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 interviews with the MOHs Histotechnician (MH) and the MOHs processor (MP) #1, the Laboratory Director failed to ensure that policies and procedures for MOHs procedures in the specialty of Histopathology were approved via signature and date upon the change in directorship on 12/11/2024. This deficient practice had the potential to affect 1,125 out of 1,125 patient MOHs testing procedures performed between 12/11/2024 through 04/17/2025. Findings Include: 1. Review of the laboratory's CMS-209 and CLIA certificate number in ASPEN CMS- 116 revealed a change of directorship on 12/11/2024 to the current Laboratory Director. 2. Review of the laboratory's policies and procedures provided on the date of the inspection, revealed the Laboratory Director's approval, via signature and date, for the laboratory's policies and procedures, were approved on 03/18/2025. 3. The MH and MP confirmed the Laboratory Director did not approve any of the laboratory's policies and procedures via signature and date upon the change of directorship on 12 /11/2024. The interviews occurred on 04/17/2025 at 9:35 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 --