Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and an interview with the laboratory director, the laboratory failed to have a complete maintenance protocol or procedure for histopathology. Findings Include: On June 30, 2018, at approximately 11:30 AM, it was confirmed by the laboratory director that the laboratory failed to have a procedure available for maintenance service for the Microscope to include the interval between service performance. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a review of procedures and confirmed in an interview with the laboratory director, the director failed to have a procedure for the microscope maintenance and schedule. Refer to: D5433 -- 2 of 2 --