Summary:
Summary Statement of Deficiencies D0000 An announced CLIA intial certification survey was performed at the Western Upper Pennisula Health Department on August 03, 2022, by a Centers for Medicare and Medicaid Services (CMS) CLIA federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The specific deficiencies are as follows: D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (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 a review of competency assessment policy and procedures, lack of documentation, and staff interviews, the technical supervisor (TS) failed to document the initial and 6- month competency assessment for the general supervisor (GS) for the Panther Fusion Hologic testing system and Abbott Architect ci 4100 test system. Findings include: 1. Competency Assessment policy states "Documented competency assessment is required for all laboratory personnel who perform testing on patient specimens." 2. On August 03, 2022, at approximately 12:00 PM, during the record review of the laboratory personnel competency records, the surveyor requested the competency assessment documents. The GS provided documents for the testing person however failed to present documented evidence of competency assessments for the GS. 3. During the exit interview, the laboratory director and technical supervisor confirmed the above finding. 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 --