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 record review and interview with technical consultant and one testing personnel, the laboratory failed to document monthly maintenance for the chemistry analyzer for 6 of 13 months reviewed. Findings are: 1. Review of chemistry analyzer maintenance logs from February 2018 to March 2019 revealed no documentation of monthly maintenance for April 2018, June 2018, August 2018, November 2018, December 2018, and February 2019. 2. On 4/3/2019 at 2PM, technical consultant and one testing personnel confirmed the laboratory failed to document monthly maintenance for the chemistry analyzer. 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 --