Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on direct observation, lack of Quality Control (QC) records, and interview with the Office Manager (OM), the laboratory failed to comply with urinalysis reagent test strip manufacturer's instructions. FINDINGS: 1. There was no documentation of Proadvantage urine test strip QC testing when new lots, shipments were received and new bottles opened. 2. This is contrary to Proadvantage urine test strip manufacturer's instructions. 3. It was noted that no QC records were available from 2022 through the survey date. 4. Approximately fifty patients were tested each year. 5. The OM confirmed the findings on September 20, 2024, at approximately 11:00 A.M. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --