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Cytogenetics

Training & Competency

In the context of Quality Management, “Training” and “Competency” are distinct but linked concepts mandated by CLIA’88 regulations. Training is the educational process of teaching an employee how to perform a task, while Competency Assessment is the periodic verification that the employee is still performing that task correctly according to standard operating procedures (SOPs). A robust program ensures that all laboratory scientist s, regardless of tenure, produce standardized and accurate results

The Initial Training Program

When a new employee joins the laboratory, or when a current employee learns a new assay (e.g., Microarray), they must undergo a structured training period. During this time, they are not authorized to report patient results independently

  • Modular Approach: Training is typically broken down by station (e.g., Setup, Harvest, Slide Making, G-Banding, Microscope Analysis, FISH)
  • The Training Checklist: A document detailing every specific step of the procedure. The trainer dates and initials each step as it is taught and demonstrated
  • Progression of Responsibility
    • Observation: The trainee watches the trainer
    • Supervised Performance: The trainee performs the task while the trainer watches
    • Independent Performance (with review): The trainee performs the task alone, but 100% of the work is checked by a senior tech
  • Release to Service: Training concludes with a Verification Run (analyzing known controls or previously tested samples). Only after the Laboratory Director (or Technical Supervisor) signs the “Release to Service” letter can the laboratory scientist report patient results

CLIA Competency Assessment Schedule

Competency is not a one-time event; it is a recurring cycle required for compliance

  • Semiannual Assessment (New Hires): During the first year of employment, competency must be assessed twice: once at 6 months and again at 12 months
  • Annual Assessment: After the first year, competency must be assessed annually for the duration of employment
  • Remedial Competency: If an employee fails a proficiency test or makes a significant error, an unscheduled competency assessment is performed after retraining to verify the fix

The Six Elements of Competency

CLIA and CAP mandate that competency assessment must include six specific methods of evaluation. Checking off a box saying “Tech is doing a good job” is insufficient; the assessment must document these six behaviors:

  1. Direct Observation of Test Performance
    • Watching the laboratory scientist perform the wet-lab work (e.g., adding hypotonic solution, dropping slides). This ensures they are not taking shortcuts (e.g., adhering to incubation times)
  2. Monitoring the Recording and Reporting of Results
    • Checking worksheets and LIS entries to ensure clerical accuracy. Are they transcribing the ISCN string correctly? Are they documenting reagent lot numbers?
  3. Review of Intermediate Test Results
    • Reviewing the raw data used to reach a conclusion. In Cytogenetics, this means a supervisor reviews the karyograms: or digitized metaphases analyzed by the laboratory scientist to ensure the banding interpretation is correct
  4. Direct Observation of Instrument Maintenance
    • Watching the laboratory scientist clean the microscope optics, change the pH probe, or perform the daily temperature checks on the incubator
  5. Assessment of Test Performance (Proficiency Testing)
    • Evaluating the laboratory scientist’s performance on external PT samples (CAP surveys) or internal blind samples
  6. Assessment of Problem Solving
    • Testing the laboratory scientist’s cognitive ability to handle non-routine situations
    • Example: Giving a written quiz asking, “What do you do if the incubator alarm goes off at 2 AM?” or “How do you handle a sample received in the wrong tube?”

Inter-Observer Variability (Standardization)

Cytogenetics is highly subjective, relying on visual pattern recognition. A critical part of competency is ensuring that Laboratory scientist A and Laboratory scientist B would call the same band level and the same breakpoint on a chromosome

  • Round Robin: A set of difficult slides or images is circulated among all staff. Everyone analyzes them blindly. The results are compared to the consensus. Outliers indicate a need for retraining
  • Blind Re-analysis: A supervisor randomly pulls 5-10 previously reported cases per month and re-analyzes them. If the supervisor finds an abnormality the original laboratory scientist missed, it triggers a competency review

Continuing Education (CE)

Quality improvement requires staying current with scientific advancements (e.g., new ISCN nomenclature updates)

  • Requirements: CAP typically requires 12 hours of CE per year for non-waived testing personnel
  • Sources
    • Internal Journal Clubs (presenting a paper)
    • Webinars/Safety Training
    • Reviewing “Case of the Month” educational materials

Documentation

Documentation of training and competency is the first thing inspectors review

  • Personnel Files: Every employee must have a dedicated file containing:
    • Diploma/Transcripts (proving qualification)
    • Job Description (signed)
    • Training Checklists (initialed)
    • Annual Competency Assessments (covering all 6 elements)
    • CE Credits
  • Signatories: Competency assessments must be performed by an individual qualified as a Technical Supervisor or General Supervisor under CLIA. Peer-to-peer assessment (Laboratory scientist assessing Laboratory scientist ) is generally not permitted for the official annual sign-off unless the peer meets supervisor qualifications