Dermatology Associates Of Palm Beaches Pllc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of Palm Beaches PLLC on 8/13/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 it was determined the laboratory failed to ensure protection from chemical hazards. Findings include: 1. On 8/13/25 at 9:20 AM, Plantinumline 95% Reagent Alcohol lot 2219211 expiration date 1/11/2025 was observed stored in the cabinet under the sink instead of in the flammable safety cabinet. There was signage on the wall for all reagents to be stored in the flammable cabinet. 2. The laboratory failed to have a fume hood or air quality monitoring device to ensure protection from chemical hazardous fumes from the reagents (95% alcohol, Pro-Par Clearant, and Hematoxylin) used by the laboratory which had hazard labels for respiratory health hazard and directed to not breathe mist/vapors/spray. 3. The Risk Manager at 9:20 AM, stated the 95% Alcohol was to be stored in the flammable safety cabinet and that the laboratory was not aware protection from chemical hazardous fumes was required. 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 D0000 An announced recertification survey was conducted on 4/22/21 at Dermatology Associates of Palm Beaches Pllc, a clinical laboratory in Delray Beach, Florida. Dermatology Associates of Palm Beaches Pllc is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview with the Laboratory Director, the laboratory failed to perform yearly preventive maintenance on the Leica microscope used for histopathology testing for 2 years ( 2019 - 2020 ). The findings included: Direct observation on 4/22/21 at 09:20 a.m., showed that the Leica microscope had a preventive maintenance sticker that stated the preventive maintenance was due 4/19. Review of the equipment maintenance records for 2019 - 2021 showed no documentation for annual preventive maintenance done on the Leica microscope. Interview on 4/22/21 at 09:30 a.m., the Laboratory Director confirmed that the preventative maintenance had not been performed and stated that the company that performs the preventative maintenance did not come in 2020 due to covid. 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 D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documented performance evaluation for 2018 for the one testing person. Findings include: Review of personnel records on 05/02/2019 revealed that there was no documentation to indicate that a competency evaluation was performed for the one person that performed moderate complexity testing. During an interview with the laboratory director and the testing person at 10:15 a.m. on 05/02/2019, they confirmed that there was no evaluation for 2018. 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 --