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 patient test reports review, procedure manual review, and interview with staff, the laboratory report report for 1 of 2 tests reported, neonatal bilirubin, failed to include the units of measure for 5 of 5 reports reviewed. The laboratory performed approximately 2 total bilirubin tests per month. Findings include: 1. The laboratory total bilirubin report failed to include the units of measure for total bilirubin for patients tested on 10/10/2016, 01/02/2017, 05/19/2017, 06/09/2017, and 11/01/2017. 2. Procedure manual review included reference ranges for mg/dl and for MMol/L, without specification for which units of measure the laboratory reported. 3. In an interview with staff on 01/18/2018 at approximately 3:45 P.M. staff confirmed the reports and reference ranges did not include the units of measure used by the laboratory for reporting Neonatal total bilirubin assays. 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 --