MEDTECH LAWS & BIOETHICS

LECTURE 1: RA 11166 Philippine HIV and AIDS policy act

CHRISTIAN VILLAHERMOSA
March 4, 2021
For updates and corrections → @mar4rii on Twitter

- Establish policies and programs to prevent the spread of

OUTLINE HIV and deliver treatment, care, and support services to
I. Details XIII. Contact tracing Filipinos living with HIV.
II. State policy XIV. Counseling and testing - Adopt a multi-sectoral approach in responding to the
III. Philippine national aids council XV. Health and support country's HIV and AIDS situation
(PNAC) ● Multisectoral- in a sense that the government
services
IV. AIDSmedium term plan (AMTP) needs a helping hand with non-government
V. Epidemiology bureau of the DOH XVI. Confidentiality
organization, private and civic and treatable
VI. Protection of human rights XVII. Exceptions on
organization to make sure that HIV is being
VII. Information, education, and confidentiality
addressed.
communication XVIII. Disclosure of HIV - Ensure access to HIV-and AIDS related services by
VIII. Preventive measures, safe -related test results
practices, and procedures
eliminating the climate of stigma and discrimination.
XIX. Discriminatory acts and ● climate of stigma and discrimination- one of the
IX. Guidelines on medical
practices reasons why we have increasing cases of HIV.
management, surgical, and
XX. Penalties If these are eliminated, it would create an open
other related procedures
society wherein we can be protected.
X. VOLUNTARY HIV TESTING
XI. COMPULSORY HIV TESTING - Positively address and seek to eradicate conditions that
XII. HIV TESTING aggravated the spread of HIV infection.
A. Conduct of HIV Testing III. PHILIPPINE NATIONAL AIDS COUNCIL (PNAC)
a) Screening
b) confirmatory - Ensures the implementation of the country's response to
the HIV and AIDS situation
- Tasked to oversee our response to HIV and AIDS.
I. DETAILS - Permanent chairperson:
● DOH Secretary
- Repealed RA 8504 or the Philippine AIDS Prevention - Vice chairperson (3-year term):
and Control Act of 1998 ● elected from the government agency
- Approved: December 20, 2018 members
- Signed by: Rodrigo Duterte. ▪ Ex: DILG, DOLE, DSWD, etc.
● Nonrenewable
- Members(3-year term, renewable once):
● from civil society organizations
▪ organization that represents key
populations of HIV (EX: groups of sex
workers or groups of living with HIV)
▪ they should be part of the council to
know the intensity or gravity of the toll
of the epidemic in the country.
● service- maximum of 6 years
IV. AIDS MEDIUM TERM PLAN (AMTP)

- The 6-year multi-sectoral strategic plan to prevent and

control the spread of HIV and AIDS in the country
- All the programs of the government are anchored to
(AMTP).
- To make sure that within six (6) years may nagawa ang
council and mga tao na involved in making sure that the
spread of HIV case in the country is prevented and
controlled.
V. EPIDEMIOLOGY BUREAU of the DOH

- Determine and monitor the magnitude and progression

of HIV and AIDS in the country (provide a list of priority
areas)
- Receive, collate, process, and evaluate all
HIV-and-AIDS-related medical reports from hospitals,
PLHIV- People living with HIV -more politically correct term to call
clinics, laboratories, and testing centers (anonymity and
people positive with HIV
confidentiality of data)
- Considered as an epidemic though it’s more gradual.
II. STATE POLICY
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 - They provide a summary of our status with regards to ● Tissue or organ donation: accepted only if -a
HIV and AIDS. sample from the donor has been tested
- They provide a list of priority areas – NCR the highest, negative for HIV
Region 4, Region 6 (Panay), Region 7, Region 11.
- The date that the bureau received are anonymous and - All donors who tested positive: notified of their HIV
confidential. status, counselled, and referred for care and clinical
management
- Submit quarterly and annual reports to the PNAC - HIV-positive samples may be accepted for research
purposes only.
VI. PROTECTION OF HUMAN RIGHTS - Second testing may be performed.
IX. GUIDELINES ON MEDICAL MANAGEMENT,
- The country's response to the HIV and AIDS situation SURGICAL, AND OTHER RELATED PROCEDURES
shall be anchored on the principle of human rights and
human dignity - DOH shall issue guidelines on medical management
● Common denominator- confidentiality of the of PLHIV and protocol on precautions against HIV
information. transmission during surgical, dental, embalming, body
- Delivery of non-discriminatory HIV and AIDS services, painting, or tattooing that require the use of needles.
VII. INFORMATION, EDUCATION, AND ● If a patient with HIV is admitted in the hospital,
COMMUNICATION the health worker should be informed.
- Wearing of necessary PPE shall be prescribed and
- Promotion of safer sex practices (abstinence, sexual required
fidelity, and consistent and correct condom use). - Guidelines on the handling and disposal of cadavers,
- Promote other practices that reduce risk of HIV infection body fluids, or wastes of persons known or believed to
Universal awareness of and access to evidence-based be HIV-positive
and relevant information and education, and X. VOLUNTARY HIV TESTING
treatment.
● All the information that is being presented by - Written consent (general rule: NO INFORMED
the DOH and the government, and the drugs CONSENT, NO TESTING)
that they dispense to people who are tested ● Before extraction, there will be counselling –to
and confirmed positive for HIV are based on inform the patient.
evidence. - 15-17 years old: consent shall be obtained from the
● Drugs are free if you are positive for HIV. child; no need for a parents or guardian's consent
- Knowledge of the rights of PLHIV and their families. - Any young person below 15 but who is pregnant or
engaged in high-risk behavior: consent obtained from
- Education in learning institutions (DepEd, CHED, the child; no need for a parents or guardian's consent
TESDA): age-appropriate instruction (mature minor doctrine).
- Education for parents and guardians: DepEd - Other young person below 15 or is mentally
- Information as health service: part of the delivery of incapacitated: parents/guardian's consent is needed;
health services by health practitioners. if no parents or guardians, consent of social worker or
- Education in the workplace: basic information and health worker but with the assent of the child (dapat
instruction + topics on confidentiality and reduction of mag yes ang bata)
stigma and discrimination. XI. COMPULSORY HIV TESTING
● Symposium and seminars.
Government decides
- Education for Filipinos going abroad: attend a seminar - When it is necessary to test a person charged with:
before being granted a certification for overseas ● Serious and slight physical injuries
assignment. ● Rape and simple seduction
● They must FIRST attend a seminar before ▪ Simple seduction- a mad had sex with a
being granted a certification for overseas woman below 18 with consent but the woman
assignment especially if their destination are was seduced because of deceit.
countries with high rates of HIV (ex: sub - When it is necessary to resolve relevant issues under
Saharan Africa) the Family Code of the Philippines (ground for
- Information for tourists and transients: educational annulment of marriage: must file within 5 years)
materials will be provided at all international and local - As a pre-requisite in the donation of blood
ports of entry and exit.
- Education for key populations and vulnerable XII. HIV TESTING
communities: peer education, support groups,
outreach activities, and community-based research. D. Conduct of HIV Testing
- Information on prophylactics: proper use and
efficacy against HIV and STI (legibly printed in All HTS facilities shall adhere to the operational requirements as
English and Filipino) stated in Annex V and HIV testing standard criteria for
- Education in communities: evidence-based, laboratories set by NRL-SLH/SACCL (see Annex VI).
gender-responsive, age appropriate, and human
rights-oriented prevention tools - HIV testing shall be routinely offered, prioritized for and
VIII. PREVENTIVE MEASURES, SAFE PRACTICES, AND promoted to the following:
PROCEDURES - These people will not be forced to be tested for HIV but
these will be suggested by the physician that they have
- Preventing mother to child HIV transmission to be tested for HIV.
- Standard precaution on the donation of blood, tissue, or
organ a. Key populations including adolescents
● All donated blood: subject to HIV testing b. High risk individuals who have not been tested

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 c. Partners, infants and children of PLHIV - Indeterminate: proteins are detected but not present in
recently HIV—test will be repeated after six weeks.
d. Patients showing signs and symptoms rHiVda
consistent with AIDS defining illness
e. Patients with Sexually Transmitted Infections The following tests are used in rHiVda Confirmatory Testing for
f. Patients with Hepatitis B and C NRL-SLH/SACCL
g. Patients with under nutrition not responsive to ● T1-Sysmex HISCL HIV Ag+Ab Assay Kit (machine used
interventions for T1)
h. All confirmed tuberculosis patients ● T2- Vidas HIV Duo Ultra or SD HIV-% 3.0 or Alere
i. All pregnant women regardless of risk Determine HIV % (higher specificity compared to T1)
● T3- Geenius HIV % Confirmatory Assay Kit (most
any laboratory procedure done on an individual to determine sensitive and specific than T1 and T2)
the presence or absence of HIV infection -has shorter turnaround time than western blot (2 weeks)
-results are released in a day if all tests are reactive.
- 2 types: Why should we send the samples to SLH?
● Screening (immunoassay) - DOH has selected several hospitals in the country to
▪ window period: 2 weeks to 6 months serve as rHiVda confirmatory testing centers.
▪ detect presence of antibodies.
XIII. CONTACT TRACING
▪ sample: serum or whole blood
Once you are confirmed positive with HIV, contact tracing will be
▪ 1 line (control) negative or non-reactive. 2
performed.
lines (control and test) positive or reactive.
- the method of finding and counselling the sexual
● Confirmatory
partners of a person diagnosed with HIV
▪ Old: Western blot
▪ New: rapid HIV diagnostic algorithm (rHiVda). XIV. COUNSELING and TESTING
- Only DOH-accredited HIV testing facilities shall be
allowed to conduct HIV testing
- HIV testing is based on informed consent, is
voluntary and confidential, is available at all times,
and provided by qualified persons
- Training of HIV and AIDS counselors must be done
(including counselors for PWD).
- Free pre-test and post-test counseling.
● Pretest- informed consent is obtained upon
short lecture.
● Post-test- release of result.

XV. HEALTH AND SUPPORT SERVICES

- Free and accessible antiretroviral therapy (ART) and

medication for opportunistic infections to all PLHIV who
are enrolled in the program
- Indigent persons living with HIV: financial support for
necessary services
- Economic empowerment and support
WESTERN BLOT STEPS: - PLHIV: counseling, social protection, welfare assistance
- pre-test counselling. Ensure informed consent. - Overseas workers living with HIV: stigma-free
- First HIV rapid test (Screening test) comprehensive
- If positive, refer to NRL (SLH or RITM) - reintegration, care, and support program
- 2 parallel test (2 immunoassay or 1 immunoassay +1 - Affected families, intimate partners, significant others,
rapid test) and children of PLHIV
- If both positive, western blot will be performed. ● Education programs and educational
- Discordant: Only 1 tested positive (proceed to assistance for children infected with HIV, and
westernblot) children orphaned by HIV and AIDS
- Westernblot: if proteins are detected—positive. - Prisons and other closed-setting institutions
● Comprehensive prevention and control
program
● PLHIV in these settings: provided with
treatment
- Health insurance: PhilHealth benefit package
● No PLHIV shall be denied of private health or
life insurance on the basis of the person's
status.
● You have to reveal that you have HIV for them
to not have any right to deny you of any
insurance packages.

XVI. CONFIDENTIALITY

- Confidentiality and privacy of any individual is

guaranteed

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 - Act of bullying: bullying in all forms, including online
● Tested for HIV
● Exposed to HIV
● Has HIV infection and AIDS-related illnesses
● Treated for HIV-related illnesses XX. PENALTIES
- Disclosure, without consent, is unlawful Misinformation
XVII. EXCEPTIONS ON CONFIDENTIALITY
- False/misleading advertising and claims of drugs,
- When complying with reportorial requirements of the devices, agents, or procedures claiming to be a cure or
national active and passive surveillance system of the DOH a fail-safe prophylactic
(the patient's identity remains confidential) - 1-10 years imprisonment
- Fines: Php 50,000-500,000
- When informing other health workers directly involved in the Knowingly or negligently causes another to get infected with
treatment and care of a PLHIV (shared medical HIV in the course of the practice of profession:
confidentiality) - 6-12 years imprisonment (may include suspension or
revocation of professional licenses and cancellation or
- When responding to a subpoena over a legal proceeding withdrawal of business permits)
where the main issue is the HIV status of an individual
Compelled any person to undergo HIV testing without his or
● Executive session her consent: 6-12 years imprisonment
- Only judges, lawyers, respondents
and defendants are present. Raids or similar police operations in sites and venues of HIV
● Personally opened by the judge prevention interventions based on the presence of used or
unused prophylactics
XVIII. DISCLOSURE of HIV-RELATED TEST RESULTS - 1-5 years imprisonment
To whom should you release the HIV results - Fine: Php 100,000-500,000
- General rule: Only to the individual who submitted to the Harassment of HIV and AIDS service providers
test - Imprisonment: 6 months to 5 years
- Below 15 years old, orphan, or mentally incapacitated: - Fine: Php 100,000-500,000
parents, legal guardian, Denial insurance services to PLHIV
- duly assigned health or social worker Below 15 years - Imprisonment: 6 months to 5 years
old but has given the consent: disclose the result to the - Fine: > Php 50,000
child. - Administrative sanctions
- Whoever gave the consent sa iyaha nimo ihatag ang
result. Breach of confidentiality
- If the results are positive
● Strongly encouraged to disclose the - 6 months to 2 years imprisonment; fine: Php
condition to the spouse, sexual partners, 50,000-100,000
and/or any person prior to engaging in Mass dissemination of HIV status of a person (e.g. online
penetrative sex or any potential exposure to and media
HIV statements)

XIX. DISCRIMINATORY ACTS AND PRACTICES - 2 years and 1 day to 5 years imprisonment; fine: Php
150,000
- Workplace: rejection of job application, termination of 350,000
employment, or other discriminatory policies in hiring, Breach of confidentiality by a health professional or any
promotion, and employment custodian of any medical record, file, data, or test result
- 5 years and 1 day to 7 years imprisonment; fine: Php
- Learning institution: refusal of admission, expulsion, 350,000-500,000
segregation, imposition of harsh disciplinary actions, or
denial of benefits and services Violation on discriminatory acts and policies

- Restriction on travel and habitation: travel restrictions, - 6 months to 5 years imprisonment

refusal of lawful entry to the Philippines, deportation, or - Fine: Php 50,000-500,000
quarantine/enforced isolation of travelers (applies to - Administrative sanctions
both Filipinos and non-Filipinos)
Uses knowledge of confidential HIV and AIDS information to
- Restrictions on shelter malign or cause damage, injury, or loss to another person

- Prohibition from seeking or holding public office: either - Liability under Articles 19, 20, 21, and 26 of the new
elective or appointive Civil Code of the Philippines and RA 10173 or the Data
Privacy Act of 2012
- Exclusion from credit and insurance services If alien: deportation after serving the penalties

- Discrimination in hospitals and health institutions: denial If government employee or public official: perpetual or
of services or charging with higher fee temporary absolute disqualification from office

- Denial of burial services Collected penalties: put into a special fund administered by
PNAC
● Cremation- norm for HIV

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 MEDTECH LAWS & BIOETHICS

LECTURE 1: RA 9165 AND OPERATIONS OF DRUG

TESTING LABORATORIES
CHRISTIAN VILLAHERMOSA
March 16, 2021
For updates and corrections → @mar4rii on Twitter

- AGE : Mean age of 32 years old, Median of 33 years

OUTLINE - SEX: Ratio of Male to Female 9:1
I. Details XIII. Documents - CIVIL STATUS: Single (49.28%)
II. Current status XIV. Drug testing specimens - STATUS OF EMPLOYMENT Employed (55.31%) ·
III. Dominant drugs in the Philippine XV. EDUCATIONAL ATTAINMENT High School Level
Specimen handling
market (27.99%)
XVI. Specimen retention ECONOMIC STATUS Average Family Income Php
IV. Private and labor sectors and lgu -
drug-free workplace XVII. Validity of specimens 13,695.65 PLACE OF RESIDENCE Urban (Specifically
V. Local government unit XVIII. Parameters for validity NCR 32.41%)
VI. Program for treatment and test - DURATION OF DRUG USE: More than six (6) years
rehabilitation. XIX. Tampering of - NATURE OF DRUG TAKING: Mono drug use (abuse of
VII. Dangerous drugs board specimens 1 drug only)
VIII. Philippine drug enforcement - DRUGS/SUBSTANCES OF ABUSE: Methamphetamine
XX. Analytical methods
agency Hydrochloride (Shabu)
XXI. Violations Cannabis (Marijuana)
IX. Drug testing in the laboratory
X. Drug testing facilities Contact Cement (Rugby)
XI. Specimen collection
XII. Personnel III. DOMINANT DRUGS IN THE PHILIPPINE MARKET
Methamphetamine hydrochloride or ‘shabu’
- ‘poor man’s cocaine’, S, shabs, siopao, sha, ice
- White odorless crystals/powder with a bitter numbing
taste
I. DETAILS - May be ingested, inhaled, sniffed, injected, or smoked
RA 9165 Comprehensive Dangerous Drugs Act of 2002 - Causes anxiety, irritability, irrational behavior
- Approved on June 7, 2002 by Gloria Macapagal-Arroyo - Long-term use: psychosis, difficulty in concentrating,
- Repealed RA 6425 or the Dangerous Drugs Act of 1972 formication (sensation of bugs: ants crawling in the
- State Policy: safeguard the integrity of its territory and body)
the well-being of its citizenry, particularly the youth, from it was introduced in the world market by Japanese scientist
the harmful effects of dangerous drugs. in the world market wherein Kamikaze (suicide pilots) used
- Contains 13 articles and 102 sections shabu for them to do their task.
- Positivist and classical thinking in criminal law
▪ Mere user of illicit drugs as a victim Marijuana
o For reformation and reintegration into - ‘mary jane’, joint, dope, pot, damo, flower
society - Comes from the plant Cannabis sativa
o If you are a drug user, at first offense - Smoked in pipes, made into candy, taken as food,
you are not going to jail, instead you sniffed in powder
will be rehabilitated because this law - Causes fast heartbeat, bloodshot eyes, dry mouth
treats a drug user as a patient or as a - Early use: stimulant, later use: depressant
sick person because drug addiction or - Detected in the lab by its metabolite, THC or
drug use is a disease. Tetrahydrocannabinol
o If nag positive for drug use at the Ecstasy
second time, he/she will be subjected - Methylenedioxymethamphetamine (MDMA), XTC,
to imprisonment and or fines. Adam, essence, E, Molly.
▪ Stiffer penalties for drug traffickers, financiers, - Swallowed or inhaled
syndicates, and public officials involved in illicit - Causes exaggerated emotions, increased heart rate and
drugs. blood pressure, dry mouth, chills, sweating, nausea,
- Integrated system of planning, implementation, and promotion of trust and closeness.
enforcement of anti-drug abuse policies, projects, and - Commonly used in parties, night raids, and night clubs
programs. added in drinks.
- Attributed in date o party rape cases wherein the victim
II. CURRENT STATUS (2019) has taken a drink with ecstasy and sumama sha
- 5, 227 admissions in treatment and rehab facilities. because it promotes trust and closeness.
- Not the exact count because these number reflect only
those people who were tested positive.

PROFILE OF DRUG ABUSERS

(Facility Based)
CY 2019

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 Window Initial Confirmation VII. DANGEROUS DRUGS BOARD
DRUGS of Screen (ng/mL) - The policy-making and strategy-formulating body in the
Detection (ng/mL) planning and formulation of policies and programs on
in Urine drug prevention and control
Marijuana 2 days to 3 50 15 - 17 members: 3 permanent, 12 ex-officio, 2 regular
weeks ▪ 3 permanent members
Methamphetamine 2-3 days 500 250 o 1 chairman: 6 years term
o 2 members: 6 years term
Amphetamine 2-3 days 1000 250 ▪ Ex- officio- secretaries or the chairmen of
government agencies by virtue of their position
Cocaine 2-3 days 300 100 they are automatically part of Dangerous drugs
Board.
VIII. PHILIPPINE DRUG ENFORCEMENT AGENCY
Initial screening- you have to reach the concentration (refer to - To carry out the provisions of RA 9165
table above) in your system in order for the test to be positive. ▪ Law enforcement and applies the rules and
regulations.
NRL Rule in methamphetamine analysis: - Director-General, 2 Deputies Director General (1 for
Kasi pede ang metabolite na ma detect is Administration, 1 for Operations)
methamphetamine or amphetamine. - PDEA Academy
POSITIVE: if meth level is > 250 ng/mL AND ▪ recruitment and training of all PDEA agents
amphetamine level is > 100 ng/mL and personnel
- Both must be present to be really sure that shabu is ▪ at least twenty-one (21) years old, of proven
present. integrity and honesty and a Baccalaureate
degree holder
IV. PRIVATE AND LABOR SECTORS AND LGU
DRUG-FREE WORKPLACE IX. DRUG TESTING IN THE LABORATORY
- develop, promote and implement a national drug abuse - Mandatory
prevention program in the workplace to be adopted by ▪ driver's and firearms license applicants.
private companies with ten (10) or more employees. o Based on recent laws, the requirements is
▪ If a company has ten (10) or more employees, not anymore required for applicants for
it is the company’s role to promote drug abuse driver's licenses.
prevention program among its employees, so ▪ law enforcers
that no employee will be enjoined to use illegal ▪ public officers*
drugs. ▪ RA 9165 violators
- mandatory drafting and adoption of company policies ▪ convicted of a crime with more than 6 years
against drug use in the workplace. imprisonment
▪ Should be part of employee’s handbook or - RANDOM
rules. ▪ Employees (government and private), students
V. LOCAL GOVERNMENT UNIT (secondary and tertiary)
- shall appropriate a substantial portion of their respective ▪ It is required in the office but not all people
annual budgets to assist in or enhance the enforcement have to be tested.
of this Act giving priority to preventive or educational ▪ Only selected students and employees are
programs and the rehabilitation or treatment of drug subjected.
dependents. - RA 10586 removed the mandatory drug testing for
▪ Dapat lahat ng LGU may existing policies for it applicants for drivers’ license
and may naka allot na population to educate its o Only mandatory if the law enforcement
population and to rehabilitate those who were officer has probable cause to believe that
tested positive for illegal drugs. a person is driving under the influence of
- Public nuisance: Any place or premises which have dangerous drugs and/or other similar
been used on two (2) or more occasions as the site of substances
the unlawful sale or delivery of dangerous drugs o A driver must only be subjected to
▪ prohibiting the conduct, operation, or mandatory drug test if the police has
maintenance of any business or activity on the enough probable cause that a person is
premises. under the influence of dangerous drugs.
VI. PROGRAM FOR TREATMENT AND REHABILITATION o If no probable cause, no mandatory drug
VOLUNTARY SUBMISSION testing must be performed.
- A drug dependent or drug user may apply for treatment - *Pimentel v. COMELEC
and rehabilitation of the drug dependency. ▪ SC ruled on the unconstitutionality of
▪ If a person acknowledges that he/she is a drug mandatory drug testing of candidates for
dependent and wants to be better, he/she may public office.
apply directly for treatment and rehabilitation. ▪ Stopped the mandatory drug testing for public
▪ If nag positive ang drug testing result mo office candidates.
(confirmed positive) you will be forced to be - *Laserna v. DDB and PDEA
rehabilitated. ▪ SC found no valid justification for mandatory
▪ Pede voluntary and compulsory drug testing for persons accused of crimes;
- Rehabilitation period: not less than 6 months and violates the right to privacy, the right against
not more than 1 year (appraisal of further confinement unreasonable searches and seizure, and the
must be done after) equal protection clause.
▪ After-care and follow-up program for at least 18 ▪ Removed mandatory drug testing for any
months after discharge person accused of a crime unless there is
probable cause.

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 ▪ donor's info
▪ CoC document
X. DRUG TESTING FACILITIES ▪ status of specimen: temperature, appearance
▪ Screening: at least 20 sq.m. floor area with a ▪ drug test requested
10 sq.m. working area (reception area) ▪ result of test
▪ Confirmatory: at least 60 sq.m. floor area with ▪ contain all the information of the test.
a 30 sq.m. working area - Chain of Custody Document
▪ can accommodate at least 5 patients at one ▪ The form/s used to document the security of
time. the specimen and all aliquots of the specimen
▪ handwashing area, toilet stalls during testing and storage
XI. SPECIMEN COLLECTION ▪ Includes the names and signatures of all
-may be performed outside the confines of a drug testing facility individuals who handled the specimen and the
and we call that remote collection. date and purpose of access.
- Must be at a permanent drug testing facility except for ▪ Just part of the CCF
remote collection which is allowed in the following: ▪ Info of handling the specimen
▪ Workplace/school/jail or prison/rehabilitation XIV. DRUG TESTING SPECIMENS
center for: - URINE: most common
o Random ▪ 60 mL is needed
o Follow-up ▪ prolonged storage at (-20 degrees C)
o Reasonable suspicion/cause ▪ collected in a 30-60 mL polyethylene specimen
o Crime scene and post-accident container.
▪ Persons who are critically-ill or disabled ▪ Easier and less invasive to collect.
▪ In these cases, sample validity tests must be ▪ Standardized
performed ▪ Specimen of choice
XII. PERSONNEL - Saliva
- HEAD OF THE LAB (Screening) ▪ 2 mL of saliva collected in a 30 mL
▪ Clinical Pathologist or any licensed physician polyethylene specimen container
w/ certification in Clinical Laboratory - Blood
Management by the DOH ▪ most expensive, most accurate
▪ 10: maximum screening labs a physician can ▪ plain test tube, 10 mL (sample: minimum of 5
handle (within 5 km radius from each other) mL)
o ONLY 10 screening labs must be ▪ No standardized procedure available
handled by the same physician. - Sweat
- HEAD OF THE LAB (Confirmatory) ▪ FDA-approved sweat patch (worn 1-2 weeks)
▪ physician/pathologist with 2 years’ experience - Hair
in analytical toxicology ▪ 100 mg hair in 200 mg capacity self-sealing
▪ chemist with a master's degree and 2 years’ transparent plastic bag
experience in analytical chemistry ▪ expensive and tedious
- ANALYST (Screening) ▪ detects chronic substance abuse
▪ either a chemist, med tech, pharmacist, or XV. SPECIMEN HANDLING
chemical engineer with training - Observed specimen collection.
- ANALYST (Confirmatory) - Ensure the integrity of urine specimen
▪ Required: full-time chemist with training in ▪ Coloring agents in toilet bowl.
chromatography and mass spectroscopy and ▪ Removal of unnecessary outer garments, body
either a med tech, pharmacist, or chemical search.
engineer with training in screening ▪ Washing and drying of hands prior to urination
▪ The personnel verify chain of custody, perform ▪ Checking urine volume, temperature, color,
test, certify results, perform QA and appearance
o Chain of custody- refers to people - Labeling of the specimen
who handled the sample. - Date/time of collection, signature of client and ASC
❖ Lahat ng personnel na (authorized specimen collector), and specimen ID
naghandle ng sample must number
affix his/her signature on the - All specimen will have their own respective ID number.
document accompanying the XVI. SPECIMEN RETENTION
specimen. - Negative: 5 days (refrigerated) after receipt of result
- AUTHORIZED SPECIMEN COLLECTOR: - Positive, adulterated, substituted, or invalid: minimum of
instructs, assists, and receives/inspects specimens. 15 days upon receipt of result; may be extended for up
▪ Always present in a drug testing facility. to a year upon request (or more that if the sample is
▪ Sa kanya binibigay ng client ang sample. involved in court case)
▪ First person to handle the sample. XVII. VALIDITY OF SPECIMENS
▪ First person to affix his/her signature. - suspicious/unobserved urine collection.
▪ Ensures that all procedures in the drug testing - invalid specimen
in the lab must be accounted for. ▪ tampered; improperly collected, handled,
o The sample will be sent to analyst for stored, and documented.
validity testing and testing for drugs.
o Analyst will affix his/her signature. XVIII. PARAMETERS FOR VALIDITY TEST
XIII. DOCUMENTS - Color
- Custody and Control Form ▪ Normal color is yellow
▪ A BHFS-approved form used to document the - Appearance: clear
collection, transport, security, and test results - Odor: aromatic
of the specimen - Volume: 30-60 mL

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 ▪ Ideal urine volume is 60 mL - Confirmatory
- Temperature: 32-38 degrees C ▪ Gold standard: gas chromatography-mass
- pH: 4.0-9.0 spectrometry (GC-MS)
- Specific Gravity: 1.003-1.030 ▪ Qualitative chemical characterization
▪ SG of a sample will never be 1 (if 1, water) o Kaya niya i release kung anong
XIX. TAMPERING OF SPECIMENS specific drug ang present.
- ADULTERATION ▪ Quantitation and determination of
▪ with a substance not normally present in the concentration of analyte
test specimen ▪ Present in EAMC
o Addition of juice, illicit drugs - Screening test: presence or absence of a drug
o Taking of drug screens like aspirin, (qualitative: positive and negative)
niacin, and zinc sulfate which interfere ▪ Presumptive positive (at or above the cutoff
with drug analysis level)
o ‘doping samples’: adding chemicals o Sent for confirmations to NRL
to urine (directly added to urine) ▪ Presumptive negative (below cutoff level,
❖ e.g. bleach, ammonia/liquid drug may be absent or present)
soap/table salt, hydrogen ▪ TAT: 30 minutes
peroxide, vinegar - Confirmatory test: presence or absence, identity of the
- DILUTION metabolite, concentration of the drug
▪ less than normal physiological constituents ▪ TAT: 15 days
o Internal dilution: plenty of water, - RESULTS ARE VALID FOR ONE YEAR
diuretics - Re-test
o External dilution: adding water to ▪ lab satisfaction for quality validation
specimen ▪ replicate test to check the initial test result of
- SUBSTITUTION: same sample
▪ submission of switched or replaced sample ▪ done by the analyst in drug testing labs.
XX. ANALYTICAL METHODS ▪ Performed twice or more than.
- Screening - Challenge test
▪ FDA-DOH-approved testing kits using ▪ replicate test when confirmatory results are
immunoassay (commonly used in the legally questioned
Philippines) ▪ complainant will pay the test fee.
▪ Instrumented screening method
o Immunoassay: ELISA, fluorescence
polarization immunoassay
o Chromatographic: TLC, HPL

Drug Testing
Must file all necessary lab record like:
Negative: 2 lines - Lab Records
Positive: 1 line ▪ training record
- Competitive Assay ▪ custody and control form
▪ Competition between free drug and o info on the specimen, date/time of
immobilised drug (immobilised antigen) for collection, name of lab, chain of
limited antibodies custody form
▪ In presence of drug, free drug binds to the ▪ QA records
antibody conjugate, preventing it from binding ▪ Reports
to immobilised drug. No colour reaction. ▪ calculations in test results
▪ If no drug present antibody complex binds to - License validity
the immobilised drug to produce coloured line. ▪ Screening Lab: 1 year
▪ Confirmatory Lab: 2 years
XXI. VIOLATIONS
- issuance of false results
▪ suspension and revocation of license
▪ 6 years and 1 day to 12 years imprisonment
▪ Php 100,000-500,000 fines
▪ revocation of license, closure of center
- others (reprimand, suspension, revocation):
▪ failure to protect confidentiality
4
 ▪ failure to pass proficiency trainings
▪ criminal offense of owner or manager
committed as an incident to the operation of
the laboratory
▪ failure to refer positive results
- investigator: BHF

5
 MEDTECH LAWS & BIOETHICS

LECTURE 3: Newborn Screening Act of 2004 (RA 9288)

CHRISTIAN VILLAHERMOSA, RMT
March 19, 2021
For updates and corrections → @mar4rii on Twitter

- to establish and integrate a sustainable newborn

OUTLINE screening system.
I. Important details i. Congenital - to ensure that all health practitioners are made aware
II. Objectives of NBS hypothyroidism (CH) of the advantages of newborn screening and their
responsibilities.
III. Definition of terms ii. Galactosemia (GAL)
- to ensure that parents recognize their responsibility in
IV. Newborn screening reference iii. Glucose-6-phosphate promoting their child's right to health and full
center dehydrogenase development.
V. Advisory committee on deficiency ▪ Before the parents can give their consent, they
newborn screening XI. Section 5. Obligation to must first be educated and be informed about
VI. Newborn screening centers inform new born screening (why is it important? why
VII. Newborn screening centers in XII. Lead agency in newborn do we do this? and, etc.)
the country screening III. DEFINITION OF TERMS
- Comprehensive National Newborn Screening System
VIII. Newborn screening continuity XIII. Genetic counseling
- Flow of newborn screening in the Philippines.
clinics ▪ education of relevant stakeholders
IX. Timeline of newborn screening ▪ collection and biochemical screening of blood
X. Heritable conditions tested samples
contact tracing ▪ tracking and confirmatory testing
i. Phenylketonuria o if nag positive ang baby during
screening.
(PKU)
▪ clinical evaluation and medical confirmation
ii. Maple syrup urine o Medical confirmation: perform
disease (MSUD) ultrasound and CT scan.
iii. Congenital adrenal ▪ medical management
hyperplasia (CAH) o pediatrician will offer medications or
dietary restrictions or regimen to the
parents.
▪ evaluation activities.
I. IMPORTANT DETAILS
o Repeated follow up check-ups.
- Approved on April 7, 2004 by Gloria Macapagal-Arroyo
- Follow-up
- Contains 19 sections
▪ monitoring of a newborn with a confirmed
- Very straightforward. heritable condition
DECLARATION OF POLICY
▪ if na confirm na positive yung baby, the baby
The State shall:
will be monitored from time to time to make
- promote and protect the right to health of the people sure that he is growing well, and he is
(including children). responding to the medications.
▪ The concern of the new born screening are ▪ Confirmed positive.
those heritable and inherited conditions which
are caused by genetic mutations—genes of the
- Recall
baby are not normal.
▪ procedure for locating a newborn with a
- institutionalize a national newborn screening program possible heritable condition for confirmatory
that is COMPREHENSIVE, INTEGRATIVE, and testing.
SUSTAINABLE ▪ Done if the baby has been screened for a
▪ shall ensure that every baby born in the
newborn screening heritable condition.
Philippines is offered the opportunity to
▪ Tracking—the baby has to be tracked by
undergo NBS. contacting the parents so that the baby will
▪ Not compulsory—not all babies have to be undergo another sample collection for
tested with new born screening because the
confirmatory testing.
parents can’t still refuse.
▪ Hindi pa confirmed (not totally positive)
- collaborate with government and non-government ▪ Nag test lang na positive sa screening and the
agencies to ensure NBS is being practiced baby must be sent back to the hospital once
▪ it needs the help of non-government agencies, again for confirmatory testing.
donors or civilians.
- Treatment
II. OBJECTIVES OF NBS ▪ provision of medicine, surgical management,
- to ensure that every newborn has access to newborn and dietary prescription for newborns
screening. ▪ offered by pediatrician once the baby has been
▪ Must be available at all times in health confirmed positive.
institutions where mothers give birth and - Health institutions
babies are present. ▪ hospitals, infirmaries, lying-in centers, health
centers, puericulture centers.

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 ▪ Newborn screening must be offered. - NSRC in NIH, UP-Manila
- Health practitioners - Visayas: WVSUMC, Iloilo City
▪ physicians, nurses, midwives, nursing aides, - Mindanao: SPMC, Davao City
traditional birth attendants, medical - Central Luzon: Angeles City, Pampanga
technologists. - Southern Luzon: Tanauan, Batangas
- Parent education - Northern Luzon: Batac, Ilocos Norte
▪ provision of information on NBS. - Central Visayas: Mandaue City, Cebu
▪ Whenever a baby is subjected to new born All the results are collected by the NSRC and NSRC will
screening, we give the parents a brochure release the statistic regarding the screening diseases.
containing information about newborn VIII. NEWBORN SCREENING CONTINUITY CLINICS
screening. - equipped to facilitate continuity of care/long-term follow-
▪ Brochures are translated into a local language. up management of patients confirmed with heritable
- Newborn (including rare) conditions.
▪ a child from the time of delivery up to 30 days - Where medical confirmation, management, and
old. evaluation are done.
- Newborn Screening - Each region has continuity clinics.
▪ collection of few drops of blood from a - Does not necessarily perform newborn screening test.
newborn using an appropriate collection card
▪ performing biochemical tests on the blood
- Heritable conditions (6 are commonly tested) currently
there are 29
▪ any condition that can result to mental
retardation, physical deformity, or death if left
untreated and undetected (usually inherited
from the genes of parents).
IV. NEWBORN SCREENING REFERENCE CENTER
- major reference center of new born screening in the
Philippines.
- the central facility at the National Institutes of Health
(NIH) in UP manila that:
▪ defines testing and follow-up protocols
▪ maintains an external laboratory proficiency
testing program
o under NSRC are seven (7) New born
screening centers—perform
screening test. IX. TIMELINE OF NEWBORN SCREENING
▪ oversees the national testing database and - 1996: commencement of the newborn screening
case registries program in 24 participating hospitals (tested in Australia.
▪ assists in training activities in all aspects of the - 1997: start of the operations of the newborn screening
program lab at the NIH
▪ oversees content of educational materials - 2004: approval of RA 9288
o makes the brochure - 2007: newborn screening package was included in
▪ acts as the Secretariat of the Advisory PhilHealth
Committee on Newborn Screening - 2014: expanded newborn screening optional
▪ test the capability of NSC’s in performing test. - 2019: full coverage of expanded newborn screening in
PhilHealth
V. ADVISORY COMMITTEE ON NEWBORN SCREENING
- review annually and recommend conditions to be
included in the newborn screening panel of disorders.
▪ Make consultations as to what diseases
should be tested in newborns.
▪ Impacts: change from 6 disease before into
the current expanded new born screening
which test 29 diseases.
- review and recommend the newborn screening fee to be
charged by NSCS.
- review the report of the NSRC on the quality assurance
of the NSCs and recommend corrective measures as
deemed necessary.
- Chairman: DOH Secretary
- Vice-Chair: Executive Director of the NIH
VI. NEWBORN SCREENING CENTERS
- facilities equipped with a newborn screening laboratory
that complies with the standards established by the NIH
and provides all required laboratory tests and
recall/follow-up programs for newborns with heritable
conditions.
- Hospitals just collect the samples and after blood
collection, it will be sent to newborn screening centers
and these centers will perform the screening test.
- They have to be regulated by the NSRC.
VII. NEWBORN SCREENING CENTERS IN THE COUNTRY

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 - Symptomatic than PKU—has signs and symptoms
X. HERITABLE CONDITIONS TESTED which can cause the death of the baby.
Initial six (6) MSUD Disease Management
- Phenylketonuria - dietary restriction of branched-chain amino acids
- Maple syrup urine disease iii. CONGENITAL ADRENAL HYPERPLASIA (CAH)
- Congenital adrenal hyperplasia - a group of disorders resulting from enzymatic defects in
- Congenital hypothyroidism the biosynthesis of steroids
- Galactosemia - 90% of CAH is due to 21- hydroxylase deficiency
- Glucose-6-phosphate dehydrogenase deficiency - results in decreased cortisol and aldosterone production
Expanded newborn screening: which in turn causes increased adrenocorticotropic
- The 6 diseases hormone (ACTH) secretion and eventually leads to
- Cystic fibrosis hyperplasia of the adrenal cortex
- Biotinidase disease - enlargement of adrenal gland.
- Organic acid disorders
- Fatty acid oxidation disorders
- Amino acid disorders
- Urea cycle disorders
- Hemoglobin disorders
i. PHENYLKETONURIA (PKU)
- An amino acid disorder in which phenylalanine cannot
be converted to tyrosine due to a deficiency or absence
of the enzyme phenylalanine hydroxylase
- Leads to increased levels of phenylalanine in the blood
and tissues.
- Elevated phenylalanine interferes with myelination,
synaptic sprouting, and dendritic pruning
- Competitively inhibits the uptake of neutral amino acids
like tyrosine and tryptophan concentrations thereby
limiting the production of neurotransmitters
- The most important and sometimes the only
manifestation of PKU is mental retardation
▪ Mousy odor in urine may be observed
Anterior pituitary gland → ACTH released to adrenal cortex→
Phenylketonuria Disease Management
create three (3) types of hormones: Mineralocorticoid,
- Dietary management
glucocorticoid, androgen.
▪ complete avoidance of food containing high
amounts of phenylalanine
Three (3) zone of cortex: glomerulosa (aldosterone), fasciculata
▪ calculated intake of low protein/phenylalanine
(cortisol), reticularis (synthesis of androgens).
natural food
- 21-hydorxylase is important in the formation of
▪ sufficient intake of fat and carbohydrates to
aldosterone and cortisol.
fulfill the energy requirements of the patient
▪ Progesterone and 17-OH- Progesterone will all
▪ calculated intake of phenylalanine-free amino
be diverted towards the third zone and will all
acid mixture supplemented with vitamins,
be utilized to form testosterone or androgens.
minerals and trace elements as the main
▪ If this enzyme is absent, no aldosterone and
source of protein
cortisol production but testosterone level is
ii. MAPLE SYRUP URINE DISEASE (MSUD) high.
- a defect or deficiency of the branched chain ketoacid Cortisol is a stress hormone and is involved in gluconeogenesis.
dehydrogenase complex in which elevated quantities It is important in the balance of glucose in our system. In cases
of leucine, isoleucine, valine, and their corresponding with Hypoglycemia, cortisol along with other hormones will try to
oxoacids accumulate in body fluids. increase glucose concentration in our system.
- An increase in leucine may cause competitive inhibition
with other precursors of neurotransmitters causing the Aldosterone- important sodium retention and involved in water
neurologic manifestations. retention to preserve homeostasis or blood pressure.
- Classical MSUD is the most severe and common form
with symptoms of poor suck, lethargy, hypo and In the case of CAH, aldosterone and cortisol are absent so it will
hypertonia, opisthotonic posturing, seizures, and coma lead to increase level of ACTH in our system. It will produce more
developing 4-7 days after birth ACTH which will repeatedly activate our adrenal cortex, resulting
▪ Odor of maple syrup in urine may be detected to the enlargement of adrenal cortex.
as soon as neurological symptoms appear Congenital Adrenal Hyperplasia (concern)
- salt-wasting (SW) manifest adrenal crisis in the first 2-4
weeks of life
- severe salt-losing crisis with hypoglycemia and
hypotension
- affected females usually present with ambiguous
genitalia
▪ virilizing characteristics- the female baby will
develop male characteristics and male
appearances.
CAH Disease Management
- glucocorticoid and mineralocorticoid replacement
therapy

3
 - female patients with prenatal virilization require surgical - Accumulation of galactose in the body is not good
repair - feeding problems, failure to thrive (most common initial
clinical symptom)—delayed growth, hepatocellular
iv. CONGENITAL HYPOTHYROIDISM (CH) damage, bleeding, and sepsis in untreated infants which
- Thyroid hormone deficiency at birth lead to mental retardation
- most common etiology of CH is thyroid dysgenesis (TD): - in approximately 10% of individuals, cataracts are
absent thyroid, ectopic, or hypoplastic thyroid (too small present
and not functional) Galactosemia Management
- correct level of thyroid hormone ensures normal growth - Dietary elimination of milk and milk products containing
and normal development of the brain, bones, and lactose
nervous system - Alternative: soy-based formula
vi. GLUCOSE-6-PHOSPHATE DEHYDROGENASE
DEFICIENCY
- Most common heritable disease in the Philippines
- G6PD is needed for the first step of the hexose
monophosphate pathway
▪ Maintains glutathione in reduced form, an
antioxidant that protects cells from oxidative
damage
▪ More valued in RBCS
o If absent, RBCs are exposed in
oxidative stress
- Causes hemolytic anemia induced by various oxidative
stresses
- patient presents sudden onset of tea-colored urine,
- Signs and symptoms of hypothyroidism: jaundice and pallor
▪ Decreased activity - dreaded effect of neonatal jaundice is kernicterus or the
▪ Large anterior fontanelle deposition of bilirubin which causes permanent damage
▪ Poor feeding to the brain or death
▪ Poor weight gain G6PD Deficiency Management
▪ Small stature or poor growth - Avoidance of oxidative insults
▪ Prolonged Jaundice - Blood transfusions for acute hemolytic crisis
▪ Decreased stooling or constipation
▪ Hypotonia
▪ Hoarse cry or weak cry
▪ Usually not apparent at birth
▪ If left untreated, may result into severe mental
retardation and impaired growth
Congenital Hypothyroidism Management
- Recommended treatment is the lifetime daily
administration of Levothyroxine
- Serum T4 or FT4 and TSH should be monitored at
regular intervals
v. GALACTOSEMIA (GAL)
- an inborn error of carbohydrate metabolism
characterized by elevated levels of galactose and its
metabolites due to enzyme deficiencies
- In classic galactosemia, the enzyme that is reduced or
missing is called galactose-1-phosphate uridyl
transferase (GALT) which enables the body to break
down galactose into glucose
- Galactose should not be present in excessive amounts
in the body because it’s toxic.

DISORDER METABOLITE CONFIRMATORY

TESTED TESTING
Phenylketonuria phenylalanine Decreased enzyme
activity
Maple syrup urine leucine Increased branched
disease chain amino acid
levels
Congenital adrenal 17-hydroxy- Plasma 17-OHP, Na,
hyperplasia progesterone K, cortisol and RBS

Congenital TSH High serum TSH and

hypothyroidism low FT4
Galactosemia Total galactose Serum galactose and
enzyme activity
G6PD deficiency G6PD enzyme quantitative analysis
activity of the rate of NADPH
production from NADP
4
 o conduct continuing information,
DISORDERS EFFECTS IF NOT EFFECTS IF education, re-education and training
SCREENED SCREENED SCREENED AND programs
TREATED o disseminate information materials on
Congenital Severe mental Normal newborn screening at least annually
Hypothyroidism (CH) retardation - Licensing and Accreditation
Congenital Adrenal Death Alive or normal ▪ DOH and PHIC requires health institutions to
Hyperplasia (CAH) provide NBS
Galactosemia (GAL) Death or cataracts Alive or normal XII. LEAD AGENCY IN NEWBORN SCREENING
Phenylketonuria Severe mental Normal - the DOH shall:
(PKU) retardation ▪ establish the Advisory Committee on Newborn
Screening (reviews conditions, fees, and
G6PD Deficiency Severe anemia, Normal
reports)
kernicterus
▪ develop implementing rules and regulations for
the immediate implementation of a nationwide
XI.
SECTION 5. OBLIGATION TO INFORM newborn screening program
'Any health practitioner who delivers, or assists in the
- ▪ coordinate with DILG for the implementation of
delivery, of a newborn in the Philippines shall, prior to the program
delivery, inform the parents or legal guardian of the ▪ coordinate with NSRC for the accreditation of
newborn of the availability, nature and benefits of NSC and for QA programs
newborn screening. Appropriate notification and
XIII. GENETIC COUNSELING
education regarding this obligation shall be the
- The process of helping people understand and adapt to
responsibility of the Department of Health (DOH).'
the medical, psychological, and familial implications of
NEWBORN SCREENING
genetic contributions to disease.
- shall be performed after 24 hours but not more than 3
▪ Interpretation of family and medical histories to
days after delivery
assess the chance of disease occurrence or
- newborns in ICU: should be tested within 7 days recurrence.
- brochure available to parents ▪ Education about inheritance, testing,
- TAT: 7-14 working days (ENBS) from the time the NSC management, prevention, resources, and
received the samples research Counseling to promote informed
choices and adaptation to the risk or condition
- 2019: only 14 genetic counselors in the Philippines

- 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
Personnel
▪ DOH with NIH shall: