Summary:
Summary Statement of Deficiencies 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 with the Mohs Technician (MT), the Laboratory Director (LD) failed to approve, sign and date the procedure manual prior to patient testing for 3 (October 2025 - December 2025) of 4 months reviewed. Findings include: 1. Review of the laboratory's procedure manual revealed the Laboratory Director signed the procedure manual on 1/9/2026. 2. An interview with the MT on 1/15/2026, at 12:00 pm, confirmed the procedure manual was implemented with patient testing in October 2025 without LD signature or date, and remained unsigned for three months, until 1/9/2026. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician (MT), the laboratory failed to ensure that histopathology reports were signed by the individual performing the interpretation for 8 (P1-P8) of 8 patient test reports reviewed. Findings include: 1. Review of 8 histopathology Mohs maps revealed a lack of signature by the 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 -- interpreting provider: a. P1 Hematoxylin and Eosin (H&E) tissue examination was performed on 10/01/2025 b. P2 H&E tissue examination was performed on 10/22 /2025 c. P3 H&E tissue examination was performed on 11/02/2025 d. P4 H&E tissue examination was performed on 11/26/2025 e. P5 H&E tissue examination was performed on 12/17/2025 f. P6 H&E tissue examination was performed on 12/31 /2025 g. P7 H&E tissue examination was performed on 01/14/2026 h. P8 H&E tissue examination was performed on 01/14/2026 2. Interview with the MT on 1/15/2026 at 12:00 pm confirmed the histopathology Mohs maps were not signed by the individual performing the interpretation. -- 2 of 2 --