Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 05/16/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. Noted deficiencies 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. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, the review of the laboratory's records in 2023, CMS 116 application, and confirmed in an interview, the laboratory failed to have documentation for 2 of 2 comparison evaluations twice a year for 2 cryostat instruments in 2023. The findings were: 1. The surveyor's direct observation on 05/16 /2024 at 10:05 am in the lab revealed the laboratory had 2 cryostat instruments and both were in use. Avantik QS12 #1 (SN: S21010141) Avantik QS12 #2 (SN: S22080107) 2. A phone interview on 05/21/2024 at 9:30 am, the nurse manager confirmed the installation date below. Avantik QS12 #1 (SN: S21010141) Installation date: April, 2021 Avantik QS12 #2 (SN: S22080107) Installation date: October. 2022 3. Review of the laboratory's records in 2023 revealed the laboratory failed to have documentation for 2 of 2 comparison evaluations twice a year for 2 cryostat instruments in 2023. 4. Review of the laboratory's CMS 116 application, signed by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory director on 05/06/2024, revealed the annual volume was 1657. 5. In an interview on 05/169/2024 at 11:22 am in the break room, the histotech confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services -- 2 of 2 --