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 surveyor's review of Quality Control (QC) records and interview with the the laboratory supervisor/testing person, the laboratory failed to follow the manufacturer's instructions for performing external positive and negative controls for the Siemens Multistix Urine testing from calendar year 2018 through the survey date. FINDINGS: 1. The packet insert for the Siemens Multistix 10 SG requires that external positive and negative controls be performed with each new Vial of Multistix 10 SG reagent Strip opened. 2. The laboratory supervisor/testing person confirmed on February 26, 2020 at approximately 1:00 PM that the laboratory only tested positive QC and failed to test negative QC with each vial of Multistix opened from calendar year 2018 through the survey date. 3. Approximately 4,000 patient specimens were tested and reported for urinalysis during this time frame. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)