transport of cells

SOP Title: Procedure for processing infusion requests, release and delivery of fresh cytotherapeutic tissues for clinical use SOP Type: Procedure

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

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 If this SOP appears inadequate or outdated it is the responsibility of all staff to bring this to the attention of their Supervisor immediately.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



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.



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)_______.



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.



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.



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).



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



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.



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 assessment for “procedure”

Staff to be accompanied and supervised until fully competent. Competency assessment by observation.

List Staff required for Training and Competency Assessment

Preparation of fresh clinical material for infusion must only be 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 Training/Competency Assessment

Complete the Training Record and Competency Assessment (Appendix 7).



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



11.0 Managerial Approval

Name Printed Signature Title Date Author: P. Elsey

Penelope Elsey Head of Quality Dept.

18/8/09

Reviewers J Davis

John Davis JGCCT Director 18/8/2009

N. O’Brien Nancy O’Brien Clinical Nurse Specialist

03.Oct.09

A. Rahemtullah

Amin Rahemtulla Medical Director JGCCT

18/8/09

K. Patel Kirtash K Patel

QA Mgr 03.Oct.09



Appendix 1 Infusion Request Form



Appendix 2 Processing Request form



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 Cell Dose 2.704x106 CD34+/Kg in 2 bags (leaving 8.73x106 in 4 bags) CYTOTOXIC TREATMENT: Melphalan 200 mg/m2 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



Appendix 4 Defects and Adverse Incidents Form



Page 2 of 2



Appendix 5 Example of Fresh Infusion Label



Appendix 6 Infusion Report



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



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 Training Started

Trainee Name

Trainee Signature

Date Training Completed

Supervisor / Trainers Signature

Supervisor / Trainer to sign, if Trainee is Competent in SOP.

Competency Assessment Method.

Documents

transport of cells