Regulation 24

the Clinical Governance Officer or designated personnel has reviewed —

the results of any representative microbiological culture performed on the human tissue, including any variance from the applicable standard for microbiological cultures determined by a Clinical Governance Officer; and

the results of the tests conducted on the donor, including any variance from the applicable standard for determining the suitability of the human tissue for recipients determined by a Clinical Governance Officer; and

the Clinical Governance Officer or designated personnel is satisfied that —

the human tissue is safe and has met the licensee’s written criteria and procedures for distribution; and

where the human tissue is non-conforming human tissue —

there is clinical indication for the human tissue to be used for the transplant or other clinical use; and

having regard to the particular circumstances, there is medical urgency to use the human tissue.

collected from a donor of any type of human tissue who was, at the time of the collection, suffering from any infectious disease applicable to that type of human tissue as specified in the first column of the Second Schedule or any other infectious disease specified by a Clinical Governance Officer; or

determined by a Clinical Governance Officer to not have met all criteria of safety and quality, and, where applicable, the viability and potency, for transplant or other clinical use.