Summary:
Summary Statement of Deficiencies D0000 An on - site announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc. on 02/06/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 staff interview, the laboratory failed to have the correct laboratory address where the histopathology reading (testing) was performed for 36 out of 36 patient test reports reviewed for two out of two years (2022 to 2023). Findings Included: Review of 36 patient test reports dated 01/19/22, 02/18/22, 03/16/22, 04/22/22, 05/06/22, 06/08/22, 07/07/22, 08/01/22, 09/02/22, 10/18 /22, 11/15/22, 12/13/22, 01/20/23, 01/25/23, 02/14/23, 02/21/23, 03/16/23, 03/22/23, 04/10/23, 04/14/23, 05/07/23, 05/22/23, 06/08/23, 06/12/23, 07/09/23, 07/11/23, 08/10 /23, 08/16/23, 09/09/23, 09/16/23, 10/16/23, 10/18/23, 11/19/23, 11/23/23, 12/12/23 (x2) revealed the patient reports had the incorrect laboratory address of the histopathology reading location. On 2/6/24 at 11:15 a.m., the Laboratory Director confirmed the patient test reports did not have the correct laboratory address for the reading/testing location. 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 --