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MUST TO KNOW IN MEDICAL TECHNOLOGY LAWS AND ETHICS

RA 5527
RA 5527 Philipppine Medical Technology Act of 1969
6/21/69
RA 6138 Amended RA 5527
8/31/70
Sections: 16, 21, 22
PD 498 Amended RA 5527
6/28/74
Sections: 2, 3, 4, 6, 7, 8 ,10, 11, 13, 16, 17, 21, 29
PD 1534 Amended RA 5527
6/11/78
Sections: 3, 8, 13
PD Presidential Decree
President Marcos
RA 6132 About the congress
8/30
Section 1 Title
Section 2 Definition of terms
Section 3 Council of MT
Section 4 Compensation: COMT
Section 5 Function: COMT
Section 6 Minimum required course
Section 7 Board of MT
Section 8 Qualification of examiners
Section 9 Executive officer of the board
Section 10 Compensation: BOMT
Section 11 Function: BOMT
Section 12 Removal of board members
Section 13 Accreditation
Section 14 Inhibition of practice of MT
Section 15 Examination
Section 16 Qualification for examination
Section 17 Scope of examination
Section 18 Report of rating
Section 19 Rating in the examination
Section 20 Oath taking
Section 21 Issuance of certificate of registration (COR)
Section 22 Fees
Section 23 Refusal to issue COR
Section 24 Administrative investigation
Section 25 Appeal
Section 26 3R‟s: Reinstatement, reissue or replacement of COR
Section 27 Foreign reciprocity
Section 28 Roster of MT
Section 29 Penal provisions
Section 30 Separability clause
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Section 31 Repealing clause
Section 32 Effectivity
House Bill No. 4032 Cong. Janette Garin

Senate Bill 2722 2/28/11


Sen. Edgardo Angara
May & November = MT board exams
September = Phlebotomy board exams
Section 2: Definition Exclusive for MT only:
of Terms -Exam of excretions/secretions/tissues
-BB procedures & techniques
-Micro/para procedures & techniques
-Histopathology, cytotechniques
---------------------------------------------------------------------
-------------------------------
-Clinical research
-Clinical laboratory QC
-Preparation of reagents & standards
-Preservation & collection of specimen
Section 3: COMT Composition: PD 1534
Chair: Director of higher education
Vice chair: PRC commissioner
Members:
a. Director of BRL
b. BOMT
c. President of PSP
d. President of PAMET
e. Representative of deans & schools of MT & PH (PASMETH)
Leila Florento PAMET president
Bernard Ebuen PASMETH president (May 2012)
Dean, Arellano university
Section 5: Functions Recommend minimum required curriculum
of COMT Det. MT students
Approve MT schools
Recommend & formulate refresher course (3x failed the
exam)
Section 6: Minimum RA 5527 = BSMT
required course - 4 yr course including 12 mos. internship
CMO #14 s. 2006
- policies, standards & guidelines for MT education
- MLS = 6 mos. internship
Section 7: BOMT Chair: Dr. Marietta Baccay (Pathologist)
Members:
- Marilyn Atienza, RMT
- Marian Tantingco, RMT
Appointed by the President of the Philippines
Term of office = 3 years
Section 8: Filipino citizen
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Qualification of Good moral character
board members Chair: Pathologist
Member: 2 RMTs
Practice of lab medicine or MT for at least 10 years prior to
appointment
Not MT faculty for at least 2 yrs prior to appointment
Section 9: Executive PRC commissioner
officer of the board RA 8981: PRC modernization act of 2000
- PRC Chairperson (highest position) = Teresita Manzala
Section 11: Functions Administer provision of RA 5527
of BOMT Administer oath taking
Issue, suspend or revoke COR
Investigate violations to RA 5527
Section 12: Removal Neglect of duty
of board members Malpractice
Immoral conduct
Can only be removed by the President of the Philippines
Section 13: MT schools = DepEd à CHED
Accreditation of MT Training lab = BRL à BHFS
schools & training lab
(1978)
Section 14: Inhibition Registration is not required:
of practice of MT a. Duly registered physicians
b. Foreign MT as visiting or exchange professional
c. MT in the service of US armed forces stationed in the
Philippines
Section 15: 2x/year
Examination ♫ <50 applicants (regional offices) = postpone the exam
♫ Deadline of application = 20 days before the exam
♫ Requirements:
a. TOR
b. NSO birth certificate
c. If married: NSO marriage certificate
d. Community tax certificate (cedula)
e. 4 passport sized picture w/ nameplate
f. P900
CMO #6 s. 2008 Accreditation of clinical laboratory as training lab for
MT/MLS interns
Clinical laboratory licensed by DOH thru BHFS shall apply to
CHED as training lab
Section 16: Good moral character
Qualification for Graduate of BSMT or PH
examination Graduate of other profession
- Can take the board exam if they perform MT for 5 years
prior to 6/21/69
Section 17: Scope of 20% = Clinical Chemistry
examination 20% = Hematology
20% = Microbiology/Parasitology
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20% = Immunology, Serology & Blood Banking
10% = Clinical Microscopy
10% = Histotechniques, Medical Technology Laws & Ethics
Section 18: Report of RA 5527: BOMT ---(120 days)---> PRC
rating RA 8981: Report result w/in 10 days
Section 19: Rating in To pass:
the exam - Gen. average at least 75%
- No grade below 50% in any major subject
- Not failed in 60% subjects computed according to their
relative weights
3x failure: (applicable to MT/PH only)
- 12 mos. refresher course in an accredited MT schools, or
- 12 mos. postgraduate training in an accredited lab
Section 20: Oath Administered by the BOMT or any person authorized by the
taking board
Section 21: Issuance To successful applicant: 21 y.o.
of COR Signed by 4 persons:
a. BOMT (3)
b. PRC chairperson
Displayed at workplace

COR as MT w/o exam Graduate of MT, w/ practice for 3 yrs, practice began prior
to 6/21/69
Graduate of other profession, w/ practice of MT for 8 yrs,
practice began prior to 6/21/69
COR as MLT Passed civil service exam for MLT given on 3/21/64
2 yrs college + 1 yr service (prior to 6/21/69):
a. For every yr in college, 2 yrs of service may be substituted
b. 10 yrs of service regardless of education
General average: 70-74.9%
1 RMT Can handle 2 MLTs
(1:2 ratio)
Section 23: Refusal Convicted by the court
to issue COR Unsound mind
Incurable communicable disease
Section 24: Revocation or suspension
Administrative Done by at least 2 members of the board + 1 legal officer = 3
investigation a. Revocation = Unanimous vote (3/3)
b. Suspension = Majority vote (2/3) = shall not exceed 2 yrs
Section 27: Foreign No foreigner is allowed to practice MT unless reciprocity has
reciprocity been established
In subjected country/state, allow Filipino MT to practice
profession
Section 28: Roster of Prepared annually by the secretary of the board
MT a. Name of RMT
b. Date of registration
c. Address
d. Other important information
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Open to the public
Section 29: Penal Violations:
provisions a. Practice MT w/o COR
b. Practice MT w/o supervision of a pathologist
c. Practice MT using other‟s COR
d. Practice MT using suspended/revoked COR
e. Fraudulent lab reports
f. Failure to display COR
Fine: P2,000-5,000 or imprisonment of 6 months to 2 years
Section 30: If any provision of RA 5527 is declared invalid, the rest will
Separability clause not be affected
Section 31: Repealing RA 5527 amends all rules & regulations & executive orders
clause that are inconsistent to it except:
a. Philippine Medical Act of 1959 (RA 2382, as amended by
RA 4224)
b. Clinical Lab Act of 1966 (RA 4688)
c. BB law (RA 1517)
Section 32: 6/21/69
Effectivity President Ferdinand Marcos
RA 4688
RA 4688 Clinical lab act of 1966
6/18/66
AO 2007-0027 Revised rules & regulations governing the registration and
licensing of clinical lab in the Philippines
8/22/07
Authority: BHFS
Scope: All clinical lab in the Philippines except governing lab
performing microscopy works for DOH
a. AFB screening
b. Malarial smear
c. Screening for STDs & cervical cancer (Pap‟s)
Classification of 1. Ownership
laboratories - a. Government
b. Private
2. Function
- a. Clinical pathology
- b. Anatomical pathology
3. Institutional character
- a. Institution-based
- b. Free-standing
4. Service capability
- General clinical lab = 1‟, 2‟, 3‟, limited service capability lab
- Special lab
1‟ laboratory Routine hematology: Hgb, Hct, WBC, WBC differential
Routine UA & FA
Qualitative platelet
Blood typing (hospital-based)
2‟ laboratory 1‟ lab plus the ff:
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Quantitative platelet
Cross-matching
Gram stain/KOH
Routine chemistry: Glucose, urea, uric acid, cholesterol
3‟ laboratory 2‟ lab plus the ff:
Special chemistry
Special hematology: coagulation studies
Immunology and serology
Culture and sensitivity
Limited service Examples:
capability lab Lab in dialysis center
Social hygiene lab clinic
Special lab Molecular biology
Assisted reproductive technology
STAT “Statim”
Immediately w/in 1 hr
General requirements 1. LTO from BHFS
(Lab) 2. Teaching/research lab = exempted but must register
3. Special lab = must register
4. POL: physician office lab = secure licence if
- Issue official receipt
- Cater to other patients
- Perform tests other than monitoring
5. POCT = diagnostic tests done at or near patient care
- Bedside testing
- Supervised & managed by licensed lab
Specific 1. Human resource
requirements (Lab) - Head: Pathologist
- Staff: RMTs
2. Equipment
3. Reagent & supplies
4. Physical plan:
- Well-lighted, well-ventilated, supply of H2O
a. 1‟ lab = 10 m2
b. 2‟ lab = 20 m2
c. 3‟ lab = 60 m2
5. Administrative policies
6. Technical procedures
7. QA (pre/analytical/post) & QC (analytical)
Mobile lab Collect specimens
Allowed to operate w/in 100 km radius from main lab
License (Lab) License no.
Validity
Name of lab
Owner
Head
Location
Service capability
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Renewal of license Nonhospital-based lab: October-November
Processed not later than 5 days after expiration
Violation Fine of P1,000-5,000
Imprisonment for not less than 1 month
RA 1517
RA 1517 BB law of 1956
6/16/56
RA 7719 Amendment of RA 1517
Nat‟l blood services act of 1994
5/5/94
Promote voluntary blood donation
Phase-out commercial BB
Implementing AO #9 s. 1995
guidelines (BB) AO #17 s. 1998
Category A (BB) Health education & counseling
Donor screening & selection
Provision, storage, issuance & transport & distribution of WB
& pRBC
Compatibility testing
Category B (BB) Health education & counseling
Donor screening & selection
Provision, storage, issuance & transport & distribution of WB
& blood products
Compatibility testing
Investigation of HTRs
Resolution of incompatible cross-match
BB Head: Pathologist/Hematologist
Staff: RMTs
1 Donor recruitment officer: MD/RN/RMT
Category A: 4 RMTs
- 1 AM
- 1 Afternoon
- 1 PM
- 1 Off
Category B: 5 RMTs
- 2 AM
- 1 Afternoon
- 1 PM
- 1 Off
AO 2008-0058 Rules & regulations governing blood service facilities (BSF)
5/02/08
1. Ownership
- a. Government
- b. Private
2. Institutional character
- a. Hospital-based
- b. Non-hospital-based (Ex. PNRC)
3. Service capability
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- a. Blood station = store WB (Ex. PNRC)
- b. Blood collection unit (BCU) = Ex. PNRC
- c. BB = blood typing, Coomb‟s, x-match
- d. Blood center = donor selection, collection of blood
RA 8504
RA 8504 Philippine AIDS prevention & control act of 1998
02/13/98
52 sections
Nationwide AIDS education & information program
PNAC Philippine National AIDS Council
- responsible for the provision of RA 8504
- 26 members
- Permanent Chair: DOH Secretary
AIDS WATCH Monitors the magnitude of HIV infection in the Philippines
HIV report issued to: Person who submitted himself to the test
Either parent of the minor
Legal guardian of an orphan or insane person
Justice of Supreme Court or Court of Appeals
RA 9288
RA 9288 Newborn screening act of 2004
4/07/04
NBS Done 24 hrs after birth to w/in 3 days
NICU: w/in 7 days
Tests:
a. Congenital hypothyroidism (cretinism)
b. Congenital adrenal hyperplasia
c. G6PD deficiency
d. Galactosemia
e. Phenylketonuria
RA 8981
PD 223 Creation of PRC
6/22/73
Amendments:
a. PD 657
b. RA 8981 = latest
RA 8981 PRC modernization act of 2000
12/05/00
Full computerization of the board exam
Monitoring of school‟s performance
Careful selection of professional regulatory board (PRB)
Composition of PRC Appointed by the President of the Philippines
Term of office: 7 yrs
Chairperson: Teresita Manzala
Commissioners (2):
- Alfredo Po
- Jennifer Manalili
Qualifications (PRC) At least 40 yrs old
w/ valid COR as professional license
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familiar w/ professional regulation and licensing
w/ at least 5 yrs executive or managerial experience
1 commissioner = past chair or member of PRB
Other Topics
RA 10069 Health worker‟s day (May 7)
Board exams Postponed exam:
a. Epidemics
b. Public calamities (25% of examiners are absent)
Set A & B exams: same questions but different in
arrangement
Nardito Moraleta Professionalized the MT course
Worked for the approval of RA 5527
Wrote the 1st MT code of ethics on 8/6/68
Norma Chang Revised the MT code of ethics on 3/7/97
Charlemagne PAMET president but not BSMT graduate
Tamondong
Carmencita Acedera Approved the 2nd (present) COE
Hector Gentapan Wrote the PAMET hymn
Gayares Jr.
Francis Jerota Created the melody & music of the PAMET hymn
Pefanco
PAMET Office Cityland 10 Tower 2 Condominium Unit 1720, 6187 bldg, Ayala
North, Makati City
RA 1517 Section 14 Color of the blood label according to blood type
A = Yellow
B = Pink
AB = White/Black/Gray
O = Blue
RA 4688 Section 20 QC
CPE PRC resolution no. 167
200 CPE units Author of MT books
PRC resolution no. Delisting of the names of delinquent professionals from its
217 rolls
PRC resolution no. Rules & regulations governing the regulation & practice of
332 professionals
PRC resolution no. Removal of names of professionals… delinquency in paying
428 their fees
PRC resolution no. Standardization policies… CPE
381
PRC resolution no. Foreigners are not allowed to take licensure exams in the
323 Philippines
CHED Approved the curriculum of MT
Research lab Does not need a license
Malarial screening lab Exempted from securing license from BHFS
PAMET National organization of all MT
Every 3 years Renewal of license (RMT)
Every 2 years Inspection of laboratories by BHFS

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DOH Approves lab‟s for accreditation as training lab for MT
students
EO 266 Institutionalization of the CPE programs under PRC
supervision
EO 200 Full computerization of licensure exams
AUP (Old: PUC) 1st school to offer MT course in the Philippines
Approved by DepEd – 1953
Manila Advenstist 1st complete set of lab sections
Medical Center
Antoinette McKelvey Newly trained lab worker under Dr. Papanicolau
Micro/para & histopath in the Philippines
Wilma Hilgert- 1st MT curriculum to be used for BSMT
Hedrick Founder of MT education in the Philippines
Shirley Cruzada Immediate past president of PAMET now
Screening drug testing lab be handled jointly by DOH-NRL &
PAMET

Dr. Pio de Roda Started training of lab workers in the Philippines at Public
Dr. Sta. Ana Health lab
Resolution 93-268 Mass oath taking
RA 5527 Sections 19 Not amended
& 27
BOMT w/ authority to change, add or remove subjects in the
licensure exam
RA 5527 MT Act
6/21/69
RA 1517 BB law
6/16/56
RA 7719 National blood services act
5/5/94
RA 8504 HIV/AIDS act
2/13/98
RA 9288 NBS act
4/7/04
RA 4688 Clin. lab act
6/18/66
AO 2007-0027 Revised rules & regulations… clinical lab
8/22/07
RA 8981 PRC modernization act
12/05/00
RA 6425 Drugs act (old)
RA 9165 Drugs act (latest)
1/13/03
PD 856 Sanitation
AO 1979-0031 Water testing lab
RA 7170 Organ donation act
1/7/92

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AO 2008-0007 Schedule of fees for the licensure of general clinical lab and
the registration of special clinical lab
James Todd A manual of clinical diagnosis  Clinical diagnosis by lab
methods (19th ed.)
Dr. Jesse Umali 1st graduate of PUC
OB-Gyne, owner of Omega Lab
Nicolas Lapeña Past PRC chairperson
6/14/61 Full recognition of 4-yr BSMT
PASMETH Formed in 1970
6/22/70 = 1st organizational meeting (UST)
5/7/71 = 1st annual meeting (UST)
Dr. Gustavo Reyes = 1st president
Dr. Ibarra Panopio = president (‟73-‟74)
Bernard Ebuen = present president
Atty. Dexter Bihis = PASMETH legal counsel („89)
PAMET Organized by Crisanto almario (9/15/63)
9/20/64 = 1st national convention (FEU)
Charlemagne Tamondong = 1st president
Nardito Moraleta = 2nd president
Venerable Oca = Quiz show (1st)
Carmencita Acedera = 10 yrs
Agnes Medenilla & Felix Asprer = 2 non-consecutive terms
Shirley Cruzada = president (‟02-‟06)
Leila Florento = present president
BB head may employ 500 blood typing, collection & processing per month
>1 min. req. personnel100 units of blood service/month
for every addition of:
PD 498 Med Tech was changed to Practice of Med Tech
Final label of blood Expiration date
bag before issuing ABO, Rh type
Storage temp
PD 1534 Designates the chairman of MT as member of the council
RA 5527
Prescribed form for Name, citizenship, domicile of the head
the application of Scope & nature of work to be undertaken
license contains Name of establishment
Licensed physicians After 3 months of training in:
may be qualified in a. QC
areas where b. Lab medicine
pathologists are not c. Lab management
sufficient:
1 Minimum required number of MT‟s in BB screening 200 donors
& performing 400 typing & x-matching per month
DOH Agency authorized to give QC test
Imprisonment for 10 Dispensing, transfusing & failing to dispose HIV-
yrs contaminated blood
PRC Made up of 1 chairman and 2 members

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Each BB should Blood components utilized
report to the BRL the Volume of blood collected & issued
ff data: No. of x-matches done
Perpetual Inexcusable failure to surrender a suspended/revoked COR
disqualification from w/in the required period of time
the practice of MT
48 hrs Disposal time for blood contaminated w/ transfusion-
transmitted diseases
HIV-reactive samples Confirm to SLH
(screening)
MLT Assist MT and/or pathologist in the practice of MT
2/3 or 3/3 votes Penalty of suspension
Surgical pathology Signed by a pathologist
report
60 CPE units Renewal of MT license
Contact tracing Finding & counseling the sexual partner/s of a person w/ STD
Anonymous testing HIV testing whereby the individual being tested does not
reveal his/her true identity
Post test counseling Providing high risk reduction information & emotional support
to the person who submitted to HIV testing
High risk behavior Person‟s frequent involving in certain activities w/c increases
the risk of transmitting/acquiring HIV
10 Maximum number of DT lab a physician can handle
Clients for Applicants for driver‟s license
Mandatory Drug Applicants for firearms license
testing Military, police & law-enforcing agencies
w/ criminal offense
Candidates for public office
Clients for Random Students (2‟ & 3‟ schools)
Drug testing Officers & employees of public or private offices (domestic
or overseas)
Testator Makes legacy of all part of his body
Decedent Any deceased individual (stillborn infant or fetus)
Recall Locating a newborn w/ possible heritable condition
RA 1517 Prevent improper collection, processing & sale of human blood
or its product to the public
Chain of custody Information identifying the specimen
contains: Date & time of collection
Name & signature of all individuals who had custody of the
sample during the collection process
Name of the drug testing laboratory
1 yr Validity of the test result performed by drug testing centers
CC lab reports Keep for at least 1yr
BB physician Terminate service/transfer supervision à inform the BRL
w/in 15 days
Records of QA Date of testing
testing Personnel involved

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Source & lot no. of reagents tested

All lab information Confidential  divulged only to the attending physician


PNRI Authorized body for matters concerning nuclear/radioactive
wastes

Code Of Ethics (New)


As I enter into the practice of MT, I shall:
a. accept (a) the (b) inherent to being a (c)
b. responsibilities
c. professional
a. uphold (a) the (b) and shall not (c) in illegal work
b. law
c. participate
a. act (a) in a (b) of (c) to all and in a spirit of (d) toward
b. strict spirit other members of the (e)
c. fairness
d. brotherhood
e. profession
a. one employer Accept employment from more than (a) only when
b. no conflict of there is (b)
interest
a. advancement Contribute to the (a) of the professional
b. allied health organization and other (b) organization
a. praises Restrict my (a), (b), views and opinions w/in (c)
b. criticisms
c. constructive
limits
a. strictly Treat any information I acquired in the course of
confidential my work as (a)
a. dignity Uphold the (a) and (b) of my profession and
b. respect conduct myself a (c) of (d), (e), and (f)
c. reputation
d. reliability
e. honesty
f. integrity
a. dedicated Be (a) to the use of (b) to promote (c) and benefit
b. clinical lab (d)
science
c. life
d. mankind
a. violations Report any (a) of the above principles of the (b) to
b. professional authorized agency & to the (c) of the organization
conduct
d. ethics
committee

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a. principles To these (a), I hereby (b) and (c) to (d) myself at
b. subscribe all times in a manner (e) the (f) of my (g)
c. pledge
d. conduct
e. befitting
f. dignity
g. profession

Panunumpa ng Propesyonal
a. ako (a), si (b) ng (c) ay taimtim na nanunumpa na
b. pangalan itataguyod ko at ipagtatanggol ang (d)
c. tirahan
d. saligang batas
ng Pilipinas
a. Medikal … at matapat kong gagampanan ng buong husay sa
Teknolohist abot ng aking makakaya ang mga tungkulin at
pananagutang iniatang sa isang itinakda na (a)
a. Diyos Kasihan nawa ako ng (a)

Panunumpa ng Kasapi
a. Maykapal … patnubayan nawa ako ng (a)

Medical Technologist’s prayer


a. O (a) (b), who, by calling…
b. God … through the (c), Christ, our Lord, (d)
c. Eternal
physician
d. Amen

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