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 04/15/2019, the laboratory failed to follow the Afinion HbA1C (Hemoglobin A1C) and Alere Cholestech Lipid test cartridge manufacturer's instructions to label cartridges with the dates the cartridges were removed from 2 to 8 degree storage, and document they performed quality control for HbA1C cartridges. 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 --