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 review of urine sediment microscopic examination quality control (QC) records, and interview with General supervisor (GS) #1, the laboratory failed to document QC procedures performed for 352 of 352 patient specimens examined for urine sediment microscopic procedure from 2017 to the date of survey. Findings Include: 1. On the day of survey, 03/28/2019, review of urine sediment microscopic examination QC records revealed the laboratory did not document QC procedures performed each day of patient testing from 2017 to 03/28/2019. 2. In 2017, 148 Urine Sediment Microscopic Examination were analyzed. 3. In 2018, 172 Urine Sediment Microscopic Examination were analyzed. 4. In 2019, 32 Urine Sediment Microscopic Examination were analyzed. 5. GS#1 confirmed on 03/28/2019 around 10:15 am, that QC was performed but not documented. 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 --