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 review of the Beckman Coulter DxH 520 hematology analyzer operator's manual, laboratory policy, random review of patient test records (04/11/2024-04/12 /2024), and staff interview, the laboratory failed to follow its own policy to ensure the provider received patient results at the time of service when Complete Blood Counts (CBC) had histogram flagged results for four of ten patients. The findings include: 1. A review of the Beckman Coulter DxH 520 CBC hematology analyzer (serial # BG050284) operator's manual stated the following, "Risk of erroneous results. Flags, codes, and messages are evaluated when the sample is analyzed. Review the results and pay close attention to any flags, codes, or messages that are intended to alert you to issues with results or with the instrument... Some flagging occurs as a result of the flagging or editing of other parameters. In all cases, follow your laboratory's policy for reviewing results." 2. A review of the procedure titled "Abnormal WBC Differential Counts-Instrument Flags" revealed the following statement, "When the analyzer flags a result, the CBC will be rerun to verify the flag. Manufacturer instructions/suggestions will be followed for any remaining flags on the retested result. After exhausting the