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 final test report and interview with the laboratory director, the laboratory's final test report failed to include the correct Suite number in the address where the laboratory testing is performed. Findings: 1. The laboratory's final test report listed the testing laboratory's address with "Suite 260." The CLIA Certificate of Registration listed the laboratory's address with "Suite 111." 2. During the initial survey on 03/15/2021 at 11:25 AM, the laboratory director confirmed that the final test report had an incorrect Suite number listed and that the laboratory's testing address should actually be at "Suite 207". 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 --