Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on interview with the technical consultant and clinical consultant and review of CBC test reports, the laboratory failed to indicate the units of measurements of CBC parameters and appropriate reference ranges of hemoglobin and hematocrit parameters for female and male patients. The findings included: 1. Coulter Diff-ACT 5 instrument printout is the test report. 2. Four of four sample test reports ( Sample ID: 14524, 10694, 14689, 11560) did not have units of measurements of CBC parameters. 3. Sample ID 14524 and 14689 from male patients have the same reference ranges as those for Sample ID 10694 and 11560 from female patients for hemoglobin and hematocrit parameters. 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 --