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 document review and interview with laboratory personnel, the laboratory failed to ensure test reports generated prior to 07/17/19 included the full name and address of the laboratory location (c)(2). Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery testing as confirmed by the Histotechnician during a tour of the laboratory at 10:05 a.m. on 07/17/19. 2. Test reports reviewed on date of survey did not include the full name and address of the laboratory location. See below Case number Date of testing BSQ18 193 05/07/18 BSQ18 481 12/03/18 BSQ19 344 05/06/19 3. The laboratory was given an opportunity to provide an alternate report format which included the required information within 7 days of the survey. 4. In an email received at 9:56 a.m. on 07/22/19, the laboratory nurse indicated a test report which included the full name and address of the laboratory was not available for cases completed prior to 07/17/19. 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 --