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 surveyor review of the Procedure Manual and interview with the Technical Consultant, the laboratory failed to follow the "Flag Procedure" for flags obtained on Hematology tests performed on the Beckman Coulter Act Diff analyzer from 1/2/19 to the date of the survey. The finding includes: 1. The PM stated to repeat samples with flags but there was no documented evidence four out of four flagged samples were repeated. 2. The TC confirmed on 2/27/19 at 10:50 am that the Flag Procedure was not followed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --