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10.-MUST-to-KNOW-in-Medical-Technology-Laws-Ethics

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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
Section 31
Repealing clause
Section 32
Effectivity
House Bill No. 4032
Cong. Janette Garin
Page | 289
Senate Bill 2722
Section 2: Definition of
Terms
Section 3: COMT
Leila Florento
Bernard Ebuen
Section 5: Functions of
COMT
Section 6: Minimum
required course
Section 7: BOMT
Section 8: Qualification of
board members
Section 9: Executive officer
of the board
Section 11: Functions of
BOMT
2/28/11
Sen. Edgardo Angara
May & November = MT board exams
September = Phlebotomy board exams
Exclusive for MT only:
-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
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)
PAMET president
PASMETH president (May 2012)
Dean, Arellano university
Recommend minimum required curriculum
Det. MT students
Approve MT schools
Recommend & formulate refresher course (3x failed the exam)
RA 5527 = BSMT
- 4 yr course including 12 mos. internship
CMO #14 s. 2006
- policies, standards & guidelines for MT education
- MLS = 6 mos. internship
Chair: Dr. Marietta Baccay (Pathologist)
Members:
- Marilyn Atienza, RMT
- Marian Tantingco, RMT
Appointed by the President of the Philippines
Term of office = 3 years
Filipino citizen
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
PRC commissioner
RA 8981: PRC modernization act of 2000
- PRC Chairperson (highest position) = Teresita Manzala
Administer provision of RA 5527
Administer oath taking
Page | 290
Section 12: Removal of
board members
Section 13: Accreditation
of MT schools & training
lab (1978)
Section 14: Inhibition of
practice of MT
Section 15: Examination
CMO #6 s. 2008
Section 16: Qualification
for examination
Section 17: Scope of
examination
Section 18: Report of
rating
Section 19: Rating in the
exam
Section 20: Oath taking
Section 21: Issuance of
COR
Issue, suspend or revoke COR
Investigate violations to RA 5527
Neglect of duty
Malpractice
Immoral conduct
Can only be removed by the President of the Philippines
MT schools = DepEd à CHED
Training lab = BRL à BHFS
Registration is not required:
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
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
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
Good moral character
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
20% = Clinical Chemistry
20% = Hematology
20% = Microbiology/Parasitology
20% = Immunology, Serology & Blood Banking
10% = Clinical Microscopy
10% = Histotechniques, Medical Technology Laws & Ethics
RA 5527: BOMT ---(120 days)---> PRC
RA 8981: Report result w/in 10 days
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)
- 12 mos. refresher course in an accredited MT schools, or
- 12 mos. postgraduate training in an accredited lab
Administered by the BOMT or any person authorized by the board
To successful applicant: 21 y.o.
Signed by 4 persons:
a. BOMT (3)
b. PRC chairperson
Displayed at workplace
Page | 291
COR as MT w/o exam
COR as MLT
1 RMT
Section 23: Refusal to issue
COR
Section 24: Administrative
investigation
Section 27: Foreign
reciprocity
Section 28: Roster of MT
Section 29: Penal
provisions
Section 30: Separability
clause
Section 31: Repealing
clause
Section 32: Effectivity
RA 4688
AO 2007-0027
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
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%
Can handle 2 MLTs
(1:2 ratio)
Convicted by the court
Unsound mind
Incurable communicable disease
Revocation or suspension
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
No foreigner is allowed to practice MT unless reciprocity has been established
In subjected country/state, allow Filipino MT to practice profession
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
Violations:
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
If any provision of RA 5527 is declared invalid, the rest will not be affected
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)
6/21/69
President Ferdinand Marcos
RA 4688
Clinical lab act of 1966
6/18/66
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
Page | 292
Classification of
laboratories
1’ laboratory
2’ laboratory
3’ laboratory
Limited service capability
lab
Special lab
STAT
General requirements
(Lab)
Specific requirements
(Lab)
b. Malarial smear
c. Screening for STDs & cervical cancer (Pap’s)
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
Routine hematology: Hgb, Hct, WBC, WBC differential
Routine UA & FA
Qualitative platelet
Blood typing (hospital-based)
1’ lab plus the ff:
Quantitative platelet
Cross-matching
Gram stain/KOH
Routine chemistry: Glucose, urea, uric acid, cholesterol
2’ lab plus the ff:
Special chemistry
Special hematology: coagulation studies
Immunology and serology
Culture and sensitivity
Examples:
Lab in dialysis center
Social hygiene lab clinic
Molecular biology
Assisted reproductive technology
“Statim”
Immediately w/in 1 hr
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
1. Human resource
- Head: Pathologist
- Staff: RMTs
2. Equipment
3. Reagent & supplies
4. Physical plan:
- Well-lighted, well-ventilated,  supply of H2O
Page | 293
Mobile lab
License (Lab)
Renewal of license
Violation
RA 1517
RA 7719
Implementing guidelines
(BB)
Category A (BB)
Category B (BB)
BB
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)
Collect specimens
Allowed to operate w/in 100 km radius from main lab
License no.
Validity
Name of lab
Owner
Head
Location
Service capability
Nonhospital-based lab: October-November
Processed not later than 5 days after expiration
Fine of P1,000-5,000
Imprisonment for not less than 1 month
RA 1517
BB law of 1956
6/16/56
Amendment of RA 1517
Nat’l blood services act of 1994
5/5/94
Promote voluntary blood donation
Phase-out commercial BB
AO #9 s. 1995
AO #17 s. 1998
Health education & counseling
Donor screening & selection
Provision, storage, issuance & transport & distribution of WB & pRBC
Compatibility testing
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
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
Page | 294
AO 2008-0058
RA 8504
PNAC
AIDS WATCH
HIV report issued to:
RA 9288
NBS
PD 223
RA 8981
Composition of PRC
- 1 Off
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
Philippine AIDS prevention & control act of 1998
02/13/98
52 sections
Nationwide AIDS education & information program
Philippine National AIDS Council
- responsible for the provision of RA 8504
- 26 members
- Permanent Chair: DOH Secretary
Monitors the magnitude of HIV infection in the Philippines
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
Newborn screening act of 2004
4/07/04
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
Creation of PRC
6/22/73
Amendments:
a. PD 657
b. RA 8981 = latest
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)
Appointed by the President of the Philippines
Term of office: 7 yrs
Page | 295
Qualifications (PRC)
RA 10069
Board exams
Nardito Moraleta
Norma Chang
Charlemagne Tamondong
Carmencita Acedera
Hector Gentapan Gayares
Jr.
Francis Jerota Pefanco
PAMET Office
RA 1517 Section 14
RA 4688 Section 20
CPE
200 CPE units
PRC resolution no. 217
PRC resolution no. 332
PRC resolution no. 428
PRC resolution no. 381
PRC resolution no. 323
CHED
Research lab
Malarial screening lab
PAMET
Every 3 years
Every 2 years
DOH
EO 266
EO 200
AUP (Old: PUC)
Manila Advenstist Medical
Center
Chairperson: Teresita Manzala
Commissioners (2):
- Alfredo Po
- Jennifer Manalili
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
Health worker’s day (May 7)
Postponed exam:
a. Epidemics
b. Public calamities (25% of examiners are absent)
Set A & B exams: same questions but different in arrangement
Professionalized the MT course
Worked for the approval of RA 5527
Wrote the 1st MT code of ethics on 8/6/68
Revised the MT code of ethics on 3/7/97
PAMET president but not BSMT graduate
Approved the 2nd (present) COE
Wrote the PAMET hymn
Created the melody & music of the PAMET hymn
Cityland 10 Tower 2 Condominium Unit 1720, 6187 bldg, Ayala North, Makati
City
Color of the blood label according to blood type
A = Yellow
B = Pink
AB = White/Black/Gray
O = Blue
QC
PRC resolution no. 167
Author of MT books
Delisting of the names of delinquent professionals from its rolls
Rules & regulations governing the regulation & practice of professionals
Removal of names of professionals… delinquency in paying their fees
Standardization policies… CPE
Foreigners are not allowed to take licensure exams in the Philippines
Approved the curriculum of MT
Does not need a license
Exempted from securing license from BHFS
National organization of all MT
Renewal of license (RMT)
Inspection of laboratories by BHFS
Approves lab’s for accreditation as training lab for MT students
Institutionalization of the CPE programs under PRC supervision
Full computerization of licensure exams
1st school to offer MT course in the Philippines
Approved by DepEd – 1953
1st complete set of lab sections
Page | 296
Antoinette McKelvey
Wilma Hilgert-Hedrick
Shirley Cruzada
Dr. Pio de Roda
Dr. Sta. Ana
Resolution 93-268
RA 5527 Sections 19 & 27
BOMT
RA 5527
RA 1517
RA 7719
RA 8504
RA 9288
RA 4688
AO 2007-0027
RA 8981
RA 6425
RA 9165
PD 856
AO 1979-0031
RA 7170
AO 2008-0007
James Todd
Dr. Jesse Umali
Nicolas Lapeña
6/14/61
PASMETH
PAMET
Newly trained lab worker under Dr. Papanicolau
Micro/para & histopath in the Philippines
1st MT curriculum to be used for BSMT
Founder of MT education in the Philippines
Immediate past president of PAMET now
Screening drug testing lab be handled jointly by DOH-NRL & PAMET
Started training of lab workers in the Philippines at Public Health lab
Mass oath taking
Not amended
w/ authority to change, add or remove subjects in the licensure exam
MT Act
6/21/69
BB law
6/16/56
National blood services act
5/5/94
HIV/AIDS act
2/13/98
NBS act
4/7/04
Clin. lab act
6/18/66
Revised rules & regulations… clinical lab
8/22/07
PRC modernization act
12/05/00
Drugs act (old)
Drugs act (latest)
1/13/03
Sanitation
Water testing lab
Organ donation act
1/7/92
Schedule of fees for the licensure of general clinical lab and the registration of
special clinical lab
A manual of clinical diagnosis  Clinical diagnosis by lab methods (19th ed.)
1st graduate of PUC
OB-Gyne, owner of Omega Lab
Past PRC chairperson
Full recognition of 4-yr BSMT
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)
Organized by Crisanto almario (9/15/63)
9/20/64 = 1st national convention (FEU)
Charlemagne Tamondong = 1st president
Page | 297
BB head may employ >1
min. req. personnel for
every addition of:
PD 498
Final label of blood bag
before issuing
PD 1534
RA 5527
Prescribed form for the
application of license
contains
Licensed physicians may
be qualified in areas where
pathologists are not
sufficient:
1
DOH
Imprisonment for 10 yrs
PRC
Each BB should report to
the BRL the ff data:
Perpetual disqualification
from the practice of MT
48 hrs
HIV-reactive samples
(screening)
MLT
2/3 or 3/3 votes
Surgical pathology report
60 CPE units
Contact tracing
Anonymous testing
Post test counseling
High risk behavior
10
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
500 blood typing, collection & processing per month
100 units of blood service/month
Med Tech was changed to Practice of Med Tech
Expiration date
ABO, Rh type
Storage temp
Designates the chairman of MT as member of the council
Name, citizenship, domicile of the head
Scope & nature of work to be undertaken
Name of establishment
After 3 months of training in:
a. QC
b. Lab medicine
c. Lab management
Minimum required number of MT’s in BB screening 200 donors & performing
400 typing & x-matching per month
Agency authorized to give QC test
Dispensing, transfusing & failing to dispose HIV-contaminated blood
Made up of 1 chairman and 2 members
Blood components utilized
Volume of blood collected & issued
No. of x-matches done
Inexcusable failure to surrender a suspended/revoked COR w/in the required
period of time
Disposal time for blood contaminated w/ transfusion-transmitted diseases
Confirm to SLH
Assist MT and/or pathologist in the practice of MT
Penalty of suspension
Signed by a pathologist
Renewal of MT license
Finding & counseling the sexual partner/s of a person w/ STD
HIV testing whereby the individual being tested does not reveal his/her true
identity
Providing high risk reduction information & emotional support to the person
who submitted to HIV testing
Person’s frequent involving in certain activities w/c increases the risk of
transmitting/acquiring HIV
Maximum number of DT lab a physician can handle
Page | 298
Clients for Mandatory Drug
testing
Applicants for driver’s license
Applicants for firearms license
Military, police & law-enforcing agencies
w/ criminal offense
Candidates for public office
Clients for Random Drug
testing
Testator
Decedent
Recall
RA 1517
Students (2’ & 3’ schools)
Officers & employees of public or private offices (domestic or overseas)
Makes legacy of all part of his body
Any deceased individual (stillborn infant or fetus)
Locating a newborn w/ possible heritable condition
Prevent improper collection, processing & sale of human blood or its product
to the public
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
Chain of custody contains:
1 yr
CC lab reports
BB physician
Records of QA testing
All lab information
PNRI
Validity of the test result performed by drug testing centers
Keep for at least 1yr
Terminate service/transfer supervision à inform the BRL w/in 15 days
Date of testing
Personnel involved
Source & lot no. of reagents tested
Confidential  divulged only to the attending physician
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
b. law
c. participate
(a) the (b) and shall not (c) in illegal work
a. act
b. strict spirit
c. fairness
d. brotherhood
e. profession
(a) in a (b) of (c) to all and in a spirit of (d) toward other members of the (e)
a. one employer
b. no conflict of interest
a. advancement
b. allied health
a. praises
b. criticisms
c. constructive limits
Accept employment from more than (a) only when there is (b)
a. strictly confidential
Treat any information I acquired in the course of my work as (a)
Contribute to the (a) of the professional organization and other (b)
organization
Restrict my (a), (b), views and opinions w/in (c)
Page | 299
a. dignity
b. respect
c. reputation
d. reliability
e. honesty
f. integrity
Uphold the (a) and (b) of my profession and conduct myself a (c) of (d), (e),
and (f)
a. dedicated
b. clinical lab science
c. life
d. mankind
Be (a) to the use of (b) to promote (c) and benefit (d)
a. violations
b. professional conduct
d. ethics committee
Report any (a) of the above principles of the (b) to authorized agency & to the
(c) of the organization
a. principles
b. subscribe
c. pledge
d. conduct
e. befitting
f. dignity
g. profession
To these (a), I hereby (b) and (c) to (d) myself at all times in a manner (e) the
(f) of my (g)
a. ako
b. pangalan
c. tirahan
d. saligang batas ng
Pilipinas
a. Medikal Teknolohist
Panunumpa ng Propesyonal
(a), si (b) ng (c) ay taimtim na nanunumpa na itataguyod ko at ipagtatanggol
ang (d)
… 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)
a. Maykapal
Panunumpa ng Kasapi
… patnubayan nawa ako ng (a)
a. O
b. God
c. Eternal physician
d. Amen
Medical Technologist’s prayer
(a) (b), who, by calling…
… through the (c), Christ, our Lord, (d)
Page | 300
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