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: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed to document the humidity for the laboratory as the Dimension EXL the chemistry analyzer requires Findings were as follows: a. Based upon review of manufacture's operators guide the laboratory failed to document the humidity 20% to 80% for the laboratory . b. At the time of the survey 01/09/2018 the laboratory failed to produce documentation of humidity, This was confirmed by the General Supervisor from the CMS 209 form on 01/09/2018 at 15:30 hours. D5783