MT Laws and Bioethics Notes

IDTOMIS (Automated Drug Testing Operations)

• Automates accreditation, drug testing, rehab operations, quality assurance, and monitoring.

• Implemented nationwide starting September 22, 2008.

• Requires orientation, biometric registration, software download, and installation for all Drug Testing Laboratories (DTLs).

Violations and Sanctions

• Not connecting to or improper use of IDTOMIS: Suspension/Revocation of Accreditation.

• Non-compliance with drug test kit usage:

  • 1st Offense: Suspension (2-4 weeks).

  • 2nd Offense: Suspension/Revocation of Accreditation.

• Issuance of DTR not generated by IDTOMIS: Suspension/Revocation of Accreditation.

• Issuance of false/fraudulent DTR: Imprisonment, Fine, Revocation of License to Practice (for practitioners), Closure of DTL (RA 9165, Article III, Section 37).

• Failure to refer screening-positive DTR to confirmatory DTL: Suspension/Revocation of Accreditation (IRR, DDB Board Regulation No. 2, s. 2003, Section 16, Paragraph 5).

• Conducting remote collection without permit and issuing DTR: Suspension/Revocation of Accreditation (BHFS Bureau Circular No. 9, s. 2004).

• Violations found during surveys: Preventive suspension (up to 60 days) and cessation of operations.

ICT Requirements for DTLs

• Computer:

  • 1.5 GHz processor.

  • 384 MB RAM.

  • 16-bit color video card.

  • 20 GB free hard disk space.

  • CD/DVD drive.

  • Windows XP SP2 (recommended).

  • Keyboard, mouse, monitor.

  • Minimum 2 USB ports.

• Webcam: Minimum 1.3 megapixels.

• Fingerprint Biometric Scanning Device: Supported by Megamatcher software.

• Internet: Minimum 128 Kbps.

• Megamatcher Client License.

• Inkjet or Laser Jet Printer.

Other Relevant Regulations and Centers

• AO no. 2010-0024: Permit to Construct for Free-Standing Screening Drug Testing Laboratories (approved July 19, 2010).

• EAMC National Reference Laboratory (NRL): For Environmental and Occupational Health, Toxicology, Micronutrient Assay.

• Board regulation no. 2, s. 2003: Implementing Rules and Regulations Governing Accreditation of Drug Testing Laboratories in the Philippines.

Republic Act No. 9288: Newborn Screening Act of 2004

• Signed by President Gloria Macapagal-Arroyo on April 7, 2004

• Comprehensive policy for newborn screening.

• 19 Sections.

Objectives

• Ensure newborn access to screening.

• Establish a sustainable newborn screening system within the public health system.

• Ensure health practitioner awareness of screening benefits and responsibilities.

• Ensure parental recognition of their child's right to health and development.

Definition of Terms

• Newborn: Child from complete delivery to 30 days old.

• Heritable Condition: Condition causing mental retardation, physical deformity, or death if untreated, usually inherited.

• Newborn Screening Center: Facility with a newborn screening laboratory meeting NIH standards.

• Newborn Screening Reference Center: Central NIH facility for testing protocols, follow-up, Advisory Committee secretariat, NRL for newborn screening, training, and EQAS.

Key Provisions

• Section 5: Obligation to Inform - Health practitioners must inform parents about newborn screening.

• Section 6: Performance of Newborn Screening - Screening performed 24 hours to 3 days after delivery (up to 7 days for premature babies).

• Section 7: Refusal to be Tested - Parents can refuse based on religious beliefs but must acknowledge the risks in writing.

• Section 8: Continuing Education.

• Section 9: Licensing and Accreditation - DOH and Philhealth require newborn screening services for health institution licensure/accreditation.

Implementation

• Lead Agency: DOH.

  • Establishes the Advisory Committee on Newborn Screening.

  • Develops implementing rules.

  • Coordinates with DILG for implementation.

  • Coordinates with the NIH Newborn Screening Reference Center.

Advisory Committee on Newborn Screening

• Composition: 8 members.

  • Chairman: Secretary of Health (Teodoro Herbosa).

  • Vice-Chairperson: Executive Director of NIH (Monica M. Bertagnolli).

  • Members: DILG Undersecretary, Executive Director of CWC (Atty. Maria Lourdes Fugoso-Alcain), Director of the Newborn Screening Reference Center, 3 representatives (pediatrician, obstetrician, endocrinologist, family physician, nurse, or midwife) appointed by the Secretary of Health (3-year term).

  • Meets at least twice a year.

Accreditation of Newborn Screening Centers

• Certified laboratory performing all tests.

• Recall/follow-up programs for positive infants.

• Supervised by trained personnel qualified by NIH.

• Subject to announced/unannounced inspections by the Reference Center.

Metabolic Diseases Screened

• Congenital Hypothyroidism:

  • Severe thyroid hormone deficiency in newborns.

  • Occurs in 1 in 3,000-4,000 children.

  • More common in females.

  • Untreated, leads to intellectual disability and growth failure.

  • Often permanent, requiring lifelong treatment.

  • Common cause: iodine deficiency in mother/infant.

  • Thyroid Gland:

    • Butterfly-shaped in lower neck.

    • Produces T3 and T4 hormones.

    • Regulates growth, brain development, metabolism.

• Congenital Adrenal Hyperplasia (CAH):

  • Genetic disorders affecting adrenal glands.

  • Lack of enzymes to make hormones.

  • Excess androgen.

  • Female: male characteristics.

  • Both: early puberty.

  • May result in facial hair and infertility in females and shorter height as well as infertility in males

  • Adrenal Glands: Above kidneys.

• Phenylketonuria (PKU):

  • Inherited disorder, increased phenylalanine levels.

  • Untreated PKU:

    • Musty odor in breath, skin, urine.

    • Mental Retardation.

    • Skin rashes.

    • Lighter skin, hair, eye color (lack of melanin).

    • Microcephaly.

• Galactosemia:

  • Inherited disorder, impairs galactose processing.

  • Mutations in GALT, GALK1, and GALE genes.

  • Symptoms (if given milk):

    • Enlarged Liver.

    • Eye Cataracts.

    • Kidney Damage.

    • Brain Damage.

    • Jaundice.

• Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD Deficiency/Favism):

  • Genetic, mostly affects males.

  • RBCs lack G6PD or it doesn't function.

  • RBCs break apart (hemolysis) causing hemolytic anemia.

  • Favism triggered by fava beans.

Benefits of Newborn Screening

• Prevents Kernicterus (yellowing of skin caused by bilirubin).

• DOH Memorandum No. 2012-0154: Inclusion of Maple Syrup Urine Disease in the Newborn Screening Panel.

• Maple Syrup Urine Disease (MSUD):

  • Branched-Chain Ketoaciduria.

  • Distinct sweet odor of urine.

  • Untreated, leads to neurological symptoms, seizures, coma, death.

Expanded Newborn Screening Program

• Two Options:

  • Screening Of 6 Disorders: Php 550

  • Full Complement (28 disorders) : Php 1500

Republic Act No. 7170: Organ Donation Act of 1991

• Approved on January 7, 1992, by President Corazon Aquino.

• Authorizes donation of body parts after death for specified purposes.

• 19 Sections.

Definition of Terms

• Organ Bank Storage Facility: Licensed facility to store human bodies/parts.

• Decedent: Deceased individual, including still-born infant or fetus.

• Testator: Individual making a legacy of body parts.

• Legatee: Individual receiving a legacy.

• Donor: Individual authorized to donate.

Persons Who May Execute A Legacy (in order of priority)

• Spouse.

• Son or daughter of legal age.

• Either parent.

• Brother or sister of legal age.

• Guardian over the person of the decedent at the time of his death.

Persons Who May Become Legatees

• Any hospital, physician, or surgeon.

• Any accredited medical or dental school, college, or university.

• Any organ bank storage facility.

• Any specified individual (for therapy or transplantation).

Presidential Decree No. 856: Code of Sanitation of the Philippines

• Approved on December 23, 1975, by President Ferdinand Marcos Sr.

• Requires Water Testing Laboratories.

Administrative Order No. 31, s. 1979

• Requirements for Accreditation of Water Analysis Laboratories.

Who can establish, operate, or maintain a water analysis laboratory?

• Any person, firm, or corporation who has completed all requirements (proper equipment, personnel, and area)

Personnel

• Licensed Sanitary Engineer.

  • Supervisor and Director of Free-Standing WTL.

  • Supervisor and Director of WTL attached to a clinical laboratory.

• Clinical Pathologist licensed to supervise the laboratory.

• Licensed Chemist, MT, or Pharmacist.

  • Supervisor in an area without a sanitary engineer or clinical pathologist with adequate experience and training of at least 3 years

• Laboratory Assistants, such as:

  • Medical Technologist.

  • Pharmacist.

  • Chemist.

  • Laboratory Aides: Responsible for laboratory support activities.

Services

• Bacteriological:

  • Multiple Tube Fermentation Technique.

  • Gram Stain.

  • IMViC.

    • I – Indole Test

    • M – Methyl Red Test

    • V – Voges-Proskauer Test

    • C – Citrate test.

  • Standard Plate Count.

  • Fecal Coliform Tests.

  • Optional Tests for Fecal Streptococcal Group.

• Biological: Quantitative and qualitative examination of phytoplankton samples.

• Radiologic:

  • Alpha and Beta Radioactivity.

  • Radioactive Strontium.

    • Strontium 90 – Radioactive tracer in medical studies

  • Radium.

• Physical and Chemical.

Presidential Decree No. 1067: National Water Code (1976)

• Approved on December 31, 1976, by President Ferdinand Marcos Sr.

• Created the National Water Resources Council.

• Aims to control and regulate water resources in the country.

Republic Act No. 9275: Philippine Clean Water Act of 2004

• Signed on March 22, 2004, by President Gloria Macapagal Arroyo.

• Provides protection, preservation, and revival of water quality.

Republic Act No. 6969: Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990

• Signed by President Corazon Aquino.

• Protects public health and the environment from risks posed by toxic substances.

• Jurisdiction of Department of Environment and Natural Resources (DENR).

• Philippine Nuclear Research Institute is the authority.

• 20 sections.

Ethics

• Examines moral judgments and concepts (right/wrong, good/evil, responsibility).

Components of Ethics

• Common Sense: Practical application of right/wrong.

• Judgment: Based on learned codes and evaluation.

• Standard: Laws and orders penalizing wrongdoing.

• Principles: Rules evaluated against a moral standard.

• Rules: Laws and orders penalizing wrongdoing.

• Public Interest: Actions aligned with public welfare.

MT Code of Ethics

• Accept responsibilities.

• Uphold dignity and respect of the profession.

• Perform tasks with confidence, reliability, and accuracy.

• Maintain confidentiality.

• Continuously improve skills and knowledge.

• Share knowledge with colleagues.

• Contribute to professional organizations.

• Act fairly and fraternally.

• Restrict criticisms to constructive limits.

• Accept employment without conflict of interest.

• Use clinical laboratory science to promote life and benefit mankind.

• Uphold the law and avoid illegal work.

• Report violations to authorized agencies.

Resolution No. 72

• On September 13 2022, the Professional Regulatory Board of Medical Technology (PRBMT) issued Resolution No. 72 revising the Code of Ethics of the Medical Technology Profession

Bioethics

• Ethical implications of health-related life science.

• Ethics: Identifying and resolving conflicts among values.

• Bio: Means "Life".

• Clinical Ethics: Resolving ethical questions in healthcare practice.

• Maslow’s Hierarchy of Needs

The Human Act

• Knowledge: Awareness or understanding.

• Freedom: Ability to do what is right.

• Willfulness: Voluntary action based on knowledge and freedom.

• Conscience: Inner guide of right and wrong.

  • Two Elements:

    • Moral Judgment.

    • Moral Obligation.

  • Kinds of Conscience:

    • Correct or True.

    • Erroneous or False.

    • Culpable.

    • Inculpable.

    • Certain.

    • Doubtful.

    • Scrupulous.

    • Lax.

Basic Ethical Principles

• Stewardship: Looking after health and life.

  • To be a Healthcare Steward:

    • Be honest and just.

    • Treat human life with utmost care and protect it from harm.

    • Recognize dependency not on his (your) capacity, but on God.

• Totality: Prioritize the good of the entire person (physical, psychological, and spiritual).

• Double Effect: Good and bad effects can happen simultaneously.

  • Conditions:

    • Action must be morally good.

    • Good effect must precede the evil.

    • Sufficient reason.

    • Evil effect should not outweigh the good effect.

• Cooperation: Working with another in an action.

  • Degrees of Cooperation

    • Formal and Material Cooperation.

    • Direct/Immediate and Indirect/Mediate Cooperation.

Major Bioethical Principles

• Autonomy: Right to determine what is done to one's body (adults of sound mind).

  • Basis for Informed Consent.

• Justice: Moral rightness based on ethics, law, religion, equity, and fairness.

  • Types of Justice:

    • Distributive: Fairness.

    • Procedural: Fair Play.

    • Restorative: Corrective.

    • Retributive: Punishment.

• Beneficence: Duty to benefit the patient.

• Non-Maleficence: Do no harm.

  • Commission or Omission – Acts you did vs acts you ought not to do

  • Affirms the need for medical competence

• Inviolability of Life: Perceive all persons as equal and immeasurable worth.

Crimes Against Human Life

• Suicide:

  • Mental Disorders.

  • Stress Factors.

• Mutilation: Physical injury that degrades appearance or function.

• Euthanasia:

  • Voluntary vs Involuntary.

  • Active vs Passive.

• Drug Addiction: Brain changes.

• Alcoholism: Problems controlling drinking.

• Abortion: Termination of pregnancy.

  • Medical vs Surgical Abortion.

• Sterilization: Medical techniques preventing reproduction.

Applied Health Ethics

• Patient Right to Information:

  • Medical Diagnosis.

  • Treatment.

  • Regimen.

  • Progress.

  • Review medical record.

• Elements of Informed Consent:
  *Condition/ Disorder/Disease
  *Further testing and follow-up requirement
  *Natural course and possible conditions of the condition
  *Consequences of non-treatment
  *Treatment options and its benefits
  *Duration and approximate cost of treatment
  *Expected outcome

• Proxy Consent: Delegation of right to consent.

  • Constraints:

    • The person making the delegation must have the right to consent

    • The person must be legally and medically competent to delegate the right to consent

    • The right to consent must be delegated to a legally and medically competent adult

Beginning of Life

• Rights of a Person to Sex and Parenthood:

  • People are able to enjoy a mutually satisfying and safe relationship
    *Free from coercion or violence and without fear of infection or pregnancy
    Able to regulate fertility without adverse or dangerous consequences

• Artificial Insemination and In Vitro Fertilization:

  • Deliberate introduction of sperm into a female's uterus or cervix for the purpose of achieving pregnancy through in vivo fertilization by means other than sexual intercourse

    • In Vivo – Inside the living human body.

    • In Vitro – Outside of the living human body.

• Surrogacy: Carrying a pregnancy for intended parents.

  • Gestational Surrogacy – Unrelated
    Traditional Surrogacy – Related

End of Life

• Death: Is not a punishment but a two-sided opportunity.
  Karl Rahner

• Needs of a Dying Person:

  • Soothe a person who is dying.

  • Prevent or relieve suffering as much as possible.

  • Physiological and spiritual needs

The Calling of a Healthcare Provider

• Health: State of complete physical, mental, and social well-being.

• A Healthy Person:

  • Is free of disease.

  • Has good energy.

  • Has good thinking processes.
    

• Profession vs Occupation:
  

Trust vs. Action vs. Objective Judgment vs. Reflective

Key Relationships

1. Trust → Action: A patient’s trust in an MT leads to consent for actions (e.g., blood draw).

2. Action → Objective Judgment: Test results (actions) inform objective diagnoses.

3. Reflective: Ensures continuous improvement (e.g., revising protocols after misdiagnoses).

Example in MedTech:

• A patient trusts an MT’s skill (subjective) → MT acts by collecting samples (task) → Uses objective data for diagnosis → Reflects on accuracy to enhance future care.

Mnemonic: "TOAR" (Trust → Objective → Action → Reflective).

Rights of a Patient: Advance Directives

Definition: Legal documents that specify a patient's healthcare wishes if they become unable to decide.

3 Key Types:

1. Living Will

   • Outlines medical treatments the patient wants or refuses (e.g., ventilator, feeding tube).

   • Example: A terminal cancer patient declines chemotherapy in their will.

2. DNR (Do Not Resuscitate)

   • Instructs healthcare providers not to perform CPR if the heart/stops.

   • Note: Requires a physician’s order (not just a patient request).

3. Power of Attorney (Healthcare Proxy)

   • Designates a trusted person to make medical decisions on the patient’s behalf.

   • Example: A spouse decides about surgery for a昏迷 (coma) patient.

Why It Matters in MedTech

• MTs must respect advance directives (e.g., no blood draws if against a DNR’s palliative care goals).

• Ensures ethical compliance (autonomy, non-maleficence).

Mnemonic: "LDP"

• Living Will

• DNR

• Power of Attorney
  

Duties of a Patient

"C.G.I.F.A.F." Mnemonic (Call, Give, Inform, Follow, Ask, Follow)

1. Call personal doctor first

   • Seek direct guidance from your primary physician before consulting others.

2. Give as many facts as you can

   • Share full medical history, symptoms, and lifestyle habits for accurate diagnosis.

3. Inform doctor if you cannot attend an appointment

   • Avoid "no-shows" to respect clinic schedules and resources.

4. Follow instructions

   • Adhere to treatment plans (e.g., fasting before tests, medication schedules).

5. Ask questions

   • Clarify doubts about procedures, risks, or alternatives (informed consent).

6. Follow rules

   • Comply with hospital policies (e.g., visitation hours, infection control).

Healthcare Team Relationships

3 Pillars of Collaboration:

Key Takeaway:

• Patient duties ensure effective care.

• Team relationships rely on trust, communication, and shared goals.

Virtues vs. Vices in Healthcare

"F.H.I.H.R.C.P.C.T.L.F.H.S" (Virtues) vs. "P.G.A.P" (Vices)

Virtues (Essential for Medical Professionals)

1. Fidelity – Loyalty to patients (e.g., confidentiality).

2. Honesty – Transparent communication (e.g., reporting lab errors).

3. Integrity – Consistency in moral principles (e.g., refusing bribes for fake results).

4. Humility – Acknowledging limitations (e.g., consulting seniors on complex cases).

5. Respect – Valuing patient autonomy (e.g., honoring cultural beliefs).

6. Compassion – Empathetic care (e.g., comforting anxious patients during blood draws).

7. Prudence – Wise decision-making (e.g., double-checking critical values).

8. Courage – Advocating for patients (e.g., reporting unethical colleagues).

9. Truth – Accurate reporting (e.g., no fabrication of data).

10. Love – Selfless service (e.g., volunteering in health missions).

11. Faith – Trust in ethical systems (e.g., following protocols despite pressure).

12. Hard Work – Diligence (e.g., meticulous sample processing).

13. Social Justice – Equity in care (e.g., prioritizing underserved patients).

Vices (Ethical Pitfalls)

1. Pride – Overconfidence leading to errors (e.g., skipping verification steps).

2. Greed – Exploitation (e.g., overcharging for tests).

3. Abuse of Power – Unethical authority (e.g., bullying junior staff).

4. Prejudice – Discrimination (e.g., biased treatment based on patient background).

Clinical Examples

• Virtue in Action: An MT admits a mislabeled sample (Honesty + Integrity).

• Vice Consequence: A lab director falsifies COVID test results for profit (Greed + Abuse of Power).

Memory Hook on Virtues: "A Fierce Hippo (F.H.) In Red Cape (I.R.C.) Puts Courage (P.C.) Toward Loving Faithful Heroes (T.L.F.H.) Saving (S) lives."