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 review of records and discussion with the Laboratory Director (LD), the laboratory failed to respond to humidity outliers when the humidity fell below their established room humidity percentage. Findings include: 1. While reviewing quality control, temperature and quality assurance documentation for February 2018, it was noted that the humidity for the lab had dropped below the lab's established humidity range of 28% - 75%, nine (9) out of ten (10) patient testing days. 2. There was no written documentation of