Flow Chart A: Investigation Requirements - Text Description

The Investigation Requirements Flow Chart (Flow Chart A), found in subsection 110(4) of this guidance, describes the steps to be taken once an unexpected adverse reaction or a serious adverse reaction occurs in a recipient. The flow chart consists of a series of boxes that span the length of the page. Each box contains a description of one or more actions to take place where each action is listed as a step, 1 through 12. The boxes are connected by arrows that indicate the next set of steps that must be performed. At times more than one arrow will stem from a box. The choice of arrow to follow will be based on the outcome of the previous steps.

The first box in the flow chart reads - An adverse reaction in a recipient takes place at a blood establishment.

There is an arrow that leads from the first box pointing to the second box, found below the first box. The second box reads - The establishment immediately: (1) Determines the donation codes of all implicated blood and (2) Identifies and quarantines the implicated blood.

There is an arrow that leads from the second box pointing to the third box found below the second box. The third box reads - The establishment: (3) After conducting a preliminary inquiry, determines if the root cause analysis suggests the adverse reaction is attributable to an activity it conducted.

There are two arrows that stem from the third box. The first arrow, labelled "YES", leads from the bottom-left side of the third box to the sixth box.

The second arrow, labelled "NO", leads from the center of the third box to a fourth box which reads - The establishment notifies: (4) The establishment that collected the implicated blood, (5) The establishment from which they received the blood and (6) Any establishment to which they distributed the blood.

There is an arrow that leads from the fourth box pointing to the fifth box, found below the fourth box. The fifth box reads - Any establishment who received a notice: (7) After conducting a preliminary inquiry, determines if the root cause analysis suggests the adverse reaction is attributable to an activity it conducted.

There is an arrow, labelled "YES" that leads horizontally from the left side of the fifth box joining with the arrow coming down from the third box. Both the arrows from the third and fifth boxes, labelled "YES", lead to the sixth box which reads - The establishment: (8) Conducts an investigation and (9) Notifies any establishment to which it distributed the implicated blood.

A second arrow, labelled "NO" from the fifth box, and the arrow from the sixth box lead directly to the seventh box which reads - Any blood establishmentthat received a notice regarding the implicated blood: (10) Notifies any establishment to which it distributed the implicated blood, (11) Quarantines any implicated blood in its possession and (12) Provides any establishment that is conducting an investigation with any relevant information in its possession with respect to the implicated blood. The flow chart ends here.