Transport of Cells

SOP Title: Procedure for processing infusion requests, release and delivery of fresh
cytotherapeutic tissues for clinical use
SOP Type: Procedure
Imperial College Healthcare NHS Trust

Clinical & Investigative Sciences Group (Clinical and Laboratory Haematology)
Quality Management Policy and Procedures
Purpose: To describe the procedure for processing infusion requests by the JGCCT, preparing,
issuing, and delivering clinical material for fresh infusions.
Scope: Applies to all laboratory staff involved in the preparation and processing of fresh clinical
material and all laboratory staff and St. Mary’s Hospital staff involved in the delivery of fresh
clinical material to the wards for infusion.
Departmental Responsibility: JGCCT Date Effective: 16.Oct.2009
Author: Review Date: 15.Oct.2011

Original: S Loaiza
Revised: P Elsey
This Copy Number is:
Document Control
The Master Copy of the Quality Manual and Standard Operating Procedure (SOP’s) will be filed
in the Quality Management Office.
Controlled copies are numbered and stamped or water marked “Controlled Copy” in red ink.
Any copies without this red stamp are uncontrolled and should be destroyed. Electronic copy will
be filed within a read only folder on the Trust shared network.
If this SOP appears inadequate or outdated it is the responsibility of all staff to bring this to the
attention of their Supervisor immediately.
Training Record
The training record for this SOP is filed with the master copy of the SOP in the Quality
Management Office.
Security Statement
This SOP is the intellectual property of the SCT Unit within Imperial College Healthcare NHS
Trust and as such, must not be circulated outside of the Trust without written approval from the
Quality Assurance Manager and the Author of this procedure.
_________________________________________________________________________
Contents
Section Subject Page
1.0 Personnel & Responsibilities 2

2.0 Background 2
3.0 Definitions 3
4.0 Health & Safety
4.1 General Health & Safety 3
4.2 Risk Assessment Status 3
SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 1 of 20

SOP Type: Procedure
5.0 Equipment/Documentation
5.1 Equipment 4
5.2 Consumables 4
5.3 Documentation 4
6.0 Procedure
6.1 Receipt of Infusion Requests 4
6.2 File making, daybook entry and preparation 5
6.3 Processing the harvest 5
6.4 Database entry and report generation 6
6.5 Preparation for issue 7
6.6 Authorisation for issue 7
6.7 Delivery to ward 7
6.8 Infusion 8
6.9 Completion of Infusion 9
7.0 Training & Comprehension or Competency Assessment 9
8.0 References 10
9.0 List of Appendices 10
10.0 Revision History 10
11.0 Managerial Approval 11
1.0 Personnel & Responsibilities
The preparation of fresh clinical material, dose verification and report generation must
only be carried out by state registered Biomedical Scientists and Clinical Scientists who
have been properly trained and are deemed to be competent. However, authorisation for
issue is to be performed by Clinical Scientists and Heads of Processing and Quality
Departments only.
Delivery to the ward can also be carried out by Senior Healthcare Assistants and at St.
Mary’s Hospital (SMH) by BMT co-ordinators and trained nursing staff.
Training must be in compliance with the training record accompanying the SOP.
Any deviations from this SOP must be documented and approved according to SOP
BMTU-QMP-006 Deviating from an SOP.
2.0 Background
Allogeneic stem cells derived from apheresis or bone marrow harvests can be infused
fresh without cryopreservation. HSC fresh infusions should be at least 24 hours after the
last chemotherapy dose and if applicable the last treatment with radiotherapy. Fresh cells
should be administered as soon as possible and within 6 hours from being issued by the
JGCCT. The expiry date and time would be given on the Infusion Label. If it is likely that
this time period will be exceeded, please inform the laboratory and the consultant in
charge of the patient. The infusion commencement and completion time should be
recorded in the patient’s notes.
In the case of ABO incompatibility between recipient and donor, bone marrow may
require some processing (red cell or plasma depletion). Microbiological sterility of the
clinical material is checked pre and if applicable post processing prior to infusion.

SOP Type: Procedure
Non-conforming clinical products are not issued for clinical use without referring as
appropriate to the Quality Manager, Medical Laboratory Director and consultant in charge
of the patient.
In accordance with GMP, documentation of the transplant procedure at all stages from
the initial stem cell collection to transplant is essential. In addition to ensuring that no
clerical mistakes occur which may result in the infusion of incorrect clinical material, the
documentation also provides the requisite legal record of the procedure detailing quality
control checks and authorisations. In this respect it is essential that documents taken to
the ward relating to the procedure are filed in the patient’s notes.
3.0 Definitions
HH – Hammersmith Hospital
SMH – St. Mary’s Hospital
HSC – Haemopoetic Stem Cells
GMP – Good Manufacturing Practice
IDMs – Infectious Disease Markers
4.0 Health & Safety
4.1 General Health & Safety
All staff must follow safe practice for dealing with biological materials as stated in the
Hammersmith Hospitals NHS Trust Infection Control Policy, Section 2: Universal
Infection Control including Safe Handling and Disposal of Sharps, Sharps Injuries and
Exposure to Blood and Body Fluids, Spillages and Waste. All human derived products
should be treated as a potential biohazard.
Refer to departmental COSHH assessments for Alcohol.
4.2 Risk Assessment Status
Is a risk assessment required for the use of this procedure Yes √ No □

and the processes defined within this procedure.
If Yes, who carried out the Risk assessment ___________Penny Elsey_________________
What was the Risk Level (rating) identified ____________High___________________.

For Extreme & High Risks staff must read the risk assessment before following this
procedure.
Document any additional control measures required ___________N/A_____________.
Where is the original risk assessment archived _________JGCCT (RA 09/003)_______.

SOP Type: Procedure
5.0 Equipment/Documentation
5.1 Equipment
Harvest transport box
5.2 Consumables RA/COSHH assessment risk
70% Denatured Ethanol Spray CA2 M

Transport polythene bags
Plastic wallet
5.3 Documentation
Infusion Request Form (Appendix 1)

Processing Request Form (Appendix 2)
Provisional Protocol (Appendix 3)
Defects and Adverse Incidents Form (Appendix 4)
Fresh Infusion Label (Appendix 5)
Infusion Report (Appendix 6)
Engraftment Form (Appendix 7)
6.0 Procedure
6.1 Receipt of Infusion Requests
6.1.1 The official notification for infusion of clinical material is the Infusion
Request Form (Appendix 1), which is filled in by the appropriate transplant
co-ordinator or consultant.
6.1.2 Fresh infusions also require a Processing Request Form (Appendix 2)

indicating what processing if any, the harvest requires. Refer to SOP
BMTU-JGCCT-13 Booking and Receipt of clinical material for processing.
6.1.3 Although advance notice of infusions may be received by phone or e-mail,

the official Infusion Request Form should be completed and delivered to
JGCCT (by hand or fax) in advance of the infusion date, ideally 5 working
days prior to the infusion date.
6.1.4 Infusion Request Forms received fax should be signed and dated as
received and faxed back to the sender. Infusion Request Forms received
by hand should be signed and dated as received, and ‘received by hand’
should be written onto the bottom of the form.
6.1.5 Ensure that all infusions, regardless of the source of notification, are
entered into the laboratory diary. The entry should include the patient’s
surname, source of notification and fresh infusion.
6.1.6 Report printing of relevant 30 day IDMs if available should be attached to

the Infusion request form. IDMs results for MUD donors will be faxed to
JGCCT prior to the infusion date or provided by the courier on delivery of
the harvest.

SOP Type: Procedure
6.1.7 Any discrepancies / ambiguities in documentation or clinical issues must

be brought to the attention of the Head of Processing / Quality so that they
can be resolved prior to the infusion of clinical material.
6.1.8 The Infusion Request Form is then stored in the Processing Pending
drawer attached to the Processing Request form (in date order) in the
laboratory office.
6.2 File making, daybook entry and preparation
6.2.1 Patient’s and if applicable donor’s addressograph labels should be

obtained from the HOPD reception for HH patients and provided by SMH
BMT co-ordinators or nursing staff for SMH patients. Details from MUD
donors will be hand written on all documentation.
6.2.2 Ideally the Processing / Fresh infusion file and daybook entry should also
be made the day before the infusion. Complete the processing number
and patient’s demographics in the laboratory daybook. The infusion
number will consist of the processing number, followed by forward slash
and the infusion number 1. (For example, 07-117-5613/1).
6.2.2 A blue file processing file is made for fresh infusions and should consist
of:
Processing & Fresh Infusion Document Checklist FRM-006

Processing Request Form FRM-001
Infusion Request Form FRM-002
Provisional Protocol
Defects and Adverse Incidents Form FRM-050
Fresh Infusion Label
Issuing Results Log FRM-010
Processing Worksheet FRM-008
Cytometry Consumables Sheet FRM-017
Processing Consumables Sheet FRM-014
Ensure that all patient / donor sample details are entered onto the forms
and the cover of the file, preferably using patient / donor addressograph
labels where appropriate.
6.2.3 IDMs results from the donor if available within 30 days prior to harvesting
should be placed in the patient’s file, refer to 6.1.5.
6.3 Processing the harvest
6.3.1 Harvests are collected, transported and handed over to SCI laboratory
staff (if applicable) in accordance with SOP BMTU-JGCCT-007 Procedure
for the transportation of samples and non cryopreserved harvests.
6.3.2 Harvests are received in the SCI laboratory in accordance with SOP
BMTU-JGCCT-013 Booking and receipt of clinical material for processing.
6.3.3 The temperature and weight of the harvest should be taken on arrival of
the harvest and recorded on the relevant documentation.

SOP Type: Procedure
6.3.4 A sample should be taken from the pigtail of the collection bag or in the
absence of pigtail lines, via the sampling port. Preparation of pigtail
samples is performed in the QA laboratory without the need for application
of aseptic techniques. Sampling from the sample port is performed using
aseptic techniques in the clean rooms of the GMP area in accordance
with SOP BMTU-JGCCT-154 Sampling harvests for WBC and TNC dose
determination.
6.3.5 Pre processing sterility testing should be performed on all harvests and
prior to sampling from the sampling ports if applicable, in accordance with
SOP BMTU SCIL-025 Pre and post processing sterility screening,
sampling, reports and actions. The final results will not be available until
14 days after the infusion (i.e. these products do not have the benefit of
pre-release sterility verification).
6.3.6 A WBC should be performed on the sample in accordance with SOP

BMTU-JGCCT-012 Procedure for operation of the Sysmex.
6.3.7 TNC, CD34 and CD3 doses where applicable should be calculated and
recorded on the Processing Worksheet in accordance with SOP BMTU-
JGCCT-154.
6.3.8 Calculated doses should be validated by another member of staff and

initialled on the worksheet as per SOP BMTU-JGCCT-059 Process and
results validation and reporting.
6.3.9 The calculated dose for HH patients should be issued to the collection
facility (if applicable) and the allogeneic transplant coordinator and the
result recorded in the daybook in accordance with SOP BMTU-JGCCT-
028 Issuing results by telephone, email and fax. Doses for SMH patients
should be issued to the consultant in charge and the BMT co-ordinators
via telephone or e-mail.
6.3.10 The transplant ward should be contacted by laboratory staff to arrange a

time for delivery of the fresh clinical material. If the material is being
transported to SMH by SMH trained staff (BMT co-ordinator or trained
nurse), the ward does not need to be contacted.
6.3.11 The harvest should be placed in the blood bank in the QA laboratory until
ready for transportation to the transplant ward.
6.4 Database entry and report generation
6.4.1 Database entry and report generation should be performed in accordance

with SOP BMTU-JGCCT-032 Database data entry and report generation for
peripheral blood CD34 enumeration, processing of clinical materials and
fresh infusion. Print 4 copies of the Infusion Report onto pink paper
(Appendix 6).

SOP Type: Procedure
6.4.2 The operator(s) should sign the Infusion Request Form against request
correlated to laboratory records, processed by and report prepared by. Not
applicable should be noted in the form against retrieved by, a copy of the
form made and then placed in the patient’s file.
6.4.3 An Engraftment Form should be generated as per SOP BMTU-SCIL-004

Engraftment Audit Process and a copy printed and placed in the
Engraftment Audit file located in the QA lab (Appendix 7). For SMH patient’s
2 copies should be printed, one to be filed and one to be taken to the
transplant ward.
6.5 Preparation for issue
6.5.1 Prepare the Defects and Adverse Incident Form (Appendix 4) to include
Recipient’s Details, Donor’s Details, Transplant Ward, Product Type (HPC-A
/ HPC- M / TC-T), Allo, Modifiers, Collection Date, Infusion Number, and Date
of Infusion and place in the patient’s file.
6.5.2 Complete the relevant Fresh Infusion Label for all harvests to include
Recipient’s Details, Donor’s Details, Blood Groups, Collection Facility
Identifier, Processing Facility Identifier, Harvest Date, Time of completion,
Volume of harvest, Volume issued, Anticoagulant used, Date / Time issued
and Expiry Date / Time and place in the patient’s file (Appendix 5).
6.5.3 Note the patient’s details, infusion number, infusion date, and type of
transplant in the Pending Final Protocol List located in the laboratory office.
6.6 Authorisation for Issue
6.6.1 The Head of Processing or in their absence the Head of Quality, re-labels the
harvest and reviews all documentation and the harvest to ensure there are no
errors or deficiencies of information. The Infusion Report is cross checked
with the clinical material, Infusion Request and Provisional Protocol. The
“Issued By” box in both copies of the Infusion Request is signed.
6.6.2 The harvest is placed in a transport polythene bag and then in a harvest
transport box ready for delivery to the transplant ward.
6.6.3 The JGCCT Director or in his absence the Designated Deputy, carries out a
final pre-release check and authorises the final release of the clinical material
before taking it to the ward. The “Issued By” box in both copies of the Infusion
Request is counter-signed.
6.7 Delivery to Ward
6.7.1 Bags for infusion at HH are transported by trained laboratory staff to the
transplant ward using a harvest transport box with the following
documentation:
Two copies of completed Infusion Request Form

A copy of a signed Infusion Report
Provisional Protocol
Defects and Adverse Incidents Form in a plastic wallet

SOP Type: Procedure
6.7.2 Bags for infusions at SMH may also be transported by SMH BMT co-
ordinators and trained nursing staff with a copy of a completed Infusion
Request Form, Protocol, Engraftment Form and Defects and Adverse
Incidents Form.
6.7.3 On arrival at the transplantation ward, sign, date and write the delivery time
on both copies of the Infusion Request Form to indicate delivery and contact
the nurse in charge of the patient.
6.7.4 Perform cross checks of the harvest bag for infusion by removing the outer
transport polythene bag and placing the fresh harvest over a bench reading
information directly from the Fresh Infusion Label relaying the patient’s and
donor’s name, DOB, hospital number, processing facility identifier and
harvest date to the nurse.
6.7.5 The transplant ward retains one copy of the Infusion Request Form, one copy
of the Infusion Report and the Defects and Adverse Incidents Form. The
Provisional Protocol should be returned with the signed Infusion Request
Form to the laboratory and be placed in the infusion file.
6.7.6 Prior to the material being prepared for infusion, 2 staff members (clinician
and / or nurse(s) overseeing the infusion), review the documentation against
the patient’s notes for correctness and if satisfactory sign the Request Form
under signature 2 (Appendix 1).
6.8 Infusion
6.8.1 Fresh infusions are only performed by medical / nursing staff on

transplantation wards as per SOP BMTU-CP-151 Infusion of non-
cryopreserved Stem Cells. SMH medical / nursing infusion SOP is under
development.
6.8.2 Any adverse reactions during the infusion of cells, should be reported in
the Defects and Adverse Incidents Form (Appendix 4). Any deviation from
the procedure must be recorded in the patient’s notes and must be
reported as per SOP BMTU-QMP-006 Deviating from an SOP for HH
infusions only.
6.8.3 Serious clinical incidents should be immediately communicated verbally to

the consultant in charge of the patient and the Laboratory Director or in
his absence the Deputy. Clinical incidents relating to SMH infusions that
take place at the JGCCT, should be reported by laboratory staff using the
HH Trust incidents reporting system. Clinical incidents that take place at
SMH, should be reported by SMH clinical / nursing staff using the SMH
Trust incidents reporting system. These incidents must be communicated
via e-mail to the consultant in charge at SMH and the JGCCT Director,
copying in all relevant staff members at both sites.

SOP Type: Procedure
6.9 Completion of Infusion
6.9.1 On completion of the infusion procedure at HH, nursing staff should

contact the JGCCT. Laboratory staff will collect from the appropriate ward,
the harvest transport box, the completed Infusion Request (ward’s copy)
and the completed Defects and Adverse Incidents Form. A copy of the
completed Infusion Request should be made and placed in the patient’s
infusion file together with the Defects and Adverse Incidents Form. The
ward’s copy of the Infusion Request should be returned to the staff nurse
in charge of the patient to go in the patient’s case notes.
6.9.2 At SMH, nursing staff are responsible for faxing the completed Infusion
Request and Defects and Adverse Incidents Form to the JGCCT as soon
as the infusion is finished. If any defects and / or adverse incidents have
been reported, the form should be brought to the immediate attention of a
senior member of staff for further investigation.
6.9.3 Documentation inside fresh infusion files should be left unbound and
placed in the laboratory’s office bench with files awaiting microbiological
sterility screening results.
7.0 Training and Competency Assessment
Type of Training Existing staff already carrying out the procedure to read SOP
but no additional training required (unless no routine
procedures carried out for twelve months).
New staff should observe up to 3 processes. The trainee will
then be observed by the trainer for al least 3 procedures or
until deemed competent.
SMH clinical and nursing transplant staff need to read this
SOP.
Method of competency Staff to be accompanied and supervised until fully competent.
assessment for “procedure” Competency assessment by observation.
List Staff required for Training Preparation of fresh clinical material for infusion must only be
and Competency Assessment perfomed by Clinical Scientists and state registered BMSs.
Delivery to the wards can also be carried out by Senior
Healthcare Assistants and SMH clinical and nursing transplant
staff. SMH staff to be aware of this procedure.
Authorisation for issue performed by Clinical Scientists and
Heads of Processing and Quality dept.
Who is to perform this training JGCCT Director, Head of Processing Dept, Head of Quality
Dept. and Specialist BMSs for staff at HH. The Clinical Nurse
Specialist at SMH needs to ensure that relevant SMH staff
read this SOP and sign the Training Record and Competency
Assessment in their copy of the SOP.
Evidence Log of Complete the Training Record and Competency Assessment
Training/Competency (Appendix 7).
Assessment

SOP Type: Procedure
8.0 References
SOPS:
BMTU-JGCCT-004 Engraftment Audit Process

BMTU-JGCCT-013 Booking and Receipt of clinical material for processing
BMTU-JGCCT-007 Procedure for the transport of samples and non cryopreserved harvest
BMTU-JGCCT-154 Sampling harvests for WBC and TNC dose determination
BMTU-JGCCT-025 Pre and post processing sterility screening, sampling, reports and actions
BMTU-JGCCT-012 Procedure for operation of the Sysmex XE2100
BMTU-JGCCT-028 Issuing results by telephone, email and fax
BMTU-JGCCT-032 Database data entry and report generation for peripheral blood CD34
enumeration, processing of clinical materials and fresh infusion
BMTU-JGCCT-059 Process and results validation and reporting
BMTU-CP-151 Infusion of non-cryopreserved cells
9.0 List of Appendices
Appendix 1 Infusion Request Form

Appendix 2 Processing Request form
Appendix 3 Provisional Protocol
Appendix 4 Defects and Adverse Incidents Form
Appendix 5 Fresh Infusion Label
Appendix 6 Infusion Report
Appendix 7 Engrafment Form
Appendix 8 Training Record and Competency Assessment
10.0 Revision history
Issue Change
1.0 First Issue
2.0 Minor:
Annual review, change SCIL to JGCCT, add from reference
numbers, several minor typos

SOP Type: Procedure
11.0 Managerial Approval
Name Printed Signature Title Date

Author:
Head of Quality
P. Elsey Penelope Elsey 18/8/09
Dept.
Reviewers
J Davis John Davis JGCCT Director 18/8/2009
Clinical Nurse
N. O’Brien Nancy O’Brien 03.Oct.09
Specialist
Medical Director
A. Rahemtullah Amin Rahemtulla 18/8/09
JGCCT
Kirtash K Patel
K. Patel QA Mgr 03.Oct.09

SOP Type: Procedure
Appendix 1 Infusion Request Form

SOP Type: Procedure
Appendix 2 Processing Request form

SOP Type: Procedure
Appendix 3 Provisional Protocol

Melphalan 200 mg/m2 and AUTOLOGOUS PBSCT for Multiple Myeloma Provisional Protocol
PATIENT DATA
Name: John LIPSCOMBE Hospital No: 1056392H Consultant: Dr. Rahemtulla
Age: 50years (DOB 10.09.1956) Ht: 164cm Wt: 82kg SA: 1.93m2 Karnofsky score100%
Blood Group: O positive CMV: Negative Hep B: neg Hep C: neg HIV:neg, Toxo:neg, Syph neg
PFT: FEV1 100%, VC 99.4% KCO 64%, ECG: 53 b /min sinus bradycardia CXR: Normal, MUGA: EF 64%. , Creat
Cl: 142mls/min
------------------------------------------------------------------------------------------------------------------------------------
CLINICAL SUMMARY
Referred by DrA Rahemtulla, Hospital
Diagnosed with IgGλ multiple myeloma August 2006. Preceding history of two months of increasing fatigue. Initially
seen by GP and noted to be anaemic with Hb 9.4, commenced on ferrous sulphate. Creatinine at this time was 141.
There was no improvement in symptoms and he subsequently re-presented 15.08.06; investigations revealed Hb 7.0
Creatinine 303, ESR 102 and Ca2+ 2.66. Serum electrophoresis revealed an IgGλ paraprotein quantified at 58g/l with
immune paresis. β2m was 4.5. Urine revealed 5.4g protein 95% Bence-Jones. Skeletal survey was normal. Renal
dysfunction resolved with aggressive hydration and he was commenced on CTD on 24.08.2006. He has received 6
cycles in total. Post cycle 1 his paraprotein fell to 24g/l and post cycle 6 to 13g/l. He underwent a
cyclophosphamide/GCSF mobilisation in January 2007. At workup: WCC 2.6 Hb 9.4 Platelets 424 Neutrophils 1.5.
CRP 5 ESR 62. Serum electrophoresis showed an 8 g/l paraprotein β2m was 2.2. Bone marrow revealed an 8%
plasma cell infiltrate in the aspirate and 20-30% on trephine biopsy. Of note he has bilateral severe carpal tunnel
syndrome and therefore is having a serum amyloid protein scan prior to his ASCT.
Disease status at work up: Multiple Myeloma in Partial Remission
------------------------------------------------------------------------------------------------------------------------------------
TRANSPLANT PROCEDURE
Patient to be admitted: 18.03.2007
Peripheral Stem Cell Infusion: 26.03.2007
6 6
Cell Dose 2.704x10 CD34+/Kg in 2 bags (leaving 8.73x10 in 4 bags)
2
CYTOTOXIC TREATMENT: Melphalan 200 mg/m
Date Dose Total Dose
23.03.2007 Melphalan 200mg/m2 386mg iv as per protocol
Hydration regimen:
Pre Hydration (start 60 mins before melphalan infusion)
1. 7 ml/kg (mean 500 mls) normal saline + 10mmol KCl is infused over 30 mins with 20-40mg Furosemide IV
2. Repeat step 1.
3. Measure urine output at 1 hr. If > 8mls/kg/hr give Melphalan.
4. If urine output < 8mls/kg/hr repeat step 1 and recheck urine output every 30 minutes until urine output is
>8ml/kg/hour.
Melphalan is then given in 100mls normal saline over 30 mins.
Post Hydration:
1. Give 500mls NS + 10mmol KCl over 1 hr. Repeat three times. Give furosemide if necessary (do not allow a
patient to go into a positive fluid balance). Maintain urine output > 8mls/kg/hour.
2. Give 2-3 litres of IV fluids over next 24hrs to maintain fluid balance.
3. Check electrolytes after 6-8 hrs diuresis and adjust IV electrolytes accordingly.
SPECIAL FEATURES
1. Hickman line to be inserted on admission
2. IV Ig at 400mg/kg on days –1 (13.03.2007), +28 (04.03.2007
3. Skeletal Survey on admission
4. ALLERGIC TO PENICILLIN
5. Needs SAP scan prior to Melphalan.
6. Repeat ECG on admission
7. PATIENT ENTERED IN PALIFERMIN TRIAL
DISTRIBUTION
Haematology Priscilla Plocki Immunology Transfusion Research Lab
Prof Apperley Linda Casey Ruhena Sergeant Registrar Nicola Foot
Prof Roberts Richard Szydlo Patient/Donor Notes Jaspal Kaeda
Dr Kanfer Lorraine Armstrong Referring Haematologist Pharmacy
Dr Rahemtulla Nicola Swan Dr Rahemtulla Ward Pharmacist (Haem) Stem Cell Lab
Dr Olavarria Chrissy Giles Dacie Ward Ward Pharmacist (Cyto) John Davis
Print name Signature Date
Amin Rahemtulla

SOP Type: Procedure
Appendix 4 Defects and Adverse Incidents Form

SOP Type: Procedure
Page 2 of 2

SOP Type: Procedure
Appendix 5 Example of Fresh Infusion Label

SOP Type: Procedure
Appendix 6 Infusion Report

SOP Type: Procedure
Appendix 7 Engraftment Form
Patient Details
Donor Details if applic:
Date of Transplant:
Material: Auto/Allo PBSC/BM

Disease:
Cell Dose:
Procedure Number:
Date of Harvest:
Day WBC Hb Neuts Lymphs PLTs RBC Tx PLT Tx GCSF Date

0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Neuts >0.5 @ Day =
Platelets >20 @ Day =
Platelets >50 @ Day =
Laboratory Medical Director: Date:
Quality
Manager: Date:
Comments: Status: Closed
Active

SOP Type: Procedure
Appendix 8 Training Record and Competency Assessment
SOP No: BMTU-JGCCT-163 Version: 2.0 SOP Type: Procedure
SOP Title: Procedure for processing fresh infusion requests, release and transport of cytotherapuetic tissues for clinical issue.
The following table constitutes the Record Training - Training Status and Competency, in this procedure, for the personnel detailed below.
Date Trainee Trainee Date Supervisor / Supervisor / Trainer Competency Assessment Method.
Training Name Signature Training Trainers to sign, if Trainee is
Started Completed Signature Competent in SOP.

Transport of Cells

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SOP Title: Procedure for processing infusion requests, release and delivery of fresh

cytotherapeutic tissues for clinical use

SOP Type: Procedure

Imperial College Healthcare NHS Trust

Departmental Responsibility: JGCCT Date Effective: 16.Oct.2009

Author: Review Date: 15.Oct.2011

This Copy Number is:

Section Subject Page

1.0 Personnel & Responsibilities 2

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 1 of 20

SOP Type: Procedure

1.0 Personnel & Responsibilities

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 2 of 20

SOP Type: Procedure

4.0 Health & Safety

4.1 General Health & Safety

Refer to departmental COSHH assessments for Alcohol.

4.2 Risk Assessment Status

Is a risk assessment required for the use of this procedure Yes √ No □

If Yes, who carried out the Risk assessment ___________Penny Elsey_________________

What was the Risk Level (rating) identified ____________High___________________.

Document any additional control measures required ___________N/A_____________.

Where is the original risk assessment archived _________JGCCT (RA 09/003)_______.

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 3 of 20

SOP Type: Procedure

Harvest transport box

5.2 Consumables RA/COSHH assessment risk

70% Denatured Ethanol Spray CA2 M

Infusion Request Form (Appendix 1)

6.1 Receipt of Infusion Requests

6.1.2 Fresh infusions also require a Processing Request Form (Appendix 2)

6.1.3 Although advance notice of infusions may be received by phone or e-mail,

6.1.6 Report printing of relevant 30 day IDMs if available should be attached to

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 4 of 20

SOP Type: Procedure

6.1.7 Any discrepancies / ambiguities in documentation or clinical issues must

6.2 File making, daybook entry and preparation

6.2.1 Patient’s and if applicable donor’s addressograph labels should be

Processing & Fresh Infusion Document Checklist FRM-006

6.3 Processing the harvest

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 5 of 20

SOP Type: Procedure

6.3.6 A WBC should be performed on the sample in accordance with SOP

6.3.8 Calculated doses should be validated by another member of staff and

6.3.10 The transplant ward should be contacted by laboratory staff to arrange a

6.4 Database entry and report generation

6.4.1 Database entry and report generation should be performed in accordance

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 6 of 20

SOP Type: Procedure

6.4.3 An Engraftment Form should be generated as per SOP BMTU-SCIL-004

6.5 Preparation for issue

6.6 Authorisation for Issue

6.7 Delivery to Ward

Two copies of completed Infusion Request Form

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 7 of 20

SOP Type: Procedure

6.8.1 Fresh infusions are only performed by medical / nursing staff on

6.8.3 Serious clinical incidents should be immediately communicated verbally to

SOP No: BMTU-JGCCT-163 Issue No: 2.0 Page 8 of 20

SOP Type: Procedure

6.9 Completion of Infusion

6.9.1 On completion of the infusion procedure at HH, nursing staff should

If Yes, who carried out the Risk assessment _Penny Elsey_______

What was the Risk Level (rating) identified High_______.

Document any additional control measures required _N/A___.

Where is the original risk assessment archived ___JGCCT (RA 09/003)_.