Notes MTLB Medical Technology Laws and Bioethics

MEDICAL TECHNOLOGY LAWS AND
BIOETHICS
BS MEDICAL TECHNOLOGY
History of the profession
•
CHAPTER 1 HISTORY OF THE Alessandra Gillani
PROFESSION
•
GLOBAL HISTORY
• Ignaz Semmelweis
VIVIAN HERRICK (1550 BC)
ANTON VAN LEEUWENHOEK (17TH CENTURY 1632-1723)
• Father of Microbiology
• Ebers Papyrus • Animalcules
•
HIPPOCRATES (300-180AD)
• MARCELO MALPHIGI (1628-1694)
• • microscopist
• • Founder of Pathology
• →
• •
•
RUDOLF LUDWIG CARL VIRCHOW (1821-1902)
• • modern Pathology
• •
• • Cell Theory
• Rene Theophile Hyacinthe Laënnec

HERMANN VON FEHLING
• Fehling’s test
•
19TH CENTURY
MEDIEVAL EUROPE
• Aniline Dyes
•
Gram Staining
• Wheel diagram
• 900AD
M. RUTH WILLIAM (1096-1438)

• • Acid Fast Staining
•
• →
THE BIRTH OF CLINICAL LABORATORY (1800)
ANNA FAGELSON (14TH CENTURY) • Dr. William Ocam
• Mondilin de Luzzi •
Josiah Villanueva
•
UNIVERSITY OF MICHIGAN
• Chemistry laboratory •
• Dr Silas Douglas
DR. PRUDENCIA STA ANA

•
DR WILLIAM HENRY WELCH (1878)
• Bellevue Medical College •
• First laboratory course in Pathology • The creation of Syllabus (1954)
• John Hopkins University •
SIR JOHN SCOTT BURDEN-SANDERSON (1885)

• Laboratory Methods
• Laboratory animals
WILLA HILGERT-HEDRICK
JOHN HOPKINS HOSPITAL (1896)
•
•
•
•
• Manila Sanitarium and Hospital
• Dr Simon Flexner
DR. JAMES C. TODD (1908)

• •
• Dr. Tood Dr.
Arthur Sanford •
• Davidson Henry expert of
microscopy.
UNIVERSITY OF MINNESOTA
• Antoinette McKelvey
•
• 1922-1923
• Dr. Papanicolaou (Pap smear)
• 1940
MEDICAL TECHNOLOGY PROGRAM
•
• 1950
•
MEDICAL TECHNOLOGY IN THE PHILIPPINES •
•
• 6th United states Army
• (208) Quiricada St. Sta. Cruz, Manila
DR. JESSE UMALI

•
DR. ALFREDO PIO DE RODA
•
•
•
• Dr. Mariano C. Icasiano THE MEDICAL LABORATORY SCIENCE

• 2006 →
DR. MARIANO C. ICASIANO (CITY HEALTH OFFICER)
•
Josiah Villanueva
•
UNIVERSITY OF STO. TOMAS

• Dr Antonio Gabriel Dr. Gustavo U. Reyes
• June 30, 1960
June 12, 1961
CENTRO ESCOLAR UNIVERSITY

• Mrs. Purificacion Sunico-Suaco Unico Hijo
• 1962
FAR EAST UNIVERSITY (1961)

• Dr. Horacio A Ylagan Dr Seragin J Juliano
• 1963
POST GRADUATE STUDIES OF MEDICAL TECHNOLOGY

•
Josiah Villanueva
PAMET and PASMETH
•
PAMET AND
Professionalism
CHAPTER 1
PASMETH
• Integrity
THE PHILIPPINE ASSOCIATION OF MEDICAL
TECHNOLOGY (PAMET)
•
• Commitment
• Mr Crisanto Gomez Almario
• 10am September 15, 1963 at the Public Health • Unity

laboratory at 208
• Conference Hall FEU Hospital (Sept 20, 1964)
PAMET PRESIDENTS
• Charlemagne
PAMET PRESIDENTS AND OFFICERS
Tamondong
Roles Officers
PAMET LOGO
• Circle
• Triangle
• Microscope & Snake
• Green
• 1964
PAMET VISION AND MISSION

Roles PAMET Officers
•
PAMET CORE VALUES (EPICU)

• Excellence
Josiah Villanueva
PAMET and PASMETH
CHARLEMAGNE T. TAMONDONG (EMERGENCE OF THE •
PROFESSION) •
•
CARMENCITA P. ACEDERA (IMAGE BUILDING)
NARDITO D. MORALETA (PROFESSIONAL RECOGNITION) • Crisanto G. Almario Memorial award
• Philippine Laws of Medical
Technologist •
• → RA 005527- Philippine Medical •
Technology Act of 1969
• Beloved PAMET Hymm Francis J. Pefanco
•
Hector G. Gayares Jr
•
•
• International Association of
MARILYN R ATIENZA (PROACTIVISM)
Medical Laboratory Technologist (IAMLT- •
Europe) •
•
•
•
•
• PAMET news
NORMA NUNEZ CHANG (INTERNATIONAL LEADERSHIP)
•
•
FELIX E. ASPRER (LEGISLATIVE AGENDA)
•
•
•
• Medical Prayer
AGNES B. MEDENILLA (ORGANIZATIONAL DYNAMISM)

•
•
•
•
BERNARDO T. TABAOSARES (CELEBRATION OF THE
•
PROFESSION)
•
•
• Teves Law SHIRLEY I. FABIAN-CRUZADA (INTERDISCIPLINARY

NETWORKING)
•
•
•
• •
•
ANGELINA R. JOSE (CAREER ADVOCACY)
•
•
• Student Research Forum
•
•
• MedTech Week celebration
VENERABLE C.V. OCA (EDUCATIONAL ENHANCEMENT)
DR. LEILA M. FLORENTO (GLOBAL PERSPECTIVE)
•
• PAMET forum
Josiah Villanueva
PAMET and PASMETH
• PAMET newslink PAMET
journals
• annual
• Microscope
convention
•
•
•
ROMEO JOSEPH J. IGNACIO (VISIBILITY, ONENESS,
INTEGRITY, COMMITMENT, EXCELLENCE) PHILIPPINE SOCIETY OF MEDICAL
•
TECHNOLOGY STUDENTS (PHISMETS)
•
•
Dr. Zenaida C. Cajucom
RONALDO E. PUNO (EMPOWERMENT) • Marilyn Bala, Nova Aida C. Cajucom, and Zennie
• B. Aceron
• One PAMET
•
•
•
•
ROMMEL F. SACEDA
May.
•
•
•
PASMETH PHISMETS SEAL

• Circles
Laurel
• Green Letters
• Cirilo S. Cajucom 5 Bubbles from a Test Tube
• Atty. Dexter Bilhis 15 Interconnected Molecules Outside a Test Tube
Microscope
PASMETH SEAL
• Circle
• Diamond
Josiah Villanueva
RA 005527
•
CHAPTER 2 RA 005527
•
SOME LAW TERMINOLOGIES •
• • Automation minimizes errors and shortens

processing time and turn-around-time
•
SECTIONS OF RA 5527
•
S1 TITLE
• Philippine Medical Technology Act
•
• June 21, 1969
• Ferdinand Marcos
•
• Nardito Moreleta
• 3 times
• S2 (DEFINITION OF TERMS)
• MEDICAL TECHNOLOGY
•
•
•
• PATHOLOGIST
• •
• •
MEDICAL TECHNICIAN
• •
• •
•
ACCREDITED MEDICAL TECHNOLOGY TRAINING
LABORATORY
•
PROFESSIONAL SERVICES
Josiah Villanueva
RA 005527
RECOGNIZED SCHOOL OF MEDICAL TECHNOLOGY

•
S3 COUNCIL OF MEDICAL TECHNOLOGY EDUCATION S7 MEDICAL TECHNOLOGY BOARD

• •
• •
• •
• •
S4 COMPENSATION AND TRAVELING EXPENSES OF S8 QUALIFICATION OF BOARD EXAMINERS

COUNCIL MEMBERS •
• •
• •
• •
•
S5 FUNCTIONS OF THE COUNCIL
S9 EXECUTIVE OFFICER OF THE BOARD
• Executive Officer of the Board
d) • Secretary of the Board
•
June
→
S10 COMPENSATION OF MEMBERS OF THE BOARD OF
EXAMINERS FOR MEDICAL TECHNOLOGY
•
•
3rd time
•
S11 FUNCTIONS AND DUTIES OF THE BOARD

S6 MINIMUM REQUIRED COURSES
•
•
•
•
•
• →
•
Josiah Villanueva
RA 005527
•
•
S18 REPORT OF RATING
•
•
S12 REMOVAL OF BOARD MEMBERS S19 RATING IN THE EXAMINATION

• •
S13 ACCREDITATION OF SCHOOLS OF MEDICAL S20 OATH TAKING

TECHNOLOGY & OF TRAINING LABORATORIES •
•
S21 ISSUANCE OF CERTIFICATE OF REGISTRATION

•
•
•
S14 INHIBITION AGAINST THE PRACTICE OF MEDICAL •
TECHNOLOGY •
•
•
•
• physician
•
• MT from other countries
•
• MT US armed forces
S22 FEES
S15 EXAMINATION •
• →
•
•
•
•
S23 REFUSAL TO ISSUE CERTIFICATE
•
•
•
S16 QUALIFICATIONS FOR EXAMINATION
•
•
•
•
S24 ADMINISTRATIVE INVESTIGATION
S17 SCOPE OF EXAMINATION •
Josiah Villanueva
RA 005527
S25 APPEAL S31 REPEALING CLAUSE

• •
S26 REINSTATEMENT, REISSUE OR REPLACEMENT OF

CERTIFICATE
• S32 EFFECTIVITY
•
•
AMMENDMENTS OF RA 005527
S27 FOREIGN RECIPROCITY
•
•
UPDATES
S28 ROSTER OF MEDICAL TECHNOLOGISTS
• Senator Edgardo Angrar
•
•
•
S29 PENAL PROVISION

• →
• Creation of Technical Panel in Medical
Technology Education (TPMTE)
•
• Rep. Leopoldo N. Bataoil (2nd district of
Pangasinan)
•
House Bill
•
3502
S30 SEPARABILITY CLAUSE

•
Josiah Villanueva
RA7722
CHAPTER 3 RA7722 S7 BOARD OF ADVISERS

• at least once a year
SECTIONS OF RA 7722 • cultural
political socioeconomic
S1 TITLE
•
• ADVISERS
• May 18,1994 Fidel V. Ramos •
•
S2 DECLARATION OF POLICY
•
•
•
•
• S8 POWER AND FUNCTIONS OF THE COMMISSION
S3 CREATION OF THE COMMISSION ON HIGHER

EDUCATION
•
• S9 THE SECRETARIAT
• Executive Officer
S4 COMPOSITION OF THE COMMISSION
•
•
•
• Dr. J. Prospero “Popoy” E. De Vera lll
•
•
• S10 THE HIGHER EDUCATION DEPARTMENT FUND

• •
• •
• •
•
QUALIFICATIONS
• •
• •
S5 TERM OF OFFICE
•
• 4 years
S11 MANAGEMENT AND ADMINISTRATION OF THE
HIGHER EDUCATION DEVELOPMENT FUND
• 3 years
• 2 years
GUIDELINES
•
S6 RANKING AND EMOLUMENTS •
•
• S12 THE TECHNICAL PANELS

•
Josiah Villanueva
RA7722
•
S13 GUARANTEE OF ACADEMIC FREEDOM

•
CURRCULAR FREEDOM
•
S14 ACCREDITATION
•
S15 TAX EXEMPTIONS

•
S16 AUTHORITY
•
S17 APPROPRIATIONS
•
S18 TRANSITORY PROVISIONS

•
S19
S20
S21 EFFECTIVITY
• 18 May, 1994
Josiah Villanueva
CMO No. 13s 2017
CHAPTER 4 CMO NO. 13S 2017 S6 PROGRAM OUTCOMES

S6.3 SPECIFIC TO BSMT/BSMLS
•
•
AIMS
•
•
•
•
•
•
•
S3 MINIMUM STANDARD REQUIREMENT FOR
BSMT/BSMLS •
•
•
•
•
S5 DEGREE NAME •
•
S8 CURRICULUM DESCRIPTION
•
173 units
1,728 hrs
INTERNSHIP EXPOSURE/CONTACT TIME IN THE LAB
S5.4 CAREERS AND OPPORTUNITIES FOR GRADUATES
S5.5 ALLIED MEDICAL FIELDS

1,664hrs or 99,840mins
Josiah Villanueva
CMO No. 13s 2017
•
S13 ADMINISTRATION QUALIFICATIONS OF DEAN

S13.1 QUALIFICATIONS OF THE DEAN FOR BSMT/BSMLS S15 LIBRARY
• •
• •
•
SEC16 LABORATORY AND FACILITIES
•
SEC16.1 LECTURE CLASSROOM REQ
•
•
•
•
SEC16.2 LAB REQ
•
•
•
•
S13.2 FUNCTIONS OF DEAN
•
•
•
•
SEC23 TRANSITORY PROVISIONS
•
S14 FACULTY
•
S14.1.1NON-LICENSURE COURSE TEACHER
•
S14.1.2 LICENSURE COURSE TEACHER

•
•
•
S26 EFFECTIVITY CLAUSE
•
• •
ARTICLE 5 SEC 7
•
ARTICLE 6 DUTIES AND RESPONSIBILITIES OF CLINICAL

INSTRUCTURE/ INTERN COORDINATOR/ CLINICAL
COORDINATOR
•
S1 CI/IC/CC DUTIES AND RESPONSIBILITIES

•
Josiah Villanueva
CMO No. 13s 2017
• d. Pull out of interns
•
ARTICLE 7 DUTIES OF RESPONSIBILITIES OF INTERN

SEC1 CONDUCT AND BEHAVIOR h. Leave of absence
• •
•
S3 GROOM
• •
•
•
• •
•
•
•
S2 ATTENDANCE AND PUNCTUALITY •
a. Duty •
• 15 mins before •
• •
•
S4 BREAKAGES
•
•
b. Tardiness
• ARTICLE 8 MERITS AND DEMERITS
• S2 POINTS OF DEMERITS
2.1 Minor Offense
• Disciplinary Offenses →
c. Absences • Academic Offenses
Excused Absences
• 2.2 Major Offenses
•
Josiah Villanueva
CMO No. 13s 2017
ARTICLE 9 RESPONSIBILITIES OF HEI AND ACCREDITED

MEDICAL TECHNOLOGY TRAINING LABORATORY
• S1
• S2
ARTICLE 10 PERFORMANCE EVALUATION

EXAMINATION
•
CLINICAL PERFORMANCE
•
SUMMARY
Josiah Villanueva
Ra 4688 Clinical Laboratory Law of 1966
CHAPTER 5 RA 4688 CLINICAL S7 REPEALING CLAUSE

• inconsistent
LABORATORY LAW OF 1966 repealed
•
S8 APPROVAL
• June 18, 1966
RA 4688 “EOM 5921” AO 59 2001

•
S1 TITLE
DOH
• Rules and Regulations Governing the
• Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines
• Note
S1 DEFINITION OF CLINICAL LAB S2 AUTHORITY

•
•
• •
• Exempted •
S3 PURPOSE
S2 LICENSE QUALIFICATIONS •
• licensed physician •
lab medicine •
pathologist
S4 SCOPE
•
•
•
S3 RESPONSIBILITY OF THE SECRETARY OF HEALTH • Acid fast bacilli microscopy
• Secretary of Health, through the Bureau of
• Malaria screening
Research and Laboratories →
enforce authorized • Cervical cancer screening
S4 PENAL PROVISION
• → S5 CLASSIFICATION
BY FUNCTION
1 month – 1 year 1k-5k, both • Clinical Pathology
S5 SEPARABILITY CLAUSE
• • Anatomic Pathology
BY INSTITUTIONAL CHARACTER
• Hospital-based(HB) laboratory
S6 BUDGET
• 50,000 more
Josiah Villanueva
• Non-hospital-based(NHB) laboratory 7.3 APPLICATION FOR RENEWAL OF LICENSE
•
BY SERVICE CAPABILITY →
Primary
• • 90 days before expiry date
•
• Blood Typing
• Schedule of Application for

Region
renewal of license
Secondary
•
• Crossmatching
• Gram Stain KOH

7.4 PERMIT AND LICENSE FEES
Tertiary
• →
•
• →
S6 POLICIES •
• Approved permit,
7.5 LATE RENEWAL PENALTIES
• Php 1,000
• BHFS
2 months late
→
• Php 100 per
• Valid license CHD
month late
• CHD Center for Health Development of DOH →

• → renewal fee for the 2 month delay
• additional 2 month delay
•
7.6 INSPECTION
S7 REQUIREMENTS AND PROCEDURES FOR APPLICATION • every 2 years or as
OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE necessary
7.1 APPLICATION FOR PERMIT TO CONSTRUCT •

BHFS/CHD or authorized
• BHFS
representative
• Site Development Plan and Floor Plan
•
7.7 MONITORING
• •
7.2 APPLICATION FOR NEW LICENSE:

•
•
lab records
→
7.8 ISSUANCE OF LICENSE

• Director of the CHD his authorized
representative
Josiah Villanueva
7.9 TERMS AND CONDITIONS OF LICENSE S12 PUBLICATION OF LIST OF LICENSED CLINICAL
• LABORATORIES
•
S13 EFFECTIVITY
• CHD at
• 15 days after publication
least 15 days before actual transfer
• 
• Manuel M. Dayrit, MD., MSe
• December 10, 2001

• Extension lab →
• change affecting the substantial conditions ANNEX A TECHNICAL STANDARDS AND

within 15 days MINIMUM REQUIREMENTS
→
STAFFING
• →
• visible location
PHYSICAL FACILITIES
S8 VIOLATIONS
• →s u s p e n s i o n revocation
EQUIPMENT/INSTRUMENTS
•
•
GLASSWARES/ REAGENTS/ SUPPLIES
•
•
WASTE MANAGEMENT
•
•
QUALITY CONTROL PROGRAM
•
REPORTING
S9 INVESTIGATION OF CHARGES OR COMPLAINTS
Charges/Complaints Actions
RECORDING
LABORATORY FEES
•
“LRCL2727 “AO 27 2007

• Revised Rules and Regulations
S10 MODIFICATION AND REVOCATION OF LICENSE Governing the Licensure and Regulation of
Clinical Laboratories in the Philippines
•
OBJECTIVE
•
• to prescribe a revised minimum standard
•
S11 REPEALING CLAUSE
Josiah Villanueva
SCOPE AND COVERAGE CLASSIFICATION BY INSTITUTIONAL CHARACTERISTICS

• except government • Institution-based
clinical laboratories doing work for specific

DOH
• Free-standing
DEFINITION OF TERMS •
CLASSIFICATION BY SERVICE CAPABILITY

General Clinical Laboratory
Primary Category 10sqm
National Reference Laboratory
Point of Care Testing
• •
Test-Short Turnaround Time
• •
Secondary Category 20sqm
Sta’tim
CLASSIFICATION OF CLINICAL LABORATORIES Tertiary Category 60sqm
CLASSIFICATION BY OWNERSHIP
• Government
• Private-owned
• Limited-Service capability
CLASSIFICATION BY FUNCTION
Clinical Pathology
Special Clinical Laboratory
•
Anatomic Pathology
Josiah Villanueva
GUIDELINES c) Glassware, Reagents, and Supplies

•
GENERAL GUIDELINES
•
•
•
BHFS
• d) Administrative Policies and Procedures

•
research and teaching purposes
• special
clinical laboratories e) Technical Procedures

• • →
f) Quality Assurance Program

•
• Internal QC program
One Stop Shop License physically
• Internal QA program
independent
• Continuous Quality Improvement prog ram
allowed to register only with the BHFS
accredited or certified international

• participate in an EQAP
local
• NOTE:
• POL
• g) Communication and Records

• receipts and performance
•
•
• reporting of results
• POCT
• name and signature
pathologist RMT
SPECIFIC GUIDELINES
1. Standards • E-signatures
a) Human Resource • workload, quality control,
•
inventory control, work schedule and
assignments
• → • incidents,
adverse events, and in handling complaints .
•
• Retention of lab records
•
h) Physical Facilities / Work Environment
b) Equipment •
•
•
• space
• ventilated lighted clean safe functional

• Contingency plan
• waste disposal
Josiah Villanueva
• physical RENEWAL OF LTO
plant facilities • →
• lab biosafety biosecurity
i) Referral of Examinations Outside of the Clinical • NHB clin lab → 1st
Laboratory day of October last day of November

• accountable to the • 5 WORKING
results produced
• automatically cancelled
•
2. LTO
• name of the licensee
INSPECTION
• 1 year
•
• Non-hospital based
•
• the accessibility of the

• Hospital based one-
premises and facilities.
stop-shop licensure →
• availability of all pertinent
separate license
records for checking / review.
• HIV testing drinking •
water analysis
MONITORING
• regularly by the
• →
BHFS or CHD Director
• Satellite lab outside →
•
separate LTO
• Mobile clinical labs only
collect 100km radius.

•
PROCEDURAL GUIDELINES
SCHEDULE OF FEES
REGISTRATION FOR SPECIAL CLINICAL LABORATORIES, NATIONAL
•
REFERENCE LABORATORIES, RESEARCH AND TEACHING LABORATORIES
•
BHFS or through CHD non-
refundable application fee for Certificate of VIOLATIONS

Registration
• Refusal EQAP
PROCEDURES FOR APPLICATION FOR INITIAL/RENEWAL OF LTO • Issuance of report
• non-refundable application fee
for LTO
• unauthorized to perform
• expired
Josiah Villanueva
•
NATIONAL REFERENCE LABORATORIES
• Lending or using the name
•
• Unauthorized use of the name signature

•
•
• Reporting a test result
•
not actually performed
•
•
•
•
• not licensed
• NATIONAL REFERENCE LABORATORY (DEPARTMENT

ORDER NO. 393-E S. 2000)
INVESTIGATION OF COMPLAINTS RESEARCH INSTITUTE FOR TROPICAL MEDICINE

• BHFS CHD Director •
representative(s)
•
SARS-
CoV-2
•
STD-AIDS COOPERATIVE CENTRAL LABORATORY (SAN
LAZARO HOSPITAL)
PENALTIES •
• 1 month imprisonment 1k to 5k fine
both
•
APPEAL EAST AVENUE MEDICAL CENTER

• •
Secretary of Health within 10 days
•
• the Office of the Health Secretary
NATIONAL KIDNEY AND TRANSPLANT INSTITUTE
final and executory
•
REPEALING CLAUSE •
SEPARABILITY CLAUSE
LUNG CENTER OF THE PHILIPPINES
EFFECTIVITY •
• 15 days after its approval •
publication
PHILIPPINE HEART CENTER
•
• Francisco T. Duque III (Secretary of
Health)
• June 18, 1966
Josiah Villanueva
PD 223 and RA8981 Professional Regulation Commission
•
PD 223 AND
Promotes
CHAPTER 6
RA8981 PROFESSIONAL S3 PROFESSIONAL REGULATION COMMISSION

REGULATION • 3-man commission (PRC)
•
COMMISSION
PD 223 S4 COMPOSITION
Hon. Teofilo S. Pilando,
Creating the Professional Regulation Commission
Jr
and Prescribing its Powers and Functions
• PRC Hon. Jose Y. Cueto, Jr.

Hon. Yolanda D. Reyes
egulating the various professions • 7 years
• June 22, 1973
• Ferdinand E. Marcos • Any vacancy before the term ends →

• Alejandro Melchor unexpired term
• 1008 P. Paredes St. Sampaloc, Manila

• term expires → most senior of the
commissioners
RA 8981
• modernizing professional regulation
QUALIFICATIONS:
commission
• 40 yrs old
• professional ID card certificate of

two important
competency
functions
professional license
conduct administer licensure
• principles methods of
examinations
professional regulation licensing
regulate supervise
• 5 years
43 Professional
• past Chairperson/
Regulatory Boards (PRBs)
member PRB
S5 EXERCISE OF POWERS AND FUNCTIONS OF THE

accredit the professional COMMISSION
organization Chairperson Commissioners
S1 TITLE
•
• PRC Modernization Act of 2000
•
S2 STATEMENT OF POLICY
Chairperson
• role of professionals in
• CEO
nation-building
preside the meeting
• Competence
• policies programs
• examination
Josiah Villanueva
• Exercise
Submit recommend the names
S6 COMPENSATION AND OTHER BENEFITS
• → license PRC card

•
foreigner
• • Requirements
•
•
S7 POWERS, FUNCTIONS AND RESPONSIBILITIES OF THE
COMMISSION
• →
special permit foreign professionals
policies
Consultants
• Administer licensure
pursuant to law
• places dates
humanitarian missions
• Use
Any officer administer oaths
•
• •
• →
•
• Refresher courses
• PRC DOLE
• exam results.
•
• list of successful examinees

•
w/o permit
→d e p o r t a t i o n
• →
sample test questionnaires syllabi
naturalization
→ special permit
• Examinee with charge and found guilty
→ →
Monitor performance of school
•
rating system
passing ratio overall performance
• Exemption
• Marine deck Engine officers

Supervision
EO. 149s 1999
•
full computerization
records
Determine and fix the fees
Josiah Villanueva
investigate • conduct summary proceedings
any PRB member
licensure •
examinations
issue summons, subpoena and subpoena
duces tecum
suspend revoke reissue
Commission PRB
reinstate COR
members
• prepare, adopt and issue syllabi
tables of specifications
examinations
initiate an investigation
• Score rate w/ board
any person
member’s name signature submit
•
• within 10 days
• •
annual report accomplishments
annual report make recommendations
SECTION 10 COMPENSATION OF THE MEMBERS OF THE

PROFESSIONAL REGULATORY BOARDS
S8 REGIONAL OFFICES • 2 salary grade lower
• commissioners
•
• authorized to create
regional offices
S11 PERSON TO TEACH SUBJECTS FOR LICENSURE
EXAMINATION ON ALL PROFESSIONS
• subjects for licensure exams
holders of valid COR

S9 POWERS, FUNCTIONS AND RESPONSIBILITIES OF THE professional licenses
VARIOUS PROFESSIONAL REGULATORY BOARD
S12 ASSISTANCE OF LAW ENFORCEMENT AGENCY

regulate the practice of the professions •
S13 APPROPRIATIONS
monitor the conditions
To hear investigate cases S14 AUTHORITY TO USE INCOME

violations
final and executory
after 15 days S15 PENALTIES FOR MANIPULATION AND OTHER
appealed CORRUPT PRACTICES IN THE CONDUCT OF PROFESSIONAL
Hearing at least 1 member of EXAMINATION
the board legal (HOC) • Leaking
Josiah Villanueva
• Tampering
• 6 years and 1 day to 12 years (CPE) programs
• 50,000 -100,000
• officer employee
member
PRC RESOLUTION NO
removed
Accomplice Delisting Delinquent

• 4 years and 1 day to 6 years
• 20,0000 to 49,000
Accessory Mass Oath
• 2 years and 1 day to 4 years taking
• 5,000 – 19,000
S16 PENALTIES FOR VIOLATION OF SECTION 7
6 months and 1 day to 6 years
50k to 500k both

examination board
S17 IMPLEMENTING RULES AND REGULATIONS delegations
→ rules
regulations EO No.
within 90 days after the Act’s approval 200
S18 TRANSITORY PROVISIONS

EO No. 266
S19 SEPARABILITY CLAUSE application/petitions

professionals w/o
examination
S20 REPEALING CLAUSE Syllabi
preparation of
questions
SECTION 21 EFFECTIVITY
•
Removal
Delinquency in the
• December 05, 2000 payment of annual registration
• Joseph Ejercito Estrada
Suspension
EXECUTIVE ORDER PRC Res. No. 381s 1995
Full computerization
Accreditation of gov’t and non-

gov’t agencies educational
institutions
Josiah Villanueva
COMPOSITION
Chairman of MT board
president PAMET
registration of
lab medical technician
FUNCTIONS
•
Evaluates accredits scientific activities
Assign CPE units

•
MEMORANDUM CIRCULAR NO.
Documents Records Papers

RA 10912
Mandating Strengthening CPD Program
certificate of credit units earned
BOARD RESOLUTION NO S1 TITLE

Continuing Professional Development Act of 2016
S2 DECLARATION OF POLICY
• promote
upgrade practice of professions
PRC BOARD RESOLUTION NO. 167 continuously improve competence
Guidelines for CPE/ Accreditation for Medical

Technologist in the PH
INTRODUCTION
•
S3 DEFINITION OF TERMS
• AIPO/APO
OBJECTIVE
• professional technical
standards of practice • Continuing Professional Development (CPD)
inculcation knowledge skills
ethical values
ACCREDITATION COMMITTEE CPE
Josiah Villanueva
• CPD Program set of learning activities • was updated to 15
units per 3 years
SECTION 11 PRESCRIBED FEES
Local
Foreign
per offering
• CPD Provider person
conduct CPD Programs Self-directed
•
S5 NATURE OF CPD PROGRAMS
•
•
•
•
• Formal learning
• Nonformal
• Informal
MATRIX OF CPD
• Self-directed
• Online learning PROFESSIONAL TRACK (TRAINING OFFERED BY

ACCREDITED CPD PROVIDERS, F2F/ONLINE)
• work experience
S19 EFFECTIVITY
•
• July 21, 2016
• BENIGNO S. AQUINO
WHY DO WE NEED TO EARN CPD UNITS

•
PRC RESOLUTION NO. 2016 990S 2016

Revised Guidelines of the CPD
ACADEMIC TRACK
Program
CPD PROCESS
• apply 45 days prior
activity
• CPD council
• mandatory renewal of PRC ID
Josiah Villanueva
PAMPHLET/ BOOK OR MONOGRAPH
SELF-DIRECTED (TRAINING OFFERED BY NON-

ACCREDITED CPD PROVIDERS, F2F/ONLINE)
CPD DRAWBACKS
• Difficulty of access
• Lack of time
• financial burden
KEY POINTS
ARTICLE PUBLISHED IN A REFEREED/ PEER REVIEWED •
PROFESSIONAL JOURNAL
•
LAWS REGARDING CPD/CPE

•
Josiah Villanueva
DOH AO No. 2020-0014 Guidelines in Securing LTO for Covid-19 Testing Facilities
•
CHAPTER 7 DOH AO NO. 2020-

0014 GUIDELINES IN
SECURING LTO FOR COVID-19
TESTING FACILITIES
•
RATIONALE/BACKGROUND
(SARS-CoV-2)
• Severe Acute Respiratory Syndrome

Coronavirus 2
• NPS ORS
• RITM
REAL TIME REVERSE TRANSCRIPTASE -POLYMERASE CHAIN

REACTION
• rRT-PCR →G o l d s t a n d a r d
test
1. REVERSE TRANSCRIPTION
Two-step RT-PCR
• Reverse Transcriptase
→
Note →
One-step RT-PCR
Josiah Villanueva
→ II. OBJECTIVES
→
• safety of personnel general public
quality accuracy
•
III. SCOPE
https://www.sigmaaldrich.com/life-science/molecular- private government “C19T”
biology/pcr/rt-qpcr.html
labs
2. POLYMERASE CHAIN REACTION
• PCR machine (thermocycler) IV. DEFINITION OF TERMS
• Applicant
3 Phases of PCR “C19T” lab

Denaturation
Annealing
DOH-LTO
extension
• • DOH-Permit to Construct or PTC
•
•
•
• prerequisite for LTO

NOTE: “C19T”
• Letter of Recommendation
labs issued by RITM
DOH Memo no.2020-0258- DOH

Expanded
Testing • →
AO No. 2020-0014 • rRT-PCR
securing a LTO
DOH Memorandum Circular No. 2020-0049
IMPLEMENTING MECHANISMS
A. GENERAL GUIDELINES
•
• standards
requirements
RITM HFSRB CHDRLED
HB “C19T” lab
Josiah Villanueva
• RITM’s
• NHB “C19T” labs

WHO risk assessment form
PERSONNEL
• minimum 7 per 8 hr shift

• limited-service
capability
• separate unit
Board Certified Clinical Pathologist
• biosafety biosecurity
guidelines
Full-time Analysts → 3 2
• Board-Certified and 1
Clinical Pathologist training
• staff trainings
• Laboratory Aide
Receptionist
Encoder
→ →
The laboratory staff shall have the following trainings:

• FDA registered testing kits reagents
devices
• compliance
•
• reporting of results DOH Molecular Diagnostic
Department Memorandum No. 2020-0110 Techniques
fit testing for respirator
annual medical examination

• shall follow
•
DOH Assessment Tool
Josiah Villanueva
continuing updated trainings
• Biosafety
• Biosecurity
EQUIPMENT AND INSTRUMENTS

PHYSICAL FACILITIES •
• BSL 2 to 4
organized
appropriately located
Unidirectional workflow
documented inventory
calibration maintenance
documented
d a i l y c l e a n i n g maintenance
• Materials and instruments
• Controlled adequate ventilation
SERVICE CAPABILITY
• Negative air pressure
• lighting
Manual of Procedures Work Instructions
SOP of the facility which shall include, but not limited to:
RITM Biorisk Management

Office Interim Biosafety Guidelines
Josiah Villanueva
QUALITY IMPROVEMENT ACTIVITIES PROCEDURAL GUIDELINES
1. LICENSING PROCESS
proficiency testing
DOH-PERMIT TO CONSTRUCT (DOH-PTC)
Identify
document
• levels 2 3 general hospitals
• specialty hospitals
NEQAS
• NHB
•
• level 1
•
Complete applications
•
RELEASE OF RESULT
DOH-LICENSE TO OPERATE (DOH-LTO)

Filing
HFSRB CHD-RLEDs
THE LABORATORY SHALL SUBMIT A LINELIST OF POSITIVE
Complete documentary requirements
SPECIMENS FOLLOWING THE LINELIST FORMAT BELOW:
application form
DOH-PTC floor plan

linelist of POSITIVE
• Usec. Myrna Cabotaje
• DOH Epidemiology Bureau

List of equipment
• Director of the Hospital

Certificate of Product Registration
• RESU CPR
• Dr. Celia Carlos Self-Assessment Tool
THE LABORATORY SHALL SUBMIT A LINELIST OF NEGATIVE

SPECIMENS FOLLOWING THE LINELIST FORMAT BELOW: For renewal
linelist of NEGATIVE
schedule an inspection
date
• DOH Epidemiology Bureau
Process for Inspection

• Director of the Hospital
• RESU
• Dr. Celia Carlos
Josiah Villanueva
unannounced monitoring
letter of
recommendation respond to complaints
RESEARCH INSTITUTE OF TROPICAL MEDICINE (RITM)

→ Issuance of
DOH-LTO
the Director IV
laboratory reference referral services
train
maintain QA program
2. VALIDITY OF DOH-LTO
• → (1) year technical evaluation
• Annual renewal annual train & authorize
cut-off dates A.O. no. 2019-0004
CENTER FOR HEALTH DEVELOPMENT — REGULATION,
LICENSING, AND ENFORCEMENT DIVISION (CHD-RLED)
enforce the provisions
DOH-LTO CHD-RLEDs
3. MONITORING • NHB
• HFSRB/CHD-RLED with RITM 3th party • level 1
assessors
unannounced monitoring
submit report Suspension/ Revocation/
4. FEES Cease and Desist Order
•
respond to complaints
EPIDEMIOLOGY BUREAU AND ITS REGIONAL

EPIDEMIOLOGY SURVEILLANCE UNITS (RESU)
ROLES AND RESPONSIBILITIES Collect aggregate data
Analyze report data

HEALTH FACILITIES SERVICES AND REGULATORY BUREAU
enforce the provisions
set standards
inspection monitoring tools
disseminate regulatory
provide consultation technical

assistance
inspect issue DOH-LTO

• Speciality, levels 2 3 general hospital
Josiah Villanueva
Laws on Blood Banking RA 1517 and RA 7719
CHAPTER 8 LAWS ON BLOOD

BANKING RA 1517 AND RA
7719 • tertiary hospital lab sole standing
blood bank laboratory

•
• HB blood bank
Blood recipients
scientific standards in blood
banking
CAVEAT IN BLOOD DONATION licensed qualified physician
Protect the donor.

• •
Protect the recipient.

•
SECTION 4.
• non-
•
profit basis
•
non-profit basis
REPUBLIC ACT NO. 1517 BLOOD BANKING
•
LAW OF 1956
• human
blood SECTION 5.
•
SECTION 1.
•
prevent trafficking in human blood products
derivatives
SECTION 6.
SECTION 2.
•
• Blood
•
• Person SECTION 7.
• Cost purchase price of June 16, 1956
unprocessed blood handling charges

LETTER OF INSTRUCTIONS NO. 42
•
•
SECTION 3.
•
Ordering the stoppage of commercialization of

human blood and human blood products
Josiah Villanueva
• Nov 28, 1972
• • Bleeding
• •
•
REPUBLIC ACT NO. 7719
voluntary blood donation
supply of safe blood regulating blood banks
penalties for violation

•
SEC. 1. TITLE.
National Blood Services Act of 1994 HIV Hepa B Hepa C Syphilis Malaria
•
SEC. 2. DECLARATION OF POLICY.
→
• voluntary blood donation
DONOR SCREENING PROCEDURE
• 110 lbs (50 kg)
• • 60 and 100 bpm regular rhythm
professional medical service •
• : 90 and 160mmHg
• •
distribution of supply of blood and blood
products
•
•
• 60 and 100mmHg
hazards commercial sale of blood
• 125 g/L
•
12.5g/dl
• participate
for voluntary and non-profit
collection of blood WHAT ARE THE STEPS IN BLOOD DONATION?

• National Blood A. Before blood donation
Transfusion Service Network
• Donor's Form
• health history
•
operate on a non-profit basis • education counselling
SEC. 3. DEFINITIONS.
• weight blood pressure pulse rate
• Blood/blood product
temperature
•
• Blood Transfusion Services
•
blood type hemoglobin level
• Screening selection procedure

• 10 to 15 minutes give
Josiah Villanueva
accurate data
confidentiality
B. During Blood Donation (Bleeding)

•
•
•
• skin to vein procedure →n a v i g a t e

•
•
•
• 10 to 15 minutes
BLOOD SERVICE FACILITIES
Blood center
C. After Blood Donation
• NHB blood service facility
• rest for 10 more minutes →
minimum
• Beverage snacks
Blood collection unit
•
•
•
Blood bank
• drink more fluids
•
• volume of fluids
• collect, process, store, transport and issue
3 to 5 hours blood
• 3 to 4 months
• provide information education
BLOOD COMPONENTS PREPARATION

→ Blood station
→ •
→ →
→ →
→
→ →
Blood Service Facility
→
→
Aphresis Facility
USE OF BLOOD PRODUCTS


Josiah Villanueva
• Philippine National Red Cross
Philippine Blood Coordinating Council
TYPES OF BLOOD BANK

•
Commercial blood bank
•
Hospital-based blood bank
Non–hospital-based Blood Bank/Center
• collection of
blood bank stations and centers and facilities
TYPES OF BLOOD CENTER •

• National Blood Center
SEC. 5. NATIONAL VOLUNTARY BLOOD SERVICES
PROGRAM
• Regional Blood Center
• PNRC and PBCC
Goal is National Voluntary Blood
Services Program
SEC. 3. DEFINITIONS.
• Voluntary Blood Donor
• Philippine Charity Sweepstakes Office
•
• Walking Blood Donor • Philippine Amusement and Gaming
Corporation
• •
• Duty Free Philippines
• ready to •
donate blood when needed in his or her
community; SEC. 6. UPGRADING OF SERVICES AND FACILITIES.
MOBILE BLOOD DONATIONS (MBD)
• •
• outside the campus •
• SEC. 7. PHASE-OUT OF COMMERCIAL BLOOD BANKS

• period of 2 years
• 1st volunteer donor

SEC. 8. NON-PROFIT OPERATION
donating at least every 3
•
months
• may collect service fees
• Pheresis
SEC. 4. PROMOTION OF VOLUNTARY BLOOD DONATION.
Josiah Villanueva
SEC. 9. REGULATION OF BLOOD SCIENCES SEC. 15. EFFECTIVITY CLAUSE

• unlawful establish • after 15 days
operate a blood bank/center unless 2 national newspapers
• May 5, 1994
• in case of emergencies • Fidel V. Ramos

attending
IMPLEMENTING RULES AND REGULATIONS
physician allowed in hospitals
SEC. 10. IMPORTATION OF BLOOD BANK

• → tax-and duty-free
SEC. 11. RULES AND REGULATIONS

• within 60 days
Collection Processing Provision
ceiling fees DOH MEMORANDUM ORDER ON

CONVALESCENT PLASMA
SEC. 12. PENALTIES
DOH Memorandum Circular No. 2020-0049
Collection charging of fees
•
convalescent plasma
• license
donation
DOH Memorandum Order No. 2020-0216

• 1 to 6 months
• Collection of convalescent plasma
• 5K to 50k both
networking
without
securing any license to operate CONVALESCENT PLASMA
fails to comply • therapeutic approach
• 12 years and 1 day - 20 years plasma
P50,000 - P500,000 both
•
dispensing transfusing failing
• →
to dispose
within 48 hours
imprisoned for 10 years • →P a s s i v e i m m u n i t y
SEC. 13. SEPARABILITY CLAUSE PLASMAPHERESIS

• liquid part
separated
SEC. 14. REPEALING CLAUSE
•
saline or albumin
Josiah Villanueva
CRITERIA FOR DONATION OF CONVALESCENT PLASMA

•
1ST PREFERENCE
•
2ND PREFERENCE
•
3RD PREFERENCE
•
SUMMARY
Josiah Villanueva
HIV Laws RA 8504 and RA 11166
CHAPTER 2 HIV LAWS RA 8504 HIV Treatment Hub
AND RA 11166 Antiretroviral Therapy

prevents the
Learning Objectives
• replication of virus
• STD/AIDS Central Cooperative Laboratory

•
•
HIV Algorithm
HIV STATISTICS
Western Blot
GLOBAL HIV & AIDS STATISTICS — 2020 FACT SHEET
• 26 million
antiretroviral therapy Confirmatory technique Gold standard
• 38.0 million CD4 Cells
living with HIV
• 1.7 million newly

HISTORY
infected
• 1981
•
Pneumocystis
jirovecii ( Pneumocystis carinii)

• 75.7 million
homosexual men
since the start of the epidemic
• Kaposi’s sarcoma
• 32.7 million died

• Karposi’s Sarcoma
from AIDS-related illnesses
•
HIV STATISTICS IN THE PHILIPPINES
• Françoise Barré-Sinoussi Luc
Montagnier 1983
HIV 1 AND HIV 2

• Kinshasa, Congo
• chimpanzees
HIV 1
• Central
• Red ribbon
Africa in 1959
•
DEFINITION OF TERMS •
HIV
•
AIDS • Pandemic Group M
PLHIV
Josiah Villanueva
HIV 2 BINDING
• 1980 •
• •
FUSION
HIV
•
• RNA
• Lentivirus
REVERSE TRANSCRIPTION
•
• Retrovirus
•
•
•
• 2nd Notorious laboratory acquired infection

INTEGRATION
• CD4 positive T cells •
REPLICATION
•
• gp120 (glycoprotein 120)

ASSEMBLY
•
• gp41 (glycoprotein 41)
• P24 Antigen gp160 BUDDING

•
VIRAL ENTRY OF HIV TO HUMAN CELLS
•
MODE OF HIV TRANSMISSION

You can get HIV via
BODY FLUIDS
•
Steps in HIV Replication
Biological Fluids that transmit HIV
Josiah Villanueva
•
ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)

• HIV left untreated
blot
•
• immune system is badly damaged, 2. Immunofluorescence go back

opportunistic infections • Chemiluminescence Microparticle
Immunoassay
• Opportunistic infection
•
•
•
Criteria to be considered as AIDS:
3. Radio Immuno-Precipitation Assay
4. Other supplemental tests for HIV antibody
•
DOH RHIVDA CONFIRMATORY TESTING
Rapid HIV diagnostic algorithm
LABORATORY DIAGNOSIS OF HIV •
SCREENING TESTS FOR HIV:

• Gold standard
CONFIRMATORY TESTS FOR HIV:

1. Western Blot
• Gold standard
Western Blot Procedure
Josiah Villanueva
CONSENT FORM GO BACK •

Safety and universal precautions
PERSONAL DATA SHEET eradicate conditions

aggravate the spread of HIV infection
Participation of affected individuals
RA 8504
S3: DEFINITION OF TERMS

prevention control
Sexually Transmitted Disease
information educational
HIV
monitoring
system
AIDS
•
• HIV Transmission
• February 13, 1998
• Fidel V. Ramos HIV/AIDS Prevention and Control
High-Risk Behavior
Prophylactic
HIV Testing
SECTIONS OF RA8504
Window Period
S1 TITLE
•
Anonymous Testing
S2: DECLARATION OF POLICIES
• AIDS no boundaries
no known cure.
Public awareness
Compulsory HIV Testing
Voluntary HIV Testing

•
HIV Negative
Full protection human rights and civil
liberties
HIV Positive
• →
Person with HIV
•
•
Josiah Villanueva
Informed Consent •
• local HIV prevention
education
Medical Confidentiality • Donated sold prophylactics
• proper efficacy
Pre-Testing Counseling
• sexual abstinence mutual
fidelity
• false intentionally
Post-Testing Counseling
misleading information
•
HIV/AIDS Monitoring
• 2 months to 2 years
ARTICLE 1 EDUCATION AND INFORMATION S5-S11
ARTICLE 2 SAFE PRACTICES AND PROCEDURES S12-S14

• Schools non-formal
•
HIV education
disposed of safely
•
•
• accepted research
strict sanitary
•
• safe surgery
• →
medical procedures
•
•
• cadavers body fluids
• →
waste HIV
•
•
• dangerous practices
• health providers →
• → 6 to 12 years
• → Permit or license canceled

•
withdrawn
• All government private employees ARTICLE 3 TESTING SCREENING & COUNSELING S15-S21
• NO compulsory
• DOH DOLE → private encouraged high-risk individuals
companies •
• Armed Forces
•
PNP oversee
•
• Filipinos going
abroad
Josiah Villanueva
• Age 15 and above • LGUs prevention care
efforts
• appropriate confidential • Livelihood efforts

HIV testing
Prohibitions on compulsory HIV testing. • Not deprived of full participation

• employment
• educational • →
• entry stay prevention control efforts
• travel • health insurance is

• available
• individual’s right to health

unlawful
Exception
• Committed crime
ARTICLE 5 MONITORING S27-S29
• AIDSWATCH council
•
Family Code of the Philippines • Determine monitor
→
• organ
• blood donation
• assuring
anonymous
reporting confidentiality
• Code given
• AIDSWATCH
→ accreditation records
from DOH maintain standards
• track HIV rates
→ counseling confidentiality
before testing
• Contact tracing confidentiality
Councilor DOH standards
• 1 week training
• Proficiency certificate
ARTICLE 6 CONFIDENTIALITY S30-S34
• All
• adequate affordable strictly observe confidentiality handling
•
Exceptions
reportorial requirements
•
• →
health workers
involved in the treatment care
•
•
• Blood units → RITM
•
subpoena duces tecum
subpoena ad testificandum
ARTICLE 4 HEALTH AND SUPPORT SERVICES S22-S26
• Hospitals provide care • HIV results may be given to
•
•
Josiah Villanueva
• S44 FUNCTIONS OF PNAC
•
• • Determine
• Legal penalties breaching • Evaluate
• Institutionalizing National AIDS Registry
• Reporting
• inform spouses sex

• anonymity
partners
Secure recommendations ensure coverage
ARTICLE 7 DISCRIMINATORY ACTS AND POLICIES S35-S42
Employers
Schools •
•
•
legal right travel live •
lodge Quarantines
•
other restrictions are illegal
•
legal right to seek public
•
office
Monitor
Insurance
Develop monitor
cannot be refused
does not lie status Coordinate strengthen
cannot refuse treatment

discriminate Coordinate cooperate
Decent burials
Evaluate recommend
Legal penalties discrimination
≤
institutions →L i c e n s e / p e r m i t s r e v o k e d S45 MEMBERSHIP AND COMPOSITION
• 26 members
ARTICLE 8 S43-S48
•
Philippine National AIDS
Council (PNAC)
• December 3, 1992 EO No.39 •
• empowered national
coordinating body
Summary of Articles
prevent the transmission
lessen its impact
Josiah Villanueva
Failure participate EQAS
quarterly statistical reports
Refusal survey monitoring
A.O. NO. 2005-0032
DEFINITION OF TERMS
ADMINISTRATIVE ORDER FOR HIV
Quality Assurance
Important Administrative Order for HIV
HIV
Quality Assessment
Testing Laboratories
QAP
HIV Testing Laboratories
(EQAs) Panels
TB and HIV Prevention and Control
HIV Counseling and

Testing in Community Health
Facility Settings
EQAS
AO NO 2005 – 0027
• →
DEFINITION
• →
HIV Test kit
EQAS Participants
NRL→SACCL/SLH
NRL-RITM NVMSP
Training Participants
NRL-SACCL/SLH
NVBSP
Proficiency Certificate
VIOLATIONS
Certificate of Qualification
Certificate of Participation
affect
QA GUIDELINES: REQUIREMENTS FOR QUALITY RESULTS
testing reporting of results
RECORDING
Failure to submit sero-active samples
Logbook information below are kept confidential

Failure report confirmed seropositive cases
Josiah Villanueva
VERIFICATION OF TRUE POSITIVE AND TRUE NEGATIVE

WORKSHEETS →
• Serves as a work map for each test run

• Filled up before the test •
•
• after
Worksheet information verifying the result confirmatory
DAILY LOG SHEET
QA GUIDELINES: QUALITY CONTROL

REVIEWING OF TRANSCRIPTIONAL MEASURES INTERNAL CONTROLS
• •
• •
• →
• →
→
EXTERNAL CONTROLS
QA GUIDELINES: TESTING •
TESTING ALGORITHM FOR HIV TESTING
Criteria for External Controls

•
0 . 8 μ m f i l t e r or
inactivated at 56C for 30mins

• →
QA GUIDELINES: REQUIREMENTS FOR REPORTING OF RESULTS
REFERRAL OF REACTIVE SAMPLES W/ THE FF INFO
Josiah Villanueva
REPORTING OF CONFIRMATORY RESULTS AND/OR CONDITIONS OF SATISFACTORY AND UNSATISFACTORY

VALIDATION OF TEST RESULTS W/ THE FF INFO RESULTS
•
• → 1 0 0 % →c e r t o f q u a l i f i c a t i o n
below 100%
→s u p e r v i s o r y v i s i t
QA GUIDELINES: STORAGE OF REACTIVE AND •
INDETERMINATE SPECIMEN FOR FOLLOW UP TESTING
-20C granted after supervisory visit
500μL recommendation
Plastic screw capped vial evaluation appropriate action
Logbook info
Aliquot several vials

GUIDELINES ON EQAS: TRAINING ON HIV PROFICIENCY
•
Avoid repeat freeze thawing
Labeled
REQUIREMENTS OF INITIAL HIV PROFICIENCY TRAINING

GUIDELINES ON EQAS: INTRO
application form
•
once a year PRC ID
Letter of endorsement
•
certification
• HIV HBV HCV Syphilis

Registration fee
GUIDELINES ON EQAS: PARTICIPATION TO EQAS

SCOPE OF THE PROFICIENCY TRAINING
•
PROCEDURE FOR THE EQAS PARTICIPATION
receive the EQAS panels
Perform the test within 7

working days
HIV PROFICIENCY TRAINING SHALL BE BASED IN THE FF:

4. Submission within 30 days
Unknown panels freezer
DURATION OF HIV TRAINING

Summary of EQAS results • 7 working days
REQUIREMENTS FOR RENEWAL OF HIV PROFICIENCY CERT

NRL-SACCL/SLH
Josiah Villanueva
Accomplished application form 3. Initial renewal proficiency certificate
• name name of the lab

certificate number validity
Photocopy period
Quarterly census form

LIMITATIONS AND THE USE OF PROFICIENCY CERT IN
HANDLING HIV TESTING LABS
Cert of performance
• service 2 HIV testing labs
Cert of training seminar convention
• Any necessary amendments
reviewed
2 ID picture
amended
• MONITORING
• EQAS participants
EXEMPTIONS FOR NON-RENEWAL OF HIV PROFICIENCY who obtain unsatisfactory results
CERTIFICATE
• observation during
Consistently practicing HIV testing
the performance of test panels
• spontaneous monitoring
Trainers
recommend
HIV proficient MT
resolution of errors
HIV Proficient MTs
VALIDITY
years
CATEGORIES OF PROFICIENT MT REQUIRING RENEWAL OF
participation 1
CERTIFICATE
qualification 2
Category I
proficiency 3
Category II GROUNDED FOR NON-ISSUANCE OF CERT OF PARTICIPATION

• unregistered expired certificate
test kits reagents

Category III
• without valid proficiency
training certificate
• non-proficient
ISSUANCE AND CONTENT OF CERT OF PROFICIENCY AND MT performing the test
EQAS QUALIFICATIONS • Switching of EQAS panels
participation • Falsification of documents
•
supervisory visit REPUBLIC ACT 10173 DATA PRIVACY ACT OF
• name of the lab 2012
qualification
• signed head of the NRL-SACCL/SLH
•
name of the lab satisfactory result
validity period
Josiah Villanueva
• •
• Benigno S. Aquino III •
• June 6, 2012. •
• Personal information
• Privileged information •
• Sensitive personal information
REPUBLIC ACT NO. 11166

•
RA no. 8504
• December 20, 2018
• Rodrigo Roa Duterte
KEY TERMS OF RA11166

•
Josiah Villanueva
RA 6425 Dangerous Drugs Act of 1972
•
RA 6425
Jan 23, 2002
CHAPTER 3
• Gloria Macapagal-Arroyo
DANGEROUS DRUGS ACT OF
ARTICLE I DEFINITION OF TERMS
1972 Administer
RA 6425
• Dangerous Drugs Act of 1972 • injection most potent
• April 4, 1972
• Ferdinand Marcos
Deliver
• Note
Use
DECLARATION OF POLICY
safeguard the youth
Chemical Diversion
apprehend trafficking use

Controlled Delivery investigative technique
penalties
program of treatment
programs rehabilitation Illegal Trafficking
Planting of Evidence
2 REGULATORY AGENCY OF DRUG ABUSE
Dangerous Drugs Board monitors
Drug Dependence
Strong desire compulsion
Philippine Drug Enforcement Agency
monitors penalizes Drug Syndicate
Financer
TYPES OF DRUGS
• Prohibited drug
Protector/Coddler
physiological effects
Pusher
• Regulated drug Self inducing sedatives Den, Dive or Resort

Clandestine Laboratory facility used for the
illegal manufacture
•
Screening Test
Methamphetamine Cannabis opiates
potential/presumptive
Confirmatory Test
•
validate and confirm
RA 9165 →
• Comprehensive Dangerous Drugs Act of 2002
Josiah Villanueva
→
Illegal Trafficking
Application Service Provider
ntegration Drug Testing Operation

Instrument Management Information System
Client/Donor
Manufacture
Cut off value
Marijuana
Cannabis sativa L.
Screening Test
Confirmatory Test
downer → Challenge Test
Opium
Papaver somniferum L.)
East Avenue Medical Center
S3 CLASSIFICATION OF DRUG TESTING LABORATORIES

Opium poppy
OWNERSHIP
• Government
Methylenedioxymethamphetamine
Ecstasy • Private
• → stimulant
Methamphetamine Hydrochloride
INSTITUTIONAL CHARACTER
• Institution-based
PDEA
Trading
• Freestanding
Sell
SERVICE CAPABILITY
Note
• Screening laboratory
• Confirmatory laboratory
IMPLEMENTING RULES AND
REGULATIONS GOVERNING ACCREDITATION
OF DRUG TESTING LABORATORIES IN THE
PHILIPPINES S5 CLIENT/DONOR OF DRUG TESTING LABORATORIES
S3 DEFINITION OF TERMS MANDATORY DRUG TESTING

• driver's license
Chain of Custody Specimen tracking
• firearm's license
• military
Custody and Control Form • law enforcers
Josiah Villanueva
• Persons w/ a criminal
offense
Screening
• Candidates for public office •
• violating
LABORATORY EQUIPMENT
Confirmatory
RANDOM DRUG TESTING
• Students Basic Equipment
• Officers employees
S6 TECHNICAL REQUIREMENTS FOR ACCREDITATION
CHAIN OF CUSTODY
•
Screening vs Confirmatory Laboratory
• 20 sqm
•
Screening
• work area 10 sqm

PHYSICAL PLANT
•
• 60 sqm
Confirmatory
• work area 30 sqm

Minimum information required on the CCF
•
• Pathologist
• Physician
Screening
HEADSHIP OF LABORATORY
•
licensed physician chemist MT •
pharmacist chemical engineer
INFORMATION TECHNOLOGY REQUIREMENTS
•
• Pathologist toxicology
Confirmatory
• chemist master’s 2
•
years Ana chem
• full-time
PMC
Screening
•
• chem engineer
•
• full time licensed chemist

•
• chromatography
Confirmatory
spectroscopy PMC STORAGE OF LABORATORY RESULTS AND SPECIMENS

PERSONNEL
Josiah Villanueva
• negative weeks
result minimum of 5 days
• EAMC
• fails to pass proficiency
• positive result →
confirmatory lab
TEST LEVELS • 1ST Failure Suspension
• • 2nd Failure Revocation
→
SPECIMEN DONOR IDENTIFICATION
• Valid Photo ID
•
•
•
PROCEDURE MANUAL
S7 VALIDITY OF THE TEST RESULT
•
•
Inclusions
1 year period from the date of
issue
Screening lab Confirmatory lab
Documents
for
LABORATORY REPORT
accreditation
Screening test result form
Signatory of test result → •
fees
Reporting test results •
Screening → Validity
Test
Confirmatory
Test
S13 RENEWAL CERTIFICATE OF ACCREDITATION
• →9 0 d a y s b e f o r e e x p i r y d a t e
• BHFS CHD
• →
conducts survey
• membrane of the
testing kit
• disapproves the renewal
• chromatogram
• →
Failure comply 15 d a y s →s u s p e n s i o n
→ revocation
PROFICIENCY TESTING
• Results of proficiency test
within 3
Josiah Villanueva
S14 MONITORING OF LABORATORIES S21 TRANSITORY PROVISIONS

• Dangerous Drugs Board-Laboratory
S16 VIOLATIONS •
results •
results
proficiency testing BOARD REGULATIONS AND AO
owner manager
criminal offense
positive screening test results
Secondary Tertiary Students
Random Drug
•
Testing
Schools
•
Free-
standing Screening Drug Testing
Laboratories
Failure to submit
• CHED memorandum order No. 64
documentation
within 6 war against illegal drugs
months of operation •
revocation
•
Refusal to allow survey, monitoring
S17 SUSPENSION OR REVOCATION CERTIFICATION OF DRUG TESTING

ACCREDITATION SCREENING TEST
→
INHIBITION IMMUNOFLUORESCENT ASSAY
Principle
→
• Most popular screening
• →
• C M
S20 PENAL PROVISION
T
C M T well C M T well C M T well
I I I I I I I
•
• C M T well C M T well
Josiah Villanueva
I I I •
•
•
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY-MASS

•
SPECTROMETER (HPLC-MS)
THIN-LAYER CHROMATOGRAPHY: A TWO-COMPONENT

•
MIXTURE
• Complicated less popular
•
• Thin Layer Chromatography
• Chromatogram
• Mass Spectrometer
ions fragments
separated mass-to-charge
Principle
(m/z) ratio
• SPECIMEN AND SPECIMEN COLLECTION
TYPES OF SPECIMEN
CONFIRMATORY TEST • More than one type may be collected
GAS CHROMATOGRAPHY-MASS SPECTROMETRY (GC-MS)

•
1. URINE SPECIMEN
• Least expensive most popular
• Gold standard • noninvasive convenient
•
Josiah Villanueva
• within the week •
• Abstaining negative
• Collection Device (Acronym: BUSSHT)
• easily tampered
2. SALIVA SPECIMEN
•
• Short detection time
• Minimum Quality of Specimen

60 ml single 30 ml two
3. BLOOD SPECIMEN
• Most expensive
1.5 ml 0.5 ml
Most accurate
5 ml
• 100 mg
•
7 to 14 days
•
METHODS OF SPECIMEN COLLECTION
4. SWEAT (PATCH) SPECIMEN
• Observed → presence of ASC
wearing 1-2 weeks • Unobserved → absence
• •
•
•
• contamination false positive
• CONDITION WHEN UNOBSERVED SPECIMEN COLLECTION IS

ALLOWED
5. HAIR SPECIMEN
•
• Twice more sensitive
• Do not detect recent use
• →
• 1.5 x 1.5 cm hair

100mg TYPES OF SPECIMEN COLLECTION
• Single specimen collection
• • Split specimen collection
COLLECTION DEVICE
• •
•
HOW TO DETERMINE A URINE SAMPLE?
• 32.5 - 37.7 C
Josiah Villanueva
Ra 10586 Anti-Drunk and Drugged Driving Act Of 2013
• SG 1.003 < SG < 1.025 •
• creatinine >20 mg/μL
A URINE SPECIMEN IS INVALID WHEN: S7 MANDATORY ALCOHOL AND CHEMICAL TESTING OF

ASD
DRIVERS INVOLVED IN MOTOR VEHICULAR ACCIDENTS
S12
CHAPTER 4 RA 10586 ANTI-
DRUNK AND DRUGGED DID NOT CAUSE PHYSICAL INJURY OR HOMICIDE
DRIVING ACT OF 2013 • 3 months P20,000 – 80,000
CAUSED PHYSICAL INJURY

RA 10586
• 100, 000 – 200,000
• Anti-drunk and Drugged Driving Act of 2013
• May 27, 2013

HOMICIDE INVOLVED
• P300.000 – 500,000 longer prison term
• Benigno S. Aquino lll
S3 DEFINITION OF TERMS • Non-professional

Alcohol 1st conviction
2nd conviction
Breath analyzer
• Professional
Chemical tests
Driving under the influence of alcohol
Field sobriety tests
S6 CONDUCT OF FIELD SOBRIETY, CHEMICAL AND CONFIRMATORY TESTS

•
Josiah Villanueva
AO No. 2006-0024 Accreditation of Laboratories for Drinking Water Analysis
CHAPTER 5 AO NO. 2006-0024

ACCREDITATION OF Quality manual
LABORATORIES FOR
DRINKING WATER ANALYSIS
Quality policy
P.D. 856
Code of Sanitation of the Philippines Specimen
• examination
Standard Method
water testing laboratories
AO NO. 2006 – 0024

Water analysis
Rules and Regulations Governing the
Accreditation of Laboratories for Drinking Water
Analysis POLICIES AND GUIDELINES
•
GENERAL POLICIES
• Francisco T. Duque III
•
• → Safe potable
OBJECTIVES B H F S →i n i t i a l i s s u a n c e COA
• protect CHD → Renewal

NRL → proficiency confirmatory
personnel training
•
standards
SCOPE/ COVERAGE OF THE LAW requirements specific conditions
• limitations are met
•
violating the provisions
→ BHFS/CHD investigate
•
DEFINITION OF TERMS
fraud result
BHFS
Change in the ownership head
w/o informing the BHFS/CHD
CHD
Refusal to allow survey monitoring
NRL
Refusal to participate proficiency testing

PNSDW
Laboratory false statement application
suspension → ≤ 60 days
Josiah Villanueva
• Office of Secretary 15 Analyst → baccalaureate degree and at
days after the receipt least 2 yrs experience
• final and Laboratory aide → at least 6 months of
executory experience
• w/in 60 days • Operation of the lab →
sanitary engineer
• unit/section of a clinical lab • no sanitary engineer →

chemist MT pharmacist
• 3 years
• clinical
• laboratory → clinical
pathologist
• Sanitary engineer → 3
•
water labs
→ Government Private
• provisionally authorized
→I n s t i t u t i o n freestanding
only 1 lab
Service Capability
Bacteriological analysis
• Lab assistants
→ PMC
Biological analysis
• Biology graduate
Physical analysis
Each service must be operated by at least

Chemical analysis
• professional
• assistant
Radiological analysis
• aide
bacteriological service
SPECIFIC POLICIES: TECHNICAL REQUIREMENTS (PHYSICAL PLANT)
30 samples/day chemical
water power supply
service 4 samples
drainage ventilation
Dust-free not introduce contamination
SPECIFIC POLICIES: LABORATORY REPORTS
Min. 20 sqm free-standing • accurate test results
bench top head analyst testing facility
• head analyst
signatures lab reports
physical provision • electronic signatures

waste disposal system shall be considered valid
• lab reports form prescribed
SPECIFIC POLICIES: PERSONNEL

Head • outsourced tests
• management training at least 3 yrs
experience
Josiah Villanueva
Separate accreditation
separated premises same
management
PROCEDURAL GUIDELINES
• →
• not able to comply

accreditation →
• American Type Culture Collection
SPECIFIC POLICIES: LABORATORY RECORDS • respond within 30 days correct

deviations within 60 days of receipt
•
•
AO NO. 1979 0031
• minimum of 5 years LABORATORY APPARATUS, MATERIALS, AND REAGENTS

• minimum retention period BACTERIOLOGICAL ANALYSIS SERVICE
NRL
•
• secure confidential
→
• written plan
transfers
ownership terminates operation
Multiple-tube fermentation technique
QUALITY MANAGEMENT
internal quality audit
• enterobacteriaceae species
• c o m m o n →E s c h e r i c h i a c o l i
CERTIFICATE OF ACCREDITATION • →
• valid for 2 years •
• Expire last day of December →
• Failure to submit renewal within

60 days expiration date →lapse Minimum equipment for Bacteriological Analysis Service
cancellation of registration
• notify BHFS change name

ownership
• transfer of location new application
BIOLOGICAL ANALYSIS SERVICE (NOT PERFORMED BY MT)

Failure to report the substantial changes • Quantitative qualitative
within 15 days suspension phytoplankton
revocation
• Zooplankton bottom fauna
Josiah Villanueva
PHYSICAL AND CHEMICAL ANALYSIS SERVICE

•
• GC-MS HPLC
• →
2. CONFIRMED STAGE TEST

•
• Eosin methylene blue agar
green metallic sheen →
3. COMPLETED TEST
• Lactose broth fermentation tube
AO NO 2017-0010
Philippine National Standards for Drinking
Water of 2017
RADIOLOGIC ANALYSIS SERVICE (NOT PERFORMED BY MT)
• Dr. Paulyn Jean B.
• Alpha Beta
Rosell-Ubial
• Radioactive Strontium • June 23, 2017
• Radium
AO NO 1979-0031
•
Requirements for the Accreditations of Water
WATER BACTERIOLOGY Analysis Laboratories

•
MULTIPLE-TUBE FERMENTATION TECHNIQUE
•
• Gold standard test
• Clemente S. Gatmaitain
• MPN
• Lactose peptone broth (LPB) medium
enterobacteriaceae species
•
→
• → 5 tubes
Positive
Negative
PRESUMPTIVE STAGE TEST

•
Josiah Villanueva
RA9288 Newborn Screening Act of 2004
CHAPTER 6 RA9288 NEWBORN

SCREENING ACT OF 2004
NEWBORN SCREENING
• early detection and management
• mental retardation
•
child's right live and safeguards
METABOLIC DISORDERS (NEWBORN SCREENING) 3. PHENYLKETONURIA (PKU)

• phenylalanine
1. CONGENITAL HYPOTHYROIDISM (CRETINISM)
hydroxylase
•
phenylalanine
thyroid glands
Screening: FeCl3 tube test
• blue-
green color complex
Confirmatory: Guthrie Bacterial Inhibition test

• Bacillus subtilis beta2-thienylalanine
Symptoms of CH •
→
→
2. CONGENITAL ADRENAL HYPERPLASIA (CAH)
• Untreated →damage to the brain and nervous system can lead to:
adrenal glands
• •
• Hermaphrodite 
• 21-, 11- and 18-Hydroxylase

Symptoms of CAH
Male Female
Josiah Villanueva
4. GALACTOSEMIA 6. MAPLE SYRUP URINE DISEASE (MSUD)

• •
• 2,4-Dinitraophenylhydrazine (DNPH)
• test
• amino acid chromatography
• • →
•
• Symptoms of MSUD
→
→
→
Symptoms of Galactosemia
•
→ • Within normal limits
5. GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY RA 9288

• glucose •
metabolism
hereditary disorders •
• April 07, 2004
• Gloria Macapagal-Arroyo
Symptoms of G6PD
NATIONAL INSTITUTE OF HEALTH (NIH)
• implementation newborn
screening
• Newborn Screening Reference Center
Josiah Villanueva
• •
• •
• →
ARTICLE 1: GENERAL PROVISION
S3: OBJECTIVES:
S1 TITLE
every newborn access to newborn
• Newborn Screening Act Of 2004
screening
HOW IS NEWBORN SCREENING DONE? sustainable newborn screening
• heel prick method system
health practitioners aware

• absorbent filter card advantages of newborn screening
• dried for 4 hours

parents recognize their responsibility
child’s right to health full
•
development
immediately within 24 hours
7 working days
ARTICLE 2: DEFINITION OF TERMS
Comprehensive Newborn Screening System
• LIFETIME • Education
MANAGEMENT • Collection biochemical screening

Effect if not Effect if screened & • Tracking confirmatory
Disorder screened
screened managed
• Clinical evaluation
• Drugs medical/surgical management
• Evaluation of activities
• outcome quality assurance
Follow-up Monitoring
Health Institutions
Health care practitioners

ESTABLISHMENT OF NSCS
Heritable condition
2 Luzon
2 Visayas NIH
1 Mindanao Newborn delivery to 30

days old
Newborn screening collecting a few
S2: DECLARATION OF POLICY
drops of blood
• shall protect and promote the right to
collection card biochemical testing
health children to
survival healthy development
Josiah Villanueva
Newborn Screening Center
ARTICLE 4: IMPLEMENTATION
newborn screening laboratory
S10: LEAD AGENCY
Newborn Screening Reference Center
• DOH
testing follow up
protocols external laboratory implementing rules regulations
proficiencies national database
Parent Education
Coordinate dept. of the interior local

Recall locating a newborn government DILG
Treatment
medicine medical surgical management
dietary treating
mitigating consequences S11: ADVISORY COMMITTEE ON NEWBORN SCREENING
• inter-agency collaboration
ARTICLE 3: NEWBORN SCREENING
•
S6: PERFORMANCE OF NEWBORN SCREENING
• Review annually recommend
• 24 hrs of life
• Review recommend
• neonatal intensive care unit
Committee: 8 members
Secretary of the DOH
• BUT
Executive director of the NIH
•
S7: REFUSAL FOR TESTING

• may refuse
religious belief
secretariat NIH
• refusal documentation
• 2 times a year
• S12: ESTABLISHMENT AND ACCREDITATION OF NEWBORN

SCREENING CENTERS
S8: CONTINUING EDUCATION, RE-EDUCATION AND

all tests newborn
TRAINING HEALTH PERSONNEL
screening program
• Disseminate information
recall/follow up programs for infants
at least annually
maternal pediatric
trained personnel
S9: LICENSING AND ACCREDITATION qualified by the NIH
• DOH PHIC Submit inspections

Reference center
S13: ESTABLISHMENT OF A NEWBORN SCREENING

REFERENCE CENTER
•
Josiah Villanueva
S14: QUALITY ASSURANCE NIH:
drafting ensuring good lab
practice
proficiency testing
certification program
technical information
Technical assistance
→ → →
S15: DATABASE
national database of patients
tested registry for each condition
submit reports annually
S16: NEWBORN SCREENING FEES

•
NBS fee shall be applied to
Josiah Villanueva
RA 7170 Organ Donation Act of 1991
CHAPTER 7 RA 7170 ORGAN S1: TITLE

• Organ Donation Act of 1991
DONATION ACT OF 1991
•
legalize permissions
INTRODUCTION
• S2 DEFINITION OF TERMS
• 113,000 people Organ Bank Storage Facility
• One more person 10

Decedent
minutes
•
Testator
Donor
WHO CAN DONATE?

• medical condition at the time of death Legatee
Donee
Hospital
•
Part
•
Person
TESTS AND PRECAUTIONS PERFORMED

•
•
Physician or Surgeon
• Human leukocyte antigen ( HLA) typing
Immediate Family of the Decadent
• → Death
• • absence
of natural respiratory and cardiac function
• Irradiated blood
Or
•
irreversible cessation
of all brain functions
RA7170
•
way of legacy or will
•
•
S3: PERSON WHO MAY EXECUTE LEGACY
(18) years old sound mind
• Cornea
• Jan 7, 1992
Josiah Villanueva
S4: PERSON WHO MAY EXECUTE DONATION

•
In order of priority
•
•
provided that prior to his death
• →
S9 MANNER OF EXECUTING A DONATION

S5 EXAMINATION OF HUMAN BODY OR PART THEREOF • 48 hours → relatives
• authorizes any examination necessary to S4 guardian
assure medical acceptability
• are
• → →
absent
→
authorized to remove
• the organ part in a public document
S6 LEGATEES OR DONEES
• death
hospital physician surgeon
education research advancement
diagnosed certified
therapy Transplantation
by (2) qualified physicians
school 1
physician
2 3
Surgeon
4
Head designated officer
organ bank storage 1
2 4 5
individual 4 5 S10: PERSON(S) AUTHORIZED TO REMOVE TRANSPLANTABLE ORGANS

•
S7: DUTY OF THE HOSPITAL
• qualified personnel staff

S11: DELIVERY OF DOCUMENT OF LEGACY OR DONATION
→
• form document
S8: MANNER OF EXECUTING A LEGACY

•
•
→
•
•
• present 2 witnesses
S12: AMENDMENT OR REVOCATION OF LEGACY OR
DONATION
•
Josiah Villanueva
• facial appearance
•
• •
S2: S10 OF RA7170 IS HEREBY AMENDED

•
S13: RIGHTS AND DUTIES AFTER DEATH

• • Removal of corneal tissues
ophthalmic surgeons ophthalmic
•
technicians
SEC. 14: INTERNATIONAL SHARING OF HUMAN ORGANS

S6
•
Feb 20 1995
RA 7885
advance corneal transplantation
S1: S9 OF RA7170 IS HEREBY AMENDED

• 48 hours → relatives hours should the medical personnel locate the nearest
S4 guardian relatives of the decedent at the time of death befor
executing the organ donation
•
absent
physician
Surgeon
Head designated officer
removal of the cornea/s (12)

hours after death
will not interfere

investigation post-mortem
Josiah Villanueva
Medical Technology Code of Ethics and Bioethical Principle
MEDICAL
Treat any information I acquired
CHAPTER 8
confidential
TECHNOLOGY CODE OF divulged only to
ETHICS AND BIOETHICAL

PRINCIPLE
ETHICS, HYMN AND PRAYER
• Code of Ethics document mission
values indicates
PAMET HYMN
• Francis Jerota Pefanco
MEDICAL TECHNOLOGY CODE OF PROFESSIONAL ETHICS • Hector Gentapanan Gayares, Jr.
• first heard 25th

As I enter into the practice of Medical Technology, I shall…
National Convention
responsibilities
PICC November 22,
Uphold the law
1989
• Roselyn P.
Avoid associating
Villones
spirit of fairness
•
BELOVED PAMET
honorable competition
refrain
Accept employment
no conflict of interest
•
Perform professional work
Review the professional work
exchanging general MEDTECH PRAYER

information experience God vocation
contributing to
the work
Restrict praises criticism views opinions
Josiah Villanueva
zeal 3. NON – MALEFICENCE
determination
•
4. JUSTICE
•
fairness & equality
PANUNUMPA NG PROPESYONAL
pangalan tirahan •
• Respect rights
EUTHANASIA
•
Active
Passive
Voluntary euthanasia
consent
Non-voluntary unable to give
their informed consent

Diyos
Involuntary against
BIOETHICAL PRINCIPLES their will
PATIENT RIGHTS AND RESPONSIBILITIES

AUTONOMY
FOUR KEY ETHICAL PRINCIPLES •
1. AUTONOMY
• right to refuse choose •
• own decisions •
• not force coerce •
2. BENEFICENCE INFORMED CONSENT

•
• act in the best interest
PATIENTS’ RIGHTS
•
• →
Josiah Villanueva
•
List of Patient’s Rights
•
DUE PROCESS
•
•
ensure fair trial for every
accused
•
• advance notice of trial
•
•
•
•
Josiah Villanueva

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MEDICAL TECHNOLOGY LAWS AND

• Rene Theophile Hyacinthe Laënnec

M. RUTH WILLIAM (1096-1438)

DR. PRUDENCIA STA ANA

• First laboratory course in Pathology • The creation of Syllabus (1954)

• John Hopkins University •

SIR JOHN SCOTT BURDEN-SANDERSON (1885)

DR. JAMES C. TODD (1908)

MEDICAL TECHNOLOGY IN THE PHILIPPINES •

• (208) Quiricada St. Sta. Cruz, Manila

DR. JESSE UMALI

• Dr. Mariano C. Icasiano THE MEDICAL LABORATORY SCIENCE

UNIVERSITY OF STO. TOMAS

• June 30, 1960

June 12, 1961

CENTRO ESCOLAR UNIVERSITY

FAR EAST UNIVERSITY (1961)

POST GRADUATE STUDIES OF MEDICAL TECHNOLOGY

• 10am September 15, 1963 at the Public Health • Unity

• Conference Hall FEU Hospital (Sept 20, 1964)

• Microscope & Snake

PAMET VISION AND MISSION

PAMET CORE VALUES (EPICU)

CHARLEMAGNE T. TAMONDONG (EMERGENCE OF THE •

• Philippine Laws of Medical

AGNES B. MEDENILLA (ORGANIZATIONAL DYNAMISM)

• Teves Law SHIRLEY I. FABIAN-CRUZADA (INTERDISCIPLINARY

PASMETH PHISMETS SEAL

• Cirilo S. Cajucom 5 Bubbles from a Test Tube

• Atty. Dexter Bilhis 15 Interconnected Molecules Outside a Test Tube

SOME LAW TERMINOLOGIES •

• • Automation minimizes errors and shortens

RECOGNIZED SCHOOL OF MEDICAL TECHNOLOGY

S3 COUNCIL OF MEDICAL TECHNOLOGY EDUCATION S7 MEDICAL TECHNOLOGY BOARD

S4 COMPENSATION AND TRAVELING EXPENSES OF S8 QUALIFICATION OF BOARD EXAMINERS

d) • Secretary of the Board

S11 FUNCTIONS AND DUTIES OF THE BOARD

S12 REMOVAL OF BOARD MEMBERS S19 RATING IN THE EXAMINATION

S13 ACCREDITATION OF SCHOOLS OF MEDICAL S20 OATH TAKING

S21 ISSUANCE OF CERTIFICATE OF REGISTRATION

S25 APPEAL S31 REPEALING CLAUSE

S26 REINSTATEMENT, REISSUE OR REPLACEMENT OF

S29 PENAL PROVISION

S30 SEPARABILITY CLAUSE

CHAPTER 3 RA7722 S7 BOARD OF ADVISERS

SECTIONS OF RA 7722 • cultural

• S8 POWER AND FUNCTIONS OF THE COMMISSION

S3 CREATION OF THE COMMISSION ON HIGHER

• S10 THE HIGHER EDUCATION DEPARTMENT FUND

• S12 THE TECHNICAL PANELS

S13 GUARANTEE OF ACADEMIC FREEDOM

S15 TAX EXEMPTIONS

S18 TRANSITORY PROVISIONS

CHAPTER 4 CMO NO. 13S 2017 S6 PROGRAM OUTCOMES

INTERNSHIP EXPOSURE/CONTACT TIME IN THE LAB

S5.4 CAREERS AND OPPORTUNITIES FOR GRADUATES

S5.5 ALLIED MEDICAL FIELDS

S13 ADMINISTRATION QUALIFICATIONS OF DEAN

S14.1.2 LICENSURE COURSE TEACHER

ARTICLE 6 DUTIES AND RESPONSIBILITIES OF CLINICAL

S1 CI/IC/CC DUTIES AND RESPONSIBILITIES

ARTICLE 7 DUTIES OF RESPONSIBILITIES OF INTERN

S2 ATTENDANCE AND PUNCTUALITY •