Summary:
Summary Statement of Deficiencies D0000 The Southbridge - St. Francis Urgent Care laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the validation survey performed on May 27, 2026. The following standard-level deficiencies were cited: 493.1413 Technical consultant responsibilities . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the technical consultants (TC) failed to perform semiannual and annual competency assessments for one of three testing personnel (TP) in 2025. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry and Hematology testing as confirmed by TC2 during a tour of the laboratory at 12:32 p.m. on 5/27/26. 2. The following items were observed as present and available for use during the tour: Abbott iStat chemistry testing device Sysmex XS-1000i hematology analyzer Olympus BX43 microscope for urine microscopic exam 3. The TCs were required to perform semiannual and annual competency assessments for TP as established in the Competency Assessment Instructions policy found in the OnBase software. 4. Annual competency assessments were found for TP2 and TP3. A 2025 annual competency assessment was not found for TP1. Additionally, a semiannual competency assessment was not found for TP1. 5. In an interview at 1:15 p.m. TC2 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 --