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Run: CLIA Waived Testing Daily Quality Control Log

Daily QC log for CLIA-waived point-of-care tests that records control results, lot numbers, expiration checks, and corrective actions in one place. Use it to...

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Session Identification

QC Log Date critical (required)

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 critical (required)

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 critical (required)

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 critical (required)

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 critical (required)

Record the lot number printed on the reagent kit or test cassette package.

Reagent Kit Expiration Date critical (required)

Record the expiration date on the reagent kit. Do NOT use expired reagents.

Reagent kit is within expiration date critical (required)

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.

Yes No N/A

Control Material Lot Number critical (required)

Record the lot number from the QC control material (positive and/or negative control vials/cartridges).

Control Material Expiration Date critical (required)

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) critical (required)

Confirm control material has not expired. Check both printed expiration and any open-vial expiration per manufacturer's package insert.

Yes No N/A

Reagents and controls stored per manufacturer specifications critical (required)

Verify storage conditions (temperature, light exposure, humidity) match manufacturer requirements. Check that refrigerated items were not left at room temperature beyond allowed time.

Yes No N/A

Positive Control Run

Positive Control Run Time

Record the time at which the positive control was run.

Positive Control Result (Qualitative) critical (required)

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 critical (required)

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.

Yes No N/A

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) critical (required)

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 critical (required)

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.

Yes No N/A

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 critical (required)

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 critical (required)

Operator performing QC must sign to attest that all entries are accurate and complete. Required for CLIA record integrity under 42 CFR §493.1105.

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