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), Patient work records and interview with the Technical Consultant (TC), the laboratory failed to follow their PM policy for "Act Diff #2 Flags and Codes" for Hematology tests run on the Beckman Coulter AcT diff 2 in the calendar year 2017. The finding includes: 1) The PM stated "All CBC's with flags and codes must be sent to reference lab" a) A review of 10 Patients work records revealed that five out of ten patients results with flags were not sent to a reference laboratory. 2) The PM stated for "XXX Aperture Alert: Invert tube and rerun. If flag does not appear, report result. Otherwise send out to reference lab." a) Patients 57163, 57174, 57173, 57175, 57171 had "XXX aperture Alert" flags and were not rerun. 3) The TC confirmed on at 11:00 am the above mentioned procedures were 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 --