Summary:
Summary Statement of Deficiencies 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 lack of documentation and interview with technical consultant 1 (TC1), the laboratory failed to document routine weekly maintenance on the Cephied GeneXpert Microbiology test system. Findings include: 1. Record review of the CMS form 116 on 6/5/2024 revealed the laboratory performs Strep A, T. Vaginalis, C. Difficile/EPI, Gonorrhea, and Chlamydia testing on the Cepheid GeneXpert. 2. Record review of the GeneXpert maintenance logs on 6/5/2024 revealed 5 out of 17 months reviewed to be missing a weekly maintenance log entry. 3. Interview with TC1 on 6/6/2024 at 9: 00am confirmed the above findings. 4. The laboratory perform 2'557 tests annually in the specialty of Microbiology. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on staff interviews and record review the laboratory failed to follow their own Quality Assurance Program policy concerning