Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS form 209, personnel records from 2020 and 2021 and confirmed in interview, the Technical Consultant failed to perform the annual competency evaluations for two of four testing personnel for the moderately complex testing in hematology. Findings were: 1. Review of the laboratory's CMS 209 signed by the laboratory director on 11/17/21 revealed four testing personnel (TP#1, TP#2, TP#3, TP#4) performing moderately complex testing in hematology. 2. Review of the laboratory personnel records from 2020 and 2021 revealed TP#1, who doesn't qualify as a TC, performed the following competencies for the following testing personnel. TP#1 has an associates degree. TP#2 (hire date 9/11/11) CBC and ESR competency performed 3/9/21 by TP#1 TP#3 (hire date 10/24/11) CBC competency performed 3 /19/21 by TP#1 3. An interview with the technical consultant # 2 on 11/18/21 at 1130 hours in the lab confirmed the above findings. key: CMS - Centers for Medicaid and Medicare Services 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 --