Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, a review of laboratory written policies and procedures, and interview with Testing Personnel 1 (TP1), the laboratory failed to accurately monitor the conditions essential for proper storage of reagents and test system operation. Findings: 1. The room temperature and humidity were being monitored and documented from a thermometer that had an expired NIST calibration. The certificate of calibration for the NIST certified Thomas 9337T07 thermometer expired 7/15/17. 2. The written laboratory policy and procedure stated the optimal ranges for temperature as 68 to 76 degrees Fahrenheit and the humidity as greater than 60 percent. 3. An interview with TP1, on 8/14/19 at approximately 930 AM, confirmed that the room temperature and the humidity were being monitored and documented from the Thomas 9337T07 thermometer and that the calibration was expired. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of maintenance records, laboratory written policies and procedures, and an interview with Testing Personnel 1 (TP1), the cryostat Avantik QS12 had not had annual preventative maintenance performed since 2015. Findings: 1. An examination of the cryostat revealed a sticker documenting the last preventative maintenance performed as 10/30/15. No other records or documentation could be located. 2. The laboratory written policy and procedure states "Preventative maintenance and grounding checks are done and documented annually." 3. An interview with TP1, on 8/14/19 at approximately 1030 AM, confirmed that no documentation of annual preventative maintenance on the cryostat could be located on site. -- 2 of 2 --