Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 11/14/2023 and concluded on 11/14/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 facility documentation, record review, and staff interview, the Laboratory Director/Technical Consultant failed to ensure initial training of testing personnel (TP) occurred for 1 (TP #23) of 23 TP listed on the CMS-209. Findings included: A review of "Quality Assessment Policies and Procedures," dated 10/30/2015, revealed under a training section, "Laboratory testing personnel will be trained in the performance of the tests they are authorized to perform" and "Personnel performing moderately complex tests are evaluated semi-annually during their first year of employment. They should be evaluated 6 months after beginning to perform moderate testing." Review of a completed Form CMS-209 on 11/14/2023 at 10:30 AM revealed TP #23 performed general chemistry and hematology testing. Review of proficiency testing (PT) records revealed TP #23 signed an attestation and performed hematology and general chemistry PT testing on 11/10/2023. During an interview on 11/14/2023 at 1:15 PM, the Technical Consultant stated she was responsible for training and competency of all employees, new and old. She acknowledged the laboratory failed to provide documentation of TP #23's initial training before TP #23 performed testing and reporting of test results. 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 --