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 a lack of laboratory quality control (QC) records and an interview with the laboratory director, the laboratory failed to test QC material when a new bottle of Siemens' 10 SG reagent strips are opened. Findings Include: It was confirmed by the laboratory director on March 30, 2018, at approximately 2:00 pm that the laboratory failed to follow the manufacturer's instruction for the Siemens' 10 SG reagent strips and test a positive and negative controls prior to patient testing. Approximately 1140 patient tests were performed for urinalysis and results reported for 2017. 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 --