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Molecular Biology

Continuing Education

In the field of Clinical Molecular Biology, the rate of technological advancement is faster than in any other area of the clinical laboratory. Techniques that were cutting-edge a decade ago (such as certain blotting methods) are now obsolete, replaced by Next-Generation Sequencing (NGS) and digital PCR. Consequently, Continuing Education (CE) is not merely a bureaucratic requirement; it is a critical professional obligation to ensure patient safety and diagnostic accuracy. A robust CE program ensures that the Laboratory Scientist remains proficient in current methodologies and knowledgeable about emerging biomarkers and regulatory changes

The Certification Maintenance Program (CMP)

For most laboratory scientists, the primary driver for Continuing Education is the maintenance of professional certification. The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) mandates a Credential Maintenance Program (CMP) for all professionals certified after 2004. Failure to maintain these credits results in the expiration of certification, which can lead to termination of employment in laboratories that require it

  • The Three-Year Cycle: CMP is tracked over a three-year period. The cycle begins the month one is certified and ends three years later
  • Credit Requirements: A total of 36 Points (contact hours) are required every three years. One contact hour of education equals one CMP point
  • Mandatory Allocations: The 36 points must be distributed across specific categories to ensure a well-rounded education:
    • 1 Point in Laboratory Safety: This is mandatory for all distinct certifications
    • 2 Points in the Area of Specialty: For a Molecular Biology (MB) certificant, at least 2 points must be specifically in molecular diagnostics. For a generalist (MLS), 2 points are required in each of the four main disciplines (Blood Bank, Chemistry, Hematology, Microbiology)
    • Remaining Points: Can be in areas of lab supervision, management, education, or other relevant clinical topics
  • Audit System: Scientists do not submit certificates for every point but must self-report them. ASCP conducts random audits. If audited, the scientist must produce physical copies of certificates for all 36 points. Therefore, documentation must be kept for at least one full cycle after submission

Regulatory & Accreditation Requirements

Beyond individual certification, the laboratory as an entity is required to provide and document education for its staff to maintain its operating license

  • CLIA ’88 Regulations: While CLIA focuses heavily on “Competency Assessment” (verifying existing skills), it also requires that the Technical Supervisor ensures that testing personnel receive regular in-service training and education appropriate for the type and complexity of the services performed
  • CAP Accreditation (College of American Pathologists): CAP checklists are more prescriptive. The Laboratory General Checklist requires the Laboratory Director to define a policy for continuing education. CAP inspectors will verify that the laboratory provides access to educational materials (journals, webinars) and that staff are utilizing them
  • State Licensure: Certain states with their own licensure boards (e.g., Florida, California, New York, Louisiana) have statutory CE requirements. For example, Florida requires 24 contact hours every two years, with specific mandates for Medical Errors and HIV/AIDS education. These state laws supersede voluntary certification requirements if they are stricter

Sources of Continuing Education

Acceptable CE activities must be structured, educational, and relevant to the laboratory. “Learning on the job” or casual conversation does not count as CE. Activities generally fall into three categories:

  • P.A.C.E.® Programs (Professional Acknowledgment for Continuing Education)
    • Administered by the American Society for Clinical Laboratory Science (ASCLS), P.A.C.E. is the industry standard for vetting educational content
    • A vendor or organization submits their course to P.A.C.E. for approval. If approved, the credits are universally accepted by ASCP and all state licensure boards
    • Look for the P.A.C.E. logo on webinar certificates or conference attendance forms to guarantee validity
  • Formal Activities
    • Professional Conferences: Attending meetings like the Association for Molecular Pathology (AMP) or the American Association for Clinical Chemistry (AACC/ADLM). Sessions attended are converted to hours
    • College Coursework: Taking a graduate-level Molecular Biology course counts significantly. Typically, 1 semester hour (credit) = 15 CMP points
    • Grand Rounds: Hospitals often hold medical lectures. If relevant to pathology or genetics, these count as CE
  • Self-Instructional Materials
    • Journal Reading: Reading a peer-reviewed article (e.g., The Journal of Molecular Diagnostics) and passing a post-test
    • Webinars: Online lectures provided by manufacturers (e.g., Roche, ThermoFisher) or the CDC. These are particularly useful for learning about new instrumentation or assay platforms before they are implemented in the lab

Competency Assessment vs. Continuing Education

It is vital for the entry-level scientist to distinguish between these two regulatory concepts. They are related but distinct

  • Continuing Education (Growth): Focuses on acquiring new knowledge or skills. It is forward-looking
    • Example: Watching a webinar about a new liquid biopsy technique that the lab does not yet perform
  • Competency Assessment (Verification): Focuses on verifying current proficiency in assigned tasks. It is retrospective
    • Requirement: CLIA mandates competency assessment at 6 months and 12 months for new employees, and annually thereafter
    • The 6 Elements: Direct observation of testing, monitoring recording of results, review of worksheets, direct observation of maintenance, proficiency testing performance, and problem-solving skills
    • Note: Performing your annual competency assessment does not usually count toward CE credits unless it includes a specific educational module (e.g., a quiz on a new SOP)

Documentation & Management

In Quality Assurance, “If it is not documented, it did not happen.” The individual scientist bears the ultimate responsibility for tracking their education

  • The CE Transcript: Most organizations utilize a Learning Management System (LMS) such as MediaLab or CAP compliance modules. These systems automatically generate transcripts of completed internal courses. However, external courses (conferences) must be manually uploaded or filed
  • Certificate Retention: Certificates of Attendance must include:
    • The Name of the Participant
    • The Title of the Program
    • The Date of Completion
    • The Number of Contact Hours awarded
    • The Name of the Provider/Approving Body (e.g., ASCLS P.A.C.E.)
  • Review: During an inspection (CAP or TJC), the inspector will review the personnel files. They will look for a diverse portfolio of education that matches the complexity of the lab. If a molecular lab is performing High Complexity sequencing, the inspector expects to see CE related to genetics and bioinformatics, not just general safety or bloodborne pathogen training