Valley County Health System - Laboratory

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 surveyor review of two patient test reports and interview with the laboratory manager the laboratory failed to have the test report date on the test report. Findings are: 1. Surveyor review of a complete blood count patient test report and review of a chemistry patient test report revealed both reports were missing the report date. 2. Interview with the laboratory manager on 8/16/2022 at 2:15pm confirmed no test report date was included on the patient test reports. 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 --

Summary Statement of Deficiencies D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of new instrumentation and personnel records, and technical consultant interview, the laboratory failed to document testing personnel training of four of four testing personnel prior to use of new moderate complexity instrument. The findings include: 1. Review of new instrumentation revealed a new moderate complexity beta-hydroxybutyrate instrument was put in service on September 2018. 2. No documentation of training was found in the personnel records for the new moderate complexity beta-hydorxybutyrate instrument prior to reporting patient test results. 3. Interview with the technical consultant on 10/13/2020 confirmed no documentation of training available at time of survey. 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 --