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, the Rhesus Factor Test Log (RFTL) Final Report and interview with the Office Manager (OM), the laboratory failed to follow the RFTL policy from March 2018 to the date of survey. The findings include; 1) The RFTL procedure states to record Rhesus Factor (RH) results in the right hand column of the RFTL as positive or negative. 2) A review of the RFTL revealed on 3/23/18, accession # 45732 had a RH results recorded as a check for positive. 3) A review of the RFTL revealed on 7/2/18, accession # 1974 had no RH results recorded. 4) The OM confirmed on 7/26/18 at 11:00 am that the laboratory did follow the RFTL procedure. 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 --