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

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 | 1

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 | 2

Section 12: Removal of board members Section 13: Accreditation of MT schools & training lab (1978) Section 14: Inhibition of practice of MT

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 aà CHED Training lab = BRL aà 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 Section 15: Examination 2x/year ♫ PRC RA 8981: Report result w/in 10 days Section 19: Rating in the To pass: 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 taking Administered by the BOMT or any person authorized by the board Section 21: Issuance of To successful applicant: 21 y.o. COR Signed by 4 persons: a. BOMT (3) b. PRC chairperson Displayed at workplace Page | 3

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 | 4

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 | 5

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 | 6

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 | 7

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 | 8

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 Lapenñ a 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 | 9

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 | 10

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 aà 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 (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 b. no conflict of interest a. advancement b. allied health a. praises b. criticisms c. constructive limits a. strictly confidential

Accept employment from more than (a) only when there is (b) Contribute to the (a) of the professional organization and other (b) organization Restrict my (a), (b), views and opinions w/in (c)

Treat any information I acquired in the course of my work as (a)

Page | 11

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)

a. Diyos

… at matapat kong gagampanan ng buong husay sa abot ng aking makakaya ang mga tungkulin at pananagutang iniatang sa isang itinakda na (a) 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 | 12