Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 11/16/2023. The laboratory was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on policy review, document review, and interview, the Laboratory Director (LD)/Technical Consultant (TC) failed to evaluate testing personnel (TP) competency for four (4) of nineteen (19) TP's in 2021 and/or 2022 (TP #7, #11, #13, and #15). The findings include: Review of an undated laboratory policy titled, "Employee Evaluation Policy" revealed, "It is the policy of [facility name], that each employee who performs any non-waived lab testing will be evaluated by the technical supervisor." In addition, review revealed "After the first year, there will only be annual evaluations done." Review of a document titled "[Facility name] - Active Clinical Employees as of 11/16/2023," revealed the date of hire for the following TP personnel: -TP #7 09/17/2019 -TP #11 08/09/2012 -TP #13 09/20/2016 -TP # 15 05/10 /2011 Further review revealed competency assessments for performance of complete blood counts and neonatal bilirubin were not found for the following calendar years for the four (4) employees: -TP #7: 2021, 2022 -TP #11: 2021, 2022 -TP #13: 2022 - TP #15: 2021, 2022 During an interview on 11/16/2023 at 10:25 AM, the TC stated TP #7, TP #11, TP #13, and TP #15 were pro re nata (PRN-as needed) employees and their competency assessments had not been performed. 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 --