Summary:
Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory director and the histotechnician at the conclusion of the survey. 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 a review of records and interview with the laboratory director and the histotechnician, the laboratory failed to ensure patient test reports included the name of the laboratory. Findings include: (1) At the beginning of the survey, the laboratory director and the histotechnician stated to the surveyor the laboratory performed microscopic examinations on dermatologic samples obtained during biopsies or Mohs surgeries; (2) The surveyors then reviewed 2 patient reports: (a) Patient #1: Microscopic examination of a tissue sample obtained from Mohs surgery, stained with H & E (Hematoxylin and Eosin). The name of the laboratory on the report was, "Advanced Dermatopathology;" (b) Patient #2: Microscopic examination of a tissue sample obtained from Mohs surgery, stained with H & E. The name of the laboratory on the report was, "Advanced Dermatopathology of Oklahoma." (3) It was identified the name of the laboratory on the patient reports, did not match the name of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory listed on the CLIA certificate: Advanced Dermatology, Inc; (4) The surveyor reviewed the findings with the laboratory director and the histotechnician who stated the name on the reports did not match the name on the CLIA certificate. -- 2 of 2 --