Lakeside Dermatology, A Forefront Derm Practice

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 laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to perform biannual method accuracy evaluations for microscopic potassium hydroxide (KOH) wet mount testing for one of two years reviewed, 2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "KOH Examination and QC", which stated, under "Accuracy:", "1. Verification of the accuracy of the KOH prep is completed with each Provider Performed Microscopy (PPM)." 2. Review of laboratory records revealed the laboratory lacked documentation of biannual method accuracy evaluations for microscopic KOH wet mount testing for 2025. 3. Interview with the laboratory representative on 01/20/2026, at 11:57 am, confirmed the laboratory failed to perform biannual method accuracy evaluations for microscopic KOH wet mount testing for one of two years reviewed, 2025. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: 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 -- Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to perform biannual method accuracy evaluations for microscopic scabies wet mount testing for two of two years reviewed, 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Ectoparasite/ Wet Mount Examination", which stated, under "Accuracy:", "1. Verification of the accuracy of the ectoparasite prep is completed with each Provider Performed Microscopy (PPM)." 2. Review of laboratory records revealed the laboratory lacked documentation of biannual method accuracy evaluations for microscopic scabies wet mount testing for 2024 and 2025 3. Interview with the laboratory representative on 01 /20/2026, at 11:57 am, confirmed the laboratory failed to perform biannual method accuracy evaluations for microscopic scabies wet mount testing for two of two years reviewed, 2024 and 2025. -- 2 of 2 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and an interview with the laboratory staff, the laboratory failed to document each lot number of commercially prepared reagents and stains, when opened, to perform Hematoxylin and Eosin (H&E) staining procedures. Findings include: 1. The laboratory procedures manual, patients test logs, and "Got Mohs" quality control (QC) and maintenance logs for the years of 2020 and 2021 were reviewed. 2. The "Got Mohs" and patients' test logs revealed the following: Four (4) Mohs procedures dates were selected for QC and maintenance logs review: 06 /24/2020; 03/24/2021; 07/21/2021; and 09/15/2021. *The QC logs failed to include the documenting of the reagents and stains it brings to the laboratory for tissue processing for the above dates. 3. The laboratory failed to ensure the travel Mohs service provided the laboratory with the list of reagents, their lot numbers and expiration dates, when brought by the "Got Mohs" TP into the laboratory to perform H & E staining. 4. On a Recertification survey conducted on 12/16/2021 at 12:15 PM, the Staff X1 confirmed the above findings. 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 --