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 record review and interview with testing personnel #4 (TP4), the laboratory failed to perform and document the monthly preventive maintenance as required for 20 (August - December 2017, January - May and August - December 2018, January, and April - July 2019) of 24 months reviewed for the dermatopathology laboratory. Findings include: 1. Record review of the "Monthly Preventive Maintenance Checklist" log revealed six tasks that were required as follows: a. "General Electric Refrig/freezer (Histo)" b. "Slide Oven" c. "Paraffin dispenser" d. "Eyewash station" e. Embedding center #1 QC" f. "Cslipper-chg tape/fill Xylene/chg filter" 2. Record review of the "Monthly Preventive Maintenance Checklist" log revealed the laboratory did not perform and document the six monthly tasks for 20 of 24 months as follows: a. Tasks a, b, c, d, and e - August - December 2017 and January - May 2018 b. Tasks b, c, and e - August and November 2018 c. Tasks a, b, c, and e -September, October, and December 2018 d. Tasks b, c, d, and e - January 2019 e. Tasks b and e - April and July 2019 f. Tasks d and e - May 2019 g. Tasks a, d, and e - June 2019 3. During the interview on August 20, 2019 at 11:40 a. m., TP4 confirmed the monthly tasks were not performed and documented as required. 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 --