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Cytogenetics

Quality Management & CQI

Quality Management in Cytogenetics ensures that every result is accurate, timely, and traceable. This involves rigorous validation of reagents, standardized tracking of errors, external proficiency testing, and continuous staff education to meet CLIA and CAP standards

Monitor Reagent Performance & Sterility

  • New Lot Verification: Critical reagents (Serum, Media, Probes) must be “parallel tested” (Old vs. New) before use to ensure cell growth and signal intensity are comparable
  • Sterility
    • Visual: Daily check for turbidity or pH shift (Yellow/Purple media)
    • Testing: Aliquots of prepared media are incubated for 48–72 hours to verify sterility
    • CoA: Manufacturer Certificates of Analysis are filed
  • Traceability: All reagent lot numbers are recorded on patient worksheets to link results to specific batches

Document Culture or Probe Failures

  • Classification: Differentiate between Specimen Failure (e.g., clotted blood) and Process Failure (e.g., incubator malfunction)
  • Incident Reporting: Log every failure in the LIS. Documentation must include the “Root Cause Analysis” (Why did it happen?) and “Corrective Action” (e.g., reflex to Microarray, request redraw)
  • Physician Notification: Failed results must be communicated clearly, with a disclaimer that failure does not rule out pathology

Record Quality Indicators (KPIs)

  • Pre-Analytical: Rejection Rate (< 1%), Specimen Transport Time
  • Analytical
    • Band Level: Average resolution (Target: \(\ge\) 550 bands for constitutional)
    • Culture Success: % of cases yielding analyzable metaphases
  • Post-Analytical
    • Turnaround Time (TAT): Track % of cases meeting the deadline (e.g., 90% of Amnios in 10 days)
    • Correction Rate: % of reports amended for clerical or analytical errors
  • Review: Indicators are reviewed monthly by the Director; trends trigger process improvements

Proficiency Testing (PT)

  • Mandate: Participation in external surveys (e.g., CAP) is required for all analytes
  • Workflow: PT samples must be treated exactly like patient samples (routine workflow, no special treatment). Staff must rotate through PT duties
  • Collusion: Strictly prohibited. Communicating with other labs about PT results leads to CLIA certificate revocation
  • Scoring: 80% is the passing threshold. “2 out of 3” consecutive failures results in a “Cease Testing” order

Accreditation Inspections

  • Cycle: Every 2 years (alternating External Peer Review and Internal Self-Audit)
  • Tracer Methodology: Inspectors follow a single specimen from receipt to report to verify the entire audit trail (Requisition \(\rightarrow\) QC Log \(\rightarrow\) Report)
  • Deficiencies: Gaps in compliance (Phase I = Minor, Phase II = Critical/30 days to fix)
  • Focus Areas: Reagent labeling, personnel competency files, and safety

Training & Competency

  • Training: Systematic instruction (Observation \(\rightarrow\) Supervision \(\rightarrow\) Independence) ending with a “Release to Service” signed by the Director
  • Assessment Schedule: Semi-annually the first year (6mo, 12mo), then Annually
  • The 6 Elements: CLIA requires assessment via:
    1. Direct Observation of Test
    2. Monitoring Recording/Reporting
    3. Review of Intermediate Results (Karyograms)
    4. Observation of Maintenance
    5. Proficiency Testing Performance
    6. Problem Solving Skills