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

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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

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 of Terms Exclusive for MT only:

-Exam of excretions/secretions/tissues

-BB procedures & techniques

-Micro/para procedures & techniques

-Histopathology, cytotechniques

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-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

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 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 of COMT Recommend minimum required curriculum

Det. MT students

Approve MT schools

Recommend & formulate refresher course (3x failed the exam)

Section 6: Minimum required RA 5527 = BSMT

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: Qualification of board Filipino citizen

members
Good moral character

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 officer of PRC commissioner

the board
RA 8981: PRC modernization act of 2000

- PRC Chairperson (highest position) = Teresita Manzala

Section 11: Functions of BOMT Administer provision of RA 5527

Administer oath taking

Issue, suspend or revoke COR

Investigate violations to RA 5527

Section 12: Removal of board Neglect of duty

members
Malpractice

Immoral conduct

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 Can only be removed by the President of the Philippines

Section 13: Accreditation of MT MT schools = DepEd à CHED

schools & training lab (1978)
Training lab = BRL à BHFS

Section 14: Inhibition of practice Registration is not required:

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: Examination 2x/year

♫ <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: Qualification for Good moral character

examination
Graduate of BSMT or PH

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

20% = Immunology, Serology & Blood Banking

10% = Clinical Microscopy

10% = Histotechniques, Medical Technology Laws & Ethics

Section 18: Report of rating RA 5527: BOMT ---(120 days)---> PRC

RA 8981: Report result w/in 10 days

Section 19: Rating in the exam To pass:

- 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)

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 - 12 mos. refresher course in an accredited MT schools, or

- 12 mos. postgraduate training in an accredited lab

Section 20: Oath taking Administered by the BOMT or any person authorized by the board

Section 21: Issuance of COR To successful applicant: 21 y.o.

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 to issue COR Convicted by the court

Unsound mind

Incurable communicable disease

Section 24: Administrative Revocation or suspension

investigation
Done by at least 2 members of the board + 1 legal officer = 3

a. Revocation = Unanimous vote (3/3)

b. Suspension = Majority vote (2/3) = shall not exceed 2 yrs

Section 27: Foreign reciprocity No foreigner is allowed to practice MT unless reciprocity has been established

In subjected country/state, allow Filipino MT to practice profession

Section 28: Roster of MT Prepared annually by the secretary of the board

a. Name of RMT

b. Date of registration

c. Address

d. Other important information

Open to the public

Section 29: Penal provisions Violations:

a. Practice MT w/o COR

b. Practice MT w/o supervision of a pathologist

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 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: Separability clause If any provision of RA 5527 is declared invalid, the rest will not be affected

Section 31: Repealing clause RA 5527 amends all rules & regulations & executive orders 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: Effectivity 6/21/69

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 laboratories 1. Ownership

- 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

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 Routine UA & FA

Qualitative platelet

Blood typing (hospital-based)

2’ laboratory 1’ lab plus the ff:

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 capability lab Examples:

Lab in dialysis center

Social hygiene lab clinic

Special lab Molecular biology

Assisted reproductive technology

STAT “Statim”

Immediately w/in 1 hr

General requirements (Lab) 1. LTO from BHFS

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 requirements (Lab) 1. Human resource

- Head: Pathologist

- Staff: RMTs

2. Equipment

3. Reagent & supplies

4. Physical plan:

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 - 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

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 guidelines (BB) AO #9 s. 1995

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

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 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

- 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

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 - 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

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Qualifications (PRC) At least 40 yrs old

w/ valid COR as professional license

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 Tamondong PAMET president but not BSMT graduate

Carmencita Acedera Approved the 2nd (present) COE

Hector Gentapan Gayares Jr. Wrote the PAMET hymn

Francis Jerota Pefanco Created the melody & music of the PAMET hymn

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. 217 Delisting of the names of delinquent professionals from its rolls

PRC resolution no. 332 Rules & regulations governing the regulation & practice of professionals

PRC resolution no. 428 Removal of names of professionals… delinquency in paying their fees

PRC resolution no. 381 Standardization policies… CPE

PRC resolution no. 323 Foreigners are not allowed to take licensure exams in the Philippines

CHED Approved the curriculum of MT

Research lab Does not need a license

Malarial screening lab Exempted from securing license from BHFS

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PAMET National organization of all MT

Every 3 years Renewal of license (RMT)

Every 2 years Inspection of laboratories by BHFS

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 Medical 1st complete set of lab sections

Center

Antoinette McKelvey Newly trained lab worker under Dr. Papanicolau

Micro/para & histopath in the Philippines

Wilma Hilgert-Hedrick 1st MT curriculum to be used for BSMT

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 Health lab

Dr. Sta. Ana

Resolution 93-268 Mass oath taking

RA 5527 Sections 19 & 27 Not amended

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

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 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

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 >1 min. 500 blood typing, collection & processing per month
req. personnel for every addition
of: 100 units of blood service/month

PD 498 Med Tech was changed to Practice of Med Tech

Final label of blood bag before Expiration date

issuing

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 ABO, Rh type

Storage temp

PD 1534 Designates the chairman of MT as member of the council

RA 5527

Prescribed form for the Name, citizenship, domicile of the head

application of license contains
Scope & nature of work to be undertaken

Name of establishment

Licensed physicians may be After 3 months of training in:

qualified in areas where
pathologists are not sufficient: a. QC

b. Lab medicine

c. Lab management

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 yrs Dispensing, transfusing & failing to dispose HIV-contaminated blood

PRC Made up of 1 chairman and 2 members

Each BB should report to the Blood components utilized

BRL the ff data:
Volume of blood collected & issued

No. of x-matches done

Perpetual disqualification from Inexcusable failure to surrender a suspended/revoked COR 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 (screening) Confirm to SLH

MLT Assist MT and/or pathologist in the practice of MT

2/3 or 3/3 votes Penalty of suspension

Surgical pathology report Signed by a pathologist

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 Mandatory Drug Applicants for driver’s license

testing
Applicants for firearms license

Military, police & law-enforcing agencies

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 w/ criminal offense

Candidates for public office

Clients for Random Drug testing Students (2’ & 3’ schools)

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 contains: Information identifying the specimen

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 testing Date of testing

Personnel involved

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 other members of the (e)
b. strict spirit
c. fairness
d. brotherhood
e. profession

a. one employer Accept employment from more than (a) only when there is (b)
b. no conflict of interest
a. advancement Contribute to the (a) of the professional organization and other (b) organization
b. allied health
a. praises Restrict my (a), (b), views and opinions w/in (c)
b. criticisms
c. constructive limits

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a. strictly confidential Treat any information I acquired in the course of my work as (a)
a. dignity Uphold the (a) and (b) of my profession and conduct myself a (c) of (d), (e), and (f)
b. respect
c. reputation
d. reliability
e. honesty
f. integrity

a. dedicated Be (a) to the use of (b) to promote (c) and benefit (d)
b. clinical lab science
c. life
d. mankind

a. violations Report any (a) of the above principles of the (b) to authorized agency & to the (c) of the
b. professional conduct organization
d. ethics committee

a. principles To these (a), I hereby (b) and (c) to (d) myself at all times in a manner (e) the (f) of my (g)
b. subscribe
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 itataguyod ko at ipagtatanggol ang (d)
b. pangalan
c. tirahan
d. saligang batas ng Pilipinas
a. Medikal Teknolohist … at matapat kong gagampanan ng buong husay sa 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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