Welsh Blood Service Quality Management System Review

Welsh Blood Service Quality Management System Review

Within this context the WBS is undertaking an ambitious modernisation and service improvement agenda that is extremely resource intensive. Consequently, the WBS is seeking to examine its Quality Management System (QMS).


1 Authority Details


Authority Name and Address

NHS Wales Procurement Services

Unit 2, Charnwood Court,

Nantgarw, Cardiff

CF15 7QZ


Rhian Davies

+44 2920196161

+44 1443846259


Address from which documentation may be obtained

As in 1.1


Completed documents must be returned to:

As in 1.1

2 Contract Details



Welsh Blood Service Quality Management System Review


Description of the goods or services required

Welsh Blood Service Quality Management System Review.

Service Overview

The Welsh Blood Service (WBS) is charged by Welsh Government (WG) to be the supplier of blood components for customer hospitals across NHS Wales. This means it must ensure that supplies are sufficient to meet demand in compliance with relevant regulatory and statutory requirements. Regulation and compliance in healthcare continues to develop both in terms of stringency and increased frequency of change. The introduction of the EU Blood Directive (2002/98/EC) transposed into UK law in 2005 as the Blood Safety and Quality Regulations (SI 50, 2005) (BSQR); this resulted in a phased shift in the extent and stringency of achieving regulatory compliance. As a result, all UK Blood Establishments became subject to regular inspection against the BSQR, by the Medicines and Healthcare Regulatory Agency (MHRA), on a minimum of 2 yearly cycles to ensure regulatory compliance.

The MHRA have powers to remove Blood Establishments’ Authorisation and can issue cease and desist orders to prevent hospital transfusion laboratories from continuing in operation. These powers derive from the relevant UK legislation, which are designed to ensure that appropriate standards of performance are achieved and maintained for the benefit of patients. This inspection process aims to generate a climate of continual quality improvement in the blood supply chain.

The remit of the WBS is wide and also includes the delivery of complex diagnostic services. Specialist immunohaematology reference and antenatal blood testing services are provided to hospitals; and the Welsh Transplantation and Immunogenetics Laboratory (WTAIL) undertakes multifaceted tissue typing to ensure that organ donors are a match for patients requiring transplants. WTAIL also administers the Welsh Bone Marrow Donor Registry and the UK National External Quality Assessment Scheme for Histocompatability and Immunogenetics. The diagnostic services provided by the WBS are subject to a variety of regulatory and licensing authorities/organisations, including the Human Tissue Authority, Clinical Pathology Accreditation UK Ltd and the European Federation for Immunogenetics.

As a result, the quality systems and resources required by the WBS to support its activity and maintain regulatory and statutory compliance, in particular, its Blood Establishment Authorisation and Wholesale Dealers Licence, have significantly increased.

Within this context the WBS is undertaking an ambitious modernisation and service improvement agenda that is extremely resource intensive. Consequently, the WBS is seeking to examine its Quality Management System (QMS); the QMS needs to be able to support core business, whilst allowing the flexibility to enable the organisation to deliver a wide reaching change programme and promote continuous service improvement.


This is an invitation to tender for the review of the existing QMS. The review should provide the WBS with proposals for the realignment of the QMS in order to ensure the required legislative and regulatory compliance whilst increasing its capacity and capability to support operational flexibility, service improvement and best practice.

The review will comprise of two key aspects: (1) diagnostic assessment and (2) future state design.

(1) Analytical Assessment

The supplier is expected to undertake an analytical assessment of the existing QMS across several dimensions. This will include: procedures, processes and resources for implementing quality management with particular emphasis on ‘Validation’, ‘Change Control’, ‘Document Control’ and ‘Supporting Infrastructure’. These activities will include engagement with key stakeholders including interviews with staff and operational managers.

(2) Future Proposals

The supplier will be required to help the WBS recognise where change would be beneficial to help the organisation meet its business objectives and support continuous improvement.

The supplier will develop and select recommended options for the future state design QMS.

Delivery Timescales

The QMS review will need to commence in March 2014 and is anticipated that it will not require more than a total of 7-10 days for completion. In addition, the supplier is expected to undertake a pre-analysis assessment of the current operating model across the key dimensions identified. This data will be used to inform / refine the required scope and approach to the subsequent full analysis and future state proposals.

Supplier Capability

Suppliers will be required to demonstrate expert knowledge of GxP best practice, GAMP® guidelines. Knowledge of the Blood Transfusion regulatory landscape is desirable but not essential. This capability may not be present in a single consultant or consulting organisation. In these circumstances potential suppliers may therefore choose to submit a joint proposal with another consultant or consulting organisation.

Supplier Selection Criteria

Potential suppliers tendering for the provision of this work are required to provide:

– Introduction to company portfolio including outline of bidder’s business and its suitability for the project;

– Evidence of delivering compliance based projects within other public and or private sector environments including ROI;

– Breakdown of costs schedule;

– Project plan that includes how the tender company will approach the project and a timetable for completion

– Contact details of two referees whom may be approached regarding previous projects.

Please also provide CVs of those who will be delivering each element of the project.

With option to add additional requirements at WBS discretion

Conflict of Interest

Bidders are required to confirm that they are not aware of any conflict of interest or any circumstances that could give rise to a conflict of interest in the performance of the proposed contract.


NOTE: The authority is using eTenderwales to carry out this procurement process. Please note this is a separate website and if you are not already registered, registration will be required.

To access eTenderwales, express your interest in this notice and access the tender documentation please visit https://etenderwales.bravosolution.co.uk/web/login.shtml and search for PQQ/ITT code Project_27635/ITT_42198 within the appropriate area.


Notice Coding and Classification

48000000 Software package and information systems

100 UK – All
1000 WALES
1010 West Wales and The Valleys
1011 Isle of Anglesey
1012 Gwynedd
1013 Conwy and Denbighshire
1014 South West Wales (Carmarthenshire, Pembrokeshire, Ceredigion)
1015 Central Valleys (Merthyr Tydfil, Rhondda Cynon Taf)
1016 Gwent Valleys (Torfaen, Blaenau Gwent, Caerphilly)
1017 Bridgend and Neath Port Talbot
1018 Swansea
1020 East Wales
1021 Monmouthshire and Newport
1022 Cardiff and Vale of Glamorgan
1023 Flintshire and Wrexham
1024 Powys


Total quantity or scope of tender

3 Conditions for Participation


Minimum standards and qualification required

4 Administrative Information


Type of Procedure

Single stage – Any candidate may submit a tender.


Reference number attributed to the notice by the contracting authority



Time Limits

a) Time-limit for obtaining documentation

b) Time-limit for receipt of completed tenders
12-03-2014  Time  12:00

c) Estimated award date 31-03-2014


Language or languages in which tenders or requests to participate can be drawn up



Tender Submission Postbox

5 Other Information


Additional Information

(WA Ref:6743)


Additional Documentation


Publication date of this notice