Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Ameripath Florida Llc on 3/10/26. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that reagents were not used after their expiration date for 66 patient tests performed between June 19, 2025, and July 31, 2025, when a bottle of Hematoxylin stain was utilized for patient testing for approximately six weeks past its recorded expiration date. Findings include: 1. A review of the laboratory document for June 2025 titled "Frozen Section H&E Stain" revealed Hematoxylin (lot number 7689) had an expiration date of 6/18 /2025. A review of the July 2025 log for "Frozen Section H&E Stain" confirmed the same lot number (#7689) remained in use for patient testing throughout that month. 2. A comparative review of the document titled "Frozen Section Log" (the primary record of patient testing) confirmed that 15 patients were tested using the expired reagent between June 19, 2025, and June 30, 2025. An additional 51 patients were tested using the same expired reagent during the month of July 2025, for a total of 66 patient specimens potentially affected by the use of an expired stain. 3. In an interview on 3/10/2026 at 10:30 AM, the General Supervisor confirmed that the documentation indicated the Hematoxylin stain was expired during the aforementioned testing periods. 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 --