Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on July 29, 2025, deficiencies were cited for Forefront Dermatology, SC in Castle Rock, Colorado. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory policies and procedures manual, and an interview with the Mohs lead technician (not included on CMS-209 form), the laboratory failed to establish a written policy or procedure for their MART-1 immunohistochemical (IHC) stain. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to have a written policy or procedure for their MART-1 IHC Stain. 2. An interview with the Mohs lead technician (not included on CMS-209 form) on July 29, 2025, at approximately 11:00 AM, confirmed that the laboratory failed to establish a written policy or procedure for their MART-1 IHC stain since the procedure was implemented in March of 2024. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's Quality Control (QC) log and an interview with the Mohs lead technician (not included on CMS-209 form), the laboratory failed to document their MART-1 immunohistochemical (IHC) stain QC results on each day of use since the laboratory began performing the procedure in March of 2024. Findings include: 1. A review of the laboratory's QC log revealed that the laboratory failed to document MART-1 QC results since the laboratory began performing the procedure in March of 2024. 2. An interview with the Mohs lead technician (not included on CMS-209 form), on July 29, 2025 at approximately 11:00 AM, confirmed that the laboratory performed MART-1 IHC stains but failed to document the QC results on each day of use. -- 2 of 2 --