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 record review and staff interview the laboratory failed to follow written procedures for reporting analyzer flagged complete blood count (CBC) results. Findings include: 1. Record review on 5/23/19 of the laboratory's procedure "Doc# ONC-20003: Results review and flagged results on the Sysmex XP-300" revealed: a. CBC results flagged by the Sysmex analyzer are required to be repeated. b. If the flag remains in the repeat analysis the result(s) need to be reported with a flag comment to alert the ordering physicians that the results need to be interpreted with caution. 2. Record review of the laboratory's