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 observation, record review and interview with office assistant, the laboratory failed to have the daily microscope maintenance records for the years 2016 to August15, 2018 from two-year review period (2016 - 2018) for the subspecialty of histopathology testing. The findings include: On 8/15/18 at 1:30PM, surveyor observed Premiere microscope. Daily QC (quality control) worksheet records from August 2016 to August 15, 2018 showed no documentation of microscope maintenance that would include maintenance for alignment, visualization, opticals, exterior, and cover for Premiere microscope. During an interview on 7/18/18, at 3:00 PM, the office assistant confirmed that: Laboratory did not have records from July 2016 to July 18, 2018 for any alignment, visualization, opticals, exterior, cover-daily maintenance for Premiere microscope in daily QC worksheet. 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 --