Benton Medical

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Benton Medical, CLIA ID 19D2104181, on June 24, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of maintenance logs and interview with personnel, the laboratory failed to perform monthly maintenance procedures per manufacturer's requirements for three (3) of eighteen (18) months reviewed in 2023 and 2024. Findings: 1. Observation by surveyor during the laboratory tour on June 24, 2024 at 2:28 pm revealed the laboratory utilizes the Beckman Coulter DxH 520 analyzer for Complete Blood Count (CBC) testing in the specialty of hematology. 2. Review of the laboratory's maintenance log for the Beckman Coulter DxH 520 hematology analyzer revealed the following monthly maintenance procedure: a) Clean the WBC Bath Filter 3. Further review of the 2023 and 2024 maintenance logs revealed the monthly maintenance was not performed for the following three (3) of eighteen (18) months reviewed: a) April 2023 b) March 2024 c) April 2024 4. In interview on June 24, 2024 at 2:21 pm, Testing Personnel confirmed the monthly maintenance was not performed as required by the manufacturer. D5781

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Benton Medical - 19D2104181 on September 17, 2018. Benton Medical was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to follow the laboratory's instructions for flags appearing on Complete Blood Counts (CBC) for four (4) of ten (10) patients reviewed. Refer to D5411. 2. The laboratory failed to ensure supplies have not exceeded their expiration date. Refer to D5417. 3. The laboratory failed to take