Skin And Cancer Associates Llp

Summary Statement of Deficiencies D0000 A recertification survey conducted on 9-30-2020, found that Skin and Cancer Associates LLP clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations and interviews, the laboratory was found to have expired Eosin 1% Alcoholic reagent in the biosafety cabinet. Findings Included: Observation of Histopathology Room revealed a biosafety cabinet that had Eosin 1% Alcoholic reagent that expired on 7-17-2020. An interview on 9-30-2020 at 10:15am, with the office manager confirmed that Eosin 1% Alcoholic reagent expired on 7-17 -2020. 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 D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the open dates for reagents used in their Hematoxylin & Eosin (H&E) stains from 8/22/16 to 8 /22/18, and failed to retain the reagent logs for 2017. Findings: Record review of the laboratory's "Chemical Substance Log" showed that the laboratory failed to record when the reagents for their H&E stains were opened, and that they did not have the reagent logs for 2017. The laboratory maintains separate reagent logs for Alcohol 100%, Hematoxylin III Gills, Eosin Y Stain, Histo Clear, and Alcohol/Histo clear During an interview on 8/22/18 at 10 AM, Testing Personnel C acknowledged that the laboratory did not record open dates for reagents used in their H&E stains, and that the reagent logs 2017 were lost. 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 --