Summary:
Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on review of the laboratory procedure manual and interview with testing personnel #1 at 3:30 pm on the day of survey, 5/29/18, the laboratory failed to follow the laboratory "General Maintenance Program" for the laboratory centrifuge. The laboratory maintenance program states the timer check and RPM (rotation per minute) on the centrifuge will be checked and documented bianually. There was no documentation on the day of survey to prove this maintenance was being performed by the laboratory or the reference laboratory during the life of the instrument. B. Based on review of the laboratory procedure manual and interview with staff at 3:30 pm on the day of survey, 5/29/18, the laboratory failed to establish a maintenance and function check procedure for the laboratory microscope. The microscope is used by the laboratory to perform post vasectomy sperm analysis (presence or absence). On the day of survey, there was no written protocol which established the service required and frequency at which the service is to be performed. 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 --