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 surveyor review of the Procedure Manual (PM), the lack of Data Entry Verification Reports (DEVR) and interview with the Laboratory Director (LD), the laboratory personnel failed to follow the PM for Data Entry Verification from 5/1/23 to 4/29/25. The findings include: 1. The PM states "verification of the manually entered results in the LIS is performed on a quarterly basis in accordance with the Data Entry Verification SOP. Results of these verification studies and