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 an on-site unannounced complaint survey conducted on 05/02/2019, the laboratory failed to follow the manufacturer's instructions to: run quality control when opening each new canister of urine test strips, and to clean the instrument daily; run quality control with each new bottle of test strips on the Quintet AC glucometer, and to clean the Afinion HbA1c analyzer every 30 days. 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 --