduct inspections in accordance with licensing requirements
 D. Renewal of LTO
o Renewal shall be on the first day of October to the last day of November
of the current year. Discount is given if complete application is filed during
this time
o Processed not later than 5 working days after the expiration of the license
o Automatic cancellation w/o notice if one fails to submit application form
and pay the fee on or before the expiration date
 Inspection
o Inspections by CHD are announced
 o Ensure accessibility of the premises and facilities
o Ensure the availability of all pertinent records
o Inspection too
 Used during inspection
 Contains standards, criteria and technical requirements
 Monitoring
o CL’s are monitored regularly
o CHD or BHFS does the monitoring
o CL’s should ensure the availability of lab records, premises and facilities
o Notice of violation for non-compliant lab is issued immediately after
monitoring
o CHD submits a quarterly summary of the violations to the BHFS stating
the name of the clinical lab, location, violation and course of action taken
o Provincial, city and municipal health officers are to report the existence of
unlicensed CL’s

Schedule of Fees:

 Initial application/ renewal of LTO has un-refundable fees

 Checks/fees shall be paid to the order of DOH in person through postal money
order
 Fees, surcharges and discounts shall follow the current DOH prescribed
schedule of fees

Violation:

 Refusal to participate on an EQAP

 Issuance of report, written or orally, in whole or portion that are not in accordance
with the documented procedure
 Permitting unauthorized persons to perform technical procedures
 Incompetence or making consisted errors
 Deviation from standard test procedures including use of expired reagents
 Reporting/ release of erroneous results
 Lending the name of the lab or the head of the lab to an unlicensed CL
 Use of name and signature of MT and pathologist to obtain LTO
 Reporting a result without performing the test
 Transfer of results from outside lab to the results form of the referring lab
 Performing and reporting test in a specialty and subspecialty in which the lab has
no license
  Giving and receiving any commission, kickback or rebate or engaging in any
split fee arrangement in any form with any facility, physician, organization,
agency or person, directly or indirectly for patients referred to the CL

Investigation of Complaints:

 BHFS or CHD conducts the investigation

 CHD director or representative, after investigation, shall suspend, cancel or
revoke for a determined period of time the LTO of the licensees who found
violating the provisions of RA 4688
 CHD can seek assistance of any law enforcement agency to execute the closure
order

Penalty:

 Imprisonment of 1 month
 Penalty of Php 1000-5000
o If the offender is a film/corporation
 Health of lab or manager is liable to the penalty

Appeal:

 Appeal is made to the office of the health secretary within 10 days after the
receipt of notice of the decision

Repealing Clause:

 Provisions form previous issuances that are inconsistent or contrary to the

provisions of this order are hereby rescinded and modifies accordingly

Separability Clause:

 In the event that any provision or part of this order be declared unauthorized or
rendered invalid by any court of law or competent authority, those provisions not
affected by such declaration shall remain valid and effective

A.O. NO 59 S. 2001:

Section 6: Policies:

 Permit to construct and design lay-out

o Secure from BHFS
o Given prior to submission of an application of a petition to operate
 Plans should be approved and construction permit should be issued by the BHFS
 Operation is permitted only with a valid license
  Lab should be organized
 Appropriate safety practices

Section 7: Requirement and Procedures for Application of Permit to Construct and LTO:

 Application for permit to construct

o Letter of application to BHFS
o 4 sets of site developments plans and floor plans approved by an architect
or engineer
o DTI/ Sec registration ( for private lab)

Technical Standards and Minimum Requirements:

Staffing:

 Pathologist
o Head of the lab
o Certified by PBP
o Physician with 3 moths training on clinical lab med, QC and lab
management may manage primary and secondary lab
o Certification should come from the BHFS
 Med Tech’s
o Should be registered
o Number should be proportional to the workload
o Available at all times
o At least one med tech per shift for the hospital-based lab
 Other
o Qualified and adequately trained
o Work assignment should be consistent with the qualification of the
concerned personnel
 Staff development
o Trainings
o Seminars
o Continuing educational program
o Available at all levels
o To upgrade the knowledge, attitudes and skills of staff

Physical Facilities:

 working space:
 category
o Primary- 10 square meters
o Secondary – 20 square meters
 o Tertiary ( to include a separate, enclosed and adequately ventilated room
for microbiology) – 60 square meters

Equipment:

Recording:

 All laboratory records should be kept on file for at least 1 year

 Anatomic and forensic pathology shall be kept permanently

SECTION 4: REPUBLIC ACT NO. 8981: PRC MODERNIZATION ACT OF 2000

Functions of the Professional Regulation Commission

Regulation of the professions is not the only function of the Commission; the
commission’s functions can be categorized as either
Quasi-judicial
- Involves the investigation of unlawful, inappropriate and destructive behavior of
examinees and professionals.
- The decision of the Commission is as authoritative as that of a Regional Trial Court
- If no appeal is made within the period the Commission provided, its decision becomes
final and executory.
Quasi-legislative
- The formulation of rules and policies falls under the quasi-legislative function of the
Commission
- These rules and policies have the same binding effect as an actual law
Executive Function
-This function of the Commission includes the implementation, administration, and
enforcement of regulatory policies of the national government with the maintenance of
professional occupational standards and ethics; and the enforcement of the rules and
regulations.
Republic Act No. 8981

➢Otherwise known as “The PRC Modernization Act of 2000”

➢ Repealed PD 223
An act modernizing the PRC, repealing for the purpose PD 223, entitled “creating the
PRC and prescribing its power and functions” and other purposes
SECTION 1: TITLE
- This act shall be called the “The PRC Modernization Act of 2000”
SECTION 2: STATEMENT OF POLICY
- Promotes the sustained development of a reservoir of professional
❖ Competence is determined by honest and credible licensure examinations

❖ Standards of professional service and practice are internationally recognized and

considered world class
- Brought about by regulatory measures, programs and activities that promotes
professional growth and advancement

SECTION 3: PROFESSIONAL REGULATION COMMISION

-A three-man commission
-referred to as “Commission”
- attached to the office of the President for general direction and coordination
SECTION 4: COMPOSITION
- One (1) full-time chairperson
- 2 full-time Commissioners
 appointed by the President for a term of seven (7) years
 without reappointment
 Terms starts as soon as they assume office
 For expiration of the term of the Chairperson, the most senior commissioner can
take his place until a permanent chairperson is appointed by the President.
❖ Qualifications of the chairperson:


40 years of age

With valid certificate of registration/professional license

Valid professional identification card or valid certificate of competency (issued
by the Commission); or
 Valid professional license (issued by any government agency)
 Familiar with the principles and methods of professional regulation and/or
licensing
 At least 5 years of executive or managerial experience
 One of the commissioners must be a past Professional Regulatory Board
SECTION 5: EXERCISE OF POWERS AND FUNCTIONS OF THE COMMISIONS
- To exercise general administrative, executive and policy-making functions of the
commission
- Establish and maintain a high standard of admission to the practice of all
professions
- Ensure and safeguard the integrity of all licensure examinations
Chairperson: PRESIDING and CEO

✓ Preside over the meetings of the commission sitting as a collegial body

✓ Responsible for the implementation of the policies and the programs adopted by
the commission

✓ Perform other activities which are necessary for the effective exercise of the
powers, functions, and responsibilities of the commission.
SECTION 6: COMPENSATION AND OTHER BENEFITS
 Chairperson: equivalent to that of a Department Secretary
 Commissioners: equivalent to that of an Undersecretary
 *Both are entitled to retirement benefits provided under RA 1568 as amended by
RA 3595

SECTION 7: POWERS FUNCTIONS AND RESPONSIBILITES OF THE COMMISSION

 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
 To perform all acts necessary in the execution and implementation of its
functions and improvement of its services
 To review, revise, and approve resolutions, embodying policies promulgated by
the Professional Regulatory Board
 To administer and conduct the licensure examinations of the various regulatory
boards in accordance with the rules and regulations promulgated by the
commission
✓ Conduct more than 1 licensure examination
 When there are 2 or more exams given per year, 1 examination should
be held on weekdays (Monday to Friday)
 When there is only 1 exam is given in a year, this should be held only on
weekdays
✓ Require a refresher course for those who failed the board exam 3 times
✓ 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
✓ Publish the list of successful examinees
✓ Provide schools offering courses with licensure exams a copy of sample test
questions on exams recently conducted
✓ Provide schools with a copy of the syllabi or terms of specifications of subjects
for licensure exams
✓ Impose the penalty of suspension or prohibition from taking licensure
examinations to any examinee found guilty of violating the rules and regulations
governing the conduct of licensure exams promulgated by the commission

 To admit the successful examinee to the practice of the profession or occupation

✓ Enter their name on their registry book and computerized data base
✓ Issue certificates of registration/professional license
Bear the name, picture and registration number
 Signed by all the members of the board and the chairperson
With official seal of board and commission
 To have custody of all the records of the various Boards
Including
Examination
Minutes of deliberation
Records of administrative cases and investigation
Examination results
 Determine and fix the amount of fees to be charged and collected
 To appoint officials and employees of the Commission necessary for the effective
performance of its functions and responsibilities
 To assign and/or reassign personnel as the exigency of the service requires
 Organize or reorganize the structure of the Commission
 Create or abolish positions or change the designation of existing positions
✓ In accordance with a staffing pattern prepared by it
✓ Approved by the Office of the President
✓ Recommended by the Department of Budget and Management (DBM) to meet
the changing conditions or as the need arises
Changes shall not affect the employment status of the incumbents, reduce
their ranks and/or salaries or result in their separation from the service
 To submit and recommend to the President names 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
 To approve the registration, issue COR/License w/ or w/o exam to a foreigner
✓ upon recommendation of the Professional Regulatory Board concerned
✓ Registered under the laws of his state or country
✓ COR has not been suspended or revoked
✓Foreign reciprocity applies (same standard with the Philippines)
 The commission may also issue COR /License or special temporary permits to
foreign professionals
under reciprocity
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
health professionals engaged in humanitarian mission for a limited period
of time
The agencies, organizations or individuals who secure the services of
foreign professional is responsible for securing the special permit from
PRC and DOLE
 To authorize any officer of the Commission to administer oaths:
 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 ensure that the terms and conditions for their practice or of their
employment are strictly complied with
✓To require the hiring or employing agency or to secure a temporary special
permit from the concerned Board subject to approval by the Commission
✓To file a criminal complaint against the head of the agency who allows the
professional to practice his profession without permit
✓To file upon due process request for deportation with the Bureau of Immigration
and Deportation (BID)
✓To supervise professionals who were former citizens of the Philippines and
were registered and were issued COR and license before becoming foreign
citizens, who may, while in the country on a visit, sojourn or permanent
residence, practice their profession
prior to their practice they shall have first been issued a special permit and
updated professional ID by the Board concerned as approved by the
commission and upon A Self-regulated Learning Module 55 payment of
the permit and annual registration fees
 To monitor the performance of schools in licensure examinations and publish the
results thereof in a newspaper of national circulation;
 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;
 To exercise administrative supervision over the various professional regulatory
boards and its members;
 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;
 To implement the program for the full computerization of all licensure
examinations
✓ including the registration of professionals not later than the year 2003 and
other operations of the Commission
 To investigate motu proprio or upon the filing of a verified complaint, any
member of the Professional Regulatory Boards for the following reasons
✓ 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
 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
 Hold in contempt in erring party or person only upon application with a court of
competent jurisdiction
 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, 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;
 To initiate an investigation, upon complaint under oath by an aggrieved party, of
any person who:
✓ practices the regulated profession or occupation without being authorized by
law
✓ without being registered and licensed by the concerned regulatory board and
issued the corresponding license/professional identification card or temporary or
special permit
✓ commits any of the prohibited acts provided in the regulatory laws of the
various professions
If acts are criminal in nature, and with strong evidence the records shall be
forwarded 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 A Self-regulated Learning Module 57 the Commission who may
prosecute said case/s upon being deputized by the Secretary of Justice
 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
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
PROFFESIONAL REGULATORY BOARDS
 Regulate the practice of the professions in accordance with the provisions of their
respective professional regulatory laws;
 Monitor the conditions affecting the practice of the profession or occupation
under their respective jurisdictions
 ✓ adopt measures for the enhancement of the profession or occupation and/or
the maintenance of high professional, ethical and technical standards,
✓ may conduct ocular inspection in industrial, mechanical, electrical or chemical
plants or establishments, hospitals, clinics, laboratories, testing facilities, mines
and quarries, other engineering facilities
 To hear and investigate cases arising from violations of their respective laws, the
rules and regulations promulgated there under and their Codes of Ethics
✓ May issue summons, subpoena and subpoena duces tecum to alleged
violators and/or witnesses to compel their attendance in such investigations or
hearings
✓ 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;
 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
 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,
✓ render summary judgment which, unless appealed to the Commission,
become final and executory after fifteen (15) days from receipt of notice of
judgment or decision
 To recommend registration w/o exam and issuance of COR and professional ID
card
✓ Subject to approval of the PRC
 After due process, to suspend, revoke or reissue, reinstate certificate of
registration or licenses for causes provided by law;
 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 should 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
✓ 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;
 ✓ determine the appropriate passing general average rating in an examination if
not provided for in the law regulating the profession
SECTION 10: COMPENSATION OF THE MEMBERS OF THE PROFFESSIONAL
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
✓ That the Chairperson of the Regulatory Board shall receive a monthly
compensation of two steps higher than the members of the Board,

✓ They are also entitled to other allowances and benefits provided under existing
laws.
SECTION 11: PERSONS TO TEACH SUBJECTS FOR LICENSURE EXAMINATION
ON ALL PROFFESSIONS
 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, assist in enforcing the regulatory law of the
profession including the rules and regulations promulgated
 ✓ By prosecuting the violators 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
 Aside from the annual appropriations of the Commission provided under the
Annual General Appropriations Act
✓ The Commission is authorized to use its income not exceeding the amount
P45,000,000.00 a year for a period of 5 years after the effectivity of this Act
SECTION 15: PENALTIES FOR MANIPULATION AND OTHER CORRUPT
PRACTICES IN THE CONDUCT OD PROFESSIONAL EXAMINATIONS
 Any person who manipulates or rigs licensure examination results
✓ Secretly informs or makes known licensure examination questions prior to the
conduct of the examination
 ✓ Tampers with the grades in professional licensure examinations

✓ Upon conviction
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.
For the accomplices

✓ 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 o For accessories

✓ 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
SECTION 16: PENALTIES FOR VIOLATIONS 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 A Self-regulated
Learning Module 63 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 to any person or
circumstances is declared invalid or unconstitutional, the remainder of this act or
application of such procisions to other persons or circumstance shall be affected
by such declaration.
SECTION 20: REPEALING CLAUSE
 Republic Act. No. 546, Presidential Decree No. 223, as amended by the
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 fifteen (15) days following its publication in the
Official Gazette or in two (2) newspapers of general circulation, whichever
is earlier.
 Approved: December 5, 2000

 (Sgd.), JOSEPH EJERCITO ESTRADA

President of the Philippines

Presidential Decree No. 223

➢ Created the PRC and defined its powers and functions

 Appropriating funds for the operation of the government of the Republic of the
Philippines during the period from July 1, 1973 to June 13, 1974 and for other
purposes.
 Approved: June 22, 1973
Presidential Decree No. 657

➢ PD NO. 657 amended Section 3 of paragraph (j) of Section 5 of PD 223 on the

creation of the PRC and which prescribes its power and functions.
Approved: February 19, 1975

E.O. No. 200

➢ Executive Order No. 200 institutionalized the partial computerization of the licensure
examination, which is perhaps one of the most important advances made in the
Commission.
Approved: June 18, 1987
By President Corazon C. Aquino

PRC Resolution No. 11 s. 2011

➢ Prescribes guidelines for the registration of Medical Laboratory Technicians

under Section 21 of R.A. 5527

➢ It included provisions on procedures and requirements for the applicants to comply

with.
 Approved: June 28, 1974
PRC Resolution No. 990 s. 2016

➢ Includes amendments to the revised guidelines on the continuing professional

development (CPD) program for all registered and licensed professionals.
Executive Order No. 226

➢ E.O. No. 226 institutionalized the Continuing Professional Education (CPE)

programs of the various Professional Regulatory Boards

➢ It consists of five (5) sections

➢ Effectivity: July 25, 1995

▪ As stated, Continuing Professional Education (CPE) is the mandatory
requirement for the renewal of a professional license.
▪ E.O. No. 226 empowers the PRC to adopt policies on CPE programs that can
enhance and maintain high professional, technical, and ethical standards in the practice
of the profession for implementation by the respective Professional Regulatory Boards.
▪ As mandated in the same E.O. 226, professionals who undertake the CPE programs
are enabled not only to upgrade or improve their technical knowledge and skills but also
to keep abreast of the modern trends and technology in their respective professions.

Section 6: Republic Act No. 8504

 An act promulgating polices and prescribing measures for the prevention and
control of HIV/AIDS in the Philippines, Instituting a nationwide HIV/AIDS
 information and educational program, establishing a comprehensive HIV/AIDS
monitoring system, strengthening the Philippine National aids council and for
other purposes

Global HIV Statistics:

 37.6 million (30.2 million-45.0M) people globally were living with HIV in 2020.
 1.5 million (1.1 m- 2.1 m) people became newly infected with HIV in 2020
 690, 000 (480, 000-1 m) people died from AIDS- illnesses in 2020
 27.4 m (26.5 m- 27.7 m) people were accessing antiretroviral therapy (to control
the virus to increase the CD four counts) in 2020
 77.5 m (54.6 m- 110 m) people have become infected with HIV since the start of
the epidemic
 34. 7 m (26.0 m- 45.8 m) people have died from AIDS- related illnesses since the
start of the epidemic
 New infection of HIV have been reduced 47% since 1988 (2.8 m newly infected)
 In 2020 around 1.5 m newly infected HIV

People living with HIV:

 In 2020. There were 37.6 m (30.2 m- 45.0 m) people living with HIV
 35.9 m (28.9 m-43.0 m) adults
 1.7 m (1.2m- 2.2 m) children (0-14 years)
 84% (68- > 98%) of all people living with HIV knew their HIV status in 2020
 About 6.0 m (4.8 m- 7.1 m) people did not know that they were living with HIV
2020
 Every week around 5, 000 young women ages to 14-24 years become infected
with HIV

Definition of terms:

 HIV stands for Human immunodeficiency virus. It is a retrovirus that causes

infection. Its entrance into the body lowers the immunity of the ability to fight off
diseases
 HIV infection is the successful entry of HIV in the human host, weakening the
immune system and leading to a spectrum of diseases
 AIDS stands for Acquired Immune Deficiency Syndrome. It is a condition
characterized by a combination of signs and symptoms caused by HIV
contracted from another which attacks and weakens the body’s immune system,
making the afflicted individual susceptible to other life threatening infection

What Causes AIDS?

  AIDS is caused by HIV (causative agent)
 HIV is a virus that gradually attacks immune system cells
o As HIV progressively damages these cells. The body becomes more
vulnerable to infections, which it will have difficulty in fighting off

1, 142 cases (34% are OFW’s):

 74% are males

o 94% transmission by Sexual Contact
 Of the 1. 142:
o Seafarers (33%)
o Domestic helpers (17%)
o Employees (9%)
o Entertainers (8%)
o Health workers

Present Scenario:

 According to the DOH HIV/AIDS are ART Registry of the Philippines (HARP),
there are now a total of 81, 169 HIV and AIDS cases reported from January 1984
to October 2020. In October 2020, there were a total 735 confirmed HIV positive
individuals. 96 % (704) of whom were male

Milestone in the Philippines:

 1984 1st HIV infection reported

 1985 1st HIV+ case confirmed
 1986 HIV and AIDS are notifiable disease
 1987 HIV and AIDS Registry established
 1992 Philippine National AIDS Council established
 1993-97 Surveillance activities established
 1997 National Workplace Policy ratified
 1998 Republic Act 8504 enacted
 2000-2004 Local AIDS council created

The Iceberg Phenomenon of HIV:

 Hidden transmission
o Those who are not tested in HIV
 Hidden groups with high risk behaviour
 Hidden fears, prejudice and misconceptions among the population

Highlights of National Status:

  12, 0000 (7, 300- 20, 00) people are living with HIV
 Low prevalence rate (less than 1%)
 Sexual contact as main mode of transmission (88%)
 58% of cases are in 25-39 years age group
 67% are male
 1 every 3 reported cases are OFW

Youth:

 Approximately:
o 3% of 15-27 of male population – YAFS
o 7% of > 18 years old population – Dr. M . Tan
 Hidden sexual networks
 High STI rates (32%)
 Increasing practice of anal sex (72%)
 Low condom use rates <20%

Red Flags:

 Number of new HIV cases increasing

 Growing size of local pool of HIV
 High level of needle sharing among IDUs
 High prevalence of risk behaviours
 High STI prevalence
 Low level of knowledge on HIV and AIDS

Challenges to Addressing the Epidemic:

 Many lack basic information about HIV/AIDS

 Most people in low and middle income countries do not have access to key
prevention and care services
 Lack of infrastructure, training, quality and monitoring systems, facilities etc. may
impede access; other barriers include price, patent laws and other regulatory
issue; and the impact of the epidemic on the health sector and health care
workers
 Collateral effects of the epidemic (epidemic exacerbates existing problems and
vice versa)
 There are promising research directions – microbicides, vaccines- but a vaccine
is still years away

Rationale of RA 8504:
  Prevention and control of HIV and AIDS
 Protection of rights and dignity of persons with HIV and AIDS
 Recognition of role of person with HIV and AIDS in prevention and control of the
diseases
 Provision of control measures in high risk settings

Key Features of RA 8504:

 Article I : education and information

 Article II : Safe practices and Procedures
 Article III: testing screening and counselling
 Article IV; health and support Services
 Article V: monitoring
 Article VI: confidentiality
 Article VII: discriminatory Acts and Policies
 Article VIII: the Philippines National AIDS council

Section 1: Title

 “ Philippine AIDS Prevention and Control Act of 1998”

Section 2: Declaration of Policies:

 AIDS
o Is a disease that recognizes no territorial, social, political and economic
boundaries
o There is no known cure
o The gravity of the AIDS threat demands strong State action today
 (a) promote
 Public awareness about the causes of AIDS
 Modes of transmission
 Consequences (effect)
 Means of prevention (prevent the transmission of IADS)
 Control of HIV/AIDS
 Through
 Educational and information campaign
 Promote value formation and employ scientifically proven
approaches
 Focus on the family as a basic social unit
 Carried out in all schools and training centers, workplaces,
and communities
  Involve affected individuals and groups including people
living with HIV.AIDS
o The state will utilizes the experience of PWA(person with AIDS) to warn
the publican identific about the disease
 They will be used in propagating vital information and education
messages
 (b) Every person suspected or known to be infected with HIV/AIDS
will be given full protection of his/her human rights and civil
liberties.
 (1) compulsory HIV testing is considered unlawful unless
otherwise provided in this Act;
 (2) the right to privacy shall be guaranteed;
 (3) discrimination, in all its forms and subtleties, against
individuals with HIV or persons perceived or suspected of
having HIV is considered inimical to individual and national
interest
 (4) provision of basic health and social services for
individuals with HIV shall be assured
 (c0 promote safety and universal precaution in practices and
procedures that carry the risk of HIV transmission
 (d) The State will seek to eradicate conditions that aggravate the
spread of HIV infection,
 Proverty,
 Nu,Gender inequality
 Prostitution
 Marginalization
 Drug abuse
 Ignorance

Section 3: Definition of Terms:

 Data privacy
 “Anonymous testing” – refers to an HIV testing procedures whereby the individual
being tested does not reveal hi/her true identity. An identifying number or symbol
is used to substitute for the name and allows the laboratory conducting the test
and the person on whom the test is conducted to match the test results with the
identifying number or symbol.
 “Compulsory HIV testing”- refers to HIV testing imposed upon a person attented
or characterized by the lock of or vitiated consent, used of physical force
intimidation or any form of compulsion
 “Contact tracing”- refers to the methods of finding and counselling the sexual
partners of a person who has been diagnosed as having sexually transmitted
disease.
 “human Immunodeficiency Virus (HIV) – refers to the virus which causes AIDS
 “HIV/AIDS Monitoring”- refers to the documentation and analysis of the number
of HIV/AIDS infection and the pattern of its spread
 “HIV/AIDS refersPrevention and Control”- refers to measures aimed at protecting
non-infected form contacting HIV and minimizing the impact of the condition of
persons living with HIV
 “HIV transmission” – refers to the transfer of HIV from one infected person to
uninfected individuals, most commonly through sexual intercourse, blood
transfusion, sharing of intravenous needles and during pregnancy
 “High-Risk Behavior- refers to a person frequent involvement in certain activities
which increase the risk of transmitting or acquiring HIV
 “ Informed Consent” – refers to the voluntary agreement of a person to undergo
or be subjected to a procedure based on full information, whether such
permission is written, conveyed verbally, or expressed indirectly
 “Medical Confidentiality” –refers to the relationship of trust and confidence
created or existing between a patient or a person with HIV and his attending
physician, consulling medical specialist, nurse, medical technologist and all other
health workers or personnel involved in any counselling, testing or professional
care of the former; it also applies to any person who, in any official capacity, has
confidential information
 (o) “Person with HIV” – refers to an individuals whose HIV test indicates, directly
or indirectly, that he/she is infected with HIV
 “ Pre- testing Counselling” – refers to the process of providing an individual
information on the biomedical aspects of HIV/AIDS and emotional support to any
psychological implications of undergoing HIV testing and the test result itself
before he/she is subjected to the test
 “ Post -test Counselling” – refers to the process of providing risk-reduction
information and emotional support to a person who submitted to HIV testing at
the time that the test results is released
 “ Prophylactic”- refers to any agent or device used to prevent the transmission of
a disease
 “sexually transmitted diseases- refers to any disease that may be acquired or
passed through sexual contact
 “voluntary HIV testing” –refers to HIV testing done on an individual who, after
having undergone pre-test counselling, willingly submits himself/herself to such
test
  “window period” – refers to the period of time, usually lasting from two weeks to
six months during which an infected individual will test “negative” upon HIV
testing but can actually transmit the infection

Article 1: Educational and Information

 The government must promote educational and information campaigns

 Schools and non-formal education programs must include HIV education
 The DOH must conduct public health education campaigns
 The government must provide education for Filipinos going abroad
 Employers, working with DOLE must develop workplace educational and safety
 The Department of Tourism must provide education for tourist and transients
 LGUs develop local HIV prevention and education efforts
 Accurate information about prophylactics will be provided
 It is against the law to give false or intentionally misleading information on
HIV/AIDS

Section 4: HIV/AIDS educational in schools:

 Intergrate instruction on the causes, modes of transmission and ways of

preventing HIV/AIDS and other sexually transmitted diseases
o In public and private schools at intermediate grades, secondary and
tertiary levels, including non-formal and indigenous learning systems
 Provided that
o If the integration of HIV/AIDS education is not appropriate or feasible, the
DECS and TESDA shall design special modules on HIV/AIDS prevention
and control
o That it shall not be used as an excuse to propagate birth control or the
sale or distribution of birth control devices
o That it does not utilize sexually explicit materials
 DECS,CHED and TESDA- will spearhead HIV/AIDS education in schools
 Information shall be provided by the Department of Health
 Consultations with Parent- Teachers-Community Associations, Private School
Associations, school, official and other interest groups will implemented
 No instruction shall be offered to minors without adequate prior consultation with
parent who must agree to the trust and content of the instruction materials
 All teachers and instructors of said HIV/AIDS courses shall be required to
undergo a seminar or training

Section 5: HIV/AIDS information as a Health Service:

  HIV/AIDS education and information dissemination will become a part of the
health services by pratitioners, workers and personnel
 Public Health Workers-enhanced to include skills for proper information
dissemination and education of HIV/AIDS
 Private sector health providers- Make available to the public information
necessary to control the spread of HIV/AIDS and to correct common
misconceptions about this disease
 The training of health workers include
o Discussions on HIV- related ethical issues such as confidentiality,
informed consent and the duty to provide treatment

Section 6: HIV/AIDS education in the workplace:

 The standardized basic information and instruction on HIV/AIDS

o Include topic on confidentiality in the workplace and attitude towards
infected employees and workers
 This will be given to:
o All government and private employees, workers, managers and
supervisors including members of the AFP and the PNP

Section 7: HIV/AIDS education for Filipinos going abroad:

 Undergo or attend a seminar on the cause, prevention and consequences of

HIV/AIDS before certification for overseas assignment
o All overseas Filipinos workers and diplomatic, military, trade as labor
officials and personnel to be assigned overseas
o DOLE, DFA, DOT, DOJ through the BOI as the case may be in
collaboration with the DOH shall overseas the implementation of this
section

Section 8: Information campaign for tourist and transients:

 International ports of entry and exit

o Information aids or materials on
 The cause
 Modes of transmission
 Prevention and
 Consequences of HIV
 The DOT, the DFA, the DOJ through the BOI in collaboration with the
DOH shall oversee the implementation of this Act

Section 9: HIV/AIDS education on communities:

  Educational and information campaign on HIV/AIDS
o LGU’S in collaboration with the DOH
o The provincial governor, city or municipal mayor and the barangay captain
shall coordinate such campaign among concerned government agencies,
non-government organizations and church-based groups

Section 10: Information on prophylactics:

 Prophylactics (e.g condom) shall contain

o Literature on the proper used of the prophylactic device or agent
o Its efficacy against HIV and STD infection
o Importance of sexual abstinence and mutual fidelity
 Such information shall be legibly printed in English and Filipino

Section 11: Misinformation on Penalties for misleading information:

 Misinformation on HIV/AIDS prevention and control through false and misleading

advertising and claims is punishable with a penalty of imprisonment for two (2)
months to two (2) years, without prejudice to the imposition of administrative
sanction such as fines and suspension or revocation of professional or business
license
 Tri-media or the promotional marketing of drug, devices, agents or procedures
without prior approval from the DOH and the BFAD and the requisite medical and
scientific basis, including marking and indications in drug and devices or agents,
purporting to be a cure or a fail-safe prophylactic for HIV infection

Article 2:

 The government will develop and promote safe medical practices

 All blood, organs and tissue for donation will be tested. If it test positive, it will be
disposed of safety, and not used
 The DOH provide guidelines on safe surgery and medical procedures
 Wilfully or negligently dangerous practices will be against the law

Section 12: requirement on the donation of blood, tissue or organ:

 Blood, tissue, organ donations should undergo HIV testing

 All HIV positive blood, tissue or organs should be disposed off properly and
immediately
 A second testing may be demanded by the recipient before transfusion or
transplant
 HIV positive may be used only for research purposes and subject to strict
sanitary disposal requirements
Section 13: Guidelines on surgical and similar procedures:

 Guidelines on precautions against HIV transmission during surgical, dental,

embalming, tattooing or similar procedures
 Guidelines on the handling and disposition of cadavers, body fluids or waste of
persons known or believed to be HIV- positive
 Necessary protective equipment such as gloves, goggles and gowns, shall be
made available to all physicians and health care providers and similarly exposed
personnel at all time

Section 14: Penalties for unsafe practices and procedures:

 Any person who knowingly or negligently causes another to get infected with HIV
in the course of the practice of his/her profession through unsafe and unsanitary
practice or procedures is liable to suffer a penalty of imprisonment for sex (6)
years to twelve (12) years
o Fines and suspension or revocation of the license to practice his/her
profession
o The permit or license of any business entity and the accreditation of
hospitals, laboratory, or clinics may be cancelled or withdrawn

Article III: testing, Screening and Counselling:

 The government will provide appropriate confidential HIV testing

 HIV testing can only be done with the consent of the person tested
 The DOH will provide anonymous HIV testing
 Counselling will be conducted before and after testing
 The DOH will make adequate and affordable HIV testing available in all the
Philippines

Section 15: Consent as a requisite for HIV testing:

 No compulsory HIV testing shall be allowed

 State shall encourage voluntary testing for individuals with a high risk for
contracting HIV :
o Written informed consent must first be obtained
 From the person concerned if he/she is of legal age
 Form the parents or legal guardian in the case of a minor or mentally
incapacitated individual
 Lawful consent to HIV testing of a donated human body, organ , tissue or blood
shall be considered as having been given when:
 o (a) a person volunteers or freely agrees to donate his/her blood, organ or
tissue for transfusion, transplantation or research
o (b) a person has executed a legacy in accordance with Section 3 of
Republic Act No. 7170 also known as the “ Organ Donation Act of 1991”
o (c) a donation is executed in accordance with Section 4 of Republic Act
No. 717

Section 16: Prohibitions on compulsory HIV testing:

 the following shall be deemed unlawful:

o compulsory HIV testing as a precondition to employment
o admission to educational institutions
o the exercise of freedom of abode, entry or continued stay in the country
o the right of travel
o the provision of medical service or any other kind of service
o the continued enjoyment of said undertakings

Section 17: Exception to the prohibition on compulsory testing

 a) when a person is charged with any of the crimes punishable under Article 264
and 266 as amended by Republic Act No 8353, 335 and 338 of Republic Act No
3815, otherwise known as the “ revised Penal Code” or under Republic Act No.
7659”
 b) when the determination of the HIV status is necessary to resolve the relevant
issues under Executive Oder No 309, otherwise known as the “ Family Code of
the Philippines”
 c) when complying with the provisions of Republic Act No. 7170, otherwise as the
“organ Donation Act” and republic Act No 7719,otherwise as the “ National Blood
Service Act”

Section 18: Anonymous HIV testing:

 the state will provide a mechanism for anonymous HIV testing and guarantee
anonymity and medical confidentiality in the conduct of such tests

Section 19:

 DOH will accredit all testing centers. Hospitals, clinics and laboratories offering
HIV testing services
 Accreditation standards will be maintained

Section 20: Pre-test and Post-test counselling:

  All testing centers, clinics or laboratories shall be required to provide and conduct
free pre-test counselling and post-test counselling for person who avail at their
HIV/AIDS testing services
o Counselling services must be provided only by persons who meet the
standards set by the DOH

Section 21: Support for HIV Testing Center:

 The Department of Health

o Build and enhance the capabilities for HIV testing of hospitals, clinics,
laboratories and other testing cnters
o Training of competent personnel who will provide such services in said
testing sites.
o Not free

Article 4: Health and Support Services:

 The government will ensure adequate health and support services for people
with HIV
 Hospitals will provide adequate care for person with HIV
 LGUs must provide community-based prevention and care efforts
 Livelihoods effort will be made available for people with HIV
 The DOH is to do STD prevention and control efforts
 The DOH is to make sure that health insurance is available to people with HIV


Section 22: Hospital-based services:

 Persons with HIV/AIDS

o Will be given basic health services
o In all government hospitals
o Optimum medical care may be provided by special AIDS wards and
hospitals

Section 23: Community-based services:

 Community-based HIV/AIDS prevention and care services

o Provided by LGU’s
 In coordination with
 Concerned government agencies
 NGO’s
 Person with HIV/AIDS
Section 24: Livelihood programs and trainings:

 Persons infected with HIV/AIDS shall not be deprived of full participation in any
livelihood, self-help and cooperative programs for reason of their health
conditions
o Trainings for livelihood, self-help cooperative programs shall be made
accessible and available to all persons with HIV/AIDS

Section 25: Control sexually transmitted diseases:

 Pursue prevention and control of sexually transmitted diseases to help contain

the spread of HIV infection
 Headed by
o DOH
o Concerned government agencies
o NGO’s

Section 26: Insurance for persons with HIV:

 Conduct a study on the feasibility and viability of setting up a package of

insurance benefits and should such study warrant it, implement an insurance
coverage program for persons with HIV
 The secretary of Health in cooperation with the Commissioner of the insurance
commission and the other public and private insurance agencies
 Principle: Access to health insurance is part of an individual’s right to health and
is the responsibility of the State and of society as a whole

Article 5: Monitoring

 The government will monitor HIV/AIDS

 The government will establish an AIDSWATCH council
 Reporting procedures will be developed to tract HIV rates, while respecting client
confidentiality
 Contract tracing is permitted provided confidentiality is not breached

Section 27: Monitoring program:

 “AIDSWATCH”
o A comprehensive HIV/AIDS monitoring program
o Established under the Department of Health
o Purpose:
 To determine and monitor the magnitude and progression of HIV
infection in the Philippines
  Evaluating the adequacy and efficacy of the countermeasures being
employed

Section 28: Reporting procedures:

 Adopt measures in assuring the reporting and confidentiality of any medical

record, personal data, file of HIV/AIDS patients
 The DOH through its AIDSWATCH monitoring program shall receive, collate and
evaluate all HIV/AIDS related medical reports
o IADSWATCH data base will utilize a coding system that promotes client
anonymity

Section 29: Contact tracing:

 Health intelligence activities

o Pursue by the DOH
o May be pursued by the Department of Health
o Any information gathered shall remain confidential and classified and can
only be used for statistical and monitoring purposes and employment,
school attendance, freedom of abode or travel

Article 6: Confidentiality:

 Confidentiality will be protected on HIV status

 All healthcare workers, and anyone handling health records will strictly preserve
patient confidentiality on HIV status and the identity of people with HIV
 HIV status can be shared by health officials in three circumstances; officials of
the AIDSWATCH council, Health Workers who are involved in treatment and
need to know for their own safety and a judge of under subpoena for an official
court case.
 HIV results may be given to the person tested, an official of the AIDSWATCH
council, and a parent or guardian. It cannot be given to anyone else
 Legal penalties can be provided for breaching confidentiality
 People with HIV must inform spouses and sex partners as soon as reasonably
possible

Section 30: Medical confidentiality:

 Strictly observe confidentiality in the handling of all medical information,

particularly the identity and status of persons with HIV
 All health professionals
 Medical instructors
 Workers, employers,
  Recruitment agencies,
 Insurance companies,
 Data encoders
 Custodians of any medical record, file, data or test results

Section 31: Exceptions to the mandate of confidentiality:

 Medical confidentiality is not considered breached in the following cases:

o (a) when complying with reportorial requirements in conjunction with the
AIDSWATCH programs
o (b) when informing other health workers directly involved or about to be
involved in the treatment or care of a person with HIV/AIDS:
 Provided
 That the treatment or care carry the risk of HIV transmission
 That the workers are still obliged to maintain the shared
medical confidentiality
o (C) when responding to a subpoena duces tecum and subpoena and
testification 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 is be properly sealed by its
lawful custodian after being double-checked for accuracy by
the head of the office or department, hand delivered and
personally opened by the judge
 The judicial proceeding be held in executive session

Section 32: Release of HIV/AIDS test results:

 All results of HIV/AIDS testing: confidential and will be released only to the
following:
o A) the person who submitted himself/herself to such test
o B) either parent of a minor child who has been tested
o C) a legal guardian in the case of insane persons or orphans
o D) a person authorized to receive such results in conjunction with the
AIDSWATCH program as provided in Section 27 of this act
o E) a justice of the court of appeals or the supreme court as provided under
subsec (c) of this Act and in accordance with the provision of section 16
hereof

Section 33: Penalties for violations of confidentiality:

 Penalty of imprisonment for (6) months to 4 years

 o Administrative sanctions
 Fines
 Suspension of revocation of the violator’s license to practice his/her
profession
 Cancellation or withdrawal of the licence to operate any business
entity and the accreditation of hospitals, laboratories or clinics

Section 34: Disclosure to sexual partners:

 Any persons with HIV is obliged to disclose his/her HIV status and health
condition to his/her spouse or sexual partner at the earliest opportune time

Article 7: Discriminatory Acts and policies:

 Discrimination against people with HIV is illegal

o Employers cannot discriminate in hiring, firing, promotion or assignment
based on actual or suspected HIV status
o Schools are not allowed to refuse admission, punish students or deny
participation in activities based on real or perceived HIV status
o A person with HIV has the legal right to travel, live and lodge with the
same freedom as any other citizens, quarantines and other restrictions are
illegal
o A person with HIV as every legal right to seek public office
o Credit services cannot be denied based on HIV status. Insurance cannot
be refused based on HIV status, provided the person does not lie about
their HIV status
o Hospitals can health services cannot refuse treatment or discriminate
based on HOV status
o Decent burials cannot be denied based on HIV status
o Legal penalties for discrimination will be enforced

Section 35: Discrimination in the workplace:

 Discrimination based on the actual or perceived or suspected HIV status is

prohibited
o From pre-employment to post-employment including hiring, promotion or
assignment
o Termination from work on the sole basis of actual perceived or suspected
HIV status of deemed unlawful

Section 36: Discrimination in schools:

 No educational institution shall

 o Refuse admission
o Expel
o Discipline
o Segregate
o Deny participation, benefits or services
 To a student or prospective student on the basis of his/her actual,
perceived or suspected of HIV

Section 37: restriction on travel and habitation:

 On account of his/her actual, perceived or suspected HIV status:

 The freedom of abode, lodging and travel of a person with HIV shall not be
abridged
 No person shall be quarantined, places in isolation or refused lawful entry into or
deported form Philippine territory

Section 28: Inhibition form public service:

 The right to seek an elective or appointive public office shall not be denied to a
person with HIV

Section 39: Exclusion from credit and insurance services:

 On the basis o his/her actual, perceived or suspected HIV status

o All credit and loan services, including health, accident and life insurance
shall not be denied
 Provided that the person with HIV has not concealed or
misrepresented the fact to the insurance company upon application
 Extension and continuation of cretid and loan shall likewise not be
denied solely on the basis of said health condition

Section 40: discrimination in hospitals and health institutions:

 On account of actual, perceived or suspected HIV status

o No person shall be denied health care service or be charged with a higher
fee

Section 41; denial of burial services:

 A deceased person who has AODS or who has known, suspected or perceived
to be HIV positive shall not be denied any kind of decent burial service

Section 42: penalties for discriminatory acts and policies

  Imprisonment for 6 months to 4 years and dine not exceeding 10,000 pesos
 In addition:
o Licenses/permits of schools, hospitals and other institutions found guilty of
committing discriminatory acts and policies described this act shall be
revoked

Article 8: the Philippine national AIDS council:

 The government will established Philippine National AIDS council

 This council will be responsible for implementing the act and conducting all
national AIDS performances

Section 43: establishment:

 The Philippines national AIDS council (PNAC)

o Created December 3, 1992 (EO 39)
o Reconstituted and strengthened
o Attached to the
o DOH
o Purpose: to enable the council to oversee an integrated and
comprehensive approach to HIV/AIDS prevention and control in the
Philippines

Section 44: Functions

 Central advisory, planning and policy- making body for the comprehensive and
integrated HIV/AIDS prevention and control program
o (a) Secure from government agencies concerned recommendation on how
their respective agencies could operationalize specific provisions of this
Act. The council shall likewise ensure that there is adequate coverage of
the following
 (1) the institution of a nationwide HIV/AIDS information and education
program:
 (2) the establishment of a comprehensive HIV/AIDS monitoring
system
 (3) the issuance of guidelines on medical and other practices and
procedures that carry the risk of HIV transmission
 (4) the provision of accessible and affordable HIV testing and
counselling services to those who are need of it
 (5)the provision of acceptable health and support services for
persons with HIV/AIDS in hospitals and in communities:
  (6) the protection and promotion of the rights of individuals with HIV;
and
 (7) the strict observance of medical confidentiality
o (b) monitoring the implementation of the rules and regulation of this Acts,
issues or cause the issuance of orders or make recommendations to the
implementing agencies as the Council considers appropriate
o (c) develop a comprehensive long term national HIV/AIDS prevention and
control program and monitor its implementations
o (d) coordinate the activities of and strengthen working relationship
between government and non-government agencies involved in the
campaign against HIV/AIDS
o (e) coordinate and cooperate with foreign and international organizations
regarding data collection, research and treatment modalities concerning
HIV/AIDS and
o (f) evaluate the adequacy of and make recommendations regarding the
utilization of national resources for the prevention and control of HIV/AIDS
in the Philippines

Section 45: Membership and composition

 26 members
 (1) the secretary of the DOH
 (2) the secretary of the DECS or his representative
 (3) the Chairperson of the CHED or representative
 (4) the director- general of the TESDA or representative
 (5) the secretary of DOLE or representative
 (6) the secretary of the DSWD or representative
 (7) the secretary of the DILG or representative
 (8) the secretary of the DOJ or representative
 (9) the director-general of the NEDA or his representatives
 (10) the secretary of the DOT or his representative
 (11) the secretary of the DVBM or his representative
 (12) the secretary of the DFA or his representative
 (13) the head of the PIA or his representative
 (14) the president of the league of governors or his representatives
 (15) the president of the league of city mayors or his representative
 (16) the chairperson of the committee of health of the senate of the Philippines or
his representative
 (17) the chairperson of the committee on the health of the house of
representatives or his representatives
  (18) two (2) representative form organization of medical health professionals
 (19) 6 representative from NGO’s involved in HIV/AIDS prevention and control
efforts or activities
 (20) a representatives of an organization of persons dealing with HIV/AIDS
 (B) Appointment to the council must ensure sufficient and discernible
representative from the fields of medicine, education, health care, law, labor.
Ethics and social services
 (c) all members of the council (appointed by the president)
o Representative of the Senate (appointed by senate president)
o Representative of the house of representative (appointed by the house
speaker)
 (d) the members appointed not later than 30 days after the date of the enactment
of this act
 (e) the secretary of DOH –permanent chairperson of the council
o The vice chairperson- elected by the members from among themselves
o Serve for a term of 2 years
 (f) for members representing medical/health professional groups and 6 non-
government organization
o Serve for a team of 2 years renewable upon recommendation of the
council

Section 46: Reports:

 Comprehensive annual reports on the activities and accomplishments of the

council
o Contain
 Assessments and evaluation of intervention programs
 Plans and strategies for the medium and long term prevention and
control program on HIV/AIDS in the Philippines
o Submit to the president and to both house of congress

Section 47: creation of special HIV/AIDS prevention and control service

 Special HIV/AIDS prevention and control service

o Function: implement programs on HIV/AIDS prevention and control. In
addition it shall also serve as the secretariat of the council
o Permanent appointment
o Supported with adequate yearly budget
o Staffed by
 Qualified medical specialist
 Support staff
Section 48: Appropriations

 20,000,000.00 from the national treasury

o Subsequent appropriation shall be provided by congress in the annual
budget of the department of health under the general appropriations Acts

Article 9: miscellaneous provisions

Section 49: implementing rules and regulations

 The council shall formulate and issue the appropriate rules and regulations
necessary for the implementation of this Act
o Within 6 months after it is fully reconstituted

Section 50: Separability clause

 If any provision of this act is declared invalid, the remainder of this act or any
provision not affected thereby shall remain in force and effect

Section 51: Repeading clause

 All laws presidential decrees, executive orders and their implementing rules
inconsistent with the provisions of this Act are hereby repeated, amended or
modified accordingly

Section 52: effectivity

 This act shall take effect 15 days after its publication in at least 2 national
newspaper of general circulation
 Approved: February 13, 1998

Section 7: Philippine Dangerous Drugs Law: R.A 9165

 RA 6425- Dangerous Drug Act of 1972

 Before it become RA 9165- Dangerous Drug Act of 2002
o And it was repealed RA 6425

Implementing Rules and Regulations Governing Licensing and Accreditation of

Drug Testing Laboratories in the Philippines:

Section 1: Scope:

 Covers all government and private drug testing laboratories in the Philippines

Section 2: Authority:
  To implement the provision of the RA 9165

Section 3: definition of Terms:

 Accreditation
o Refers to the formal authorization issued by the DOH to an individual,
partnership, corporation or association in compliance with set standards
set at a maximum achievable level to stimulate improvements over time
o There should be a proper inspection of the laboratory to provide
accreditation
 Act
o This refers to Republic Act No. 9165
 Applicant
o Refers to the owner or head of a laboratory that is applying for the
issuance of a license/accreditation
 Application service provider
o Refers to third party entities that manage and distribute software-based
services and solutions to customers across a wide area network from a
central data center.
 Bureau
o Refers to the Bureau of Health Facilities and Services of the DOH. It shall
exercise the regulatory functions
 Chain of Custody
o Refers to procedures to account for each specimens by tracking its
handling and storage from point of collection to final disposal
 These procedures requirement that the applicants identity is
confirmed and that a chain of custody form (CCF) us used from
time of collection to receipt by the laboratory
 Within the laboratory, appropriate chain of custody must account for
the samples until disposal
 Chain of Custody form
o Refers to the form used to document the procedures from time of
collection until receipt by the laboratory
 CHD
o Refers to the Center for Health Development, which is the DOH Regional
Field Office
 Client/Donor
o Refers to the individual from whom a specimen is collected
 Confirmatory test
o Refers to the analytical procedures to identify and quantify the presence of
a specific drug or metabolite
  Independent of the initial test
 Used a different technique and chemical principle from that of the
screening test in order to ensure reliability and accuracy
 Cut Off
o Refers to the concentration level set to determine whether the sample is
positive (higher) or negative(lower) for the presence of the drug
 Dangerous Drugs
o Include those listed the schedule annexed to the Act and its implementing
rules and regulations
 DOH
o Refers for the department of health
 Laboratory
o Refers to a private or government facility that is capable of testing a
specimen to determine the presence of dangerous drugs therein
 License
o Refers to a formal authorization issued by the DOH to an individual,
partnership, corporation or association in compliance with standards set at
a minimum level to ensure an environment with minimum risk to health
safety
 It is a prerequisite for accreditation of a laboratory
 Licensee
o Refers to a laboratory that is issued a license
 NRL
o Refers to the National Reference Laboratory for Environmental and
Occupational Health, Toxicology and Micronutrient Assay designated by
the Secretary of Health
 Capable of doing screening and confirmatory laboratory services,
training surveillance and external quality result is challenged, the
NRL shall make the final decision
 Located in East Avenue Medical Center
 Procedure Manual
o Refers to the written document giving detailed steps to be followed when
undertaking a particular task
 Screening test
o Refers to a test to eliminate negative specimen form further consideration
and to identify confirmatory testing
 Secretary
o Refers to the Secretary of Health
 Specimen
o Refers to the body fluid that is collected form a person
Section 4: Classification of Drug Testing Laboratories:

 Ownership
o Government
 Operated and maintained partially or wholly by the national,
provincial, city or municipal government, or other political unit, or by
any department, division, board or agency thereof.
o Private
 Privately owned, established and operated with funds through
donation, principal, investment or other means, by any individual,
corporation, association or organization.
 Institutional Character
o Institution-based-located within the premises and operates as part on
institution (e.g. hospital, medical facilities for overseas workers and
seafarers).
o Freestanding-located-outside the premises of an institution and operated
independently
 Service capability
o Screening Laboratory
 a laboratory capable of performing screening test
o Confirmatory Laboratory
 a laboratory capable of performing qualitative and quantitative
examinations of dangerous drugs from the specimen.

Section 5: Client/Donor of Drug Testing Laboratories:

 RA 9165 article III Section 36

 Mandatory Drug Testing:
o Applicants for driver’s license
o Applicants for firearm’s license
o Officers and members of the military, police and other law enforcers
o Persons charged before the prosecutor’s office with a criminal offense
having an imposable penalty of imprisonment of not less than six (6) years
and one (1) day.
o Candidate for public office whether appointee or elected both in the
national or local government
o Persons apprehended or arrested for violating the provisions of this Act
 Random Drug Testing
o Students of secondary and tertiary schools
o Officers and employees of public and private offices whether domestic
oroverseas
Section 6: Technical Requirement for Licensing:

 Lab is licensed as “special clinical laboratory”

 Technical requirements
 1. Physical plant
o a. Screening Laboratory
 20 square meters in floor area
 Working area-10 square meters
 with exhaust fan, sink and storage cabinet
o b. Confirmatory Laboratory
 60 square meters in floor area
 Clinical work area must be thirty (30) square meters
 with exhaust fan, sink, stock room and instrumentation room.
 All lab should be able to receive at least 5 prospective clients, donors/ subjects at
a given time
o With hand washing facility, toilet facility, collection stall
 A DOH accredited hospital or non-hospital secondary or tertiary category need
not put up the extra 20 square meters
 2. Headship of the Laboratory
o Licensed laboratory:
 A licensed physician certified in Clinical Pathology by the Philippine
Board of Pathology shall head a Screening
 A licensed physician trained in laboratory management and drug
testing operation
o Confirmatory Laboratory:
 A licensed physician certified in Clinical Pathology by the Philippine
Board of Pathology with at least 2 years of active laboratory
experience in analytical toxicology
 A licensed chemist with master’s degree in Chemistry, Biochemistry
or a branch of chemistry and at least 2 years of active laboratory
experience in analytical chemistry
 If not a license physician it can be chemical engineer with a master
degree of chemistry
o If part of a clinical laboratory:
 Licensed Physician
 Chemist
 Medical Technologist
 Pharmacist
 Chemical Engineer
o Functions and Responsibilities:
 Head
  Administrative
o General overall supervision of the facility
o General supervision and conduct of all laboratory
personnel
o Formulates and implements standards operation
manual that govern the operation of the drug-testing
lab
o Prepares financial and annual reports
o Provides other administrative support services such
as communications, security and maintenance
services
 Technical
o Supervises and directs all analytical procedures
o Assures quality of all lab test results
o Issues, signs out and interprets lab results
o Evaluates and recommends reagents, supplies and
equipment
o Reviews the CCP and reports received from
authorized collector
o Interviews the Client/donor/subjects if necessary
o Cancels the results of all specimen which are not
collected and tested in accordance to standard set by
DOH
o Review, rejects and refers for confirmation and
retesting all specimen and test result that are positive,
adulterated, substituted or invalid
o Implements remedial actions necessary to maintain
satisfactory operation and performance in the lab
o Directs protocol for preventive maintenance of
equipment
o Provides comprehensive, continuing training and
education of personnel related to conduct of drug lab
 3. Personnel
o Screening Laboratory:
 Licensed Chemist
 Medical Technologist
 Pharmacist
 Chemical Engineer
o Confirmatory Laboratory:
 Licensed chemist, training in chromatography, spectroscopy
  Medical technologist/ pharmacist/ chemical engineer:
 Training in screening test procedures for dangerous drugs
o Analyst: must be a registered
 Chemist
 Chemical engineer
 Medical technologist
 Pharmacist
o Authorized Specimen Collector
 At least high school graduate
 Must undergone appropriate training
o Other laboratory personnel
 Must have educational background appropriate for the task assigned
 Must have appropriate training and preferably with experience
o Training Requirements
 Head
 Theory and practice of drug testing procedures
 Chain of custody, reporting and record keeping
 Review and interpretation of test results
 Quality Assurance Program
 Dangerous Drugs Regulations and Policies
o Analyst
 Analytical methods and procedures
 Maintenance of chain of custody
 Reviewing and reporting test results
 Proper remedial action in response to problems that may arise
 Quality control procedures and practices
 Dangerous drugs regulation and policies
o Authorized Specimen Collector:
 Training
 Collection procedures for each type of specimen
 COC and record keeping
 Specimen integrity and security
 Dangerous drugs regulations and policies
 Retraining
 The collection procedure changes significantly (new custody
and control form, CCF, is used)
 The specimen collector made a mistake that caused a test to
be cancelled
o Analyst: Responsibilities:
 Verifies the completeness of CCF
  Prepares specimen for analysis
 Examines, records, release and signs out lab results
 Assist in the implementation of quality assurance program
 Assists in the evaluation of reagents, supplies, and equipment
 Refers to the head of the lab as the need arises
o Authorized Specimen Collector Responsibilities
 Ensures the security of the specimen at the collection site
 Restricts unauthorized personnel to enter the collection site
during collection
 Verifies identity of the client
 Provides security to specimen supplies, records and
documents at collection site
 Informs the client the procedures of specimen collection
 Performs only one specimen collection at a time
 Accepts and seals the specimen container in the presence of
the client
 Accomplishes CCF
o Persons not authorized to collect
 Employer of the client
 Investigation at the crime scene
 Complaint
 Owner/administrator of the establishment
 4. Laboratory Equipment:
Service Confirmatory Lab Screening lab
Screening test Immunoassay equipment
or BFAD registered
drugtesting kit or TLC
Confirmatory Gas chromatography- A equipment or BFAD
examination Mass spectrometer (GC- registered drug-testing
MS), HPLC-MS (High kit or TLC
Performance Layer
Chromatography-Mass
Spectrometer) or some
other modern or accepted
equipment
Gas chromatography-
Mass spectrometer (GC- Basic equipment:
MS), HPLC-MS (High ref/freezer
Performance Layer
Chromatography-Mass
Spectrometer) or some
other modern or accepted
 equipment

 5. Application Services Provider (ASP)- used to store and achieve all record
electronically
o ITI system requirement for Confirmatory lab and screening lab
 Computer
 600 MHZ processor
 128 MB memory
 4 GB hard disk
 56K modern
 Printer
 Account with local internet services provider (ISP)

Section 7: Technical Requirements for Accreditations:

 1. Records
o Records of personnel
 The laboratory shall maintain a record of all its personnel.
 These records shall include:
 Resume of training and experience
 certification or license
 incident reports (if any); and
 other information, which will establish the competence of the
employee.
o Documentation
 All aspect of the testing process involved in the generation records of
a positive results
 Training records on all individuals authorized to have access
to samples
 Chain of custody forms
 Quality assurance/quality control records
 All data including calibration curves and any calculations
used in determining test results
 Reports
 Records of performance testing and computer generated
data
 Security
o To control access to the premises
o To ensure that only authorized personnel
 Handle or have access to the processes
  Enter areas where records are stored
o All authorized visitors, maintenance and services personnel are escorted
at all times while inside the laboratory
o Records of date, time of entry and exit and purpose of entry of non-
employees
 Chain of Custody
o To maintain control and accountability of specimens
o Minimum info on COC form:
 Identifying info of specimen
 Date and time of collection
 Name of testing lab
 Name and signature of people who had custody of the specimen
 Storage of laboratory reports and specimens
o To be determined by the DOH
o (+) specimen are discarded 15 days after receipt if not contested
o Specimen may be kept for a year if requested
o Specimen collected
 Blood – minnimum of 5 mL
 Fingernails- to be determined
 Saliva (oral fluid)- 2 mL “neat” specimen
 Scalp hair- 100 mg of hair 1 cm above the scalp
 Sweat (patch)- 1 patch worn 7-14 days
 Tissue- to be determined
 Urine- 60 mL
o Storage of Specimen:
 Blood- separate serum then immediately freeze
 Fingernails- to be determined
 Scalp hair- stored in a cool dry place
 Tissue- macerated and frozen
 Saliva- deep- frozen at least 8-10 C
 Sweat- to be determined
 Urine- initial= 2-6C for one day
 Prolonged storage= -20C
 Test levels
o Acceptability of cut- off levels will depend upon
 Method
 Equipment
 Registered testing kits
 Procedure Manual
 o A laboratory shall have a procedure manual validated by the NRL which
shall include:
 Principles of each test
 Preparation of reagents
 Standards and controls
 Calibration
 Procedures
 derivation of results
 Linearity of methods
 Sensitivity of the methods
 Cut-off values
 Mechanisms for reporting of results
 Control criteria for unacceptable specimens and results
 Remedial actions to be taken when the test systems are outside of
acceptable limits
 Reagent expiration dates
 References and quality control measures.
 Copies of all procedure and dates
 Equipment and Instruments
o Volumetric pipettes and measuring devices
 Certified for accuracy
 Checked by gravimetric, colorimetric or other verification procedures
by the DOST-ITDI
o Automatic pipettes and dilutors
 Checked for accuracy and reproducibility
o Written procedures
 Instrument set- up and normal operations
 Schedule for checking critical operating characteristics
 Tolerance limits for acceptable function checks
 Instruction for major troubleshooting and repair
 Calibrators and Control
o Prepare using
 Pure drug reference materials
 Stock standard and solutions obtained from other lab
 Standard solution from commercial manufactures
o Properly labelled as to content and concentration
 Date received
 Date prepared or opened
 Date placed in service
 Expiration date
  Urine Specimen collection, handling and disposal
o Universal precaution is followed all the time
o 2 types of Urine Collection for Drug testing
 Observed- collected in the presence of the authorized specimen
collector
 Unobserved- collected in the absence of an authorized specimen collector

Urine Collection for Drug Testing:

 Preliminary procedures for specimen collection

o The authorized specimen collector shall
 Prepare and secure all collection supplies, materials and records
 Verify the client identification
 Explain the basic collection procedure
 Answer any reasonable and appropriate question regarding the
collection procedure
o Basic steps in collecting urine specimen for drug testing
 The client removes all unnecessary outer garments after which a
bodily search will be done
 The ASC directs client empty his/her pockets and check items
 The client washes hands prior to collection, the ASC must remain in
the presence of the ASC with no access to anything that could
adulterate the sample
 The ASC may allow the client to choose the collection container from
the available supplies and is opened in full view of the client
 The ASC directs the client to go in the toilet facility for urination
 The ASC will observe closely the entire procedure
o A tempered specimen is sent to the lab for validity
 The ASC will document the tampering on the CCF
 The ASC will again instruct the client to provide another urine
specimen under direct observed collection
 The second specimen is once again sent to the lab
o The ASC will check
 Temperature
 Volume
 Inspect physical characteristics
o The ASC and client must keep the specimen in full at all times prior to
sealing
o A tamper-evident label/seal must be used
o Both ASC and client must affix their signature on the seal together with
date and time
 o The ASC must complete CCF
o The client affixes signature on the CCF
 The ASC may ask the client to enumerate at the back of the CCF,
any medication he/she may have taken in the past two weeks
o If the specimen is to be transported, it should be sealed, labelled and
secured in a transparent plastic bag
o Unobserved Specimen Collection
 Condition:
 Physical unable to go to the lab or designated collection site
 Involved in a crime scene
 Critically ill
 Unobserved samples are subject to specimen validity test
 Laboratory report:
o Screening of test result- result is prescribed by the DOH
o Signatory of test results – signed by: the analysts and the head of the
laboratory
o Reporting test results
 Screening: reported as positive or negative
 Confirmatory: presence or absence and the identity and
concentration of the drug
 The original copy is given to the client
 Other copies as given to the DOH and the requesting
agency and the testing laboratory itself
 Results given to the DOH
o Include the membrane of the registered testing kit for
screening test
o Chromatogram, if confirmatory
 Access to laboratory test result- results are confidential
 Only a government agency, upon written request shall be
provided with a copy of the lab test result
 Proficiency testing
o The NRL shall conduct a continuing assessment of the proficiency of
screening and confirmatory laboratories
o Participation in proficiency testing- failure means revocation of license and
accreditation
o Results of proficiency test- submit within 3 weeks after receipt of the
testing samples
o Failure to pass proficiency test- another test will be given within 1 month
after the failed test. Failure on the second test will mean revocation of
license and accreditation
Section 8: Validity of the test results:

 Drug test certificate issued by a lab is valid only for a year from the date issue

Section 9: allowable Service Fees:

 Fees should not be greater than the prescribed amount by the DOH

Section 10: Procedural Guidelines for Licensing and Accreditation

 Document to be submitted
 LTO
o BHFS application form files either at the Bureau or CHD
o Letter of endorsement to the Bureau director (if filed at CHD)
o DTI/SEC registration (for private lab)
o Enabling act (for national government lab)
o Approved board resolution (for local government lab0
o Mayor’s permit
 One (1) set of floor plan showing specific location of equipment and work area
required, appropriately dimensioned, properly identified and completely labelled.
It shall be signed and sealed by an architecture or engineer
 List of personnel, notarized, including Xerox copies of current PRC identification
cards and certificates of training
 List of equipment with specifications
 Contract of lease (if facility is rented)
 Certified of Accreditation
o BHFS application form filed either at the Bureau or CHD
o Letter of endorsement to the Bureau Director (if filed at the CHD)
o Copy of DOH LTO
o Record of lab personnel
o Documentation of COC
o Quality control program, (for screening lab)
o Certification for quality Standard System by a DOH
o Proficiency testing results
o Procedure manual
 procedures for application for initial license/accreditation:
o Applicant requests for relevant information and prescribed form from the
Bureau or CHD
 In person
 Thu mail
 Email
 Internet
 o accomplishes required documents and submits them to the Bureau or
CHD and then pays the required amount to the DOH
o The Bureau conducts survey on site to determine compliance with
standards and technical requirements of licensing/accreditation
o The Bureau approves or disapproves the issuance of license to
operate/certificate of accreditation for compliance.
 If approved- the Bureau registers the laboratory and issues and initial
license to operate/certificate of accreditation to the applicant
 If disapproved- the Bureau sends the findings and recommendations
to the applicant for compliance.
o If not approved, the applicants may submit an appeal to the Secretary
within 15 days

Section 11: License/Accreditation Fees:

License fees Accreditation fees

Confirmatory lab Php 5, 000. 00 Php 5, 000. 00
Screening lab Php 2,000.00 Php 2,000.00

 Laboratories outside Metro Manila (Luzon, Visayas, and Mindanao) applying for
accreditation shall shoulder the travelling expenses (transportation and
accommodation).
 Initial certificate of accreditation – Php 20,000.00
 Fees as subject to change from time to time

Section 12: Content of License to Operate/Certificate of Accreditation:

 name of the owner

 head of lab
 procedures or specialties authorized
 validity period
 signed by the Bureau or CHD director

Section 13: Validity:

 valid for 2 years for confirmatory and 1 year for screening

Section 14: Renewal of License to Operate/Certificate of Accreditation:

 1.Application for renewal of license/certificate of accreditation shall be filed ninety

(90) days before the expiry date to the Bureau or CHD
 2. required documents
  a. Renewal of License to Operate
o Notarized: Application for Renewal of License
o Notarized List of Personnel
o List of equipment/instrument
o Current Certificate of Accreditation
o Current Mayor’s Permit
 b. Renewal of Certificate of Accreditation
o Current License to Operate
o Current Certification for Quality Standard System (renewed yearly) –
Confirmatory Laboratory
o Current Proficiency Test Result (renewed yearly)
 3. The following are the procedures for application for renewal of
license/accreditation:
o a. Applicant requests for relevant information and prescribed form from the
Bureau or CHD
 in person
 thu mail
 email
 internet
o Applicant accomplishes required documents and submits them to the
Bureau or CHD. And then pays the required amount to the DOH
 The Bureau or CHD conducts a survey on site to determine compliance with
standards and technical requirements of licensing/accreditation
 The Bureau or CHD approves or disapproves the issuance of license to
operate/certificate of accreditation for compliance
o if approved- the Bureau or CHD renews the license to operate/certificate
of accreditation to the applicant
o If disapproved- the Bureau or CHD sends the findings and
recommendations to the applicant for compliance. The applicant requests
the Bureau or CHD for another survey
 If not approved, the applicant may submit an appeal to the Secretary within 15
days

Section 15: Monitoring of Laboratories:

 The bureau or CHD conducts the monitoring of lab

 Conducted unannounced
 It shall document the overall quality of the laboratory setting

Section 16: Terms and Conditions of Licensing/Accreditation

  A license or accreditation granted in accordance with prescribed
licensing/accreditation requirements and on the basis of specific conditions and
limitations established during survey
 A license or accreditation on that is not renewed is considered lapsed and will be
cancelled
o A new application is required before a lab can be allowed to operate
 Any right under the license. Accreditation cannot be assigned or otherwise
transferred directly or indirectly to any party
 Bureau is notified of any change in management name or ownerships
o Transfer of location- new application of license/accreditation
 Failure to report changes may be a basis for suspension or renovation of the
license/ accreditation
 For lab or branches maintained separate premises but operated by the same
management- separate license/accreditation
 The license be displayed in a conspicuous are of the laboratory
o Rules and regulations should be made available to all lab personnel

Section 17: Violations:

 Issuance of false or fraudulent drug test results.

 Failure to protect the confidentiality of drug test results.
 Failure to participate in a proficiency testing (for Confirmatory Laboratory).
 Conviction of the owner or manager of a laboratory for any criminal offense
committed as an incident to the operation of the laboratory.
 Failure to refer the positive test results to a Confirmatory Laboratory.
 Any other cause which materially affects the ability the ability of the laboratory to
ensure the full reliability and accuracy of drug tests and the accurate reporting of
results.
 Refusal to allow survey, monitoring of a laboratory by the Bureau or CHD at an
appropriate time.
 Any act which is contrary to the accepted clinical laboratory practices.

Section 18: Suspension or revocation of LTO/Certificate of Accreditation

 By the bureau
 Based on complaints
 Investigation
 Suspension is not more than 60 days
 License revocation means accreditation revocation

Section 19: Reapplication for LTO/ certificate of Accreditations

  Those lab whose LTO/ certificate of accreditation is revoked may reapply for a
new license

Section 20: Appeal

 Files within 15 days after receipt of notice

Section 21: Penal Provisions

 Issues a false or fraudulent drug test result knowingly, wilfully through gross
negligence
o Imprisonment: 6 years 1 day to 12 years
o Fine: Php 100,000.00-5000,000.00
o Revocation of license
 Effectivity: January 13, 1003

SECTION 8

REPUBLIC ACT NO. 9288 or NEWBORN SCREENING ACT OF 2004

- An act promulgating a comprehensive policy and a national system for ensuring

newborn screening
NEWBORN SCREENING (NBS)

- A procedure used to determine if a baby has congenital metabolic disorder that

may lead to mental retardation and even death if left untreated.
- Usually for 1-2 days infants
PARAMETERS IN PHILIPPINE NBS

 Congenital Hypothyroisdism (CH)

 Congenital adrenal hyperplasia (CAH)
 Galactosemia (GAL)
 Phenylketonuria (PKU)
 Glucose-6-PO4 DH deficiency (GPD def)
PROCESS

 Blood is collected from 24 to 4 hours (72 hours)

 The baby must be screened again after 2 weeks
 Who can collect blood?
Physician
MT
Nurse
 Midwife
 A few drops of blood is collected from the baby’s heel and placed in a special
absorbent paper
 Blood is dried for 4 hours and sent to the NBS lab

GENERAL PROVISIONS

ARTICLE 1

- This act shall be known as the “Newborn Screening Act of 2004”.

SECTION 2: THE DECLARATION OF POLICY

-Institutionalize a national newborn screening system that is comprehensive,
integrative and sustainable
- ensure that every baby in the Philippines is offered the opportunity to undergo
Newborn Screening and thus be spared from heritable conditions that can lead to
mental retardation and death if undetected and untreated.

SECTION 3: OBJECTIVES

– The objectives of the National Newborn Screening System are:

(a) To ensure that every newborn has access to newborn screening for certain heritable
conditions that can result in mental retardation, serious health complications, or death if
left undetected and untreated;

(b) To establish and integrate a sustainable newborn screening system within the public
health delivery system;

(c) To ensure that all health practitioners are aware of the advantages of newborn
screening and of their respective responsibilities in offering newborns the opportunity to
undergo newborn screening; and

(d) To ensure that parents recognize their responsibility in promoting their child’s right to
health and full development, within the context of responsible parenthood, by protecting
their child from preventable causes of disability and death through newborn screening

SECTION 4: DEFINITION OF TERMS

1) Comprehensive Newborn Screening Sytem includes:
-education of relevant stakeholders
-collection and biochemical screening of blood samples taken from newborns;
-tracking and confirmatory testing to ensure the accuracy of screening results
-clinical evaluation and biochemical/medical confirmation of tests results
 -drugs and medical/surgical management dietary supplementation to address the
heritable conditions
-evaluation activities to assess long term outcome, patient compliance and
quality assurance
2) Follow-up
-monitoring of a newborn with a heritable condition
-To ensure that the newborn patient complies fully with the medicine of dietary
prescriptions
3) Health institutions
-hospitals, health infirmaries, health centers with obstetrical and pediatric
services, whether public or private.

4) Healthcare practitioner- physicians, nurses, midwives, nursing aides and

traditional birth attendants.

5) Heritable condition – condition that can result in mental retardation, physical

deformity or death if left undetected and untreated.

-usually inherited from the genes of either or both biological parents of the
newborn.

6) NIH – National Institute of Health

7) Newborn – a child from the time of complete delivery to 30 days old

8) Newborn screening – the process of collecting a few drops of blood from the
newborn and performing biochemical testing for determining if the newborn has a
heritable condition.

9) Newborn Screening Center – a facility equipped with a newborn screening

laboratory

- complies with the standards established by the NIH

-provides all required laboratory tests and recall/follow-up programs for newborns
with heritable conditions

10) Newborn Screening Reference Center

-the central facility at the NIH

- maintains an external laboratory proficiency testing program

-oversees content of education materials

-acts as the Secretariat of the Advisory Committee on Newborn Screening

 11) Parent Education – providing parents or legal guardian’s information about
newborn screening

12) Recall – to provide the newborn with appropriate laboratory tests to confirm
the diagnosis

-to provide treatment

13) Treatment – the provision of prompt appropriate and adequate medicine,

medical, and surgical management or dietary prescription to a newborn.

ARTICLE 3 includes information on the following:

✓ Section 5: Obligation to inform - requiring all healthcare providers who have assisted
in the delivery of the newborn to inform the parents or guardian about the availability,
nature, and benefits of the newborn screening procedure

✓ Section 6: Performance of the NBS procedure – should be done within 24 – 48 hours

from the time of complete delivery but not later than 3 days; however,

- a newborn that must be placed in intensive care unit may be exempted from the
3-day requirement but must be tested by seven (7) days of age.

✓ Section 7: Refusal to be tested – should be acknowledged in writing if the

parents/legal guardian refuses the testing procedure because of religious beliefs

✓ Section 8: Continuing Education – re-education and re-training of healthcare

personnel and providers (To be facilitated by the DOH with the assistance of NIH and
other government agencies)

 The DOH, shall:

- (i) conduct continuing information, education, reeducation and training
programs for health personnel on the rationale, benefits, procedures of newborn
screening;
- (ii) disseminate information materials on newborn screening at least annually to
all health personnel involved in maternal and pediatric care.

✓ Section 9: Licensing and Accreditation

– The DOH and the Philippine Health Corporation (PHIC) shall require health
institutions to provide Newborn screening services as a condition for licensure and
accreditation.
Article 4: Implementation

– The lead agency for the implementation of the NBS procedure as stated in Article 4 of
this Act, shall be the Department of Health.

▪ The remaining provisions include the repealing, separability, and effectivity clauses.

SECTION 12: ESTABLISHMENT AND ACCREDITATION OF NEWBORN

SCREENING CENTERS

 The DOH will ensure that NBS centers are strategically located
 No Newborn Screening Centers shall be allowed to operate unless it has been
duly accredited by the DOH
 A Newborn Screening Center shall
- (i) have a certified laboratory performing all tests included in the NB program
- (ii) have a recall/follow up programs for infants found positive for any and all of
the inheritable conditions
- (iii) be supervised ad staffed by trained personnel who have duly qualified by the
NIH;
- (iv) submit to periodic announced or unannounced inspections by the Reference
Center in order to evaluate and ensure quality Newborn Screening performance.
SECTION 13: ESTABLISHMENT OF A NEWBORN SCREENINF REFERENCE
CENTER

 Newborn Screening Reference Center,

-responsible for
National testing database and case registries, training
Technical assistance
Continuing education for laboratory staff in all Newborn Screening
Centers.
SECTION 14: QUALITY ASSURANCE

 NIH Newborn Screening Reference Center is responsible for

-drafting and ensuring a good laboratory practice standards for newborn
screening centers
-establishing an external laboratory proficiency testing and certification
program
-acting as the principal repository of technical information relating to
newborn screening standards and practices
-provide technical assistance to newborn screening centers needing such
assistance.
SECTION 16: NEWBORN SCREENING FEES


The PHIC shall include cost of newborn screening in its benefits package.
The newborn screening fee shall be applied to, among others, testing
costs, education, sample transport, follow-up and reasonable overhead
expenses.
 APPROVED: APRIL 7, 2004

FROM THE MODULE

Introduction

Since the past few decades, newborn screening has been popularly known as an
infant’s screening or neonatal screening. This test reached full recognition when
Republic Act No. 9288 or the Newborn Screening Act of 2004 was enacted and
implemented. Its purpose is to identify the manifestation of genetic disorders or
conditions so that prompt attention can be given to affected newborns. Understanding
the importance of a newborn screening test, the identification of clinical disorders, and
laboratory tests paved the way to the enactment of the law, making the test legal and
operational.

Principle of Newborn Screening Procedure

➢ The newborn screening test is non-diagnostic because a series of follow-up

procedures should be made to verify abnormal results. The newborn is usually subject
to laboratory examination. Both urine and blood samples are collected and a series of
laboratory tests are performed including the ferric chloride test, sodium nitroprusside
clinitest, and Guthrie test. Other related tests are carried out depending on the inborn
metabolism disorder being presumptively screened.

Rationale of Newborn Screening Procedure

➢ Since newborn screening is mandated by law, all newborn babies are screened,
even if they may look healthy since some clinical conditions are asymptomatic. With this
idea, the clinical disorders that may manifest soon after birth, such as brain damage or
organ damage, can be detected or somehow prevented. However, in making decisions
for early newborn screening procedure, the following factors should be considered:
1. An understanding of the newborn’s condition’s natural history – it is necessary to
discuss the condition with the parents to trace the history of inborn error of metabolism

2. An acceptable treatment protocol that changes the outcome for patients diagnosed
early with the disease – in addition, gene therapy can be employed, especially in special
genetic disorders such as alkaptonuria

3. An understanding of who will be treated as a patient – early detection of genetic

disorders can be traced from the family as well.

Clinical Conditions Screened

The clinical conditions and genetic disorders that the newborn may inherit from their
parents are mostly hemoglobinopathies, endocrinopathies, and inborn error of
metabolism (amino acid disorders).

▪ Congenital Hypothyroidism

▪ Congenital Adrenal Hyperplasia

▪ Galactosemia

▪ Phenylketonuria

▪ G6PD Deficiency

A. Hemoglobinopathies

➢ Hemoglobinopathy is a condition associated with abnormal heme synthesis,

hemoglobin variants, and globin synthesis. The various hemoglobinopathies are the
following:

1. Porphyria – characterized by a defect in one or more enzymes involved in heme

synthesis resulting in the accumulation of porphyrin in the bone marrow (erythropoietic
porphyria) or the liver (hepatic porphyria).

2. Sickle cell disease – characterized by the presence of hemoglobin S in a

homozygous state while sickle cell trait is characterized by the presence of hemoglobin
S in heterozygous state. Sickle cell anemia is a clinical condition in which erythrocytes
become rigid and trapped in capillaries. Blood flow is restricted, causing a lack of
oxygen supply to the tissues which may lead to tissue necrosis.
3. Hemoglobin C disease – characterized by having an amino acid substitution of lysine
for glutamic acid on the sixth position of the beta chain. The red blood cells appear as
target cells or less often, precipitated as hemoglobin C crystals that can be
demonstrated within the red blood cell.

4. Hemoglobin SC disease – is a double heterozygous condition in which an abnormal

S gene from one parent is inherited and an abnormal C gene for another parent is also
inherited.

5. Hemoglobin D disease – characterized by having an amino acid substitution

glutamine at the 121st position of the beta chain

6. Hemoglobin E disease – characterized by an amino acid substitution lysine at the

26th position of the beta chain and may cause mild anemia with the presence of
microcytes and target cells.

7. Hemoglobin constant spring – characterized by having 31 amino acids added to the

alpha chain and may be caused by a replacement of a terminator codon with a codon
for glutamine resulting in the addition of the 31 amino acids before a stop codon is
reached.

8. Thalassemia – a clinical condition whose predominant cause is gene deletion. The

alpha and beta thalassemia are the most common.

B. Amino Acid Disorders

1. Phenylketonuria – the most common form of amino acid disorder. This is an inherited
autosomal recessive disorder characterized by a deficiency in phenylalanine
hydroxylase that may result in severe mental retardation

2. Other amino acid disorders include: MSUD, Alkaptonuria, tyrosinemia/tyrosyluria and

cystinuria

C. Fatty Acid Oxidation Disorders

1. Medium chain acetyl-CoA dehydrogenase deficiency – a life threatening fatty acid

oxidation disorder. The patient may experience muscle problems, poor feeding,
vomiting, and seizure.
D. Cystic Fibrosis – an autosomal recessive disorder which is characterized by a thick
mucus in the lungs and digestive system resulting in respiratory infection and difficulty in
food digestion.

E. Endocrinopathies – the most common endocrine disorders include the following:

1. Congenital Hypothyroidism – characterized by the absence or poor functioning of the

thyroid gland, resulting in the reduced production of thyroxine. Newborns with a
deficiency of thyroxine may suffer from severe intellectual disabilities and growth
problems.

2. Classic adrenal hyperplasia – a clinical disorder characterized by a deficiency of the

enzyme steroid 21-hydroxylase which comes in two forms, namely simple virilizing and
salt-wasting.

Provisions of R.A. 9288

▪ Republic Act No. 9288 was enacted and declared as the "Newborn Screening Act of
2004”. It mandates the newborn screening procedure as it is a national policy in favor of
the children’s health. This Act consists of five articles including the general and final
provisions.

▪ The objectives are stated in the general provisions of this Act. Accordingly, the State
has extended its general policy of protecting and promoting the constitutional right of
citizens to good health, thereby mandating the Filipinos to carry out the newborn
screening procedures as comprehensive, integrative, and sustainable.

▪ For full implementation of this Act, all government and non-governmental sectors
including hospitals and clinics are required to undertake screening procedures.

▪ Article 1 includes the following:

✓ Title of this Act (Section 1)

✓ Declaration of Policy (Section 2)

✓ Objectives (Section 3)

Guidelines Prior to Test Procedures:

1. Provide parents/legal guardians an information brochure that tells the benefits of
newborn screening procedure

2. Explain the newborn screening procedure to the parents or legal guardians.

3. Discuss the reasons for the collection of samples, especially if a second sample is
needed to be collected.

4. Advise parents/legal guardians to arrange further testing if needed.

5. Document informed consent from the parents/legal guardians. Refusal to have their
newborn to undergo screening should be in writing and should form part of the medical
record of the child.

Steps in Sample Collection:

1. Ensure the complete identification of the newborn

2. Collect the blood sample within 24 – 72 hours. Capillary heel puncture is the
preferred technique as shown below:

3. Cleanse the baby’s heel with an alcohol cotton swab. Air-dry the heel before
puncturing.

4. Prick the heel (slight angle) and wipe the first drop of blood. Have the heel dependent
facing down.

5. Wait for the spontaneous flow of blood. Lightly touch the circle of the card with the
drop of blood as shown below. Allow the blood to soak and completely fill the circle on
the card. Fill each circle with a drop of blood and air-dry the spots for few hours on a flat
non-absorbent surface. Observe for the completeness and sufficiency of blood.

Section 9: WATER TESTING LABORATORIES: A.O NO. 31 s 1979:

Introduction:

 PD 856
o Code of sanitation of the Philippines
o The examination of drinking water should be performed only in water
testing laboratories accredited by the DOH
o OBJECTIVE:
 To protect and safeguard the health and welfare of the community
 Prevent the establishment operation and maintenance of poorly
equipped, substandard water testing laboratories
A.O.NO. 31 s. 1979

 Subject:
o Requirement for the accreditation of water analysis laboratories
 Basis
o Philippine Standard Methods for Air and Water Analyses- January 1978
o National Standard for Drinking Water- September 1978
 Purpose
o Safe and potable water for everybody
 Process
o Standardized testing

Water testing laboratories:

 Not set up as any commercial enterprise for profit

 It is set primarily to assist maintain the safe and potable quality of the water
supply for the community
 It is a civic responsibility

Requirements for the Accreditation of a Water Analysis Laboratory:

 Services rendered by an accredited water analysis laboratory

 Bacteriological
 Chemical
 Radiological
 Physical
 Biological
 A combination of the abovementioned services
 Accreditation may be renewed every year
1. Basic Requirements
 Accomplish an application form which includes the following attachments
 Name, citizenship and docimile of the head of the lab
 The municipality and where it is to be established
 Name of the establishment
 Name citizenship and docimile of the owner
 Scope and nature of work, specifying procedures
 Statement that applicant has complied with all business requirements
under existing laws or ordinances od applied for
 Tax clearance for preceding year
 Inspector from the BHFS will inspect within 60 days after filling of
application
  If approved- certificate of accreditation will be issued
 If disapproved- the application will be returned to the applicant with
notation on shy the application was denied
2. Personnel
 Head
o Licensed Sanitary Engineer
 May head, manage or supervise up to 3 weeks laboratories,
but it should be continuously located in a particular area
o If attached to a licensed clinical lab- Clinical pathologist
o If in areas without pathologists or Sanitary Engineers- Licensed
chemist, Medical technologist, pharmacist- provisional
 Allowed to supervise only one laboratory
 Must have 3 years’ experience
 Laboratory Assistants
o Involved in the technical aspects of water analysis
o Should be a registered pharmacist, medical technologist, chemist
o May supervise not more than two skilled workers
o BsBio- for biological analysis of water
o Should be
 Trained
 One year experience
o Laboratory Support Personnel
 Laboratory aside- clean glass wares, assist in the
preparation of media
 Trained personnel- sampling, clerical work
o Service capabilities
 Each service must be operated by at least
 One registered professional
 One lab assistant
 One lab aide
 Bacteriological service- 30 samples per day
 Chemical service- 5 samples for routine chemistry per day
3. Physical Plant
 Work rooms
o Housed in a permanent building
o Made from strong materials- concrete or semi-concrete
o Floor- concrete or tiled or linoleum finished
o With adequate drainage
o Should be well ventilated
o Provision for natural or artificial lighting
  Work space
o Requirements include
 Sufficient bench top area-1.20-1.80 m of continuous area per
analyst
 Storage space for media
 Glass wares and portable equipment
 Area for cleaning glass ware and sterilizing materials
o Working area for a specific service- 20m
o Head for chemical, radiological and bacteriological units must be
provided
o Analytical balance- on a level form stand
o Bench height- 90 cm
 Laboratory bench – 75 cm high
o Others
 Adequate running water and not stored water
 Shower facilities
 Adequate physical provisions for safety of lab personnel
 Safety and building code
4. Laboratory Apparatus, Materials and Reagents
 Criteria
o Sensitive
o Reliable
o Need minimum service repairs
o Efficient
o Effective
o High grade quality reagents and media
 Applications for accreditation should indicate the laboratory service
to be rendered
o Bacteriological Analysis Service
 Multiple-tube fermentation technic
 Gram stain technic
 IMViC test
 Standard Plate Count
 Fecal coliform test
 Optional- test for fecal streptococcal group
o Biological Analysis
 Quantitative and qualitative examination of phyto-plankton
samples
 Zooplankton and bottom fauna examination
o Physical and Chemical Analysis Service
  Refer to book (medtech’s books) for the enumeration of
service rendered
o Radiological Analysis Service
 Gross Alpha and Gross Beta Radioactivity
 Total suspended and Dissolved
 Total Radioactive Strontium in Water
 Strontium- 90 in water
 Total radium (Precipitation Technique)
 Radium- 226 by Radon (Soluble, Suspended and Total)

Minimum Equipment for Each Service

 Bacteriological Analysis
o Incubator
o Waterbath- 37C, 45.5 +_ 0.5C (if E.coli is to be performed)
o Autoclave
o pH meter
o analytical balance
o colony counter
o microscope
o hot plate or stove
o oven, sterilizing
o Bunsen burner
o Refrigerator
 Chemical Analysis Service
o pH meter
o over, sterilizing
o candle turbidimeter
o pipette washer
o spectrophotometer, spectronic 20 or AA
o magnetic stirrer
o waterbath
o refrigerator
o gas chromatographer
o vacuum filter
 Biological Analysis Service
o Water sampler
 van dorn
 Kemmerrer
 Wansen buttner
 Improvised Neyer or LLDA’s Modifier sampler
 o Water pump with graduated intake
o Bottom dredge
o Inverted microscope
o Compound microscope
 Radiological Analysis Service
 Minimum Required References
 Request and Results

SECTION 10

Republic Act No. 7170

Or “ORGAN DONATION ACT OF 1991”

▪ Section 1 covers the short title of this Act (Organ Donation Act of 1991)

▪ Section 2 includes the Definition of Terms

Organ Bank Storage Facility – a facility licensed to store human bodies of parts thereof

Decedent – a deceased individual

 Includes a still-born infants or fetus

Testator – a person who makes a legacy of all or the part of his body

Donor – an authorized individual who can donate all or part of the body of a decent
Hospital

Part – transplantable organs, tissues, eyes, bones, arteries, blood, other fluids and
other portions of the human body

Person – legal entity

Physician/Surgeon

Immediate family of the decedent – section 4a

Death – the irreversible cessation of circulatory and respiratory functions or the

irreversible cessation of all functions of the entire brain including the brainstem

 Legally dead if
 Absence of natural respiratory and cardiac functions and attempts at
resuscitation would not be successful. Death is deemed to have occurred
at the time these functions ceased.
 Irreversible cessation of all brain functions. Attempts at a resuscitation or
continued supportive maintenance would not be successful in restoring
supportive maintenance would not be successful in restoring these natural
functions. Death occurred at the time when these conditions first
appeared.
 Death is determined:
o In accordance with the acceptable standards of medical practice
o Diagnosed by the attending physician and another consulting
physician
o Recorded in the patient’s ,medical record

▪ Section 3.

Persons who may ++execute a Legacy:

➢ At least 18 years of age

➢ Sound mind

▪ Section 4.

Person who may execute Donation:

o Spouse

o Son or daughter of legal age

o Guardian over the person of the decedent at the time of his death
▪ Section 5:

Examination of human body or part thereof

o Legacy of donation

✓ Authorizes any examination necessary to assure medical acceptability of the legacy

or donation for the purpose(s) intended

✓ An autopsy shall be conducted on the cadaver of accident, trauma, or other medico-

legal cases immediately after the

SECTION 10:

REPUBLIC ACT NO. 7170: ORGAN DONATION ACT OF 1991

Pronouncement of death, to determine qualified and healthy human organs for

transplantation or in furtherance of medical science.

▪ Section 6: Persons who may become Legatees or Donees

o Any hospital, physician or surgeon

– for medical and dental education, research, advancement or medical and dental
science, therapy or transplantation

o Any accredited medical or dental school, college or university

– for education, research, advancement of medical or dental science or therapy

o Any organ bank storage facility

– for medical or dental education, research, therapy or transplantation

o Any specified individual

– for therapy or transplantation needed by him

▪ Section 7: Duty of Hospitals

o Hospitals authorized to receive organ donations or to conduct transplantation:

✓ Train personnel and staff to handle the task of introducing the organ donation
program in a humane and delicate manner to the relatives of the donor-decedent

o Documents must be accomplished as proof of compliance

▪ Section 8: Manner of Executing a Legacy o Will

– becomes effective upon the death of the testator without waiting for probate of the will

✓ If the will is declared invalid for testamentary purposes, the legacy is nevertheless
valid and effective

o Card

– carried on a person, must be signed by the testator (or may be signed for him in his
presence if he cannot sign) in the presence of two witnesses who must sign in the
presence of the testator

✓ Legacy becomes effective upon death of the testator and must be respected by and
binding

o The legacy may be made to a specified legatee or without specifying a legatee

✓ If the legatee is absent at the time of death of the testator the physician or surgeon
may accept the legacy as legatee (in the absence of any expressed indication that the
testator desired otherwise)

✓ If the legacy does not specify a

legatee, the legacy may be accepted by the attending physician or surgeon as legatee
upon or following the testator’s death

✓ If the physician becomes a legatee, he shall not participate in the procedures for
removing or transplanting a part/s of the body of the decedent

o Testator may designate in his will/card/document , the surgeon who will carry out the
appropriate procedures

✓ In the absence of designation, the legatee or other persons authorized to accept the
legacy may authorize any surgeon or physician for the purpose
▪ Section 9: manner of Executing a Donation

o Any donation by a person authorized under subsection (a) of section 4 hereof shall be
sufficient if it complies with the formalities of a donation of a movable property o In the
absence of any persons and in the absence of any document of organ donation the
following may authorize the removal of body parts:

✓ The physician in charge

✓ The head of the hospital

✓ Designated officer of the hospital who has custody of the body of the deceases
classified as accident, trauma, or other medico-legal cases

Provided that the physician, head of hospital or officer designated by the hospital
for this purpose has exerted reasonable efforts, within forty-eight (48) hours, to
locate the nearest relative listed in Section 4 hereof or guardian of the decedent
at the time of death.

o In all donations, the death of a person, shall be diagnosed separately and certified by
two (2) qualified physicians neither of whom should be:

✓ A member of the team of medical practitioners who will effect the removal of the
organ from the body; nor

✓ The physician attending to the receipt of the organ to be removed; nor

✓ The head of hospital or the designated officer authorizing the removal of the organ.

▪ Section 10. Person(s) Authorized to Remove Transplantable Organs

o Only authorized medical practitioners in a hospital shall remove and/or transplant any
organ which is authorized to be removed and/or transplanted pursuant to Section 5
hereof

▪ Section 11. Delivery of Document of Legacy or Donation

o If the legacy or donation is made to a specified legatee or donee, the will, card or
other document, or an executed copy thereof, may be delivered by the testator or donor,
or his authorized representative, to the legatee or done to expedite the appropriate
procedures immediately after death
o The will, card or other document, or an executed copy thereof, may be deposited in
any hospital or organ bank storage facility that accepts it for safekeeping or for
facilitation or procedures after death.

o On the request of any interested party upon or after the testator's death, the person in
possession shall produce the document of legacy or donation for verification

▪ Section 12. Amendment or Revocation of Legacy or Donation o If the document was

delivered, the testator or donor may amend or revoke the legacy or donation either by:

✓ The execution and delivery to the legatee or donee of a signed statement to that
effect; or

✓ An oral statement to that effect made in the presence of two other persons and
communicated to the legatee or donee; or

✓ A statement to that effect during a terminal illnes or injury addressed to an attending

physician and communicated to the legatee or donee; or

✓ A signed card or document to that effect found on the person or effects of the testator
or donor.

o If the document was delivered to the legatee or donee, it may be revoked by the
testator or donor in the manner provided in subsection (a) of this Section or by
destruction, cancellation or mutilation of the document and all executed copies thereof.

▪ Section 13. Rights and Duties After Death

o The legatee or donee may accept or reject the legacy or donation as the case may be.

o If the legacy of donation is of a part of the body, the legatee or donee, upon the death
of the testator and prior to embalming, shall effect the removal of the part, avoiding
unnecessary mutilation.

o After removal of the part, custody of the remainder of the body rests in the surviving
spouse, next of kin or other persons under obligation to dispose of the body of the
decedent.

o Any person who acts in good faith in accordance with the terms of this Act shall not be
liable for damages in any civil action or subject to prosecution in any criminal
proceeding of this Act.

▪ Section 14. International Sharing of Human Organs or Tissues

o through exchange programs duly approved by the Department of Health

o Provided, That foreign organ or tissue bank storage facilities and similar
establishments grant reciprocal rights to their Philippine counterparts to draw organs or
tissues at any time.

▪ Section 15. Information Drive

o In order that the public obtain the maximum benefits from this Act,

o The Department of Health, in cooperation with institutions, involved in the donation

and transplantation of human organs, shall undertake a public information program.

Approved: January 7, 1992

SECTION 11: INTRODUCTION TO BIOETHICS

Introduction

Ethics is a branch of moral philosophy which deals with the institution of ethical
reasoning in the execution of human conduct. This part of the module describes the
nature, classes and principles of ethics and delivery of its ethical reasoning, and how
ethics is defined from different perspectives.

Description and Nature of Ethics

 Ethics is an application of a moral code of conduct and good behavior in the

field of professional endeavor

 It illustrates the act of professionalism in any professional service and enters

every sphere of life while a person carries out his/her moral obligations and
responsibilities

 It includes the relationship with the Almighty Being, for instance, as well as the
duty and responsibility of a physician to his/her patients and the obligations of
an attending medical technologist in providing accurate and reliable results.

Definition of Ethics:
  Ethics is derived from the Ancient Greek word ethos which means the “theory
of things” or “way of living”

 Ethics is also derived from the Latin word ethica which means “of or for
morals, moral, or expressing character”; and modern Latin mores which
means “customs”.
 It also defines how individuals interact with one another in a society with norms
and values and shows what is good for the individual and society, and how to
establish one’s duty which one owes to oneself and to one another.

 Ethics encompasses the analysis and institution of moral concepts such as right
or wrong, good or evil, and responsibility or abandonment.

 Ethics is considered as the fundamental concept of what is meant as the

decency of human conduct.

 Ethics may also mean “morality”

Nature and Scope of Ethics

 Ethics covers the concepts and principles of defending, systematizing,

remodeling, and interconnecting the implications of right and wrong deeds.

 Concept of Defending – encompasses the principle of placing justice

for the things done and services rendered

 Concept of Systematizing – deals with the manner or ways of putting

actions in the proper order

 Concept of Remodeling – entails the process of reshaping the sphere

of goodness and righteousness

 Concept of Interconnecting – covers the process of internalizing the

action done and relating it to a future action.
  Ethics is a philosophy because it touches the principles of righteousness and
goodness. It includes the code of right conduct (code of ethics) in the everyday
struggle for life.

 It covers what is morally right or morally good for the person and society

 Ethics is also a science because it is aimed at attaining a systematized

knowledge and experience.

 Ethics also includes everything that has reference to free human acts with
emphasis on the principle or cause of action (virtues, laws, or conscience) and
circumstances of actions (such as penalty, punishments, or rewards).

 It also enquires into what constitutes virtues (law, conscience, or duty).

In ethics, the sense of duty, moral obligations, and responsibility for actions are
also considered.

General Components of Ethics

 Rules
 These are set of laws or orders that may penalize wrongdoing.
 They may guide an individual to act in conformity with the law, ordinance,
directive, or policy.
 Once the rules of conduct are considered as policies, an individual may
be an observant of formal-or non-formal guidelines before an action is
done or executed.
 If the rules of conduct are classified as directives, the conduct of any
person can be guided at its micro-level.
 For instance, if the rule is “do not steal”, the same rule applies to an
individual at its micro-level (serving as a directive).
 Standards
 Any individual or society may set certain standards that the individual or
group of individuals or the entire community should observe.

 An example of standard set by an individual is the social policy of

prohibiting same-sex marriage
▪ Principles

 When the rules of conduct are evaluated against a standard rule, it is

otherwise known as a “principle of the moral system”.
 A principle of a rule of conduct is against a standard if there is a valid
and justified ground to support the premise.
 An example of principle is the social policy of no same-sex marriage
when justified by lawful orders such as an approved bill or ordinance.
 Judgement
 Judgement is a product of learned codes of conduct and the cognitive
evaluation of each situation.
 For example, it may determine whether or not an act or omission
constitutes robbery.
 Such act is judged as wrong or unlawful.
 Common Sense
 Common sense is a practical application of what the conscious mind
dictates whether the action is right or wrong.
 It is, however, the product of cognitive, practical, and critical thinking.
 In some cases, common sense is justified and practical without referring
to underlying laws or ordinances.
 Values
 The term “values” came from the Latin word valere which means
“having worth or being worthy”.
 It is conceived as an abstract object of interest or worth.
 Examples of these values are happiness, love, affection, sincerity,
fortitude, and the like.

 Public Interest
 Public interest when an action has been done and executed in
congruency with public welfare.
 An example is drug addiction. If an act is against public safety, then such
an act is wrong and illegal.
General Types of Ethics

 By convention, meta-ethics seeks the use of ethical reasons for the

things or events that have happened or have been happening as the will
of the Almighty God.
 It also dictates the role of ethical reason in rendering an ethical
judgement and the true meaning of ethical terms.
A. Meta-ethics
 o Meta-ethics literally means ethics far beyond the physical world
that is the rule of power on the will of Almighty God over human
reasoning.
o Meta-ethics involves two values:
 Metaphysical issue answering the question of whether
morality is supreme over humans
 Psychological issue disclosing the issue of mental
judgement over human conduct
o Consequently, several contracting issues cloud over meta-ethics.
o These contradicting issues include the existence of objectivism versus
relativism as a metaphysical issue, and psychological issues that illustrate
several conflicting areas such as:
 Egoism versus altruism
 emotion versus reason
 male versus female morality.
o Determining the real meaning of two contrasting areas of metaphysical
issues denotes that objectivism holds the idea that things really exist and all
things existing in the universe are real
B. Applied ethics
o A branch of ethics that refers to the analysis of moral issues such as
abortion, animal rights, and euthanasia.
o Various subdisciplines of applied ethics have been created. They
include environmental, medical, social, and business ethics.
o Applied ethics attempts to adopt a defensible theoretical framework
and then derive the normative advice by applying the theory.
C. Normative ethics
o Implies the institution of moral conduct in regulating what is right or
wrong.
o The basic principle following normative ethics is the Golden Rule,
which is, however, governed by three theories: virtue theory, duty
theory, and consequentialist theory.
o Normative ethics bridges the gap between meta-ethics and applied
ethics attempts to establish that an act is right from wrong or
distinguish a good act from a bad one.
Deontological (Duty) Approach

 The deontological approach to ethics denotes duty on the part of the agent or
doer of the action.
 For instance, it is the obligation of parents to send their children to school.
  The term “deontology” is derived from the Greek word deon (t) which simply
means “bind”.
 Two essential principles which are derived from the deontology approach are
the religions (religious doctrine) and Kantian ethics.
 Kantian ethics (formulated by Immanuel Kant) is based on categorical
(absolute) imperatives that are derived from rational analysis instead of
revelations set by priests or religious leaders.
 It formulates a test that can determine in an act done is right or wrong.
 The Kantian ethics test includes the questions: “Is it universal?” and “Is it
reversible?”
Consequentialist Ethics

 Consequentialist ethics, otherwise known as teleological ethics, is based on the

premise that if the outcomes are good, then the related actions can be good
regardless of the motive of the actor.
 Similarly, philosopher John Stuart Mill mentioned that public policy should be
judged on the outcomes.
 Actions are right if they tend to promote happiness which is understood as the
greatest good for the greatest number. Those who are more interested in
addressing what people actually do want – whether or not obtaining this will,
objectively speaking, turn out to be good for them – are called subjectivists.
APPLIED ETHICS

 Ethics in Medicine
 Ethics in medicine involves the use of moral values and judgments in
medical practice, especially in handling patients and inter-relationships
with other health workers.
 Western medical ethics, however, adopts the so-called Hippocratic
Oath (briefly stated as “to practice the profession and to prescribe
medicine to the best of the physician’s ability for the good of the
patients and to try to avoid doing harm to the latter”).
 Six values commonly apply to medical ethics, namely honesty,
beneficence, non-maleficence, dignity, justice and autonomy.
 Ethics in Psychology
 Some psychologists believe that moral behavior is reshaped by moral
reasoning through the formulation of theories.
 Theories are based on the assumption that the moral behavior
prescribed by ethics can be seen as an adaptation of evolution.
 One of the most popular humanistic theories is Maslow’s hierarchy of
needs (formulated by Abraham Maslow).
  Maslow’s theory includes self-actualization, pertaining to the self-
fulfillment of one’s potential, as the highest tier in the hierarchy of needs.
 Ethics in Health Care
 Ethics in health care is commonly practiced by health workers such
as nurses, psychologists, geneticists, pharmacists, physicians, and
other allied health workers.
 Some medical practices that remain ethical issues are abortion,
euthanasia, nuclear research, stem cell therapy, and vaccine clinical
trials.
 Ethics in Politics and Economics
 Ethics in politics and economics pertains to business ethics and Marxist
principles.
 Evident among employers and corporate workers, this type of ethics is
anchored on sensitivity to employees’ status and circumstances.
 Economic ethics in particular is derived from family structure and culture,
including the way a society views an individual’s roles and values.
 Ethics in Environment
 This type of ethics deals with how humans utilize the Earth’s limited
resources.
 However, the common trend in society is to combine both ecology and
economics in order to analyze the basis for utilizing environmental
resources.
PROFESSIONAL ETHICS

Professional ethics applies to the workforce and professionals. Professionals act

according to certain standards of behavior. For instance, medical technologists are
guided by the Medical Technology Code of Ethics.

 Principles of Professional Ethics

 Every individual or group of individuals acting in its own capacity usually
carries the burden of ethical responsibility.
 Professional ethics emanates from the moral reflection of professional
endeavors enveloped in a code of ethics.
 All professional organizations have their own rules of conduct and
standards of behavior required for professionals within the context of
professional endeavors, including doctors, medical technologists,
nurses, engineers, biologists, and the like.
 Professionals such as registered medical technologists are expected to
demonstrate and manifest ethical behaviors such as as the following:
1. Impartiality and objectivity
 -A medical technologist, like any other health worker, should
make impartial judgments especially in the final release of
work.
- This principle goes with the saying “Whatever a medical
technologist has examined must be verified and
released.”
- A medical technologist should report the result of laboratory
examination on the basis of actual judgment and analysis.
2. Openness and full disclosure
- A registered medical technologist should execute openness
and full disclosure on the basis of what has been
examined.
- He/She should release the laboratory results as what is
expected of the profession.
- Openness and full disclosure can be seen in any of the
following instances: o Infectious disease testing
o HIV testing o Reporting of infectious diseases o Treatment
and record keeping o Duty to warn o Disclosure of infectious
diseases
3. Due Diligence
- A registered medical technologist must demonstrate due
diligence, especially in the execution of his/her work.
- Every laboratory examination must be carried out with due
care and diligence.
4. Confidentiality
- Confidentiality of records is an important value among
health workers, particularly registered medical
technologists.
- By principle, confidentiality controls the release of medical
records, limits the ability of persons to testify in court based
on information obtained when providing professional
services (testimonial privilege), or prohibits disclosure of
information regarding specific diseases, such as HIV and
drug use.
5. Fidelity to professional responsibilities
- As mandated by the Code of Ethics, dedication to
work and fidelity or loyalty to responsibilities should be
observed. A registered medical technologist should
perform his/her job to the best of his/her abilities and
potential.
 6. Reliability at work
- Laboratory results must be treated with accuracy and
reliability; thus, a registered medical technologist must be
reliable and credible. He/She should have a basis in
releasing the reported laboratory results.

7. Avoidance of conflict of interest

- In any clinical laboratory, a registered medical
technologist should avoid conflicts of interest, especially
those involving one’s own personal desire or wants.
o information program.

SYNTHESIS

Ethics is derived from ancient Greek word ethios which means “theory of things” or
“way of living”. It is appreciated for the purposes it holds. The theory of things views
that the happening of events, decisions, and actions is the product of rightful thoughts
and deeds. Ethics is also derived from the old French word ethique, Late Latin ethica
which means “of or for morals, moral, or expressing character”, and Modern Latin
mores which means “customs”. Therefore, ethics examines and investigates the
justification of moral judgment in the long term of life. Ethics covers the concepts and
principles of defending, systematizing, remodeling, and interconnecting the
implications of right and wrong deeds.
 SECTION 12: HUMANS AND THEIR ACTS AND ACTIONS

Introduction

From the moment of birth, human beings are endowed goodwill and kindness. They
live in a society where they acquire traits and behaviors that further remold their
naïve character and deposition. In all human acts and interactions, they need to
protect themselves and their families. As much as possible, human action is always
centered on good intention and keen intuition. However, when these actions cause
harm to others, humans often deny the action done. This is the very nature of
humans while mingling to other people.

Human Acts vs. Acts of Humans

 When a person does or chooses to do an act and the act is

done, it is referred to as a human act

 When a person has no control over an act but still executes it,
such thing is called the act of human.

 The metaphysical point of view explains that if an act is

done with bad intentions, then such act can turn out to be
bad.

 Hence, human acts are either morally good or morally

bad; and their goodness and badness is imputed to a
person.

 In consequence, these acts are either worthy or praise or

blame, so a person, who elicits them, is regarded as
virtuous or wicked, innocent or guilty, and deserving of
reward or punishment.
 Human acts may include the acts of:

 Kindness
  Giving

 Compassion

 Acts of human on the other hand, may occur when acts are solicited
while the does of the actions has no control over them.

 Example: when a crime is committed against a

person or property Morality and its Determinants

 Essence of Morality

 When a child does what is good for himself or herself, then that is
morally right. Oftentimes, some acts of a child are bad. If so, then these
acts are morally wrong.

 The essence of morality may follow the saying that if an act is

commented and approved by ethical reason, then such an action is
right.

 On the other hand, if an act has been disproved by ethical reason and
blamed others for the outcomes of such action, then it is morally wrong.

 The primary ideas of right and wrong are similar to truth and falsity,
cause and effect, or substance and accident, which are common and
being experienced all men.

 The distinction between right and wrong usually corresponds to the

difference existing objectively in human acts

Morality of Human Acts

 Every human act is either good or evil and right or wrong in the context
of morality

 If besides the good effects directly intended in an act, evil effects are
foreseen as likely to result, the act is illicit unless it fulfills the following
conditions:
 1. That the evil effect be not directly intended

2. That the good effect intended be not produced by means of the evil
effect, for it is never allowed to do evil so that the good may come.

3. That the good directly intended exceed the evil effects. No one could
licitly bombard a city for the sake of a slight advantage
4. That the doer of the act be not under the obligation of averting the evil
consequences in question.

➢ If the act is intended for no other purposes, except to serve others, then it is morally
good. In some occasions, the conditions are present:

1. If the act done is praising the Supreme being

2. If the act is a personal obligation or responsibility

3. If the act of doing good things to others is the doer’s passion

4. If the act done may benefit the poor, weak and children

Determinants of Morality

A. Object of the Act

- An object of an act is good depending on the specification.

o Example: going to church or praising God is good in itself because
God is the supreme goodness

B. End or Purpose of an Act

- If the motive of an act is good, then the act is good.

- Sometimes, “the end does not justify the means” means the purpose or
end of an act is good but the employed means is wrong, thus, the act is
vitiated.

o Example: going to church every Sunday is good, but if the end or

purpose of going to church is to show off one’s new dress and to
wear an expensive perfume, then the act is bad.
C. Circumstances of an Act

- If the act itself is good but the prevailing circumstances are not favorable
to the act done, the act is still wrong.

o Example: giving to poor people or beggars is morally good

because it is an act of sharing your blessing. However, if the
beggar does not do anything to earn a living, then the act is wrong
because such act tolerates the habit of begging.

Accountability for and Hindrance to Moral Acts

 A person must be accountable for the acts done, whether consciously or

unconsciously or whether such action is good or bad and regardless of the
circumstances or end or purpose of an act.
 Such accountability of free acts is imputable to the person who does it. For acts
or omissions considered as felonies, the person should be liable for such acts;
that is the meaning of accountability.

 There are hindrances to doing moral acts, which are described as follows:

o Ignorance of the Act

- If a person chooses to do a free act even if such an act is

evil, he/she is still liable for such act even if he/she has no
knowledge that such act is evil

• Example: a person does a felony without his/her

knowledge that such act is a crime. He/she is still liable for
such act because as a rule, ignorance of the law excuses
no one from non-compliance therewith.
o Fear

- This hindrance is present when a person is afraid to do a good act.

• Example: the rules of policemen in keeping peace

and order in the community cannot be carried out if some
policemen do not want to perform their duties because of
the work-related risks.

o Violence

- This is a strong impulse from without, tending to force the

agent to perform an act against his/her choice

• Example: a person who is convinced to do a felony

because his/her family needs money will have no choice
but to commit such an act

o Concupiscence

- This is a strong impulse of the sensible appetite inclining the will

to seek sensible good and fly from sensible evil.

- When it arises unbidden by the will, it is termed antecedent

- When it arises at the command, or continues with the consent of
the will, it is called consequent
- The first impulse is not free, and, consequently, not imputable to
the individual. In as far as concupiscence impels the will, it
restrains one’s own liberty, and, thus, lessens one’s
accountability.
Values and Dignity of Human Beings

 Common values of a person:

o Dignity

- This means respecting the inherent values and worth of each

person

- The dignity of a person is difficult to define and describe when a

person is still young because dignity is usually appreciated in an
older person for it is associated with seniority and respect.

o Collaboration

- This translates to working together with people who support

common values and vision to achieve shared goals.

- In the pursuit of knowledge, collaboration is needed, most

especially with colleagues who know better and have acquired a
higher intellectual capability.

o Justice

- This is achieved by advocating social change and acting in ways

that promote respect for all persons and demonstrate
compassion for our fellow human beings who are powerless.

- The same value is commonly seen in an everyday setting in

which each person is given an equal chance to participate

o Stewardship

- This means cultivating the resources entrusted to us to

promote healing and wholeness. It is an important value which is
common among Filipinos who belong to a healthcare system.
 o Excellence

- This refers to exceeding expectations through teamwork and

innovation.

- It is the most difficult thing to achieve because of the presence of

intervening factors and obstacles in life.
 Dignity of a person

o Personal identity

- This is found to be the most relevant in the context of older

people:
it relates to self-respect and reflects an individual’s identity as a
person

- This can be violated by physical interference as well as by

emotional or psychological conditions such as humiliation, insult,
or embarrassment.

o Merit

- This relates to dignity or social status that is ascribed to

people because of their role or position in society, or because of
what they have achieved.

• Example: a nurse, or a doctor, or a therapist has status

that is recognized by other people.

o Moral status

- This is emphasized by the person’s moral autonomy or integrity

- If an older person is able to live accordingly to his/her own moral
principles, then that person will experience a sense of dignity.
Ignorance and Negligence

 Ignorance

o Ignorance means lack of technical and theoretical knowledge in the act

of doing work, task or any thing. In order to prove any evidence of
ignorance, the following conditions must be present:

1. A person is not competent to do the job

2. He/she does not have any experience in doing the job

3. He/she does the act without any knowledge of its consequence

4. He/she has the ability to discernment but fails to execute the job
because he/she has knowledge about the job.

 Negligence
o Refers to a persons’ failure to use reasonable care. It can take two forms:
either the failure to take action that a reasonable person would do, or doing
something that a reasonable person would not do.
o Some prerequisites to prove negligence are:

1. Cause of action

- Here, the accused owes a duty to the other party and

has failed to conform to the required standard of conduct,
resulting in an injury

2. Intervening cause

- Sometimes a plaintiff’s injury results from more than

one cause.

• Example: a defendant negligently injures a

pedestrian in an automobile accident; the defendant
in this case is an emergency doctor who negligently
treats the plaintiff, aggravating his/her injury
 3. Proximate cause

- The concept of proximate cause limits a defendant’s

liability for his/her negligence to consequences reasonably
related to the negligent conduct.

4. Reasonable care

- A person has acted negligently if he/she has departed

from the conduct expected of a reasonably prudent person
acting under similar circumstances.

5. Duty

- A defendant is not liable for negligence, even if he/she did not act
with reasonable care, or if he/she did not owe a duty to the
plaintiff.

- In general, a person is duty-bound to all persons at all times to

exercise reasonable care for their physical safety and the safety
of their property.

Human Actions as Dictates of Conscience

▪ Conscience

- The word conscience contains the word science which means

“to know” or “knowledge”
- A person thinks of his/her conscience as his/her own knowledge,
especially when it comes to one’s own morals, feelings or ideas
about what is right or what is wrong.

- In the case of healthcare providers, one’s conscience may be

pricked if standard care or reasonable care has not been
extended to the patients
 The conditions in which the dictates of conscience are evident includes:

1. Health care extended to the patient

2. Decision-making in clinical management

3. Establishing good rapport with colleagues

4. Communications and correspondence

- Since conscience is an act of consciousness, there are occasions

in which the dictates of conscience cannot be entertained. These
occasions include:

1. Acts of omission constituted as a crime

2. Act done is too immediate or abrupt
3. Struggling for physiological needs
4. Greediness for wealth and power

Torts and Malpractice

 Torts include the non-observance of the standard protocol in a clinical

setting; they are committed when healthcare providers violate the standard of
care which they think is nothing but the minimum healthcare threshold level that
should be provided to the patient.

 Common torts may include:

1. Assault

- It involves an attempt to do harm to someone or to initiate a

harmful contact with person.

- In the healthcare system, assault is committed especially if there

is a conflict of interest in the service rendered.

-
 2. Battery

- This is the intentional and offensive acting upon a threat, hence,

involving physical contact.
- A classic example includes healthcare providers who do not use
or adopt the principles of self-control justice and benevolence.

3. Intentional or Accidental damage to personal property

- This tort is evident in clinics or hospitals, especially in cases

that focus on wealth and power and not on the delivery of service.

 Other types of torts or malpractice include:

1. Intentional torts – example of this one is when a person performs an

operation even though he/she is not a licensed physician

2. Negligence – the conscious or unconscious commission of an evil act

3. Strict liability –this refers to the unconscious commission of an evil act

SECTION 13-A: BIOETHICAL ISSUES: ABORTION

Introduction

Abortion is defined as the termination of a pregnancy at any time within the

9month period prior to childbirth. In some countries, abortion is a legal medical
procedure which can be performed if the patient meets certain qualifications. In the
Philippines, although there are no laws that state that the abortion is legal, there is
still a steady rise of cases of abortion. This part of the module tackles about the
bioethical issues involving abortion and how abortion is viewed from a medical and
humanistic perspective.
 Why Some Women Choose Abortion Over Life?

 There are several reasons why some women here in the Philippines choose to
have an abortion rather than to continue the life they carry in their womb.

 One reason is the incapacity to take care of the baby due to poverty

 Some women opted to choose abortion if it is a rape cases

 Another reason involves unwanted pregnancy among minors

 Despite the reasons given, under the Revised Penal Code of 1930, a woman
who undergoes abortion and anyone assisting in the process, shall face
imprisonment

 Revocation of license may be imposed to a person with professional license

who performs abortion procedure

Risks of Abortion

 The effects of abortion to a woman may vary from physical, emotional, and
psychological effects to a combination of all these.

▪ Physical risks:
 Excessive bleeding
 Bacterial infections
 May cause sterility
▪ Emotional and Psychological risks:
 Long-term clinical depression
 Depression
 Anxiety
 Relationship and sexual difficulties
 Post-abortion syndrome
Legal and Ethical Considerations in Abortion
 The legal and ethical considerations of abortion revolve around the norms
and values of the family
 Provisions of the Penal Code of the Philippines:
 The penalty of prision correccional in its medium and maximum
periods shall be imposed upon a woman who shall practice abortion
 upon herself or shall consent that any other person shall do so. Any
woman who shall commit the offense to conceal her dishonor shall
suffer the penalty of priosion correccional in its medium and minimum
periods.
 If the crime is committed by the parents of the pregnant woman or
either one of them, and they act with consent of the said woman for
purpose of concealing her dishonor, the offender shall suffer the
penalty of prision correccional in its medium and maximum periods.
(Article 258, Revised Penal Code of the Philippines)
 From this legal point of view, and inference can be established that even if
the cause of abortion is conceal dishonor, still the intention of carrying out
an abortion is legally punishable.
 Although the concealment of dishonor is an ethical consideration, the law
still penalizes those who put the legal decision in their hands because the
end does not justify the means.
Abortion and Crime
 Considering the provisions of the Revised Penal Code, the two kinds of
abortion, which are penalized by law are the intentional and unintentional
abortion. Hence, the Revised Penal Code provides:
➢ Any person who shall intentionally cause an abortion, shall suffer:
o The penalty of prision mayor if he shall use any form of
violence upon the persons of the pregnant woman;
o The penalty of prision mayor, if without using violence, he shall
act without the consent of the woman;
o The penalty of prision correccional in its medium and
maximum period, if the woman shall have consented.
(Intentional
Abortion in Article 256, Revised Penal Code)
o The penalty of prision correccional in its minimum and medium
periods, shall be imposed upon any person who shall cause an
abortion by violence, but unintentionally. (Unintentional
Abortion in Article 257, Revised Penal Code)
▪ Upon careful analysis of the provisions, abortion is a crime and
punishable by law whether the reasons for carrying it out are intentional
or unintentional.
 SECTION 13-B: BIOETHICAL ISSUES: EUTHANASIA

Introduction

The legality or morality of the concept of euthanasia (mercy killing) which is the
act of assisting or abetting a person afflicted with an incurable disease to commit
suicide has been the topic of debates in many countries across the globe. In some
parts of the world, however, it is legal. Euthanasia was legalized in some countries
through the “Death Dignity Act”. In the Philippines the act of mercy killing remains a
controversial subject among lawmakers. This part of the module aims to explain the
different types and aspects of euthanasia.

Euthanasia vs. Assisted Suicide

 Euthanasia is committed when a person’s last act causes the death of the
patient

 On the other hand, if the patient’s last action causes his/her own death,
assisted suicide has taken place.

Classifications of Euthanasia

 Voluntary Euthanasia
- Euthanasia is a voluntary if consent is given by the patient before the
act of euthanasia
 Involuntary Euthanasia
- Involuntary euthanasia is when the patient is incapable of giving his/her
consent (mentally ill, coma, etc.)
 Active Euthanasia
- Euthanasia can be classified as active when a lethal substances or
forces are used to end a patient’s life
▪ Passive Euthanasia
- Passive euthanasia is withholding life-saving and life-prolonging
treatments to the patient.
Roles and Concerns of the Society about Euthanasia

 To eliminate the option for performing euthanasia, the WHO (World Health
Organization) has proposed improving the quality of life of terminally ill patients
through medical intervention to relieve them of pain and other problems
▪ In short, death is neither hastened nor postponed.
 The healthcare providers simply manage the conditions of the patients who can
live as actively as possible until the moment of their death.
 Another is the approval of the House Bill No. 564 better known as the Magna
Carta for Patient’s Rights
 The said bill states that a patient has the right to refuse diagnostic and medical
treatment
 On the other hand, House Bill No. 8148 asserts that a patient has the right to
terminate his/her life upon will or with the assistance of a physician.

Ethical Considerations of Euthanasia

 There are two (2) ethical considerations of euthanasia:

o Norms and values of the society regarding what is morally right o Norms
and values that manifest in the person himself/herself or within family
members.

Moral Issues of Euthanasia

 The moral issues of euthanasia revolve around religious affiliations and beliefs

 Euthanasia is viewed as a crucial act or a case of murder while voluntary

euthanasia is said to be a case of attempted suicide.

 Another point of view is the premise that when there is life, there is hope. With
this notion, there should be an attempt to bring about cure or to administer
palliative care.

 However, once euthanasia becomes an acceptable health procedure, then it

will be subject to economic considerations.
Legal Issues of Euthanasia

 Some of the legal issues and concerns of euthanasia are:

1. The illegal conduct of euthanasia

2. Power and wealth

3. Classification as an assisted suicide

4. Lack of consent of the victim’s family members or relatives

 In the case of euthanasia as an assisted suicide, it is clearly provided by the

provision of Revised Penal Code that:

➢ Any person who shall assist another to commit suicide shall suffer
from prision mayor, if such person leads his assistance to another to
extent of doing the killing himself, he shall suffer the penalty of reclusion
temporal. However, if the suicide is not consummated, the penalty of
arresto mayor in its medium and maximum periods shall be imposed.
(Giving Assistance to Suicide, Article 253, Revised Penal Code of the
Philippines)

SYNTHESIS

Euthanasia is otherwise known as mercy killing. It is classified into voluntary and

involuntary, furthermore, it can come in the form of active and passive. The WHO has
proposed improving the quality of life of terminally ill patients through palliative care.
Lastly, the House Bill No. 564 otherwise known as the Magna Carta for the
Patient’s Rights which was approved on August 22, 2000 states that a patient has
the right to refuse diagnostic and medical treatment.