Sarasota Pathology

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview the laboratory failed to establish and follow safety procedures to ensure protection from physical, chemical and electrical hazards. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure protection from physical, chemical and electrical hazards. 2. During an interview on June 25, 2024 at 10:45 AM, when asked if the laboratory had written safety procedures to ensure protection from physical, chemical and electrical hazards that were specific to the laboratory being surveyed, the Supervisor replied "no." 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sarasota Pathology on 02 /02/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy of cytology (non-gynecological) testing twice a year for one (#A) out of two Testing Personnel (#A, #B) for 2 out of 2 years (2021 - 2022) reviewed. Findings Included: Review of the policy titled "Semi-Annual Peer Review" revised 08/25/2020 revealed: "3. Procedure a. Biannually five random specimen slides, requisitions, and pathology reports will be retrieved from the slide center b. The cases will be sent to a pathologist within the practice for evaluation of accuracy and quality." Record review for 2021 and 2022 revealed no evidence of cytology (non- gynecological) peer review records to verify accuracy were completed for Testing Personnel #A, who is also the Laboratory Director. On 02/03/23 at 12:30 PM, the Laboratory Director stated she did not know that twice annual verification of accuracy needed to be performed on cytology (non-gynecological) testing. 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 --