Summary:
Summary Statement of Deficiencies D0000 An announced CLIA exempt-state validation survey was conducted at Montefiore Nyack Hospital Affiliated Laboratory on February 15, 2023, by the CMS New York CLIA Branch Location federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to be in compliance with condition-level CLIA requirements. The following standard-level deficiency was found during CLIA exempt-state validation survey performed on February 15, 2023. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review the Roche Cobas Integra 400 plus maintenance logs and interview with laboratory staff, the laboratory failed to document weekly and monthly maintenance each month from February 2022 to January 2024. Findings Include: 1. The Roche Cobas Integra 400 plus maintenance log is a monthly two page document that is used to record daily checklists, Daily maintenance, weekly maintenance, monthly maintenance, quarterly maintenance, general procedures, semi-annual maintenance, electrode replacement, as needed maintenance and periodic maintenance. 2. A review of the Roche Cobas Integra 400 plus maintenance logs from February 2022 to January 2024 revealed, the following logs only had daily checklists and Daily maintenance documented: - January 2024. - August to December 2023. - April to June 2023. 3. Laboratory staff stated testing personnel #1 wrote down all missing maintenance records at the bottom of the first page of the log, but further review revealed, the weekly and monthly maintenance for the above months were not documented from February 2022 to January 2024. 4. The laboratory staff confirmed the findings above on February 15, 2024 at 3:15 PM. 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 --