Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/18/2024 found the ROBB E WILENTZ MD LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 reports and interview with laboratory director (LD), the laboratory failed to include the name and address of the laboratory where the technical component for the stains was performed for six out of six patient's reports and failed to use the correct name for the laboratory where histopathology reading (testing) was performed for six out of six patient test reports reviewed. Findings include: Review of six final patient reports: P#1(date 04/10/2022), P#2 (dated 06/15/2022), P#3 (dated 12 /05/2022), P#4 (dated 06/03/2023), P#5 and P#6 (dated 12/06/2023); revealed that the reports failed to have the laboratory name and address where the technical component was performed and failed to use the correct name for the laboratory where the histopathology interpretation was done. During an interview on 01/18/2024 at 10:30 AM, the LD confirmed that the final reports reviewed did not include the name and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- address of the laboratory where the technical component for the stains was performed and failed to use the correct name for the laboratory where histopathology reading (testing) was performed for the test reports reviewed. -- 2 of 2 --