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 hematology Medonic procedure and interview with the technical consultant the laboratory failed to follow procedure for hematology quality control. Findings: 1. Review of Medonic hematology quality control procedure states "if either control is greater than 2 SD from the established mean. Obtain a fresh control specimen. If both old and new control values are unacceptable, troubleshoot the problem and notify the supervisor." 2. Review of quality control showed on 11/16/19 WBC low control was not within acceptable limits. The quality control was repeated three times and then the analyzer was cleaned. 3. Interview with the technical consultant on January 16, 2019 at 12:00 PM confirmed the laboratory failed to follow procedure for hematology quality control that is not within acceptable limits. 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 --