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Medicines: Blood

These regulations affect blood establishments (e.g. the UK Blood Service) and hospital blood banks, by setting standards for the collection, testing, processing, storage and distribution of human blood and blood components. The purpose of these regulations is to assure the safety and quality of blood and blood components (red cells, white cells, plasma, and platelets) supplied in the UK.

We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections. You can find the regulations that relate to blood safety and quality to the left below. Note that the Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008, SI 2008/941 listed in the clinical trials section of this website also applies to blood.

Tell us what you think should happen to these regulations and why, being specific where possible:

• Should we scrap them altogether?
• Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
• Could they be reformed, simplified or merged? How?
• Can we reduce their bureaucracy through better implementation? How?
• Can we make their enforcement less burdensome? How?
• Should they be left as they are?

15 comments on “Medicines: Blood”

1. Peter Senior on April 10, 2012 at 1:41 pm said:

   Should we scrap them altogether?
   Not in favour; if it is ‘the law’ then the regulations will help drive uniform compliance and improvement (there is an incentive to comply and importantly a consequence if you don’t)
   Could their purpose be achieved in a non-regulatory way (e.g. through a voluntary code?)
   Not convinced; see above
   Could they be reformed, simplified or merged?
   Possibly – why dont the regulatory bodies communicate and work together. Each will have a focus but the common elements of inspection (including the quality system) could be looked at by e.g just one who would report back to all bodies (this would reduce inspection time/cost and save duplication of effort)
   Can we make their enforcement less burdensome?
   Yes – we could work with the regulators to help improve the consistency in approach. One inspector may take a true risk based view and another wish to review every last detail; this adds to the burden of inspection on some sites depending on which inspector is in attendance.

   If the regulator was prepared to provide written advice then this may help drive consistent interpretation of regulations and provide a reference point for both an inspector and auditee.
   Should they be left as they are?
   No, see aboveComment Tags: BSQR
2. Stephen Thomas on April 10, 2012 at 1:38 pm said:

   Should we scrap them altogether?
   Not altogether, but BSQR is unwieldly – it is too specific and too difficult to make changes to (ref upper limit for platelet pH, West Nile Virus deferral)
   Could their purpose be achieved in a non-regulatory way (e.g. through a voluntary code?)
   No, regulation and inspection is necessary and appropriate to maintain patient care
   Could they be reformed, simplified or merged?
   Audit blood component production versus Red Book or CE guide rather than BSQR, remove all the specifications in the back of BSQR.
   Can we make their enforcement less burdensome?
   Interesting issue around blood service pathogen inactivation treatment of imported plasma – apparently on a small scale (as now) this falls within blood regs, but if we went to 100% then our processing would be treated as pharmaceutical.

   On medicines, the licensing of fibrinogen concentrate for congenital but not acquired hypofibrinogenaemia is a source of frustration. Whilst its use instead of cryoprecipitate is not necessarily better, there is not a proper debate as it is a moot issue.Comment Tags: BSQR
3. Ed Harvey on April 10, 2012 at 1:35 pm said:

   Should we scrap them altogether?
   I don’t think we should scrap the regulations and being EU law it’s probably impossible anyway. However closer alignment between MHRA/HTA and resulting simplicity joint inspections would help
   Could their purpose be achieved in a non-regulatory way (e.g. through a voluntary code?)
   Voluntary codes could work as in CPA, EFI etc but the main problem is the need for some peer review process which could over time become just as bureaucratic and costly to manage.
   Could they be reformed, simplified or merged?
   As above the blood and tissue regulations are already similar and general requirements could be covered by one inspection with specialist targeted inspections for specialist activities.
   Can we make their enforcement less burdensome?
   I think the MHRA are going some way to help by reducing the number of days inspection at some sites but until they really do evaluate inspections on a risk basis we will be under the same level of inspection.
   By not inspecting areas of low risk to the product/patient and where no deviations have been raised in previous visits some savings in inspection costs and less impact on the organisation could be seen
   Should they be left as they are?
   MHRA and other bodies need to move forward but in a way that ensures standards are maintained. This could only be done using an effective risk based approach to inspection combined with the requirements of UK and EU law.
4. Alan Slopecki on April 10, 2012 at 1:29 pm said:

   • Should we scrap them altogether? No as they provide assurance that organizations operate Quality management systems based on best practice which have been built up through evidenced based learning over the past 40 years and if properly implemented protect patients
   • Could their purpose be achieved in a non-regulatory way (e. G. through a voluntary code?) No, a voluntary code is not strong enough to protect public health, as there are significant problems with un licensed operators already. For BSQR this brings consistency across EU which would otherwise not be possible, the regulations replaced voluntary codes which were loosely applied
   • Could they be reformed, simplified or merged? I believe there is already an exercise in the medicines area to already do this and fully support the initiative, BSQR, GLP are relatively straight forward.
   • Can we reduce their bureaucracy through better implementation? Simplify the licensing process for large multi site operations
   • Can we make their enforcement less burdensome? The balance seems about right.
   • Should they be left as they are? YesComment Tags: Blood, BSQR
5. Alan Slopecki on April 10, 2012 at 1:27 pm said:

   Should we scrap the regulations altogether?
   No as they provide assurance that organizations operate Quality Management Systems based on best practice which has been built up through evidenced based learning over the past 40 years and if properly implemented protect patients. Closer alignment between MHRA and the Human Tissues Authority (HTA) resulting in simplicity of joint inspections would help. Some regulations / EU directives are unwieldy for example Blood Safety and Quality Regulations (BSQR) where it is difficult to make evidence based changes to, for example, the annexes concerning donor selection criteria and component specification.

   Conversely some changes made to the EU directive, for example pH limit for platelet concentrates, are then not transcribed into BSQR creating further anololies.
   Could their purpose be achieved in a non-regulatory way (e.g. through a voluntary code?)
   No, a voluntary code is not strong enough to protect public health, as there are significant problems with un licensed operators already. For Blood Safety and Quality Regulations (BSQR) anomalies this brings consistency across EU which would otherwise not be possible, the regulations replaced voluntary codes which were loosely applied, and often assessed in a non standard way.

   Could they be reformed, simplified or merged?
   NHSBT believe there is already an exercise in the medicines area to already do this and fully support the initiative. BSQR, Good Laboratory Practice, and Good Pharmaceutical Practice are relatively straight forward and do not need improvement. The latter two capture learning from 4 decades of inspection and enforcement and should be retained as a cornerstone of the inspection process. Auditing against professional best practice, in parallel with regulatory requirements for the BSQR would be beneficial.

   Can we make their enforcement less burdensome?
   No the balance seems about right but it woukld be advantageous if the inspections of the MHRA for BSQR, the Human Tissues Authority for The Tissue Safety and Quality regulations and the Clinical Pathology Accreditation inspections could be merged, reducing the number of external inspections a Blood Establishment is exposed to in a 2 year cycle of inspection. Having one competent authority for Blood and Tissues might reduce overheads in license management.
   The MHRA have already implemented a risk based approach to inspection and are reducing the frequency of inspections where this is allowed by law, where inspection frequency is proscribed by law, BSQR, they are reducing the number of inspection days where warranted. This approach is supported and should be retained / strengthened.
   It would be good if Inspectors were more consistent in their approach with one inspector taking a risk based view and another reviewing every last detail, this adds to the burden of inspection depending on which inspector is in attendance. More written advice from the regulator might provide a reference point and deliver consistency
   There are unresolved anomalies for example pathogen inactivation of imported plasma for individual blood components or small pools is covered under the BSQR, but if we were to pathogen inactivate all materials this would be considered to fall under pharmaceutical licensing activity.
   On medicines, the licensing of fibrinogen concentrate for congenital but not acquired hyperfibrinogenaemia is a source of frustration, whilst its use instead of cryoprecipitate is not necessarily better; there is no proper debate to resolve the moot issue.
   Should they be left as they are?

   Yes, but MHRA and other bodies need to move forward in a way which ensures standards are maintained but the correct effort / resource is applied to ensure that, for example the risk based inspection process cited above.Comment Tags: Blood, MHRA, NHSBT
6. Graham Rowe on March 28, 2012 at 1:46 pm said:

   I would support the MHRA inspection process as their desire is to improve safety & quality (systems) & we have made significant progress, when working in partnership with MHRA inspectors. CPA seem a very “old boys network” cosy club with a very parochial & pedantic approach & have no real power or influence & tend to be behind the times on important issues such as change control & IT developments & maintaining control of any changes that are implemented.
   In terms of BSQR 2005 SI 2005/50 & subsequent iterations I really think the annexes should be withdrawn as it takes an act of parliament to agree any changes, so they quickly become out of date as they cannot be reviewed on a regualr basis to keep pace with modern transfusion service developments & improvements. I quote a recent example regarding removing an upper pH limit for platelets:

   Directive 2011/38/EU was not transposed into UK law and and the maximum pH level of 7.4 at the end of shelf life in the Blood Safety and Quality Regulations 2005 remains unamended.

   The UK abstained from the vote taken in the Regulatory Committee on Blood and Blood Components on 28 October 2010 concerning the adoption of the Draft Commission Directive amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelet concentrates at the end of shelf life.

   Whilst acknowledging the merit of the proposed amendment, the UK Coalition Government was unable to agree to commit resources to transpose into national law a Directive consisting of a single minor technical amendment to Annex V of Directive 2004/33/EC.

   ” It was not minor for the blood services or we would not have requested the change”!! my input

   As permitted by Article 4(2) of Directive 2002/98/EC, the UK will continue to apply the more stringent provisions of the current text of Annex V of Directive 2004/33/EC that specifies for platelet concentrates an upper pH limit at end of shelf life of 7.4. “which has no evidence to support it” my input

   [Text deleted]

   The limit is not more stringent in terms of safety, in fact it has the potential to cause a platelet shortage if the limit is breached & perfectly good platelets have to be discarded where there is no evidence to support that the upper limit makes any clinical sense. That the Government do not accept or understand that is worrying, what is small & inconvenient to them may be critical for the continued safe supply of platelet components. It seems bizarre the rest of Europe will change but not the UK whose experts made the case with evidence to remove this inappropriate limit. I would suggest that in removing the annexes they are replaced with reference to the current Council of Europe “Guide to the preparation, use & quality assurance of blood components” as it applies europe wide & is updated & reviewed annually so has a chance of keeping pace with developments in the field of blood transfusion.
   I would also appreciate the ability of inspectors to consider the sense & safety aspects of any deviations from guidelines that is evidence based & supports the safety & quality of blood components where there may well be different expert opinion in peer reviewed publications rather than just state that is the law, a bad law does not mean safety is improved as science & improvements can be stiffled or even stalled when it makes perfect sense to make the improvements! The recent example regarding pH proves the point, annexes that are not subject to regular update & review (like SOP’s, MP’s, Competencies etc) can quickly become out moded & out of date. I cannot imagine the MHRA would sanction a review once every 7 years (& counting ) & let any BE or hospital BB get away with it!! So why is it acceptable for BSQR annexes?Comment Tags: Blood, Council of Europe, CPA, Document reviews, MHRA, Parliament
7. Simon Goodwin on March 28, 2012 at 8:51 am said:

   I think you should slow down a bit, it has taken the 7 years since the BSQR 2005 came into law to see real changes in the quality of blood transfusion laboratories. The regulations in themselves are not a bad thing. It must be said that they were implemented in a ‘seemingly’ very heavy handed way, they literally put the fear of God into transfusion laboratories and the stakes were very high, executive teams who did not really understand the depth of the regulations would take a very dim view of a blood bank manager and pathology managers and Transfusion Practitioners should a lab fail. The experience we have had could not be described as pleasant, but it has really improved the quality of the work in the laboraoty and given a better understanding I believe at a higher level of what is required to run and maintain a safe transfusion laboratory.

   Talk to lab managers, get the gist of what the best parts are, how the MHRA through a painful process admittedly has helped lab managers to improve the safety of laboratories.

   From the 6 years in my post I have not decided for myself the best balance between hard regulation and more flexible regulation. If regulation was so flexible, then no one would pay it any attention. Too inflexible and hard and it can cause you to lose the will to live and can destroy sincere motivation.

   The aims of this project overall are good, but I think there is a huge danger of undermining some really good work that has taken place. I have to say that the Tory rhetoric which has been and continues to be put out to the public as a part of the overall denigration of the public sector, i.e. how lazy public sector workers are, how the public sector has bled the country dry again etc, is highly politcal and frankly disgusting nonsense. I am genuinely worried this will get the upper hand. It has to be understood that many parts of the public sector do not have direct comparisons to private industry and are highly complex, so cannot be reduced to a natty headline that would suit the prejudice of most of the [Text deleted].

   Sorry, I am making my point in a political way to but the point is serious, don’t chop away too many safe guards, putting them back into place again takes very much longer than slash and burn.

   Last word, I don’t agree with the other commentators that the NPSA competencies were unachievalble, that view is too simplistic and takes no account of all the benefits that have been gained. Assessments need to be repeated because staff get into bad habits, what is needed is a robust system that allows clinical areas to be self sufficient in assessment. The other way that this works is that staff realise that the system does not endorse poor standards, with so many pressures, unless staff are re-assessed, their standards will drop.Comment Tags: Don’t throw the baby out with the bath water.
8. Jo Hickey on March 20, 2012 at 12:24 pm said:

   It would be nice if these organisations had some understanding of the pressures involved with trying to achieve these standards. I am all for this type of legislation but find the finer nuances can be a little too fine with no joined up thinking between the different organisations. MHRA stick to the standards for manufacturing and laboratories providing patients with components and products do not manufacture anything. Therefore the standards are completely open to interpretation and vary from investigative officer. One will pass something and another won’t. All the inspectors vary by their experience and background and are therefore different in their approach. We have been inspected 4 times and each time different things were said. CPA gives a set of standards to work too and all officers appear to follow the same set of rules. The camaraderie between the 2 is non existent to the point of being resentful. The NHSLA competencies are unachievable but they were told this at the time, choosing to ignore those of us who knew this was an impossible task. Moving the goalposts each year has not helped and now they want to remove transfusion as one of their standards, which won’t help us on the shop floor to push transfusion training. It would be useful to have the standards set in stone, to help us compete with the other priorities in a large DGH.Comment Tags: Blood, Competencies, Legislation
9. Lesley Barsley on March 20, 2012 at 8:26 am said:

   I agree with other comments that the present system is far too bureaucratic with MHRA, NPSA and NHSLA all inspecting and scrutinising organisations with different priorities, to comply with one often causes problems in another area. The competency should be assessed once, and then annual updates, with repeat competency assessment only being necessary if the individual’s practice is in question or incidents highlight problem areas. The 100% compliance is unachievable in an every changing employment organisation with staff moving, joining and leaving continually. It would be far better to say that all transfusions episodes must be undertaken by a competent person in the same manner as we do with drugs and procedures with professional accountability ensuring individual’s compliance.
10. JULIE JOHNSON on March 19, 2012 at 9:17 am said:

    I feel the administrative burden of multiple legislations and inspection requirements on Transfusion Laboratories is excessive given the risk involved in ensuring safe Transfusion Practice both within the laboratory and across the clinical areas. To give an example in the last 8 weeks we have been inspected by CPA, JACIE, NHSLA, on top of HTA year before. Added to this we have 3 yearly NPSA Competencies, annual Transfusion Training to meet Better Blood Transfusion requirements, annual MHRA compliance reports. The BSQR should be replaced with a single CPA inspection process to ISO standards for hospital Transfusion Laboratories, with full GMP / MHRA inspections for NHSBT and the rare hospital laboratory who could be classed as the manufacturer’s of blood / components. In summary I support standards, legislation and guidance to ensure patient safety in the Transfusion process, and would support one body for inspection process (BUT it must be against standards) alongside a simplified annual mandatory statement of compliance to legislation.Comment Tags: BSQR 2005
11. Lee Carter on March 16, 2012 at 2:59 pm said:

    I agree with having legislation, guidelines, and protocols in place. These protect us and patients. Having gone through 3 MHRA inspections, is no easy or joyous task. But why both CPA and MHRA? One meets the expectations of the CPA but fails with the MHRA. The CPA inspections are carried out via our peers, who have knowlegde and expertise in the field. I’m not saying the MHRA is no less experienced, not at all. But, in reference to a previous comment, would it be better done via one thorough inspection? The paper work generated has become immense in some situations. E.g change controls, i’ve never seen a Biochemistry department have to jump through so many loops just to change a fridge or freezer. Definite changes can be made to inspection regimes, standards to be meet and achievalbe goals. Inspect to a standard, as found with a certain group, each inspector had their own ideas.
12. James Piper on March 16, 2012 at 10:48 am said:

    Cold chain requirements and temperature mapping evidence gathering is excessive. It is not based on scientific models.
13. Karen Madgwick on March 15, 2012 at 11:54 am said:

    The individual aspects of the legislation are sensible. However, the monitoring of compliance to the various ‘interpretations’ of the legislation has increased paperwork disproportionately to any potential patient benefits. Working for an NHS Trust I spend approximately 30% of my time producing documentation for NHSLA, CPA, MHRA, HTA and various Haematology / Oncology peer reviews. Often the requirements are subtly different with different inspection bodies indicating compliance and non compliance to the same evidence. A more pragmatic approach linked to risk reduction would be welcome.
14. Claire Atterbury on March 14, 2012 at 1:25 pm said:

    I must state that I was the chair of the NPSA Blood Transfusion Competencies working group BUT although I have implemented the competencies in full across the Trust I would like to change the legislation around competencies in the Laboratory and in the clinical areas so that blood transfusion competency only had to be demonstarted formally and assessed formally once (much like Intravenous drug giving) and then mandatory updates every year rather than redoing competencies every 2-3 yearsComment Tags: Blood, Competencies
15. Charlotte Mustoe on March 14, 2012 at 1:06 pm said:

    Please make inspection of Blood services part of CPA as they already do this and it is duplication of inspections and adminstration costs.Comment Tags: blood comes under CPA to simplify things