Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 review of the manufacture's maintenance requirements for the Viva ProE chemistry analyzer, review of the laboratory's Viva ProE maintenance records from January 2023 to December 2024, and staff interview, the laboratory failed to have documentation of performing required quarterly maintenance for 3 of 8 quarters. The findings included: 1. A review of the manufacture's maintenance requirements for the Viva Pro-E chemistry analyzer identified the following maintenance steps to be performed quarterly: Replace water filter Replace mixer belt Replace drying block on wash arm 2. A review of the laboratory's Viva ProE maintenance records from January 2023 to December 2024 identified the laboratory failed to have documentation of the following: a) 2nd Quarter 2023 - Replace water filter - Replace mixer belt b) 3rd Quarter 2024 - Replace water filter - Replace mixer belt c) 4th Quarter 2024 - Replace water filter - Replace mixer belt - Replace drying block on wash arm 3. Testing personnel #1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 03/17/2025 at 1030 hours in the break room. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical consultant performing semiannual competency assessments on 1 of 1 testing personnel. The findings included: 1. A review of the laboratory's personnel records determined testing personnel #1 (as listed on Form CMS 209) started performing moderate complexity testing in June 2023. 2. Further review of the personnel records for testing personnel number #1 identified a single competency assessment was performed in October 2024 (16 months after starting testing.). No other competency assessment were available for review. 3. Testing personnel #1 confirmed the findings in an interview conducted on 03/17/2025 at 0940 hours in the break room. -- 2 of 2 --