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 test order review, slide review, test report review, and interview with director, 1 of 2 cases with special stains reviewed failed to include results report of 2 of 4 special stains ordered. (SOX10 and S-100 Protein). Findings include: 1. Patient test orders for ID19-197646 include special stains for S-100 Protein, SOX10, Fontana- Masson Silver, and Perls' Iron. 2. Slide review for ID19-197646 included 4 patient slides labeled with the patient ID and S100, SOX 10, Fontana, and Iron. 3. Final report for ID19-197646 included "Fontana-Masson stain +, Perl stain -", S100 and SOX100 results not listed. 4. Interview with director on 3/3/20 at approximately 11:15 am confirmed results for S-100 Protein and SOX10 were not included in patient 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 --