Summary:
Summary Statement of Deficiencies D0000 An initial survey was performed on July 16, 2025. The facility was found to be NOT in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1219 - Condition: Histopathology D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Histopathology records and laboratory personnel interviews, the laboratory failed to ensure positive identification of a patient's Mohs specimen (Refer to D5203); failed to establish QA policies and procedures and failed to document QA activities (Refer to D5291, D5391, D5791 and D5891); failed to establish policies for slide labeling (Refer to D5311); failed to ensure the Mohs test procedure included control procedures,