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 one of two patient final test results, the Centers for Medicare and Medicaid Services (CMS)-116 form and interview with the laboratory director, the laboratory name and address were not correct for the professional component on the final laboratory report for July 22, 2017, until June 2, 2018. The findings include: 1) Review of patient S17-6685 final test result dated 07/22/17 revealed the following name and address: NeoGeonomics Tennessee, 618 Grassmere Park Drive, Nashville, TN 37211. 2) Review of the CMS -116 form revealed the laboratory name and address is NeoGeonomics Hampton Avenue, 3604 Hampton Ave, Nashville, TN 37215. 3) Interview on June 4, 2018 at 11:30am with the laboratory director confirmed the name and address was incorrect on the laboratory final reports from opening date of 7/18/ 2017 until June 2, 2018 without a corrected report being issued. 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 --