How to conduct a laboratory management review?

Opening Remarks for Laboratory Management Review

A laboratory management review should systematically evaluate all phases of the total testing process—pre-analytical, analytical, and post-analytical—with emphasis on quality indicators, personnel competency, and corrective actions to ensure optimal patient outcomes and regulatory compliance. 1

Purpose and Framework

The management review serves as a critical quality management system (QMS) tool to assess laboratory performance and identify improvement opportunities across the entire testing continuum. 2, 1 This review must be visible, demonstrate progress, and express clear commitment from laboratory leadership through active participation and timely feedback. 2

Key Areas for Systematic Evaluation

Pre-Analytical Process Assessment

• Specimen collection, handling, transportation, and storage protocols require thorough evaluation as 60% of laboratory errors occur in this phase. 2, 1
• Review documentation of demographic and clinical information including birth weight, gestational age, nutritional status, and transfusion data where applicable. 2
• Assess specimen identification practices and labeling compliance to prevent sample mismatch. 2

Analytical Process Review

• Instrument performance records, quality control data, and maintenance documentation must be systematically monitored. 1
• Evaluate reagent quality control protocols and calibration verification results. 2, 1
• Review proficiency testing and external quality assessment (EQA) performance, as these programs provide essential information about overall laboratory competence and training needs. 2, 1

Post-Analytical Process Evaluation

• Assess timeliness of result reporting, critical value notification compliance, and report clarity to ensure effective communication with clinicians. 1
• Review turnaround time data and customer satisfaction survey results to identify service gaps. 1
• Evaluate the effectiveness of result interpretation and reporting practices. 2

Personnel and Competency Management

Staff competency assessment is pivotal and requires job descriptions, training documentation, confirmation of skills, and routine re-assessment before task performance. 2, 1 Most analytical errors in clinical bacteriology relate to knowledge and skills deficiencies, making educational programs essential. 2 Training should be straightforward, explain the science behind errors, and emphasize correct practices with appropriate redundancy. 2

Quality Assurance Activities

• Review all non-conforming events, errors, and incidents with root cause analysis to identify systemic issues rather than blaming individuals. 1, 3
• Evaluate corrective and preventive actions (CAPA) implementation and effectiveness. 1
• Monitor internal quality control performance alongside external proficiency testing results. 2, 1
• Document all quality assurance activities comprehensively. 2

Risk Management and Error Prevention

Error review represents an excellent entry point for activating QMS and should be applied early in implementation. 2 Identify potential errors throughout the workflow, implement risk mitigation strategies, and evaluate the effectiveness of previous risk reduction measures. 1 Daily supervisory review at the bench provides valuable opportunities for teaching, standardizing subjective examinations like Gram stains, and detecting procedural deviations. 2

Resource and Performance Management

• Evaluate equipment performance, maintenance schedules, and inventory management to ensure efficient resource utilization. 1
• Review information system performance and identify technology needs. 1
• Benchmark laboratory performance against peer institutions to identify competitive improvement opportunities. 1

Documentation and Regulatory Compliance

Standard operating procedures (SOPs) must be legible, readable, and comprehensible with sufficient procedural detail. 2 Communication should be efficient and adapted to laboratory size and complexity. 2 Ensure compliance with all documentation requirements including federal and state regulations for training and education. 2 Review and revise policies and procedures at established intervals to maintain adherence to the quality assurance program. 2

Strategic Planning and Continuous Improvement

• Assess new testing methodologies and technology acquisition plans to keep services current. 1
• Identify workflow optimization opportunities for operational efficiency. 1
• Analyze quality indicator trends to measure improvements following implementation of changes. 1

Critical Pitfalls to Avoid

Do not focus exclusively on analytical processes while neglecting pre- and post-analytical phases where most errors occur. 1 Avoid failing to document corrective actions, neglecting to close the feedback loop with laboratory users, implementing overly complex documentation systems, or launching too many improvement initiatives simultaneously. 1 Never overlook the importance of engaging peer champion advocates among laboratorians, clinicians, and administrators to promote a culture of quality. 2