Chris Elliott, Chair of the IBMS Specialist Advisory Panel (Transfusion), discusses changes in the MHRA assessment and inspection regime for hospital blood transfusion laboratories.
On 27 February a letter (see below) was distributed by the MHRA via an email list derived from the SABRE reporting system. This draws hospital transfusion laboratories’ attention to changes and issues in the regulatory compliance system for these laboratories. The information included in the letter was discussed prior to release at the most recent Blood Consultative Committee (BCC), attended by myself and colleagues. Following a recent IBMS meeting, I was ask to write additional background information for publication in The Biomedical Scientist.
Every year, to remain compliant with Blood Safety and Quality Regulations, each hospital blood transfusion laboratory must submit a Blood Compliance Report (BCR) to the MHRA. The BCR collects a range of information from which the MHRA makes an assessment of each laboratory and using a pre-set scoring system (not published) gives them a risk score for each laboratory. These scores determine which laboratories the MHRA will inspect that year, although a small group of labs (five to six) with low scores are selected as a random sample for inspection, so no laboratory could ever say it was not going to get inspected in any given year.
In previous years the MHRA would communicate whether a laboratory had been selected for inspection following the assessment process, usually in July. However, this is now changed so that only confirmation that assessment has occurred will be communicated and laboratories will only be informed of inspection a maximum of one week prior to the inspection taking place. The intention is to try and ensure that laboratories maintain a compliant level of quality management irrespective of whether they are due for inspection or not. The MHRA retains the authority to inspect without any notice where they have received information that leads them to believe that there may be a significant risk to patient health.
Dear Colleague,
You are receiving this email because you are either registered on SABRE or are included in your hospital’s distribution list for the SABRE account email address.
If you are not the Hospital blood bank manager, please forward it to your HBB manager and/ or HTT.
The following message has also been posted on SABRE and the MHRA blood forum.
From 01 April 2018, MHRA will be changing its approach to inspection notification for hospital blood banks (HBBs).
Following submission of the annual blood compliance report, HBBs will be provided with a letter to confirm that assessment has been completed, without indicating the outcome (i.e. inspection or no inspection). All inspections will be performed with a maximum of 7 days’ notice.
This action is being taken because several MHRA hospital blood bank inspections during 2016 and 2017 identified good practice failures resulting in compliance management escalation, or regulatory action. Failures were often linked to lack of resources and/or failure of management oversight. Indicators suggest that organisations may reduce focus on regulatory compliance until an inspection notification is received.
Performing inspections with a shortened notice period will encourage senior management to focus on maintaining compliance, rather than waiting until notified of an inspection date.
MHRA also plans to publish the outcomes from hospital blood bank inspections. This will act as an educational tool for others, and further highlight the importance of on-going compliance.
Compliance reports and inspections are used to determine an organisation’s compliance with the Blood Safety and Quality Regulations 2005 (SI 2005/50, as amended). The Chief Executive of a hospital managed by a health service body (or in the case of an independent hospital the Registered Person) is responsible for compliance. Transfusion laboratory managers are requested to make their Chief Executive / Registered Person aware of this change in practice.
David Churchward
Expert GMDP Inspector
IE&S MHRA
151 Buckingham Palace Road
London
SW1W 9SZ
UK
Prior to 2016 the MHRA had seen a reduction in major non-compliances following inspections, however, over the last two years there has been an upsurge in major non-compliances raised following site inspections. It was also true that some sites inspected had considerable new documentation in place and, while the inspectors expect a certain amount of “new paint” in the quality management system, sometimes it was evident that a lot of work had gone in rapidly to try and bring a lab up to standard, reducing confidence of compliance prior to and following the inspection. While on a couple of inspections the information in the submitted BCR bore little resemblance to the processes seen at the inspection, this is an extremely serious situation and, while the MHRA would not go into any detail as to how this was being dealt with, the legislation clearly indicates that provision of fraudulent or misleading information is a criminal offence, punishable by fines or imprisonment.
Expectations
It is important to note that when the MHRA states “failures were often linked to lack of resources and/or failure of management oversight”, the management that they are referring to is not blood bank manager or even Pathology Services Manager level, but that of Chief Executive and Trust Board. The regulators expectation is that any serious compliance issues (particularly those relating to resources) would be raised to and acknowledged by the trust executive. What many higher trust managers fail to realise is that this legal regulatory compliance is not a blood transfusion laboratory issue but a trust compliance issue and that is why there is the requirement for Chief Executives to sign the BCR. This is why the end of the letter contains a request to ensure that Chief Executives are informed of these changes.
Agreements
The other significant change is the intention to publish in full all inspection reports, as prior to this year these were kept between the MHRA and each institution inspected. While this will undoubtedly act as an “educational resource” what has not been stated is what effect this may have on institutional reputation or CQC compliance. There is a move within central government to rationalise and integrate regulation and assessment, so there is a formal agreement between the MHRA and HTA to share information on compliance issues so that each can do their job more effectively. While there is no current formal agreement between MHRA and CQC, it seem likely that the CQC would be very interested in inspection reports from the MHRA detailing major non compliance. The CQC does have standards specifically detailing requirements around blood transfusion and laboratories in general, but they rarely do detailed assessment of labs if compliance with MHRA and UKAS can be demonstrated. This may well encourage higher management to take more of an interest in the health of laboratory quality management. This is important to the MHRA, for while they wield considerable power, the “nuclear option” of closing laboratories is not one to be taken lightly because of the huge impact it has on the acute healthcare system supported by that laboratory (stops surgery, obstetrics, trauma, medical anaemia management, so most of the hospital really). Therefore, they are interested in any mechanism that enables them to encourage maintenance of quality management compliance without resorting to closure.
The MHRA letter does mention the blood forum, which can be found on its website, and this is a valuable resource for laboratories with communications from the MHRA released here and also the ability to discuss issues and solutions (in confidence as the inspectors will not use these as a reason to inspect). Staff in senior transfusion laboratory positions and in pathology quality manager positions should check the forum regularly, even if they do not contribute (although the wider the active contribution the more useful the forum will be).
While the letter is confined to hospital blood transfusion compliance the issues raised will resonate throughout pathology disciplines and if this helps raise trust management awareness of pathology quality management (its requirements both in terms of activities and resources) then this can only be of benefit.
My big concern is that hospital transfusion laboratory staff, especially those in senior posts, will face even more pressure than they already do now in ensuring compliance and be held accountable for this. Given that in many situations they do not have and are unable to get the resources/capacity to deliver the mandatory requirements, this is unreasonable. The full support of pathology and trust management, especially during periods of change, will be required to enable successful maintenance of the legally required standards of quality management in blood transfusion.
Chris Elliott is Chair of the IBMS Specialist Advisory Panel (Transfusion) and IBMS representative on MHRA Blood Consultative Committee (BCC). He would like to thank BCC colleagues Stephen Bassey and Joan Jones for reviewing this article before submission.
