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 procedure manual review and interview with the technical consultant (TC), the laboratory did not ensure that the procedure for reviewing hematology quality control (QC) accurately reflected the current practice in the laboratory. Findings: 1. The procedure, "Quality Control Policy and Procedure" "Control Review" states that the "Team leader should review Quality Control daily and ensure that all Quality Control is within the acceptable ranges and that if it is outside the acceptable ranges