Dermatology Associates Of Tampa Bay, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at John L Millns MD PA on 04/17/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 Administrator, the laboratory failed to perform competency assessment for two out of two years (2021 - 2022) for one Testing Personnel (#B) out of two Testing Personnel (#A and #B). Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 04/14/2023 revealed the Laboratory Director was also the Technical Consultant and there was one additional Testing Personnel (#B). Review of staff records revealed Testing Personnel #B had been performing testing at the laboratory for the past two years with no evidence of competency evaluations during this two year timeframe (2021 - 2022). During interview on 04/17/2023 at 11:22 AM, the Administrator confirmed competency assessment had not been completed. 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 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 review of peer review records and interview with the Administrator, the laboratory failed to ensure the accuracy of potassium hydroxide (KOH) and scabies testing for 1 out of 4 testing personnel (#D) twice a year for 2 of 2 (2017-2018) years reviewed in the subspecialty of Mycology and Parasitology. Findings Included: Review of peer review records revealed that Testing Personnel #D had performed no peer reviews in 2017 for KOH or scabies and only one peer review for KOH in 2018 (4/27/2018). Interview on 01/10/2019 at 11:50 AM. with the Administrator confirmed that Testing Personnel #D had not performed peer review for KOH and scabies in 2017 and had only performed peer review once for KOH in 2018 (4/27/2018). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of employee competency records and interview with the Administrator, the Technical Consultant failed to perform competency evaluations on 1 of 4 Testing Personnel (#D) who performed potassium hydroxide (KOH) and Scabies testing in the subspecialties of Mycology and Parasitology for 2 of 2 (2017- 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 -- 2018) years reviewed. Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the lab director on 1/3/2019 revealed Testing Personnel #D performed moderate complexity testing. Review of employee competency records revealed no competency evaluations were present for Testing Person #D who performed KOH and Scabies testing. On 01/19/2019 at 10:15 AM, the Administrator confirmed that there was no documented competency evaluations for Testing Person #D. -- 2 of 2 --