Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 06/26/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 patient final reports and confirmed in interview, the laboratory failed to specify where the laboratory testing was conducted for 15 of 15 final patient test reports reviewed in February 2024. The findings included: 1. Review of patient final reports from February 2024 included the following two tests reported: - Microscopic Description - Gross Review of the patient final reports included, as a foot note on the bottom of the page, two laboratory address locations. Surveyor asked for clarification on the two addresses and the Director of Regulatory Compliance stated the laboratory's address (A) is where the microscopic description test procedure is performed, and the laboratory address (B) is where the grossing test procedure is performed. Surveyor asked for a final patient report to specify the performing location for each test result, grossing or microscopic description, and none was provided. 2. Review of patient final reports for February 2024 included the following 15 patient with a microscopic description and a tissue gross description (performed at a second laboratory location) without specification of the performing location for each test 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 -- result: Accession Date Reported S24-5350 2/15/2024 S24-5351 2/15/2024 S24-5352 2 /15/2024 S24-5353 2/15/2024 S24-5354 2/15/2024 S24-5355 2/15/2024 S24-5356 2 /15/2024 S24-5357 2/15/2024 S24-5358 2/15/2024 S24-5359 2/15/2024 S24-5360 2 /15/2024 S24-5361 2/15/2024 S24-5362 2/15/2024 S24-5363 2/15/2024 S24-5364 2 /15/2024 3. In an interview on 6/26/2024 at 11:40 hours, in the break room, the Director of Regulatory Compliance and Quality Manager confirmed that the patient final test report did not specify which location performed which test. -- 2 of 2 --