Blood Compliance Reports 2019

[TW-B]

This is a good question that I would like to know more on.
From our SLA with these locations I have always had this in place

• "Site A" will pay the agreed fee to "Hospital" for carrying out key tasks (as above in "Hospital" responsibilities) which will exempt "Site A" Hospice from being classified by the MHRA as a Blood Facility

“HOSPITAL” responsibilities:

• “HOSPITAL” will ensure that "Site A" is provided with a copy of the current Trust Transfusion Policy (XXXX) and that "Site A" will be informed in a timely manner of any changes to blood transfusion practice
• “HOSPITAL” will report all serious adverse reactions and events to the Serious Adverse Blood Reactions and Events (SABRE) scheme on behalf of "Site A"
• All cold chain and traceability records will be maintained by “HOSPITAL”
• “HOSPITAL” will temperature map all blood transport containers once per annum
• “HOSPITAL” will complete the annual Blood Compliance Report (BCR) for submission to the MHRA on behalf of "Site A"

Regards

[Rashmi]

Hi All,
I have to confess that I was somewhat confused by this too. However, if you look at this as a 'quality improvement' activity then it makes sense in that responsibilities for compliance is shared with the SLA sites and relies on timely communication etc .Its all very well having SLAs in place but does anyone actually remember or understand their part? I think its a good move for sites to submit a declaration and I have asked mine to copy me in when they finally return their forms, not sure if this is the correct approach, but we are all learning. One of my sites had enthusiastically completed their declaration last week and were a little disappointed when it was mentioned the declaration had to be dated and sent in April as per the guidance notes- you have to smile! but at least they are trying.
I'm sure an email to Mike.Dawe@mhra.gov.uk would help clarify further.
bw

[Shirley-Stagg]

Dear All
Hopefully the Q&A below will be helpful in answering your queries.

The MHRA have recently contacted blood facilities to request the completion of a Blood Facility Declaration form; this should be filled in after 01 April and sent to the MHRA by 30 April 2019. Feedback from hospital blood banks and facilities has alerted us to some confusion over the definition of a blood facility and highlighted some issues with the Facility Declaration Form. To this end we have corrected and clarified the form and provided some clarity on the responsibilities of the blood facility.
The corrected form is available here.

What is a facility?
A ward in a hospital (note this does not mean a ward in the same hospital as the HBB), hospice or care home etc which receives blood from a Hospital Blood Bank for transfusion purposes (but does not perform compatibility tests on site) is defined as a ‘Facility’.

Am I still considered a facility if I don’t store blood and receive fully cross-matched units for named patients on day/time of transfusion only?
Yes.
Regulations 12A and 12B of the Blood Safety and Quality Regulations 2005 (as amended) (BSQRs) for blood facilities concern the requirements to retain certain data, for not less than 30 years, to ensure full traceability of blood and blood components and to report serious adverse reactions and events. These requirements are in place regardless of whether blood is stored. Where there is storage there are, of course, additional requirements in terms of monitoring, maintenance and calibration of any controlled temperature storage equipment.

Do I need to fill in the Blood Facility Declaration form if I have a Service Level Agreement (SLA) in place with the Hospital Blood Bank that states that they will maintain traceability records and report serious adverse reactions and events to SABRE?
Yes, all facilities must fill in a Blood Facility Declaration form and send it to the MHRA.
Where a facility has made arrangements for a Hospital Blood Bank to maintain traceability and submit SABRE reports on their behalf this should be evidenced by a written agreement. The SLA may also cover monitoring, maintenance and calibration of fridges used for blood storage. SLAs do not need to be submitted to the MHRA. The blood facility is still subject to the requirements of the BSQRs in that they must provide the appropriate data for retention and supply the information necessary to allow SABRE reporting within the regulated timescale. The blood facility is also still responsible for maintaining the integrity of the blood components by the proper use of controlled temperature storage equipment including transport boxes. The facility should ensure that it operates in compliance with the BSQRs and has a quality system based on the principles of good practice. This is necessary to confirm that personnel, premises, documentation and quality management including non-conformances support their ability to meet compliance requirements.

What is the purpose of the Blood Facility Declaration form?
It demonstrates that you are aware of the requirements of the BSQRs and your responsibilities as a facility.
Under regulation 15 (6) of the BSQRs, the person responsible for the management of a facility can be served notice to supply information concerning the compliance of the facility. The declaration form is a vehicle to request this information. The form has now been corrected to ensure that it clearly signals that key individuals at the facility have read and understood the BSQRs, have ensured that arrangements have been made for the provision of their responsibilities under regulations 12A and 12B and have a quality system in place that will facilitate compliance with the regulations.

Who should sign the Blood Facility Declaration form?
The declaration form should be signed by the person completing the form and the "person responsible for management of a facility", as defined by Regulation 1 of the BSQRs. Where the provision of services is outsourced to a third party (e.g. private company or other legal entity such as a pathology partnership), the Chief Executive of the outsourced service provider should also sign. The form does not need to be signed by the supplying Hospital Blood Bank.
Please note the form must be signed and scanned not merely typed with the name of the person responsible for management of a facility.

What happens if I have already signed the Blood Facility Declaration form?
If this is the case there is no need to re-sign the corrected version of the form, please just submit the version you already have.

[EClarke]

Many thanks for the above

[Shirley-Stagg]

To clarify - we only need one declaration form from each facility. If your facility receives blood from more than one blood bank, a form for each is not necessary. The declaration covers the responsibilities of the facility in terms of requirements of the BSQRs. Specific arrangements between blood banks and facilities should be covered in agreements between the two parties.