Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CARLOS RICOTTI PA on June 17, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: 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 on record review and staff interview, the laboratory failed to list the complete laboratory name in the final report for three out of three patient reports reviewed from April 9th, 2025 to November 11,2025 for the interpretation of Hematoxylin and Eosin stain. Findings Included: 1-Review of three patient reports in the following dates: Patient #1 (P#1) (04/09/2025), P#2 (04/16/2025) and P#3 (11/11/2025), revealed that the reports for the three patients failed to include the correct laboratory name. 2- During an interview on 06/17/2026 at 11:30 AM, The Risk Management representative confirmed that the reports of the laboratory failed to include the complete name of the laboratory that performed the Hematoxylin and Eosin stain interpretation in Frozen sections. 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 --