MLS 406 | Medical Technology Laws and Bioethics

TOPIC: RA 11166 – Philippine HIV and AIDS Policy LECTURER: Atty. Francis C. Brion, RMT
Act Transes by: Miguel Astronomo
SOURCE: Quipper PDF M 01 March 01, 2023

RA 8504 Section 6 – Membership & Composition (21

members)
"Philippine AIDS Prevention and Control Act of 1998."
Approved: February 13, 1998 • DOH
• DepEd
Section 2- Declaration of Policies • DOLE
• DSWD
(a) Establish policies & programs to prevent the spread • DILG
of HIV & deliver treatment, care and support • CSC
services to Filipinos living with HIV. • CHED
(b) Adopt a multi-sectoral approach in responding to
• NYC
the country's HIV & AIDS situation.
• PIA
(c) Ensure access to HIV & AIDS related services.
(d) Positively address & seek to eradicate conditions • DBM
that aggravate the spread of HIV infection. • Chair of Com. Health & Demography in Senate
• Chair of Com. Health in Lower House
Section 3 – Definition of Terms • 2 Reps from org of PLHIV
• 1 Rep from Private org. expert in standard setting &
• (b) Anti-retroviral Therapy (ART) service delivery
• (c) Bullying • 6 Reps from NGO works in welfare of key
• (d) Civil Society Organizations (CSO) populations
• (e) Community-Based Research • (Heads of agencies or rep [Asst. Sec.] &
• (f) Comprehensive Health Intervention for Key presidential appointments)
Populations
n Meets quarterly
• (g) Evolving Capacities of the Child
n 10 members quorum
• (h) Gender Expression
n DOH Sec permanent chair
n Vice chair to be elected (3 vear term)
• (k) Gender Identity n CSO member (3 vear term for 2 consecutive terms)
• (I) Health Maintenance Organization (HMO)
• (m) High Risk Behavior Section 8 – AIDS Medium Term Plan
• (y) Informed Consent Updated annually the 6 vear AMTP
• (z) Key Affected Populations
• (bb) Mature Minor Doctrine Section 9 – The Role of DOH
• (cc) Medical Confidentiality
• (ee) Partner Notification • National HIV & AIDS &STI Prevention & Control
• (ff) Person Living with HIV (PLHIV) Program (NASPCP)
• (gg) Pre-exposure Prophylaxis • Epidemiology Bureau
• (hh) Pre-test Counseling
• (ii) Post-exposure Prophylaxis Section 10 – Protection of Human Rights
• (jj) Post-test Counseling
• (kk) Prophylactic Section 11 – Prevention Program
• (Il) Provider-initiated Counseling & Testing
• (mm) Redress (a) Safer sex practice
• (nn) Safer Sex Practices (b) Practices reducing risk of HIV infection
• (oo) Sexually Transmitted Infections (STIs) (c) Universal awareness & access to treatment
• (pp) Sexual Orientation (d) Knowledge of diff. rights of PLHIV & families

Section 4 – Philippine National Aids Council (PNAC) Section 12 – Education in Learning Institutes
[skipped]
Section 13 – Education for Parents and Guardians
Section 5 – Functions
Section 14 – Education as a Right to Health and
• (a) Develop AMTP Information
• (b) Ensure operationalization & implementation of
AMTP Section 15 – HIV and AIDS Information as a Health
• (c) Strengthen collaboration bet. Govt. Agencies & Services
CSOs
• (d) Develop & Ensure guidelines of this Act Section 16 – Education in the Workplace

• (j) Advocate policy reforms.
• (k) Submit Annual Report
• (I) Identify gaps in national response
• (m) Recommend policies & programs.
Section 17 – Education for Filipinos Going Abroad
Section 18 – Information for Tourist & Transients
Section 19 – Education in Communities

1
 Section 20 – Education for Key Populations &
Vulnerable Communities
Section 21 – Information on Prophylactics
Section 22 – Misinformation on HIV & AIDS
Section 23 – HIV Preventive Measures
(a) Creation of right-based & community led behavior
modification programs
(b) Establishment & enforcement of rights- based
mechanisms for partner disclosure
(c) Establishment of precautionary measures in private
& public health facilities
(d) Accessibility of ART & management of opportunistic
infections.
(e) Mobilization of communities of PLHIV
(f) Establish comprehensive human rights & evidence-
based policies & programs
Section 24 – Comprehensive Health Intervention for
Key Populations
Section 25 – Preventing Mother-to-Child HIV
Transmission
Section 26 – Standard Precaution on the Donation
of Blood, Tissue and Organ
(a) Accept only donated tissue & organ that is HIV
negative tested
(b) All donated blood shall undergo HIV testing
(c) All HIV positive donor will be notified, counselled &
referred to clinical management immediately
(d) All HIV positive donated blood, organ & tissue can
be accepted for research purposes & follows strict
sanitary disposal
(e) 2nd HIV testing can be demanded as a right of the
donee
Section 27 – Testing of Organ Donation
(a) A person volunteers or freely agrees to donate
one's blood, organ, or tissue for transfusion,
transplantation, or research
(b) A legacy and donation following RA 7170 (Organ
Donation Act of 1991)
Section 28 – Guidelines on Medical Management,
Surgical, and Other Related Procedures
• DOH will issue guidelines against HIV transmission
during surgical, dental, embalming, body painting,
or tattooing.
• Mandatory use of gloves, googles & gowns to all
medical personnel 7 tattoo artist
• Disposal of cadaver, body fluids, waste of HIV
positive persons
Section 29 – HIV Testing
• Voluntary HIV Testing
• Mandatory written consent
(a) 15-17 y NO CONSENT (evolving capacity of child)
(b) 14 below pregnant or high risk behavior with
licensed social worker NO CONSENT
Section 30 – Compulsory HIV Testing
(a) Charged with Art 264 RPC-Administering injurious
substance or beverages
(b) Charged with Art 266 RPC- Serious (Art 263 &
Slight Physical Injuries
(c) Charged with Art 335 RP/RA 5383-Rape
(d) Charged with Art 338-Simple Seduction having sex
over single female/widow of good refute 13-17 by
deceit
(e) Resolving Family Code issues(EO 209)
(f) Blood Donation (RA 7170 & RA 7719)
Section 31 – Mechanism and Standards on Routine
Provider-Initiated HIV Counseling and Testing
(a) Accredit public & private HIV testing facilities
(b) Develop guidelines for HIV counseling & testing
including MOBILE HIV counseling & testing
(c) Accredit institutions training HIVIAIDS counselors in
coordination w/ DSWD
(d) Accredit HIV/AIDS counselors for PWD in
coordination with National Council for Disability
Affairs (NCDA)
(e) Set standards for HIV counseling & work with CSOs
(f) Ensure access to routine provider initiated
counseling & testing
• FREE pre & post counseling in all HIV testing
facilities
• INFORMED Consent & CONFIDENTIALITY
Section 33 – HIV Testing for Pregnant Women
Section 33 – Treatment of Person Living with HIV
and AIDS
• FREE and ACCESSIBLE
Section 34 – Access to Medical Services by
Indigents
Section 35 – Economic Empowerment and Support
Section 36 – Care & Support for PLHIV
Section 37 – Care & Support for OFW-LHIV
Stigma-free comprehensive integration program
Section 38 – Care & Support for Families, Children &
Partners of PLHIV
(a) Education programs to remove stigma
(b) Educational assistance for children w/ HIV and orphans
due to HIV
(c) HIV treatment & management of minors w/HIV not
covered by PHIC-OHAT (out patient HIV & AIDS treatment
Section 39 – Care & Support Program in Prisons &
Other closed-setting Institutions
Section 40 – Non-discriminatory HIV & AIDS
Services
Section 41 – Protection of HIV Educators, Licensed
Social Workers, Health Workers, & Other HIV & AIDS
Service Providers from Harassment
Protection from civil, criminal & administrative liability HIV
prevention services rendered
Section 42 – Health Insurance & Similar Health
Services
PHIC to
(a) develop benefit package for PLHIV
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(b) develop benefit package for unborn & newborn of HIV
infected mother
(c) Set a preference price for HIV services in govt. hospitals
(d) Conduct programs to educate human resource to PHIC
package on HIV/AIDS
(e) Develop a mechanism for orphans LHIV to access HIV
benefit package
Section 50 – Penalties
(a) Misinformation on HIV and AIDS
1-10 y imprisonment & 50K to 500K fine
Manufacturer, Importer & Distributor of drugs
5-10 y imprisonment & 500K to 5M fine

NO DISCRIMINATION in HMO & Life Insurance
Section 43 – HIV & AIDS Monitoring & Evaluation
(a) Determine & monitor the magnitude & progression of
HIV/AIDS in Phil.
(b) Receive, collate, process & evaluate HIVIAIDS medical
reports
(c) Submit annual report to PNAC
Section 44 – Confidentiality
(b) Viol of Sec. 24 on police operations
1-5 y imprisonment & 100K to 500K fine
(c) 1. Deliberately & Negligently caused HIV
infection thru unsafe practice of profession
2. HIV testing without consent
6-12 y imprisonment & fines
(d) Viol. Of Sec. 41 protection of HIV educators,
counselors, etc.
6 m -5 y imprisonment & 100K to 500K fine

Covers: (e) Viol. Of Sec. 42 on Health Insurance

1. tested for HIV 6 m -5 y imprisonment & 50K min. fine
2. exposed to HIV
3. HIV/AIDS infected (f) Viol. Of Sec. 44 on Confidentiality
4. being treated for HIV/AIDS 1. Breach of Confidentiality
6 m -5 y imprisonment & 50K to 150K fine
VIOLATIONS:
a. Disclosure of confidential HIV & AIDS information 2. Mass dissemination of HIV status
(written consent needed) 2 y 1 d- 5 y imprisonment & 150K to 350K fine
b. Media Disclosure
3. Record Custodian Breach of Confidentiality
Section 45 – Exceptions 5 y 1 d-7 y imprisonment & 350K to 500K fine

a. When complying w/ national surveillance system of (g) Viol. Of Sec. 49 on Discriminatory Acts
DOH 6 m- 5 y imprisonment & 50K to 500K fine
b. When informing health workers involved in care of
PHLV (h) Person who will use HIV/AIDS data to malign or
c. When there is SUBPOENA (executive session damage another person
hearings) Punished under Art. 19, 20, 21 & 26 of New Civil
Code & RA 10173 (Data Privacy Act of 2012)
Section 46 – Disclosure of HIV-Related Test Results
Section 51 – Penalties Collected
1. Who was tested Goes to PNAC—Philippine National AIDS Council
2. 14 & below, orphan, mentally incapacitated
released to parent, legal guardian or license Quipper Quiz
social/health worker
3. Authorized rep of DOH monitoring body Is this the original HIv/AIDS No
law of the Philippines?
Section 47 – Disclosure to Persons with Potential Can a registered Medical Yes
Exposure to HIV Laboratory Scientist
(Medtech) who is HIV
STRONGLY ENCOURAGE to disclose to sexual partner positive be hired at a
Hospital?
Section 48- Duty of Employers, Heads of Govt. Which of the following 14 years old and below
Offices, Heads of Public & Private Schools, or NEEDS parental consent
Training Institutions, & Local Chief Executives before HIV testing?
What is the punishment No punishment of
(a) Promulgate rules and regulations prescribing provided by law for persons imprisonment
procedures for investigation of discrimination cases who deliberately infect
& its administrative sanctions other person with HIV
(b) Create an ad hoc committee on the investigation of through sexual intercourse
discrimination cases without declaring he/she is
HIV positive?
Section 49 – Discriminatory Acts & Practices Can a Donee (receiver) Yes
legally demandaas a matter
(a) Discrimination in workplace of right a 2nd HIV test
(b) Discrimination in Learning Institutions under the HIV/AIDS law?
(c) Restriction in Travel & Habitation
(d) Restrictions on Shelter
(e) Prohibition from seeking or holding Public Office
(f) Exclusion from Credit & Insurance Services

3
MLS 406 | Medical Technology Laws and Bioethics
TOPIC: RA 9165 – Comprehensive Dangerous LECTURER: Atty. Francis C. Brion, RMT
Drugs Act of 2002 Transes by: Miguel Astronomo
SOURCE: Quipper PDF M 02 March 01, 2023

RA 9165 A. Screening Lab - at least 20 sq. m. floor area

• Amended RA 6425 " Dangerous Drug Act of 1972
o Different penalties
o More prohibited drugs included
o DEN, DIVE, RESORT
o Planting of Evidence prohibition was
added
o Chain of custody elaborated
IMPLEMENTING RULES AND REGULATIONS
GOVERNING LICENSING AND ACCREDITATION OF
DRUG TESTING LABORATIES IN THE PHIL.
With 10sqm working area with exhaust fan,
sink, and storage cabinet.
B. Confirmatory Lab - at least 60 sq. m. floor area
with 30sqm working area with exhaust fan,
sink, stock room and instrumentation room.
DTL must accommodate 5 patients at the same time
2. Head of DTL
Clinical Pathologist (screening & confirmatory lab)
or any physician with training in Clin. Lab.
Management may head a screening lab.

Section 1. It applies to all government and private Clinical Pathologist can handle up to 10 DTL
drug testing laboratories provided they are within 5 km radius.

Section 3. Definition of Terms DTL which is a division or section of Clin Lab. Maybe headed
by either:
Ø CHAIN OF CUSTODY - refers to procedures to 1. Licensed Physician
account for each specimen by tracking its handling 2. Chemist
and storage from point of collection to final disposal. 3. Medical Technologist
4. Pharmacist
Ø CONFIRMATORY TEST- refers to the analytical 5. Chemical Engineer
procedure to identify and quantify the presence of a
specific drug or metabolite. Section 7. Technical Requirements for Accreditation
3. Chain of Custody
Ø SCREENING TEST - refers to a test to eliminate Minimum information required in Chain of Custody
negative specimen from further consideration and to Form:
identify the presumptively positive specimen that
requires confirmatory testing. 1. Information Identifying the specimen
2. Date and time of collection
Section 4. Classification of DTL 3. Name of the Testing Lab.
4. Name and signature of all individuals who had
1. According to Ownership custody of the sample during the collection process.
A. Government
B. Private
4. Storage of DTL reports and specimens:
2. According to Institutional Character
A. Institutional-based 1. 24 to 72 hours depending on the SOP of the
B. Freestanding DTL
2. Unchallenged positive results- 15 days 3
3. According to Service Capability 3. Specimen can be kept for max of 1 year upon
A. Sceening Laboratory request.
B. Confirmatory Laboratory
DL retain a copy of the results
Section 5. Client/Donor of DTL
11. Proficiency Testing:
MANDATORY DRUG TESTING
Results of proficiency test must be submitted within 3 weeks
1. Applicant of Firearm's License after receipt of sample to NRL.
2. Officers and members of the military, police and
other law enforcers. If DTL failed a second proficiency test will be given within 1
3. Person charged before the prosecutor office with a month. Failure to pass the test would mean Revocation of
criminal offense punishable by imprisonment of License and accreditation.
above 6 years.
4. Persons apprehended in violation of RA 9165 Section 8. Validity of the Test Result
Shall only be valid for 1 year.
RANDOM DRUG TESTING
Section 10. Procedural Guidelines for Licensing and
1. Students of High School and College Accreditation
2. Officers and employees of public and private offices
whether domestic or overseas. DTL application not approved can be appealed to Secretary
of DOH within 15 days
Section 6. Technical Requirements for Licensing
Section 13. Validity
1. Physical Plant

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 • Confirmatory Lab. License is valid for 2 years This refers to the place Drug DEN
• Screening Lab. License is valid only for 1 year. were drug addicts went to
use drugs.
Section 14. Renewal LTO/COA A primary drug testing 20 sq m
Laboratory has a minimum
Shall be renewed to BHFS/CHD 90 days before expiry date floor area requirement of
how many square meters?
Section 16. Terms and Conditions of Confirmatory Drug Testing 2 years
Licensing/Accreditation Laboratory's license is valid
for how many years?
Failure to report in writing within 15 days from any
substantial changes of DL shall result to suspension or
revocation of license.

Section 17. Violations

1. Issuance of false or fraudulent drug test results.

2. Failure to protect the confidentiality of drug test
results.
3. Failure to participate in a proficiency testing
4. Conviction of the owner or manager of a laboratory
for any criminal offense committed as an incident to
the operation of DTL.
5. Failure to refer the positive test results to a
Confirmatory Lab.
6. Any other cause which materially affects the ability
of the lab. to ensure full reliability and accuracy of
drug tests and the accurate reporting of results.
7. Refusal to allow survey, monitoring of a laboratory
by the BHFS/CHD at the appropriate time.
8. Any act which is contrary to the accepted clinical
laboratory practices.
9. Refusal to perform drug test to submitted sample.
10. Failure to follow IDTOMIS procedure

Section 18. Suspension or Revocation of License to

Operate/Certificate of Accreditation

• BHFS will investigate MUTO PROPIO or upon

complaint any erring DTL.
• Preventive Suspension of not more than 60 days
can be imposed.

Section 20. Appeal

Appeal shall be in the Office of the DOH Secretary within 15

days, a copy(Notice) of the appeal shall be given to BFHS in
order to forward to records of the case to the Office of the
DOH Secretary

Section 21. Penal Provisions

• Any person who issue false and fraudulent drug test

result knowingly, willfully or through negligence
shall suffer the penalty of imprisonment of 6 years
and 1 day to 12 years and fine of P100,000.00 to
P500,000.00.
• Revocation of LTO/COA and recommend
suspension/revocation of professional license to
PRC

Approved on January 13, 2003 by DOH Secretary Manuel

M. Dayrit

Quipper Quiz
The original drugs law RA 6425
was…?
Which of the following does Those applying for Driver’s
not require mandatory drug license
testing examination?

2
 MLS 406 | Medical Technology Laws and Bioethics
TOPIC: RA 7170 – Organ Donation Act of 1991
SOURCE: Quipper PDF
Learning Objectives
At the end of the lecture, the students should be able to:
• Define relevant terms in Section 2 of RA 7170; -
• Discuss the following provisions
how legacies are executed
how donations are executed
• Enumerate the purposes of organ donation; and
• Discuss relevant rules and regulations governing
organ donation.
Important Details
Ø Date of Approval: January 7, 1992
Ø Approved by: Corazon C. Aquino
Ø Total Number of Sections: 19
Ø Purpose: 'to authorize the legacy or donation of all
or part of a human body after death for specified
purposes'
Definition of Terms
• Organ Bank Storage Facility
o licensed, accredited, and approved to
store human bodies and/or human body
parts
• Decedent - a deceased individual (includes a
stillborn infant or fetus
• Testator - an individual who makes a legacy of all
or part of his body
o - legatee (recipient of legacy)
• Donor - an individual authorized to donate all or
part of the body of the decedent
o - donee (recipient of donation)
• Part - includes transplantable organs, tissues, eyes,
bones, arteries, blood, other fluids, and other
portions of the human body
How is death determined?
In the opinion of the attending physician:
• ABSENCE OF NATURAL RESPIRATORY AND
CARDIAC FUNCTIONS
• RESUSCITATION ATTEMPTS WOULD NOT BE
SUCCESSFUL
In the opinion of the consulting physician:
• IRREVERSIBLE CESSATION OF ALL BRAIN
FUNCTIONS
• RESUSCITATION ATTEMPTS WOULD NOT BE
SUCCESSFUL
Medical Definition of Death
• Brain Death
o deep irreversible coma (flat EEG, no
reflexes or movements or breathing, no
responses)
o absence of electrical brain activity –
o complete cessation of all vital functions
• Cardio-respiratory death
o continuous and persistent cessation of
heart action and respiration
Execution of Legacy
LECTURER: Atty. Francis C. Brion, RMT
Transes by: Miguel Astronomo
M 03 March 04, 2023
• Who may execute a legacy?
o Any individual
o at least 18 years old
o of sound mind
• How to execute a legacy?
o Last will and testament
o Organ donor card
Legacy may be made through:
• a specified legatee (recipient of the legacy) or
without specifying a legatee
• testator may designate surgeons/physicians to
perform the procedure
• the legacy document should be signed by the
testator in the presence of two witnesses
What if the specified legatee is not around during the death
of the testator?
• the attending physician/surgeon will serve as the
temporary legatee
What if the testator did not specify a legatee?
• the attending physician/surgeon will serve as the
legatee
Who may execute a donation?
• legal spouse
• son or daughter of legal age
• either parent
• brother or sister of legal age
• guardian of the decedent at the time of his death
What if the nearest kin is absent?
• Who will execute the donation?
• the attending physician
• the head of the hospital
• designated officer of the hospital
• BUT FIRST... the family of the deceased should be
located within 48 hours.
In all organ donations:
• diagnosis of death should be made separately by
two qualified physicians
• these physicians should not be:
o a member of the medical team who will
remove the organ
o the attending physician of the recipient of
the organ
o the head of the hospital/designated officer
authorizing the removal of the organ
Examination of Human Body or Body Parts
• necessary to ensure medical acceptability
• only trained/qualified personnel shall
remove/transplant organs
• in case of medico-legal cases:
o perform autopsy to determine suitable
organs
Legatees/Donees
• any hospital, physician, or surgeon
• any accredited medical or dental school, college, or
university
• any organ bank storage facility
1
 • any specified individual RA 7170 was enacted on? January 7, 1992
This refers to the document Legacy
Delivery of the Document of Legacy/Donation executed by a person who
• if the legacy/donation is made to a specified wishes to donate organs
legatee: after his/her death.
o the legacy/donation documents How many witnesses is/are 2
(will/card/donation document) should be require when you execute a
delivered to the legatee/donee document for organ
o the documents could also be stored in an donation?
organ bank storage facility for safekeeping It refers to the person Donee/Legatee
receiving the organ
Amendment of Revocation of Legacy/Donation donated.
Is the donation of organs No
• if the will/card/document was delivered: before death covered by
o signed statement RA 7170?
o oral statement with 2 witnesses (sent to
legatee)
o dying declaration (physician to legatee)
o signed card/document found on the person
• if the will/card/document was not delivered:
o (conditions mentioned above)
o destruction, cancellation, or mutilation of
the documents
• revocation of wills

Rights and Duties Post-Mortem

• legatee may accept/reject the legacy

• removal of organs without MUTILATION
• international sharing of organs or tissues:
RECIPROCITY

HOPE

Human Organ Preservation Effort

(HOPE)
• Established in 1983
• NKTI (National Kidney and
Transplant Institute)
program that coordinates
organ donation
• retrieval, preservation, and
allocation of organs and tissues for clinical
transplantation

Current Issues

Case: G.R. 175540

• Dr. Filoteo Alano v. Zenaida Magud-Logmao

• Issue: to set aside the CA ruling adjudging the
petitioner liable for damages
• Facts:
o Zenaida: mother of Arnelito Logmao (died
due to intracranial hemorrhage after falling
from an overpass in Cuba)
o Dr. Alano: Executive Director of NKTI
o wrong name was recorded by EAMC

2
 MLS 406 | Medical Technology Laws and Bioethics
TOPIC: AO 24 s. 2006 – Rules & Regulations LECTURER: Atty. Francis C. Brion, RMT
Governing the Accreditation of Laboratories for Transes by: Miguel Astronomo
Drinking Water Analysis
SOURCE: Quipper PDF M 01 March 01, 2023

Related Laws PERSONNEL

• PD 856 a. Licensed Sanitary Engineer

o Code Sanitation of the Philippines b. Clinical Pathologist
• A0 18-A s 1993 c. Licensed Chemist
o Standards of Quality and Requirements for d. Registered Medical Technologist
the Processing, Packaging and Labeling of e. Licensed Pharmacist
Bottled Drinking Water
o AO 39 s. 1996: New amendment No. of WTL allowed to handle:
• RA 9275 ( May 22, 2004) a. 3 = sanitary engineer
o Philippine Clean Water Act of 2004 b. 1 = others provisionally authorized

Types of Water Laboratory Assistants

1. Bottled Water a. Licensed Chemist

2. Drinking Water b. Registered Medical Technologist
3. Natural Water c. Licensed Pharmacist
4. Artesian Water
5. Well Water NOTE:
6. Spring Water 1. One year experience
7. Mineral Water 2. 1:2 = ratio of technical assistant to a skilled worker
8. Purified Water
9. Carbonated Water Services Offered
10. Fluoridated Water
• BACTERIOLOGICAL
Types of Water, According to Level • PHYSICO-CHEMICAL
• BIOLOGICAL
a. Level I (Point Source) • RADIOLOGICAL
a protected well or a developed spring with an outlet
but without distribution system NOTE:
1. Each service must be operated by at least 1
b. Level II (Communal Faucet System or Stand registered professional, 1 laboratory assistant and 1
posts) laboratory aide
A system composed of a source, a reservoir, a 2. 30 samples/day:: bacteriological
piped distribution network and communal faucets, 3. 5 samples day :: chemical
located no more than 25 meters from the farthest 4. Laboratory records are kept for min. 5 years.
house 5. Internal Quality Audit every 6 months
6. Cert of Accreditation (COA) 2 years validity
c. Level III (Waterworks System or Individual
House Connections) PHYSICAL PLANT
A system composed of a source, a reservoir, a • Bench-top working area for processing
piped distribution network and communal faucets, samples :1.20 - 1.80 m
located no more than 25 meters from the farthest • Working Space at least 20 sq. m
house • Compliance with safety and building code

Primary Objective Suggested Water Sampling Techniques

To protect and safeguard the health and welfare of the

community by preventing the establishment, operation and
maintenance of poorly equipped substandard water testing
laboratory

Basic Requirements for Accreditation

IMPORTANT DATA:
1. Name, citizenship and domicile of head and owner
2. Address
3. Name of establishment
4. Scope and nature of work
5. Certifications of compliance with
6. Business requirements
7. Tax clearance of preceding year

Accreditation of WTL (Water Testing Laboratories)

1
 Bacteriological Analysis

SERVICES OFFERED:
a. Multiple Tube Fermentation Technique
b. Gram staining
c. IMViC Test
d. Standard Plate Count
Standard Request Form e. Fecal Coliform Test
f. Test for Fecal Streptococci (optional)

Sample Result Forms

2
 Biological Analysis

SERVICES OFFERED:

a. Quantiative and qualitative examination of

phytoplankton samples
b. Zooplankton and bottom Fauna examination

MINIMUM EQUIPMENT:

a. Water sampler
b. Water pump with graduated intake
c. Bottom drodge
d. Microscope (inverted and compound)

Radiological Analysis

SERVICES OFFERED

a. Gross a and B radioactivity

b. Total Radioactive
c. Strontium in water Strontium-90 in water
d. Total Radium: Precipitation Technique
e. Radium 226 by Radon Soluble
Physico-Chemical Analysis (Suspended and Total)

SERVICES OFFERED

a. Color
b. Odor
c. pH value: acidity and alkalinity
d. Specific Conductance
e. Taste
f. Temperature
g. Turbidity
h. Total Solids and Hardness
i. Presence of significant minerals and contaminants

Sample Result Form

3
Quipper

Water Testing Laboratory 2

(WTL) license is valid for
how many years?
Which of the following laws AO 20-A series of 2000
are not related to Water
Testing Laboratory?
The minimum working 20 sq m
space required for a Water
Testing Laboratory (WTL)
is?
Which of the following is Serological
not part of the services of
Water Testing Laboratory?
A Licensed Sanitary 3
Engineer can only handle
this maximum number of
Water Testing
Laboratories?

4
MLS 406 | Medical Technology Laws and Bioethics
TOPIC: RA 9288 LECTURER: Atty. Francis C. Brion, RMT
SOURCE: Quipper PDF M 05 March 14, 2023

Newborn Screening Act of 2004 ● Newborn

● RA 9288
● April 7, 2004
Declaration of Policy
● The State shall:
○ promote and protect the right to health of
the people (including children)
○ institutionalize a national newborn
screening program that is
COMPREHENSIVE, INTEGRATIVE, and
SUSTAINABLE
■ shall ensure that every baby born
in the Philippines is offered the
opportunity to undergo NBS
○ collaborate with government and
non-government agencies to ensure NBS
is being practiced
○ a child from the time of delivery up to 30
days old
● Newborn Screening
○ collection of few drops of blood from a
newborn
○ using an appropriate collection card
○ performing biochemical tests on the blood
● Heritable conditions (6 are commonly tested)
○ any condition that can result to mental
retardation, physical deformity, or death if
left untreated and undetected (usually
inherited from the genes of parents)

Objectives of NBS

● to ensure that every newborn has access to

newborn screening
● to establish and integrate a sustainable newborn
screening system
● to ensure that all health practitioners are made
aware of the advantages of newborn screening and
their responsibilities
● to ensure that parents recognize their responsibility
in promoting their child's right to health and full
development

Definition of Terms

● Comprehensive National Newborn Screening

System
○ education of relevant stakeholders
○ collection and biochemical screening of
blood samples
○ tracking and confirmatory testing
○ clinical evaluation and medical
confirmation Phenylketonuria (PKU)
○ medical management
○ evaluation activities

● Follow-up
○ monitoring of a newborn with a heritable
condition
● Recall
○ procedure for locating a newborn with a
possible heritable condition
● Treatment
○ provision of medicine, surgical
management, and dietary prescription for
newborns

● Health institutions
○ hospitals, infirmaries, lying-in centers,
health centers, puericulture centers
● Health practitioners
○ physicians, nurses, midwives, nursing
aides, traditional birth attendants, medical
technologists
● Parent education
○ provision of information on NBS
● absent PHENYLALANINE HYDROXYLASE

Edited by: Astronomo, A. M. 1

● high phenylalanine is toxic and causes significant
brain problems mental retardation microcephaly)
● MOUSY odor in urine
● Management: no phenylalanine-rich food in the diet
○ meat products (turkey, chicken, beef, pork)
○ seafood (cod, crabs, salmon, sardines,
prawn, tuna)
○ dairy products (milk, cheese)
Maple Syrup Urine Disease
● absent or reduced branched-chain a-ketoacid
dehydrogenase
● accumulation of amino acids (leucine, isoleucine,
valine) in blood
● normal at birth but quickly exhibits:
○ lethargy
○ vomiting
○ lack of appetite
○ failure to thrive
● maple syrup or burnt sugar odor in urine
○ mental retardation
● Management: no galactose in diet (milk, celery,
cereals, honey)
Glucose-6-Phosphate Dehydrogenase Deficiency
● oxidative denaturation of hemoglobin in the
presence of reactive oxygen species
● G6PD: necessary for reduced glutathione formation
● reduced glutathione: protects enzymes and Hgb
from oxidation
● will result to hemolvtic anemia
● oxidants: infections, drugs, fava beans
● research: G6PD deficiency may be protective
against malaria

Congenital Adrenal Hyperplasia

● 21-HYDROXYLASE deficiency
● decreased cortisol and aldosterone production,
● increased androgens increased adrenocorticotropic
hormone (ACTH)
● Cortisol: stress hormone, promotes
gluconeogenesis
● Aldosterone: for electrolyte balance, excretes K,
retains Na, increases blood pressure and volume
● Management: oral glucocorticoids
● Females: ambiguous genitalia

Definition of Terms (Cont.)

● Newborn Screening Center

○ a facility equipped with a newborn
screening laboratory
○ provides all required lab
tests/recall/follow-up
○ 7 NBS Reference Centers in the
Philippines:
■ NSC-NIH in Manila, NSC-
Northern Luzon in Batac, locos
Norte
■ NSC-Visayas in Iloilo, NSC-
Central Visayas in Mandaue,
Cebu
Congenital Hypothyroidism ■ NSC-Mindanao in Davao
■ NSC-Central Luzon in Angeles
● thyroid hormone production (11 weeks of gestation) City
● inadequate thyroid hormone production: growth, ■ NSC-Southern Luzon in Tanauan
brain development, metabolism
● 80-85% of cases: thyroid dysgenesis
● 15-20% of cases: thyroid dyshormonogenesis
● mental retardation, 'good babies'
● Causes: gene mutation, low iodine intake of the
mother
● Management: thyroid replacement therapy

Galactosemia

● deficient GALACTOSE-1-PHOSPHATE
URIDYLYLTRANSFERASE
● impaired galactose metabolism: accumulation is
toxic
● gene mutations that code for the enzyme
● s/s: ● Newborn Screening Reference Center at NIH
○ lethargy/failure to thrive/vomiting ○ responsible for:
○ jaundice ■ national testing database and
○ cataract case registries

Edited by: Astronomo, A. M. 2

 ■ training/technical
assistance/continuing education
for laboratory staff
■ definition of testing and follow-up
protocols
Section 5. Obligation to Inform
● 'Any health practitioner who delivers, or assists in
the delivery, of a newborn in the Philippines shall,
prior to delivery, inform the parents or legal
guardian of the newborn of the availability, nature
and benefits of newborn screening. Appropriate
notification and education regarding this obligation
shall be the responsibility of the Department of
Health (DOH).'
Newborn Screening
● shall be performed after 24 hours but not more than
3 days after delivery
● newborns in ICU: should be tested within 7 days
● brochure available to parents
Newborn Screening Procedure
What if the Results tested POSITIVE?
● REFUSAL TO BE TESTED
○ parents or legal guardians may refuse to
test their newborns
○ shall acknowledge in writing that refusal for
testing exposes their newborns at risk
○ copy of the refusal: part of the official
medical record
○ indicated in the database
● Continuing Education
Program/Re-education/Training of Personne
○ DOH with NIH shall:
○ conduct continuing information, education,
re-education and training programs
○ disseminate information materials on
newborn screening at least annually
● Licensing and Accreditation
○ DOH and PHIC requires health institutions
to provide NBS
Lead Agency in Newborn Screening
● the DOH shall:
○ establish the Advisory Committee on
Newborn Screening (reviews conditions,
fees, and reports)
○ develop implementing rules and
regulations for the immediate
implementation of a nationwide newborn
screening program
○ coordinate with DILG for the
implementation of the program
○ coordinate with NBS RC for the
accreditation of NBSC and for QA
programs
Edited by: Astronomo, A. M. 3