Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/20/22 at Delray Dermatology LLC, a clinical laboratory in Delray Beach, Florida. Delray Dermatology LLC is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 observation, record review, and interview the laboratory failed to store 100% Reagent alcohol according to the manufacturer's instructions. The findings included: During a tour of the laboratory on 09/20/22 at 1:00 p.m., 4 boxes that contained 4-1 gallon bottles of 100% Reagent alcohol was seen stacked up beside of the cryostat. Also observed was a 5 gallon and 10 gallon waste container in front of the boxes of 100% Reagent alcohol that contained 100% Reagent alcohol. Review of Mercedes Scientific safety data sheet for 100% Reagent alcohol revealed that the storage conditions was to "Store in an approved Flammable Liquids storage area." Interview on 09/20/22 the Laboratory Manager confirmed that the 100% Reagent alcohol was stored outside of the flammable cabinet. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to verify the accuracy of testing at least twice a year for 1 (2021) out of 2 years (2020-2022) reviewed for Histopathology. The findings included: Review of Quality Assurance (QA) peer reviews from 07/2020 to 09/2022 revealed that there was no documentation of any performed in 2021. Interview on 09/20/22 at 1:00 PM the Laboratory Manager confirmed that there were no peer reviews to verify the accuracy of testing in 2021. -- 2 of 2 --