Aqua Dermatology Of Florida Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Waters Edge Dermatology LLC on 07/15/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Coordinator, the laboratory failed to evaluate the accuracy of the subspecialty parasitology Scabies testing at least twice a year for 2 out of 2 years (2018-2020) reviewed. Findings Included: Record review of the laboratory's policy and procedure revised 1/15/2014 for "Verification Testing KOH Prep" revealed the laboratory "will perform a 6 month verification of KOH prep reading at 6 month intervals for every provider for all sub-specialties...If there is no sub-specialties testing to be performed during this period for specific locations then testing materials will be brought in from another location, so that verification testing for each provider can be performed". Review of records for Scabies testing revealed no documentation for the verification of accuracy was available for 2018-2020. Interview on 07/15/20 at 11:20 a.m. with the Lab Coordinator, confirmed that verification of accuracy records for Scabies testing were not available for review. She also stated she did not know that the 6 month verification of accuracy had to be performed even if patients were not tested. 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 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 and interview with the Lab Specialist, the laboratory failed to dispose of the Eosin Y, Hematoxylin, Clear-Rite, and the alcohol per the disposal instructions on the label of the reagents for two of two (2017-2018) years reviewed. Findings Included: A tour of the laboratory on 06/28/18 at 12:00 PM, revealed the Eosin Y, Hematoxylin, Clear - Rite, and alcohol reagents had label instructions that documented "Dispose of contents/container to an approved waste disposal plant." On 06/28/18 at 12:10 PM, the Lab Specialist stated that the Eosin Y, Hematoxylin, Clear- Rite, and the alcohol was disposed of down the drain of the sink with lots of water. 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 --