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 (PM) and interview with the Technical Supervisor (TS), the laboratory failed to establish a detailed procedure for reviewing results with Morphology flags obtained on the Horriba Pentra XL analyzer used for Hematology tests from 12/7/16 to the date of survey. The findings include: 1. The PM stated to follow "laboratory procedures" for Morphology flags but the laboratory did not have a documented procedure to follow. 2. The TS confirmed on 12 /6/18 at 12:10 pm the PM did not have a detailed procedure for Morphology flags. 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 --