Regulation 19

implement appropriate and adequate processes for the processing, testing and quarantine of all human tissue in the possession or custody of the licensee; and

determine and implement all tests for the human tissue that may be necessary.

develop and implement written policies and procedures for the processing, testing and quarantine of human tissue;

develop and implement written criteria and procedures for the evaluation and assessment of the quality of the human tissue for the purposes of storage or distribution, in particular the safety and quality, and, where applicable, the viability and potency, of the human tissue;

where the human tissue is collected from the body of a deceased donor, ensure that the body is reconstituted with dignity and sensitivity;

ensure that the environment within which the human tissue is collected, processed, tested and quarantined is appropriate to ensure the safety and quality, and, where applicable, the viability and potency, of the human tissue, and the safety of all personnel handling the human tissue;

establish and validate the time period within which the processing and testing of human tissue has to be completed such that the human tissue remains suitable for its intended use at the end of that time period;

ensure that the human tissue is collected, processed and stored within the appropriate time period for the particular type of human tissue to ensure the retention of the biological functions compatible with the intended use of the human tissue;

ensure that the human tissue collected from a donor is not pooled with the human tissue collected from any other donor;

take all reasonable steps to minimise the risk of contamination of the human tissue throughout the processes of retrieval, processing and storage of the human tissue;

use methods validated by the licensee and appropriate protocols for the processing and testing of human tissue, to maintain the safety and quality, and where applicable the viability and potency, of the human tissue and ensure the retention of the biological functions compatible with the intended use of the human tissue;

where the size or dimensions of the human tissue processed by the licensee may be measured — keep and maintain records of the size or dimensions of the human tissue;

maintain the traceability of all materials and equipment by keeping records of each material or equipment used to process any human tissue such that the specific material or equipment used to process the human tissue is known;

before any human tissue (other than ocular tissue) is cryopreserved, ensure that representative microbiological cultures of the human tissue are obtained and tested for bacteria and fungi;

discard the human tissue if any pathogenic and highly virulent microorganism is found to be present, unless treated with an appropriate sterilising procedure that has been validated to eliminate the infectivity of the microorganism;

where the safety or quality, and, where applicable, the viability or potency, of the human tissue may be affected by its release into the licensee’s inventory — quarantine the human tissue while it is being processed or tested; and

ensure that any quarantined human tissue is released into the licensee’s inventory or distributed to any other person only in accordance with the licensee’s written criteria and procedures and with the approval of a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer.