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 the surveyor's review of the laboratory's final report, the Test Volume Worksheet, and an interview with the technical consultant (TC); the laboratory failed to ensure test reports include all information as specified in 493.1291(c)(1)- (c)(6), specifically * (c)(2) The name and address of the laboratory location where the test was performed; affecting 723 patients' reports. Findings: 1. The "final report" of 3 out of 3 patients reviewed states that the Creatinine tests were performed at the following location: Northwestern Memorial Hospital Lab 251 E. Huron 7307 Chicago, IL 60611 Lab Director: Gregory Retzinger The documents presented and viewed in the electronic medical record (EMR) system showed that the tests were performed at Bucktown Radiology. 2. The test volume worksheet documents that from January of 2018 to January of 2019, 723 patients were tested for Creatinine at Bucktown facility. 3. On a Recertification survey conducted on 01/18//2019 at 11:15 AM, the TC confirmed the above findings. 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 --