MEDICAL TECHNOLOGY LAWS Professor Rodolfo R. Rabor June 7, 2016
1. Why does MT perform laboratory test? To diagnose To treat To maintain health 2. Who brought MT practice to the Philippines? US Army 1945 – establish the 1st clinical laboratory in the Philippines (Quiricada, Sta. Cruz) After war, closed! Dr. Pio De Roda – reopened (2nd laboratory – Manila Public Health) Offered non-formal training Formal training (for 6 months – issued Certificate of Completion) Followed SYLLABUS – Dr. Prudencia Sta. Ana 3. Who is the founder of MT education in the Philippines? Dr. Willa Hilgert Hedrick 1954 – PUC in cooperation with Manila Sanitarium Hospital, Baesa, QC - Offer the 1st BSMT - MT as elective subject (BS Pharma Curriculum) 1956 – BSMT course Dr. Jesse Umali – 1st BSMT course (PUC) 4. What is the difference between PAMET and PASMETH? PAMET (Philippine Association of Medical Technologists) – RMT professionals PASMETH (Philippine Association of Schools of Medical Technology and Public Health) – association of schools offering MT 5. What is RA 5527? Philippine Medical Technology Act of 1969 1. Laboratory worker ---- Professional 2. Laboratory work ---- Profession 1. Difference between occupation & profession? 2. Difference between skilled worker & professional? 3. Difference between MT & Laboratory Technician Laboratory worker – skilled worker without license Professional – with formal education, training & license 6. How many sections in RA 5527? 32 sections 1: Title 2: Definition of terms 29: Penal Provisions 32: Effectivity
7. President who signed RA 5527? President Ferdinand Marcos June 21, 1969 8. Exclusive practices of RMT professionals? Analysis of blood, urine & other secretions as well as from biological specimen Bacteriologic, Mycologic, Parasitologic Examination Histopathology, Cytotechnology Blood Banking Non-exclusive practices of RMT professionals? Specimen collection Clinical Research involving patients Quality Control Preparation & Standardization of Reagents 9. What government agency recognizes school of MT? CHED (Commission on Higher Education) Permit to offer BSMT Recognized status: Performance of 1st batch licensure examination = national passing rate Accredited: 1. PACUCOA (Philippine Association of Colleges and Universities Commission on Accreditation) 2. PAASCU (Philippine Accrediting Association of Schools, Colleges and Universities) 10. What government agency accredits MT training laboratory? CHED (Commission on Higher Education) Before: DOH (Department of Health) MT training - the last year of course 1. Hospital laboratory 2. Tertiary category laboratory 11. Composition of Board of MT (BOMT)? 3/Three 1: Pathologist - Dr. Marietta C. Baccay 2: RMTs – Ms. Marian M. Tantingco - Ms. Marilyn R. Atienza 12. What are the qualifications of the members of the board? Filipino citizen Good moral character Graduate of BSMT/BSPH (Recognized school) Holder of RMT license (Atleast 9 years) Not a faculty of School of MT No direct/indirect interest SMT What is the term of office of BOMT? ---- 3 years without reappointment but may be extended 13. What are the grounds of removal of the members of BOMT? Incompetence Malpractice/Corruption
Death & Physical Disability Convicted by court (Immoral, Unethical, Unprofessional Conduct)
14. Who are not inhibited against the practice of MT? Licensed Physician Foreign Consultants US Air Force 15. Qualifications of admission to the licensure examination? Graduate of BSMT/BSPH Filipino citizen Good moral character 16. What is the scope of licensure examination? Major: 20% (Chemistry, Hematology, ISBB, Bacte/Para) Minor: 10% (CM, Histopathology/MT Laws) 17. How can a candidate pass a licensure examination? Weighted average – 75% & above No grade less than 50% in Major subject No failure 60% 18. After 3 failures, how can a candidate qualify for the licensure examination? REFRESHER COURSE 1. Choose either 1 year internship or 2. 1 year professional subjects 19. How many exams are given to 1 candidate? 3/Three How may one be a medical laboratory technician? 1. Works under RMT 2. Grade of 70-74.9 1964 – 1st and only exam for laboratory technician 20. What is the age requirement to be issued a RMT license? 21 years old 21. Why does the board refuse to issue a license to a candidate? Underage Unsound mind Common disease Convicted by court (Immoral, Unethical, Unprofessional Conduct) 22. Who may conduct an administrative investigation of a RMT? 2 members of BMOT 1 legal officer 1. UNANIMOUS VOTE: 3/3 agreed = to impose penalty of revocation 2. MAJORITY VOTE: 2/3 agreed = to impose penalty of suspension 3. 1 VOTE: verbal/written reprimand = warning
23. Difference between Penalty of Suspension & Penalty of Revocation? Penalty of Suspension – maximum of 2 years Penalty of Revocation – lifetime 24. If Penalty of Suspension &/or Penalty of Revocation is imposed to a MT professional, what must he do? If he fails to do it, what is the punishment? Surrender Certificate of Registration (COR) within 30 days If he failed to do it, Perpetual Disqualification 1. COR = only once (display in work area) 2. ID = renewal once in 3 years 25. After Penalty of Suspension has been served, how can a professional be reinstated as RMT? Written request 26. What are considered illegal practices of RMT? Work without Pathologist Work without valid license (unexpired, renewed) Making fraudulent laboratory report False advertisement Impersonation Submitting fake documents to secure a license Employing MTs, Technicians or Laboratory Technicians who are not registered Failure to display COR in the work area *All are enumerated in Section 29 27. What is foreign reciprocity? Mutual understanding of 2 countries regarding MT 28. How many employers may RMT have? 2/Two 29. To whom do we report illegal practices of MT profession? Report to authorities Report to ethics committee 30. What is the law that created PRC? What are the roles of PRC? PD 223 PRC = under the office of the President 1. PRB (Professional Regulatory Boards) – administer licensure exam 2. CPEC (Continuing Professional Education Council) – renewal of license OLD: Professional practice = supervised by Civil Service Commission (CSC) NOW: Professional practice divided into 2: 1) Private practice – supervised by PRC 2) Government practice – supervised by CSC
31. What is TOS? Table of Specifications 32. What is CPE? Continuing Professional Education 33. For RMT, what are the required units of CPE for the renewal of license? 60 units – MT 30 units – Laboratory Technician 34. What is RA 4688? Clinical Laboratory Law 35. 3 types of laboratory according to function? Clinical Pathology Laboratory – blood, urine, CSF (usual) Anatomic Pathology Laboratory – tissues, organs (biopsy, autopsy) Forensic Pathology Laboratory – medicolegal examinations (not popular in the Philippines) 36. Who may manage a clinical laboratory? Authorized/licensed Physician Pathologist 37. Service capabilities of primary, secondary & tertiary laboratories? 1◦ - basic laboratory, routine tests (CBC, fecalysis, UA, GS) 2◦ - 1◦ tests plus chemistry tests 3◦ - 2◦ tests plus culture & sensitivity as well as special tests
1◦
Free Standing (outside the hospital) Pathologist
2◦
Pathologist
3◦ Pathologist *Maximum of 4 laboratories
Hospital Based
Licensed Physician Inadequate Pathologist = Licensed Physician Adequate Pathologist = Pathologist Pathologist
38. What is RA 7719? National Blood Services Act of 1994 Before: RA 1517 – Blood Banking Law of 1956 (old BB law) 1. 2 kinds of Blood Bank Private/Commercial Government Blood Bank 2. 2 kinds of blood donor Professional/Paid donors Voluntary donors Repealed by RA 7719 (new BB law) – with policies & guidelines 1. Only recognizes 1 BB
Government Blood Bank Commercial/Private BB should be close 2. Only voluntary donors are accepted Walk-In donors Replacement donors 39. What are the kinds of blood donors? Type of donors encouraged by government? 40. Kind of BB phased out by RA 7719? 41. What is RA 8504? Philippine HIV/AIDS Law – prevention & control of HIV/AIDS 42. How can HIV/AIDS paralyze the immune system? A retrovirus infecting/kills T helper cells = T helper count decreases T helper cells convert B cells to plasma cells to produce antibodies What are the common methods of HIV transmission? Sexual intercourse Blood transfusion Perinatal transmission Parenteral transmission 43. What is AIDSWATCH? What is Pink Ribbon Society? AIDSWATCH – maintains statistics of AIDS Pink Ribbon Society – community of AIDS patients 44. What is anonymous testing? Owner of the specimen is not known 45. Difference between RA 6425 & RA 9165? RA 6425 – Comprehensive Drugs Act of 1972 RA 9165 – Comprehensive Drugs Act of 2002 46. What is the validity of drug test result? 1 year 47. Difference between mandatory & random drug testing? Mandatory – Police, Armed Forces, Candidate in Election, Fire Arms License Random – Students, Interns 48. Difference between screening & confirmatory drug testing laboratory in terms of capability? In terms of personnel? Screening – result is POSITIVE or NEGATIVE - MT, Pharma, Chemist Confirmatory – Qualitative & Quantitative - should always have Chemist 49. What is RA 7170? Organ Donation Act
What are the transplantable parts of the body? Kidney Heart Liver Eyes Bones 50. What is immediate family? Decides if the body or parts will be donated or not 1. Spouse 2. Children 3. Parents 4. Siblings 5. Relatives 51. How can one execute a legacy to donate part of his body? 18 years old with sound mind 52. What is RA 9288? Newborn Screening Act of 2004 NBs should be screened on heritable conditions. Performed after 24 hours of life but not later than 3 days Exemption: NBs in ICU – 7 days/1 week 53. How can one refuse NB screening? What are the results of undetected & untreated heritable conditions: Religious beliefs Results of undetected & untreated heritable conditions: 1. May Die/death 2. Physical deformities 3. Mental retardation 54. What is the minimum requirement for technical staff of Hospital Category A BB? Hospital Category B BB? A = 4 (1 am, 1 pm, 1 night, 1 off) B = 5 (2 am, 1 pm, 1 night, 1 off) 55. What is National Blood Services Program Committee? Committee that implements the voluntary blood donations 56. What is the composition of the Hospital Blood Transfusion Committee? QC officer (RMT), hematologist, Hospital Training Officer, Attending Physician, Nurse 57. Who is the head of BB? Licensed Physician/Pathologist Technical staff members? RMT & 1 recruitment officer (Nurse, RMT, MD) 58. What type of BB is to be phased out by RA 7719? Commercial/Private BB
59. What are the sources of funds for the NVBSP? NVBSP - National Voluntary Blood Services Program 1. Government 2. PAGCOR (Philippine Amusement and Gaming Corporation) 3. PCSO (Philippine Charity Sweepstakes Office) 4. Duty Free Shop 60. What is the kind of blood donor encouraged by the government? Voluntary donors (Walk-In & Replacement donors) 61. What are the lead agencies for professional education of voluntary blood donation? PAMET (Philippine Association of Medical Technologists) PNA (Philippine Nurses Association) PSHBT (Philippine Society of Hematology and Blood Transfusion) PSP (Priority Setting Partnership) 62. What are the lead agencies for public education of voluntary blood donation? PBCC (Philippine Blood Coordinating Council) PNRC (Priority Setting Partnership) DOH (Department of Health) 63. What are the blood transmissible diseases? HIV, Syphilis, Malaria, Hepatitis B, Hepatitis C 64. What old law is repealed by National Blood Services Act of 1994? RA 1517 repealed by RA 7719 65. What is the National Blood Services Act of 1994? RA 7719 66. How many members are there in PNAC? Who is the permanent Chairperson of the PNAC? Vice Chairperson? Philippine National AIDS Council – groups of people helping in the prevention of HIV/AIDS 26 members Chairperson: DOH Secretary Vice Chairperson: anyone from the other members 67. Who is the overseer of an integrated & comprehensive approach to HIV/AIDS prevention & control? PNAC (Philippine National AIDS Council) 68. Difference between AIDSWATCH & Pink Ribbon Society? AIDSWATCH – updates statistics of AIDS Pink Ribbon Society – HIV/AIDS victims
69. Lead agencies of HIV/AIDS education in communities? DILG - Department of the Interior and Local Government 70. Lead agencies of HIV/AIDS education in workplace? PNP –( Philippine National Police) DOLE (Department of Labor and Employment) Armed Forces 71. Lead agencies of HIV/AIDS education for Filipinos going abroad? DFA (Department of Foreign Affairs) DOLE (Department of Labor and Employment) 72. Lead agencies of HIV/AIDS education information as health service? DOH (Department of Health) 73. What are the lead government agencies for HIV/AIDS education in schools? IBE (International Bureau of Education) 74. What is informed consent? Properly informed what kind of tests to be done/perform Medical Confidentiality? Any tests performed to the patient should never be shared to others 75. Methods of Transmission of HIV/AIDS? Sexual intercourse Blood transfusion Perinatal transmission Parenteral transmission 76. Anonymous testing? Owner of the specimen is not known Contact tracing? Past records/investigate previous sex partners 77. What are the human rights & civil liberties of a person with HIV/AIDS? Privacy No discrimination 78. What is the Philippine AIDS Prevention & Control Act of 1998? RA 8504 79. What is NRL? National Reference Laboratory 80. What is the validity of drug test result? 1 year
81. When will the confirmed result become a permanent record? If not challenged within 15 days 82. Technical staff of a screening drug testing laboratory? RMT, Pharmacists, Chemists Technical staff of a confirmatory drug testing laboratory? Chemists 83. Who may head drug testing laboratory? Licensed Pathologist 84. Who should undergo mandatory drug testing? Police, Armed Forces, Candidate in Election, Fire Arms License Random? Students, Interns 85. Difference between screening & confirmatory drug testing laboratory? 86. Difference between screening & confirmatory drug test? Screening – POSITIVE/NEGATIVE results Confirmatory – Qualitative/Quantitative 87. What is the chain of custody? From the collection up to disposal 88. Comprehensive Drug Act of 1972? RA 6425 Of 2002? RA 9165 89. Transplantable organs? Liver, Heart, Kidney, Eyes, Bones 90. Authorized to remove transplantable organs? Pathologist/Physician 91. Manner of executing legacy or donees of human bodies or parts? Hospital School/University Organ Donation Bank 92. Who may execute a legacy of all or part of his body for the purpose of transplantation? 18 years old with sound mind 93. Who can declare if a person is medically & legally dead? Heart & Respiratory Dead – Attending Physician Brain – Consulting & Attending Physician 94. Difference between decedent & testator? Decedent – person has died Testator – alive
95. Organ Act of 1991? RA 7170 96. What are the treatable genetic, hematologic, endocrinologic, metabolic diseases of NB which are expected to be eradicated with the NB screening program? Congenital Hypothyroidism Congenital Adrenal Hyperplasia Galactosemia G6PD Deficiency Maple Syrup Urine Disease (MSUD) Phenylketonuria 97. Specimen for NB screening? Blood 98. Where is the secretariat of the Advisory Committee on NB screening? NIH (National Institutes of Health) 99. What are the possible consequences if heritable conditions are left undetected/untreated? Death Physical Deformities Mental Retardation 100.
When to refuse? Religious beliefs
101. When the NB is placed in Intensive Care Unit, when is screening be performed? Must be tested by 7/seven days of age 102.
When is the performance of NB screening? After 24 hours of life but not later than 3 days
103. Who has the obligation to inform the parents or legal guardian of the availability, nature & benefits of NB screening? MT on duty 104. Advisory Committee on NB screening consists of 8 members including the DOH Secretary as Chairman. Who is the Vice Chairperson? Director of NIH (National Institutes of Health) 105.
Where is the NB Screening Reference Center? NIH (National Institutes of Health)
106.
What is Newborn Screening Act of 2004? RA 9288