Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 upon review of patient reports and interview of facility personnel the laboratory failed to include the location of the laboratory where tests were performed in five of five histopathology final reports reviewed. The findings included: 1. Review of five final patient reports found the laboratory used the address of their primary location (under another CLIA number) as the name and address for the testing site. 2. During interview of the histotechnician conducted August 14, 2025 at 11:32 AM, he confirmed that the laboratory did not include the name and address of the laboratory where testing was performed on the final reports. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, the laboratory's personnel files and staff interview it was revealed the technical consultant failed to assess the competency at least semi-annually in the first year of testing for one of two testing personnel performing Microbiology procedures. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory identified two testing personnel performing moderate complexity testing. 2. Review of the laboratory's personnel files found no semi-annual competency assessments for testing person two. 3. During interview of the histotechnician conducted August 14, 2025 at 10:55 AM, he confirmed there were no semi-annual competency assessment available for review for testing person two. -- 2 of 2 --