Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 surveyor review of the Procedure Manual (PM), observation of Staining Station (SS) and interview with the Testing Personnel (TP), the laboratory failed to follow the PM for "H&E staining protocol" from 1/29/24 to the date of the survey. The findings include: 1. The PM stated step 1 "Alcohol 100% 7-10 seconds" but the SS had 95% alcohol 2. The PM stated step 9 "Alcohol 100% 5 dips" but the SS had 95% alcohol 3. The TP confirmed on 10/18/24 at 1:30 pm that the laboratory did not follow the PM. 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 --