Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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 a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical supervisor performing a competency assessment, at least twice during the first year of testing, for one of two testing personnel performing high complexity testing (urinary stone analysis) in 2023 and 2024. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 2 testing personnel performing high complexity testing. 2. A review of the laboratory's personnel records revealed the following testing person, their hire date, and date(s) a competency assessment was performed: a) Testing person #2 Hire date: April 2023 Competency assessment performed: April 2023 Based on the hire date, testing person #2 should have had at least 2 competency assessments performed prior to April 2024. 3. In an interview on 10/10/24 at 9:40 a.m. in the office, after review of the records, the general supervisor (as indicated on the CMS 209 form) confirmed the above 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 --