Summary:
Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure quality control (QC) material was being performed every eight hours for four of four months reviewed (January 2017, February 2017, May 2017, and January 2018). The findings include: The record review on 2/20/18 of the quality control documentation for Prothombin testing showed QC was not performed every 8 hours of operation for the following dates: January 2, 3, 9, 10, 16, 17, 23, 24, 30, and 31 of 2017 February 1, 7, 8, 10, 13, 15, 18, 21, 22, and 28 of 2017 May 2, 9, 10, 16, 17, 19, 23, 24, 30, and 31 of 2017 January 2, 3, 9, 10, 16, 17, 23, 24, 30, and 31 of 2018 The 2/20/18 interview with the Technical Supervisor at 1:08pm confirmed QC was only performed twice on those dates when QC should be performed three times daily. 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 --