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 with the laboratory director, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Sixteen of the nineteen complete blood cell count (CBC) parameters for female and male ranges and four of the six parameters for microscopic urinalysis listed on the laboratory information system(LIS) report differed from those in the approved procedure manual. Findings: 1. Review of the patient reports from the LIS system revealed sixteen of the nineteen parameters for female and male ranges did not correctly match those reference ranges for the CBC test in the procedure manual and four of the six parameters for microscopic urinalysis exams on the LIS report did not match the procedure manual. LIS patient report Procedure manual WBC 4.0-10.5(male/female)) 3.4-10.8 RBC 4.1-5.6(male) 4.14-5.80 RBC 3.8-5.1(female) 3.77-5.28 HGB 12.5-17.0 (male) 13.0-17.7 HGB 11.5-15.0(female) 11.1-15.9 HCT 36.0-50.0(male) 37.5-51.0 HCT 34.0-44.0(female) 34.0-46.6 MCV 80-98(male/female) 79-97 MCH 27-34.(male /female) 26.6-33.0 MCHC 32-36(male/female) 31.5-35.7 RDW 11.7-15.0(male /female) 12.3-15.4 PLT 140-415(male/female) 150-379 monocytes 4-13(male/female) 4-12 eosinophils 0-7(male/female) 0-5 basophils 0-3(male/female) 0-2(female) neutro abs 1.8-7.8(male/female) 1.4-7.0 lymph abs 0.7-4.5(male/female) 0.7-3.1 mono abs 0.1-1.0(male/female) 0.1-0.9 basos abs 0.0-0.2(male/female) 0.0-0.3(female) LIS patient report Procedure manual WBC 0-3 0-5 Epithelial cells 0-3 0-10 Casts none Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- seen rare Crystals few none seen 2. Interview with the laboratory director on August 10, 2018 at 1:30 PM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. -- 2 of 2 --