Section one: Contracting authority
one.1) Name and addresses
NHS Blood & Transplant
North Bristol Park
Filton, Bristol
BS34 7QH
Telephone
+44 1179217218
Country
United Kingdom
NUTS code
UK - UNITED KINGDOM
Internet address(es)
Main address
one.3) Communication
Additional information can be obtained from the above-mentioned address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Enhanced Chemical Analysis for Copper Sulphate
Reference number
NHSBT1491
two.1.2) Main CPV code
- 71900000 - Laboratory services
two.1.3) Type of contract
Services
two.1.4) Short description
NHSBT are seeking an enhanced analysis of Copper Sulphate solution which is an in vitro, semi-quantitative reagent used for investigation on the acceptance of blood donor minimum haemoglobin levels when taken from a capillary blood sample. The reagent is used to test a droplet of blood from a donor’s finger, following the use of a lancet, which will be transferred into the solution using a pipette.
NHSBT must update the product conformity profile for this device and must understand the impact when exposed to different variables throughout its formulation process, transportation, use and storage. The profile is to be produced through a number of studies for visual, chemical and therapeutic analysis. In current practice, NHSBT Copper Sulphate solutions are used professionally for male and female specific testing to ensure only suitable donors are bled. Therefore, all studies must be conducted for scenario 1) Female Donation and Scenario 2) Male Donation.
two.1.6) Information about lots
This contract is divided into lots: Yes
Maximum number of lots that may be awarded to one tenderer: 6
two.2) Description
two.2.1) Title
Study 1 - Assessment of products useful life
Lot No
1
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 1 - Assessment of products useful life
This is to be determined through the maximum number of drops of blood that can be added to the copper sulphate before the product returns an inaccurate result under varying conditions.
two.2) Description
two.2.1) Title
Study 2 - Assessment of the device’s stability during shelf life
Lot No
2
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 2 - Assessment of the device’s stability during shelf life
During routine storage at what point does the device start to fail:
(a) Visually
(i) Photostability storage study
(ii) Integrity of the labels when exposed to routine use, light.
(b) Chemically
(i) Chemical analysis storage study
(ii)Theoretical analysis of formula to outline potential chemical interactions that may degrade over time.
two.2) Description
two.2.1) Title
Study 3 - Bacterial contamination
Lot No
3
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 3 - Bacterial contamination
(a) During routine storage, at what point does bacterial ingress occur – Bacterial storage study to be conducted on fresh and end of shelf life product.
(b) If the product is challenged with routine environmental microbiological contaminants does this result in proliferation of the contaminants? - Controlled bacterial challenge study conducted on fresh and end of shelf life product.
two.2) Description
two.2.1) Title
Study 4 – Packaging
Lot No
4
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 4 – Packaging
Study to challenge the packaging to address the impact and potential for:
(a) Product leakage
(b) Product damage – Physical and degradation of the bottles and or seal
(c) Product evaporation
(d) Electrostatic impacts (from packaging material)
two.2) Description
two.2.1) Title
Study 5 – Health and Safety
Lot No
5
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 5 – Health and Safety
Health and safety evaluation in accordance with Directive:
(a) Risk to individuals
(b) Appropriate method of discard
(c) Shipping and Transportation recommendations
two.2) Description
two.2.1) Title
Study 6 – Impacts to Specific Gravity
Lot No
6
two.2.2) Additional CPV code(s)
- 71900000 - Laboratory services
two.2.3) Place of performance
NUTS codes
- UK - UNITED KINGDOM
two.2.4) Description of the procurement
Study 6 – Impacts to Specific Gravity
Assessment of the impact of temperature on the specific gravity of the device:
(a) Theoretical analysis of the device to calculate in the potential changes in Specific gravity that could occur under routine storage conditions
(b) Study protocol to test the male and female device for specific gravity under a range of routine storage temperatures and in use parameters
two.3) Estimated date of publication of contract notice
17 March 2021
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes