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 a procedure manual review and an interview with the laboratory manager, the laboratory failed to establish in writing a procedure to ensure positive identification of specimen and integrity of the patient's specimens for the pre-analytic and post-analytic test system requirements for bacteriology tests performed on the MicroProbe Affirm VP since the last survey on July 17, 2017. Findings: 1. A review of the laboratory procedure manual for the Affirm VP revealed the laboratory failed to establish in writing a procedure for the pre-analytic phase of testing to include patient specimen preparation, collection, submission, labeling, storage, processing, and acceptability requirements. 2. A review of the laboratory procedure manual for the Affirm VP revealed the laboratory failed to establish in writing a procedure for the post-analytic phase of testing to include test reporting,