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 upon observation, review of policy and procedure, review of quality control (QC) reports for complete blood cell analysis (CBC), lack of documentation, and interview with laboratory staff,the laboratory procedures for QC and