The Importance of Compliance and a Laboratory Consulting Service

Maintaining compliance with CAP, COLA, TJC, ISO, and CLIA/CMS is essential for laboratories to ensure patient safety and quality testing. Compliance not only protects labs from legal and financial penalties but also enhances their reputation and credibility. Depending on which organization(s) you may choose, each organization sets rigorous standards that labs must meet to provide reliable services in today’s healthcare landscape, making compliance a crucial factor for operational success.

Regulatory Oversight and Risk Assessment

• Establish and maintain policy and procedural development aligned with CLIA, CAP, and TJC expectations.

• Plan and execute CLIA mock inspections, gap analyses, and corrective action plans.

• Develop and manage documentation control, SOPs, and record retention policies.

• Oversee biosafety program design, chemical hygiene, and emergency procedures.

• Lead regulatory readiness activities, including labels, certificates of compliance, and audit trails.

• Manage lot numbers oversight, usage windows, expiration dating, and chain-of-custody for regulated materials.

Evaluation, Validation, and Instrument Comparison

• Conduct method validation/verification for new tests, instruments, and workflows.

• Perform instrumentation installation, IQ/OQ/PQ, and routine performance evaluations.

• Coordinate device integration and configuration with LIS/EHR interfaces; manage changes and upgrades.

• Lead comparison studies and performance benchmarking for POCT and LDMS platforms.

• Develop evaluation dashboards, utilization metrics, and testing cost analyses.

• Compile proficiency testing materials, order management, and supplier communications for evaluation purposes.

Standardize Compliance and Accreditation Readiness

• Develop and maintain standardization across test menus, reference intervals, and reflex testing algorithms.

• Create and maintain documentation that supports CAP/CLIA accreditation visits.

• Implement SOP harmonization, document control, and version tracking for all service areas.

• Prepare checklists, mock survey responses, and evidence packages for surveys.

• Monitor calibration and QC standards; ensure instrument and method alignment with recognized standards.

Utilization, Availability, and Workflow Optimization

• Optimize laboratory workflows for TAT reduction and resource utilization.

• Ensure lab-wide lifecycle management, including device additions/replacements and POC program coordination.

• Manage device integration, configuration, installation, and inter-device interoperability.

• Oversee temperature and maintenance monitoring across devices and work environments.

• Coordinate preventive and annual maintenance with manufacturers and the company’s service teams.

• Ensure continuous operation through monitoring of POC testing supply chains, lot-controlled reagents, and expiration management.

• Facilitate monthly check-ins, document sign-offs, and cross-functional communications.

Laboratory Data Integrity and Instrumentation Monitoring

• Implement LDMS governance for data capture, device status, and analyzer health.

• Maintain document and form development for data integrity, traceability, and audit readiness.

• Manage microscope and other device inventories; track calibration and service histories.

• Lead document consolidation efforts, central repository maintenance, and version control.

• Oversee proficiency testing scheduling, materials procurement, and return documentation.

• Establish monthly performance reviews, sign-off workflows, and escalation paths.

Testing Capability, Technology Integration, and Regulatory Alignment

• Align testing capabilities with regulatory expectations and clinical needs.

• Integrate technology platforms (analyzers, POCT devices, LDMS) with the LIS/EHR ecosystem.

• Manage installation, configuration, and ongoing maintenance scheduling with manufacturers.

• Plan and execute proficiency testing programs, including scheduling, material management, and result submission.

• Support device management for POCT, including additions or replacements and performance validation.

• Maintain thermometer, pipette, timer calibration records and associated documentation.

• Implement comprehensive documentation practices, including monthly check-ins and required sign-offs.