Reprocessing of Sterile Bifurcated Needles

This is a contract for the collection in phases (from various UK depots) of 62 469 100 bifurcated needles for re-sterilization, re-packaging and delivery back to various depots across the UK with a 5-year sterility shelf life and by the following dates:

Date: Quantity:

• 02/2020: 6 467 100,

• 05/2020: 8 001 000,

• 06/2020: 8 000 000,

• 07/2020: 16 001 000,

• 08/2020: 8 000 000,

• 09/2020: 8 000 000,

• 10/2020: 8 000 000.

All applicable legislation must be followed and certification obtained (including CE Certification) in order for the product to be suitable for its original manufactured purpose for the required shelf life.

Additional information: The works, supplies or services can be provided only by a particular economic operator for the following reason:

absence of competition for technical reasons

Explanation:

NHS Supply Chain believes that the award of this contract without prior publication of a contract notice in OJEU is lawful under Article 32(2)(b)(ii) of Directive 2014/24/EU.

In providing the service, the service provider must:

• comply with all legislation (including certification requirements) which were followed by the manufacturer and supplier of the original product and/or such other legislation as is now applicable to bifurcated needles to ensure the goods are fit for purpose (that being use in the healthcare sector), and,

• take on legal liabilities associated with the manufacture of the needles (for their entire new shelf life) - effectively as original manufacturer - when they are returned to NHS Supply Chain, and,

• ensure that the entire stockpile of 62 469 100 bifurcated needles is re-sterilized, re-packaged and returned with a new 5-year shelf life before the shelf life of the current stockpile expires (timescales for the phased performance of the service were detailed in the associated Prior Information Notice noted below).

As indicated above this is an extremely specialised technical service, with stringent associated legal obligations, which is required to be performed upon a large number of medical devices within a strict timescale.

The contract requirements are critical and essential by virtue of the subject matter of the contract. They neither have the intention nor effect of artificially narrowing down the parameters of the procurement.

In order to 'test the market', NHS Supply Chain published a Prior Information Notice on 3.4.2019 setting out its requirements and its intention to publish a Contract Notice. However, this PIN did not receive any expressions of interest (or indeed any informal enquiries) from service providers.

This lack of response has led NHS Supply Chain to the conclusions that:

• (i)no supplier (other than the one identified in this notice) has the technical and other capacity to take on these obligations indicated above and to deliver the service required;

• (ii)it is extremely unlikely that any capable provider would bid for the contract if a call for competition was then issued via the intended Contract Notice (when would then excessively delay the award); and

• (iii)it is reasonable to conclude that competition for this award is absent for technical reasons.

The service provider cited in this notice has signaled that it is in a position (in terms of technical capacity etc) to perform this contract on the terms outlined above. Given the nature and importance of the service required, it has to be outsourced and awarded to a single supplier so, in the circumstances, the authority does not believe that there is any reasonable alternative or s