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 surveyor review of chemistry maintenance records and interview with the Technical Consultant the laboratory has not consistently documented required maintenance. Findings include: 1. Review of maintenance records in 2016 and 2017 shows required maintenance is not consistently being documented on the Chemistry Maintenance Log. September 2016: Weekly maintenance for "Clean Probes and Splash Guard" was documented 3 out of 4 times that month. Weekly maintenance for "Clean ISE Tower" was documented 2 out of 4 times that month. October 2017: Weekly maintenance for "Clean Probes and Splash Guard" and "Clean ISE Tower" was documented 3 out of 4 times that month. Weekly maintenance for "Backup Database" was performed 2 out of 4 times that month. Monthly "Clean Waste Box Fitting" was not documented as having been performed. November 2017: Weekly maintenance for "Clean Probes and Splash Guard" was documented 3 out of 4 times that month. Weekly maintenance for "Clean ISE Tower" was documented 2 out of 4 times that month. 2. Interview with the Technical Consultant on February 13, 2018 at 2:30 PM confirms testing personnel did not document chemistry maintenance as required. D5781