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 policy and procedure manuals, manufacturer's instruction, temperature logs, and interview with staff, the laboratory failed to follow manufacturer's instructions for operational environment relative humidity for ABL90 Flex Plus. Findings follow: A) Review of the ABL90 Flex Plus Instruction for use revealed the operating environment for relative humidity is "20 to 80% ". B) Review of the Blood Gas Policy and Procedure manual stated, " Humidity range is 20% to 80%". C) Review of the Baptist Health Extended Care Hospital ABG Room Temperature and Humidity Log for January 2022 revealed 8 days out of 31 days humidity below 20%. February 2022 4 days out of 28 days humidity below 20%. D) During an interview on 10/27/2023 at 12:47 p.m. the laboratory staff member General Supervisor (GS) confirmed the 12 days below 20% humidity. No