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 lack of a microscope maintenance policy and interview with the facility personnel, the laboratory failed to have a microscope maintenance policy that indicates specific routine maintenance procedures as well as scheduled preventative maintenance procedures. Findings include: 1. The policy and procedure manual presented for review during the survey did not contain any policies with regards to microscope maintenance. 2. The facility personnel acknowledged that there were no microscope maintenance policies contained in the manual. 3. The laboratory's annual test volume under the sub-specialty of Histopathology is approximately 8,000 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 --