Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at COMPREHENSIVE PATHOLOGY ASSOCIATES, PA on 07/02/2024 found the 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 ensure that the patient report listed the name and address of the laboratory where the professional component was done for six out of six patient's reports reviewed. Findings include: Review of six final patient reports: P#1(date 03/14 /2024), P#2 (dated 03/19/2024), P#3 (dated 06/20/2024), P#4 (dated 06/21/2024), P#5 (date 06/18/2024) and P#6 (dated 06/20/2024); revealed that the reports failed to have the laboratory name and address where the histopathology interpretation was done. During an interview on 07/02/2024 at 10:30 AM, the LD confirmed that the final report reviewed did not include the name and address of the laboratory where histopathology reading (testing) was performed for the test reports reviewed. 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 --