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. Ten of the ten complete blood cell count (CBC) parameters 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 ten of the ten parameters for male ranges did not correctly match those reference ranges for the CBC test in the procedure manual. LIS patient report Procedure manual WBC 3.9- 10.9 5-10 RBC 4.0-6.0 4.40-5.60 Hgb 13.5-16.9 male 14-18 HCT 40-49 male 40-54 MCV 81.8-95.5 80-100 MCH 27.0-32.3 27-33 MCHC 31.8-35.0 32-37 Platelets 170- 390 150-400 2. Interview with the Laboratory Director on March 1 at 2:00 PM 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 --