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 Technical Consultant, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Three of the nine tests of the basic Metabolic Profile parameters for ranges and two of the four 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 three of the nine parameters for females did not correctly match those reference ranges for the Basic Metabolic Profile in the procedure manual and four of the four parameters for microscopic urinalysis exams on the LIS report did not match the procedure manual. LIS patient report ranges Procedure manual ranges NA 136-148 mEq/L 136-145 mEq /L CA 8.5-10.6 mg/dL 8.5-10.1 mg/dL Glucose 70-118 mg/dL 74-106 mg/dL Epith /HPF 0-few 0-5 Bacteria 0-trace none 2. Interview with the Technical Consultant on Augus 28, 2019 at 10:30 AM 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 --