Clia - Pre-inspection Check List - Illinois

This printable "Clia - Pre-inspection Check List" is a document issued by the Illinois Department of Public Health specifically for Illinois residents.

Download a PDF of the latest edition of the form down below or find it through the department's forms library.

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CLIA - PRE-INSPECTION
CHECK LIST
The following list of required laboratory practices and documents is an overview of what the on-
site survey inspection may consist off; however, please know that additional documents may be
required by the surveyor. Use this list only as a guide to prepare your laboratory. Documentation
should be organized and available before the scheduled arrival of the inspector. The better
organized you are, the easier your inspection will be.
ADMINISTRATION
Yes
No N/A
Inspection Package Instructions Reviewed?
Laboratory - Declaration of Ownership Completed?
Laboratory Personnel (CLIA) CMS-Form 209 Completed?
CMS-116Application – Section VIII (Past Year) Annual Test Volume per
specialty completed?
CMS-116Application - All areas completed and Signed by the Lab Director?
Previous CLIA Inspection reviewed?
LABORATORY PERSONNEL
Yes
No N/A
All non-waived laboratory personnel listed in CMS Form 209?
Lab Director qualifying documents on file?
Moderate Complexity lab-Technical Consultant & Clinical Consultant
documents, on file?
High Complexity lab- Clinical Consultant, Technical Supervisor & General
Sup on file?
Testing personnel qualifying academics on file (GED, High School, AA, BS,
MS, PhD, MD, etc)?
Testing Personnel Job Description and Test Authorization on file?
Testing personnel Training records on file?
New Testing personnel Semi-annual (twice-first year) Competency
assessments on file?
Testing personnel yearly Competency assessments on file?
LABORATORY WRITTEN POLICIES PROCEDURES AND RECORDS
Yes
No N/A
List of laboratory test performed available?
Laboratory Policies and Test procedure manuals available?
Equipment Manufacturer manuals available?
Manufacturer kits or reagent inserts available?
Laboratory Safety Manual available?
QUALITY ASSESSMENT/QUALITY ASSURANCE
Yes
No N/A
Quality Assurance manual available?
Quality Assurance plan monitored and corrective actions documented?
PROFICIENCY TESTING (PT) RECORDS
Yes
No N/A
Laboratory is enrolled in a PT program for every test or analyte it performs
patient testing?
For tests challenges not available from a PT program, and considered non-
regulated. Does the laboratory verify the accuracy of its test results twice
annually (split-specimens challenges)?
PT test results or Evaluation of split-specimens report reviewed and signed
by laboratory director or designee?
Investigation and Corrective actions Documented for unsuccessful PT
performances?
CLIA - PRE-INSPECTION
CHECK LIST
The following list of required laboratory practices and documents is an overview of what the on-
site survey inspection may consist off; however, please know that additional documents may be
required by the surveyor. Use this list only as a guide to prepare your laboratory. Documentation
should be organized and available before the scheduled arrival of the inspector. The better
organized you are, the easier your inspection will be.
ADMINISTRATION
Yes
No N/A
Inspection Package Instructions Reviewed?
Laboratory - Declaration of Ownership Completed?
Laboratory Personnel (CLIA) CMS-Form 209 Completed?
CMS-116Application – Section VIII (Past Year) Annual Test Volume per
specialty completed?
CMS-116Application - All areas completed and Signed by the Lab Director?
Previous CLIA Inspection reviewed?
LABORATORY PERSONNEL
Yes
No N/A
All non-waived laboratory personnel listed in CMS Form 209?
Lab Director qualifying documents on file?
Moderate Complexity lab-Technical Consultant & Clinical Consultant
documents, on file?
High Complexity lab- Clinical Consultant, Technical Supervisor & General
Sup on file?
Testing personnel qualifying academics on file (GED, High School, AA, BS,
MS, PhD, MD, etc)?
Testing Personnel Job Description and Test Authorization on file?
Testing personnel Training records on file?
New Testing personnel Semi-annual (twice-first year) Competency
assessments on file?
Testing personnel yearly Competency assessments on file?
LABORATORY WRITTEN POLICIES PROCEDURES AND RECORDS
Yes
No N/A
List of laboratory test performed available?
Laboratory Policies and Test procedure manuals available?
Equipment Manufacturer manuals available?
Manufacturer kits or reagent inserts available?
Laboratory Safety Manual available?
QUALITY ASSESSMENT/QUALITY ASSURANCE
Yes
No N/A
Quality Assurance manual available?
Quality Assurance plan monitored and corrective actions documented?
PROFICIENCY TESTING (PT) RECORDS
Yes
No N/A
Laboratory is enrolled in a PT program for every test or analyte it performs
patient testing?
For tests challenges not available from a PT program, and considered non-
regulated. Does the laboratory verify the accuracy of its test results twice
annually (split-specimens challenges)?
PT test results or Evaluation of split-specimens report reviewed and signed
by laboratory director or designee?
Investigation and Corrective actions Documented for unsuccessful PT
performances?
PROFICIENCY TESTING (PT) RECORDS (Conti-)
Yes
No N/A
Documented Review of PT results against the PT provider participant’s
summary results, for non-graded, non-consensus or artificially assigned
scores on file?
Documented review of PT minimum passing scores of 80% on file?
Review of patient test results to ensure that no tests results were affected
during the failed PT?
Documented records of all testing personnel participating in PT events?
LABORATORY SYSTEMS CALIBRATIONS AND VERIFICATIONS
Yes
No N/A
Calibration policies available?
System Calibration records (bi-annual, once every 6 months) or more
frequently if required?
Comparison of Test Results available when performing the same test using
different methodology or Instruments? (bi-annual, every 6 months)
New equipment Installation (correlation verification studies) available?
Performance Specifications for Mod- FDA system or in-house developed
methods available?
LABORATORY QUALITY CONTROLS
Yes
No N/A
Quality Control records for the past two years (logs, instrument print outs or
LIS) available?
Levey-Jennings charts including other assay ranges available?
Documented QC reviews by lab director or designee available?
Documented investigations and corrective actions for any QC failures
available?
TESTING RECORDS
Yes
No N/A
Patients test requisitions, accession logs, instrument print outs, or LIS test
records available?
Logs reviewed?
Normal and Panic test values available?
Reference Laboratory log available?
LABORATORY MAINTENANCE RECORDS
Yes
No N/A
Laboratory equipment and systems maintenance logs available?
Lab equipment (centrifuges, pipettes, thermometer, timers, hoods, etc)
calib/verif available?
All Equipment Repairs documented?
Test systems repairs or replacement of parts include documented
Calibration Verifications?
TEMPERATURE CONTROLLED SPACES, EQUIPMENT AND INSTRUMENTS
Yes
No N/A
Equipment/Instruments monitored for acceptable temperature ranges?
Facility space, temperature and humidity logs available?
LABORATORY TESTING - AREA, SUPPLIES AND SAFETY
Yes
No N/A
Reagents monitored for date received, open and expiration dates?
Expired reagents and test accessories (kits, collect tubes, etc) discarded?
Laboratory safety equipment, biohazard waste containers and labels in
place?
Laboratory with adequate space, good ventilation and clean?
Self Evaluation Conducted by: _____________________________________ Date: __________

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