CLIA Waived Testing Daily Quality Control Log

Daily quality control log for CLIA waived point-of-care tests. Captures control results, lot numbers, reagent expiration, operator initials, and corrective actions to support compliance with CLIA 42 CFR §493 Subpart B waived testing requirements.

Session Identification

• QC Log Date
  Date on which quality control testing is being performed.
• Testing Location / Department
  Specify the clinic, department, or POC site where testing is performed (e.g., ED, Urgent Care, Lab Draw Station).
• Instrument / Analyzer Name and ID
  Enter the full name and unique instrument ID or serial number of the analyzer being QC'd (e.g., Abbott i-STAT SN-12345, Quidel Sofia 2 SN-67890).
• Test Name / Analyte
  Specify the CLIA-waived test being performed (e.g., Influenza A/B, SARS-CoV-2 Antigen, Urine hCG, Blood Glucose, Group A Strep).
• Operator Name
  Full name of the operator performing QC testing. Must be a trained, authorized user per CLIA 42 CFR §493.1489.
• Operator Initials
  Initials of the operator performing QC testing, used for log authentication.

Reagent and Control Material Verification

• Reagent Kit Lot Number
  Record the lot number printed on the reagent kit or test cassette package.
• Reagent Kit Expiration Date
  Record the expiration date on the reagent kit. Do NOT use expired reagents.
• Reagent kit is within expiration date
  Confirm the reagent kit expiration date has not passed as of today's date. Expired reagents must be removed from service immediately per CLIA 42 CFR §493.1252.
• Control Material Lot Number
  Record the lot number from the QC control material (positive and/or negative control vials/cartridges).
• Control Material Expiration Date
  Record the expiration date on the control material. Include open-vial expiration if applicable per manufacturer instructions.
• Control material is within expiration date (including open-vial expiry if applicable)
  Confirm control material has not expired. Check both printed expiration and any open-vial expiration per manufacturer's package insert.
• Reagents and controls stored per manufacturer specifications
  Verify storage conditions (temperature, light exposure, humidity) match manufacturer requirements. Check that refrigerated items were not left at room temperature beyond allowed time.

Positive Control Run

• Positive Control Run Time
  Record the time at which the positive control was run.
• Positive Control Result (Qualitative)
  Record the qualitative result of the positive control run (e.g., Positive, Reactive, Detected).
• Positive Control Result (Quantitative, if applicable)
  If the test produces a numeric result, record the quantitative value for the positive control. Leave blank for qualitative-only tests.
• Positive control result is within manufacturer's acceptable range
  Confirm the positive control result meets the expected outcome per the manufacturer's package insert. A 'No' result requires immediate corrective action and suspension of patient testing.
• Positive Control Photo (if result is borderline or invalid)
  Attach a photo of the positive control result strip/display if the result is borderline, invalid, or unexpected.

Negative Control Run

• Negative Control Run Time
  Record the time at which the negative control was run.
• Negative Control Result (Qualitative)
  Record the qualitative result of the negative control run (e.g., Negative, Non-Reactive, Not Detected).
• Negative Control Result (Quantitative, if applicable)
  If the test produces a numeric result, record the quantitative value for the negative control. Leave blank for qualitative-only tests.
• Negative control result is within manufacturer's acceptable range
  Confirm the negative control result meets the expected outcome per the manufacturer's package insert. A 'No' result requires immediate corrective action and suspension of patient testing.
• Negative Control Photo (if result is borderline or invalid)
  Attach a photo of the negative control result strip/display if the result is borderline, invalid, or unexpected.

Overall QC Acceptance and Corrective Action

• Overall QC Status for This Session
  Select the overall QC acceptance status based on both positive and negative control results.
• Corrective Action Taken (if QC failed or invalid)
  If QC failed, describe the corrective action taken: e.g., repeated QC with new controls, opened new reagent kit lot, recalibrated instrument, contacted manufacturer technical support, or removed instrument from service. Leave blank if QC was accepted.
• Repeat QC Performed After Corrective Action
  If corrective action was required, was repeat QC performed and accepted before resuming patient testing?
• Supervisor / Lab Director Notified of QC Failure
  If QC failed, confirm that the laboratory supervisor or CLIA laboratory director was notified per facility policy.
• Additional Comments
  Record any additional observations, instrument errors, environmental conditions, or notes relevant to this QC session.
• Operator Signature
  Operator performing QC must sign to attest that all entries are accurate and complete. Required for CLIA record integrity under 42 CFR §493.1105.