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 approved reference ranges in the laboratory procedure manual and interview, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Findings: 1. Review of the patient reports from the LIS system revealed four of the nine parameters for microscopic urinalysis exams on the LIS report did not match the procedure manual. 2. Patient report ranges for UA WBC, UA RBC, UA Bacteria, and UA Squam Epith, all are listed as [None Seen] 3. Procedure manual lists abnormal ranges only. WBC >5/HPF RBC >3/ HPF Bacteria > trace/HPF Epithelial Cells Any epithelial cells other than squamous 3. Interview with the Laboratory Director at 11:05 a.m. November 10, 2020 confirmed, the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. 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 --