Bay Dermatology And Cosmetic Surgery Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 06/26/2025. 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 staff interview, the laboratory failed to evaluate the accuracy of testing twice annually for fungi and ectoparasites for two of two years 2023 and 2024 for three of three testing persons (TP #A, B, C). Findings included: 1. The laboratory's Quality Assurance of KOH and Ectoparasite policy, issued 11/10 /2005 was reviewed. The policy stated, "this policy and procedure is to ensure the continued quality performance and results of KOH (fungi) and Ectoparasite procedures and results." The procedure stated, "A program has been set-up to review 1% of the results semi-annually by a dermatologists... All cases that are reviewed are documented on the appropriate review sheet and signed by the reviewing dermatologist." 2. Quality Assurance documentation related to evaluating the accuracy of fungi and ectoparasite testing was reviewed for TP #A, B, and C for 2023 and 2024. None of the TP had completed accuracy evaluations for either test for 2023 or 2024. 3. Interview with the Lab Director on 06/26/2025 at 12:15 p.m., revealed they were not aware the twice annual accuracy verifications for fungi and ectoparasites were not completed for 2023 or 2024. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 -- 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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the established quality assessment program failed to identify the laboratory failed to evaluate the accuracy of testing twice annually for fungi and ectoparasites for two of two years 2023 and 2024 for three of three testing persons (TP #A, B, C). Findings included: 1. (See D5217). 2. Quarterly Quality Assurance Checklists were reviewed from May 2023 through May of 2025, totaling 9 checklists. The checklists were signed by the Lab Director on 05/22/2025, 02/20/2025, 11/14/2024, 08/15/2024, 05/09/2024, 02/15/2024, 11/09/2023, 08/24 /2023, and the May 2023 was signed but undated. Every form documented "Y" or yes for; (A) "Proficiency test results were evaluated, failures were investigated, and

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the office staff, the laboratory failed to evaluate the accuracy of the Scabies and Potassium Hydroxide (KOH) testing at least twice a year for 2 out of 2 years (2017-2018) for the Scabies testing and KOH testing (See D5217). This is a repeat deficiency from the recertification survey conducted on 01/25/2017. 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 review of employee competency records and Laboratory Personnel Report (CMS -209), and interview with the Office Manager, the laboratory failed to perform competency evaluations on 2 of 2 Testing Personnel (#B for 2017 - 2018) and (#C whose hire date was 06/2017 did not have competency evaluation for 2018) who Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- perform potassium hydroxide (KOH) and Scabies testing in the subspecialties of Mycology and Parasitology for 2 of 2 (2017-2018) years reviewed. Findings Included: Review of employee competency records and the Laboratory Personnel Report (CMS - 209) revealed no competency evaluations performed on Testing Person #B for 2017- 2018 and #C for 2018 who perform KOH and Scabies testing. Interview on 02/26 /2019 at 11:50 AM confirmed that the laboratory had competency forms but documented competency evaluations for Testing Person #B and #C were not available. 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 Office Manager, the laboratory failed to evaluate the accuracy of the Scabies and Potassium Hydroxide (KOH) testing at least twice a year for 2 out of 2 years(2017-2018) for the Scabies testing and the KOH testing. This is a repeat deficiency from the recertification survey conducted 01/25 /2017. Findings Included: Review of peer review records for Scabies and KOH revealed that documentation had not been performed for 2017-2018. Interview on 02 /26/18 at 10:50 AM the Office Manager confirmed that peer reviews were not available for review. Review of the recertification survey conducted on 01/25/2017, revealed that not performing Scabies and KOH peer review was a repeat deficiency. The