Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 03/12/2024. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 review of the laboratory's policy and confirmed in staff interview, the laboratory failed to ensure the laboratory director (LD) had approved, signed, and dated one (1) of one (1) laboratory procedures before use. Findings include: 1. Review of the laboratory policy titled, "University of Dermatopathology Operating Procedure" revealed that the document was not approved, signed or dated by the laboratory director. 2. In an interview on 03/12/2024 at 12:30 p.m. in the administrative office, the LD was asked to confirm that the laboratory policy titled, "University of Dermatopathology Operating Procedure" was currently in use. The LD confirmed that the documents shown were the current procedure and it was not signed or dated prior to the survey. This confirmed the 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 --