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 patients' final report, laboratory's 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), affecting 56 patients. Findings: 1. Review of the patients' electronic medical records (EMR) revealed that the patients' final reports does not include the following: (c)(2) The name and address of the laboratory location where the test was performed. 2. All reports reviewed showed Evanston Hospital as the laboratory testing site. 3. The laboratory's volume worksheet documents 56 patients were tested and reported during the period of January through June of 2018.. 4. On an Initial survey conducted on 07 /19/2018 at 12:30 PM, the TC and laboratory director (LD) confirmed 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 --