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 review of patients final reports and interview with the laboratory director, the laboratory did not ensure that the final test report listed the name and address of the laboratory performing the interpretation of the slides that were prepared at another location. Findings: 1. During the survey four patient charts were pulled to review the final report with the patients test results. Four of the four that were reviewed did not include the name and address of the laboratory that was being surveyed. The laboratory being survey was performing the interpretation of the slides. 2. The name and address listed on the final report belonged to the facility that prepared the slides for interpretation. The facility that prepares the slides also provides the laboratory information system (LIS) for generating the final report to the customer. 3. During the survey on 02/06/2019 at 10:00 AM the laboratory director confirmed that all the final reports generated from the LIS provided by the facility that prepared the slide did not include the name and address of the laboratory performing the interpretation of the tests. 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 --