Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control record review and interview with the Laboratory Manager and Laboratory Assistant Manager on (02/06/2019), the laboratory failed to include a positive and negative control each day of patient testing for Wet Prep and Urine Sediment examination. Findings include: 1.The labororatory did not include a negative and positive control material at least once a day patients specimens were examined for , Wet Prep, and Urine Sediment Examination for tests preformed from (01/01/2019) through the date of survey (02/06/2019). 2. During the survey, the Laboratory Manager, confirmed that positive and negative controls are not documented each day of patient testing for Wet Prep, and Urine Sediment Examination. 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 --