Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of competency assessment records, laboratory records, email and interview with the Laboratory Director, who is the Technical Consultant, the Technical Consultant's evaluation of competency for two of two testing personnel in 2018 and nine of nine testing personnel in 2019 was not specific to the UW Health Beaver Dam location and the competency assessment forms do not document testing personnel competency with the current hematology analyzer at the UW Health Beaver Dam location. Findings include: 1. Review of competency assessment records for 2018 and 2019 showed no evaluation of competency specific for the UW Health Beaver Dam location for two of two testing personnel in 2018 and nine of nine testing personnel in 2019. 2. Review of the competency assessment records for 2018 and 2019 showed the hematology analyzer as the Sysmex XS1000i hematology analyzer. 3. Review of laboratory records showed the laboratory performs hematology testing on the Sysmex XN450 hematology analyzer as of July 2, 2018. 4. Email correspondence from the Laboratory Director, who is the Technical Consultant, received on September 24, 2020 at 1:49 PM stated the initial training for testing personnel was performed in April 2018 for the Sysmex XN450 and competency training was completed in the fall for the XN450. 5. Interview with the Laboratory Director, who is the Technical Consultant, on September 23, 2020 at 10:20 AM, confirmed the Technical Consultant's evaluation of the testing personnel competency was not specific to the testing location. Further interview confirmed the hematology competency documentation did not accurately reflect the hematology analyzer used with the competency evaluation at the testing location. 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 --