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 Urine reagent strips are opened. Findings Include: It was confirmed by the laboratory director on April 3, 2018, at approximately 11:45 am that the laboratory failed to follow the manufacturer's instruction for the Siemens' 10 SG Urine 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. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on no proficiency test verification records and an interview with the laboratory director, the laboratory failed to verify the accuracy of urine microscopy test procedure. Findings Include: On April 4, 2018, at approximately 11:50 AM and confirmed by the laboratory director, the laboratory failed to perform twice annual verification for the urine microscopy procedure performed from the date of the last Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- survey April 19, 2016, through the date of this survey. Approximately 300 patient specimens were tested and reported for the urine microscopy procedure performed. 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 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)