Essential Steps for Successful Laboratory Inspections


Unlocking Laboratory Excellence: Mastering Inspections for Quality Assurance.

  1. Mastering Laboratory Inspections: A Path to ExcellenceClinical laboratory inspections often evoke anxiety, akin to public speaking or tax matters. However, these assessments, with experience, can be seen as opportunities for improvement rather than inconveniences. While inspections are crucial, they serve to fine-tune operations, and collaboration with inspectors can enhance laboratory practices. It’s common for lab managers to strive excessively to avoid citations, but a balanced approach acknowledges that citations signal areas for improvement, redirecting resources for better daily processes.

    Understanding the Inspection Process

    Laboratories must strive for compliance with regulatory and accreditation standards, but unclear or redundant requirements may warrant a more practical approach. Embracing inspections as opportunities to clarify specific lab issues is essential. For instance, when dealing with similar instruments, like a new coagulation analyzer, it’s crucial to follow inspection requirements, even if they seem redundant. While inspections can be stressful, laboratory directors should focus on being prepared and vigilant in their operations. Following general guidelines and inspection checklists can help alleviate anxiety and foster confidence in facing inspections.

    A Framework for Successful Inspections

    Over the years, several practical suggestions have proven effective, whether you’re the inspector or the one being inspected:

    1. Create an Inspection Notebook: Before inspections, establish a notebook that includes the checklist, documenting questions and answers for clarity.
    2. Maintain Notebook Updates: Regularly update the notebook with new and removed questions from the inspecting agency.
    3. Review Previous Inspection Results: Prevent recurring deficiencies by revisiting past inspection outcomes.
    4. Validate Instrument Settings: Ensure accuracy in instrument settings, particularly for prothrombin INR, patient normal, and ISI settings.
    5. Vigilance Over Temperature Logs: Maintain meticulous temperature monitoring and documentation.
    6. Engage in Dialogue: Seek clarification if an inspector’s question appears vague or unreasonable.
    7. Challenge Citations Appropriately: Formally challenge unjust citations while maintaining a non-confrontational approach.
    8. Seek On-Site Corrections: Inquire about on-site corrections to prevent deficiencies.
    9. Conduct a Communication Drill: Prepare key employees for communication in case they are off-site during inspections.
    10. Verify Policy Adherence: Ensure policies align with practices and are documented.
    11. Maintain Neatness: Present the laboratory and documentation professionally.
    12. Prepare for Post-Inspection Follow-Up: File necessary paperwork and propose actionable solutions for cited deficiencies in a timely manner.
    13. Conduct Mock Inspections: Use mock inspections to prepare staff and alleviate anxiety leading up to actual inspections.

Thankfully, inspection questions tend to revolve around similar areas from one visit to the next, making the process progressively easier for all parties involved. Successfully navigating a laboratory inspection can bring a tremendous sense of relief, regardless of the outcome. Always remember that these activities should serve as opportunities for improvement, which all laboratories are subject to. Each laboratory is unique, so the tips provided here should serve as a general guide for your tailored approach to inspections. Nevertheless, the laboratory inspection process can be seen as an achievement accomplished as a team and a source of pride.