Medtech Laws Study Notes
INTRODUCTION
Continuing Professional Development (CPD)
Concept of CPD is not new.
In 1973, Professional Regulatory Boards (PRBs) were authorized to assess conditions affecting various professions and implement measures for enhancement.
The Medical Technology Board (MTB), acting as the PRB for medical technology, issued Board Resolution No. 167, Series of 1988 to govern continuing professional education (CPE).
In 1995, President Fidel V. Ramos issued Executive Order No. 26, institutionalizing CPE programs. This led to PRC Resolution No. 381, which standardized CPE implementation guidelines.
On December 5, 2000, R.A. No. 8981 was enacted, repealing P.D. No. 223, but reaffirmed that PRBs must adopt measures to enhance professional standards.
In 2004, PRC Resolution No. 2004-179 standardized the procedures for CPE implementation.
In 2008, the PRC revised CPE regulations with PRC Resolution No. 2008-466, introducing the term “CPE/CPD system.”
In 2013, PRC Resolution No. 2013-774 officially adopted “continuing professional development (CPD)” and dropped the term CPE.
Compulsory Compliance
On July 21, 2016, R.A. No. 10912, or the Continuing Professional Development Act of 2016, was enacted, making CPD mandatory for renewing professional identification cards (PICs).
PRC Resolution No. 1032, Series 2017, mandating CPD compliance, took effect on March 15, 2017.
On April 16, 2018, MTB issued Medical Technology PRB Resolution No. 07, Series of 2018.
PRC Resolution No. 2019-1146, on February 7, 2019, amended PRC Resolution No. 1032.
REPUBLIC ACT NO. 10912
Known as the Continuing Professional Development Act of 2016, which requires compliance with CPD for the renewal of professional identification cards for all professionals regulated by the PRC.
Enactment of R.A. No. 10912
Lapsed into law on July 21, 2016, effective August 26, 2016, after publication.
Unique because it became law without presidential signature, as the president did not act within the 30-day period.
CONTINUING PROFESSIONAL DEVELOPMENT (CPD)
Definition: Inculcation of advanced knowledge, skills, and ethical values for assimilation into professional practice, self-directed research, and lifelong learning.
Lifelong Learning: Involves activities throughout one's life for developing competencies and professional qualifications.
Self-Directed Learning: Includes various activities such as online training, seminars, and non-degree courses that may not undergo CPD accreditation but can earn CPD units.
NATURE OF CPD
CPD is mandatory for renewing PICs for all PRC-regulated professionals, including RMTs and MLTs.
CPD CREDIT UNIT
CPD Credit Unit (CU): Represents the value of learning that can be transferred to qualifications achieved through various settings including professional work experience.
Mandatory for PIC renewal every three years.
Guidelines for Earning CPD CUs:
Maximum of one CU per hour of activity.
Full credit for attendance/completion of assessment:
50% CU for Certificate of Attendance.
Full CU for completion of Certificate of Completion with pre/post-tests.
Maximum of 20 CUs for professional track programs lasting three days or more.
Programs under academic track, such as Master's or Doctorate, yield full CUs; total does not exceed allowable full CUs for the compliance period.
Officials limits on creditable units for self-directed learning:
RMTs: 15 CUs
MLTs: 10 CUs
Unavailable to overseas RMTs/MLTs during compliance.
Applications for self-directed learning must be filed within five years post-completion.
Certificates of Attendance/Completion must indicate corresponding CPD units.
Excess CPD Credit Units: Cannot be carried over to the next compliance period; no provision allows for this under CPD Act of 2016.
CPD COUNCIL
The Council is established to promote and ensure continuous professional improvement according to standards.
Composition:
Chairperson: Chosen member of the MTB.
First Member: Officer of PAMET.
Second Member: Officer of PASMETH.
Chairperson's term aligns with their PRB term; other members serve two-year terms.
Chairperson Responsibilities:
Preside over Council meetings.
Direct and supervise activities.
Submit annual reports by January 15.
Sign certificates for accredited CPD providers/programs and credit units.
Functions of CPD Council:
Ensure adequate CPD program provision.
Evaluate applications for CPD provider/program accreditation.
Monitor CPD program implementation.
Upgrade accreditation criteria for CPD providers regularly.
Develop and validate mechanisms for diverse learning processes.
Conduct research for international alignment of CPD programs.
Issue operational guidelines with PRC and PRB approval.
Perform related functions for CPD implementation.
MAJOR AREAS OF CPD ACTIVITIES FOR MEDICAL TECHNOLOGY
Areas underpinning CPD with respective credit unit requirements:
Ethics:
Content: Code of ethics applications, regional/international ethics.
Required Units: 18% (RMTs: 8 CUs; MLTs: 5 CUs).
Standards of Professional Practice:
Content: Related laws, DOH regulations, PRC resolutions.
Required Units: 27% (RMTs: 12 CUs; MLTs: 8 CUs).
Enhancement of Professional Practice and Technical Competence:
Content: Updates, capacity, and credential building.
Required Units: 44% (RMTs: 20 CUs; MLTs: 14 CUs).
Environmental Factors:
Content: Gender development, personality development, environmental concerns.
Required Units: 11% (RMTs: 5 CUs; MLTs: 3 CUs).
Total Required: 100% (RMTs: 45 CUs; MLTs: 30 CUs).
TRANSITION PERIOD PROVISIONS (PRC Resolution No. 2019-1146)
Professionals overseas are exempt from CPD requirements.
Newly licensed professionals are exempt during the first renewal cycle.
CPD requirements shall not exceed 15 units for each category during transition.
Transitional CU Requirements for RMTs/MLTs: 15 CUs, others specific to senior citizens/differently-abled.
Transition timeline defined for eventual full CPD Act application post-completion.
PROFICIENCY TIERS FOR CPD ACTIVITIES
Adopted the Dreyfus Model of Skill Acquisition for categorizing CPD activities in medical technology based on career progression:
Beginner: Basic knowledge and limited experience, requiring guidance.
Competent: Sees actions in context and performs tasks independently.
Proficient: Integrates experience and manages laboratory operations effectively.
Expert: Deep understanding enables strategic design and problem-solving.
NATURE OF CPD PROGRAMS
CPD programs encompass accredited learning activities leading to advanced skills and knowledge. Types include:
Formal Learning: Educational arrangements leading to recognized qualifications.
Non-formal Learning: Flexible approaches complementing formal education.
Informal Learning: Daily experiential learning recognized through assessments.
Online Learning: Internet-based structured or unstructured learning initiatives.
Professional Work Experiences: Engagements in a specific field providing learning opportunities.
CLASSIFICATIONS OF CPD PROVIDERS
CPD Provider: Natural or juridical entity accredited to conduct CPD programs.
Accreditation Criteria:
Local CPD Providers (Individuals/Firms/Government Institutions) must meet specific standards and conditions.
Foreign CPD Providers must demonstrate sustainability and capability.
PRC and PRBS officials are disqualified from being CPD providers.
Validity of Accreditation: Three years, subject to renewal.
CLINICAL LABORATORIES REGULATIONS
INTRODUCTION
Clinical laboratories are critical for providing health care services necessary for disease diagnosis and monitoring.
Regulated by the Department of Health (DOH) since the establishment of the Bureau of Research and Laboratories (BRL) in 1958.
REPUBLIC ACT NO. 4688
The law regarding the operation of clinical laboratories ensuring quality, access to affordable health services, and accountability for accurate lab results.
Regulates licensing and standards via a series of administrative orders.
ADMINISTRATIVE ORDERS
Several directives have supported clinical laboratory regulation, addressing licensing, quality assessment, and operational standards. Key orders include:
The National Framework of the National Health Laboratory Network (A.O. No. 2012-0021).
Implementation of External Quality Assessment Programs (Dept. Memo No. 2009-0086).
Rules governing the licensure and regulation of clinical laboratories.
OBJECTIVES
Prescribe minimum standards for accurate laboratory results.
Safeguard public health access to affordable health services.
CLINICAL LABORATORY CLASSIFICATIONS
Defined by ownership, function, institutional character, and service capability. Areas include:
Ownership: Government vs. Private laboratories.
Function: Clinical pathology vs. Anatomic pathology.
Service Capability: Classified by categories, further defining services offered.
LICENSING
Issued by the DOH, validating compliance with standards. Requires annual renewal.
Exemptions exist for specific government labs performing minimal functions.
VIOLATIONS AND PENAL PROVISIONS
Violations of R.A. 4688 or its regulations may lead to penalties including fines, suspension, and revocation of licenses.
Investigations into complaints about clinical laboratories are mandated; violations can lead to license forfeiture.
SUPERVISION, MANAGEMENT, AND STAFFING
Supervised by certified pathologists; mandates a minimum staffing ratio based on workload.
NATIONAL BLOOD SERVICES ACT
INTRODUCTION
R.A. No. 7719 promotes voluntary blood donation, repealing prior commercial blood banking practices.
NECESSITY OF REGULATION
Safeguards health rights of citizens; emphasizes need for non-profit blood collection and education on safe practices.
BLOOD SERVICE FACILITIES
Blood Service Facility (BSF) classifications include: Government vs. Private, Hospital-based vs. Non-hospital-based, and service capability categories.
Transfusion Transmissible Infections (TTIs) are screened blood components.
LICENSING AND MONITORING
Regulations for estate blood banking, with specific ATO/LTO managed by the DOH and oversight by HFSRB.
INTRODUCTION - Continuing Professional Development (CPD)
Concept of CPD is not new.
In 1973, Professional Regulatory Boards (PRBs) were authorized to assess conditions affecting various professions and implement measures for enhancement.
The Medical Technology Board (MTB), acting as the PRB for medical technology, issued Board Resolution No. 167, Series of 1988 to govern continuing professional education (CPE).
In 1995, President Fidel V. Ramos issued Executive Order No. 26, institutionalizing CPE programs. This led to PRC Resolution No. 381, which standardized CPE implementation guidelines.
On December 5, 2000, R.A. No. 8981 was enacted, repealing P.D. No. 223, but reaffirmed that PRBs must adopt measures to enhance professional standards.
In 2004, PRC Resolution No. 2004-179 standardized the procedures for CPE implementation.
In 2008, the PRC revised CPE regulations with PRC Resolution No. 2008-466, introducing the term “CPE/CPD system.”
In 2013, PRC Resolution No. 2013-774 officially adopted “continuing professional development (CPD)” and dropped the term CPE.
Compulsory Compliance
On July 21, 2016, R.A. No. 10912, or the Continuing Professional Development Act of 2016, was enacted, making CPD mandatory for renewing professional identification cards (PICs).
PRC Resolution No. 1032, Series 2017, mandating CPD compliance, took effect on March 15, 2017.
On April 16, 2018, MTB issued Medical Technology PRB Resolution No. 07, Series of 2018 to further heighten compliance framework.
PRC Resolution No. 2019-1146, on February 7, 2019, amended the earlier resolution to address increasing professional development needs and enhance clarity on CPD activities.
REPUBLIC ACT NO. 10912
Known as the Continuing Professional Development Act of 2016, which requires compliance with CPD for the renewal of professional identification cards for all professionals regulated by the PRC.
Enactment of R.A. No. 10912
Lapsed into law on July 21, 2016, effective August 26, 2016, after publication.
Unique because it became law without presidential signature, as the president did not act within the 30-day period, making it a significant legislative achievement that reinforces the need for ongoing professional education.
CONTINUING PROFESSIONAL DEVELOPMENT (CPD)
Definition: Inculcation of advanced knowledge, skills, and ethical values for assimilation into professional practice, self-directed research, and lifelong learning aimed at enhancing service delivery.
Lifelong Learning: Involves activities throughout one's life for developing competencies and professional qualifications, emphasizing adaptability to changing industry standards.
Self-Directed Learning: Includes various activities such as online training, seminars, and non-degree courses that may not undergo CPD accreditation but can earn CPD units, thereby allowing professionals to tailor their learning experiences according to their specific career needs.
NATURE OF CPD
CPD is mandatory for renewing PICs for all PRC-regulated professionals, including RMTs and MLTs, thereby fostering a culture of continuous improvement and professional excellence.
CPD CREDIT UNIT
CPD Credit Unit (CU): Represents the value of learning that can be transferred to qualifications achieved through various settings including professional work experience, securing a standardized approach to measuring professional development.
Mandatory for PIC renewal every three years.
Guidelines for Earning CPD CUs:
Maximum of one CU per hour of activity.
Full credit for attendance/completion of assessment:
50% CU for Certificate of Attendance, which acknowledges participation without full requirements.
Full CU for completion of Certificate of Completion with pre/post-tests, ensuring thorough comprehension of material.
Maximum of 20 CUs for professional track programs lasting three days or more to encourage in-depth specialization.
Programs under academic track, such as Master's or Doctorate, yield full CUs; total does not exceed allowable full CUs for the compliance period, thus promoting higher education engagement.
Officials limits on creditable units for self-directed learning:
RMTs: 15 CUs
MLTs: 10 CUs
Unavailable to overseas RMTs/MLTs during compliance.
Applications for self-directed learning must be filed within five years post-completion, balancing necessary documentation with support for ongoing education.
Certificates of Attendance/Completion must indicate corresponding CPD units, ensuring transparency and accountability in professional development activities.
Excess CPD Credit Units: Cannot be carried over to the next compliance period; no provision allows for this under CPD Act of 2016, emphasizing the importance of timely participation in CPD activities to meet requirements.
CPD COUNCIL
The Council is established to promote and ensure continuous professional improvement according to standards, playing a pivotal role in overseeing CPD implementation.
Composition:
Chairperson: Chosen member of the MTB, providing leadership and direction.
First Member: Officer of PAMET, representing the interests of medical technology professionals.
Second Member: Officer of PASMETH, contributing a broader educational perspective.
Chairperson's term aligns with their PRB term; other members serve two-year terms to ensure stability and continuity.
Chairperson Responsibilities:
Preside over Council meetings to facilitate discussion and decision-making.
Direct and supervise activities to achieve CPD goals.
Submit annual reports by January 15, providing accountability and transparency.
Sign certificates for accredited CPD providers/programs and credit units.
Functions of CPD Council:
Ensure adequate CPD program provision to meet professional needs.
Evaluate applications for CPD provider/program accreditation rigorously.
Monitor CPD program implementation for compliance and effectiveness.
Upgrade accreditation criteria for CPD providers regularly to maintain high standards.
Develop and validate mechanisms for diverse learning processes, recognizing various modalities for adult education.
Conduct research for international alignment of CPD programs to ensure relevance and effectiveness globally.
Issue operational guidelines with PRC and PRB approval for clarity and consistency.
Perform related functions for CPD implementation, reinforcing the CPD framework to adapt to evolving professional landscapes.
MAJOR AREAS OF CPD ACTIVITIES FOR MEDICAL TECHNOLOGY
Areas underpinning CPD with respective credit unit requirements:
Ethics:
Content: Code of ethics applications, regional/international ethics, underpinning professional integrity and responsibility.
Required Units: 18% (RMTs: 8 CUs; MLTs: 5 CUs).
Standards of Professional Practice:
Content: Related laws, DOH regulations, PRC resolutions that guide practice and ensure legal compliance.
Required Units: 27% (RMTs: 12 CUs; MLTs: 8 CUs).
Enhancement of Professional Practice and Technical Competence:
Content: Updates, capacity, and credential building provide professionals with current knowledge and skills.
Required Units: 44% (RMTs: 20 CUs; MLTs: 14 CUs).
Environmental Factors:
Content: Gender development, personality development, environmental concerns to create a well-rounded professional.
Required Units: 11% (RMTs: 5 CUs; MLTs: 3 CUs).
Total Required: 100% (RMTs: 45 CUs; MLTs: 30 CUs), emphasizing the comprehensive nature of CPD.
TRANSITION PERIOD PROVISIONS (PRC Resolution No. 2019-1146)
Professionals overseas are exempt from CPD requirements, recognizing the unique challenges they face.
Newly licensed professionals are exempt during the first renewal cycle, facilitating their initial transition into professional life.
CPD requirements shall not exceed 15 units for each category during transition, ensuring manageable compliance as they adapt.
Transitional CU Requirements for RMTs/MLTs: 15 CUs, others specific to senior citizens/differently-abled, reinforcing inclusivity.
Transition timeline defined for eventual full CPD Act application post-completion, providing a roadmap for integration into ongoing professional development.
PROFICIENCY TIERS FOR CPD ACTIVITIES
Adopted the Dreyfus Model of Skill Acquisition for categorizing CPD activities in medical technology based on career progression:
Beginner: Basic knowledge and limited experience, requiring guidance to develop competencies.
Competent: Sees actions in context and performs tasks independently, building confidence in professional capabilities.
Proficient: Integrates experience and manages laboratory operations effectively, demonstrating leadership potential.
Expert: Deep understanding enables strategic design and problem-solving, influencing the future of the profession.
NATURE OF CPD PROGRAMS
CPD programs encompass accredited learning activities leading to advanced skills and knowledge. Types include:
Formal Learning: Educational arrangements leading to recognized qualifications, such as degrees and certifications.
Non-formal Learning: Flexible approaches complementing formal education including workshops or community education courses.
Informal Learning: Daily experiential learning recognized through assessments, fostering on-the-job learning experiences.
Online Learning: Internet-based structured or unstructured learning initiatives, offering accessibility to diverse learners.
Professional Work Experiences: Engagements in a specific field providing practical applications of knowledge and skills.