IMDNA provides scientific, technical, and non-regulatory support for laboratory personnel training and competency-assessment programs. Support can include training-needs review, assay and instrument training, workflow orientation, technical learning materials, observation checklists, competency-assessment tools, documentation templates, problem-solving exercises, remediation support, continuing technical education, and implementation assistance.
Training and competency assessment are related but different. CMS explains that training develops the knowledge, skills, and behaviors needed before personnel begin testing, while competency assessment evaluates whether personnel can correctly apply those skills and follow laboratory procedures during actual work. IMDNA can help laboratories build the technical training and assessment tools, while the laboratory retains responsibility for personnel qualification review, required competency assessments, documentation, authorization of testing personnel, and compliance with applicable requirements.
CDC laboratory-training resources emphasize beginning with a training-needs assessment: identify the gap between current and desired performance, then choose a learning approach that addresses that gap. Laboratory training can combine demonstration, guided practice, written resources, eLearning, hands-on activities, and supervised performance according to the complexity of the task.
Identify what personnel must know and be able to do for the specific assay, instrument, specimen, workflow, or laboratory role.
Explain assay principles, reagents, controls, specimen requirements, instrument operation, limitations, and troubleshooting.
Support supervised practice of sample preparation, instrument use, assay setup, control handling, data review, and routine workflow.
Use structured observation and practical assessment tools to evaluate whether trained personnel can perform assigned procedures consistently.
Use observed gaps, errors, workflow changes, new methods, or performance trends to guide remediation and continuing education.
Training support can be tailored to a new employee, new assay, instrument installation, method transfer, workflow change, laboratory expansion, or ongoing technical-development program.
Help identify knowledge, technical-skill, workflow, instrument, assay, and troubleshooting gaps that should be addressed by the training program.
Provide technical orientation on assay principles, reagents, controls, sample preparation, workflow, analysis, limitations, and common troubleshooting considerations.
Support practical familiarization with instrument workflow, startup/shutdown, routine operation, software, maintenance considerations, controls, and technical troubleshooting within IMDNA's expertise.
Train personnel on specimen movement, reagent preparation, batching, testing sequence, repeat work, storage, technical review, and day-to-day laboratory organization.
Use the laboratory's approved SOPs and work instructions as the basis for technical orientation so training reflects the actual laboratory method.
Provide demonstrations, guided practice, technical walkthroughs, and supervised exercises where appropriate to the project and laboratory setting.
Develop slide decks, job aids, checklists, workflow diagrams, quick-reference guides, worksheets, and technical learning resources.
Develop quizzes, case scenarios, troubleshooting questions, sample exercises, or other tools to reinforce technical understanding.
Create technically relevant scenarios involving QC failures, instrument errors, discordant results, contamination, sample issues, or other workflow problems.
Provide templates for orientation records, training checklists, topics covered, trainer/trainee signatures, dates, and technical follow-up.
Help design targeted retraining when performance gaps are identified, focusing on the specific knowledge or technical skill that requires improvement.
Support refresher training for method changes, instrument updates, new reagents, workflow revisions, recurring technical issues, or expanded laboratory responsibilities.
IMDNA's support model separates learning from competency assessment while connecting both to the laboratory's actual procedures and technical workflow.
This distinction is important. CMS's current competency brochure states that training, personnel evaluations, and competency assessments are different activities. Training occurs before independent testing and develops knowledge and skills; competency assessment determines whether personnel continue to perform their laboratory duties correctly.
| Activity | Primary Purpose | Examples |
|---|---|---|
| Orientation | Introduce the laboratory, workflow, safety expectations, documents, equipment, and assigned responsibilities. | Laboratory tour, workflow map, document review, instrument overview, role expectations. |
| Training | Develop the knowledge, skills, and behaviors needed to perform a procedure before independent testing. | Technical instruction, demonstration, guided practice, SOP review, supervised runs. |
| Knowledge Assessment | Determine whether the learner understands technical concepts. | Quiz, oral questions, case studies, troubleshooting exercises. |
| Competency Assessment | Evaluate whether personnel can correctly perform their assigned laboratory duties and follow laboratory procedures. | Direct observation, record review, testing of known/unknown materials, problem-solving assessment. |
| Performance Evaluation | Assess broader job behaviors, goals, productivity, communication, or role performance. | Annual job review, performance goals, workplace behaviors. |
| Remedial Training | Address a specific knowledge or performance gap that has been identified. | Focused retraining, supervised repeat practice, technical coaching, reassessment. |
CMS identifies six minimum competency-assessment procedures for personnel performing moderate- or high-complexity laboratory testing. These procedures apply to each test an individual is authorized to perform. IMDNA can help laboratories develop technically appropriate tools, checklists, exercises, and training resources around these elements, but formal CLIA competency assessment must be conducted and documented by the laboratory in accordance with the applicable personnel requirements.
Observe routine performance, including patient preparation where applicable and specimen handling, processing, and testing.
Evaluate whether results are recorded, entered, reviewed, and reported according to the laboratory's procedure.
Review intermediate results or worksheets, QC records, PT results, and preventive-maintenance records as applicable.
Directly observe instrument performance, maintenance, and function checks where applicable to the test system.
Assess performance using previously analyzed specimens, internal blind samples, or external proficiency-testing samples, as applicable.
Evaluate how the individual responds to technical problems, unexpected results, QC failures, or other defined scenarios.
IMDNA can help laboratories translate assay and instrument workflows into practical competency-assessment tools that correspond to what personnel actually perform.
The laboratory should determine who is qualified and authorized to perform each required assessment, the applicable assessment schedule, and the records that must be maintained. IMDNA's role can be technical and educational, but it does not replace the laboratory director, technical consultant, technical supervisor, general supervisor, or other authorized person responsible under the laboratory's applicable framework.
Competency should be evaluated for the actual test or workflow performed. IMDNA can support technical training and assessment-tool development across laboratory technologies within its scientific expertise.
Extraction, reagent preparation, assay setup, controls, contamination prevention, instrument operation, amplification review, analysis, multiplex workflow, and troubleshooting.
Sample dilution, standards, controls, plate setup, incubation, washing, reading, calculation, acceptance workflow, and troubleshooting.
Bead preparation, calibrators, controls, sample dilution, incubation, washing, acquisition, instrument workflow, analyte review, and troubleshooting.
Sample preparation, staining, controls, instrument setup, compensation/unmixing, acquisition, gating workflow, data review, maintenance, and technical troubleshooting.
Cell handling, culture workflow, plating, stimulation/treatment, controls, viability, readout, equipment use, contamination awareness, and assay troubleshooting.
Instrument startup/shutdown, routine maintenance, cleaning, calibration-support activities, function checks, logs, and problem escalation.
Receipt, labeling, preparation, aliquoting, centrifugation, extraction, storage, retention, repeat handling, and referral workflow.
Control preparation, acceptance workflow, trending, documentation, repeat testing, troubleshooting, and corrective technical actions.
Technical review of instrument outputs, calculations, analysis software, result-entry workflow, interpretation rules, and defined escalation pathways.
CMS competency guidance links competency monitoring with identification of remedial-training and continuing-education needs. When a performance gap is identified, retraining should address the specific weakness rather than repeating unrelated material.
Help determine whether a problem relates to technical knowledge, specimen handling, assay setup, instrument operation, QC review, documentation, or problem-solving.
Develop targeted training around the observed gap using demonstration, guided practice, written resources, cases, or supervised exercises.
Provide scientific and technical guidance during retraining to clarify assay principles, workflow logic, controls, limitations, and troubleshooting.
Help develop new practical exercises or observation tools that allow the laboratory to reassess the corrected skill.
Support retraining when instruments, reagents, SOPs, software, controls, or assay configurations change.
Develop refresher modules and advanced technical content for recurring issues, emerging technologies, and expanded laboratory responsibilities.
Training and competency records should clearly show what was assessed or taught, when it occurred, who participated, and what follow-up was required. IMDNA can help develop practical documentation tools while the laboratory determines its own required record-retention and approval processes.
Document objectives, topics, methods, trainer, trainee, equipment/assay covered, and planned completion steps.
Track demonstrations, supervised practice, SOP review, controls, instrument operation, maintenance, analysis, and troubleshooting topics.
Develop test-specific forms aligned with the applicable assessment elements and the laboratory's workflow.
Provide structured templates for observations, findings, gaps, follow-up actions, and laboratory determination.
Document the identified gap, retraining provided, additional practice, reassessment, and technical follow-up.
Help laboratories organize personnel, assays, instruments, assigned training, assessment status, and upcoming review needs in a practical tracking format.
IMDNA provides general scientific, technical, laboratory-training, competency-tool development, remediation-support, workflow, and non-regulatory implementation support based on the needs of each laboratory organization. Support may include assistance with training-needs assessment, assay and instrument training, workflow orientation, technical learning materials, training checklists, competency-assessment templates, direct-observation tools, problem-solving exercises, remediation support, continuing technical education, and training documentation.
Where appropriate, IMDNA may provide technical demonstrations, educational materials, guided practice, scientific explanations, troubleshooting exercises, or draft competency tools through its scientific, technical, and laboratory-experienced team.
IMDNA is not a regulatory, licensing, accreditation, certification, legal, or governmental authority. IMDNA does not determine whether an individual meets CLIA or other personnel qualification requirements and does not replace the laboratory personnel who are responsible for formal competency assessment, authorization, supervision, or regulatory compliance.
Each laboratory is responsible for determining the personnel qualifications, training requirements, competency-assessment procedures, assessment frequency, assessor qualifications, documentation, remediation, reassessment, authorization, and other requirements applicable to its own laboratory, personnel, test complexity, methods, and location.
Any training, checklist, assessment tool, technical material, observation form, or guidance provided by IMDNA is intended to support the laboratory's own training and competency program and should not be interpreted as regulatory approval, certification of personnel, accreditation, legal determination, or a guarantee of regulatory acceptance.
References to governmental, regulatory, standards-development, scientific, or professional organizations are provided for general informational purposes only and do not imply endorsement, approval, affiliation, certification, or sponsorship of IMDNA or its services.
The following official resources support the general concepts of laboratory training, personnel competency, competency-assessment procedures, remediation, and continuing education. They are provided for independent educational use and do not imply endorsement of IMDNA or establish one universal personnel-training program for every laboratory.
Tell IMDNA about your laboratory section, assays, instruments, staff experience, workflow, SOPs, new-hire needs, competency challenges, recurring technical issues, or upcoming method changes. Our scientific and technical team can help organize a practical training-support program covering learning materials, hands-on technical guidance, observation tools, competency templates, problem-solving exercises, remediation, and continuing technical education.