Summary:
Summary Statement of Deficiencies D0000 Noted deficiency and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of the technical supervisor performing twice annual competency assessments for 1 of 1 testing personnel. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 1 testing personnel. Testing personnel number 1 started in October 2021. 2. A review of the laboratory's personnel records revealed the laboratory had documentation of a competency assessment being performed on testing personnel number 1 in April 2022. There was no documentation of another competency being performed. 3. The laboratory was asked to provide documentation of a second competency assessment being performed by October 2022. No documentation was provided. 4. An interview with the technical supervisor on 03/29/2023 at 1005 hours in the break room revealed he was unable to find the second competency assessment for testing personnel number 1. This confirmed the 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 --