PROF.

NENITA LIM

laboratory technician from

performing histopathologic
BLACK TEXT – from Canvas
BLUE TEXT – additional info techniques and procedures.
– amendments of PD 498 5. Clinical research involving
– amendments of PD 1534
patients or human beings
requiring the use of and/or
– others
application of medical technology
knowledge and procedures;
6. Preparations and standardization
REPUBLIC ACT NO. 5527 of reagents, standards, stains and
• The Philippine Medical Technology Act of 1969 others, provided such reagents,
• It was approved on June 21, 1969. standards, stains and others are
• Medical Technology – profession exclusively for the use of their
• Medical Technologist – professionals laboratory;
• USA recognizes Medical Technologists as 7. Clinical laboratory quality control;
professional 8. Collection and preservation of
• As amended by specimens;
o RA 6138: August 31, 1970 Provided, that any person who
▪ Amended sections: has passed the corresponding Board
16 [a, b], 21, and 22 of RA 5527 examination for the practice of a
o PD 498: June 28, 1974 profession already regulated by existing
▪ Amended sections: law, shall not be subject to the provisions
2 [a, d], 3, 4, 7, 8 [par. 3 & 5], 11 [c, of the last four preceding paragraphs if
g, h, i], 13, 16 [b], 17, 21 and 29 [j] the performance of such acts or services
of RA 5527 is merely incidental to his profession.
o PD 1534: June 11, 1978 b. Pathologist
▪ Amended sections: o A duly registered physician who is
3, 8 [par. 3], 11 [g, i], and 13, specially trained in methods of laboratory
of RA 5527 and also medicine, or the gross and microscopic
section 12 of PD 498 study and interpretation of tissues,
secretion and excretions of the human
Section 1: Title body and its functions in order to diagnose
• “The Philippine Medical Technology Act of 1969” disease, follow its course, determine the
An Act Requiring the Registration of Medical effectivity of treatment, ascertain cause of
Technologist, Defining Their Practice, and for death and advance medicine by means of
Other Purposes (Complete title ) research.
c. Medical Technologists
Section 2: Definition of Terms o A person who engages in the work of
a. Practices of Medical medical technology under the supervision
Technology Amended by PD 498 of a pathologist or licensed physician
o A person shall be Section 2. authorized by the Department of Health in
deemed to be in a. Practices of Medical places where there is no pathologist and
the practice of Technology who having passed the prescribed course
medical d. Medical Laboratory (Bachelor of Science in Medical
technology within Technicians Technology/Bachelor of Science in
the meaning of Hygiene) of training and examination is
this Act, who shall for a fee, salary or other registered under the provision of this Act.
compensation or reward paid or given d. Medical Laboratory Technicians
directly or indirectly through another, o A person certified and registered with the
renders any of the following professional Board as qualified to assist a medical
services for the purpose of aiding the technologist and/or qualified pathologist
physician in the diagnosis, study and in the practice of medical technology as
treatment of diseases and in the defined in this Act.
promotion of health in general: o The board may issue COR as Medical
1. Examination of tissues, Laboratory Technician without
secretions and excretions of the examination, who:
human body and body fluids by → Upon application and payment of
various electronic, chemical, P50.00
microscopic, bacteriologic, → He passed the Civil service
hematologic, serologic, examination for medical
immunologic, nuclear, and other technician given on March 21,
laboratory procedures and 1964.
techniques either manual or → He finished 2-yr college course,
automated; has atleast 1 year experience as
2. Blood banking procedures and medical technology technician
techniques; → Has failed to pass the board
3. Parasitologic, Mycologic and examination for medical
Microbiologic procedures and technology, but obtained general
techniques; rating of at least 70%.
4. Histopathologic and
Cytotechnology; provided that
nothing in this paragraph shall
inhibit a duly registered medical
 e. Accredited Medical Technology Training
Amended by PD 498
Laboratory
Section 4.
o A clinical laboratory, office, agency, clinic,
“Sec. 4. Compensation and Traveling Expenses
hospital or sanitarium duly approved by
of Council Members. For every meeting actually
the Department of Healthor its authorized
attended, the Chairman shall be entitled to a fifty pesos
agency.
(P50.00) per diem while the members shall be entitled
f. Recognized School of Medical Technology
to twenty-five pesos (P25.00) each regardless of
o Any school, college, or university which
whether or not they receive regular salaries from the
offers a course in Medical Technology
government. In addition, the Chairman and members of
approved by the department of Education
the Council shall be entitled to traveling expenses in
in accordance with the requirements
connection with their official duties.”
under this Act, upon recommendation of
the council of medical technology
education. Section 5: FUNCTIONS OF THE COUNCIL OF MEDICAL
g. Council TECHNOLOGY EDUCATION
o The council of medical technology a. To recommend the minimum
education established under this Act. required curriculum for the course of medical
h. Board technology
o The Board of Examiners for Medical b. To determine and prescribe the number of
Technology established under this Act. students to be allowed to take up the medical
technology course in each school, taking into
Section 3: Council of Medical Technology Education, Its account the student-instructor ratio and the
Composition availability of facilities for instruction
Now known as: TECHNICAL COMMITTEE FOR MED.TECH. c. To approve medical technology schools meeting
EDUCATION the requirements and recommend closure of
o CHAIRMAN: President of PASMETH those found substandard
o 2 PASMETH members d. To require all medical technology schools to
o 2 PAMET members submit an annual report, including:
o 1 PRC Officer (the chairperson or either of o Total number of students and instructors
the two commissioners) o List of facilities available for instruction
o List of their recent graduates and new
SMT and PH admission
- Schools of Medical Technology and Public Health
▪ On or before the month of JUNE
PSP
- Philippine Society of Pathologists e. To inspect, when necessary, the different medical
PAMET technology schools in the country
- Philippine Association of Medical Technologies f. To certify for admission into an undergraduate
PRC internship student who have satisfactorily
- Professional Regulation Commission completed three years of the medical technology
BRL course or its equivalent and to collect from said
- Bureau of Research and Laboratories student the amount of five pesos for the operating
fund of the Council
g. Formulate and recommend approval of refresher
Amended by PD 498 course for applicants who shall have failed the
Section 3. Board Exam for the third time
Chairman Commissioner of the PRC h. To promulgate and prescribe and enforce
Vice-Chairman Chairman of the MT Board necessary rules and regulations for the proper
Director of the BRL of DOH implementation of the foregoing functions.
Director of Private Education or its
duly authorized Section 6: Minimum Required Course
representative - Medical Technology course shall be at least four
Members 2 members of the MT Board years, including a 12-month satisfactory
Representatives of: internship in accredited laboratories
Deans or heads of private - The Council of MT Education is authorized
schools of medical (subject to the approval of CHED) to change,
technology remove from or add to the subjects listed above as
the needs and demands of progress in the science
of medical technology may require.
Amended by PD 1534
LATEST
Section 7: Medical Technology Board
Section 3.
• MT Board is under the (PRC)
Chairman Director of Higher Education
• The Board holds the office for Three (3) years
Vice-Chairman PRC Chairman
without re-appointment, Except for the first
Director of the BRL of the DOH
appointees and for those who shall serve the
Chairman of the MT Board
Board for less than one (1) year.
2 members of the MT Board
Members Representatives of: • COMPOSITION:
Deans of SMT and PH o Chairman: Pathologist
Presidents of the PSP and o 2 Members: RMT
the PAMET • The Board is under the direct supervision and
control of the PRC.
o Supervision – to see to it that the Board is
Section 4: Compensation and Traveling Expenses of functioning within the bounds of law
Council Members o Control – the power to alter, revise, modify
• For every meeting actually attended, the Council or change the decisions of the Board
shall be entitled to a P25.00 per diem for every
meeting
• The council shall be entitled to travelling expenses
in connection with their official duties
 Amended by PD 498 Section 9: Executive Officer of the Board
Section 7. • The Commissioner of Civil Service
MT BOARD o Executive Officer of the Board
- Appointed by the President o shall conduct the examinations
- Recommendation of the PRC • The Secretary of the Board of Examiners
Chairman Pathologist o Secretary of the Board.
Members 2 Registered MT o shall keep a register of all persons to
whom COR have been granted
“…The Chairman and members of the Board shall
hold office for three (3) years after appointment or until Section 10: Compensation of Members of the Board of
their successors shall have been appointed and duly Examiners for MT
qualified: Provided, That the incumbent members will • Each applicant examined
continue to serve until the expiration of their terms. • Each applicant w/ COR w/out exam.
In case of death, disability, or removal of a
member of the Board, his successor shall serve only the Section 11: Functions and Duties of the Board
balance of his terms.” a. Administer the provisions of this Act
b. Administer oaths
Originally: c. Issue, suspend, and revoke CORs of medical
technologists and medical technicians
MT BOARD d. Look into conditions affecting the practice of MT
- Appointed by the President in the Philippines
Pathologist e. Investigate violations of this Act, and for this
- Derived from the list purpose issue subpoena and subpoena duces
Chairman
submitted by the tecum to secure appearances of witnesses and
PSP production of pertinent documents.
2 Registered MT o Subpoena
- Derived from the list o There are two kinds of subpoenas:
Members
submitted by the ▪ subpoena ad testificandum
PAMET brings people to testify before
the court or hearing;
▪ subpoena duces tecum
Section 8: Qualification of Examiners
describes evidence (documents,
• Filipino citizen tape recordings, photos, guns,
• Of good moral character etc.) which must be brought
• Qualified pathologist (Chairman); Registered before the court or hearing.
Medical Technologists (Members) f. Draft such rules and regulations as may be
• Has been in the practice of laboratory medicine or necessary to carry out the provisions of this Act:
medical technology for at least ten years prior to Provided, that the same shall be issued only after
his/her appointment the approval of the President of the Philippines;
• Not a member of the faculty of any MT school for g. To determine the adequacy of the technical staff
at least 2 years prior to appointment or having of all clinical laboratories and blood banks before
pecuniary interest direct or indirect in such they could be licensed with the Department of
institution Health in accordance with R.A. No. 4655 and
1517;
Amended by PD 498 h. To prescribe the qualifications and training of
Section 8. medical technologists as to special fields of the
Paragraph 3 and 5 of Section 8: profession and supervise their specialty
“Sec. 8. Qualification of Examiners. No person examination conducted by the professional
shall be appointed a member of the Medical Technology organization of medical technologists accredited
Board unless he or she: by the Professional Regulation Commission;
3) is a duly registered medical technologist of i. To classify and prescribe the qualification and
the Philippines with the degree of Bachelor of Science in training of the technical staff of clinical
Medical Technology/Bachelor of Science in laboratories as to:
Hygiene/Public Health; o Medical Technology;
5) is not a member of the faculty of any medical o Medical Technologist;
technology school for at least two (2) years prior to o Senior Medical Technologist;
appointment or having any pecuniary interest direct or o Medical Technologist; and
indirect in such institution.” o Medical Laboratory Technician.

• The functions of the Board can be divided into

Amended by PD 1534 three:
Section 8.
“Sec. 8. Qualification of Examiners. No person 1. Administrative
shall be appointed as a member of the Medical execute and implement laws
power
Technology Board unless he or she: . . . is a qualified 2. Quasi-legislative draft rules and regulations to
Pathologists, or a duly registered Medical Technologist, power implement laws
of the Philippines with the degree of Bachelor of Science investigate, hear, and finally to
in Medical Technology/Bachelor of Science in 3. Quasi-judicial
decide issues brought
Hygiene/Public Health; . . .” power
before an agency

Originally:
Does not state how many years is required to be not a member
of the faculty of any MT school
 Amended by PD 498 Section 14: Inhibition Against the Practice of MT
Section 11. • No person shall practice the medical technology
Subsection (c) is amended profession unless he/she has a valid COR from the
Subparagraphs (g), (h), and (l) are added MT Board.
“Sec. 11 • provided that registration shall not be required of
(c) Issue, suspend and revoke certificates of the following:
registration for the practice of medical technology and a. Duly registered physicians.
medical laboratory technician; b. Medical technologist from other countries
(g) To determine the adequacy of the technical called in for consultation or as visiting or
staff of all clinical laboratories and blood banks before exchange professors to colleges or
they could be licensed with the Department of Health in universities: Provided, they are only practicing
accordance with R.A. No. 4655 and 1517; the said function.
(h) To prescribe the qualification and training of c. Medical technologists in the service of the
medical technologist as to special fields of the United States Armed Forces stationed in the
profession and supervise their specialty examination Philippines rendering services as such for
conducted by the professional organization of medical members of the said forces only
technologists accredited by the Professional Regulation
Commission; Section 15: Examination
(i) To classify and prescribe the qualification • A graduate can only practice the MT profession if
and training of the technical staff of clinical laboratories he/she is able to pass the written board
as to: Chief Medical Technologist; Senior Medical examinations.
Technologist; Medical Technologist and Medical • Examinations are given twice a year (March and
Laboratory Technician.” September)
• Examination sites are: GMA, CEBU, BAGUIO,
CAGAYAN DE ORO, LEGASPI, and DAVAO
Amended by PD 1534
• Thirty days before the examination, written notice
Section 11.
shall be published in at least three (3)
Subparagraphs (g) and (i) of Section 11 of Republic Act
newspapers with national circulation
No. 5527 are repealed.
Section 16: Qualification of Examination
Section 12: Removal of Board Members • In good health
• Grounds to remove a Board member from his • Of good moral character
office: • Has completed at least 4 years of BS MedTech /
1. Neglect of duty BS Public Health
2. Incompetency • Graduates of other professions if they have been
3. Malpractice practicing the profession for the last 5 years prior
4. Unprofessional, unethical, immoral or to the date of examinations (if such performance
dishonorable conduct began before June 21, 1969
*Members of the Board may be removed by the • Foreigners may take licensure exam if:
President of the Philippines upon the recommendation of o He has complied with all the requirements
the PRC embodied in the PRC Resolution No. 323,
series of 1994.
Section 13: Accreditation of SMT and Training • The alien applicant must show that;
Laboratories o The Board has an established
• SMT must first acquire an authority from CHED to reciprocity in the practice of the
be able to offer the BS Medical Technology course. profession between the Philippines and
• Training laboratories must get a license from DOH his country / state.
(through BHFS). To get a license, the laboratory o Three (3) years permanent residence
must possess qualified personnel and is properly o The curricula are substantially similar
equipped to carry out the laboratory procedures
commonly required in the field of Medical Amended by PD 498
Technology. Section 16.
• Fields: Subparagraph (b):
o Clinical Chemistry, “Sec. 16 x x x
o Microbiology, (b) Has completed a course of at least four (4)
o Serology, years leading to the degree of Bachelor of Science in
o Parasitology, Medical Technology or Bachelor of Science in Public
o Hematology, Health conferred by a recognized school, college or
o Blood Banking, university in accordance with this Decree or having
o Clinical Microscopy, and graduated from some other profession and has been
o Histopathologic techniques actually performing medical technology for the last five
(5) years prior to the date of the examinations, if such
RA 5527 PD 498 PD 1534 RA 7722 performance began prior to June 21, 1969.”
Approved
Approved by CHED
by DepEd
DepEd, through
Schools Approved by in conjunc-
recommend Technical
of MT DepEd tion with
ed by MT Committee
the MT
Board for MT Edu.
Board
Approved
CHED
for accre- Approved by Approved
through
Training ditation by PRC, recom- by DOH
Technical
Labs DOH thru the mended by through
Committee
rec. of the MT Board BRL
for MT. Edu.
MT Council

RA 7722
- Higher Education Act of 1994
- latest
Section 17: Scope of Examination ▪ Hard ....................................... 15%
▪ Average (Moderate)............... 50%
Clinical Chemistry = 20% – 100 items ▪ ................................................ 35%
Microbiology & Parasitology = 20% – 100 items ▪ Easy – recall questions
Hematology = 20% – 100 items ▪ Average (moderate) – recall,
Blood Banking and Serology = 20% – 100 items problem solving, interpretative
Clinical Microscopy = 10% – 100 items question.
Histopathologic Techniques, ▪ Hard – problem solving,
Cytotechnology, MT = 10% – 100 items interpretative and analytical
Laws questions
100% – 600 items
Major subjects 20% 1. Clinical Microscopy (10%)
Minor subjects 10% o Urine ....................................................40%
o Feces ...................................................10%
o Seminal Fluid ........................................8%
• 100 hundred questions each area
o CSF ...................................................... 10%
• Questions has been standardized by the
o Transudate & Exudate............................8%
Commission through Resolution 338, series of
o Synovial Fluid .........................................2%
1994, dated November 24, 1994
o Amniotic Fluid.........................................2%
o Gastric fluid & Duodenal drainage.........4%
Amended by PD 498 o Sputum ...................................................5%
Section 17. o Bronchial washings ...............................2%
“Sec. 17. Scope of examination. The examination o Peritoneal, Pleural, Pericardial fluid......5%
questions shall cover the following subjects with their o Quality Control .......................................4%
respective relative weights…. 2. Histopathologic tech. & MT Laws (10%)
o Histopathologic techniques ....... 85%
PRC Resolution 338, series of 1994 ▪ Tissue Processing ................ 40%
• Standard of Technical Competence ▪ Routine .................................. 30%
o The board examination should test ▪ Special ................................... 10%
whether a candidate has the minimum ▪ Cytology .................................10%
standard of technical competence that is ▪ Staining ..................................20%
expected of a newly-qualified member of ▪ Routine ...................................15%
the profession ▪ Special ......................................5%
• Nature of Questions ▪ Autopsy ....................................5%
o Examination should emphasize technical ▪ Special procedures ..................5%
knowledge that is modern in the ▪ Clerical/Logging ......................5%
profession, adequately discussed in o Tech. Laws............................... 15%
textbooks and other professional ▪ Tech. Laws......................... 10%
literatures. ▪ Related Laws ........................... 3%
o Trivial, outdated, unsettled, and ▪ Code of Ethics ..........................2%
controversial questions should be 3. Hematology (20%)
avoided. o Blood collection, anticoagulants
• Level of Difficulty ……..….10%
o Exam should measure entry-level o Cell counts: RBC, WBC,
technical competencies platelet………...…30%
o Questions should be neither too easy nor o Blood tests: hemoglobin,
too difficult hematocrit….15%
o Between these two ends, a “difficulty o Cell morphology:………………………………...20%
scale” should be used to have a suitable o Coagulation tests: BT, CT,PT………………...
mixture of easy, moderate, and difficult 15%
questions. o Special tests……………….………………………….5%
• Test of Cognitive Abilities – o Quality control……..........………………………..5%
o Questions should not be limited to 4. Microbiology/Parasitology (20%)
recalling memorized informations. o Microbiology…………………………70%
o Tests of higher cognitive abilities: • Bacteria 85%, Fungi 5%,
▪ Comprehension Virus 10%
▪ Interpretation ▪ Collection ………………………….…..10%
▪ Application ▪ Preparation and Staining
▪ Analysis ……….15%
▪ Problem solving ▪ Culture and Identification
▪ Other higher-order thinking skills ………40%
o Topic Classification and Corresponding ▪ Sensitivity ……………………………..10%
Percentage ▪ Media
▪ Nice to Know..........................10% Preparation.…………….....10%
▪ Desirable or Useful to Know... 30% ▪ Sterilization……………………………..5%
▪ Must Know....................... 60% ▪ Water, food, milk and
▪ Nice to Know- recent advances in utensils...5%
technology and historical data of ▪ Quality Control………………………..5%
the topic. o Parasitology ………………30%
▪ Desirable to Know – basic ▪ Life Cycle ………10%
information / concepts / ▪ Morphology ……50%
principles. ▪ Tests …………….25%
▪ Must Know – basic knowledge ▪ .……………15%
and skills of day to day practice 5. Blood Banking and Serology (20%)
of the profession o Blood Banking………………………..………… 50%
o Item Classification According to Difficulty ▪ Typing, Cross matching, AHG… 20%
and Corresponding Percentage ▪ Blood types ………………………....20%
 ▪ Genetics: Principles and Testing
………….5%
▪ Blood storage and Transport
…………….10%
▪ Donor recruitment and
Bleeding..….15%
▪ Blood components .………15%
▪ Transfusion practice …………10%
▪ (Elution, etc.) ..…………………...….5%
o Serology……………………………………………….50%
▪ The immune system
……………………………20%
▪ Antigen, Antibodies complement,
HLA….20%
▪ General principles
……………………...10%
▪ Methods, procedures and
interpretation…….45%
▪ Updates (HIV Tests, etc.)
……………………5%
6. Clinical Chemistry (20%)
o Specimen collection .……………………..5%
o Instrumentation and calibration ....……5%
o Reagent preparation and Laboratory
math.........5%
o Quality Control ………………………………10%
o Clinical Chemistry proper …………………..50%
o Biochemistry…………………………………..10%
o Principles and Methods ……………….....20%
o Interpretation ............……………………….10%
o Normal values (SI units) ……………………10%
o Endocrinology and Toxicology …………10%
o Blood gas analysis …………………………….10%
o Laboratory safety……………………………………5%
• The Board shall prepare the schedule of subjects
for examination.
• The Board shall submit the schedule to the
Chairperson of PRC for publication
• The Board shall compute the grades of each
examinee.
• The Board has the power to change, add to, or
remove from the list of subjects or weights above
as progress in the MT may require.
• Publication of the changes made should be at
least 3 months prior to the date of exams.
Section 18: Report of Rating
• Board should report the results of the board
examination 120 days after the completion of the
exams to the Chairperson of the PRC.
• Results shall be submitted by the
PRC Chairperson to the President of the
Philippines for approval.
Section 19: Rating in the Examination
• To pass the board examination, a candidate must:
o Obtain a general average of at least 75% in
the written test
o No rating below 50% in any major subjects
o Has not failed in at least 60% of the
subjects computed according to their
relative weights.
• No further examination will be given after failing
three
• Unless until completion of:
o 12 months refresher course in a MT
school, or:
o 12 month postgraduate training in an
accredited laboratory
• Graduates of other paramedical professions
(other than BS MedTech or BS Public Health)
admitted to an examination (under the provisions
of this Act) SHALL NOT BE GIVEN FURTHER
EXAMS AFTER HIS FAILURE TO PASS FOR THE
THIRD TIME.
Section 20: Oath Taking
• All successful examinees shall be required to take
a professional oath before the Board or before any
person authorized to administer oaths before
entering the practice of Medical Technology in the
Philippines.
Section 21: Issuance of COR
• COR – issued after applicant passed MT Board
exams
• No COR shall be issued to a board exam passer
who is less than 21 years old.
• RMTs shall be required to display his COR in the
place where he works.
• Payment Application of P150.00
• The Board shall issue COR as MT without
examination:
o BS MT or BS Public Health (duly
recognized schools) in the Philippines or
in any foreign country.
• In the case of the latter:
• the standard of MT Education is substantially the
same as ours;
• (2) Shall have been in the practice of MT for at
least 3 years. If such performance began prior to
JUNE 21, 1969
• graduates of other courses who have been
actually performing MT practice for the last 8
years and such performance began prior to JUNE
21, 1969
• The Board shall issue a COR as medical
technician without examination:
o Application: 00
o who passed the Civil Service Examination
for medical technician given on March 21,
1964
o who finished a 2-year college course and
has at least (1) year experience as medical
laboratory technician
• Provided, further, that an applicant who has at
least 10 years of experience as medical
laboratory technician as of the date of approval of
this Decree (PD 498) regardless of his academic
attainment may qualify for COR without exam
• Has failed to pass the board exam for MT but had
obtained a general rating of at least 70%.
• A registered medical technician when employed in
the government shall have the equivalent civil
service eligibility not lower than second grade.
Amended by PD 498
Section 21.
“Sec. 21. Issuance of Certificate of Registration.
Every applicant who has satisfactorily passed the
required examination for medical technologist shall be
issued a certificate of registration ….”
Section 22: Fees
• The Board shall charge each applicant for:
o Fee for examination
o Registration
o Issuance of COR
o New certificate lost, destroyed or
mutilated
• COR bears the signatures of:
o Chairperson of the PRC
o 3 Members of the Board (Chairman and
two members)
Section 23: Refusal to Issue Certificate
• The Board shall refuse to issue a COR to:
o Any person convicted by court
o immoral or dishonorable conduct
o Unsound mind
o Incurable, communicable disease
Section 24: Administrative Investigation
• Investigation conducted by:
o At least 2 members of the Board
o With the presence 1 legal officer – shall
not participate in the proceedings but
sees to it that the investigation is within
the bounds of law.
• Penalty of reprimand and suspension of license
o Majority vote (2/3)
• Penalty of revocation
• Unanimous vote (3/3) –
Section 25: Appeal
• Revocation or suspension of license can be
appealed to the PRC whose decision shall become
final after 30 days unless appealed to the
President of the Philippines
Section 26: Reinstatement, Reissue or Replacement of
Certificate
• If suspension period has already finished, COR
shall be re-issued upon request.
• The Board of Medical Technology may re-issue
revoked COR for reasons deemed proper and
sufficient after the application of re-issuance.
Section 27: Foreign Reciprocity
• No foreigner shall be admitted to examination or
be given a COR or be entitled to any of the rights or
privileges under this Act unless the country or
state of which he is a subject or a citizen permits
Filipino MTs to practice within its territorial
limits on the same basis as the subjects or
citizens of said country or state.
• Foreign professionals who are called by the
government for consultation, exchange
professors or instructors in the specialized
branches of the professions
• Foreign professionals who come to Philippines by
virtue of international convention.
Section 28: Roster of Medical Technology
• Prepared annually by the Secretary of the Board
• Name, address, citizenship, date of registration
• Open for Public Inspection
• “DELISTING OF NAMES OF DELINQUENT
PROFESSIONALS FROM THE ROLLS OF
REGISTERED PROFESSIONALS”
• mandates the various Boards to suspend the COR
of registered professionals who have been
missing the payment of annual registration
fees for five (5) continuous years from the year it
was last paid, and to delist their names from the
rolls, with or without surrender of said COR.
o PRC Resolution No. 217, series of 1992,
dated May 14, 1992
• Those whose COR have been suspended and
whose names have been delisted from the rolls are
not allowed to practice their professions until such
time that the suspension has been lifted.
• Those found practicing illegally will be criminally
liable.
Section 29: Penal Provision
• Penalty:
o P2,000 - P5,000 or:
o 6 months to 2 years imprisonment or:
o BOTH
• Punishable acts of a medical technologist:
a. Any person who shall practice Medical
Technology in the Philippines without
being registered or exempted from
registration in accordance with this Act
b. Any RMT who practices without the
necessary supervision of a qualified
pathologist or physician authorized by
DOH
c. Any RMT who shall make fraudulent
laboratory reports
d. Any RMT who shall refuse or fail, after due
warning by the MT Board, to display his
COR
e. Any person presenting or attempting to
use as his own, the COR of another
f. Any person who shall give any false or
fraudulent evidence of any kind in
obtaining a COR as a medical technologist
g. Any person who shall impersonate any
registrant of like or the same name
h. Any person who attempts to use a
revoked or suspended COR
i. 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
j. Any person or corporation body who shall
allow anyone in his employ who is not a
medical technologist/medical technician
to practice medical technology or
recommend for appointment anyone for
the position of medical
technologist/medical technician knowing
that he/she is not registered as such
k. Any person or corporate body who shall
violate the rules and regulations of the
Board or orders promulgated by it after
having been duly approved and
recommended by the PRC for the purpose
of carrying out the provisions of this Act.
Amended by PD 498
Section 29.
Subparagraph (j)
“(j) 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
• This is the part that states that if any section or
provision of this Act is held to be unconstitutional
or revoked, the other sections or provisions of the
law shall not be affected.
Section 31: Repealing Clause
• All acts, executive orders, 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 (RA 2382, as amended by RA 4224),
the Clinical Laboratory Act of 1966, and the Blood
Banking Law of 1956.
Section 32: Effectivity
• This Act shall take effect upon its approval
• Gil Puyat
o Senate President
• Jose B. Laurel, Jr.
o Speaker of the House of Representatives
• Inocencio B. Pareja
o Secretary of the House of Representatives
• Ferdinand E. Marcos
o President of the Philippines
• Approved
o June 21, 1969
PROF: NENITA LIM

I. Rationale
BLACK: from Canvas
TEAL: from synch class, • The registration, operation and maintenance of Clin. Lab. In
ppt, others. the Phils.
• Preventing substandard, Improperly managed and poorly
: synch class, others.
equipped clinical laboratories

Introduction II. Objective

• Basic License Requirements • Promulgated to prescribe a revised minimum standard for
o “Petition to Establish, Operate and Maintain a clinical laboratories
Clinical Laboratory”
• Inspection of Laboratory III. Scope & Coverage
o w/in 60 days after filling of application • Applies to all entities performing the activities and functions
• Expiration of License of clinical labs
o Every last day of December of the year • Excludes government laboratories doing laboratory
• Renewal of License examinations limited to AFB microscopy, malaria
o Every last 2 months of the year screening and cervical cancer screening; declared
as extension of a licensed government clinical lab
Bureau of Research and Laboratory
• DOH (through the BRL) IV. Definition of Terms
• The central governmental agency authorized to regulate the • Applicant
operation and maintenance of lab o who intends to operate a clinical lab
• The secretary of DOH through the director of BRL • BHFS
• Formulate rules and regulations o Bureau of Health Facilities & Services
• CHD
Administrative Orders o Center for Health Development
• AO 201 s. 1973- The 1st implementing rules and regulation • Clinical Laboratory
• AO 201 s. 1973 o A Facility where tests are done on specimens and
• AO 290 s. 1976 test in clinical chem, hematology, cytology,
• AO 52 s. 1983 Toxicology, endocrinology
• AO 49-B s. 1988 • Critical values
• EO 102 s. 1999 o panic values that needs for some corrective action
o Redirecting the Functions & Operations of the DOH • DOH
• AO 59 s. 2001 o Department of Health
o Rules & Regulations Governing the Establishment, • EQAP
Operation & Maintenance of Clinical Laboratories o External Quality Assurance Program
in the Philippines • Inspection Tool
o November 19, 2001 o checklist used by regulatory officer
• AO 27 s. 2007 • Institution
o Revised Rules & Regulations Governing the o any corporate body organized for educational,
Licensure and Regulation of Clinical Laboratories medical, charitable or similar purpose
in the Philippines • License
o August 22, 2007 o document issued by DOH to applicant upon
compliance
SECTIONS • Licensee
o whom the license is issued
SECTION 1: TITLE • LTO
• Title depends on the AO o license to operate
• Latest AO: AO 27 s. 2007 • Mobile Clinical Laboratory
o moves from testing site but affiliated with base lab
SECTION 2: AUTHORITY • Monitoring Examinations
• DOH through the BRL o series of tests on patients
o Agency that authorizes the regulation and • NRL
maintenance of the clinical lab o National Reference Laboratory
o Confirmatory testing;
SECTION 3: PURPOSE o surveillance;
To protect and promote the health of the people by o resolution of conflicting results;
ensuring availability of the clinical laboratory that are properly o training; research;
managed with adequate resources with effective and efficient o evaluation of diagnostic kits and reagents
performance through the compliance of the quality standards. o implementation of EQAS;
o gov’t hospital lab designated by DOH and may or
SECTION 4: SCOPE & COVERAGE may not be a part of general clinical lab
• See III. Scope & Coverage • POL
o Physician Office Laboratory
SECTION 5: CLASSIFICATION OF LABORATORIES • POCT
• See V. Classification of Laboratories o Point of Care Testing (at or near the site of the
• Classifications according to service capability, patient)
institutional character, function, and ownership • Routine Test
o Mentioned in the AO 27 s. 2007 o basic, commonly requested tests
• Satellite Testing Site
SECTION 7: REQUIREMENTS AND PROCEDURES FOR o any testing site that performs lab exams outside
APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO the physical confines of the base lab
OPERATE • STAT Tests
Discusses the technical standard and minimum o urgent tests and to be released within one hour
requirements to operate a clinical laboratory after procedure (abbreviation of Statimmeans
immediately.)
SECTION 8: VIOLATIONS

SECTION 9: INVESTIGATION OF CHARGES OR COMPLAINTS

V. Classification of Laboratories
• Classification by Ownership
o Government
o Private
• Classification by Function
o Clinical Pathology
▪ Clinical chem, Hematology,
Microbiology Parasitology,
Mycology, Clinical Microscopy,
▪ Immunology, Immunohematology
Endocrinology, Molecular Biology,
cytogenetics, toxicology and TDM.
o Anatomic Pathology
▪ Surgical pathology, histochemistry,
immunohistopathology, cytology,
post mortem examinations
▪ autopsy, forensic pathology,
molecular pathology.
▪ Forensic Pathology
▪ Includes all medico-legal
examinations
• Classification by Institutional Character
o Institution-based
▪ Operates within the premises and as
part of institution (medical clinic,
school, medical facility for overseas
workers and seafarers, birthing
home, psychiatric facility, drug
rehabilitation.
o Freestanding
▪ Not form part of any institution
• Classification by Service Capability
o General Clinical Laboratory
▪ Primary
• Routine hematology (CBC) – Hb,
Hct, WBC & Differential count
• Qualitative platelet
determination
• Routine urinalysis
• Routine fecalysis
• Blood typing
▪ Secondary
• primary lab services +
o Routine clinical
chemistry – includes
blood glucose, BUN,
BUA, Crea & total
cholesterol
o Quantitative platelet
determination
o Cross matching
o Gram staining
o KOH
▪ Tertiary
• secondary lab services +
o special chemistry
o special hematology
o immunology/serology
o Microbiology (C/S)
▪ Limited Service Capability (for institution
based only) – i.e. dialysis centers & social
hygiene clinics
• Note: Labs can be permitted to
offer other lab services provided
they comply with reqt’s with
respect to, staff, equipment,
reagents and supplies and listed
under its LTO
o Special Clinical Laboratory – offers highly
specialized laboratory services that are usually not
provided by a general clinical laboratory
▪ Assisted Reproduction Technology Labs
▪ Molecular and Cellular Technology
▪ Molecular Biology
▪ Molecular Pathology
▪ Forensic Pathology
▪ Anatomic Pathology
National Reference Laboratory
• RITM
o Dengue, Influenza, TB and Malaria
o NRL for confirmatory testing of blood units.
• SLH
o San Lazaro Hospital
o HIV/AIDS, Hepatitis, Syphilis and other Sexually
Transmitted Infections (STls).
• East Avenue Medical Center
o Toxicology and Micronutrient Assay
• NKTI: National Kidney and Transplant Institute
o Hematology / Immunohematology
• Lung Center of the Philippines
o Biochemistry
o POL – Physician Office Laboratory
o POCT – Point of Care Testing (at or near the site of
the patient)
o Routine Test – basic, commonly requested tests
o Satellite Testing Site – any testing site that
performs lab exams outside the physical confines
of the base lab
o STAT Tests – urgent tests and to be released
within one hour after procedure
• NRL: Operating independently of the hospital laboratory but
accredited by international agency or local accrediting
agency recognized by the DOH.
o Local accrediting agency:
▪ CDC
▪ WHO
VI. Guidelines
• General Guidelines
o The LTO shall be issued only to clinical labs
that comply with standards and technical
reqts formulated by the BHFS
o Clinical labs operated and maintained for research
and teaching purposes – exempted but needs to
be registered w/ BHFS
o Special clinical labs are required to register w/
BHFS w/o being licensed (if not subject to other
AO)
o NRL- designated by DOH shall be covered by
license of the clinical lab of the hospital
▪ Register only w/ BHFS if physically
independent & duly accredited
by international certifying body
▪ CDC, WHO
o POL – required of license if doing any or all of the
ff:
▪ Issue official lab results
▪ Perform more than monitoring exams
▪ Cater not only to physician’s own patients
• Specific Guidelines
o Standards
▪ Human Resources
▪ Equipment
▪ Glassware, Reagents & Supplies
▪ Administrative Policies & Procedures
▪ Technical Procedures
▪ Quality Assurance Program
▪ Communication & Records
▪ Physical facilities/ Work Envt
▪ Referral of Examinations Outside of the
Clinical Lab
o LTO
▪ Issued in the name of licensee and is non-
transferrable
▪ Valid for 1 year
▪ Expires on the date set forth by CHD
▪ Capability to perform HIV testing and
/or drinking H2O analysis shall be
specifically indicated in the LTO
▪ Mobile labs permitted to collect
specimens only & operate w/n 100 kms
radius from base lab
▪ Any substantial changes shall be reported
to CHD w/n 2 wks in writing
• Procedural Guidelines Technical Standards and Minimum Requirements
o Registration for Special Clinical Labs, NRL,
Research & teaching Labs Staffing
o Procedures for Application for Initial/Renewal of o Managed by licensed Physician certified by the Philippine
LTO Board of Pathology
o Renewal of LTO ▪ “Any clinical laboratory weather attached or
▪ Hospital-based – processed under unattached to a hospital or clinic performing not
the One-Stop-Shop Licensure System for more than 800 examinations a month should have
Hospitals atleast one medical technologist
▪ Non-hospital based – beginning 1st day ▪ For every other additional 800 or fraction thereof,
of October until end of November of another medical technologist should be hired”
current year ▪ If not available –w. 3 mos training on clinical lab
▪ Automatic cancellation of LTO medicine, QC & management may manage a
• Failure to submit duly primary/secondary lab as certified by BHFS
accomplished form o RMTs – available at all times during operation hours
• Non-Payment of proper fee on or ▪ Hospital-based lab – at least 1 RMT/shift
before expiration date o Staff development & CPE program instituted
o Inspection
▪ CHD shall conduct announced Physical Facilities
inspections at reasonable time using • Well-ventilated, adequately lighted, clean & safe
inspection tool • Work space reqt’s (at least)
o Monitoring o 1º - 10 m2
▪ BHFS/CHD Director or rep shall monitor o 2º - 20 m2
clinical labs o 3º - 60 m2
▪ Notice of violation for non-compliant labs
shall be issued immediately
Equipment/Instruments
▪ CHD concerned shall submit quarterly
summary of violations to BHFS
Primary Secondary Tertiary
▪ Provincial, City & Municipal Health
All those in 1º All those in 2º
Officers can report existence of Clinical centrifuge
plus the ff: plus the ff:
unlicensed labs
Hemacytometer Refrigerator Incubator
Microhematocrit Photometer or its
VIII. Violations centrifuge equivalent
Balance
• Refusal on any clinical lab to participate in EQAP Microscope with Waterbath or its
• Issuance of a report, orally or in writing which is not in Rotator
OIL equivalent
accordance w/ documented procedures Hemoglobinomet Timer or its Serofuge or its
• Permitting unauthorized persons to perform technical er or equivalent equivalent equivalent
procedures Differential
• Incompetence counter or Autoclave
• Deviations from standard test procedures equivalent
Drying oven
• Lending or using the name of licensed lab or head or
Biosafety cabinet
RMT to an unlicensed lab
(BSC) or
• Unauthorized use of the name and signature of
equivalent
Pathologist and RMT to secure LTO
• Reporting a test result for clinical specimens even if the Glasswares/Reagents/Supplies
test was not actually done
• Transferring results of tests done in an outside lab to Waste Management
the result form of the referring lab
• Performing and reporting tests in a specialty or Laboratory Rates
subspecialty in which the lab is not licensed • Usual rates should take into consideration costs of
• Giving and receiving any commission, bonus or production and QC of various laboratory procedures.
kickback or rebate or engaging in any split-free for • Services shall be treated separately and not included in the
referral to clinical labs licensed by DOH laboratory rate.

IX. Investigation of Charges or Complaints Quality Control Program

• BHFS/CHD Dir or rep shall investigate the complaint
• BHFS/CHD Dir or rep shall suspend, cancel or revoke &
may seek any law enforcement agency to execute the
closure of any erring lab when necessary
XI. Penalty
• Imprisonment of not < 1 month; not > 1 year or
• Fine not < PhP 1,000 but no > PhP 5,000; or
• Both
• If a corporation- managing head or owner is liable
XII. Appeal
• Office of the Health Sec w/n 10 days after receipt of
notice of decision
• Decision is final & executory
XIII. Repealing Clause
XIV. Separability Clause
• Internal QC
o Programs performed within the hospital lab
• External QC
o All labs shall participate in an EQAS given by
designated NRL
o Satisfactory performance rating – criteria for
renewal of license
o Refusal to participate in EQAS-NRL – basis for
suspension/revocation of license
• Reporting
o Bear the name & signature of Pathologist & RMT
o No report orally or in writing without directive from
pathologist or associate except in emergency
cases
• Recording
o All requests and reports of all specimens
submitted and examined
o Kept in file for at least 1 year
o Anatomic and forensic pathology reports are kept
permanent

XV. Effectivity
 PROF: NENITA LIM

PRC RESOLUTION NO. 381

STANDARDIZED POLICIES AND PROCEDURES FOR THE
IMPLEMENTATION OF THE CPE PROGRAMS FOR ALL
PROFESSIONS

• The CPE of PRBs is under the supervision of PRC

o E.O. no. 266; July 25, 1995
PD NO. 223: • PRC
Creating the Professional Regulation Commission o issue the necessary standardized guidelines and
procedures for the implementation of the CPE
and Prescribing Its Power and Functions programs for all professions
• ARTICLE I
PRC: Professional Regulation Commission o CPE OBJECTIVES,
• Komisyon sa Pamamalakad ng mga Propesyonal o DEFINITION,
• Office of the Boards of Examiners (Old name) o NATURE
o RA 546 – was created by RA 546 o RATIONALE
o CSC – under Civil Service Commission • ARTICLE II
• PD 223 – June 22, 1973 o CPE COUNCILS:
• PRC was 1st created as a National Government Agency by o CREATION,
PD 223; Signed by P. Marcos o COMPOSITION,
o Architech Eric C. Nubla (The first PRC o TERMS OF OFFICE,
Commissioner) o FUNCTIONS,
o MEETINGS
R.A 8981: • ARTICLE III
PRC Modernization ACT of 2000 o CRITERIA FOR ACCREDITATION OF PROVIDERS,
o PROGRAMS,
• Repealed PD NO. 223
o ACTIVITIES OR SOURCES;
• Test results were released and published within an average o EQUIVALENT CREDIT UNITS;
of three (3) days o CREDIT REQUIREMENTS;
• Test results were released and published simultaneously in o EXEMPTIONS AND OTHER MATTERS
Manila and Regional offices within an average of three (3) • ARTICLE IV
days o SANCTIONS
• Statistical report on performance of Schools was released • ARTICLE V
to CHED o TRANSITORY PROVISION,
• Composed of 21 sections o REPEALING CLAUSE,
o EFFECTIVITY
Professional Regulatory Boards
• PRBs under the Commission are 46 PRBS which exercise: • ARTICLE I
o Administrative / Executive o Section 1 – 4
▪ execute and implement laws • ARTICLE II
o Quasi-legislative o Section 5 - 12
▪ draft rules and regulations to implement • ARTICLE III
laws o Section 13 - 18
o Quasi-judicial powers • ARTICLE IV
▪ investigate, hear and decide issues o Section 19
o Over their respective professions • ARTICLE V
o Section 20 - 22
Functions of PRBs
1. Prepare the contents of licensure examinations. ARTICLE I
Determine, prescribe, and revise the course CPE Objectives, Definition, Nature and Rationale
requirements Section I: Objectives
2. Recommend measures necessary for advancement in • CPE Programs objectives:
their fields o To provide and ensure the continuous education
• Visit / inspect schools and establishments for feedback o To raise and maintain professional’s capability for
o To check / monitor the function of schools delivering professional services
• Adopt and enforce a Code of ethics for the practice of their o To attain and maintain the highest standard and
respective professions quality of the practice of his profession
o March 7, 1991 o To make the professional globally competitive
• Administer oaths and issue Certificate of Registration o To promote the general welfare of the public
• Investigate violations of set professional standards and
adjudicate administrative and other cases against erring Section 2: Definition
registrants • CPE
o Erring- Capable of making an error o The inculcation, assimilation and acquisition of
• Suspend, revoke, or reissue Certificate of Registration for knowledge, skills, proficiency, ethical and moral
causes provided by law values that raises and enhances the professional’s
o Revoke – cancel, invalidate, withdraw skills and professional competence
o inculcation- instilling/ frequent instruction/
Professional Regulatory Boards repetition
Professional Regulation Commission o Assimilation- absorption
o -acquisition- acquiring
• A three-man commission attached to the office of the
President of the Philippines
o 1 Fulltime and 2 associate commissioners Section 3: Nature
• To regulate and supervise the practice of the professionals • CPE Programs
who constitute the highly skilled manpower of the country o Programmed activities
o Requiring the participation of professionals to
• PRC plays a strategic role in developing the corps of
meet the requirements for the renewal of their
professionals for industry, commerce, governance and the
license
economy
o Corps - organization

YELLOW - important terms PINK - important dates PURPLE - definition GREEN - important person
Section 4: Rationale • Article
• Compliance with CPE program is an effective and o Single author
credible substitute for requiring a professional to o Two authors
pass another examination in order to allow him to continue o Three or more
his practice • Inventions
o 10-30 c.u. / invention
ARTICLE II • Study / Observation Tour
o 2 c.u/day
Section 6: Composition • Professional Chair
Chair Chosen by PRB members from among o 10 c.u / chair
themselves
Two (2) Members Section 15: CPE Credit Units
Member 1 President or any officer of APO
Member 2 President or any officer of org of deans or
dept of schools, colleges or universities
offering the course for licensure exam
In the absence of such org, the 2nd member shall be chosen
and appointed by the PRC from at least 3 academicians
recommended by the PRB

Section 7: Terms of Office

Chairman Shall be co-terminus with
Chosen incumbency in the PRB
by PRB members
1st Member Shall have a term of office co-
(Officer of APO) terminus with incumbency
2nd Member Shall have a term of office co-
(Officer of organization terminus with incumbency
of deans or heads of
department)
Academician appointed 2 years
by the PRC (w/ one reappointment)

Section 8: Exercise of Powers and Functions

• Accept, evaluate and approve
o applications for accreditation of CPE providers
o applications for accreditation of CPE programs, a
ctivities or other sources, determine the number of
CPE credit units submitted by the CPE providers;
• applications for exemptions from CPE requirements.
• Monitor the implementation by the CPE providers of
their program, activities or sources.
• Assess periodically and upgrade criteria for accreditation
of CPE providers and CPE programs, activities or sources.

ARTICLE III

Section 14: Programs, Activities and Sources for

Accreditation and Equivalent Credit Units
• Seminars
o Participant 1 c.u/hr
o Resource speaker 5 c.u/hr
o Panelist / Reactor 3 c.u/hr
o Facilitator / Moderator 2 c.u/hr
• Academic Preparation
(Residential and Distance Mode)
• Doctoral Degree
o 2 cu additional unit
o 45 cu additional unit completion
• Masteral Degree
o 1 cu additional unit
o 30 cu addtnl unit
• Fellowship
o 15 cu /year
• Residency / Externship 10 cu / year
• Self Directed Learning Package
o Module 10 cu / complete set of module
o Technical Paper / Professional Journal article
▪ 1 cu / professional / tech. article
• Authorship
o Research / Innovative programs / Creative
projects
▪ 10 Credit units
o Editors ½ of the authorship category
• Book / Monograph
o Single author
o Two authors
o Three or more
PROF: NENITA LIM

• BLOOD COLLECTION UNIT

BLACK: From Canvas o an institution or facility duly authorized by the
TEAL: from synch class, Department of Health to recruit and screen donors
from RA or AO, others and collect blood
: synch class, others.
• BLOOD STATION
o a government or private hospital or a Philippine
National Red Cross chapter which has not been
licensed as a blood center but has been authorized
R.A. 1517 R.A. 7719 by the Department to store and issue blood and
National Blood Service blood products, and perform compatibility testing,
TITLE Blood Bank Law
Act of 1994
when necessary, according to specific regulations
DATE June 16, 1956 May 5, 1995 in Section 40 hereby
An Act Promoting:
An Act Regulating the:
• Voluntary Blood • BLOOD SERVICE FACILITY
• Collection,
Donation,
processing and o any unit, office, institution providing any of the
• Providing for an
Sale of Human blood transfusion services, which can be a Blood
Adequate Supply of
Blood, Bank/Center, a Blood Collection Unit or a Blood
DESCRIPTION Safe Blood,
• Establishment and Station
• Regulating Blood
Operation of Blood
Banks,
Banks and Blood
• Providing Penalties • BLOOD TRANSFUSION TRANSMISSIBLE DISEASES
Processing
for Violation o diseases which may be transmitted through blood
Laboratories
Thereof transfusion, including, but not limited to,
OTHER INFO Repealed by RA 7719 Repealed RA 1517 o Acquired Immune Deficiency Syndrome (AIDS)
▪ Hepatitis B
▪ Hepatitis C
IMPLEMENTING RULES ▪ Malaria
• A.O # 9, S. 1995 Rules and Regulations implementing ▪ Syphilis
o April 28, 1995 republic act no. 7719
• A.O # 17–A, S. 1998 Requirements and Procedures for a license to operate
TECHNICAL REQUIREMENTS
o May 12, 1998 a BB/BC in the Philippines
• A.O # 2005–0002 PHYSICAL FACILITIES
o January 10, 2005 • Should be solely for the use of BB and its related activities
• A.O # 2008–0008
• Shall be well–lighted and ventilated, clean, free of dust, safe
o May 2, 2008
and with adequate supply of water
• A separate space must be provided for the bleeding or
EVENTS collection of blood
PNRC launched the National Blood Program
(NBP) • BRL will evaluate compliance of technical standards for BB
July 17, 1948
President E. Quirino as the first
Blood Donor. CLASSIFICATION OF BLOOD BANK
June 16, 1956 R.A. 1517
May 5, 1995 R.A. 7719
Hospital Free-Standing
Second week of
Blood Donor’s Week Primary Category 20 sq. m 30 sq. m.
July
Secondary Category 30 sq. m. 40 sq. m.
DEFINITION OF TERMS Tertiary Category 40 sq. m. 50 sq. m.
• BLOOD/BLOOD PRODUCT
o Refers to human blood, processed or unprocessed CATEGORIES OF BLOOD SERVICE CAPABILITIES
and includes blood components, products and with its corresponding minimum required service capabilities
derivatives.
• BLOOD BANK (BB) • NON–HOSPITAL BASED CATEGORY A
o A laboratory / institution that has the capability to: o Recruitment of voluntary donors
▪ recruit and screen blood donors o Health education and counseling
▪ collect, process, store, transport and issue o Donor screening and selection
blood for transfusion o Blood collection
▪ provide information and/or education on o Basic blood processing and testing
blood transmissible diseases; o Provision of whole blood and packed RBC
1. Hospital–Based Blood Bank o Issuance, transport and distribution of blood/blood
2. Free–Standing Blood Bank products
3. Commercial Blood Bank o Storage of blood/blood products
• HOSPITAL-BASED BLOOD BANK • NON–HOSPITAL BASED CATEOGRY B
o a blood bank/center which is located and o All listed in non–hospital–based cat. A plus:
performing blood bank services within the ▪ whole blood, all blood products and
premises of a hospital and which can perform components
compatibility testing of blood • HOSPITAL–BASED CATEGORY A
• NON-HOSPITAL BASED BLOOD BANK o All listed in non–hospital–based cat. A plus:
o a blood bank/center which is not located and not ▪ compatibility–testing
performing blood bank services within the • HOSPITAL–BASED CATEGORY B
premises of a hospital and is not part of a hospital o All listed in hospital–based cat. A plus:
• COMMERCIAL BLOOD BANK ▪ whole blood, all blood products and
o A blood bank that exists for profit, money or any components
material gain earned out of sale of, or exchange for, ▪ performing investigation of transfusion
blood or blood products which profit, money or any reactions
material gain are not used solely for the operation ▪ resolution of incompatible cross–
and maintenance of the blood bank service. matching results
o Phase–out of Commercial Blood Bank (RA 7719; p.
140)
▪ All commercial BB shall be phase-out 2
years after May 5, 1994 (Nat’l Blood
Service Act approval)
 APHERESIS FACILITY DISPENSING OF BLOOD
• A blood service facility where blood collection procedure is • Dispense only upon proper request by attending physician /
done in which whole blood is removed, a selected hospital authority / another BB (recorded and subject to
component separated and the remainder returned to the inspection)
donor.
RECORDS
LICENSE • All records in BB are kept permanently
Application “Petition to Establish / Operate a BB” • Including: Storage, Blood typing and Serologic tests
BRL– Screening and Approval o (Take note of Reactive Blood)
Inspection 60 Days after filling of application • Also: Quantity of blood in storage, disposed or transferred
Expiration At the end of December of the year • Blood typing should be done each test
Transfer No licensed shall be transferred without • The following should also be recorded
consent in writing of the Secretary of o Compatibility test used
Health o Issue for transferring/transporting of blood donor
o Transfusion complication
PERSONNEL/HUMAN RESOURCE
VIOLATIONS
HEAD • Any material false statement in the application
Pathologist / Hematologist 2 BB • Misinterpretation of facts or falsification of documents or
Physician 1 BB records
• Refusal to make available its books, accounts and records of
• Licensed Physician certified by Phil. Board of Pathology in operation to an authorized person from the BHFS/CHD
Clinical Pathology or Blood Banking / • Charging of blood service fees above the maximum fees set
• Philippine Board of Hematology and Blood Transfusion by the DOH
• Has Completed atleast three (3) months of training in BB • Collection of blood from paid or remunerated donor whether
• Has passed the examination given by the BRL payment comes from the hospital or from the
patient/relatives.
MEDTECH o Remunerated – salaried / compensated
1. Primary Category Atleast 1 full time Medtech • Refusal to participate in EQAS conducted by NRL
With 1 personnel for non-technical • Without securing any LTO
activities
2. Secondary and
4 RMTS with 1 non-technical activity PENALTY
personnel • Operating a blood bank without securing any license or fails
Tertiary
o 2 RMT in the morning shift
to comply with the standards prescribed by the Department
o 1 RMT in the afternoon shift
o 1 RMT for off duty o imprisonment:
3. With atleast one not <12 years and 1 day nor >20 years or;
more set of personnel 100 units of Blood serviced / 500 Bld. o fine:
for every: Typing, collection, screening and not < P50,000 nor > P500,000
(1 MT / 20 donors per cross matching per month o Or both
day: p. 99) • Collection of charges and fees greater than the maximum
4. During blood There shall be at least two BB staff in prescribed by the Department
collection: attendance o License suspended or revoked
o Also:
BLOOD DONORS ▪ imprisonment:
• Voluntary blood donors not <1 month nor > 6 months or;
o one who donates blood on one's own volition or ▪ fine:
initiative and without monetary compensation. not < P5,000 nor > P50,000
• Paid donors ▪ Or both
• Replacement donors • Dispensing, transfusing and failing to dispose, within 48
hours blood contaminated with blood transfusion
5 CORE TEST (WHO) transmissible disease
Screening test o Imprisonment:
▪ 10 years
HIV ELISA
Serum Hepatitis HBsAg
Antibody to Hepatitis C
Test for Syphilis RPR/VDRL
Malaria Thick & Thin Smear

• ELISA
o enzyme-linked immunosorbent assay
o enzyme-linked immunoassay test
• RPR
o Rapid plasma reagent
• VDRL
o venereal disease research laboratory

COLOR DESIGNATION

BLOOD TYPE BLOOD TYPING SERA

A Blue
B Yellow
AB Pink
O White

• Blood typing sera used by the compatibility test should meet

the standards set by the Bureau of Food and Drugs (BFAD)

RE-ISSUE OF BLOOD
• Blood collected in Plastic containers may be re–issued if:
o Seal is unbroken
o Before 24 hours w/ no hemolysis
o Sufficient donor tubing is left with bag

BLUE - definition of acronyms

PROF: NENITA LIM
BLACK: From Canvas
TEAL: from synch class,
from RA, others
: synch class, others.
[ SEC.] Section no. in the RA
R.A. 8504
Phil. AIDS Prevention and Control Act of 1998
• Approved on: 13 February 1998
• An act promulgating:
o Policies and prescribing measures
the prevention and control of HIV/AIDS in the
Philippines
o Instituting Information and Educational Program
o Establishing monitoring system
o Creating PNAC
▪ PNAC: Philippine National AIDS Council
• Signed by House of Representative: Jose De Venecia, Jr.
• Signed by President of Senate: Neptali Gonzales
• Total number of sections: 52
• Total number of Article: IX
• "Rules and Regulations Implementing the PHILIPPINE AIDS
PREVENTION AND CONTROL ACT OF 1998”
• To disseminate the principles of RA 8504 and prescribe
guidelines, procedures and standards for its implementation,
to facilitate compliance to and achieve the objectives of the
law.
E.O. no. 39
PHILIPPINE NATIONAL AIDS COUNCIL
• December 3, 1992 (Creation)
• Functions: to set the national agenda regarding AIDS/STI
prevention and control in the Phils.
• Composition: appointed by the President of the Philippines
o Chairperson: DOH Secretary
o Vice Chairperson: Elected from among the [26]
members representing medical or health
professional group
▪ Term in office: 2 years
Important Events
1984 First AIDS case reported
National AIDS Prevention and Control
1988
Program created
1992 PNAC Executive Order No. 39 created
Bahay Lingap (Halfway Home of
1995 Asymptomatic HIV Positive Filipinos)
inaugurated
R.A. 8504 (Philippine Aids Prevention and
1998
Control Act of 1998)
DEFINITION OF TERMS
[SEC.3.]
(a) Acquired Immune Deficiency Syndrome (AIDS)
o is a condition characterized by a combination of
signs and symptoms, caused by HIV contracted
from another person and which attacks and
weakens the body's immune system, making the
afflicted individual susceptible to other life-
threatening infections.
(b) Anonymous Testing
o refers to an HIV testing procedure whereby the
individual being tested does not reveal his/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.
(c) Compulsory HIV Testing
o refers to HIV testing imposed upon a person
attended or characterized by the lack of or vitiated
consent, use of physical force, intimidation or any
form of compulsion.
(d) Contact tracing
o refers to the method of finding and counselling the
sexual partner(s) of a person who has been
diagnosed as having sexually transmitted disease.
(e) Human Immunodeficiency Virus (HIV)
o refers to the virus which causes AIDS.
(f) HIV/AIDS Monitoring
o refers to the documentation and analysis of the
number of HIV/AIDS infections and the pattern of
its spread.
(g) HIV/AIDS Prevention and Control
o refers to measures aimed at protecting non-
for
infected persons from contracting HIV and
minimizing the impact of the condition of persons
living with HIV.
(h) HIV-positive
o refers to the presence of HIV infection as
documented by the presence of HIV or HIV
antibodies in the sample being tested.
(i) HIV-negative
o denotes the absence of HIV or HIV antibodies upon
HIV testing.
(j) HIV Testing
o refers to any laboratory procedure done on an
individual to determine the presence or absence of
HIV infection.
(k) HIV Transmission
o refers to the transfer of HIV from one infected
person to an uninfected individual, most commonly
through sexual intercourse, blood transfusion,
sharing of intravenous needles and during
pregnancy.
(l) High-Risk Behavior
o refers to a person's frequent involvement in certain
activities which increase the risk of transmitting or
acquiring HIV.
(m) Informed Consent
o 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.
(n) Medical Confidentiality
o refers to the relationship of trust and confidence
created or existing between a patient or a person
with HIV and his attending physician, consulting
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 acquired or may have acquired
such confidential information.
(o) Person with HIV
o refers to an individual whose HIV test indicates,
directly or indirectly, that he/she is infected with
HIV.
(p) Pre-Test Counselling
o 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.
(q) Post-Test Counselling
o 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
result is released.
(r) Prophylactic
o refers to any agent or device used to prevent the
transmission of a disease.
(s) Sexually Transmitted Diseases
o refer to any disease that may be acquired or passed
on through sexual contact.
(t) Voluntary HIV Testing
o refers to HIV testing done on an individual who,
after having undergone pre-test counselling,
willingly submits himself/herself to such test.
(u) Window Period
o refers to the period of time, usually lasting from two
(2) weeks to six (6) months during which an
infected individual will test "negative" upon HIV
testing but can actually transmit the infection.
Policies
• Compulsory HIV testing shall be considered unlawful
o An HIV testing of a person attended by the lack of
consent
• The right to privacy
o Medical Confidentiality:
▪ All health professionals with any medical
record / test results are directed to strictly
observe confidentiality particularly the
identity and status of persons with HIV.
• Discrimination shall be considered inimical to individual and
national interest
o Inimical - unfavorable
o A prejudicial act of making distinctions or showing
partiality in the granting of privileges, benefits or
services to a person on the basis of his/her actual,
perceived or suspected HIV status.
▪ Privileges – education; employment;
burial; credit cards; marriage; politics
Training of health workers to always wear PPE
Purpose
1. To provide HIV education and information to protect
themselves from HIV infection
2. Minimize the risk of HIV transmission
3. Decrease the socio-economic impact of HIV/AIDS.
HIV Information
• In the workplace:
o Shall provide awareness on the confidentiality in
the workplace and attitude towards infected
employees and workers.
• For Filipinos Going Abroad:
o Shall undergo a seminar on HIV.
• For Tourists and Transients:
o All airports shall provide informational aids about
HIV
• In the Communities:
o LGU shall conduct an educational and information
campaign on HIV/AIDS.
• on Prophylaxis:
o Shall indicate appropriate information about HIV
(Its efficacy and proper use)
o Prophylactic
▪ A medical agent or device used to prevent
the transmission of a disease.
Penalty for Misleading Information
[SEC. 11]
• Misinformation on HIV/AIDS prevention and control through
false and misleading advertising and claims in any of the tri-
media or the promotional marketing of drugs, devices,
agents or procedures without prior approval from the
Department of Health and the Bureau of Food and Drugs and
the requisite medical and scientific basis … is punishable
with a penalty of imprisonment for:
o 2 months to 2 years imprisonment and suspension
or revocation of professional or business license
DECLARATION OF POLICIES
ARTICLE III
Testing, Screening a nd Counselling
HIV Testing
• A laboratory procedure done on an individual to determine
the presence or absence of HIV infection.
• Anonymous Testing
o An HIV test procedure whereby the identity of the
individual being tested is protected or not known.
o A code number is provided with the sample of the
patient.
o Section 18: Anonymous HIV Testing
o Voluntary HIV Testing
▪ An individual who’s willing to undergo the
HIV test
▪ Upon consent
o Window Period
▪ 2 weeks – 6 months
▪ Test will give "negative" for HIV antibodies
▪ Still capable of transmitting the disease.
o Informed Consent
▪ The voluntary verbal or written
agreement of a person to undergo or be
subjected to a procedure based on full
information.
Consent as a Requisite for HIV Testing
[SEC. 15.]
• Encourage voluntary testing for individuals with a high risk
for contracting HIV
• A written informed consent must first be obtained if of legal
age / from the parents or legal guardian (minor or a mentally
incapacitated individual.)
• Use of Thumbprint can be used if the person is unable to
write
• Use of Codename / Assumed Name can be used (allowed by
the law)
Prohibitions on Compulsory HIV Testing
[SEC. 16.]
• Compulsory HIV testing as a precondition to employment,
admission to educational institutions, the provision
of medical service or any kind of service shall be deemed
unlawful. (Compulsory- obliged; required)
o Entry or continued stay in the country; Right to
travel;
o The enjoyment of human rights and civil liberties,
including the right to enter into marriage and
conduct a normal family life
Exception to the Prohibition on Compulsory Testing
[SEC. 17.]
Compulsory HIV testing may be allowed only in the following
instances:
1. When resolving issues relevant to the Family Code
2. When complying with requirements of organ or blood
donation
o provisions of the:
▪ Republic Act No. 7170
"Organ Donation Act"
▪ Republic Act No. 7719,
"National Blood Services Act".
3. Reportorial requirements (charged with any crimes)
4. When informing health workers directly involved in treatment
and care of persons with HIV/AIDS
5. When responding to legal proceedings where the main issue
is the HIV status of a person
HIV Counseling • HIV-negative
• Pre-Test Counseling o Absence of HIV or HIV Abs upon HIV testing.
o The process of providing information on the • HIV-positive
biomedical aspects of HIV/AIDS and the possible o Presence of HIV infection or HIV Abs upon HIV
results of the HIV test and conducting testing.
Counseling before he undergoes the test. • HIV status
• Post-Test Counseling o Denotes whether a person who has undergone an
o The process of providing risk-reduction HIV test is HIV-positive or HIV-negative.
information and counseling after the test result is
released.
SEC. 27. Monitoring Program.
POST-TEST counseling after a negative A comprehensive HIV/AIDS monitoring program or
test result shall include the following: "AIDSWATCH" shall be established under the Department of Health:
1. Release of the test result • to determine and monitor the magnitude and progression of HIV
2. Review of the meaning of infection in the Philippines,
negative test result • and for the purpose of evaluating the adequacy and efficacy of
the countermeasures being employed.
PRE-TEST counseling POST-TEST counseling after a positive
shall include the test result shall include the following:
following: 1. Assistance and emotional
1. Purpose of HIV support to the person in coping ARTICLE VI
testing with the positive (+) test result; Confidentiality
2. Window period 2. Review of the meaning of a Medical Confidentiality
3. HIV test positive test result;
[SEC. 30.]
procedure 3. Review of HIV/AIDS infection
transmission and risk reduction; • All health professionals, medical instructors, workers,
4. Meaning of a
4. Explanation of the importance employers, recruitment agencies, insurance companies, data
negative and a
positive test of seeking health care and encoders, and other custodians of any medical record, file,
result; supervision; data, or test results are directed to strictly observe
5. Guarantees of 5. Arrangements for referral to confidentiality in the handling of all medical information,
confidentiality health care and other particularly the identity and status of persons with HIV.
and risk-free community services and to any
disclosure organization of people living
with HIV/AIDS; and Medical Confidentiality
6. Assistance with the disclosure • Protecting and upholding the right to privacy of HIV positive
of HIV status and health patient
condition to the spouse or • Disclosure of All information that directly or indirectly lead to
sexual partner, as soon as the identity and HIV status of the patient.
possible
Exceptions to the Mandate of Confidentiality
[SEC. 31.]
Right to pre-counseling a) when complying with reportorial requirements in
1. What an HIV antibody test is.
conjunction with the AIDSWATCH programs
2. How HIV is transmitted and prevention methods.
provided in Section 27 of this Act
3. Explain the two possible results: reactive and negative
b) When informing other health workers directly
and what it means
involved or about to be involved in the treatment or
4. You will be asked details about your personal history to
care of a person with HIV/AIDS and such treatment
identify what behaviors are high-risk, such as drug use
or care carry the risk of HIV transmission
c) When responding to a subpoena duces tecum and
Right to post-counseling subpoena ad testificandum issued by a court with
• You have a right to receive counseling after the test whether jurisdiction over legal proceedings where the main
or not your test result is positive. issue is the HIV status of an individual
• If your test results are NEGATIVE, your counselor will
reinforce the importance of ABCDE: Release of HIV/AIDS Test Results
o A – abstinence [SEC. 32.]
o B – be faithful a) Person who was tested
o C – correct and consistent use of condoms b) Parent of minor if minor
o D – don’t do drugs c) Legal guardian of mentally handicapped person
o E – educate yourself continuously d) Person authorized to receive results for
• Test yourself every 6 months if you engage in risky sexual AIDSWATCH
behavior. e) Justice of Court of Appeals or Supreme Court
• If found you are POSITIVE:
o Do confirmatory test at the Penalties for Violations of Confidentiality
o Releasing of result: after 2 weeks [SEC. 33.]
• The counselor: • 6 months to 4 years imprisonment, fines, suspension or
o will explain the need for confirmatory testing. revocation of license/accreditation
o will tell treatment options
o will help link you with support groups. • Contact tracing
• If truly you are REACTIVE: o A method of finding and counseling the sexual
o fill up a National Epidemiology Center form for the partner(s) of a person who has been diagnosed as
DOH HIV/AIDS Registry where your results will be having a sexually transmitted disease or diseases.
registered.
Disclosure to Sexual Partners (Sec. 45)
HIV Testing Center [SEC. 34.]
• Confirmatory Test o Any person with HIV is obliged to disclose his/her
o SLH HIV status and health condition to his/her spouse
o National reference center for HIV testing or sexual partner at the earliest opportune time.
o RITM
• HIV testing centers accreditation
o DOH which shall set and maintain reasonable
accreditation standards.
 ARTICLE VII
Discriminatory Acts and Policies

From RA [SEC. 35 – 41]

• Discrimination in the Workplace
• Discrimination in Schools
• Restrictions on Travel and Habitation
• Inhibition from Public Service
• Exclusion from Credit and Insurance Services
• Discrimination in Hospitals and Health Institutions
• Denial of Burial Services

DISCRIMINATORY ACTS AND POLICIES

• Discrimination in any form work on the sole basis of actual,
perceived or suspected HIV status is deemed
• They shall be entitled to the same employment rights,
benefits and opportunities with other employees
• HIV infected employees shall act responsibly to protect own
health and prevent HIV transmission
• Acts of discrimination shall be reported to DOLE
• Universal Precautions is the basic standard of infection
control.
• Assume that all patients and staff are potentially infected
with blood-borne pathogens such as HIV and hepatitis B
virus.

Penalties for Discriminatory Acts and Policies

• imprisonment for six (6) months to four (4) years
• and a fine: not exceeding Ten thousand pesos (P10,000)
• licenses/permits of schools, hospitals, and other institutions
found guilty of committing discriminatory acts and policies
described in this Act shall be revoked.
PROF. NENITA LIM

BLACK: From Canvas

TEAL: from synch class, from RA, Board Reg, other

: synch class, other

RA 6425 RA 9165
Comprehensive Dangerous Drugs Act of 2002
102 sections
Dangerous drugs act of 1972
Approved by: Pres. Gloria Macapagal-Arroyo
January 23, 2002
Repealed by RA 9165 Repealed 6425

REPEAL: revoke, annul, renounce

Drug Abuse Prevention and Control Week

every third week of November

PDEA
• Philippine Drug Enforcement Agency
• PDEA is the implementing arm of the Dangerous Drugs Board. (DDB).
• DDB
o the policy-making and strategy-formulating body
o Dangerous Drugs Board
o The National policy-making and strategy-formulation on prevention and control of DOA.
o Issues implementing rules and programs
o (Other functions are on Section 81 RA 9165)
o Law Enforcement, Regulatory Compliance and Judicial and Legislative Measures

Dangerous Drugs
• An addictive drug
• Increase alertness and physical disposition (Cocaine, Caffeine)
• Reduces pain and Induces sleep (Narcotic drugs)
• Reduce anxiety and excitement (alcohol)
• Alters mood and behavior
• THC – Marijuana
o Tetrahydrocannabinol
o bhang, pot, weed / brownies
o Plant materials from Cannabis sativa
o Dried and prepared for smoking / oral
• MET – Shabu
o (Methamphetamine HCL)
o Poorman’s coccaine, ubas, siopao, sha and ice
o A white odorless crystal / power with bitter numbing taste
o Ingestion / inhalation / injection

DRUG TESTING LABORATORY

• Classification by 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
▪ operated with funds through donation, principal, investment or other means, by any individual, corporation,
association or organization

• Institutional Character:
o Institutional Based
▪ a laboratory that is located within the premises and operates as part of an institution (e.g. hospital, medical
facilities for overseas workers and seafarers).
o Freestanding
▪ a laboratory that is located outside the premises of an institution and operates independently.

• Service Capability:
o Screening Laboratory
▪ a laboratory capable of performing screening tests.
▪ determines if positive or negative for the presence of drugs
o Confirmatory Laboratory
▪ a laboratory capable of performing qualitative and quantitative examinations of dangerous drugs from the
specimen
▪ qualitative: specifies the dangerous drugs present
▪ quantitative: amount or concentration of the drug

CENIZAL
CLIENT / DONOR
Section 36, Article III of RA 9165:
• AUTHORIZED DRUG TESTING
o shall be done by any government forensic laboratories or by any of the drug testing laboratories
▪ accredited and monitored by the DOH
• 36, letter d: R.A. 9165
o Any officer or employee found positive for use of Dangerous Drugs:
▪ Ground for suspension / termination, subject to the provisions of:
• Article 282 of Labor Code
• Civil service law
MANDATORY DRUG TESTING RANDOM DRUG TESTING
Applicants for driver’s license Students of secondary and tertiary schools.
Applicants for firearm’s license, and permit to carry firearms
outside of residence. Provided, that: Officers and employees of public and private offices whether
• all person who by the nature of their profession, carry domestic or overseas.
firearms
Officers and members of the military, police and other law
enforcers
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
Candidates for public office whether appointed or elected both
in the national or local government
Persons apprehended or arrested for violating the provisions of
this Act

TECHNICAL REQUIREMENTS

TECHNICAL REQUIREMENTS
FOR THE ISSUANCE OF THE LICENSE TO OPERATE A DTL

PHYSICAL PLANT
• Screening Laboratory TECHNICAL REQUIREMENTS
o 20sqm (floor area) (as discussed in synch class)
FOR LTO
o 10sqm (work area) • Physical Plant
▪ with exhaust fan, sink and storage cabinet. • Personnel and Headship of the Laboratory
• Confirmatory Laboratory • Equipment/Instrument
• Application of Service Provider
o 60sqm (floor area)
o 30sqm (work area) FOR ACCREDITATION
▪ with exhaust fan, sink, stock room and instrumentation room. • Records
• Chain of Custody
• All labs shall accommodate: • Storage of Lab Reports and Specimens
o at least 5 clients at a time. • Test Levels
o Hand washing facility • Proficiency Testing
• Validity
o Toilet facility • Renewal
o Stall for the collection of the specimen • Monitoring

EQUIPMENT/INSTRUMENT
Mentioned in synch class:
Equipment in bold text

SERVICE CONFIRMATORY LABORATORY SCREENING LABORATORY

Screening Test
Confirmatory Examination
• Immunoassay equipment • Immunoassay equipment
• BFAD registered drug-testing kit • BFAD registered-drug-testing kit
• Thin Layer Chromatography (TLC) • Thin Layer Chromatography (TLC)
• Gas Chromatography–Mass Spectrometer
(GC–MS),
• High Performance Liquid
Chromatography–Mass Spectrometer
(HPLC–MS)
• or some such modern and accepted
equipment
Basic equipment:
• Laboratory oven
• Analytical balance
• Refrigerator Basic equipment
• Freezer • Refrigerator/freezer
• Fume hood
• Other necessary equipment based on the
procedure used.

APPLICATION OF SERVICE PROVIDER

Application Service Provider
• The third-party entities that manage and distribute software-based services
• Approved and maintained by the DOH
CENIZAL
PERSONNEL AND HEADSHIP

HEADSHIP PERSONNEL
• Licensed Physician • either a full-time licensed chemist, medical
o trained in Clin. Lab. Management technologist, pharmacist or chemical engineer
SCREENING
o can handle 10 screening Lab o with appropriate training in screening test
DRUG TEST LAB
o physical feasible to supervise (within procedures for dangerous drugs
5 km radius) • DOH shall recognize the training program
• full time licensed chemist,
o successfully completed extensive and
• Pathologist
appropriate training in chromatography,
o w/ 2 yrs. active lab exp. In analytical
spectroscopy
toxicology
• medical technologist, pharmacist or chemical
CONFIRMATORY • Licensed Chemist
engineer
DRUGTEST LAB o w/ Master’s degree in Chemistry/
o with appropriate training in the screening
Biochemistry/ branch of chemist w/ 2
test procedure for dangerous drugs.
yrs. active lab experience in analytical
• DOH shall recognize the training program
chem.
• Lab staff: required to pass a proficiency test
o established and administered by the NRL
HEAD OF THE LAB:
(according to Sec. 6 if Bd. Reg. 2. s. 2003)
• shall have:
o training and/or experience in the
theory and practice of the procedures
used in laboratories, resulting in his or A laboratory shall have
her thorough understanding of quality • administrative
Other info about control procedures and practices; o e.g. clerk, secretary,
the head/personnel: o the review, interpretation and • non-technical personnel
(for both screening and reporting of test results; o e.g. analyst, specimen collector, laboratory
confirmatory DTL) o the maintenance of chain of custody aide
o proper remedial actions to be taken in • have the necessary training and skills for the tasks
response to test systems being out of assigned to them.
control limits or quality control results.
• have the overall responsibility for the
professional, organizational, educational and
administrative activities of the drug testing
facility.

There are 4 Professionals who can be a Certified Drug Analyst

• Medical Technologist
• Chemist
• Pharmacist
• Chemical Engineer

Seminars
• East Avenue Medical Center
o East Avenue Diliman, Quezon City 1101

TECHNICAL REQUIREMENTS
FOR ACCREDITATION

RECORDS
• Records of the personnel
• Shall include:
o resume of training and experience
o certification or license
o incident reports (if any)
o other information, which will establish the competence of the employee.

CHAIN OF CUSTODY
(documentation of procedure)
• Control form
o Specimen tracking procedures from point of collection to final disposal.
o D of Donor
o Time of collection
o Time received
o Name of DTL

According to Bd. Reg. 2. s. 2003:

• A laboratory shall use documented chain of custody procedures to maintain control and accountability of specimens.
• The date and purpose shall be recorded, every individual in the chain shall be identified
• Authorized collection staff shall be responsible for each specimen in their possession and shall sign and complete the forms
• The minimum information required on the Custody and Control Form are the following:
o Information identifying the specimen
o Date and time of collection
o Name of testing laboratory
o Name and signatures of all individuals who had custody of the sample during the collection process
CENIZAL
STORAGE OF LABORATORY REPORTS AND SPECIMENS
SPECIMEN REPORT:
• kept by the testing laboratory for a minimum period to be determined by the DOH
• Negative specimens
o Minimum of 5 days
• Positive specimens (not challenged)
o 15 days
o All specimens
▪ Minimum of 5 days to 1 year
• A specimen may be kept for a maximum of one (1) year upon request

LABORATORY REPORT
• Result form is prescribed by DOH
• Signed by the analyst and head of lab.
• Manner of Reporting:
o Screening
▪ POSITIVE or NEGATIVE.
• pertains to the presence of drugs
o Confirmatory
▪ Analyte and Concentration
• specifies the drug present and the concentration detected
• 2 two copies must be produced

TEST LEVELS
Test
• Screening Test
o Potential/presumptive positive result. Qualitative test.
TLC Thin Layer Chromatography
o TLC GC–MS Gas Chromatography–Mass Spectrometer
• Confirmatory Test HPLC–MS High Performance Liquid
o D. & Quantify the metabolite using different technique / chemical principle. Chromatography–Mass Spectrometer

o GC–MS / HPLC – MS
• Test Levels
o NRL sets the required cut-off level IDTOMI Integrated Drug Test Operation
o The equipment and drug testing kit must be register to the IDTOMI: Management Information System
• Each laboratory shall submit its protocol indicating the initial cut-off levels in screening specimens to determine whether they are
negative or for confirmation of the presence of dangerous drugs.
• Acceptability of the cut off levels shall depend on:
o the methods used by the laboratory
o equipment
o registered testing kits.

PROFICIENCY TESTING
• NRL assess DTL (Screening / Confirmatory lab)
• All DTL must participate (they must pass the testing to renew their license) PROFICIENCY TESTING:
• to assess the performance of laboratories for their
• Submit result w/in 3 weeks conduct of specific test, measurements or calibrations
• 1st time failed: another chance • to assess the accuracy and precision of the tests
• 2nd time failed: revocation of license

VALIDITY OF THE TEST RESULT

• A DRUG CERTIFICATE is valid for 1 year from the date of issue
o Which may also be used for other purpose.

VALIDITY (CERFICATE OF ACCREDITATION)

• Screening – 1 year
• Confirmatory – 2 years

RENEWAL (CERTIFICATE OF ACCREDITATION)

• Shall be filled 90 days before the expiration of license
• License always expires on the last day of the year.

MONITORING OF LABORATORIES
• The CHD (or the Bureau) conduct a visit unannounced.
CHD: Centers for Health Development
• Monitoring shall document the overall quality of the laboratory setting.
1. 11 Section 14

CENIZAL
VIOLATIONS
• Issuance of fraudulent result
• Failure to protect the confidentiality of a drug test result
• Failure to participate in a proficiency testing
• Failure to refer a positive result to a confirmatory laboratory
• Refusal to CHD to inspect their laboratory

PUNISHMENT
• 6 years and 1 day to 12 years Imprisonment
• PLUS:
o Fine 100,000 – 500,000
o Revocation to license to practice

FRAUDULENT RESULT CONFIDENTIALITY REFUSAL TO TESTIFY AS A WITNESS

• 6 years and 1 day to 12 years • 6 months and 1 day to 6 years • 12 years and 1 day to 20 years
Imprisonment Imprisonment Imprisonment
• Fine 100,000 – 500,000 • Fine: 1,000 – 6,000 • Fine: 500,000

SPECIMENS FOR DRUG TESTING

PRESERVATION ADVANTAGES
SPECIMENS AMOUNT & CONTAINER
TECHNIQUE AND DISADVANTAGES
• Most common method • 60 mL ideally
• Least expensive • Polyethylene bottle, wide mouth screw cap
• Standardized procedure
Urine • –20°C temp
• Can only detect drug used within a week Minimum Quantity:
• Abstaining produces negative reaction 60 mL (single)
• Established specimen with validity test 30 mL each for split sample
• Gives the most accurate • 10 mL
• Serum separated first • Least common method • Clean sterile plain tube
Blood • Freezing temp, about • Most expensive
–20°C • short detection time Minimum Quantity:
• Procedure not established and standardized 5 mL
• 2x more sensitive than urine
• 1.5x1.5 cm hair clump
• Detects chronic substance abuse
• Self-sealed transparent plastic bag
• Can determine temporal pattern
Hair • Cool and dry area
• expensive
Minimum Quantity:
• do not detect recent use of drugs
100 mg
• not affected by drug abstinence
• 30 mL
• Uncommon method • Polyethylene bottle
• At least –8°C to – • Easy to administer
Saliva
10°C temp • Short detection time Minimum Quantity:
• No reference standardized 2 mL (single),
1.5 and 0.5 (spit)
• Macerated
Body tissue • Screw capped plastic container
• Frozen
• Uncommon method
• Requires wearing of patch 1-2 weeks
• No reference standards develop
Sweat • BFAD approved sweat patch
• Surface contamination can cause false
positive
• Can detect use for extended period of time

FORMS OF TAMPERING SPECIMEN

• Dilution
o Internal dilution
▪ Drinking plenty of water
▪ Diuretics like Lasix, Tea, Coffee, Beet
o External dilution
▪ Addition of water
• Substitution
o Methods:
▪ Catherization
▪ Concealed container, e.g. condoms
▪ Injection into bladder
▪ Another liquid like juics
▪ Stealing other urine
• Adulteration
o Additives/Adulterants:
▪ Bleach inc pH slower Ab-Ag rxn
▪ Ammonia inc pH
▪ Liquid soap inc pH
▪ Table Salt inc pH
▪ Vinegar dec pH
▪ Visine eye drops interferes with EMIT (enzyme-multiplied immunoassay technique)
• Drug screens: masks/interferes drugs analysis
o Aspirin, Niacin, and Zinc sulfate

CENIZAL
PROF. NENITA LIM

Commission on Higher Education and CHED Memorandum Order No. 14 Series of 2006

REPUBLIC ACT NO. 7722: THE HIGHER EDUCATION ACT OF 1994.

• Chairperson of the Commission on Higher Education Commissioners

o Approved: May 18, 1994
o Speaker House of Representative: Jose de Venecia, Jr.
o Senate President: Edgardo J. Angara
o President: Fidel V. Ramos
• CHED
o Commission on Higher Education
o Created on May 18, 1994
o Attached agency to the Office of the President
o Headed by a chairman with Four commissioners
o the creation of CHED was part of a broad agenda of reforms on the country’s education system outlined by the
Congressional Commission on Education (EDCOM) in 1992.
o Part of the reforms was the trifocalization of the education sector into three governing bodies:
▪ CHED = tertiary and graduate education
▪ DepEd= basic education
▪ TESDA= technical-vocational & middle-level education
• The Commission En Banc
o acts as a collegial body in formulating plans, policies and strategies relating to higher education and the operation of
CHED.

VISION
• The Commission on Higher Education (CHED) is the key leader of the Philippine Higher Education System effectively working in
partnership with other major higher education stakeholders in building the country's human capital and innovation capacity
towards the development of a Filipino Nation as a responsible member of the international community.

MANDATE
• Promote relevant and quality higher education
• ensure that quality higher education is accessible to all who seek it particularly those who may not be able to afford it
• guarantee and protect academic freedom for continuing intellectual growth, advancement of learning and research, development
of responsible and effective leadership, education of high level professionals, and enrichment of historical and cultural heritages.
• commit to moral ascendancy that eradicates corrupt practices, institutionalizes transparency and accountability and
encourages participatory governance in the Commission and the sub-sector.

COMPOSITION OF THE COMMISSION AND TERM OF OFFICE

• 5 full-time members
o CHAIRMAN
▪ 4 years with reappointment
o 4 COMMISSIONERS
▪ First two: 3 years
▪ Other two: 2 years

CHED POWERS AND FUNCTIONS

• Formulate and recommend development plans, policies, priorities, and programs on higher education and on research
• Recommend to the executive and legislative branches priorities and grants on higher education and research
• Set minimum standards for programs and institutions of higher learning
• Monitor and evaluate the performance of programs and institutions of higher learning for appropriate incentives as well as
the imposition of sanctions
• Identify, support and develop potential centers of excellence in program areas needed for the development of world-class
scholarship, nation building and national development;
• Recommend to the Department of Budget and Management (DBM) the budgets of public institutions of higher learning as well
as general guidelines for the use of their income
• Rationalize programs and institutions of higher learning and set standards, policies and guidelines for the creation of new
ones as well as the conversion or elevation of schools to institutions of higher learning.
• Develop criteria for allocating additional resources such as research and program development grants, scholarships, and the
other similar programs
• Direct or redirect purposive research by institutions of higher learning to meet the needs of agro-industrialization and
development;
• Devise and implement resource development schemes;
• Administer the Higher Education Development Fund, as described in Section 10 of R.A. 7722, which will promote the purposes
of higher education;
• Review the charters of institutions of higher learning and state universities and colleges including the chairmanship and
membership of their governing bodies and recommend appropriate measures as basis for necessary action.
• Promulgate such rules and regulations and exercise such other powers and functions as may be necessary to carry out
effectively the purpose and objectives of R.A. 7722;
• Perform such other functions as may be necessary for its effective operations and for the continued enhancement, growth and
development of higher education.

CENIZAL
CHED Memorandum Order No. 14 Series of 2006
Subject:
• The Policies and Standards and Guideline for MT education

Article I
Introduction
• Section 1
o MT education / MLS Education aims to develop a foundation in the fundamentals of MLS and to make it responsive to the
demands for manpower in the paramedical service
o Lab. Testing plays a crucial role in the detection, diagnosis, prognosis, prevention and treatment of disease.
o MT/MLS must have a combination of education, clin. Lab. Internship and specialized training

Article II
Authority to Operate
• Section 2
o MT/MLS Institutions as wells as State Universities and Colleges must first secure proper authority from the Commission.

Article III
Program Specifications
• Section 3.
o Graduates of this program shall be conferred BS MT / BS MLS degree
• Section 4.
o Program Description
o This course is a four (4) year program
o 6 months internship program
▪ Internship program in different sections:
• Clinical Chemistry
• Hematology,
• Microbiology
• Immunohematology (Blood Banking)
• Immunology and Serology,
• Urinalysis and other Body Fluids (Clinical Microscopy),
• Parasitology
• Histopathologic/Cytologic techniques
• and other emergent technologies

Article IV
Competency Standards
• Section 5.
• MT/MLS graduate duties and responsibilities:
1. collect samples, prepare specimen for analysis, determine the acceptability of samples within guidelines, perform the test
according to standard methods/techniques;
2. demonstrate skills in judgment and decision making to analyze quality control and recognize implausible results and take
appropriate actions to maintain accuracy and precision;
3. perform accurately data gathering, processing and encoding into the computer system;
4. observe the principles of data security or patient confidentiality, maintain ethical standards in working with other laboratory
and hospital personnel;
5. possess good communication and human relation skills for effective and healthy interaction with health care professionals;
6. take responsibility for their own professional development or continuing education especially computer education in the
application and management of data and computerized laboratory equipment; and,
7. acquire basic management, supervision, administrative skills to contribute to the resolution of conflicts pertaining to
laboratory management, implementation of changes in response to technology and laboratory procedures, development of
safety management procedures and improvement of standards of practice.

Article V
Curriculum
• Section 6.
o Higher Education Institutions offering Medical Technology/ Medical Laboratory Science education may exercise flexibility
in their curricular offering. However, medical technology/medical laboratory science subjects as prescribed in the sample
program of study shall be implemented.
• Section 7.
o Curriculum outline
• Total Units
o General Education Courses -----------------84 units
o Core Courses ----------------------------------- 16 units
o Professional Courses ------------------------- 50 units
o Research ---------------------------------------- 3 units
o Seminar ----------------------------------------- 6 units
o Internship -------------------------------------- 18 units
o Grand Total ---------------------- 177 units
Article V on Appendix A
• Total of forty (40) hours per week of duty
• Total of 1,080 hours in twenty-seven weeks.
• The interns must render the following number of hours in each discipline:
o Clinical Chemistry - 230 hrs.
o Clinical Microscopy & Parasitology - 230 hrs.
o Microbiology - 150 hrs.
o Hematology - 120 hrs.
o Blood Banking - 150 hrs.
o Histopathologic Technique & Cytology - 100 hrs.
o Immunology & Serology - 100 hrs.

Article VI on Appendix A
• There shall be one (1) clinical instructor/interns’ coordinator/clinical coordinator for every 25 students/interns
• The C.I. functions
o Acts as a liaison officer between the school and the hospital
o coordinates with chief MT in the proper implementation of the internship training programs

Article VII on Appendix A

• Duties and Responsibilities of Interns:
o Shall observe proper decorum
o Adhere strictly to the policies of the institution and training center on absences and tardiness

Article VIII on Appendix A

• Offenses and Sanctions
o excused absence = eight (8) hours make-up
o unexcused absence = twenty-four (24) hours make-up
o tardiness of sixty minutes = 8 hours make-up
o out-of-post = eight (8) hours make-up
“for accumulated absences exceeding twenty percent (20%) of the total number of internship hours per hospital
rotation, REPEAT INTERNSHIP.”
• Section 8.
o Program study.
o The Minimum Curriculum
▪ Note: “Instrumentation and Quality Control shall be integrated in all Professional Laboratory Courses.”

Article VI
Course Specifications
• Section 11.
o Course Name
o Course Description
o Course Outline

Article VIII
Other Requirements
• Section 12. Program Administration
o The Institution shall be administered by a full-time dean/head, with the following qualifications:
▪ A Filipino citizen of good moral character;
▪ Must be a registered Medical Technologist in the Philippines with at least master 's degree in Medical
Technology or other health related courses
▪ Have at least five (5) years of very satisfactory teaching experience (Medical Technology professional subjects)
and must have adequate managerial competence and technical expertise in school management.
o The general functions and responsibilities of the Dean of Medical Technology:
▪ administers general policies of the college /university;
▪ exercises educational leadership among Medical Technology faculty members
• The dean shall have a maximum of twelve (12) units of teaching load and at least twenty (20) hours of administrative services per
week

• Section 13. Faculty

o Qualifications for those teaching subjects included in the licensure examination
▪ RMT with license
▪ S. degree holder
▪ 1 year internship experience and 1-year clinical laboratory experience
o Qualifications for those teaching non-licensure subjects
▪ S./PhD degree in related fields
▪ At least 2 years experience

• Section 14. Library

o The library shall be open at least eight (8) hours a day on school days.
o at least two (2) titles of each current edition of Medical Laboratory Science books as basic reference reading materials
for each Medical Technology subject.
o a minimum of one (1) international journal and two (2) local journals as well as Health Science periodicals
o at least one (1) copy of each textbooks for every fifteen (15) students enrolled in the class.
• Section 15. Facilities and Equipment
o Fully equipped laboratory facilities instruction
o Laboratory rooms with 2 exits
o floor space 1 m2 for every 1-2 students,
o Locker for every 1-5 students

• Section 17. Instructional Standards

o The institution shall maintain a high standard of quality of instruction.
1. The institution shall have attained recognition status.
2. The professional licensure performance rating shall be 50% of NPR (National Passing Rate) for the last 5 years

Article XI
Effectivity
• Section 19.
• His set of Policies, Standards and Guidelines for Medical Technology Education shall take effect beginning S.Y. 2006 – 2007
• Chairman: Carlito S. Puno

EXPANDED PRACTICE OF THE PROFESSION

• Diagnostic molecular scientist
• Research scientist
• Educator/Academician
• Diagnostic product specialist
• Public health practitioner
• Health care leader
• Drug analyst
PROF. NENITA LIM

BLACK: From Canvas, ppt

TEAL: from synch class, from RA, others

: synch class, other

NEWBORN SCREENING
• simple procedure to determine whether a baby has congenital metabolic disorder that may lead to mental retardation and even
death if left untreated.
• done on the 48 hours or at least 24 hours from birth.
• The baby must be screened again after 2 weeks for more accurate result.
• A physician, medical technologist, nurse, a midwife can collect sample for newborn screening.
• A few drops of blood are obtained from the baby’s heel and blotted on a special HEEL-STICK PUNCTURE
absorbent filter card. TECHNIQUE
• Disorders included • blood collection technique
o Congenital hypothyroidism (CH)
o Congenital adrenal hyperplasia (CAH)
o Galactosemia (GA)
o Phenylketonuria (PKA)
o Glucose-6-phosphate dehydrogenase deficiency (G6PD def)

DISORDERS:
CONGENITAL HYPOTHYROIDISM
• Deficiency in the production of the thyroid hormone: THYROXINE
• Prevalence: 1:3,350
• Poor growth, mental retardation, deafness and neurological abnormalities can result without prompt identification and treatment.
• Early diagnosis and adequate treatment with thyroxine within the first weeks of life results in normal growth and intelligence.

CONGENITAL ADRENAL HYPERPLASIA

• A group of inherited disorders caused by abnormalities in specific enzymes of the adrenal gland
• Ninety percent of congenital adrenal hyperplasia cases are caused by the lack of the enzyme steroid 21-HYDROXYLASE
• Prevalence: 1:13,500 PSEUDO-HERMAPHRODITES
• Babies with untreated congenital adrenal hyperplasia may develop vomiting and • Surgically feminized at birth
severe dehydration (aldosterone deficient, salt-wasting CAH), which can be life • Females born with masculine looking
threatening external genitals, although they have
• Increased production of androgens can result in ambiguous genitalia in infants ovaries

ENZYME DEFICIENCIES RESULTING IN CAH

MINERALO-
DEFICIENT ENZYME SUBSTRATE PRODUCT ANDROGEN % OF CAH
CORTICOID
Progesterone Deoxycorticosterone   >90%
21-hydroxylase 17-hydroxy
11-deoxycortisol
progesterone
11β-hydroxylase Deoxycorticosterone Corticosterone   5%

Steroidogenic acute Necessary for cholesterol

regulatory protein – transport into   Rare
(STAR) mitochondria

3β-hydroxysteroid Pregnenolone, Progesterone,

dehydrogenase 17-OH pregnenolone, 17-OHP,   Rare
(3 β-HSD) DHEA 4
-androstenedione

Pregnenolone 17-OH pregnenolone   Rare

17-hydroxylase
Progesterone 17-OH (17-ohp)

PHENYLKETONURIA (PKU)
• Autosomal recessive disorder caused by the lack of PHENYLALANINE HYDROXYLASE,
o the enzyme that converts the amino acid phenylalanine to tyrosine
• Phenylalanine is present in almost all foods
• Prevalence: 1:20,000
• Without early diagnosis and strict adherence to a special diet, brain damage and mental retardation can occur
• If child is not screened during routine newborn screening test, the disease may present clinically with:
o Seizures, albinism, and a musty odor to the baby’s sweat and urine
• Untreated children are normal at birth, but fail to attain early developmental milestones, the following major clinical problems are
developed:
o microcephaly, hyperactivity, EEG abnormalities, seizures, and severe learning disabilities
GALACTOSEMIA
• “Galactose in the blood”
• Autosomal recessive disorder
• Primary form is a deficiency of GALT
(GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE)
o enzyme needed to break down the milk sugar lactose
o deficiency causes galactosuria, which then leads to galactosemia
• Prevalence: 1:60,000
• Clinical Manifestations:
o Life-threatening galactosemia, If a galactosemic infant is given
o mental retardation, milk, unmetabolized milk
o blindness sugars build up and damage the
o Brain damage liver, eyes, kidneys, and brain
o Cataracts
o Jaundice
o Enlarged liver
o Kidney Damage
• Clinical symptoms may present as early as the first week of life.
•

G6PD: GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY

• G6PD:
o Enzyme that helps red blood cells work. It also protects them from substances in the blood that could harm them.
• G6PD deficiency:
o genetic disorder that most often affects males.
o happens when the body doesn't have enough of an enzyme called GLUCOSE-6-PHOSPHATE DEHYDROGENASE
(G6PD).
o Happens after exposure to oxidative drugs e.g.:
▪ Aspirin
▪ Sulfonamides
▪ Nitrofurantoin
▪ Dapsone
▪ Primaquine
▪ Quinidine
o either the red blood cells do not make enough G6PD or what they do make doesn't work as it should.
o Without enough G6PD to protect them, the red blood cells break apart: HEMOLYSIS. When many red blood cells are
destroyed, a person can develop HEMOLYTIC ANEMIA.
o can cause tiredness, dizziness, and other symptoms.
o Red blood cells that don't have enough G6PD are sensitive to some medicines, foods, and infections. When these things
trigger a quick loss of red blood cells over a short time, it's called a HEMOLYTIC CRISIS. In these cases, the symptoms
stop when the cause is gone.
o In rare cases, G6PD deficiency leads to CHRONIC ANEMIA regardless of exposure to triggers.
Disorders ulit pero nakatable hehe

DISORDER ETIOLOGY
• Deficiency in the
Congenital
production of the
hypothyroidism
thyroid hormone:
(CH)
THYROXINE
• group of inherited
disorders caused by
Congenital adrenal
abnormalities in
hyperplasia (CAH)
specific enzymes of the
adrenal gland
CLINICAL MANIFESTATIONS
PREVALENCE OTHER INFO
if untreated:
• Poor growth,
• Early diagnosis and adequate
• mental retardation,
treatment with thyroxine within
1 : 3,350 • deafness,
the first weeks of life results in
• neurological
normal growth and intelligence.
abnormalities
• Ninety percent of congenital
adrenal hyperplasia cases are
caused by the
lack of the enzyme steroid 21-
HYDROXYLASE
• vomiting
• Increased production of
• severe dehydration
1 : 13,500 androgens can result in
(aldosterone deficient,
ambiguous genitalia in infants
salt-wasting CAH)
PSEUDO-HERMAPHRODITES
• Surgically feminized at birth
• Females born with masculine
looking external genitals,
although they have ovaries
Without early diagnosis
• brain damage
• mental retardation

If not screened during

• Autosomal recessive
routine newborn screening
disorder caused by the
test
lack of
• Seizures, albinism, and
PHENYLALANINE
Phenylketonuria a musty odor to the
HYDROXYLASE, the 1 : 20,000
(PKA) baby’s sweat and urine
enzyme that converts
the amino acid
Fail to attain early
phenylalanine to
developmental milestones
tyrosine
• microcephaly,
hyperactivity, EEG
abnormalities, seizures,
and severe learning
disabilities
may present as early as the
first week of life:
• Life-threatening • GALT:
galactosemia, o enzyme needed to
• Autosomal recessive
break down the milk
disorder, primary form • mental retardation,
sugar lactose
is a deficiency of GALT: 1 : 60,000 • blindness
Galactosemia (GA) • If a galactosemic infant is given
(GALACTOSE-1- • Brain damage
milk, unmetabolized milk
PHOSPHATE URIDYL • Cataracts
sugars build up and damage
TRANSFERASE) • Jaundice
the liver, eyes, kidneys, and
• Enlarged liver brain
• Kidney Damage

G6PD
• Enzyme that helps red blood cells
work. It also protects them from
substances in the blood that
could harm them.
G6PD deficiency:
• happens when the body • genetic disorder that most often
doesn't have enough of affects males.
an enzyme called • either the red blood cells do not
make enough G6PD or what they
GLUCOSE-6-
do make doesn't work as it
PHOSPHATE
should. Without enough G6PD to
DEHYDROGENASE
protect them, the red blood cells
Glucose-6- (G6PD). break apart: HEMOLYSIS. When
phosphate • Happens after • Tiredness many red blood cells are
dehydrogenase exposure to oxidative • Dizziness destroyed, a person can
deficiency (G6PD drugs e.g.: etc. develop HEMOLYTIC ANEMIA.
def) o Aspirin • Red blood cells that don't have
o Sulfonamides enough G6PD are sensitive to
o Nitrofurantoin some medicines, foods, and
infections. When these things
o Dapsone
trigger a quick loss of red blood
o Primaquine cells over a short time, it's called
o Quinidine a HEMOLYTIC CRISIS. In these
cases, the symptoms stop when
the cause is gone.
• In rare cases, G6PD deficiency
leads to CHRONIC ANEMIA
regardless of exposure to
triggers.
 RA. 9288 Newborn Screening Act of 2004
An Act Promulgating a Comprehensive Policy and a National System for Ensuring Newborn Screening.
Approved: April 7, 2004

ARTICLE 1: GENERAL PROVISION

SECTION 1: SHORT TITLE:

“Newborn Screening Act of 2004”

SECTION 2: DECLARATION OF POLICY

• The state shall protect and promote the right to health of the people, including the rights of children to survival and full and healthy
development as normal individuals.
• The state shall institutionalize a national newborn screening system that is comprehensive, integrative, and sustainable and will
facilitate collaboration among government and non-government agencies at the national and local levels, the private sector, families
and communities, professional health organizations, academic institutions, and NGOs
• The national newborn screening shall ensure that every baby born 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:
• 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.
• Establish and integrate a sustainable newborn screening system within the public health delivery system.
• 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.
• 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.

ARTICLE 2: DEFINITION OF TERMS

SEC. 4 DEFINITIONS
• COMPREHENSIVE NEWBORN SCREENING SYSTEM:
o Education of relevant stakeholders
o Collection and biochemical screening of blood
o Tracking and confirmatory testing
o Clinical evaluation and biochemical/medical confirmation of test results
o Drugs and medical/surgical management and dietary supplementation to address the heritable conditions
o Evaluation of activities to assess long term outcome
o Patient outcome and quality assurance.

• FOLLOW-UP:
o Monitoring of a newborn

• HEALTH INSTITUTIONS:
o Hospital, health infirmaries, health centers, lying-in centers, puericulture centers (public or private)

• HEALTH CARE PRACTITIONERS:

o Physicians, nurses, midwives, nursing aides, and traditional birth attendants.

• HERITABLE CONDITION:
o Condition that can result in mental retardation, physical deformity or death.

• NIH:
o National Institute of Health

• NEWBORN:
o Means a child from the time of complete delivery to 30 days old.

• NEWBORN SCREENING:
o Process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing
biochemical testing for determining if the newborn has a heritable condition.

• NEWBORN SCREENING CENTER:

o Facility equipped with a newborn screening laboratory that complies with the standards.

• NEWBORN SCREENING REFERENCE CENTER:

o Central facility at the NIH that defines testing and follow up protocols, maintains an external laboratory proficiencies and
national database.

• PARENT EDUCATION:
o Various means of providing parents or legal guardians information

• RECALL:
o Procedure of locating a newborn

• TREATMENT:
o The provision of prompt, appropriate and adequate medicine, medical and surgical management or dietary prescription to
a newborn for purposes of treating or mitigating the adverse health consequences.
ARTICLE 3: NEWBORN SCREENING

SECTION 5: OBLIGATION TO INFORM

• Health practitioner informs the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening.
• Education and notification – responsibility of the DOH.

SECTION 6: PERFORMANCE OF NEWBORN SCREENING

• Shall be performed after 24 hours of life but not later than 3 days from complete delivery of the newborn
• Newborn in the ICU
o may be exempted from the 3-day requirement but must be tested by 7 days of age.
• Shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn
screening is performed.

SECTION 7: REFUSAL TO BE TESTED

• A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their newborn at
risk for undiagnosed heritable conditions.
• A copy of this refusal documentation shall be made part of the newborn’s medical record and refusal shall be indicated in the
national newborn screening database.

SECTION 8: CONTINUING EDUCATION, RE-EDUCATION AND TRAINING HEALTH PERSONNEL

• DOH with the assistance of the NIH
• conduct continuing information, education, re-education, and training programs for health personnel on the rationale, benefits,
procedures of newborn screening.
• Disseminate information materials on newborn screening at least annually to all health personnel involved in maternal and pediatric
care.

SECTION 9: LICENSING AND ACCREDITATION

• DOH and the Phil Health Insurance Corporation (PHIC) shall require health institutions to provide newborn screening services as a
condition for licensure or accreditation.

ARTICLE 4: IMPLEMENTATION

SECTION 10: LEAD AGENCY

• DOH: Lead Agency
• Establish the advisory committee on newborn screening
• Develop the implementing rules and regulations for the immediate implementation of a nationwide newborn screening program
within 108 days from the enactment of this Act.
• Coordinate with the Department of the Interior and Local Government (DILG) for the implementation of the NBS programs.
• Advisory Committee on Newborn Screening
• Coordinate with the NIH NBS Reference Center for the accreditation of Newborn screening centers and preparation of defined testing
protocols and quality assurance programs.
• Coordinate with DILG for implementation of the NBS program.

SECTION 11: ADVISORY COMMITTEE ON NEWBORN SCREENING

• Ensure sustained inter-agency collaboration
• Integral part of the office of the secretary of the DOH
• Review annually and recommend conditions to be included in the newborn screening panel of disorders
• Review and recommend the newborn screening fee.
• Committee: 8 members:
o Chairman: Secretary of the DOH
o Vice Chairman: Executive director of the NIH
o Undersecretary of the DILG
o Executive Director of the Council for the Welfare of Children
o Director of the Newborn Screening Reference Centers
o 3 representatives appointed by the Secretary of Health
▪ (pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife)
▪ term: 3 years subject for reappointment for another 3 years.
o NIH: secretariat of the committee

SECTION 12: ESTABLISHMENT AND ACCREDITATION OF NEWBORN SCREENING CENTERS

• Strategically located and accessible
• Certified laboratory performing all tests included in the newborn screening program
• recall/follow up programs for infants found positive for any and all of the heritable conditions.
• Be supervised and staffed by trained personnel who have been duly qualified by the NIH
• Submit to periodic announced and unannounced inspections by the Reference center.

SECTION 13: ESTABLISHMENT OF A NEWBORN SCREENING REFERENCE CENTER

• NIH shall establish a NBS Reference Center
• National testing database
• Case registries, training, technical assistance
• Continuing education for laboratory staff
SECTION 14: QUALITY ASSURANCE
• NIH:
o Responsible for drafting and ensuring good laboratory practice standards for newborn screening centers
o Establish an external laboratory proficiency testing and certification program
o Principal repository of technical information relating to newborn screening standards and practices
o Technical assistance to newborn screening centers needing such assistance.

SECTION 15: DATABASE

• NBS Reference Center shall maintain a national database of patients tested and a registry for each condition.
• NBS Reference Center shall submit reports annually to the committee and to the DOH on the status of a relevant information derived
from the database

SECTION 16: NEWBORN SCREENING FEES

• Testing costs
• Education
• Sample transport
• Follow-up cost
• Reasonable overhead expenses

ARTICLE 5: FINAL PROVISIONS

SECTION 17: REPEALING CLAUSE

SECTION 18: SEPARABILITY CLAUSE

SECTION 19: EFFECTIVITY

RA. 7170 Organ Donation Act of 1991

An Act Authorizing the Legacy or Donation of All Part of a Human Body After Death for Specified Purposes
Approved: January 7, 1992

SEC 1: TITLE
“Organ Donation Act of 1991”

SEC 2: DEFINITION OF TERMS:

• ORGAN BANK STORAGE FACILITY
o a facility licensed, accredited or approved under the law for storage of human bodies or parts thereof.

• DECEDENT
o a deceased individual, and includes a still born infant or fetus

• TESTATOR
o an individual who makes a legacy of all or parts of his body.

• DONOR
o an individual authorized under this act to donate all or part of the body or decedent.

• HOSPITAL
o a hospital licensed, accredited or approved under the law, and includes a hospital operated by the government.

• PART
o includes transplantable organs, tissues, eyes, bones, arteries, blood, other fluids and other portions of human body.

• PERSON
o an individual corporation, estate, trust, partnership, association, the government owned or controlled corporations or
any other legal entity.

• PHYSICIAN OR SURGEON
o a physician or surgeon licensed or authorized to practice medicine under the laws of the Republic of the Philippines

• “IMMEDIATE FAMILY” OF THE DECADENT

o the person enumerated in sec 4 of this act.

• DEATH
o the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions of the
entire brain, including the brain stem. A person shall be medically and legally dead.

SEC 3: PERSON WHO MAY EXECUTE LEGACY:

who can donate organs:
At least 18 years old and of sound mind, may give by way of legacy, to take effect after his death, all or part of his body for any
purpose specified in sec 6

SEC 4 PERSON WHO MAY EXECUTE DONATION

(a) Any of the following persons, in the order of priority stated.
1. Spouse
2. Son or daughter of legal age
3. Either Parent
4. Brother or sister of legal age
5 Guardian over the person of the decedent at the time of his death
(b) The persons authorized by sub-section (a) of this Section may make the donation after or immediately before death.

SECTION 5: EXAMINATION OF HUMAN BODY OR PART

• A legacy or donation of all or part of a human body authorizes any examination necessary to assure medical acceptability of the
legacy or donation for the purpose intended
• An autopsy shall be conducted on the cadaver of accident, trauma or other medico-legal cases immediately after the pronouncement
of death to the determine qualified and healthy human organs for transplantation and or in furtherance of medical science

SEC 6: WHO CAN BENEFIT THE ORGANS

• Any hospital, physician or surgeon
o For medical or dental education, research advancement of medical or dental science, therapy or transplantation.
• Any accredited medical or dental school, colleges or university:
o For education, research, advancement of medical or dental science or therapy;
• Any organ bank storage Facility:
o For medical or education, research, therapy or transplantation
• Any specified individual:
o For therapy or transplantation needed.

SEC 7: DUTY OF THE HOSPITAL

A hospital authorized to receive organ donations or to conduct transplantation shall train qualified personnel and their staff to
handle the task of introducing the organ donation program in a humane and delicate manner to the relatives of the donor-decedent
enumerated in Section 4 hereof.
SEC: 8 MANNER OF EXECUTING A LEGACY:
• Legacy of all or part of the human body made by will.
• Legacy becomes effective upon the death of the testator without waiting for probate of the will
o If the will is not probated, it is a declared invalid for testamentary purposes, to the extent that it was executed in good
health is nevertheless valid and effective.
• The legatee may also be made in any document:
o The legacy becomes effective upon the death of the testator and shall be respected by and binding upon his executor
or administrator,
o The document which maybe a card or any paper designed to be carried on a person
o Must be signed by the testator in the presence of TWO WITNESSES and should sign also for the presence.
• The testator may designate in his will, card or other document, the surgeon or physician who will carry out the appropriate
procedures.

SEC 9: MANNER OF EXECUTING A DONATION:

• In the absence of any document of organ donation, the physician in charge of the patient, the head of the hospital or a designated
officer of the hospital to undergo transplantation, within 48 hours must locate the nearest relative.
• In all donations, the death of a person from whose body of an organ will be removed after his death for the purpose for the
transplantation to a living person
o Shall be diagnosed separately and certified by 2 QUALIFIED PHYSICIANS
▪ Member of the team of medical practitioners who will effect the removal of the organ from the body.
▪ Attending physician to the recipient of the organ to be removed
▪ The head of hospital or the designated officer authorizing the removal of the organ
SEC. 10 PERSON(S) AUTHORIZED TO REMOVE TRANSPLANTABLE ORGANS.
• 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.

SEC 11. DELIVERY OF DOCUMENT OF LEGACY OR DONATION.

• 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 is authorized representative, to the legatee or donee to expedite the appropriate procedures
immediately after death.
• 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.
• 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.

SEC 12. AMENDMENT OR REVOCATION OF LEGACY OR DONATION.

SEC 13: RIGHTS AND DUTIES AFTER DEATH

• The legatee or done may accept or reject the legacy or donation as the case may be.
• 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

SEC 14. INTERNATIONAL SHARING OF HUMAN ORGANS OR TISSUES.

• Sharing of human organs or tissues shall be made only through exchange programs duly approved by the DOH:
• 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.

SEC 15. INFORMATION DRIVE.

• In order that the public will obtain the maximum benefits from this Act, the DOH, in cooperation with institutions, such as the National
Kidney Institute, civic and non-government health organizations and other health related agencies, involved in the donation and
transplantation of human organs, shall undertake a public information program.
• The Secretary of Health shall endeavor to persuade all health professionals, both government and private, to make an appeal for
human organ donation.

SEC 16. RULES AND REGULATIONS.

• The Secretary of Health shall promulgate such rules and regulations as may be necessary or proper to implement this Act.

SEC 17. REPEALING CLAUSE.

All laws, decrees, ordinances, rules and regulations, executive or administrative orders, and other presidential issuance inconsistent with
this Act, are hereby repealed, amended or modified accordingly.

SEC 18. SEPARABILITY CLAUSE.

The provisions of this Act are hereby deemed separable. If any provision hereof should be declared invalid or unconstitutional, the
remaining provisions shall remain in full force and effect.

SECTION 19. EFFECTIVITY.

This Act shall take effect after fifteen (15) days following its publication in the Official Gazette or at least two (2) newspapers of general
circulation.
PROF. NENITA LIM

CODE OF ETHICS

PAMET Version of the Code of Ethics (1997 Revision)

As I enter the practice of medical technology, I shall:
• Accept the responsibilities inherent to being a professional.
• Uphold the law and shall not engage in illegal work nor cooperate with anyone engaged.
• Avoid associating or being identified with any enterprise of questionable character
• Work and act in a strict spirit of fairness to employer, clients, contractors, employees and in a spirit of personal helpfulness and
fraternity toward other members of the profession.
• Use only honorable means of competition for profession employment or services and shall refrain from unfairly injuring, directly
or indirectly the professional reputation, projects or business of a fellow medical technologist.
• Accept employment from more than one employs only when there is no conflict of interest.
• Perform professional work in a manner that merits full confidence and trust with absolute reliability, accuracy, fairness and
honesty.
• Review the professional work of other medical technologist when requested, fairly and in confidence whether they are
subordinates or employees, authors of proposals for grants or contracts, authors of technical papers or other publications or
involved in litigation.
• Advance the profession by exchanging general information and experience with fellow medical technologists and other
professionals and by contributing to work of professional organizations.
• Restrict my praises, criticisms, views and opinions within constructive limits and shall not use the knowledge know for selfish
ends.
• Treat any information I acquired about individuals in the course of my work as strictly confidential and may be divulged only to
authorized persons on entities or with consent of the individual when necessary.
• Uphold the dignity and respect of my profession and conduct myself a reputation of reliability, honesty and integrity.
• Be dedicated to the use of clinical laboratory science to promote life and benefit of mankind.
• Report any infractions of these principles of professional conduct to the authorities responsible for enforcement of applicable
laws or regulations, or to the ethics committee of the Philippine Association of Medical Technologists (PAMET) as may be
appropriate.
• To these principles, I hereby subscribe and pledge to conduct myself at all times in a manner of befitting the dignity of my
profession.

Code of Ethics (IMLS version)

Medical Laboratory Technologists/Scientists will endeavour to work as part of the multidisciplinary health team to provide
quality laboratory service for the ultimate benefit of the patient and the wider community.
Medical Laboratory Technologists/Scientists shall observe and be bound by the following code of professional conduct.
Medical Laboratory Technologists/Scientists shall:
• be dedicated to the use of medical laboratory sciences to benefit mankind;
• exercise their professional judgement, skill and care to the best of their ability in such a manner to bring credit to the profession
and in meeting established standards;
• actively seek to establish cooperative and specific working relationships with other health professionals;
• provide expertise to advice and counsel other health professionals;
• maintain confidentiality of patients information gained in the conduct of their profession and not wittingly disclose results or
information, of a personal or confidential nature to unauthorised persons;
• safeguard the dignity and privacy of patients;
• be responsible for the logical process from the acquisition of the specimen to the production of data and the final report of test
results;
• be accountable for the quality and integrity of medical laboratory service;
• maintain a responsible approach to the community at large with respect to the handling and disposal of hazardous material;
• conduct themselves in a manner to uphold and maintain the dignity and respect of the profession and strive to maintain a
reputation of honesty, integrity and reliability;
• strive to improve their professional skill and knowledge and disseminate such knowledge to fellow members and persons under
their control; and
• refrain from practices restricted by law and not indulge in unfair or improper practices for personal or professional gain.
The Code of Ethics is based on the code of ethics that was adopted by the IAMLT* general assembly of delegates at the 20th IAMLT
Congress in Dublin, Ireland 1992 and had since been revised at the IFBLS 29th World Congress in Nairobi 2010.*
PAMET HYMN:

BELOVED PAMET
MUSIC: FRANCIS JEROTA PEFANCOLYRICS: HECTOR GENTAPANAN HAYARES, JR.

From various lands, races and places

With grateful hearts we blend our voices
This day to our beloved PAMET
From whence unity and love cometh
We join together in brotherhood
To live up to thine ideals we should
In fields of advancement and learning
Thy noble goals may be our bearing
Loyal and true we'll be to thee
Beloved PAMET this we say
For service to God and humanity
With joy we sing for thee till eternity
Loyal and true we'll be to thee
Beloved PAMET this we say
For service to God and humanity
With joy we sing for thee till eternity

Medical Technologist's Prayer

God, who by calling us to the vocation of a medical technologists, has placed upon us the obligation of being a constant help in the
scientific care of the sick, grant us by thy divine light a deep insight into the serious responsibilities of our task.

By thy divine wisdom awaken in us a growing zeal and determination to increase our knowledge of how to search for the underlying
causes of sickness and disease; how to recognize the evidence of physical changes; how to make important chemical analyses, and
other valuable test so helpful in caring for the sick.

By thy divine love permit us in this way to share with those who directly care for the sick, that thus we may be of constantl y working
through the eternal physician, Christ our Lord, Amen.