Summary:
Summary Statement of Deficiencies D0000 The Specialty Care Inc United Hospital Surgery/Perfusion 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 21, 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 initial and/or semiannual competency assessments for two of three testing personnel (TP) hired in 2024 and four of four TP hired 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 12:04 p.m. on 5/21/26. 2. An Abbott iStat device and a Medtronic HMS+ blood gas analyzer were observed as present and available for use during the tour. 3. The TCs were required to perform initial training and semiannual competency assessments for TP as established in the Competency Assessment - POC Laboratory policy found in the Sharepoint software. 4. Competency assessments were performed by TC1, TC2, and TC3 as indicated in the competency assessment documents found in personnel files. The laboratory was unable to provide the missing competency assessment documents upon request. See below. Initial 6 month TP3 -- -- TP4 -- -- TP6 06/25 -- TP7 07/25 -- TP8 06/25 -- TP9 06/25 -- 5. In an interview at 1:29 p.m. TC1 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 --