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 Techincal Consultant (TC), the laboratory failed to follow their procedure for "Error Flags" from 1/10/22 to the date of survey. The finding include: 1. The "Error Flags" states "If an asterisk or flag appears net to any CBC parameter, the CBC results are unreliable and must be sent to OMC for analysis". 2. Two out of five patient results had an analyte flagged with and AG. 3. There was no documented evidence that the patient sample was sent out to the reference laboratory. 2. The TC confirmed on 2/22 /22 at 11:21 am the policy "Error Flags" was not being 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 --