Aqua Dermatology Of Florida Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Naples Center for Dermatology and Cosmetic Surgery d/b/a Riverchase Dermatology on 05/20/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on American Academy of Family Physician (AAFP) proficiency record review and staff interview, the laboratory did not test proficiency testing samples the same number of times that it tests patient samples for 4 events (2018 B, 2019 A, 2019 C and 2020 A) out of 7 events reviewed (2018, A, B, C, 2019 A, B, C, and 2020 A) for the subspecialties of mycology and parasitology. Findings included: Record review of the AAFP laboratory's proficiency testing attestation records showed that 2 of 2 Testing Personnel performed 4 events on 2018 B, 2019 A, 2019 C, and 2020 A in duplicate, however, patient samples were not performed in duplicate. Interview on 5/20/20 at 11: 00 am with the Moh's Laboratory Supervisor confirmed that the laboratory does not routinely test patient samples more than once, and the proficiency testing samples for the 4 events were tested in duplicate. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 with the Moh's Laboratory Supervisor, the laboratory failed to have documentation of competency assessment for the subspecialties of mycology (fungi) and parasitology (scabies) for 2 out of 2 years reviewed (2018-2020) for Testing Personnel B. Findings Included: Review of the CMS 209 signed by the Laboratory Director on 05/20/20 revealed the laboratory had two Testing Personnel: Testing Person #A (who is also the Laboratory Director) and Testing Person #B. Review of Testing Person #B's personnel file revealed that competency assessments had not been performed for 2 out of 2 years (2018-2020). Review of the Quality Assurance procedure revealed that, "In addition, a detailed competency evaluation will be included in their annual evaluation." On 05/20/20 at 11: 40 AM, the Moh's Laboratory Supervisor confirmed that there were no competency assessments for Testing Personnel #B. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Clinical Administrator the laboratory failed to perform a competency evaluation on 1 out of 1 ARNP (Advanced Registered Nurse Practitioner) Testing Person in 2017. Findings Included: Review of employee records revealed no competency evaluations performed on the ARNP in 2017 who was performing Scabies and KOH (Potassium Hydroxide) testing. During an interview on 03/26/18 at 12:38 PM the Laboratory Clinical Administrator confirmed that no competencies had been performed on the ARNP. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Clinical Administrator the laboratory failed to have Quality Assurance (QA)documentation for 2 out of 2 years (2016-2018) reviewed. Findings Included: Review of laboratory records revealed no documentation that QA audits had been performed from 03/2016 to 03/2018. During 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 -- an interview on 03/26/18 at 12:38 PM the Laboratory Clinical Administrator confirmed that no QA audits had been documented. -- 2 of 2 --