Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/20/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. 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 laboratory's random patient reports and staff interview, the laboratory failed to include on its final report the name and address of the laboratory where intraoperative histopathology consultation for histology samples was performed for 2 of 2 patient reports reviewed from June/July 2024. Findings included: 1. Review of random patient reports for case numbers SB-24-02312 and SB-24-02629 revealed there was no mention of the laboratory's name or address where the intraoperative histopathology consultation took place. 2. In an interview on 08/20/2024 at 1020 hours in the office, the Laboratory Director (as indicated on submitted Form CMS 209) stated that the laboratory performed intraoperative consultation for histopathology samples but did not document on patients final report the laboratory's name or address where the consultation took place. This confirmed the 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 --