Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the laboratory's procedure, lack of documentation, and staff interviews, the laboratory failed to document maintenance as outlined in the established procedure for the cryostat instrument used to process patient tissue samples for slide examination in 2025 and 2026. The findings include: 1. Observation of the laboratory revealed the Triangle Biomedical Sciences Minotome Plus cryostat instrument used to process patient tissue samples removed during surgical procedures for slide review. 2. A review of the laboratory's procedure titled "Cryostat Maintenance, Cleaning, and Disinfecting" revealed "Day of Use Maintenance", "Weekly", and "Occasionally or when required" maintenance procedures for the cryostat instrument. 3. The laboratory did not have documentation of maintenance procedures for surveyor review on the date of the survey (06/11/2026) for 2025 or 2026. 4.An interview with the laboratory operations manager on 06/11 /2026 at 11:30 a.m. confirmed the survey findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. 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 procedures, patient operating room consultation forms, and staff interview, the laboratory failed to define the predicted characteristics of the Hematoxylin and Eosin (H&E) stain used for frozen tissue slide examination in 2025 through the survey date (06/11/2026). The findings include: 1. A review of the laboratory's procedure titled "Histology Prep Quality" revealed no definition of the predicted characteristics of the H&E stain quality. 2. A review of the laboratory's patient operating room consultation forms (Account 64939 on 10/22/2025 and Account 34647 on 05/27/2026) used to document daily quality control revealed no documentation of the predicted characteristics of the H&E stain quality. 3. An interview with the laboratory operations manager on 06/11/2026 at 11:30 a.m. confirmed the survey findings. D5781