Thank you for asking for clarification and further information. As noted, The XW-100 is contraindicated for critically ill patients. CMS defines a critical illness or injury as one which “acutely impairs one or more vital organ systems such that there is a high probability of imminent or life-threatening deterioration in the patient’s condition.” (Medicare Claims Processing manual, Chapter 12, Section 30.6.12A.).
Additionally, the XW-100 is not for use in a clinical area which cares for only critically ill patients, such as intensive care units. However, in some environments, physicians will encounter critically ill patients as well as those who are not. In those cases, it is important for the physician to follow the IFU and only use the XW-100 for patients who are not critically ill. Use in critically ill patient populations is not only contraindicated, but is likely to result in suppression of a large portion of the results.
Please also visit www.sysmex.com/xwsafety to learn more.