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 review of the operator's manual, maintenance records, and staff interview, the laboratory failed to ensure the humidity in the laboratory met the manufacturer's operating conditions for the Sysmex 1000i hematology analyzer and the Sysmex CA600 coagulation analyzer during the first three months of 2019. Approximately 90 patient specimens had been tested and reported. Findings include: a. The manufacturer requires an operating environment of 30-85% relative humidity for the Sysmex 1000i and the Sysmex CA600 analyzers. b. Maintenance records for 2019 showed that the humidity in the laboratory was below 30% for a total of 31 of 63 days of testing (Jan. =14/22 days, Feb.=14/20 days, Mar.=3/21 days). c. On 4-9-19 at around 11:00 a.m., the laboratory director stated that they were aware that the humidity was outside the acceptable range for the Sysmex analyzers, and stated that they were gathering data to extend the acceptable humidity range for the laboratory. d. On 4-9-19 at around 11:00 a.m., the laboratory director confirmed the laboratory had not ensured a testing environment of at least 30% humidity as required by the Sysmex manufacturer and federal CLIA regulations. D5781