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  • Site conducted

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  • Prepared by

Clinical Laboratory Mock Inspection Items

  • Please immediately remedy deficiencies events identified in this internal inspection report. Sign and submit this form to L&A once issues have been corrected (within 30 calendar days of inspection) or indicate whether further discussion, resources or other considerations are necessary for resolution.

  • Inspection Date:

  • Area Inspected:

  • Area Supervisor:

  • Inspectors:


  • Equipment maintenance records and function checks on file and current

  • Calibrations completed and current scales, thermometers, etc

  • Floor tiles are in good repair and clean

  • Air vents clean and functional

  • Ceiling tiles are clean and do not show evidence of leak or damage

  • Comments or Notes on Maintenance

Physical Lab

  • CAP signage and applicable lab permit is posted conspicuously

  • Only bench excerpts signed by lab director are posted

  • PPE available and being used as appropriate

  • No items stored directly on floor, under sink and less than 18" from ceiling

  • Unobstructed Safety Equipment (Fire Extinguishers, Safety Showers, and Eyewash Stations

  • Spill kits are available, stocked and employees know how to use them

  • Reagents and chemicals are appropriately labeled. No expired reagents in use

  • Reagents are labeled appropriately with received, opened and expiration dates

  • Acids, bases, and flammables are appropriately stored

  • Trash and biological waste are being disposed of appropriately

  • Sharps are discarded in a sharps container and not overfilled. Conveniently located and closed when not in use

  • Patient information is protected, handled and discarded appropriately per HIPAA

  • Handoff communication records are available for review

  • Applicable signage and warnings are posted such as Biohazard or exit signs, etc

  • Chemical inventories in order and up to date

  • Reagent lot to lot validations up to date

  • Equipment validations completed and on file

  • Equipment Labeled: Safety labels, PM/Calibration labels, Biohazard labels

  • Current laboratory charts and logs are in place and current e.g. temperature and humidity logs

  • Equipment logs and laboratory charts are appropriately reviewed and signed

  • Safety Data Sheets are available

  • Hallways, entrances, and exits are clear and unobstructed

  • Corrosives are stored above eye level

  • Eye wash stations are clean and checked on a weekly basis for function

  • Signage where UV lights are in use (Biological Safety Cabinets BSC)

  • Notes or Comments about the Physical Lab Section

Employee Files

  • Employee competencies completed at appropriate intervals using appropriate forms

  • Employee files are up to date and contain all necessary elements such as training records, degrees, licenses, verifications, etc

  • Fire safety, chemical safety, biohazard training and functional trainings are on file

  • Delegation documentation is on file and current a appropriate

  • Notes or Comments about the Employee Files

Employee Awareness

  • All employees sign and attest to review of applicable SOPs

  • Employees are aware of applicable safety and fire procedure e.g. how to access SDS and the location of the nearest fire extinguishers, fire alarm, safety showers, spill kits, etc

  • Employees all wearing ID above the waist

  • Relevant SOPs are available or accessible from inside the lab

  • Makeup application, cell phone use, food consumption is done only outside the lab

  • Employees wearing appropriate PPE for job function performed

  • Notes or Comments for Employee Awareness

Document Control

  • Relevant SOPs are on file and are readily accessible to all employees

  • All employees sign and attest to review of applicable SOPs

  • Lab Director or appropriate designees have reviewed and approved SOPs at appropriate intervals

  • Relevant SOPs are available in lab

  • Notes or Comments for Document Control

Proficiency Testing

  • Proficiency testing is being performed as appropriate

  • PT failures are investigated and addressed in a timely manner

  • Lab Director or appropriate designee signs evaluation reports within 2 weeks of receipt

  • Alternative assessments are conducted, documented an approved for tests where no commercially available PT options exist

  • Notes or Comments for Proficiency Testing

Mock Inspection Closure

  • I have reviewed the above listed inspection report and have not corrected the above listed issues for the following reason:

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