BLOOD MANAGEMENT
traceability data is retained in a readable and appropriate storage medium for a period of 30 years. Traceability data ensures that each donation (and the various blood components processed from that donation) can be traced from the do- nor to the recipient, and vice versa.
The purpose of the 30 year record retention is to ensure that donors and recipients can be identified over an extended period of time in rare cases where a potentially infectious donor is identified (ena- bling the fate of donations prior to the detection of the disease marker to be determined – ‘look back’), or where a patient who has received a blood transfusion sub- sequently tests positive for a dis- ease marker (to enable an inves-
tigations regarding whether the blood transfusion may have been implicated – ‘trace back’).
SABRE and SHOT
MHRA is responsible for ensuring that organisations involved with blood components comply with the regulations by:
• Submitting applications for blood establishment authorisation or submitting an annual blood compliance report • Maintaining a quality system based on the principles of good practice • maintaining records to ensure full traceability from donation to the point of delivery for not less than 30 years
• notifying the competent author- ity of any serious adverse events or reactions via SABRE • Being subject to an inspection from the competent authority at least once every two years (for blood establishments) or on an ‘at risk’ or control basis for hospital blood banks and blood facilities The work of the MHRA in this re- spect is funded through fees paid by the relevant organisations in- volved.
In addition to MHRA’s responsi- bilities outlined above, MHRA is also responsible for providing a mechanism for the reporting and recording of serious incidents. For this purpose the MHRA has de- veloped the fully accessible online reporting system, SABRE.
This system also provides UK reporters with an individual an- nual summary report which, once verified, is collated into a UK sum- mary report for submission to the EU Commission. All reports are checked for timeliness, adequacy and quality of content. The MHRA haemovigilance team regularly li- aise with colleagues in the Inspec- tion, Enforcement and Standards division to advise them of any high risk reports, non-reporters or or-
ganisations with recurrent prob- lems which might indicate a risk to patient safety.
The number of reports submit- ted via SABRE has increased each year from just 90 reports in 2005 (two months data only) to 1,762 in 2010.
SHOT is a separate organisation which collects haemovigilance in- formation and is funded by the UK blood services. Reporting to SHOT is not mandatory and is not a re- quirement of the Blood Safety and Quality Regulations.
The future
UK and EU legislation relating to blood for transfusion is unlikely to change significantly in the near future. Work is ongoing at a Euro- pean level to draft guidance docu- ments which relate to provisions already present in current legisla- tion, such as detailed guidance on the principles of Good Practice, which is referred to in Article 2 of Directive 2005/62/EC (relating to the Quality System requirements for blood establishments).
FOR MORE INFORMATION Visit
www.mhra.gov.uk
Ann Dennard of Labcold here gives another take on the storage and management of blood and blood products. B
SQR 2005 (SI 2005/50) means that hospital blood
banks have to supply an annual compliance report to the MHRA, the body responsible for regulating blood establishments.
One question, always asked, refers to “the control of monitoring, main- tenance and calibration of any con- trolled storage equipment on site”.
In addition, blood banks have to complete SABRE reports if any- thing goes wrong.
Part 4 of BSQR defines how blood products are to be stored. For ex- ample, red cells need to be stored at a constant 2-6o
extremely important to ensure the quality of products for transfusion. If blood products are not stored correctly, they cannot be used (fro- zen blood will kill a patient) and if the MHRA inspect an establish- ment and find the storage is not acceptable they can close it down, which would have a massive impact on the hospital.
C and can only
be outside this temperature for 30 minutes or less, so the cold chain is
It is therefore vital that all equip- ment for the storage of blood and blood products meets BSQR regu- lations and that it is appropriately alarmed. Given the reporting re- quirement, which is based on GMP and GDP in the MHRA Orange Book, the equipment also needs to be properly maintained and vali- dated, including annual tempera- ture mapping and calibration. This
80 | national health executive Sep/Oct 11
is important for both patient safety and compliance. The cost effective way to manage this problem is to use equipment for cold storage that comes from a manufacturer with medical device accreditation or ISO 13485. The reason why this is im- portant is that it means the manu- facturer has to comply with medical device regulations and GMP so has to have traceable systems in place for both parts and manufacture.
This assists with blood establish- ment compliance reports, because if you also have a manufacturers’ maintenance contract you can be confident that any maintenance/ validation or calibration is traceable and to OEM standards. It also helps if SABRE reports are raised because the manufacturer can assist and
pin- point the relevant information.
The EU and MHRA have defined blood bank refrigerators, plasma freezers and platelet agitators as borderline medical devices, and by using only cold chain equipment which is manufactured by a medical device manufacturer, you have the reassurance that these products are designed and manufactured in ac- cordance with detailed and exacting standards; the manufacturers, their procedures and documentation are independently audited on a regu- lar basis; and a standardised set of safety criteria are applied across all blood storage products.
FOR MORE INFORMATION Visit
www.labcold.com
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