Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on September 18, 2025. 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: Review of the laboratory provided CMS209, laboratory menu, personnel competency assessments, and confirmed in interview, the technical consultant failed to perform the competency assessments for one of one testing personnel performing moderate complexity testing in 2024 and 2025. The findings included: 1. Review of the laboratory provided CMS-209, and supporting documents, included one testing personnel with a hire date of 7/15/2024. 2. Review of the laboratory test menu included the following moderate complexity testing being performed by the testing personnel: Microscopic Urine Sediment Analysis CBC's performed on the Sysmex XN-L hematology analyzer 3. Review of testing personnel (TP) 1 competency assessment did not include the technical consultant's evaluation for the following competency assessment dates: 01/30/2025 - Hematology and Urinalysis 08/05/2025 - Hematology and urinalysis 4. In an interview on 09/18/2025 at 13:15, in the laboratory, TP1 confirmed the competency assessments were not performed by the technical consultant, but by personnel at a separate facility who reviewed TP1s work electronically. KEY: CMS: Centers for Medicare & Medicaid Services CBC: Complete blood count Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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: Review of the laboratory provided CMS209, laboratory menu, personnel competency assessments, and confirmed in interview, the technical supervisor failed to perform the competency assessments for one of one testing personnel performing high complexity testing in 2024 and 2025. The findings included: 1. Review of the laboratory provided CMS-209, and supporting documents, included one testing personnel with a hire date of 7/15/2024. 2. Review of the laboratory test menu included the following high complexity testing being performed by the testing personnel: CBC manual differential; high complexity, to include the identification of immature cells. 3. Review of testing personnel (TP) 1 competency assessment did not include the technical consultant's evaluation for the following competency assessment dates: 01/30/2025 - Hematology 08/05/2025 - Hematology 4. In an interview on 09/18 /2025 at 13:15, in the laboratory, TP1 confirmed the competency assessments were not performed by the technical supervisor, but by personnel at a separate facility who reviewed TP1s work electronically. KEY: CMS: Centers for Medicare & Medicaid Services CBC: Complete blood count -- 2 of 2 --