Dermatology Group Of Florida, Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at DERMATOLOGY GROUP OF FLORIDA, PA from 02/21/2025 to 02/24/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on random patient reports review and staff interview, the laboratory failed to ensure that the patient report listed the name of the laboratory that performed the testing for four out of four patient's reports reviewed. Findings include: Review of four final patient reports: P#1(dated 11/03/2023), P#2 (dated 03/25/2024), P#3 (dated 10/15/2024) and P#4 (dated 02/10/2025), revealed that the reports failed to list the name of the laboratory that performed the histopathology testing. During an interview on 02/21/2025 at 11:30 AM, with the laboratory histotechnician, he confirmed that the final report reviewed did not include the name of the laboratory that performed the histopathology testing for the test reports reviewed. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory personnel, the laboratory had expired reagents in use in the laboratory. Findings include: The surveyor observed at 12:00 p.m. on 09/13/18 that the one bottle of eosin and the one bottle of hematoylin that were in the flamable cabinet had expired. Lot # 050589 or Gill 3 Hematoxylin expired 06/18 and lot # 41312 expired on 09/18. During an interview with the office manager at 12:45 p.m., she confirmed that the reagents were expired. 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 --