Where will you
be in 30 years?

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The Blood Safety and Quality Regulations 2005 (BSQR) was implemented. This provided a regulatory requirement to ensure full traceability from donor vein to patient vein, these records must be kept for no less than 30 years.

Following the Advisory Committee for safety of Blood, Tissues and Organs’ (SaBTO) recommendations in October 20211 the Scottish Government Health Department (SGHD) issued an instruction in November 2021 to further enhance blood safety. This was to reduce the risk of Hepatitis B transmission from doors with occult Hepatitis B infection (OBI). The instruction encompassed implementation of anti-hepatitis B core (anti-HBc) testing for all active blood donors and recipient lookback if required.

05 April 2022 SNBTS introduced anti-HBc screening for active donors and initiated lookback programme. Component swap out programme performed and completed.

Through the anti-HBc national lookback programme, blood banks across Scotland performed component fating. 1524 components were traced spanning from 04 Nov 1998 – 02 Apr 2022. 1162 were transfused, 346 were recorded as discards and 16 components were unable to be fated.

From the 16 components unable to be fated 13 were bled before the BSQR 2005 came into regulation and 3 were post BSQR 2005. The BSQR highlights the responsibility of the blood banks for traceability of components whilst ensuring accountability at the Health Board level within the NHS.

Through the programme seven cases have shown evidence of a past infection, two of which that didn’t manifest clinically

Infected Blood Inquiry report published 20 May 2024.

A sobering extract from the volume 1 of the IBI report:

“It is likely to be of significant importance to establish the outcome of every transfusion. If this had been achieved at the time of the principal events described in the Report, it seems likely that alarm bells would have rung sooner; that infections would have been detected (clinically, if they could not be established by existing tests) and advice to patients have been better informed, more quickly2”.

The report highlights the importance of accurate records to enable successful lookbacks and highlight the need for an improved electronic clinical system for blood transfusion across the UK.

The initial stages of the programme blood banks faced challenges in trying to access legacy Laboratory Information Systems (LIMS), locate historical paperwork within archive stores, legacy data storage systems or piece together blood banks that amalgamated. Through these obstacles it raises the questions how can traceability be future proofed?

Exploratory work should be undertaken to ascertain the possibilities and put procedures in place that will benefit traceability in the next 30 years, considerations to the following:

Storage of traceability - possibilities for Amazon Web Services (AWS) or the Cloud
Cost of storing paper records
Sustainability impact of storage
Ensuring the next workforce generation can access records that are being generated now

A tremendous effort has been made by all blood banks across Scotland to trace components as part of the programme. This element of the programme has played a pivotal role and has highlighted the impact the BSQR has played in traceability and the efforts gone into historical traceability.

Safety of our blood supply is valuable when emerging diseases come along, in these situations it is uncommon that 100% traceability is required. However, the nature of audit shines a light on why traceability has always been critically important. Of the 1524 fating requests that were generated 13 that were prior to 2005 were unable to be fully traced, this compares to 3 components after 2005 - Could this be better?

Based on data collected from the programme we can forecast 12 components would have been transfused (76% transfusion rate), considering the death rate this would see 3 recipients alive, 4 components would be discards (discard rate of 23%) and an unknown fate rate of 1% - could this be improved for future situations that may arise?