CLIA Inspection Checklist

Use this CLIA inspection checklist to conduct internal laboratory audits ahead of official inspections, ensuring quality standards in compliance with CLIA regulations.

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CLIA Inspection Checklist



Organization & Personnel (QSE 1 & 2)

1. Has the laboratory director been confirmed to be present, accessible, and performing all required responsibilities?


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2. Is there a current organizational chart that clearly defines reporting relationships and management structure?


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3. Does the laboratory have adequate staffing levels to meet its workload and scope of testing?


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4. Is there a current personnel file for every employee that includes documentation of required qualifications, education, and experience?


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5. Is a position description or statement of duties maintained for each position?


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6. Is initial and ongoing training documented for all personnel, including specific training on new tests or equipment?


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7. Is competency assessed and documented for all testing personnel at the required intervals?


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Equipment, Facilities & Safety (QSE 3)

1. Is all equipment essential for testing confirmed to be in good working order and meeting manufacturer specifications?


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2. Is there a written procedure and schedule for calibration and maintenance of all testing equipment?


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3. Are records of all maintenance (routine and remedial) and calibration procedures easily accessible and current?


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4. Are temperature monitoring logs maintained for refrigerators, freezers, and incubators used for specimen/reagent storage?


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5. Are facilities and the working environment adequate to ensure the proper performance of tests (e.g., lighting, ventilation)?


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6. Are safety policies and procedures in place, communicated to staff, and consistently followed?


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Purchasing, Inventory & Process Management (QSE 4 & 5)

1. Is there a documented process for the selection, purchasing, and acceptance of all critical reagents, consumables, and supplies?


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2. Are all reagents and critical supplies inspected upon receipt for damage, proper storage temperature, and acceptable expiration dates?


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3. Are there procedures for managing inventory, including stock rotation (FIFO), to ensure materials are not used past their expiration date?


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4. Is there a detailed procedure for specimen collection, transport, and handling?


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5. Is specimen integrity maintained during transport and storage before testing?


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6. Are laboratory testing procedures validated or verified before being placed into service, and are changes documented?


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Quality Control (QC), Proficiency Testing (PT) & Reporting (QSE 6 & 7)

1. Are written QC procedures established and followed for all test systems?


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2. Is QC data reviewed and verified by the designated technical supervisor/director at required frequencies?


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3. Does the laboratory participate in PT for all specialties and subspecialties for which it performs testing?


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4. Are PT results reviewed and signed by the laboratory director/supervisor, and are any failures investigated with corrective action?


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5. Are test results reported with all necessary information (patient ID, test name, results, reference range, signature/date)?


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6. Are critical (panic) values identified, and is the procedure for timely notification of these values to the clinician documented and followed?


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Documents, Records & Improvement (QSE 8 & 9)

1. Is there a documented system for creating, approving, distributing, and retrieving all policies and procedures?


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2. Is a retention schedule defined and followed for all patient records, QC records, and administrative records?


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3. Is there a procedure for investigating and documenting nonconforming events (e.g., patient complaints, errors, instrument failures)?


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4. Are corrective actions (CAs) developed, implemented, and monitored for effectiveness to prevent recurrence of nonconformities?


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5. Are internal audits or quality assessments conducted at planned intervals to monitor the effectiveness of the entire quality system?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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