Medical Technology Laws and Ethics and Laboratory Management

MEDTECH LAWS & LAB MANAGEMENT

RELATED LAWS
  • Organ Donation Act of 1991 (RA 7170)
    • Approval Date: January 7, 1992
    • Amended by: RA 7885
    • Policy-Making Body: Dangerous Drug Board (DDB)
    • Implementing Arm: Philippine Drug Enforcement Agency (PDEA)
    • Key Definitions:
    • Decedent: Deceased individual (of legal age), including still-born infants or fetuses.
    • Testator: Individual who makes a legacy of all or part of the body; next of kin.
    • Donor: Authorized individual to donate all or part of the body of a decedent.
    • Examination of Donation: Authorization of any examination necessary to assure medical acceptability of the legacy or donation.
REVISED REGULATIONS FOR KIDNEY TRANSPLANTATION
  • Required services:
    • HIV Testing
    • Blood Banking
    • Dialysis and Laboratory Diagnostic Capability
    • Monitoring of immunosuppressive drug levels
    • Imaging or Nuclear Medicine Facility
COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002 (RA 9165)
  • Approval Date: June 7, 2002
  • Repealed: RA 6425 (Dangerous Drugs Act of 1972)
DRUG TESTING LABORATORIES REGULATIONS
  • Classification based on:
    1. Ownership
    2. Institutional Character
    3. Service Capability: Screening Laboratory vs. Confirmatory Laboratory
DRUG TESTING MANDATES
  1. Mandatory Drug Testing includes applicants for:
    • Driver's licenses
    • Firearm licenses
    • Military, police, and other law enforcement officers
    • Public office candidates
    • Individuals charged with offenses
  2. Random Drug Testing applies to:
    • Secondary and tertiary students
    • Employees in public and private sectors
TECHNICAL REQUIREMENTS FOR LICENSING
  • Physical Plant Specs:
    • Screening Laboratory: 20m² overall, 10m² work area
    • Confirmatory Laboratory: 60m² overall, 30m² work area
  • Leadership: Licensed physician, chemist, or medical technologist.
CHAIN OF CUSTODY (COC) IN LABORATORIES
  • Minimum info required:
    • Specimen identification
    • Date and time of collection
    • Testing laboratory name
    • Signatures of all individuals handling the sample
LABORATORY REPORTS & SPECIMENS
  • Reports kept for a minimum period determined by DOH.
  • Positive test results must be challenged within 15 days or discarded.
  • Laboratory Report Validity: 1 year from issue date.
HIV TESTING REGULATIONS (RA 8504)
  • Voluntary Testing: Consent required for minors; different regulations for mental incapacity.
  • Confidentiality: Strict disclosure rules, exceptions include:
    1. DOH reporting requirements.
    2. Involvement of health workers in care, subpoena compliance.
NEWBORN SCREENING ACT OF 2004 (RA 9288)
  • Testing performed within 24-72 hours after birth.
  • Positive results released within 24 hours; negative within 7 days.
  • Expanded Screening Program added 22 disorders including hemoglobinopathies and endocrine disorders.
CONTINUING PROFESSIONAL DEVELOPMENT ACT (RA 10912)
  • CPD Credit Units:
    • RMTs: 45
    • MLTS: 30
  • CPD programs must be accredited by PRC and are mandatory for license renewal every 3 years.
PHILIPPINE QUALIFICATIONS FRAMEWORK (RA 10698)
  • Levels regulated by TESDA and CHED, includes courses from Technical (NC I-IV) to Doctoral degrees.
UNIVERSAL HEALTH CARE ACT (RA 11223)
  • Employment guarantees for health professionals, inclusion of primary care competencies in curricula.
MEDICAL ETHICS PRINCIPLES
  1. Autonomy: Respect for patient decisions.
  2. Beneficence: Do good, provide benefits.
  3. Non-maleficence: Avoid harm.
  4. Justice: Fair treatment for all patients.
CODE OF ETHICS FOR MEDICAL TECHNOLOGISTS
  • Commitment to responsibilities, continuous skill improvement, and respect for colleagues.
LABORATORY MANAGEMENT
  1. Leadership Styles: Autocratic, Democratic, Consensus, and Laissez-faire.
  2. Maslow's Hierarchy of Needs in motivation: Self-actualization, esteem, social needs, safety needs, physiological.
  3. Functions of Manager: Planning, organizing, directing, and controlling operations.
QUALITY MANAGEMENT SYSTEMS
  • Approaches include PDCA cycle, Six Sigma, Lean, and ISO 15189.
  • Quality Tools include Pareto charts, cause-and-effect diagrams, and control charts.
EMPLOYEE PERFORMANCE APPRAISAL
  • Regular evaluations based on clear expectations, with common errors to watch for such as error of central tendency and halo effect.
INFORMATION SYSTEM IN LABORATORIES
  1. Components: Hardware (CPU, RAM), Software (OS, Applications).
  2. Communication Systems: LAN and WAN connection.
  3. Autoverification of Results: Automated processes handle defined subsets of lab results without manual intervention.
FINANCIAL CONSIDERATIONS
  • Budget Phases: Development of goals, budget assumptions based on past performance and volume.
SAFETY IN LABORATORIES
  • Hierarchical Controls: Effective measures such as elimination, substitution, and personal protective equipment (PPE).
  • Biosafety Levels: Class I to IV indicating the risk level of microbes handled.
HAZARDS AND EMERGENCY RESPONSE
  • Chemical Hazards: Identification and proper storage of hazardous materials following Material Safety Data Sheets (MSDS).
  • Fire Safety: Classification of fire extinguishers and methods to extinguish different types of fires.
  • Ergonomic Hazards: Prevention of cumulative trauma disorders through proper design and equipment use.
BIOHAZARD AND RADIATION HAZARDS
  • Biohazards include universal precautions such as decontamination and PPE use.
  • Radiation safety and precautions: Involves knowledge of non-ionizing radiation types and their applications in a laboratory setting.
ERGONOMIC HAZARDS
  • Prevention methods for work-related musculoskeletal disorders require ergonomic assessments and equipment.