Sylvan Dermatology Llc

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 lack of documentation and interview with the laboratory director (LD), the laboratory failed to ensure that the verification of accuracy for MOHS micrographic surgery slide examinations was performed at least twice annually in 2021. Findings Include: 1. On the day of the survey, 03/13/2023 at 09:30 am, the laboratory could not provide documentation that the verification of accuracy for MOHS micrographic surgery slide examinations was performed at least twice annually in 2021. 2. The laboratory performed 2 MOHS micrographic surgery slide examinations in 2021. 3. The LD confirmed the finding above on 03/13/2023 around 10:30 am. 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 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 laboratory procedure manuals and interview with the laboratory (LD), the laboratory failed to establish a competency assessment procedure to assess 1 of 2 testing personnel (TP) and 1 of 1 consultant/supervisor competency in 2021. Findings include: 1. On the day of survey, 03/23/2021, the LD could not provide a competency assessment procedure to assess the competency for 1 of 2 TP and 1 of 1 consultant/supervisor competency in 2021. 2. The LD confirmed the findings above on 03/23/2021 around 9:10 am. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of records and interview with laboratory director (LD), the laboratory failed to document QC procedures each day of patient testing for 6 of 6 patient specimens examined for Potassium hydroxide (KOH) microscopic 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 -- examinations from 1/5/2021 to 03/20/2021. Findings Include: 1. On the day of survey, 03/23/2021, the LD was unable to provide QC records performed each day of patient testing for 6 of 6 KOH microscopic examination performed from 1/5/2021 to 03/20 /2021. 2. One patient was examined for KOH microscopic examinations on each of the follow days: 01/05/2021, 02/05/2021, 02/12/2021, 02/26/2021, 03/12/2021 and 03 /20/2021. 3. The LD confirmed the findings above on 03/23/2021 around 9:20 am. -- 2 of 2 --