Awaiting assessment? Yes No Conditional approval date: DD/MM/YYYY Any further information, such as explanation of the activities covered by the accreditations: To be completed by the Designated Individual Does the establishment have any satellite sites? Yes No If yes, please complete the below information for each satellite site. If you have more than two satellite sites you can copy and paste this part of the form onto a separate sheet. Satellite 1 Name: Address: Postcode: Activities to be licensed under the Human Tissue Act 2004 The storage of relevant material which has come from a human body, for use for Scheduled Purposes other than transplantation under the Human Tissue Act 2004 Activities to be licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 Procurement Testing Processing Storage Distribution Import Export Person(s) Designated at the site Job title Email address Telephone number Primary: Additional: Additional:
Please explain what responsibilities the staff at the satellite site have for meeting the consent requirements of the Human Tissue Act and Codes of Practice Does the satellite store relevant material on behalf of any organisation other than the hub? Yes No If yes, please provide details. Does the satellite supply or use relevant material for research purposes? Yes No Please state how many adverse events have occurred at the satellite in the last year Does the satellite have any form of accreditation, such as CPA, MHRA, JACIE, ISO etc? Yes No If yes, please provide the following information for each accreditation: Accrediting body: Date accreditation obtained: Current status: For each tissue type please state how many units on average are procured, processed, stored, distributed and imported / exported by the satellite each year. Please continue on a separate sheet if necessary. Tissue type: Usage: Average number of units: Procured Tested Processed Stored Distributed Imported Exported Procured Tested Processed Stored Distributed Imported Exported Procured Tested Processed Stored
PFE2d Staff are provided with appropriate protective clothing and equipment that minimise the risk of contamination of tissue and /or cells and the risk of infection to themselves. Not applicable Not met Partially met Almost met Fully met or exceeded PFE3 There are appropriate facilities for the storage of tissues and cells, consumables and records. PFE3a Tissues, cells, consumables and records are stored in secure environments and precautions are taken to minimise risk of damage, theft or contamination. Not applicable Not met Partially met Almost met Fully met or exceeded PFE3b There are systems to deal with emergencies on a 24 hour basis. Not applicable Not met Partially met Almost met Fully met or exceeded PFE3c Tissues and/or cells are stored in controlled, monitored and recorded conditions that maintain tissue and/or cell integrity. Not applicable Not met Partially met Almost met Fully met or exceeded PFE3d There is a documented, specified maximum storage period for tissues and/or cells. Not applicable Not met Partially met Almost met Fully met or exceeded
PFE5b Critical equipment is maintained and serviced in accordance with the manufacturer’s instructions. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5c Equipment affecting critical processes and storage parameters is identified and monitored to detect malfunctions and defects and procedures are in place to take any corrective actions. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5d New and repaired equipment is validated before use and this is documented. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5e There are documented agreements with maintenance companies. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5f Cleaning, disinfection and sanitation of critical equipment is performed regularly and this is recorded. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5g Instruments and devices used for procurement are sterile, validated and regularly maintained. Not applicable Not met Partially met