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 document review and interview with laboratory personnel, the technical consultant (TC) failed to evaluate testing personnel for competency in all moderately complex test procedures performed by the laboratory in 2017. Findings are as follows: 1. The laboratory performed Hematology testing using the Beckman Coulter AcT Diff 5 system as confirmed by the TC during a tour of the laboratory on 04/18/19, at 10:05 a.m. 2. Review of personnel records indicated 1 of 2 testing personnel were not evaluated for competency on the Beckman Coulter AcT Diff 5 system in 2017. The laboratory was unable to provide the missing competency assessment documents upon request. 3. In an interview on 04/18/19, at 10:55 a.m., the TC confirmed the above findings. 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 --