** Update ** Clinical Safety Issue - Vision+ eGFR Calculator.

This is an update to the communication originally published on 6th March 2020 regarding an issue discovered with the use of the tool available in the Vision+ product named the eGFR calculator that may be used to estimate renal function in patients.

Vision has identified an issue specifically in relation to the way that a creatinine clearance (CrCl) result calculated using the additional “Cockcroft-Gault (ideal weight)” option made available within the Vision+ eGFR calculator via the SIS10490 release of Vision software deployed during December 2019 is displayed graphically. An incorrect CrCl value is presented in the graphical display for some patients. This may affect decision making regarding patient care where based on viewing the incorrect CrCl value shown by the graphical display.

The issue only affects where a CrCl result is graphically displayed (RHS of screen) – but NOT in the actual calculation or CrCl value recorded in the patient record which is correct (LHS of screen). The graphical view is displayed where a patient has 3 or more CrCl values recorded.

As an example, the following shows how the information is presented to a user for a CrCl result correctly calculated, recorded and displayed numerically as 46 using ideal weight (LHS of screen) but graphically displayed incorrectly as 69 based on incorrect calculation using actual weight (RHS of screen):

CrCl

In full mitigation of this issue, the graphical display will be disabled via the SIS10500 release of Vision software that is currently scheduled for deployment by the end of March 2020.

In the meantime, as additional mitigation of the clinical safety risk specified above, users are requested to disregard and suspend use with immediate effect the graphical view (RHS of screen) of the Vision+ eGFR calculator where displayed for patients and ensure that any clinical decisions for patient care are entirely based upon the information presented on the LHS of the screen.

Vision is working to identify patients for whom a graphical view of an incorrect CrCl value is displayed and will communicate directly with practices with advice on any actions required to mitigate the risk to these patients.