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 person, the laboratory failed to perform and record microscope maintenance for the year 2017 from two-year review period (2016 - 2018) for the subspecialty of histopathology. The findings include: On 7/3/18 at 11:30AM, instrument maintenance records from January 1, 2016 to July 3, 2018 showed documentation of microscope maintenance for dates 2/25/2016 and 6 /2018, no records for due date of 2/2017 for the year 2017. During an interview on 7/3 /18, at 12:30 PM, the testing person confirmed that the laboratory did not perform yearly microscope maintenance for the due date of 2/2017 for the year 2017. 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 --