Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 1, 2025. Endocrinology of Central Florida was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to maintain daily quality control (QC) slide documentation for Cytology stains for two days out of three months reviewed in 2024 (8/7/24 & 9/4/24). Findings include: Review of QC documentation showed no record for the quality of the Cytology stains used during Fine Needle Aspiration Biopsy on 8/7/24 (3 patients tested) and 9/4/24 (3 patients tested). Interview with the Nurse Manager on 4/1/25 at 10:35 AM confirmed that the documentation was missing. 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 --