Summary:
Summary Statement of Deficiencies D6101 Based on a review of the laboratory Form CMS-209, the laboratory personnel records, and the interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to ensure that all personnel had the appropriate education prior to testing patients' specimens as defined by CLIA regulations. See D6143 D6141 Based on a review of the laboratory Form CMS-209, the laboratory personnel records, and the interview with the Technical Supervisor (TS), the laboratory failed to ensure that the General Supervisor (GS) education documents meet the Clinical Laboratory Improvement Amendments (CLIA) qualification requirements for GS. See D6143. D6143 Based on a review of the laboratory's Form CMS-209, review of education records, and an interview with the laboratory Technical Supervisor (TS), the laboratory failed to ensure that the General Supervisor (GS) had the educational requirements to qualify as GS. Findings include: 1. A review of Form CMS-209 revealed one (1) of one (1) GS (GS-1 See Form CMS-209). 2. A review of education records for GS-1 revealed that the GS-1 received their education outside of the United States. 3. A request for documentation of an International Equivalency Assessment for the GS-1 revealed the laboratory failed to obtain documentation of educational equivalence assessment from an approved International equivalency agency. 4. The laboratory TS confirmed by an email interview on 03/11/2024 at 1:46 p.m. that an educational equivalency assessment was not completed for the GS-1. 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 --