Standard Operating Procedures for HTA samples

Transcription

1 Standard Operating Procedures for HTA Samples Page 1 of 16 Standard Operating Procedures for HTA samples NB the Standard Operating Procedures (SOPs) listed below define the physical laboratory processes emplaced to ensure the particular requirements outlined by the HTA are met. Version Number : 2 Review Date: September 2015 Authors: Lucy Ghali Graham Shennan Position Designated Individual Deputy Technical Manager Approved by: Celia Bell Head of Department Licence No: 12533

2 Standard Operating Procedures for HTA Samples Page 2 of 16 Index Page Title 2 Sample receipt 3 Sample handling 4 Sample storage 5 Transport of samples 6 Sample disposal policy 7 Freezer monitoring and maintenance 8 Cleaning and decontamination fridges, freezers and surrounding areas 9 Freezer failure 11 Reporting failures of HTA processes

3 Standard Operating Procedures for HTA Samples Page 3 of 16 Sample receipt SOP 1 Samples may only be received from pre-arranged sources with whom Middlesex has a Material Transfer Agreement (MTA) in regard to samples covered by the HTA (please refer to HTA Transportation of Human Tissue SOP and HTA Import & export SOP ) 2 All persons handling HTA samples must be, or be under the supervision of, an HTA Designated Person and have passed the in-house HTA training. 3 All HTA sample handling must take place within the designated Hatchcroft laboratories following all local rules. 4 Samples must have been transported in packaging compliant with UN3373, preferably by a courier competent with this activity - report any deficiencies to the Designated Individual (DI) asap. 5 The sample receiver must check that the sample meets all the criteria of the MTA. No samples known or suspected of being infected with a Blood-Borne Virus (BBV) may be received, handled or stored anywhere in Middlesex University. 6 Check the sample(s) is intact and in good condition - report any deficiencies to the Designated Individual (DI) and PD in charge as soon as possible. 7 Check all forms accompanying the sample must have been adequately completed report any deficiencies to the DI asap. Minimum Documentation includes: - Copy of the ethical approval letter - Informed consent form - Risk assessment form - Signed Material Transfer agreement form 8 Assign a unique, standardized anonymizing identifier code to the sample following local process guidance. Thereafter the sample must follow a cradle-to-grave approach for records

4 Standard Operating Procedures for HTA Samples Page 4 of 16 9 Complete all required paperwork 10 Update records immediately

5 Standard Operating Procedures for HTA Samples Page 5 of 16 Sample handling - SOP 1 All sample handling must be done within the defined laboratories, at the appropriate Containment Level and complying with H&S rules 2 Samples must be handled following Good Laboratory Practice and wearing all appropriate PPE (labcoat, nitrile gloves etc) 3 Sample containers must (only) be labeled using the anonymized identifier code assigned. 4 When disposing of HTA samples, these must be disposed as biohazard waste in line with local laboratory rules but using separate, marked (HTA), biohazard containers in accordance with HTA guidance (please refer to HTA Disposal SOP).

6 Standard Operating Procedures for HTA Samples Page 6 of 16 Sample storage SOP New samples 1 Once unique code has been assigned, label anonymized sample(s) 2 Store sample in designated area at appropriate Containment Level. All frozen / refrigerated HTA samples must be stored within one of the designated freezers in H217. Update storage records immediately. 3 Fridges and freezers designated for storing HTA samples must be kept locked at all times other than when in actual use. Used samples 4 Once a sample has been used, complete records according to sample disposal policy 5 When disposing of HTA samples, these must be disposed as biohazard waste in line with local laboratory guidance but using separate, marked (HTA), biohazard containers in accordance with HTA regulations on dignified disposal of human tissue

7 Standard Operating Procedures for HTA Samples Page 7 of 16 Transport of samples SOP Transport of samples to Hatchcroft Labs from another HTA approved establishment 1 HTA samples may be received from another HTA licensed establishment with whom Middlesex have a functional Material Transfer Agreement (MTA) (please refer to HTA Transportation of Human Tissue SOP and HTA Import & export SOP ). 2 Such samples must be transported in accordance with UN3373 and in a manner that ensures the integrity of the sample. Any deviation from expected conditions must be reported as an adverse HTA incident to the DI as soon as possible. 3 Each transfer must be previously agreed formally between the supplying institution and the recipient. Transport of samples between designated labs 4 HTA samples are permitted to be stored and handled only within the HTA designated labs. Samples must be transported safely between labs to avoid loss and risks to health use closed and drop-resistant containers. In the event of spillage, follow local spillage action and report incident to the DI. Transfer of samples to another HTA approved establishment 5 HTA samples may be transported to another HTA licensed establishment with whom Middlesex have a functional Material Transfer Agreement (MTA) (please refer to HTA Transportation of Human Tissue SOP and HTA Import & export SOP ). 7 Each transfer must be agreed formally between the supplying institution and the recipient.

8 Standard Operating Procedures for HTA Samples Page 8 of 16 8 The sender must assure themselves, on each occasion that the samples are received by the intended recipient. Any deviation from expected conditions must be reported as an adverse HTA incident to the DI as soon as possible. 9 Records must be updated in accordance with the local HTA sample disposal policy 10 HTA samples may be transported to another laboratory outside the UK if written confirmation is received from the institution that the samples will be treated in accordance with the consent obtained from the donors and standards expected by the HTA.

9 Standard Operating Procedures for HTA Samples Page 9 of 16 Sample disposal Please refer to the Middlesex University HTA disposal SOP NB - When disposing of HTA samples, the process must follow the waste disposal guidance for the generating lab (either directly as clinical waste or pre-treated by autoclaving followed by disposal as clinical waste) but in order to comply with HTA guidance on dignified disposal of human tissue, these samples must be separated from other biological waste using separately marked (HTA) biohazard containers (bags or sharps bins).

10 Standard Operating Procedures for HTA Samples Page 10 of 16 Freezer maintenance and monitoring SOP Planned Preventative Maintenance 1 All freezers and fridges within H217 are on annual PPM contract 2 Any requirement to call out for emergency repair should be reported directly to the emergency number on the fridge freezer and advise the technical team. In-house maintenance 3 Users must ensure that the fridge / freezer inlet filter is kept clear of obstruction and the filters cleaned regularly to ensure they do not block 4 Users must undertake a rota of regular defrosting and decontamination of freezer (and surrounding floorspace). Within this rota, each freezer should be decontaminated once per annum This must be logged and recorded on the individual freezer. Alarms 5 All freezers and fridges within H217 are alarmed locally. 6 All freezers and fridges within H217 are monitored regularly for temperature fluctuations. This monitoring does not activate any alarms and must be reviewed monthly. Fluctuations can give insight to poor usage and to potential equipment failure. Results to be communicated to responsible users / posted on freezer doors.

11 Standard Operating Procedures for HTA Samples Page 11 of 16 Cleaning and decontamination of freezers and surrounding areas SOP Periodic defrosting and decontamination 1 The identified person in charge of each freezer or fridge containing HTA samples is responsible for periodic defrosting the freezer to clear any ice and to decontaminate the freezer and the floor around it. Within the rota each freezer should be defrosted and decontaminated annually. 2 Switch on back-up freezer if not already running and allow to stabilise at desired temperature 3 Transfer samples to the backup freezer. 4 Defrost the original freezer during working hours to ensure no floods occur clearing any run-off immediately in accordance with local disinfection policy. 5 Once defrosted, disinfect the freezer in accordance with local disinfection policy. 6 Move the freezer out of position to enable the surrounding area to be decontaminated. Report any dropped samples found to the DI. 7 Move the freezer back into position and switch on. 8 When steadily running at correct temperature move the samples back to original freezer. 9 Switch off back-up freezer and decontaminate 10 Report any undesired occurrences to the DI asap. 11 Note the date of defrosting and decontamination upon the door of the freezers. 12 Fridges should also be subject to periodic decontamination.

12 Standard Operating Procedures for HTA Samples Page 12 of 16 Fridge / freezer failure SOP NB In the event of freezer failure the following SOP must be followed Investigation 1 Whether responding to local alarm, remote alarm or to observance of unacceptable temperature fluctuation, the USER must investigate the issue and decide on the most appropriate way forward from the below. NB - The specific Air-Conditioning to the H217 suite should also be checked to ensure it is set and operating to agreed parameters. NB any unexpected alarm should be reported to the DI asap as an undesired occurrence. Air-Conditioning to H217 suite 2 If air-conditioning to the H217 suite is observed to have failed or settings to have changed from agreed working parameters, the USER must inform Unicare immediately and notify the deputy Technical Manager as well as other users of the suite. NB any unexpected alarm should be reported to the DI asap as an undesired occurrence. Temporary failure (alarm) or unacceptable temperature variation 3 The responsible USER must ascertain whether the fault lies with USE of the equipment (eg blocked inlet filter or door being left open too long or unit being unplugged) or with the EQUIPMENT itself as below.

13 Standard Operating Procedures for HTA Samples Page 13 of 16 Failure of individual freezer/fridge 4 The USER should call the maintenance company called to fix problem move all samples to back-up freezer (once steadily running at desired temperature). USER must ensure the unit is safe to be worked on (decontaminate if necessary) by the PPM contractor and arrange Lab-Permit-to-Work or accompany the contractor at all times. 5 IF there is no available freezer of suitable capacity or temperature range, the PPM contractor should be contacted immediately to arrange a piece of loan equipment to cover for down time until the unit is repaired. Failure of H217 suite In the event of failure of the entire H217 suite, the USER must contact Unicare immediately to investigate in case of power failure to the suite. NB - The specific Air-Conditioning to the H217 suite should also be checked to ensure it is set and operating to agreed parameters. IF the fault is not immediately repairable, process must be initiated to move equipment to another safe and secure location on the Hendon campus. Failure of power to the Hendon Campus No alternative yet defined Referenced SOPs Middlesex University HTA SOP Disposal of Human Tissue Middlesex University HTA SOP Transportation of Human Tissue Middlesex University HTA SOP Management of Records Middlesex University HTA SOP Import/Export of Human Tissue

14 Standard Operating Procedures for HTA Samples Page 14 of 16 Contacts LH Middlesex University represented by Jan Williams DI Lucy Ghali Lead PDs Hemda Garelick Frank Hills Lygeri Demetriou Health & Safety Graham Shennan Declaration I confirm that I have read and understood fully the Middlesex University Standard Operating Procedure for HTA Samples and agree to follow the procedures laid out in this document. Print Name Signature Date

15 Standard Operating Procedures for HTA Samples Page 15 of 16 Reporting failures of HTA processes SOP The HTA requires that any Serious Adverse Events are reported to them. The Human Tissue Authority Code of Practice: The removal, storage and disposal of human organs and tissue defines Serious Adverse Events thus: Serious adverse event: Any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolonged hospitalisation or morbidity As a monitoring process to regularly look at minor failures and hopefully prevent major failure, the following SOP applies. 1 Any failures relating to HTA processes must be reported to the Designated Individual immediately for review and action in addition to reporting to other relevant persons. Such events would include: a Any accident or near-miss occurring within an authorized laboratory (all accidents and near misses must also be reported through the standard process via the Deputy Technical Manager (NS)) b Any loss of samples in transit or in use c Any failure of freezer holding HTA material (or near miss) d Any loss (or near miss) of samples resulting from failure of other equipment or processes 2 In the event of a Serious Adverse Event, the DI must make a full report within 24 hours to the: Head of Department (Natural Sciences) Dean of School (Science and Technology) HTA licence holder (Middlesex University) The HTA

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