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 review of the Laboratory Test List & Annual Volume form, patient test reports, and confirmed by laboratory personnel #2 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 8/13/2019, the laboratory failed to have the name and address of the testing facility on the test report for one out of 12 patient test reports (Patient identifer A) from April 2019. The findings include: 1. Patient identifier A had a complete blood cell count with automated differential, erythrocyte sedimentation rate, glucose, blood urea nitrogen, creatinine, calcium, sodium, chlorine, bicarbonate, and c-reative protein performed on 4/17/2019. 2. The Laboratory Test List & Annual Volume form confirmed that Madison County Health Care performed the above non-waived testing. 3. The test report for Patient A indicated the name and address of the testing facility as Earlham Medical Clinic located at 125 W 1st Street, Earlham, IA 50072. 4. Laboratory personnel confirmed that the Earlham Medical Clinic only performed waived testing and the test report did not have the correct name and address of the testing facility. 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 --