LESSON 1: INTRODUCTION

RA 5527 -Philippine MedTech Law

• June 21, 1969 -Charlemagne Tamondong

SEC Register No. 3975

• October 14, 1969 -Nardito Moraleta

Proclamation No. 1181 -Medtech Month

• September 6, 1973 -Pres. Marcos
• every THIRD WEEK of September

Department of Health
• 1939

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PAMET
• 47 Prov. Chapter + 4 International
• PAMETLINK (official publication)
• Crisanto G. Almario -PAMET Father
• Charlamange Tamondong -1st President
• PRC Res. No. 2018-1089 -only APO of RMT in PH
• Sep. 15, 1963 -1st Org. Meeting at Public Health Lab, 208-Quiricada St. Sta Cruz, Manila
• Sep. 20, 1964 -Election of 1st Officer at FEU
• BELOVED PAMET -official hym (Nov. 22, 1989)
⁃ Writer: Hector Gayares Jr.
⁃ Composer: Francis Pefanco
⁃ (Both Student of PUC) -> sang during 25th National Convention at PICC by 20 Choirs
• Rommel F. Saceda -Current President

PASMETH
• May 13, 1970
• June 22, 1970 -1st Org Meeting at UST
• Gustavo Reyes -1st President
• Bernard Ebuen -Current President (AU)

PHISMETS
• supervise by PASMETH Committee on Student Development
• 2002 -by Zenaida Cajucom
• Marilyn Bala (CHS), Nova Cajucom (FEU), Zennie Aceron (UST) -1st Advisers
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LESSON 2: CHED

RA 7722 -Higher Education Act of 1994

• May 18, 1994
• Under Office of the President
• Section 4: 1 Chariman & 4 Commisioners (4 year term each)
⁃ Chairman: Prospero De Vera
⁃ Commissioners:
⁃ Lilian Llagas (BS Hygiene)
⁃ Ronald Adamat (BS Education)
⁃ Perfecto Alibin (Ed.D Educ Admin)
⁃ Aldrin Darilag (BSMT & BSN)
• Section 7: Board of Advisers
⁃ assist in aligning policies and plans (meet once a year); 9 members (2 appointees)
⁃ Chairman: DepEd Secretary
⁃ Co-Chairman: NEDA Direc. Gen.
• Section 9: Secretariat
⁃ Head: Executive Officer
• Section 10: Development Fund
⁃ 500 M- Seed Capital
⁃ 50 M -Initial Operation
• Commission En Banc -collegial body formmulating plans
• Section 12 -Technical Panels
⁃ Setting minimun technical standards for programs
• Section 13: Academic Freedom
SIGNATORIES:
Jose Venecia Jr. House Speaker
Edgardo Angara President of State
Camilo Sabio House Secretary
Edgardo Tumangan Senate President
Fidel Ramos Philippine President

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LESSON 3: PRC & MEDTECH

RA 8981 - PRC Modernization Act of 2000

• December 5, 2000
• Under Office of the President
• Section 4: Composition
⁃ 1 Chairman & 2 Commissioners
⁃ (Seven Years Term!!!)
⁃ Chairman (40 y/o, 5 years executive management experience
• EO 200- Online Viewing of Passers
• Section 15: Penalties for Exam Leaked
⁃ 6-12 Years Imprisonment
⁃ 50K- 100K Fine
⁃ If PRC member- removal and perpetual “dq” from any public position

RA 5527 - Philippine MedTech Act of 1969

• June 21, 1969
• Amendments:
⁃ RA 6138
⁃ PD 498
⁃ PD 1534
• 32 Sections
• Pathology
⁃ head of lab (3 months training)
⁃ To manage:
⁃ 4 Lab, 2 BB, 10 SDTL
• MedTech
⁃ can supervice 3 Med.Technician
• Section 3: Council of Medical Technology
⁃ Chairman: DepEd Higher Education Director
⁃ Vice-Chairman: DOH Director of Bureau of Research and Laboratories
⁃ Member: 1 Chairman of the Board & 2 Members of the Board
⁃ Representative: Deans of SMT and PH, President of PSP & PAMET
• Section 3 (Updated): Technical Committee for MedTech Education
⁃ Chairman: PASMETH President
⁃ 2 PASMETH members
⁃ 2 PAMET members
⁃ 1 PRC Officer
• Section 5: Functions-
⁃ 50% Passing of School -warning
⁃ 1:25 (faculty-students)
⁃ Refresher Course:
⁃ 1 Year MedTech School
⁃ 1 Year Lab Training
• Note:
⁃ Board -examination
⁃ Council -schools
⁃ CMO No. 14 s.2006 -6 mons intern
• Section 7: MedTech Board
⁃ Chairman: Pathologist -> nominated by PSP
⁃ Member: 2 RMT -> nominated by PAMET
⁃ Under supervison & control of PRC
⁃ Note:
⁃ FIRST APPOINTEES
⁃ Chairman: Dr. Marieta Baccay
⁃ Member: Marilyn Atienza & Matian Tiangco
⁃ CURRENT APPOINTEES
⁃ Chairman: Dr. Marilyn Barza
⁃ Member: (same)
• Section 8: Qualifications
⁃ 10 Years MedTech Practice
⁃ 2 Years not member of any school of MT
⁃ Phillipine President can ONLY appoint and remove
• Section 9: Board Executive Officer
⁃ Commissioner of Civil Service
⁃ EO conduct examination
⁃ Secretary of Board of Examiners
⁃ register and COR
• SUBPOENA -> command to appear at a certain time to give testimony
⁃ TWO KINDS
⁃ Ad Testiicandum -> testify BEFORE court hearing
⁃ Duces Tecum - EVIDENCE must brought befor hearing
• Section 14: No liscence = No practice
• Section 15: Examination
⁃ 2 (Twice) a Year -March and September
⁃ Result release after 3 days (average)
• Section 17: Scope of Exam
Clinical Chemistry 20% - 100 items
Microbilogy and Parasitology 20% - 100 items
Blood Banking and Serology 20% - 100 items
Hematology 20% - 100 items
Clinical Microscopy 10% - 100 items
Histopath and Cytology, MT Laws 10% - 100 items
100 % - 600 items
Major Subjects 20%
Minor Subjects 10%
• Section 19: Rating of Examination
⁃ 75% GWA
⁃ No rating below 50% Major Subjects
⁃ Not failed at least 60% of the Subjects computed according to their relative weight
⁃ Refresher Course after 3 failed attempts
• Section 21: Issuance of COR
⁃ Less than 21 years old - no COR
⁃ COR must display at place he work
⁃ Payment Application: Php. 150.00
⁃ COR Signatories
⁃ PRC Chairman
⁃ 3 Members of Boards
• Section 24: Administrative Investigation
⁃ INVESTIGATION TEAM
⁃ 2 member of MT Board
⁃ 1 Legal Officer PRC
⁃ Penalty of Reprimand & Suspension (2/3) -majority vote
⁃ Penalty of Revocation (3/3) -unanimous vote
⁃ Suspension: 2 years maximum
⁃ Revocation: within 30 days return Liscense
• Section 29: Penalty of Provision
⁃ 2K - 6K or 6 months - 2 years imprisonment or both
Gil Puyat Senate President
Jose Laurel Jr. House Speaker
Inocencio Pareja House Secretary
Ferdinand Marcos Philippine President

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LESSON 3: CPD

RA 10912 - Continuing Professional Development Act of 2016

• July 21, 2016
• 19 Sections
• promote and upgrade the practice of profession: post-liscensure specilaization
• Under PRC and PRB
• CPD -process of inculcation of advance knowledge, skills, and ethical values
• CPD Council - body created to promote and ensure continous improvement of professional
⁃ Chairperson: PRB Member
⁃ Member 1: PAMET Officer
⁃ Member 2: PASMETH Officer
⁃ Note:
⁃ Chair -PRB Coterminous
⁃ Members - 2 years
• CPD Credit Unit - value of an amount learning
• CPD Program - set of leaenung activities accredited by CPD Council
• CPD Provider - juridicial person by the CPD Council to conduct CPD Programs
⁃ 3 years valid
⁃ at least 1 CPD program per year
• Section 9: Secretariat
⁃ provide technical, administrative, and operational support
⁃ Head: Executive Director (PRC appointed)
Franklin Drilon Senate President
Oscar Yabes Senate Secretary
Feleciano Belmonte House Speaker
Marilyn Barua-Yap House Secretary
Benigno Aquino III Philippine President

• PRC Resolution No. 1032 s. 2017

⁃ implementing rules and regulation of CPD Law

THE CPD PROCESS

• Every 3 Years (Renewal)
• RMT - 45 CU (Full Credit Unit) -15 NOW
• MLT - 30 CU (Fill Credit Unit) -10 NOW

MEDTECH MAJOR CPD AREAS

• 18% - Ethics
⁃ RMT: 8
⁃ MLT: 5
• 27% - Standard of Professional Practice
⁃ RMT: 12
⁃ MLT: 8
• 44% - Enhancement of Professional Practice and Technical Competence
⁃ RMT: 20
⁃ MLT: 14
• 11% - Environmental Factors Affecting the Profession
⁃ RMT: 5
⁃ MLT: 3
Teofilo Pilando Chairman
Angeline Chiaco Comissioner
Yolanda Reyes Comissioner

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LESSON 4: CLINICAL LAB LAW

RA 4688 - Clinical Laboratory Law of 1966

• June 18, 1966
• Renewal: ANNUAL to Health Secretary
• Bureau of Research and Laboratories -enforcing provisins
• Penalties:
⁃ 1 Month - 1 Year Imprisonment
⁃ 1K - 5K Fine
⁃ Both
• AO 59 s.2001 -Rules and Regulations
• AO 27 s.2007 -Revised Rules and Regulations (Aug. 22, 2007)
⁃ BHFS & CHD -you will apply here
⁃ CHD ->inspect, monitor, supend, revoke LTO
⁃ If corporation -Managing Head or Owner will be punished
• Renewal
⁃ Every last 2 months of the year
• Expiration
⁃ Every last day of December /year
• Inspection
⁃ within 60 days after filling application
National Reference Laboratories
RITM Dengue, Influenza, TB, Malaria
San Lazaro HIV/AIDS, Syphilis, Hepatitis and STDs
East Avenue Toxicology and Micronutrient Assay
National Kidney Hematology/Immunohematology
Lung Center Biochemistry

Administrative Order No. 2020 -0014

• LTO for COVID-19 Testing Facilities
• April 07, 2020
• Standard Testing Procedure is using rRT-PCR

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LESSON 4: BLOOD BANK

• Ph Red Cross - fisrt National Blood Program on July 17, 1948

• Pres. Elpidio Quirino -first Blood Donor
• Blood Donor’s Week - July 2nd Week
• RA 1517 -Blood Bank Law (reappelled) -June 16, 1956

RA 7719 - National Blood Service Act of 1994

• May 5, 1994
• Bill by Sen. R. Saguisag
ANTI-COAGULANT
ACD 21 Days
Citrate-Phosphate-Dextrose (CPD) 21 Days
CP2D 25 Days
CPD-Adenine 1 35 Days
CPDA2 42 Days
Heparin 2 Days
• Apheresis Facility - blood is collected and process
• End-User Facility -perform red cell typing but no blood bank
• Blood Service Network - informal organization of blood bank facilities
• Walking Blood Donors -for areas without blood bank
• PNRC & PBCC implement the National Voluntary Blood Services Program (NVBSP)
• Penalties:
⁃ 12-20 years imprisonment
⁃ 5K-500K Fine
⁃ Both
⁃ 10 Years -Dispensing, Transfusing, and Disposing within 48 hours
Jose Venecia Jr. House Speaker
Camilo Sabio House Secretary
Edgardo Angara President of State
Edgardo Tumangan Senate President
Fidel Ramos Philippine President

Administrative Order No. 2008-0008

• Rules and Regulation for Blood Bank
Blood Station storage, distribution transport
Blood Collection Unit recruitment
Blood Bank mostly hospital
Blood Center Test for TTI (all)
• Hospital LTO -via One-Stop-Shop Licensure
• Separate LTO for every BSF Branch
• Center for Health Development (CHD) -inspector
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LESSON 5: HIV/AIDS LAW

-> AIDS only disease that has its own LAW
-> HIV originated in Congo (Chimpanzees)
-> AIDS (1979 First described)
-> Transfusion-Associated AIDS in INFANT (1882)
-> 1984 -1st HIV Case in PH
-> AO 57 s. 1989 -HIV Screening in Blood Units
-> EO 39 s. 1992 - PH National AIDS Council (PNAC)
-> From RA 8504 to 11166

RA 11166 -Philippine HIV and AIDS Policy Act of 2018

• December 20, 2018
• Reappealled: RA 8504 -PH Aids Prevention and Conctrol Act of 1998
• Comprehensive Health Intervention for Key Population -evidence-based programs and policis
to reduce HIV transmission
• Mature Minor Doctrine -legal principle wherein minors can consult independently (less than 15
yo)
• 2 Types of Consent/Waiver (Express- sec 29, before testing or Implied -sec 27, indirectly
given) -BOTH MANDATORY IN NATURE

Excutive Order No. 39 - Phillipine National AIDS Council of 1992

• December 3, 1992
• oversee HIV/AIDS program (response is achored with principle of human rigths and human
dignity)
⁃ e.g. AIDS Medium Term Plan (AMTP)
⁃ 6-year national multi-sectoral strategic plan to prevent the spread of HIV and AIDS
• Under DOH but separate budget
• Head: Executive Director
• 21 All Members (DOH as Chairman) apponinted by Philippine President
⁃ meeting once every quarter
⁃ Vice-Chaiperson (any from government agencies) -3 years term
⁃ CSO -3 years (can be renew for max of 2 consecutive terms)
• Secretariat -coordinate and manage
• National HIV & AIDS & STI Prevention Program (NASPCP) -Epidemiology Bureau
⁃ monitor and evaluate program
⁃ report to PNAC
• HIV TESTING CONSENT
15-18 Years Old child consent
15 Years Old Below (Pregnant or engaged in high risk) child consent with assistance
15 Years Old Below esp mentally incapacitated parent/ legal gurdian consent or if not available,
social worker or health worker

-Based on PRINCIPLE OF EVOLVING CAPACITIES OF THE CHILD (15-18)

-Based on MATURE MINOR DOCTRINE (Below 15 pregnant ) a.k.a Gillick Principle or
Competence
NOTE: Assent of the child is important to before testing

HIV COUNSELING TWO PHASE

⁃ Pre-test Counseling - biomedical info and emotibal support
⁃ Post-test Counseling -risk reduction info and emotional support

ART - Anti-Retroviral Therapy -it should be FREE

NOTE: Before disclosing any INFO about HIV, WRITTEN CONSENT must be done from PLHIV

SCREENING TEST
⁃ Enzyme Immunoassay
⁃ Particle Agglutination
⁃ Rapid Immunoassay
⁃ HIV Antibody

CONFIRMATORY TEST
⁃ Western blot
⁃ Line Immunoassay
⁃ Immunoflourescence Assay
⁃ PCR
⁃ Rapid HIV Diagnostic Alogorithm (rHIVda) - DOH new recommended confirmatory procedure
in PH
⁃
If REACTIVE in screening:
NRL FOR HIV - San Lazaro Hospital (NRL-SACCL) STD/AIDS Cooperative Central Laboratory
⁃ HIV Proficiency Certificate for RMT - valid for 3 YEARS

TAKE NOTE:
⁃ Compulsary Testins is prohibited by law except:
1.) Person charge with offenses punishable by law (esp for rape cases)
2.) Nesecassry to resolve relevant issues (family code) -annulment
3.) Prerequisites before donation of blood

If BLOOD UNITS is reactive:

NRL- RITM

• Penalty:
⁃ Confidentiality
⁃ 6mons-2 years | 50K - 150K
⁃ Mass Desimination
⁃ 2-5 years | 150K - 350K
⁃ Health Practioner (negligence)
⁃ 1-7 years | 350K - 500K
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LESSON 6: Drug Law

• FDA -testing kits
• Dangerous Drugs Board - policy and strategy formulation
• PDEA -law enforcement
• Pernicious Effect -felt by addicts in their families
• Family -ultimate drug menance victims
• IDTOMIS -Integrated Drug Test Oprations and Management Information System
⁃ captures data for DTL
⁃ verification of transactions
⁃ monitoring and evaluation
⁃ October 2003 (designed)
⁃ April 2006 (updated)
⁃ January 5, 2009 (nationwide)
⁃ Location: HFSRB
⁃ 24/7 Open

RA 9165 - Comprehensive Dangerous Drugs Act of 2002

• June 7, 2002
• 102 Sections
• DOH through HFSRB- Health Facilities and Services Regulatory Bureau
⁃ liscense and accredit
• Screening DTL
⁃ HEAD:
⁃ Freestanding -> Pathologist or Licensed Physician
⁃ Institution-Based -> Licensed Physician, Chemist, MedTech, Pharmacist, Chem. Engineer
⁃ 1 Patho = 10 DTL
⁃ FLOOR AND WORK AREA
⁃ F: 20 sqm, WA: 10 sqm
⁃ QUALITATIVE TEST: Pos or Neg
⁃ Immunoassays
⁃ EIA, EMIT, FP, RIA
⁃ COA: Valid for ONE YEAR

• Confirmatory DTL
⁃ HEAD: Pathologist/ Chemist w/ Master’s Degree
⁃ 1 Patho = 10 DTL
⁃ FLOOR AND WORK AREA
⁃ F: 60 sqm, WA: 30 sqm
⁃ QUANTITATIVE TEST: Metabolites
⁃ Chromatography
⁃ TLC, GC, LC
⁃ Hyphenated Technique
⁃ combination of two sophisticated method
⁃ COA: Valid for TWO YEARS
⁃ NOTE: 2 Copies must produced
⁃ Orig to Client
⁃ Copy of DTL
⁃ Drug Certificate Validity: ONE YEAR

5 donors at a time

CUT-OFF DOH REQUIREMENT (URINE)

Drugs Window of Detection Initial Screening Ng/ Confirmatory
Marijuana (TCH) 2 days - 3 weeks 50 15
Shabu (Methamphetamine HCL) 2 - 3 days 500 250
• Urine (Most Common Sample)
⁃ 60 mL (Single Container)
⁃ 30 mL (Two Containers -Split)
• Chain of Custody
⁃ procedures to account for each specimen by tracking its handling and storage
• MFR -Memorandum for Records
⁃ a record to document the specimens that had been rejected or canceled.
SHABU MARIJUANA
Metabolite: Methamphetamine hydrochloride Metabolite: Tetrahydrocannabinol (THC)
Other Name: Meth, Crank, Crystal meth, speed Other Name: Cannabis, Pot
Note: Origin in Japan by Dr. Nagai Nagayoshi Note: Cannabis sativa -medical use
• Ecstasy - Hallucinogen
• Coccaine

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LESSON 7: NEWBORN SCREENING

-> January 3, 2000 - AO 1 s. 2000 - Policies for Nationwide Implementation of NBS
- Congen. Hypothyro, Congen. Adrenal Hyperplas., Galactosemia, Phenylketonuria
-> December 9, 2003 - AO 121 s. 2003 - Strengthening Implementation of NBS
- mga nauna + G6PD
-> January 20, 2004 - Procalmation No. 540 - National Newborn Screening Week (every 1st
Week of October) by GMA
-> May 15, 2012 - Memorandum No. 2012-0154 -MSUD (completion of Option 1 = 6 panels)

-> November 19, 2014 - Memorandum No. 2014-0045 -Guidelines in Expanded NBS (Option 2
= 28 panels)
- + hemoglobinopathies, amino acid disordes, oragnic acidurias, fatty acids oxidation disorders,
carbohydrate metabolism disorders, biotin medtabolism disorders, cystoc fibrosis, endocrine
disorders

-> November 5, 2018 - AO 2014-0025 - National Policy and Strategic Framework for 2017-2030
-> March 19, 2019 - AO 2014-0025 A - Option 1 will be offerered until April 30, 2019 only.
- Option 2 will be offered May 1, 2019 onwards only.
RA 9288 - Newborn Screening Act of 2004
• April 07, 2004
• Conducted after 24 hours of Life but Max of 3 days
• Baby in NICU: 7 days
• Informed Consent; Parent may refuse
• Baby’ Heel : Special Absorbet Filter Card
• Heel Prick Method (colllection)
• Filter Card -fill it using BLACK or BLUE BALPPEN (NO PENCIL)
• Always do SPOT CHECK for validity
Newborn Screening Center
⁃ lab test, follow up, recall
Newborn Screening Reference Center
⁃ central gacility
Recall
⁃ procedure for locating newborn with possible heritable condition for confirmatory
• DOH and Phil Health Insurance Corp
⁃ liscening ans accredidation NSF
• Advisory Committee
⁃ rules and regulation, under DOH Sec
⁃ 8 Members
⁃ NIH Executive Director -Vice Chair
⁃ Meeting Twice a Year
• NSC is located strategically
• COA FOR NSC -3 years (BSHF AND DOH)
• LTO FOR NBCC - 1 year (NBFS AND BSHF)
Jose De Venecia Jr House Speaker
Roberto Nazareno House Secretary
Oscar Yabes Senate Sectetary
Franklin Drilon Senate President
Gloria Aroyo Philippine President

ADMINISTRATIVE ORDER NO. 2014-0045

-Guideline in Expanded NBS Program
• Novemeber 19, 2014
• Option 1 - 6 disorders
• Option 2 - 28 disorders
• DOH Sec. Enrique T. Ona

PD 856 - Sanitation Code of the Philippines

RA 9275 - Philippine Clean Water Act of 2004

-> PD 856 -December 23, 1975 -Code on Sanitation of the PH

- accreditation of water analysis laboratories
-> RA 2975 -March 22, 2004 -PCWA
-> AO 24 - rules and regulation by DOH

COA - 2 YEARS
RESULTS - min of FIVE YEARS TO KEEP

ADMINISTRATIVE ORDER NO. 31 s.1995

⁃ Water Analysis Accreditation and Supervison and Analyst ONLY AO

SUMMARY
• 4-5-7-7-8-8-9-9-9-10-11

RA 4688 -CLINICAL LAB 1966

RA 5527 -MEDTECH 1969
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RA 7722 -HIGHER EDUCATION 1994
RA 7719 -BLOOD BANK 1994
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RA 8504 -HIV/AIDS 1998 (now RA 11166)
RA 8981 -PRC 2000
RA 9165 -DRUGS 2002 (03 signed)
RA 9288 -NEWBORN 2004 -JULY 7, 2004
RA 9274 -WATER 2004
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RA 10912 -CPD 2016
RA 11166 -HIV 2018