Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of the CLIA recertification onsite survey conducted at your facility on March 14, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the laboratory maintenance records, instrument operator's manuals, and interview with the testing personnel, the laboratory failed to perform and document the instrument maintenance required by the manufacturer. The findings include: The manufacturer of the AVANTIK Tissue Processor requires annual inspection once per year by a qualified service engineer authorized by Leica. The last documented maintenance was 6/29/12 by Swercdlick System, based on a label adhered to the instrument. There was no preventative maintenance agreement for annual inspections for the laboratory equipment and instrumentation. This was confirmed by the testing personnel. The laboratory states that it performs approximately 2,600 histopathology tests per year. 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 --