Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 30, 2018. Midstate Skin Institute LLC clinical laboratory had one deficiency found at the time of the visit. 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 record review, and interview, it was determined that the laboratory did not monitor the Cryostat ( Avantik QS 12 ) temperature requirements to assure optimal operation temperatures several days from April to October 2017. Review of the laboratory procedures indicated that the Cryostat ( Avantik QS 12 ) operates at a freezing temperature of -21 degrees to -30 degrees Celsius. The temperature log for the year 2017 ( 4/27, 5/4, 6/1, 6/14, 7/24, 9/7, and 10/19 ) showed abnormal ranges of -14 to -20 degreees Celsius. There was no