What should be included in a sample checklist for a monthly pathologist visit to a freestanding clinical laboratory?

Monthly Pathologist Visit Checklist for Freestanding Clinical Laboratory

A comprehensive monthly pathologist visit checklist should systematically address quality assurance across all phases of laboratory testing (preanalytical, analytical, and postanalytical), personnel competency, regulatory compliance, and continuous quality improvement initiatives.

Quality Control and Quality Assurance Review

Preanalytical Phase Monitoring

• Review specimen handling procedures including fixation times, cold ischemia documentation, and specimen adequacy criteria 1
• Verify documentation systems for time of specimen removal, fixative placement time, duration of fixation, and fixative type on accession slips 1
• Assess specimen rejection rates and reasons for inadequate samples, particularly for molecular and immunohistochemistry testing 1
• Evaluate compliance with fixation protocols: excisional biopsies fixed 6-48 hours in neutral buffered formalin, needle biopsies minimum 1 hour 1

Analytical Phase Assessment

• Review external and internal control performance for all testing platforms, ensuring controls include negative, positive, and low-percentage expression samples 1
• Verify ongoing equipment maintenance logs and calibration records for all analytical instruments 1
• Assess quality control data from the past month, identifying any out-of-range results and corrective actions taken 1
• Review turnaround times for all test categories and identify bottleneck areas requiring improvement 2

Postanalytical Phase Review

• Audit report completeness using synoptic reporting templates for tumor staging, histologic type, margins, and lymph node status 1
• Verify critical value reporting and documentation of clinician notification 1
• Review amended reports and reasons for amendments to identify systematic issues 2

Personnel Competency and Training

Pathologist Performance

• Conduct peer comparison reviews among pathologists for concordance, targeting ≥95% agreement on interpretations 1
• Review discordant cases from the past month, including second opinion requests and external consultation results 1
• Assess interpretation of challenging cases, particularly those with low expression (0-10% staining) or borderline results 1

Technical Staff Competency

• Review competency assessment records for all laboratory personnel performing testing 1
• Verify completion of required training on standard operating procedures, particularly for any new or modified tests 1
• Document ongoing education activities and continuing medical education participation 1

Proficiency Testing and External Quality Assessment

• Review proficiency testing results from external programs, ensuring ≥90% correct responses on graded challenges 1
• Analyze any proficiency testing failures with root cause analysis and implementation of corrective actions 1
• Verify participation in required external quality assessment programs with at least two testing events per year 1
• Document interlaboratory comparisons for rare tests where formal proficiency testing is unavailable 1

Test Validation and Revalidation

• Review any new test implementations to ensure proper validation with ≥95% concordance with reference methods 1
• Assess need for revalidation following significant changes to test systems, reagents, or equipment 1
• Verify semiannual assay reassessment has been performed for all established tests 1
• Review reference ranges for appropriateness to the laboratory's patient population, considering age, sex, and physiologic state 1

Regulatory Compliance and Accreditation

• Verify CLIA compliance for all testing performed, including proper test categorization and personnel qualifications 1
• Review accreditation checklist items relevant to the laboratory's scope of testing (CAP, Joint Commission, or COLA standards) 1
• Assess documentation completeness for standard operating procedures, including any updates or revisions 1
• Verify proper labeling and disclaimers for laboratory-developed tests using analyte-specific reagents 1

Risk Assessment and Quality Improvement

• Conduct monthly risk assessment using failure mode effects analysis principles, balancing defect frequency, potential harm, and detection difficulty 3
• Review quality indicators across all testing phases, focusing on 7-14 high-priority monitors rather than excessive numbers 3, 2
• Analyze customer satisfaction data and clinician feedback regarding test ordering and result reporting 2
• Evaluate laboratory stewardship initiatives, including education interventions for test ordering clinicians 3

Safety and Environment

• Inspect testing room environment for adequate space, lighting, ventilation, temperature control, and emergency equipment accessibility 1
• Verify emergency preparedness, including defibrillator functionality and emergency procedure compliance 1
• Review safety incident reports and implementation of preventive measures 2

Documentation and Reporting Systems

• Audit report format compliance with CLIA requirements: patient identifiers, laboratory address, test date, specimen source, results with units, and reference ranges 1
• Review interpretive comments for appropriateness and clarity, particularly for complex molecular or immunohistochemistry results 1, 4
• Verify proper documentation of specimen inadequacy and disposition of rejected samples 1
• Assess turnaround time documentation and communication of delays to ordering clinicians 2

Common Pitfalls to Avoid

• Do not rely solely on structural inspections without connecting process measures to actual quality outcomes 3
• Avoid excessive quality indicators (>35 monitors) that become unwieldy and unused; focus on 7-14 high-impact measures 1, 3
• Do not neglect preanalytical variables, as fixation time and specimen handling significantly impact test accuracy 1
• Ensure internal controls are present and documented for all cases with borderline results (0-10% staining) 1