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Proper Training for Molecular Testing

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Vol. 18 • Issue 1 • Page 16
The Molecular Edge

Editor's note:

This is the first of a two-part article. Part 2, to be published in the March issue, will examine competency assessment.

Molecular techniques began easing their way into clinical laboratory medicine and into the hands of the clinical laboratory scientist (CLS) approximately 20 years ago. While there are several routes of education and training to become a CLS, probably the most common path is a bachelor's degree in Medical Technology or a related field, including professional training1consisting of lectures and "hands on" experience in hematology, urinalysis, chemistry, blood bank, microbiology and immunology. Technologists also receive vital information and experience in handling clinical samples using aseptic techniques and universal precautions. These skills make them well suited to become excellent clinical molecular technologists.

In recent years, the number of molecular techniques and accompanying instrumentation in clinical labs has increased dramatically. CLS programs have struggled to find time to include training appropriate for this new discipline. Laboratory supervisors are charged with providing the necessary "initial employment" training1for their employees.

While the College of American Pathologists (CAP) and The Joint Commission (TJC) have increased their oversight of laboratory programs for training and determination of competency, the amount and type of documentation for initial training on technical assays is left to the discretion of laboratory directors.2,3CAP tends to emphasize competency standards and provides little guidance for standardization of initial training.2Therefore, supervisors direct more thought to the design and documentation of competency verification programs and less to initial training. However, initial employment training and competency are like the proverbial "horse and carriage." Detailed documentation of initial training should be considered the first step in a thorough competency program. This is especially true in a molecular laboratory; pre-employment training in molecular techniques is often minimal or lacking.

A Formal Training Plan

Reasons for having a thorough initial training program can be easily enumerated (e.g., to provide excellent patient care by maximizing employee performance, meet regulatory standards, etc.), and special consideration should be given to promoting employee satisfaction and confidence. CLSs are professionals. They need to feel confident that they are performing at a high level and they want their employer to have the same confidence. Formal training and ongoing competency programs will satisfy these desires and communicate the institution's position on the importance of documentation and participation.

Written Procedures

A formal training program needs a written Standard Operating Procedure (SOP) with supplemental forms (e.g., training checklist, trainee feedback forms and quizzes). The SOP should describe the plan for training a new hire on a specific procedure but should be flexible enough to accommodate the trainee's previous training and experience. For instance, the usual plan for training a new CLS graduate for adenovirus PCR may require him to observe a trainer's performance twice, then perform three trial runs while being observed by the trainer. The same training plan for a new employee with five years of experience performing this same assay would be a waste of resources. If part of the usual training is waived, a note on the training record should be made (e.g., due to five years of experience with adenovirus PCR, training will consist of one observation and one successful trial run).

Desirable components of an SOP for initial training program are stated objective(s) of the training program, definitions of when training is to take place (e.g., at the time of hiring, adding a new procedure to the test menu, a retraining event), and definitions of trainer and trainee and outlines of their responsibilities.

Responsibilities of the trainer, a technologist who has shown successful performance and ongoing competency for the instrument/assay/process and has been approved by the supervisor to perform the task unobserved:

• Perform training duties only for tasks deemed competent.

• Demonstrate task to trainee according to current in-service SOP.

• Utilize current training checklist for task being demonstrated to ensure consistency of training among trainers.

• Observe trainee performing assay on samples that will not be reported (trial runs).

• Sign and date the checklist only when confident that the trainee is capable of performing the assay/process/instrument operation properly with minor assistance from trainers.

The trainee is a technologist newly hired or undergoing retraining and should:

• Observe training task being performed by trainer per current SOP.

• Make notes and ask questions.

• Perform the task according to current SOP while being observed by trainer and later when unobserved.

• Complete the feedback form and discuss with supervisor.

The following also should be part of the plan:

• Determine method of training (e.g., observation of trainer, computer tutorial, lecture, self-study).

• Determine method of evaluating the success of the training (e.g., successful performance of task while observed/unobserved, trial runs with unknowns, written/oral quizzes).

• Define acceptable limits for trainee's performance for specific tasks (e.g., 80 percent of trainee's results on blinded samples must be within 0.35 log of expected value based on control values over a 10 month period of time ±2 SD).

• Outline plan of action in event of unsuccessful performance.

• Designate person(s) eligible to assess trainee's competency.

• Describe method of documentation (e.g., written, electronic).

• Detail training record storage, retention and access (records must be secured from unauthorized alteration, yet inspectors must have access, even on unannounced inspections).

Training Checklist

Training checklists promote efficiency and thoroughness of the training process and ensure consistency. Checklists should consist of line items that reflect the tasks to be learned and can be divided into pre-analytical, analytical and post-analytical sections.

Critical or troublesome items (e.g.,critical timing or temperature) should be specifically highlighted. All safety concerns (e.g., use of protective equipment, proper disposal of specific reagents, etc.) should be listed on the list and other technical training forms even if these line items appear on multiple checklists. Additionally, the version number of the SOP being learned should be recorded.

Dr. Carr is technical director, Virology and Molecular Microbiology, St. Jude Children's Research Hospital, Memphis, TN.


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