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 patient test reports and interview with the practice manager and technical consultant at 1:50 PM on 7/19/2018, the laboratory failed to have the address of the testing location on the patient test reports. Findings are: 1. Review of 3 patient test reports for Gardnerella, Trichomonas and Candida testing performed on 6 /12/2018, 5/1/2018 and 2/19/2018 revealed no testing location address on all 3 reports. 2. Interview with the practice manager and technical consultant confirmed the address had been omitted on all the previous and current test reports when a new software system was started on 3/5/2018. 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 --