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: Review of pathology reports and interview of facility personnel found that the laboratory failed to ensure the name and address of the laboratory performing the microscopic analysis of tissue specimens obtained during frozen section surgical procedures appeared on five of five reports reviewed. The findings included: 1. Review of five final pathology reports found no documentation of the name and address of the laboratory performing microscopic analysis for the following Accession numbers: SPC21-03228 tested June 3, 2021 SPC21-06213 tested October 14, 2021 SPC22-00764 tested February 2, 2022 SPC22-03330 tested May 17, 2022 SPC22- 04472 tested July 11, 2022 2. Interview of the Laboratory Director conducted on July 27, 2022 at 10:58 AM confirmed that the name and address of the laboratory performing the frozen section tissue examination did not appear on the final report. 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 --