One of the key considerations and potential areas of apprehension for implementing liquid chromatography tandem mass spectrometry (LC-MS/MS) is staff training. The number of laboratory staff with exposure to LC or MS/MS is relatively limited, and even fewer have experience with clinical applications of LC-MS/MS. In this article we describe our approach for training staff, which has evolved throughout our laboratory’s 10-year experience with this technology.
Hiring for fit is critical to the success of any operation, and this is particularly true for clinical LC-MS/MS labs. LC-MS/MS is becoming more user-friendly and automated, but the workflows are often highly engaging and manual. Staff need to have excellent critical thinking skills and knowledge of the technology in order to engage in effective troubleshooting and method development, and procedures require high attention to detail with an extraordinary level of analytical skill (Table 1).
Identifying staff with the right attitude and aptitude for this type of work is a crucial first step. But devising an effective and continuous training program is equally vital to ensuring a quality operation. The CLSI GP21-A3 guideline on training and competence outlines training in four stages (1). Although our training program takes a quality management systems approach, we will focus our discussion of these stages for processes and procedures specific to LC-MS/MS.
Step 1: Define the Training Needs
Beyond the steps of the specific assay method, the unique characteristics of LC-MS/MS and its relatively recent emergence in clinical laboratories demands education related to the science and basic principles of chromatography, MS/MS, and sample preparation techniques. At our institution, we begin with this material, as we have found that one can’t assume that staff are familiar with these fundamental concepts, which explain how the system components relate and affect the end results of the analytical method. More advanced training covers how to optimize and manipulate the instrumentation appropriately, including disassembly, cleaning, and assembly or replacement of key components and consumable parts.
Technologists also must be trained in accurate and precise weighing and liquid transfer technique. These skills are paramount to successful preparation of samples, reagents, calibrators, and quality control materials. System checks and documentation practices may also be more extensive and rigorous than that of other lab areas, given the manual processes and prevalence of laboratory-developed tests.
LC-MS/MS equipment and commonly used reagents also may pose unique safety issues for lab staff that should be covered during training. Prevention of contamination is another area that requires specific focus and is unlikely to have been of major concern to staff inexperienced in LC-MS/MS.
Finally, since quantitation requires manually reviewing a significant amount of instrument data, staff need to understand peak integration methods to ensure consistent and accurate results. Staff also must learn early on to adjust to the manual nature of the work and become competent in utilizing the designed workflows, job aids, and environmental controls that are in place to maximize quality and employee safety and minimize instrument contamination.
Step 2: Develop the Training Packet
We recommend mapping training needs to learning objectives and matching them with the materials and methods that will be used for training. In addition, we suggest establishing a timeline to provide the trainer and trainee with the sequence of learning and an estimated duration for each step. We use a packet containing documents for each training event that is used throughout the training process, and provide an overview of the learning objectives with an explanation of how each will be assessed in a competence assessment plan document. This document also serves as the summary page of the training and contains the overall competence sign-off by trainee and supervisor (See sample training documents below).
We prefer an interactive approach during training, relating key points in the procedures to basic principles of the instrumentation and workflows, making sure to incorporate “why we do it this way.” Both trainers and trainees receive clear instructions about their role and responsibilities, as well as detailed training checklists to guide and standardize the training experience and emphasize certain topics. We created direct observation checklists for self- and trainer-assessment during training. The training packet also includes a feedback form that enables the learner to evaluate the training process and trainer(s) (See sample training documents below).
While we emphasize face-to-face, hands-on instruction, we also use a number of online resources that cover key concepts in varied levels of detail. These exist in several formats that several technologists may view simultaneously or use as self-paced learning tools, accessed repeatedly over a specified period of time. The online supplement to this article includes a selection of available resources covering topics relevant for LC-MS/MS laboratories.
Step 3: Implement Training
Well thought out and thorough training plans are important for efficient and effective training, but the dissemination and execution of the plan is also crucial. The trainer and training environment must be conducive for learning, and the pace and expectations should be flexible and at an appropriate level, based on the experience of the trainee. In our laboratory, new staff members’ training usually takes about 1 month until the individual is able to perform independently a simple assay procedure such as for immunosuppressant drugs.
We dedicate the first few weeks to lab orientation and learning about a specific assay method, with an additional 1–2 weeks spent on routine and advanced maintenance procedures. The trainer should provide feedback to the trainee on his or her areas of strength, with plans for remedial training or other review, throughout the training process. This expedites learning and builds trainee comfort and confidence.In addition, we recommend performing training activities as close as possible to the actual workflow.
Trainers should have a high level of skill, comprehension of key concepts, and an appropriate demeanor, with the desire to teach others. Character traits of successful trainers include enthusiasm, objectivity, patience, and effective communication skills. Mentoring, feedback, and recognition are important in cultivating a robust train-the-trainer educational system.
Step 4: Evaluate and Document Training
Before a trainee independently performs clinical testing, we evaluate the effectiveness of the training through a competence assessment, which documents both successful completion of training and any need for further instruction (Table 2). We design competency documents to demonstrate that the employee learned the skill and can apply it in a clinical setting. Following CLSI GP21-A3, we employ a variety of methods to validate competence, including written and oral assessments of knowledge with observation of actions. We use direct observation methods to demonstrate that employees follow defined procedures. These are particularly useful for evaluating error-prone processes and other integral procedural steps where deviations may lead to compromised quality.
We review a variety of reports and documentation records to reveal errors or other issues that highlight a lack of competence. Written tests gauge cognitive skills related to theory, technique, interpretation, and problem-solving, and we try to incorporate actual situations and data produced from our laboratory. We also provide unknown-to-the-trainee samples to evaluate the trainee’s handling and analysis of the sample through all phases of the testing process. Examples are provided in the online supplement.
Of note, both quality assurance and regulatory compliance require ongoing competence assessments. The steps outlined above apply to initial training, remedial training, and periodic assessments, with the extensiveness of the approach tailored to fit the purpose. Unsuccessful training situations and recurring patient safety events are the types of occurrences that warrant critical examination for root causes related to any possible deficiency in the training program, as well as appropriate corrective action. Post-training interviews and review of training evaluation forms are other ways to identify areas in which a training program needs to improve.
Of course, the training needs of a laboratory change over time, requiring continuous improvement. But establishing a solid foundation for learning with the intention of developing selected staff to advance from trainee to trainer will ensure lasting success and increased employee satisfaction, even as the laboratory’s needs evolve. Laboratories should also look for and incorporate, as appropriate, innovations in the delivery of education that enhance learner retention and engagement. Beyond specified training events, we provide education and reinforce key learning points continuously in the context of the daily life of our lab, including method development projects, clinical testing scenarios, troubleshooting efforts, and routine instrument maintenance.
Clinical and Laboratory Standards Institute (CLSI). Training and competence assessment; Approved Guideline—Third Edition. CLSI document GP21-A3 2009.
Sample Training Documents
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