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Management of Community Blood Banks Standard Operating Procedure

of 18 Pathology Management of Community Blood Banks Standard Operating Procedure V8.0 09FEB16

Document Control

Title


Author Blood Transfusion Laboratory Manager

Author’s job title Blood Transfusion Laboratory Manager

Directorate Clinical Support Services

Department Transfusion

Version Date

Issued Status Comment / Changes / Approval

1.0 16.02.12 Final Based on Good Manufacturing Guidelines (MHRA)

2.0 16.10.12 Final Transfusion Laboratory Manager







Main Contact Blood Transfusion Laboratory Manager Pathology Department North Devon District Hospital Barnstaple

Lead Director N/A

Document Class Standard Operating Procedure

Target Audience Laboratory staff and staff involved in blood transfusions at Community Hospitals

Distribution List Transfusion Champions at Community Hospitals?

Distribution Method Trust’s internal website

Superseded Documents None

Issue Date February 2016

Review Date February 2019

Review Cycle Three years

Consulted with the following stakeholders

Contact responsible for implementation and monitoring compliance: Transfusion Laboratory Manager

Education/ training will be provided by: CNS IV Fluid Management Transfusion Practitioner

Approval and Review Process

Hospital Transfusion Team



Local Archive Reference: Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-68 Local Path Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-68 File name Q Pulse/Documents/Pathology/Transfusion/SOP/T-SOP-68

Policy categories for Trust’s internal website (Bob) Blood Transfusion

Tags for Trust’s internal website (Bob)



CONTENTS

DOCUMENT CONTROL ………………………………………………………………….…. ..1

Document Control........................................................................................................................ 1

1. Background ....................................................................................................................... 4

2. Scope and Purpose .......................................................................................................... 4

3. Responsibility ................................................................................................................... 4

4. Definitions ......................................................................................................................... 4

5. Storage of Blood ............................................................................................................... 5

6. Return of Blood ................................................................................................................ 5

7. Maintenance of Blood Banks .......................................................................................... 5

8. Training .............................................................................................................................. 9

9. Notification of blood supply suspension ...................................................................... 9

10. Management of returned paperwork .............................................................................. 9

10.1 Receipt of paperwork ......................................................................................................... 9

11. Dealing with blood bank faults ..................................................................................... 10

11.1 Action on receiving notification of a fault ...................................................................... 10

11.2 Issue of suspension notice ............................................................................................ 10

11.3 Lifting a suspension notice ............................................................................................ 11

12. References ...................................................................................................................... 11

13. Associated Documentation ........................................................................................... 11

14. Appendices......................................................................................................................... 12



1. Background

1.1. Management of the community blood banks listed on page 1 is the responsibility of Northern Devon Healthcare NHS Trust. This document sets out the Trust’s procedures for management of these blood banks and safe storage of blood products in accordance with requirements detailed below.

2. Scope and Purpose

2.1. 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.

2.2. The Blood Safety and Quality Regulations (BSQR) (2005) is the legislation which governs adherence to NHSBT guidelines on blood product storage. The Medicines and Healthcare Regulatory Agency (MHRA) is the body which checks and enforces the requirements of these regulations across any site used for blood/product storage and ultimate transfusion. They require evidence that the “cold chain” has been maintained i.e. that we can prove that blood and products have been stored correctly.

2.3. The cold chain involves vein to vein traceability i.e. we have to be able to account for every minute of a blood product’s ‘life’ from donor to recipient or disposal.

2.4. Every procedure in this document is mandatory under BSQR/MHRA requirements.

3. Responsibility

3.1. All staff involved with blood transfusions have a responsibility to ensure safe transfusion practice is followed. This includes ensuring that blood and blood products are correctly stored in exact accordance with BSQR requirements.

3.2. Failure to follow these procedures in their entirety will result in immediate and indefinite suspension of blood supply to the hospital. This is an MHRA requirement.

4. Definitions

4.1. Blood: Red blood cells in additive solution, red cell concentrates.

4.2. SOP: standard operating procedure

4.3. Community Blood bank: a fridge specifically designed for storage of blood that is situated in a hospital other than the NDDH that comes under the NDDH Transfusion department’s responsibility.

4.4. Mapping: a check that the temperature is even in all areas within the fridge.



5. Storage of Blood

Blood must be stored at 4oC 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.

Blood bank refrigerators are located at each community hospital which undertakes blood transfusions. These are listed on page 1. 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.

6. Return of Blood

Any blood which is returned to the issuing hospital must be packed in a validated box according to the correct procedure. The blood must be packed in the box and surrounded by cool packs which completely fill all the dead air space. The cool packs must be pre-cooled to 4oC for a minimum of 24 hours before use. The Clinimed boxes are validated according to size. Boxes issued by RD&E are validated for 4 hours while those issued by NDDH are validated for 3.5 hours. Once packed, the box must be sealed with a plastic tie to prevent tampering. The box must be accompanied by the relevant paperwork which lists the contents and states the time of packing.

7. Maintenance of Blood Banks

7.1. General requirements

7.1.1. Servicing

All NDHT blood fridges are under maintenance contracts with Labcold. They are on contract for an annual maintenance inspection and the Transfusion laboratory will inform the community staff when these visits are due.

Please note that separate arrangements are in place for Stratton Hospital and North Devon Hospice as they are not part of the NDHT

7.1.2. Calibration

All blood fridges are calibrated annually and this is included in the maintenance inspection.



These contracts plus ad-hoc calls to repair fridges and recalibrate charts are arranged and managed by the Transfusion Laboratory at NDDH

7.1.3. Reporting a fault

For NDDH hospitals, to report a fault contact the Transfusion on 01271 322327. It is the responsibility of community staff to ensure that the fridge is clearly marked as “OUT OF SERVICE” and properly sealed off using the tape provided.

Please note that Labcold do not offer a repair service out of hours or at weekends.

Eastern region sites will also need to contact the Transfusion Laboratory at the RD&E hospital on 01392 402461 / 402466.

Separate arrangements are in place for Stratton Hospital and North Devon Hospice as they are not part of NDHT and are responsible for their own maintenance arrangements.

Please ensure that you send copies of ALL engineer reports, calibrations etc. to NDDH Transfusion using the address labels provided.

7.1.4. Mapping

Mapping is a procedure used to ensure that the fridge is at the correct temperature throughout the cabinet. The load temperature is only measured at one point, mapping measures the temperature at 5 points for a period of 24-48 hours. Data is collected by a logger attached to 4 bags of liquid to simulate blood packs.

All fridges require routine mapping annually and additionally after any major repair or re-siting of the fridge.

Mapping is carried out by the NDDH transfusion department who must be informed of repairs or re-siting in order to carry the work out in a timely manner, as blood cannot be issued to the fridge until it is done and confirmed as satisfactory by the laboratory

7.2. Daily and weekly checks/maintenance

These are summarised on the checklist (T-RECORD SHEET-24) that is used at each site. See appendix 4.1. These checks must be carried out on day shifts in order for necessary actions to be carried out as soon as possible. There is no-one to contact about maintenance or breakdown problems out-of-hours.

7.3. Daily maintenance

Record air temperature (on fridges that indicate this). This is the temperature of the air in the fridge and will go up and down as the door is opened. It must always be in the range 2oC to 8oC.



Record load temperature. This is the temperature that the load, or blood, will be at. It should not vary much at all and be as close as possible to 4oC.

Record day/time chart is set to. The chart is our only permanent record of how blood has been stored. It MUST accurately reflect the day and time of measurement. This check ensures the chart was placed correctly and is running at the right speed. Check that the trace is even and circular. If there are any problems with the trace, report them to NDDH transfusion and make a note on the chart if a reason is known (e.g. engineer visit, door left open etc).

Check chart is reading the same as the load temperature. The chart is calibrated against the load temperature and should be within 1oC of the digital display.

Check pen is working, if not replace nib. This is essential for a clear record. Ensure there are plenty of spare nibs available and staff know how to fit them. Usually they are a simple push fit over the end of the chart recorder arm.

Check expiry date of any blood in the fridge. If blood is past its expiry date, inform NDDH (North) or RD&E (East) blood transfusion lab immediately. At the same time check that any blood in the fridge has been recorded on the ‘blood in’ chart. See appendix 4.4 for a copy of this chart.

Check that there are no non-blood products in the fridge. A blood bank must not be used for anything other than blood. Ensure this is adhered to and inform any staff putting anything other than blood in the fridge of this.

7.4. Weekly maintenance

Check the fridge alarm. It is vital that, should the fridge go out of temperature, somebody is warned immediately. Hence all fridges have a built in audible alarm and one connected to a remote alarm when the area is not manned. Check the alarm according to the procedure for your fridge and ensure it sounds.

NB - Please note that the screens on the fridges are fragile and work by detecting the temperature of your finger. To operate these screens touch them gently and await a response.

PLEASE DO NOT PUSH ON THE SCREEN, IT WILL CRACK AND THIS CONSTITUTES A FAULT MEANING SUSPENSION OF BLOOD SUPPLY.

Any blood which is in the fridge must be set up within 30 minutes of a 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 their transfusion laboratory as well (01392 402461/ 402466).

Write date and hospital on circular chart/replace the chart. This chart is our only permanent record of storage temperature and has to be kept by NDDH Transfusion for 30 years. They are changed every week. It is vital that they are correctly labelled, positioned on the recorder and returned to NDDH transfusion weekly.



The information from the temperature charts is recorded in the Transfusion Laboratory. Any discrepancies must be noted and senior staff informed.

Check fridge interior is clean and dry. Ensure nothing has leaked in the fridge and there is no condensation or water in the fridge. If there is, dry it up and report to the responsible person at your site. Check the overall condition of the fridge including cleanliness and fit of the door seal and clean if necessary with warm soapy water.

Attach the circular chart to this record and return to NDDH transfusion immediately using the address labels provided. We have to keep complete records for each site. Failure to return the check sheets and circular chart, correctly filled in, will result in suspension of blood supply.

If, for any reason, the check sheet didn’t get filled in or there are problems with the chart recorder or trace, ensure the reasons for this are clearly marked on the fault sheet (T-RECORD SHEET-42) and ensure that NDDH Transfusion is notified immediately. A copy of the fault sheet must be returned with the chart/checklist to NDDH.

7.5. Spares required

At least 4 spare charts, 4 maintenance check lists and 2 pen nibs must always be available. This will ensure records can continue to be kept in the event of failure to order more.

Also at least 2 good quality (e.g. Duracell) spare batteries (size AA) should be kept available for the chart recorder.

7.6. Blood movement log

A sheet is provided to record all blood placed into the blood bank, and all blood removed for either transfusion, return to lab or disposal. Please ensure this log is kept up to date and signed as it constitutes the final part of the cold chain for traceability. A copy of this chart is in appendix 4.4 at the end of this document. After every transfusion episode a copy of this log should be returned to the laboratory which supplied the blood to provide evidence that the blood transfusion was completed within 4 hours of removal from the fridge. For the Eastern hospitals supplied by RD&E, please also complete the start/stop time of the unit on this form. Northern hospitals should continue to put this information on the pink compatibility slip which is returned to NDDH.

7.7. Action in the event of an alarm sounding

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 contact the Transfusion Laboratory to arrange for an engineer to visit. When the alarm sounds you must complete the log to record the event (T-RECORD SHEET-41) and send a copy of the sheet to NDDH Transfusion Laboratory immediately.

Before and following repair of the equipment the laboratory must be informed, and any paperwork copied to it. The transfusion manager will then arrange to have the equipment mapped where relevant. (See 7.1.3 above).



7.8. Day Case Hospitals

Some of the hospitals are not manned 24/7 and separate arrangements are in place for the management of alarms. The alarm is connected to an external company who also monitor the fire and burglar alarms. Should the alarm be activated out of hours the company will inform NDDH switchboard who will alert the on call BMS. For Eastern hospitals, the BMS will inform on call BMS at RD&E. BMS staff NDDH will ensure that the cause of the alarm is investigated as soon as possible. BMS staff at the issuing hospital will make arrangements to have any blood in the fridge quarantined and returned. No further blood can be issued until the problem is fully resolved.

8. Training

Transfusion Champions will be appointed for each community hospital. They will be responsible for and cascade training to staff as appropriate. Transfusion competency assessments for Northern staff are available on the transfusion section of BOB. Please contact the laboratory on 01271 322327 for further information. Eastern staff are required to complete the Learn Pro e learning package. Please contact the Transfusion Practitioner at RD&E for further details. All staff must be assessed for the relevant competencies on a regular basis. The Transfusion Practioner will be responsible for maintaining records of staff competencies and training.

A named responsible person will also be designated at each site; this would usually be the senior matron or ward manager.

9. Notification of blood supply suspension

In the event of failure to comply with this SOP, findings found at audit, non-return of documentation to NDDH transfusion etc, blood supply to the hospital will be suspended until appropriate remedial action has been carried out. The laboratory will notify the hospital of this and also when supplies will be resumed, by telephone and confirm by email. A form will also be issued to the hospital showing the necessary information for the hospital’s blood bank records.

10. Management of returned paperwork

10.1 Receipt of paperwork

Transfusion laboratory staff at NDDH are required to check and file the paperwork returned from the community hospitals.

Each hospital has its own file in the transfusion laboratory. Upon receipt of check lists and tachograph charts, staff should check that the sheets are fully completed and that the charts match the information given.

N.B. If there are any anomalies or missing data then you must inform the Transfusion Manager who will decide whether the blood supply needs to be suspended. Please place the records in the red folder on the Transfusion manager’s desk for her immediate attention. In her absence please inform another senior member of staff for immediate action.



Record the temperature on the chart in the appropriate section of the file marked chart recorder records. Make a brief note of any anomalies. Mark on the white board that the records have been received with any appropriate comments. If all is correct, then file the check sheet and chart record in the individual hospital file.

11. Dealing with blood bank faults

11.1 Action on receiving notification of a fault

Record brief details of any conversation with the community hospitals in the communications log. Staffs who are notified of a fault in any of the fridges must inform a senior member of staff. For NDHT fridges this member of staff will arrange for an engineer’s visit if appropriate.

Please note that Stratton Hospital and North Devon Hospice have their own maintenance arrangements and they are responsible for arranging engineers’ visits.

The staff at the community hospitals are responsible for informing the Transfusion Laboratory and for ensuring that the fridge is clearly marked as “OUT OF USE” and sealed with the tape provided. Laboratory staff must ensure that the fridge is marked as out of use on the white board. If the hospital is in the Eastern region then inform RD&E Transfusion Laboratory (01392 402461) that the fridge is out of use. Record in the communications log which member of staff at RD&E took the message. RD&E staff will ensure that no blood is supplied to the fridge until they are informed it is back in use.

Add the event as a non-conformance to the asset list on Q Pulse and issue a suspension notice (see 6.2 below). Scan the suspension notice and attach the file to the Q Pulse record.

11.2 Issue of suspension notice

Senior staff will make the decision to suspend the blood supply to a hospital if:

The paperwork is unsatisfactory.

A fault has been reported by a hospital. Complete a suspension notice (see 7.5 below). Email the notice to the matron responsible for the hospital concerned (contact list available on Q Pulse) and copy the email to:

Blood Transfusion Manager (Maggi Webb)

Operational Manager Haematology/Biochemistry (Tim Watts)

Deputy Manager Eastern Region (Anne Cameron) If the hospital is in the Eastern region and is supplied by RD&E then also copy the email

to:

Transfusion Manager RD&E (James Piper)

Transfusion Deputy Manager RD&E (Penny Donnelly)

Transfusion Practitioner RD&E (Veronica Sansom)

Eastern Hospitals Transfusion Practitioner (Julie Mitchell)



If the hospital is in the Eastern region then telephone the Transfusion Laboratory RD&E (01392 402461) and inform the staff there that the fridge is out of use. Record in the communication log the name of the staff member who took the message.

Mark on the white board in Transfusion that the fridge is out of use and make a brief note of the reason.

File the hard copy of the suspension notice in the relevant hospital’s blood bank records.

11.3 Lifting a suspension notice

A suspension notice for a fault may be lifted when the laboratory has evidence that the fault has been repaired and the fridge has been mapped if appropriate. The matron at the hospital should complete the bottom section of the suspension notice and return it to the laboratory with copies of any relevant engineers’ reports.

Please note: Fridges may not be returned to service until the engineers’ reports have been reviewed by NDDH senior laboratory staff.

A senior member of staff will complete the Q Pulse record and attach the engineers’ reports. Hard copies of the reports should be filed in the maintenance section of the hospital file.

A suspension notice issued as a result of incomplete paperwork may be lifted when the laboratory has received a complete set of paperwork (usually the following week)

For Eastern hospitals supplied by RD&E please inform the Transfusion Laboratory at RD&E and email confirmation to the same people as listed in 7.2 above.

12. References

1. Guidelines for the Blood Transfusion Services in the UK (Red Book) 8th edition 2013

2. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Orange Book)

3. NDHT Blood Transfusion Policy version 4.0 (BOB)

4. Clinical Guidelines for Transfusion, NDDH Guidelines. (BOB)

5. BSQR (2005)

6. Q Pulse for a full asset list of these fridges

13. Associated Documentation

T-SOP-58: Temperature Mapping of Storage Units

T-RECORD SHEET-24 Blood bank checklist

T-RECORD SHEET-41 Blood fridge alarm log

T-RECORD SHEET-42 Blood Fridge Fault/Error Log

Competency Assessment:Management of blood fridge (Community Based)



14. Appendices

14.1 Sign-off sheet

Please ensure that all staff who have read and understood this SOP have signed this sheet at the end of the document. Please ensure that a copy of the sheet, once complete, is sent to the NDDH Transfusion laboratory.

14.2 Blood Movement Log

Please complete and return to the issuing laboratory after each transfusion episode.

14.3 Suspension of blood supply form

This form will be issued to hospitals when blood supply is to be suspended. It details reason(s), remedial action required and a timescale for completion.

14.4 Blood return paperwork

This form to be completed when returning blood to the issuing hospital



Sign off sheet

The undersigned staff confirm that they have read and are conversant with the contents of this SOP and the rationale behind it. SOP Version number 7.0 Issue Date: November 2015 Name of Hospital………………………………………………………………………………

Name Position Sign and Date

Please forward a copy of this sheet to NDDH Transfusion when completed.



Blood Movement log

Name of Hospital……………………………………………………………….

BLOOD INTO FRIDGE BLOOD OUT OF FRIDGE ADMINISTRATION

DATE TIME PATIENT’S NAME

NHS/HOSPITAL NUMBER

UNIT NUMBER

SIGNED DATE TIME SIGNED FATE OF UNIT 1

START TIME

STOP TIME

PINK SLIP COMPLETED 2

1. Fate of unit: Transfused / Returned to Transfusion Lab (give reason). 2. Pink slip completed applies to hospitals supplied by NDDH only.

PLEASE PHOTOCOPY THIS SHEET AND RETURN TO RELEVANT TRANSFUSION LABORATORY AFTER EACH TRANSFUSION EPISODE.



Suspension of blood supply form

NOTIFICATION OF SUSPENSION OF BLOOD SUPPLY

Hospital/site…………………………………………………………………................... Effective date of suspension………………………………………………………….. Reason(s)…………………………………………………………………………………. ………………………………………………………………………………………………. ………………………………………………………………………………………………. Remedial action(s) required…………………………………………………………… ……………………………………………………………………………………...….…… ………………………………………………………………………………………………. To be completed by (date)……………………………………………………………… Signed (Laboratory contact)……………………Print name………………………… Blood supply will be reinstated once the laboratory has seen evidence that remedial action has been carried out and has been effective. Community Hospital use only. I certify that the remedial action recommended above has been carried out and I have sent the necessary evidence to NDDH Transfusion. Signed…………………………………………………..Print name…………………………….… Position………………………………………………… Blood supply reinstated on (date)……………………………………………………………….



Return of blood paperwork