Compliance management service sought for national organ procurement

The HSE has gone to tender for the provision of a quality and compliance consultancy service for national organ procurement.

The successful tenderer will be appointed for a period of two years with an option to extend for a further period of 12 months.

“The overriding requirement from this service provider will be provision of quality and compliance management, oversight, and development for the national organ procurement service (NOPS) quality system at Organ Donation Transplant Ireland (ODTI),” according to tender documents.

Compliance is in the context of the European directives on transplantation.

On the basis of these directives, a framework for quality and safety of human organs intended for transplantation has been developed to set out the requirements and regulatory functions in the area in Ireland.

“The main principle is that careful attention is paid to all aspects of quality of the entire process from organ donation to transplantation or disposal of organs,” according to the tender.

“In order to deliver this, ODTI require a quality and compliance management service input to provide the required expertise.”

NOPS is the clinical team responsible for the coordination of organ donation and retrieval of human organs for transplantation and is the only authorised procurement organisation in Ireland for the provision of these services.

Licensing is provided on the basis of satisfactory reported inspections on a two-yearly basis. Inspections are carried out by the Health Products Regulatory Authority, which also has responsibilities as a competent authority under the EU directives.

The successful tenderer will manage, oversee, and develop the NOPS quality system within the ODTI.

This responsibility will include the day-to-day management and maintenance of the quality management system of NOPS ensuring it meets the requirements of the legal framework.

The provider will also have a quality role in relation to the broader functions of ODTI.

“Tenderers should note that the available budget will not be disclosed; however, as HSE has a very limited budget available for this service, it seeks to achieve value for money,” according to the tender.

The closing date for the tender is 15 August.