Summary:
Summary Statement of Deficiencies D0000 Premier Dermatology of Florida clinical laboratory was found to be in non- compliance with the 42 CFR Part 493, Requirements for Laboratories. Initial certification survey was conducted January 25, 2019. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the stain quality control results for Hematoxylin and Eosin (H & E) stain for 5 out of 5 months of patient testing reviewed. The findings include: Review of a sample of five patients' H & E (Hematoxylin and Eosin) stain test results from five different days and corresponding quality control documentation for the H & E stain showed that quality control documentations were missing. Five samples chosen randomly showed no H & E quality control results were recorded from August 2018 through January 2019. Interview with the Histology Technician on 1/25/19 at 10:30 AM, confirmed that the quality control for patient slides H & E stain were not documented. 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 --