Comprehensive Study Guide for MedTech Laws, Bioethics, and Clinical Internship Guidelines

Policies, Standards, & Guidelines for Medical Technology / Medical Laboratory Science Program (CMO No. 13, s. 2017)

Legal Authority & Mandate

• Governing Law: Issued in accordance with pertinent provisions of Republic Act No. 7722, otherwise known as the "Higher Education Act of 1994".
• Quality Assurance System: Formulated in pursuance of an outcomes-based quality assurance system as advocated under CHED Memorandum Order (CMO) No. 46, s. 2012, entitled "Policy Standards to Enhance Quality Assurance (QA) in Philippine Higher Education Through an Outcomes-Based & Typology-Based QA".
• Institutional Coverage:
  • Private Higher Education Institutions (PHEIs): All PHEIs intending to offer BSMT/BSMLS must first secure proper authority from the Commission on Higher Education (CHED) in accordance with these Policies, Standards, and Guidelines (PSG).
  • Existing Programs: All PHEIs with existing BSMT/BSMLS programs are required to shift to an outcomes-based approach based on this PSG.
  • Public Institutions: State Universities and Colleges (SUCs) and Local Universities and Colleges (LUCs) must strictly adhere to the provisions of these policies and standards.

Outcomes-Based Education (OBE) Paradigm

• Definition & Concept: Represents a fundamental paradigm shift in the educational system—changing the way students learn, teachers think, and schools measure excellence and success.
• Educational Integration Model:
  • Theory: Mastery-Based Education.
  • Practical: Competency-Based Education.
  • Theory + Practical = Proficiency: Outcomes-Based Education.

Degree Name & Program Overview

• Official Degree Name: The degree program shall be designated as Bachelor of Science in Medical Technology or Bachelor of Science in Medical Laboratory Science (BSMT/BSMLS).
• Program Structure: A four-year degree program consisting of general education and professional courses.
• Fourth-Year Internship Program: Consists of a $1\text{-year}$ intensive practical and theoretical training program in a CHED-accredited clinical training laboratory with rotational duties across different sections:
  • Clinical Chemistry
  • Hematology
  • Microbiology
  • Immunology & Serology
  • Parasitology
  • Clinical Microscopy (Urinalysis & Body Fluids)
  • Blood Banking (Immunohematology)
  • Histopathologic / Cytologic Techniques
  • Other emergent technologies

Program Goals & Graduate Competencies

• Core Goal: Develop knowledge, skills, professional attitude, and values in the performance of clinical laboratory procedures needed to assist physicians in proper diagnosis, treatment, prognosis, and prevention of disease.
• Key Competencies & Outcomes:
  • Acquire critical thinking skills in Medical Technology / Medical Laboratory Science.
  • Engage in research and community-related activities.
  • Participate in activities related to promoting the profession and actively engage in lifelong learning undertakings.
  • Develop collaborative and leadership qualities.

Career Opportunities & Allied Fields

• Specific Professions / Careers / Occupations for Graduates:
  • Licensed Medical Technologists / Medical Laboratory Scientists
  • Diagnostic Molecular Scientists
  • Research Scientists
  • Educators
  • Diagnostic Product Specialists
  • Public Health Practitioners
  • Healthcare Leaders
• Allied Medical Practice Fields:
  • Public Health / Epidemiology
  • Veterinary Laboratory Science
  • Molecular Biology / Biology
  • Nuclear Science
  • Forensic Science
  • Health Administration / Management
  • Food & Industrial Microbiology

Program Administration & Qualifications of Dean / Head

• Administration Requirement: Higher Education Institutions (HEIs) offering the BSMT/BSMLS program shall be administered by a full-time Dean or Department Head.
• Qualifications of Dean / Head:
  1. Must be a Filipino citizen.
  2. Must possess good moral character.
  3. Must be a Registered Medical Technologist in the Philippines with an updated Professional Regulation Commission (PRC) license.
  4. Must hold a Master's degree in Medical Technology, Public Health, Education Administration, or other MT/MLS-related programs, OR be a Doctor of Medicine with a Master's degree.
  5. Must have at least $5\text{ years}$ of very satisfactory teaching experience in MT/MLS professional courses.
  6. Must have at least $2\text{ years}$ of managerial/supervisory competence and technical expertise in school management.
  7. Must be an active member in good standing of the following organizations:
     • PRC-Accredited Professional Organization for Medical Technologists (PAMET).
     • Association of Schools of Medical Technology (PASMETH).
• General Functions & Responsibilities of Dean / Head:
  • Administers the general policies of the Higher Education Institution (HEI).
  • Exercises educational leadership among Medical Technology faculty members, as stated in the Manual of Regulations for Private Schools Eighth Edition 1992, Article VIII, Section 41 on the Qualifications & Functions of the Dean.

Faculty Qualifications & Conditions of Employment

• Faculty Teaching Non-Licensure Courses: Must hold an appropriate Master's or Doctoral degree in related fields to teach courses not included in the licensure examination.
• Faculty Teaching Licensure Courses:
  • Must be a Registered Medical Technologist with a current and valid PRC license (unless a special temporary permit to teach is issued by the PRC).
  • Must hold a Master's degree in Medical Technology, Public Health, or other MT/MLS-related fields.
  • Must have at least $1\text{ year}$ of clinical experience.
• Teaching Load & Status Rules:
  • Full-time faculty members shall have a regular teaching load regardless of lecture or laboratory classes, with no more than $3$ course preparations in any single semester.
  • A faculty member shall hold full-time status in only $1$ HEI.
  • In case of a vacancy in the teaching force during the school year, a substitute or replacement with similar or higher qualifications must be employed.
  • At least $60\text{\%}$ of the faculty in every college/university handling professional courses must hold full-time status.
  • The required ratio of teaching faculty is at least $2$ full-time faculty members for every $50\text{ students}$.
• Professional Development & Memberships:
  • Must be an active member in good standing of the PRC-Accredited Professional Organization for Medical Technologists and the Association of Schools of Medical Technology.
  • Faculty members shall actively pursue Continuing Professional Development (CPD).
  • Faculty members shall be actively involved in research activities.
• Employment Regulations:
  • Employment conditions must align with institutional policy.
  • Probationary periods must conform to the provisions of the Labor Law Code 1422.
  • Every institution must maintain a faculty manual containing policies on all faculty matters.

Library Requirements

• Standards Conformance: Library personnel, facilities, and holdings must conform to existing CHED requirements embodied in separate CHED issuances.
• Holdings & Resources: Every institution offering the BSMT/BSMLS program shall provide adequate library resources relevant to MT/MLS in sufficient quantity to serve student needs, aligning with development and expansion plans.
• Collection Designation: A well-developed MT/MLS library collection—whether established separately or as a section within a general library—must be clearly defined as an MT/MLS collection.

Laboratory & Physical Facilities Requirements

• Classroom & Laboratory Ratios:
  • Lecture Classroom Ratio: Maximum of $1:40$ faculty-to-student ratio.
  • Laboratory Room Ratio: Maximum of $1:20$ faculty-to-student ratio.
• Architectural & Space Specifications:
  • Classrooms and laboratory rooms must feature swing-out type entrance and exit doors.
  • Laboratory rooms require a minimum floor space of $1\text{ square meter}$ for every $1\text{ to } 2\text{ students}$.
  • Storage lockers must be provided at a ratio of $1\text{ locker}$ for every $1\text{ to } 5\text{ students}$.
  • Rooms must be well-lighted and well-ventilated.
• Safety Devices & Utility Standards:
  • Adequate supply of water, gas, and electricity.
  • Fire extinguishers
  • Emergency shower
  • First aid kit / cabinet
  • Safety posters
  • Exhaust system & fume hoods
  • Acid-resistant laboratory table-tops
  • Eye wash
  • Sand box
• Required Laboratory Subject Facilities:
  • Chemistry (Inorganic, Organic, Analytical, & Biochemistry)
  • Anatomy & Physiology
  • Clinical Chemistry
  • Immunology & Serology
  • Blood Banking & Serology
  • Hematology
  • Microbiology
  • Clinical Microscopy
  • Parasitology
  • Histopathology
  • Toxicology
  • Molecular Biology & Diagnostics
• Laboratory Combination: Institutions are permitted to combine professional laboratories, including: Clinical Chemistry, Hematology, Blood Banking, Immuno-Serology, Microbiology, Parasitology, Clinical Microscopy, and Histopathology.
• Simulated Clinical Laboratory: Highly recommended for pre-clinical training.
• Waste Disposal: Institutions must establish an appropriate and safe waste disposal system.

Evaluation Criteria & Sanctions for HEIs

• Evaluation Criteria: Compliance of MT/MLS schools is evaluated based on:
  1. MTLE Performance: Institutional passing average of graduates in the Medical Technologist Licensure Examination (MTLE) over the past $3\text{ years}$, as provided by the Professional Regulatory Board of Medical Technology.
  2. Joint CHED-PRC Monitoring Results: Evaluation across eight core areas:
     • Dean / Administration
     • Faculty
     • Curriculum & Instruction
     • Research & Publication
     • Laboratory & Physical Facilities
     • Library & Learning Facilities
     • Students (Admission, Promotion, & Retention)
     • Clinical Internship Training Program

MTLE Performance Sanctions

Non-Compliance with PSG Evaluation Areas

Transitory, Repealing, & Effectivity Clauses

• Repealing Clause: Supersedes all previous issuances concerning MT/MLS education that are inconsistent or contradictory with any provisions herein.
• Effectivity Date: Signed on May 08, 2017 by Patricia B. Licuanan, PhD (Chairperson). Takes effect $15\text{ days}$ after publication in the Official Gazette or a newspaper of national circulation.
• Implementation Date: Full implementation beginning Academic Year 2018-2019.

General Guidelines for the Medical Technology Internship Program

Vision & Mission

• Vision: The Medical Technology / Medical Laboratory Science Internship Training Program will be a global academic enterprise recognized worldwide. It will serve as the benchmark for measuring institutional internship training performance, characterized by competence, teamwork, initiative, and student responsiveness to patient needs in healthcare delivery.
• Mission: To provide quality training for Medical Technology / Medical Laboratory Science students, helping them develop into humane, competent, globally competitive Medical Technologists / Medical Laboratory Scientists committed to serving global health needs.

Internship Rotational Breakdown & Hours

• Program Structure: Situated in the fourth-year level, providing intensive practical and theoretical training across clinical laboratory sections.
• Weekly & Yearly Total Hours: Interns render $32\text{ hours/week}$ of clinical duty, completing exactly $1,664\text{ hours}$ in $1\text{ year}$.

Discipline Rotational Hours Breakdown

Internship Objectives & Admission Requirements

• Internship Objectives:
  1. Enhance knowledge, skills, and attitudes required for healthcare team members to perform clinical laboratory procedures with precision and accuracy to aid physicians in diagnosis, treatment, and prevention.
  2. Develop a well-rounded personality with a healthy outlook oriented toward intelligent, ethical, and active participation in professional and community welfare activities.
  3. Develop critical thinking skills to participate in research and respond to professional challenges.
  4. Cultivate humane, competent, globally competitive practitioners.
• Admission Requirements:
  1. Completion of all academic course requirements for the first $3\text{ years}$ of the BSMT/BSMLS curriculum.
  2. Mandatory physical and laboratory examinations:
     • Complete Blood Count (CBC)
     • Urinalysis
     • Fecalysis
     • Drug Testing (Methamphetamines & Cannabinoids)
     • HBsAg, Anti-HBs, Chest X-ray, and/or Sputum Microscopy
     • Proof of Hepatitis B vaccination
  3. Applicants testing positive for infectious diseases shall be temporarily suspended from starting training until proof of complete, adequate treatment is submitted.
  4. Compliance with all specific HEI institutional requirements.

Administrative Rules & Affiliation Fee Allocation

• General Administrative Rules:
  • Training programs must align with updated CHED rules on Medical Technology Internship Program (MTIP).
  • Formal Memorandum of Agreement (MOA) must be executed between the HEI and the training laboratory.
  • Interns shall be assigned exclusively to CHED-accredited training centers.
  • The HEI shall conduct relevant educational seminars as mandated by CHED.
• Affiliation Fee Structure:
  • Maximum Fee Cap: Cap of no more than $\text{Php } 600\text{ per intern per month}$. No other fees shall be collected unless new guidelines are issued by CHED.
  • Applicability: Applies equally to both public and private training facilities.
  • Disbursement Split: Collected by the HEI and disbursed to the accredited training laboratory, split as:
    • Hospital Share: $50\%$
    • Laboratory Staff Involved in Training: $50\%$

Clinical Instructor / Intern Coordinator

• Staffing Ratio: Required ratio of $1\text{ Clinical Instructor / Intern Coordinator}$ (Registered Medical Technologist) for every $25\text{ interns}$.
• Duties & Responsibilities:
  1. Acts as the official liaison officer between the HEI and the CHED-accredited affiliating hospital or free-standing clinical laboratory.
  2. Coordinates with the Training Officer and Chief Medical Technologist regarding internship implementation.
  3. Conducts progressive evaluation of intern attendance, behavior, and performance during official visits at least once a week.
  4. Prepares and submits monthly administrative reports.
  5. Participates in reviewing, revising, and updating the internship training program.
  6. Performs other related functions assigned by the Dean.

Professional Code of Conduct for Interns

• Maintain professional, disciplined behavior at all times and treat patients with compassion.
• Avoid undue familiarity, intimacy, or accepting gifts/fees in any form from patients.
• Treat laboratory staff with utmost respect and courtesy.
• Maintain strict confidentiality of test results. Statements or certifications concerning results may only be issued with explicit permission from the Laboratory Head or Chief Medical Technologist.
• Work harmoniously with fellow interns and laboratory personnel.
• Strictly adhere to the Code of Ethics of Medical Technologists.

Attendance, Shift Calculations, & Absence Sanctions

• Reporting Standards: Punctuality is strictly enforced. Interns must report at least $15\text{ minutes}$ prior to shift start.
• Duty Schedule Mathematical Options:
  • Option A: Two $8\text{-hour}$ regular duties ($16\text{ hours}$) + One $16\text{-hour}$ duty ($16\text{ hours}$) = $32\text{ hours/week} \times 52\text{ weeks/year} = 1,664\text{ hours}$.
  • Option B: Four $8\text{-hour}$ duties ($32\text{ hours/week}$) = $32\text{ hours/week} \times 52\text{ weeks/year} = 1,664\text{ hours}$.
• Rest & Seminar Days: Interns are allowed $1\text{ day off}$ per week, plus $1\text{ day}$ dedicated to the Medical Technology Assessment Program and Seminars at their HEI. Shifts of $24\text{ hours}$ are strictly prohibited.
• "Out of Post" (OP) Sanctions:
  • Found OP within laboratory premises: Given $2\text{ hours}$ of make-up duty by the section head or training officer.
  • Found OP outside hospital premises: Given $3\text{ days}$ of make-up duty.
• Tardiness Penalties:
  • $3\text{ consecutive tardiness}$ = $1\text{ day}$ unexcused absence.
  • Accumulated $60\text{ minutes}$ of tardiness = $1\text{ day}$ make-up duty.
  • Habitual tardiness = Formal conference with Clinical Instructor, parents/guardians, and/or suspension.
• Absence Penalties:
  • Excused Absence: Requires $1\text{ day}$ make-up duty per day missed.
  • Unexcused Absence: Requires $2\text{ days}$ make-up duty per day missed.
  • Excessive Absences (Exceeding $20\%$ of total internship hours):
    • Per Section: Repeat section rotation.
    • Per Hospital Rotation: Repeat entire internship program.
• Excused Absence Categories:
  • Death of immediate family members.
  • Illness or medical emergencies (sickness requires medical certificate validated by University Physician and approved by Training Officer).
  • Inclement weather, transportation strikes, national security incidents, natural calamities.
• Pull-Out & Make-Up Regulations:
  • No make-up duty required if HEI officially pulls out interns via written notice to the Chief of Laboratory at least $3\text{ days}$ prior.
  • Attending to academic deficiencies/backlogs from previous years is not an excused absence.
  • Prohibition: Completing make-up duties/absences via cash, gifts, or projects is strictly forbidden.
  • Training laboratories must allow students to complete make-up duties at least $2\text{ months}$ prior to rotation end.
• Leave of Absence (LOA): Formal letter submitted to the Dean at least $3\text{ days}$ prior to internship start.

Grooming & Uniform Standards

1. Must maintain clean, professional grooming at all times.
2. Must wear official school uniform with laboratory gown on duty.
3. Closed shoes required for all interns.
4. No colored shoes, colored stockings, sandals, or slippers. Rubber shoes permitted only during $16\text{-hour}$ duties.
5. Hair trimmed and kept away from face. Long, untidy, fancy, or spiked hair prohibited for males. Hair dyeing strictly prohibited.
6. Beards, goatees, and mustaches prohibited. Earrings prohibited for male interns.
7. Fingernails kept short, clean, without bright polish.
8. Elaborate jewelry and dress ornaments prohibited.
9. Heavy make-up, nose rings, lip rings, and one-sided rings for males prohibited.
10. Cleanliness and neatness required at all times.

Equipment Breakages & Property Damage

• Investigation Procedure: Formal investigation with due process required.
• Financial Liability: Proven negligent interns are responsible for settling the full replacement or repair cost of damaged equipment, provided wear-and-tear factor is eliminated.

Merits, Demerits, & Offenses

• Points of Merits: Awarded for exemplary performance, extraordinary diligence, or participation in extra-curricular activities outside regular training (e.g., sports fest, foundation day, christmas party, grand duty, medical missions).
• Points of Demerits: Issued for violations of rules and regulations.
• Minor Offenses:
  1. Disciplinary Offenses: Penalized via make-up duties.
  2. Academic Offenses: Pre-analytical, analytical, and post-analytical errors. Reflected in performance evaluation (NOT penalized via make-up duties or demerits). Clinical laboratory workload is the responsibility of registered medical technologists; interns must be supervised at all times (CMO No. 06, s. 2008). Interns are not legally liable for technical errors committed under active supervision.
• Major Offenses (Sanctions determined jointly by Training Center and HEI):
  1. Dishonesty in any form (forgery, falsification of documents)
  2. Alcohol intoxication
  3. Inflicting physical injuries
  4. Carrying deadly weapons
  5. Possession/use of prohibited drugs
  6. Sexual harassment
  7. Vandalism
  8. Deliberate destruction of hospital property
  9. Gambling
  10. Stealing
  11. Acts of moral turpitude

Institutional & Training Laboratory Responsibilities

• Responsibilities of Higher Education Institution (HEI):
  • Secure CHED permit/recognition and comply with Republic Act No. 5527 (Medical Technology Law).
  • Assign Clinical Instructors to monitor attendance, behavior, and performance.
  • Ensure interns settle or replace damaged equipment and supplies.
  • Ensure compliance with hospital rules and maintain discipline.
• Responsibilities of Training Laboratories:
  • Must be a licensed tertiary clinical laboratory accredited by CHED.
  • Maintain adequate staff of Registered Medical Technologists.
  • Provide adequate physical space ($1\text{ sq. meter per intern}$).
  • Provide equipment and supplies proportionate to test volume and intern count.
  • Provide structured supervision led by a RMT (preferably holding a Master's degree).
  • Establish clear training objectives, test quotas, ethical standards, and evaluation systems.
  • Conduct orientation and report violations to the HEI Clinical Coordinator.
• Joint Responsibilities: Jointly implement training programs, hold periodic evaluation conferences, and adhere to MOA terms.

Performance Evaluation & Graduation Policy

• Evaluation Components:
  1. Examinations: Theoretical and Practical exams.
  2. Clinical Performance: Competency skills, attitude, behavior, attendance, and punctuality.
• Graduation Requirement: No intern shall be allowed to graduate unless he or she has completed all internship requirements.
• Laboratory Accreditation Sanctions: Accredited training laboratories found non-compliant during renewal inspections are given $3\text{ months}$ to comply. Significant violations or routine inspection findings will be investigated, potentially leading to non-renewal of Certificate of Accreditation.