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 Hematoxyilin-Eosin (HE) staining from 7/23/19 to the date of the survey. The findings include: 1. The SS in the laboratory did not correspond with the staining procedure in the PM. 2. The observation of the staining solutions and reagents were as follows: Scotts blueing, Hematoxylin, Acid alcohol, 95% alcohol, "unlabeled" staining jar, for stations one through five. 3. The PM stated Hemotoxylin, Water Rinse, Acid Alcohol, Water Rinse, Scotts Bluing solution, for stations one through five. 4. The TP confirmed on 7/26/22 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 --