Document Control Title Controlled Storage of Blood and Blood Products Standard Operating Procedure Author Transfusion Laboratory Manager Author s job title Transfusion Laboratory Manager Directorate Clinical Support Services Department Transfusion Version Date Issued Status Comment / Changes / Approval 0.1 May 2007 Draft Based on MHRA requirements 3.0 Aug 2007 Final Approved by Transfusion Laboratory Manager 4.0 May 2009 Final Approved by Transfusion Laboratory Manager 5.0 May 2011 Final Approved by Transfusion Laboratory Manager 6.0 Jun 2014 Final Approved by Transfusion Laboratory Manager 7.0 Oct 2014 Final Approved by Transfusion Laboratory Manager 8.0 Jan 2016 Final Approved by Transfusion Laboratory Manager Main Contact Transfusion Laboratory Manager Transfusion Laboratory North Devon District Hospital Raleigh Road Barnstaple, North Devon, EX31 4JB Lead Director N/A Document Class Standard Operating Procedure Distribution List Community Transfusion Champions Superseded Documents None Issue Date Review Date February 2016 February 2019 Consulted with the following stakeholders Community Transfusion Champions Community Matrons Approval and Review Process Hospital Transfusion Team Target Audience Transfusion Laboratory Staff Community Hospital Staff responsible for blood banks Distribution Method Trust s internal website Review Cycle Three years Contact responsible for implementation and monitoring compliance: Transfusion Laboratory Manager Education/ training will be provided by: Transfusion Laboratory Manager Transfusion Practitioner (Eastern Hospitals) Page 1 of 10
Local Archive Reference Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-11 Local Path: Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-11 File name: Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-11 Policy categories for Trust s internal website Tags for Trust s internal website (Bob) (Bob) Pathology/Blood Transfusion Page 2 of 10
CONTENTS DOCUMENT CONTROL... 1 1. BACKGROUND... 4 2. DEFINITIONS... 4 3. SCOPE... 4 4. STORAGE OF BLOOD AND BLOOD PRODUCTS... 4 4.1. BLOOD... 4 4.2. PLATELETS... 5 4.3. FRESH FROZEN PLASMA AND CRYOPRECIPITATE... 5 4.4. HUMAN ALBUMIN SOLUTION... 5 4.5. IMMUNOGLOBULIN PREPARATIONS... 5 4.6. COAGULATION FACTOR CONCENTRATES... 5 5. MAINTENANCE OF STORAGE FACILITIES... 6 5.1. MAINTENANCE CHECK LIST.... 6 5.2. DAILY MAINTENANCE... 6 5.3. WEEKLY MAINTENANCE... 6 5.4. ALARMS - ACUTE SITE... 6 5.5. SERVICING AND CALIBRATION... 7 5.6. TEMPERATURE MAPPING... 7 6. CONTINGENCY PLANNING... 7 6.1. BLOOD BANK FAILURE... 7 6.2. PLATELET AGITATOR FAILURE... 8 6.3. FFP FREEZER FAILURE... 8 6.4. DRUG FRIDGE FAILURE... 8 7. TRAINING AND COMPETENCY ASSESSMENT... 8 7.1. ACUTE SITE... 8 7.2. COMMUNITY HOSPITALS... 8 8. REFERENCES... 9 9. ASSOCIATED DOCUMENTATION... 9 Page 3 of 10
1. Background The storage conditions for blood and blood products are defined by NHS Blood and Transplant (NHSBT) to ensure the safety of all blood products for transfusion. They are laid out in the Guidelines for the Blood Transfusion Services in the UK 1 and have been adopted by the Northern Devon Healthcare Trust. In addition the Medicines and Healthcare Regulatory Agency (MHRA) require evidence that the cold chain has been maintained i.e. that we can prove that blood and products have been stored correctly. 2. Definitions T Blood: Red blood cells in additive solution, red cell concentrates. Platelets: Pooled platelet concentrate, apheresis platelets Frozen Blood Products: Fresh Frozen Plasma (FFP), Cryoprecipitate 3. Scope 3.1. All staff involved in blood transfusion have a responsibility to ensure safe transfusion practice is followed. This includes ensuring that blood and blood products are correctly stored. 4. Storage of blood and blood products 4.1. Blood Blood must be stored at 4 o C (+/- 2 o C) in a certified blood bank refrigerator fully compliant with BS4376 Part 1 1991. All blood banks are fitted with a temperature recorder and an audible alarm. There are 4 blood bank refrigerators on the NDDH site: Main Stock : Within Pathology Laboratory Ward Bank : Outside Pathology Level 1 Theatre Bank: Main Theatre Entrance Level 3 Maternity Unit: CDS1. Access to the main stock blood bank is strictly limited to Pathology staff. Access to the other blood bank refrigerators in the acute Trust is controlled by the Blood Audit and Release System (B.A.R.S.). This is a computerised system which audits all activity and only staff who have been B.A.R.S. trained are able to access the blood banks. Blood bank refrigerators are also located at each hospital which undertakes blood transfusions. These are as follows: Bideford Hospital Torrington Hospital Page 4 of 10
Holsworthy Hospital South Molton Hospital Ilfracombe Tyrrell Hospital Axminster Hospital Exmouth Hospital Honiton Hospital Okehampton Hospital Ottery St Mary Hospital Seaton Hospital Sidmouth Hospital Tiverton Hospital North Devon Hospice Stratton Hospital These blood banks must be positioned in an area which is manned 24/7 to ensure any alarms are heard and acted upon. Alternatively they must be fitted with a remote alarm to a suitable area. Blood bank refrigerators may only be used to store blood and blood products. Separate storage facilities are available for non-blood products and drugs. 4.2. Platelets Platelets must be stored at 22oC (+/- 2oC) with continual agitation. The platelet incubator is located in the Pathology Laboratory and access is strictly limited to Pathology staff. The agitator is fitted with a temperature recorder and an audible alarm. 4.3. Fresh Frozen Plasma and Cryoprecipitate Frozen blood products must be stored at 30oC or below. The freezer is located within the Pathology laboratory and access is limited to Pathology staff. The freezer is fitted with a temperature recorder and an audible alarm. 4.4. Human Albumin Solution This must be stored in the dark at <25oC. Stocks are held in the laboratory and are issued to the wards on a named patient basis for immediate use. Product is issued one bottle at a time to help prevent the product being stored on the wards if not used. 4.5. Immunoglobulin Preparations Immunoglobulin preparations, e.g. anti-d are stored in the blood transfusion pharmacy refrigerator at 4oC. These are only issued on a named patient basis for immediate use. Storage on the wards is not permitted. 4.6. Coagulation Factor Concentrates Freeze-dried coagulation factors are stored in the blood transfusion pharmacy refrigerator at 4oC. These are issued on a named patient basis. Patients who store the product at home have suitable refrigerator space reserved for this purpose Page 5 of 10
5. Maintenance of Storage Facilities 5.1. Maintenance check list. The maintenance check list T-RECORD SHEET-24 should be completed as described in 5.2 and 5.3 below. 5.2. Daily Maintenance All the storage facilities are subject to daily maintenance checks. These checks cover the temperature display, the recorded temperature, a check on the temperature chart, the pen nib and the expiry date of any blood in the fridge. These checks are recorded on a day sheet and this sheet is returned to NDDH Transfusion Laboratory on a weekly basis with the chart recording. 5.3. Weekly maintenance All the storage facilities are fitted with temperature chart recorders. The temperature charts are changed weekly. Completed charts are stored in the laboratory for 30 years. The information from the temperature charts is recorded in the Transfusion Laboratory. Any discrepancies must be noted and senior staff informed. Weekly maintenance also includes an alarm check and a cleaning check. 5.4. Alarms - Acute site All the blood and product storage facilities on the acute site have an audible alarm. All are also alarmed to switchboard to ensure prompt action if the alarm is activated outside laboratory hours. If the alarm sounds, contact the Blood Transfusion Laboratory on 2327 or out of hours the on-call Haematology BMS via switchboard. The laboratory will arrange for an engineer to check the equipment. Community Hospitals If the alarm sounds, check the equipment for obvious faults e.g. the door has been left open or the unit has been disconnected. If there is no obvious cause for the alarm then inform a senior member of staff who will arrange for an engineer to visit. Any blood which is in the fridge must be set up within 30 minutes of a temperature failure. If this is not possible then it must be discarded. Inform the blood transfusion laboratory (01271 322327) immediately if there is a fridge failure. For hospitals supplied by RD&E contact both Transfusion Laboratories (01392 402467) Following repair of the equipment the laboratory must be informed. The transfusion manager will then arrange to have the equipment mapped. (see2.4 below) Page 6 of 10
Community Hospitals not manned 24/7 Several of the community hospitals are closed overnight and at weekends. Special arrangements are in place for monitoring the alarm when the hospitals are closed. The alarms are connected to an external company who also monitor the burglar and fire alarms for the building. Should the alarm be activated then the company will inform NDDH switchboard who will inform the on call BMS. The on call BMS will make a note that the alarm has been activated and ensure that the cause is investigated as soon as possible. He/she will also inform RD&E Transfusion Laboratory or on call BMS. BMS staff will make arrangements to have any blood in the fridge returned and will ensure that no further blood is issued until the situation has been resolved. 5.5. Servicing and Calibration The blood bank refrigerators and the FFP freezer are on contract for annual service by Labcold. The service includes a calibration check and adjustment if required. Service records are held on Q Pulse. The platelet agitator is serviced and calibrated by Deva Medical twice annually. MHRA regulations require that accreditation certificates of equipment used for calibration are available and these are also stored on Q Pulse. 5.6. Temperature Mapping MHRA regulations require that the temperature of the blood bank fridges is mapped on an annual basis and also after any repair or move. This is achieved by placing Comark temperature loggers in the fridge at the top middle and bottom, front and back of the fridge. These should be left for 24-48 hours and then removed and the data uploaded onto a PC. This data should be examined. If satisfactory then save for future inspection if required. If the temperature data is unsatisfactory (i.e. any area of the fridge does not conform to the required temperature of 2-6oC) then inform a senior member of staff who will arrange for an engineer to visit. The fridge may not be used until the temperature has been corrected. A suspension notice will be issued by the laboratory and the fridge put out of service. Any blood must be removed and alternative storage arranged. Senior staff will decide whether to discard the blood. 6. Contingency Planning 6.1. Blood bank failure Should any of the blood banks fail then the blood must be immediately moved to an alternative blood fridge. If the main stock fridge fails, then the blood must be moved to the ward bank and the fridge must be locked to prevent unauthorised access. If a fridge in a community hospital fails, then any blood must be quarantined according to the procedure and returned to the issuing blood bank. Page 7 of 10
6.2. Platelet agitator failure Should the platelet agitator fail, NHSBT advice is that the platelets may be used for a period of up to 24 hours. If they are unable to be used within this time then they must be discarded 6.3. FFP Freezer failure Should the FFP freezer fail there are 2 freezers in Biochemistry which run at -80oC. The frozen blood products may be transferred to these until the freezer is repaired. Please note there is no chart recorder but the freezers do have an audible alarm so Biochemistry BMS staff should be made aware that the blood products have been transferred. 6.4. Drug fridge failure Many of the batch products may safely be stored up to 25oC. There is a list on the door of the fridge which indicates the storage temperature of the products. Any which require to be stored at 2-8oC should be transferred to the blood bank as a temporary measure. Those which can safely be stored up to 25oC may be placed under the bench as a temporary measure. Please note: The manufacturers have no data on storage below 0oC so if the fridge should fall below this temperature then the products must be discarded. 7. Training and competency assessment 7.1. Acute site Laboratory staff will receive training on recruitment. Update training will be available on rotation into Transfusion. The transfusion laboratory will arrange training for all new portering staff who require access to the blood banks. Please contact the laboratory on 2327. Clinical staff who require training for B.A.R.S. should access STAR and complete the Transfusion sections relevant to their role prior to booking B.A.R.S. training. Competency assessment for laboratory staff and portering staff is on recruitment and is included in the annual re-assessment. 7.2. Community Hospitals Transfusion Champions will be appointed for each community hospital. They will cascade training to staff as appropriate. A competency assessment on the Management of Community Blood Fridges was approved in February 2014. All staff must be competency assessed on a regular basis. Please contact the laboratory on 01271 322327. Page 8 of 10
8. References Guidelines for the Blood Transfusion Services in the UK (Red Book) 8th edition 2013 EU guide to Good Manufacturing Practice 2014 (Orange Book) NDHT Blood Transfusion Policy version 4.0 (BOB) Clinical Guidelines for Transfusion, NDDH Guidelines. (BOB) 9. Associated Documentation Blood Transfusion Policy version 43 Clinical Guidelines for Blood Transfusion4 T-SOP-58: Temperature Mapping of Storage Units T-SOP-68: Management of Community Blood Banks Page 9 of 10
Appendix 1. T-RECORD SHEET 42 Page 10 of 10