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: During an onsite recertification certification survey on 07/26/2018, based on the HmX hematology analyzer operator's guide, laboratory temperature records, and testing personnel interview, the laboratory failed to document an acceptable room temperature and humidity for 1 out of 7 months reviewed in 2018 (July). Findings include: 1. The HmX hematology analyzer operator's guide stated that the instrument should be operated in an ambient room temperature between 60 to 90 degrees fahrenheit and humidity between 0 and 95%.. 2. Review of the laboratory's temperature records revealed 1 out of 7 months in 2018 (July) during which room temperature and humidity was not documented. There was no