Defining a Molecular Dx Curriculum for Clinical Lab Scientists

April 23, 2014
Defining a Molecular Dx Curriculum for Clinical Lab Scientists
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Kevin Mayer

To date, training programs in molecular diagnostics have been proliferating beyond anyone’s ability to define a curriculum. But at least one organization is trying to provide some guidance. This organization is the Association for Molecular Pathology (AMP). Because the AMP is home to all molecular diagnostics professionals, contends Elaine Lyon, Ph.D., the organization’s president, it “has a responsibility to help guide the training of future molecular technologists.”

To fulfill this responsibility, the AMP issued a set of recommendations that appeared April 22 in the Journal of Molecular Diagnostics, in a report entitled “Molecular Pathology Curriculum for Medical Laboratory Scientists.” The report’s authors, who represent the Medical Laboratory Scientist (MLS) Curriculum Task Force of the AMP Training and Education Committee, were fully aware of the unique challenges faced by educators, students, and clinical laboratories.

As indicated in the report, “Curriculum development is a challenge because educators must balance the requirements of accreditation, certification, and the needs of the job market. Educators in molecular diagnostics face another challenge in maintaining relevance of their programs with the rapidly changing technological advances in the field.”

While formulating its response to these challenges, the AMP solicited inputs from three key elements:

1. The National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) guidelines for accreditation of molecular diagnostics programs.
2. Guidelines of several key certifying bodies for clinical laboratory scientists.
3. Feedback from current employers of molecular diagnostics scientists via a survey of AMP members.

All the stakeholders tended to focus on general education, not facility with specific laboratory platforms. Possibly this emphasis reflected the stakeholders’ recognition that different laboratories use a diverse variety of platforms, and even an individual laboratory may deploy new platforms as technology advances. In any event, the report indicated that educators “should encourage the development of fundamental skills in trainees, with the focus on understanding core concepts and skills that are generally universal across laboratories, such as DNA isolation, PCR-based methods, quality assurance, and critical thinking skills.”

Where the guidelines do become specific, however, relates to the academic levels of laboratory scientists who perform molecular diagnostic testing. “There are at least three major professional levels of laboratory scientist who perform molecular diagnostics testing: the generalist MLS/CLS, the bachelor’s-level laboratory scientist with specialized molecular training, and the master’s-level laboratory scientist with specialized molecular training,” said the report. “Individuals in each of these professional categories are expected to perform molecular diagnostic testing at different entry-level proficiencies.”

The AMP defines the different levels of proficiency across numerous variables, which range from nucleic acid chemistry to basic laboratory mathematics to familiarity with concepts of assay validation and assay development.

Up-and-coming molecular diagnostic laboratory scientists should complete an NAACLS-accredited training program, asserts the AMP, then become certified or licensed in their state of employment. According to the AMP, if its specific curriculum recommendations are adopted, tomorrow's medical laboratory scientists will be prepared for “the reality that molecular diagnostics are an integral and growing part of the clinical diagnostic laboratory.”