Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures for Cryostat, a review of the Equipment Quality Control (QC) records, and interviews with laboratory staff, the laboratory failed to follow written procedures for Cryostat QC. Survey findings include: A. The laboratory Equipment Quality Control Form 3 Cryostat and Microtome use protocol states: " Cryostat thermometer check is done quarterly ". B. A review of the Frozen Lab Quality Control Log records for the year 2025 showed no documentation of quarterly thermometer checks performed. C. In an interview, at 11: 40am on 7/23/26, the technical consultant confirmed that no documentation of quarterly thermometer checks performed for 2025. 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 --