Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/12/2023 found the DERMATOLOGY GROUP OF FLORIDA, PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, record review and interview the laboratory failed to monitor the Xylene and Formaldehyde exposure for 1 out of 2 years reviewed (2021 and 2022). The laboratory failed to effectively control the exposure to Xylene for the staff in 2022. Findings include: -During the arrival of the surveyor on site on 01/12/2023 at 10:30 AM, the surveyor noted a strong odor for a chemical product. During the permanence of the surveyor onsite for 4 hours, she could sense the permanence of the strong chemical odor. -Review of exposure measure for 2021 and 2022 revealed the following: -The laboratory failed to perform exposure measurement during 2021 for Xylene and Formaldehyde. -The Xylene report for exposure measurement established an aceptable level as below 100 ppm in 8 hours as per OSHA requierement. -The report of the laboratory exposure measurement for two staff performed on 12/15/2022 showed that the level for Xylene exposure for two employees were outside of the acceptable range: Staff A level was 189 ppm and for Staff B was 147 ppm in 8 hours. During an interview on 01/12/2023 at 3:30 PM, the risk manager confirmed that the laboratory failed to effectively control the Xylene exposure and that the values obtained in December 2022 were above the aceptable range. 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 --