1) Inspection Readiness Program Management

• Gap assessment against CLIA + your accreditor standards (CAP/COLA/TJC) and California LFS expectations

• Readiness roadmap (prioritized actions, owners, timelines)

• Document control cleanup plan (versions, approvals, distribution)

• Inspection calendar + recurring compliance schedule (daily/weekly/monthly/annual)

• On-site / remote “war room” support leading up to inspection week

2) Mock Inspections and Tracer Audits

• Full mock inspection (CLIA/CAP/COLA/TJC style)

• Departmental tracers: Pre-analytical → Analytical → Post-analytical workflows

• Personnel file tracers (licensure, training, competency, continuing education)

• Patient result/report tracers (critical values, corrected reports, amended reports)

• Specimen integrity tracers (acceptance/rejection, recollect, stability, chain-of-custody if applicable)

• Follow-up mock inspection after corrective actions

3) Quality Management System Setup and Optimization

• Quality plan and quality policy (lab-specific)

• Quality indicators (TAT, specimen rejection rate, redraw rate, critical value TAT, QC failures)

• Nonconformance / occurrence reporting workflow

• CAPA program (root cause analysis, effectiveness checks)

• Management review program (agenda, minutes templates, required inputs/outputs)

• Risk management (FMEA or similar) for high-risk steps (specimen receipt, LIS, reporting)

4) SOP and Document Control Services

• SOP writing/rewrite to meet CLIA/CAP/COLA/TJC (and CA LFS) expectations

• Method validation/verification SOPs (CLSI-aligned)

• Equipment, maintenance, and calibration SOPs

• Reagent/lot verification SOPs

• Quality control and QC review SOPs

• Document control system design: indexing, master list, approvals, review cycles

• Forms/logs package: temperature logs, QC logs, maintenance logs, competency forms, etc.

5) Method Validation / Verification Support

• Method verification plans (precision, accuracy, reportable range, reference intervals, AMR, LOD/LOQ when applicable)

• Reference interval verification (including demographic stratification where needed)

• Linearity / reportable range studies

• Comparisons/correlation studies (new analyzer, reagent change, LIS change)

• Uncertainty/risk-based validation approach for LDTs (if applicable)

• Validation report writing + inspection-ready binders

6) Proficiency Testing and Alternative Assessment

• PT enrollment strategy (analyte-by-analyte mapping)

• PT event management: receipt, handling, testing, reporting, attestation

• PT review documentation (investigations for failures/near misses)

• Alternative assessment design where PT not available

• Competency tie-in to PT performance (training/corrective actions)

7) Personnel Files, Training, and Competency Programs

• Role-based training curricula (pre-analytical, analytical, post-analytical)

• Annual competency program (6 elements where required; direct observation, QC review, blind samples, etc.)

• Remediation plans and retraining documentation

• High-complexity personnel qualification review (CLIA) + California CLS licensing verification

• Supervisor/technical consultant responsibilities checklist

• Continuing education tracking system

8) Specimen Management and Pre-Analytical Excellence

• Specimen acceptance/rejection criteria overhaul

• Collection/handling instructions (client-facing)

• Sample stability and storage requirements alignment

• Courier/transport validation support (temperature, timing, packaging)

• Chain-of-custody program (when needed: tox, legal, employer testing, etc.)

• Send-out testing program controls and oversight (reference lab agreements, result integration)

9) Analytical Systems, QC, and Instrument Compliance

• IQ/OQ/PQ documentation framework (as applicable)

• Daily QC design (Westgard strategy where applicable) + QC review training

• Calibration, calibration verification, and frequency justification

• Maintenance schedules and logs review

• Reagent/consumable inventory controls (expiration, storage conditions, FEFO)

• Autoverification rules review and validation (if LIS supports it)

10) LIS / Informatics / Cyber and Data Integrity Readiness

• LIS change control + validation for upgrades/interfaces

• Result integrity checks (units, reference ranges, flags, delta checks)

• Corrected/amended report process validation

• Data backup/recovery evidence and downtime procedures

• Audit trail review readiness; access control & role permissions

• PHI/HIPAA privacy/security workflows (as required for your setting)

11) Post-Analytical and Resulting Compliance

• Critical value policy (thresholds, notification documentation, read-back)

• Turnaround time definitions and monitoring

• Result review and release authorization policy

• Physician notification documentation and escalation pathways

• Client complaint handling and service recovery documentation

• Record retention schedule (CLIA + state + accreditor)

12) Safety, Facilities, and Emergency Preparedness

• OSHA/Cal-OSHA compliance package (BBP, HazCom, PPE, exposure control)

• Chemical hygiene plan / spill response / eyewash testing logs

• Biohazard and medical waste program documentation

• Temperature mapping for fridges/freezers (where needed)

• Disaster preparedness + downtime drills (TJC-style readiness)

• Environmental monitoring plan (where relevant)

13) Contracts, Reference Labs, and Vendor Qualification

• Vendor qualification process (supplies, service providers, calibrators)

• Service contracts review (response times, preventive maintenance)

• Reference lab agreements (responsibilities, result reporting, QA expectations)

• Specimen transport vendor compliance review

14) Inspection Day Preparation and Staff Coaching

• “Inspection binder” build (policies, org chart, licenses, PT, validations, QMS evidence)

• Staff interview coaching (how to answer, where to find documents)

• Role assignments for inspection day (runner, document control, section leads)

• Real-time support during inspection (on-site or remote)

15) Deficiency Response and Sustained Compliance

• Plan of Correction (POC) writing support for CLIA/CAP/COLA/TJC

• CAPA and effectiveness checks documentation

• Evidence package assembly (what to submit, how to show sustainability)

• 30/60/90-day compliance stabilization plan

• Ongoing internal audit program (quarterly mini-audits)