Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Forefront Dermatology SC Corp dba Knight Dermatology a Forefront Dermatology Practice on March 23, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to approve, sign, and date the procedure manual before the first day of patient testing on 06/05/2025. Findings included: 1. Review of the Mohs accession log revealed, Mohs surgical procedures were performed on 06/05/2025, 06/06/2025, 07/10/2025, 07/31/2025, 09 /04/2025, 09/05/2025, 10/02/2025, and 10/03/2025. 2. Review of the Lab Director's Signature Page of the procedure manual revealed, the Laboratory Director signed the manual on 10/20/2025 3. During an interview on 03/23/2026 at 11:40 AM, the Practice Manager acknowledged the Laboratory Director signed the procedure manual on 10/20/2025 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient 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 -- testing is conducted. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to document maintenance and function checks for two (10/03/2025, 11/06/2025) of 12 (06/05/2025, 06/06/2025, 07/10/2025, 07/31/2025, 09/04/2025, 09/05/2025, 10/02/2025, 10/03/2025, 11/06 /2025, 11/07/2025, 12/04/2025, 12/05/2025) days that Mohs surgical procedures were performed in 2025. Findings included: 1. Review of the Mohs accession log revealed there were Mohs surgical procedures performed on 06/05/2025, 06/06/2025, 07/10 /2025, 07/31/2025, 09/04/2025, 09/05/2025, 10/02/2025, 10/03/2025, 11/06/2025, 11 /07/2025, 12/04/2025, and 12/05/2025. 2. Review of the Laboratory Daily Maintenance Log, Microscope QC log, and Room Temp/Humidity log revealed there was nothing documented for 10/03/2025 and 11/06/2025. 3. Review of the Mohs accession logs revealed there were 9 surgical procedures performed on 10/03/2025 and 10 on 11/06/2025. 4. During an interview on 03/23/2026 at 11:04 AM, the Practice Manager acknowledged the logs were not completed for those days.. -- 2 of 2 --