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), Quality Control records and interview with the Techincal Consultant (TC), the laboratory failed to have a complete procedure for Quality Control (QC) failures for Urinalyses, endocrinology chemistry and hematology testing from 9/14/21 to the date of survey. The findings include: 1) The PM did not state how many consecutive failed QC tests performed require