Accreditation Inspections

Accreditation is the “seal of approval” that certifies a clinical laboratory meets established quality standards. In the United States, the Centers for Medicare & Medicaid Services (CMS) grants “deemed status” to accrediting organizations like the College of American Pathologists (CAP) or The Joint Commission (TJC) to perform inspections on their behalf. The inspection cycle is a rigorous, ongoing process of self-assessment and external peer review designed to ensure patient safety and regulatory compliance (CLIA’88)

The Inspection Cycle

Inspections are not random surprises; they follow a predictable 2-year cycle

• Year 0 (External Inspection): An inspection team from CAP (peer professionals from other labs) visits the laboratory physically
• Year 1 (Self-Inspection): The laboratory performs a formal “Internal Audit” using the current checklists to identify and fix gaps before the next external visit
• Year 2 (External Inspection): The cycle repeats
• Unannounced Inspections: While the window is known (usually 90 days prior to the certificate expiration date), the exact day of the CAP inspection is unannounced. The lab must be “inspection ready” every day during this window

The Checklists (The “Bible” of Inspection)

CAP inspections are conducted using detailed Checklists that translate complex regulations into specific questions. Cytogenetics labs are primarily inspected under two checklists:

1. Laboratory General Checklist (GEN): Covers safety, personnel files, computer systems, and general quality management applicable to the whole lab
2. Cytogenetics Checklist (CYG): Contains questions specific to chromosome analysis, FISH, and Microarray
   • Example Question: “Is the quality of banding sufficient to recognize structural abnormalities?”
   • Example Question: “Are FISH probes verified on normal and abnormal controls before use?”

Focus Areas During an Inspection

Inspectors utilize the ROGER method (Read, Observe, Group, Examine, Retest) or tracer methodology to “follow a specimen” through the entire system

• Specimen Tracking (The Tracer)
  • The inspector will pull a random accession number from 2 years ago and ask to see:
    • The original requisition
    • The worksheet with laboratory scientist initials
    • The QC records for the media used that day
    • The final report
    • The archived images or slides
  • Goal: To verify Traceability. If the lab cannot find the QC log for the media used on that specific patient, it is a deficiency
• Personnel Records
  • Inspectors verify that every person touching a patient sample has:
    • A diploma/transcript proving they meet CLIA complexity requirements
    • Documented training for their specific job
    • Competency Assessment: A yearly evaluation covering 6 specific elements (Direct Observation, Monitoring Recording, Specimen Handling, etc.). Failure to document the 6th element (Problem Solving) is a common citation
• Proficiency Testing (PT)
  • Inspectors review the PT binder to ensure:
    • All failures were investigated
    • The Laboratory Director signed the attestation statement
    • There is no evidence of “referral” (sending PT to another lab)
• Safety Walkthrough
  • Checking eyewash stations (logged weekly?)
  • Checking expiration dates on reagents in the fridge (a “low hanging fruit” for inspectors)
  • Verifying gas cylinders are secured

Types of Deficiencies

If the inspector finds a gap, it is cited as a Deficiency

• Phase I Deficiency
  • Lower severity. Often related to minor documentation or clerical issues
  • Action: The lab must document a corrective action internally, but formal proof does not always need to be sent to CAP (though this is changing to require documentation for all)
• Phase II Deficiency
  • High severity. These issues may affect patient care or safety
  • Action: The lab has 30 days: to correct the issue and submit supporting evidence (photos, new logs, revised policies) to CAP. Failure to do so can result in suspension of accreditation
• Immediate Jeopardy
  • Critical threat to patient/employee safety (e.g., no fire extinguishers, falsifying data)
  • Action: The lab may be shut down immediately until the hazard is removed

The Internal Audit (Self-Inspection)

In the “off-year” (Interim Year), the lab must inspect itself

• Objectivity: Ideally, the Cytogenetics supervisor inspects the Molecular department, and vice-versa, to provide fresh eyes
• Value: This is the best time to catch “drift” - sloppy habits that have formed over time (e.g., techs stopped initialing the temperature chart on weekends)
• Documentation: The findings of the self-inspection and the subsequent fixes must be recorded and presented to the Laboratory Director

Role of the Laboratory Director

Ultimately, the CLIA Laboratory Director (MD or PhD) is legally responsible for the inspection. They must sign off on the checklists and are the ones sanctioned if major fraud or negligence is found. However, the day-to-day preparation is usually delegated to the Quality Manager or Supervisor

Common Cytogenetics Citations (What to Watch For)

1. Reagent Labeling: Open bottles missing “Open Date” or “Expiration Date.”
2. Competency Assessment: Missing one of the 6 required elements for a staff member
3. Temperature Logs: Gaps in recording incubator temps on weekends/holidays
4. Plan Review: SOPs not signed annually by the Director
5. Correlation: Discrepancy between the FISH result and the G-band result not explained in the report