Dear Colleagues

I wanted to post a reminder about reporters' obligations to report SAEs and suspected SARs as soon as known. I will often see an SAE Notification and Confirmation report posted on the same day where the error occurred over a month previously, or SAR reports made only after the investigations have been completed. It is especially important that Notification reports of suspected bacterial and viral transmission are reported to both MHRA and SHOT as soon as known, even if there is a possibility of the cause being attributable to something other than the blood.

Chris

From the BSQR (Relevant bits only)

Requirement to report serious adverse reactions and events

12B.—(1) A person responsible for management of a reporting establishment shall ensure that the reporting establishment—

(b)notifies blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood or blood components; and

This is the requirement for hospitals to report reactions to the blood establishment for investigation. “May” indicated that they report to you even if it is not yet determined that the reaction IS a result of the quality or safety of the component transfused

(c)notifies the Secretary of State as soon as is known all relevant information about suspected serious adverse reactions using the notification formats set out in Section A and Section C of Part 7 of the Schedule.

This section requires hospitals to report suspected reactions to MHRA. “Suspected” is used to ensure that MHRA are informed before the outcome of the relevant investigations are known. Section A of the Schedule refers to the Notification section of SABRE, and section C the Confirmation section of SABRE. In practice, once a hospital suspects a reaction may be a result of the quality or safety of the blood, they must first inform a Blood establishment to ensure the relevant investigations are started, and then they report a Notification report on SABRE. This is the hospital’s responsibility, not the Blood establishment. Once the investigations are completed and BE have reported back to the Hospital, the hospital then reports the Confirmation to SHOT via the SABRE workspace, and SHOT submit the Confirmation report to MHRA once the outcome is known.

(2) A person responsible for management of a reporting establishment shall ensure that the reporting establishment

(a)notifies the Secretary of State of all relevant information about serious adverse reactions of imputability level 2 and 3 as referred to in Section B of Part 7 of the Schedule, which may be attributable to the quality and safety of blood or blood components;

This section requires the confirmation report to be a full investigation report where the Imputability indicates that the reaction was likely, probably or certainly a result of the blood transfused (note that it does not at this stage have to be due to the quality or safety of the blood). Imputabilities of 1 or less, still require a confirmation report, but it can be less detailed.

(b)notifies the Secretary of State, as soon as is known, of any case of transmission of infectious agents by blood or blood components;

This section highlights the need that a Confirmation report to the CA is required to be submitted when transmission of infectious agents by blood is confirmed (note, following the above regulation means we already have the Notification report, but the Confirmation report must be submitted urgently back from BE to the Hospital, to SHOT and then MHRA)

(c)as part of the notification referred to in paragraph (a), describes the actions taken with respect to other implicated blood or blood components that have been distributed for transfusion or for plasma fractionation;

(d)as soon as is reasonably practicable after each suspected serious adverse reaction, evaluates that reaction according to the imputability levels set out in Section B of Part 7 of the Schedule;

(e)completes the serious adverse reaction notification, upon conclusion of the investigation, using the format set out in Section C of Part 7 to the Schedule;

In summary, the process described above is that which should be happening for all SARs reportable to MHRA and SHOT and as described is the responsibility of the Hospital, not BE. MHRA must be notified as soon as known all “suspected” (not confirmed) SARs i.e. before the completion of the investigation.

It is important that the regulatory process does not interfere with the process to investigate these matters, including the identification and quarantine/recall of implicated components and the deferral of potentially implicated donors. But, it is equally important that the regulatory process is also maintained.