FMI Clinical Laboratory Mock Inspection

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• 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:

  Date

• Area Inspected:

• Area Supervisor:

• Inspectors:

  Sign

Maintenance

• Equipment maintenance records and function checks on file and current

  Yes

  No

  N/A

• Calibrations completed and current scales, thermometers, etc

  Yes

  No

  N/A

• Floor tiles are in good repair and clean

  Yes

  No

  N/A

• Air vents clean and functional

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Comments or Notes on Maintenance

Physical Lab

• CAP signage and applicable lab permit is posted conspicuously

  Yes

  No

  N/A

• Only bench excerpts signed by lab director are posted

  Yes

  No

  N/A

• PPE available and being used as appropriate

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Acids, bases, and flammables are appropriately stored

  Yes

  No

  N/A

• Trash and biological waste are being disposed of appropriately

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Handoff communication records are available for review

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Chemical inventories in order and up to date

  Yes

  No

  N/A

• Reagent lot to lot validations up to date

  Yes

  No

  N/A

• Equipment validations completed and on file

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Equipment logs and laboratory charts are appropriately reviewed and signed

  Yes

  No

  N/A

• Safety Data Sheets are available

  Yes

  No

  N/A

• Hallways, entrances, and exits are clear and unobstructed

  Yes

  No

  N/A

• Corrosives are stored above eye level

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Notes or Comments about the Physical Lab Section

Employee Files

• Employee competencies completed at appropriate intervals using appropriate forms

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Delegation documentation is on file and current a appropriate

  Yes

  No

  N/A

• Notes or Comments about the Employee Files

Employee Awareness

• All employees sign and attest to review of applicable SOPs

  Yes

  No

  N/A

• 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

  Yes

  No

  N/A

• Employees all wearing ID above the waist

  Yes

  No

  N/A

• Relevant SOPs are available or accessible from inside the lab

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Employees wearing appropriate PPE for job function performed

  Yes

  No

  N/A

• Notes or Comments for Employee Awareness

Document Control

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

  Yes

  No

  N/A

• All employees sign and attest to review of applicable SOPs

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Relevant SOPs are available in lab

  Yes

  No

  N/A

• Notes or Comments for Document Control

Proficiency Testing

• Proficiency testing is being performed as appropriate

  Yes

  No

  N/A

• PT failures are investigated and addressed in a timely manner

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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: