Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the approved reference ranges in the laboratory procedure manual, review of patient report, and interview with the laboratory director (LD), the laboratory failed to ensure the test report included pertinent reference ranges as determined by the laboratory. Two (2) out of ten (10) urine microscopic examination reference ranges listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings include: 1. Review of the Laboratory Corporation Standard Operating Procedure (SOP) - Microscopic Examination of Urine SOP #003772/003038 reveals the following reference ranges. a) Crystals reference range = Not Applicable (N/A) b) Epithelial Cells (renal) = Reference ranges not listed in SOP 2. Review of patient report 6112893 from the LIS system revealed the following. LIS Patient Report Procedure Manual Microscopic Examination Crystal None seen/hpf N/A Epithelial Cells (renal) None seen/hpf Not listed in SOP 3. Interview with the LD confirmed the laboratory failed to ensure correct references ranges approved in the procedure manual were the same as in the LIS patient reports on 04/02/2024 at 11:00 am. 4. The laboratory reports 590 urine microscopic examinations annually. 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 --