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 review of the laboratory's personnel competency policy, review of personnel records, and phone interview with TC(technical consultant)1/25/21 and 1/27/21 , the technical consultant failed to evaluate the competency of 4 of 7 TP(testing personnel) for testing performed on the Hemocue WBC analyzer. Findings: The laboratory's Personnel Competency Policy states under Employee Competency Assessment Plan, "a. Non-Waived Testing: The competency of each person to perform each testing platform must be assessed initially, at 6 months, at 12 months, and annually thereafter for non-waived testing by the Technical Consultant or Lab Director." Review of personnel records revealed there was no competency assessment documentation for Hemocue WBC for TP#3, TP#4, TP#5, and TP#6 in 2018, 2019, and 2020. Review of personnel records also revealed initial training was completed again for Hemocue WBC on 11/24/20 for TP#3, TP#4. TP#5, and TP#6. During phone interview at approximately 3pm 1/25/21, the TC confirmed the 4 TP were testing and reporting patients for Hemocue WBC. She stated that it appeared the former TC failed to assign the competency assessments for Hemocue WBC in MediaLab when the laboratory moved from paper format to electronic format in 2018. During phone interview at approximately 9:45am 1/27/21, the TC confirmed the TP's competency assessments were available in MediaLab from 2018 to 2020 for all other non-waived testing except for the Hemocue WBC. 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 --