Hospital blood banks
There are certain obligations that hospital blood banks must meet under legislation. Some of which are:
- Operate to International Standard ISO 15189 (Medical laboratories – Requirements for Quality and Competence) of the International Organisation for Standardisation.
- Undergo HPRA inspections of the hospital blood bank, where required.
- Submit a hospital blood bank annual report to the HPRA every year.
ISO 15189 accreditation
In Ireland, the Irish National Accreditation Board (www.inab.ie) supplies laboratory accreditation for medical laboratories to ISO 15189.
For hospital blood banks however, ISO 15189 does not fully meet the EU legislative requirements of Directive 2002/98/EC, specifically Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events).
For this reason, a guidance document on the minimum requirements for blood bank compliance has been developed by the Irish National Accreditation Board.
The document is also used by INAB assessors during the assessment of hospital blood banks to ISO 15189 accreditation and by HPRA inspectors.
HPRA inspections of hospital blood banks
The HPRA may inspect hospital blood banks to ensure that hospital blood banks and persons responsible for the management of them comply with the requirements of S.I. No. 360 of 2005.
Hospital blood bank annual report
Each year, hospital blood banks must complete a report on its previous year's activity. Completed and signed forms should be returned to the HPRA by 1st of March with the associated fee.
You can find guidance on completing the hospital blood bank annual report in our Guide below.