OPERATIONS USER GUIDE

Transcription

1 OPERATIONS USER GUIDE 1 Ver 1.3 (06/12)

2 CONTENTS 1 Background and organisation of Anthony Nolan 3 2 Patients for whom a search may be requested 5 3 Procedure for requesting HLA testing and a search 6 4 The search process 8 5 Matching of patients and donors 10 6 Graft identification advisory service 14 7 Collection of Peripheral Blood Stem Cells (PBSC) or bone marrow 16 from an Anthony Nolan Donor 8 Facilitating the collection of Peripheral Blood Stem Cells (PBSC) 20 for bone marrow from an International Donor 9 Subsequent donations from Anthony Nolan Donors 23 and international donors 10 Provision of Cord Blood Units from the Anthony Nolan Cord Blood 25 Bank 11 Provision of Cord Blood Units from the NHS and overseas HTA/NMDP Reporting Cryopreservation and Transportation of cell product Procedure after donation Histocompatibility testing Anthony Nolan s Accreditation and Regulation Fees and finance Contacts Definitions 42 2

3 1 BACKGROUND AND ORGANISATION OF ANTHONY NOLAN 1.1 Background Anthony Nolan is a charity which was founded in Amongst other things, Anthony Nolan finds matches for patients with blood cancers who need a blood stem cell transplant. More information about the work and history of Anthony Nolan can be found on our website Guide This User Guide sets out the procedures to be followed by Transplant Centres and International Registries using Anthony Nolan s services. The contract between Anthony Nolan and the UK Transplant Centre is divided into two, this User Guide and a separate Service Level Agreement which is signed by both parties. This is for administrative convenience. This User Guide and the signed Transplant Centre (UK) agreement together form the contract between Anthony Nolan and the UK Transplant Centre. International Registries may or may not have signed agreements with Anthony Nolan. By following relevant sections of this guide when using Anthony Nolan Services, International Registries will find the working collaboration will run more smoothly. 1.3 Services Provided by Anthony Nolan Anthony Nolan: manages a register of volunteers willing to donate haemopoietic stem cells or lymphocytes, facilitates the procurement and distribution of haemopoietic stem cells or lymphocytes, maintains a bank of cord blood units, and a cord blood inventory, provides international donor search facilities, imports and exports therapeutic cells and cord blood units, liaises with International Registries and Cord Blood Banks on behalf of Transplant Centres, provides laboratory testing and Histocompatibility services, and provides a graft identification advisory service 1.4 Operations Division of Anthony Nolan The Operations Division of Anthony Nolan is divided into teams. Search and Selection, and Harvest and Welfare, are the teams with which external users of Anthony Nolan s services have most contact. 1.5 Useful Web Links The most recent version of this user guide and many of the forms referenced in later chapters can be found here. 3

4 1.5 Search and Selection Team The Search and Selection Team carries out the following functions: Worldwide Database Graft Search: The Search and Selection Team runs computerised searches for matching unrelated Donors and/or Cord Blood Units, on behalf of UK and overseas patients. The Search and Selection Team searches all UK and International Registries for UK patients, but searches only the Anthony Nolan Register and the Anthony Nolan Cord Blood Bank on behalf of overseas patients. Cord Blood Banks, facilitating the cord requests for UK transplants. Donor Welfare: This section, together with the Medical Officer(s) of Anthony Nolan, are responsible for monitoring each Donor s physical, emotional and psychological wellbeing after the donation procedure. Verification and Extended Typing: The Search and Selection Team arranges verification and extended typing of Anthony Nolan, NHSBT and International Donors and Cord Blood Units selected by UK Transplant Centres. The Search and Selection Team also arranges extended typing or shipment of blood samples for verification typing of Anthony Nolan Donors and Cord Blood Units selected by International Registries. GIAS: The Search and Selection Team provides professional help to Transplant Centres in selecting Donors and/or Cord Blood Units for verification and extended typing in order to provide a transplant for a patient in an efficient and cost effective way. 1.6 Harvest and Donor Welfare The Harvest and Welfare Team is divided into the following sections. Harvest: This section is responsible for the work-up of each Anthony Nolan Donor and Cord Blood Unit selected for transplant, and for monitoring the Donor s physical, emotional and psychological well being during the work-up process. This section also liaises with International Registries for the work-up of International Donors, and liaises with International 4

5 2 PATIENTS FOR WHOM A SEARCH MAY BE REQUESTED 2.1 Patients for Whom a Search May Be Requested Each patient for whom a search is requested must be recommended by a recognised clinician for an unrelated stem cell transplant and must satisfy Anthony Nolan s requirements regarding diagnosis, age and any other factors which Anthony Nolan may in its discretion consider relevant. 2.2 Patients for Whom a Search May Be Requested Diagnosis When considering the diagnosis of a proposed patient Anthony Nolan will use the Indications Table on The British Society of Blood and Marrow Transplantation (BSBMT) website pages/64- Indications_Table and the list of conditions from Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009 Bone Marrow Transplantation (2009) vol 45, , as guideline documents. 2.3 Patients for Whom a Search May Be Requested Age of Patient The Transplant Centre s physicians may exercise their discretion about whether a patient is of a suitable age for a transplant, provided that such physicians follow the relevant national and international standards and ethically approved protocols. 2.4 Patients for Whom a Search May Be Requested Unusual Requests The Transplant Centre must refer any unusual requests to Anthony Nolan. The Transplant Centre must provide a brief clinical history of the proposed patient, and a copy of an ethically approved treatment protocol. 2.5 Source of Cells The Transplant Centre may specify whether it requires Peripheral Blood Stem Cells, or marrow derived stem cells or a Cord Blood Unit. If the diagnosis for which the Transplant Centre is requesting a Donor is not mentioned in the guideline documents referred to above, Anthony Nolan may ask for further clinical information from the Transplant Centre. 5

6 3 PROCEDURE FOR REQUESTING HLA TESTING AND A SEARCH 3.1 Procedure for requesting HLA Testing at the Anthony Nolan Laboratories - for a patient Histocompatibility Testing will be provided by Anthony Nolan if the UK Transplant Centre has requested this service by ticking the relevant box in the separate Service Level Agreement, which is signed by both parties. A signed agreement in place is not essential to use our laboratory services however. A more detailed description of services can be found in the Anthony Nolan Histocompatibility Laboratory User Guide. If the Transplant Centre requires HLA testing for a patient, the Transplant Centre must send the patient s blood sample to Anthony Nolan with the appropriate completed Histocompatibility testing request form: Patient Histocompatibility Testing Request Form. 3.2 Procedure for requesting HLA Testing at the Anthony Nolan Laboratories - for a related donor Anthony Nolan also provides testing services for related donors. If the Transplant Centre is proposing a transplant using a related donor, such as a sibling, the Transplant Centre may also request that Anthony Nolan carries out HLA testing for such sibling by sending the sibling s blood sample to the Anthony Nolan Laboratories with the appropriate completed histocompatibility testing request and consent form: Related Donor Histocompatibility Testing Request Form. 3.3 HLA Testing of Blood Samples Anthony Nolan will HLA type the blood samples, perform ABO and Rhesus blood grouping and test the blood samples for CMV status. 3.4 HLA Typing Reports Anthony Nolan shall issue an HLA typing report and shall send this to the Transplant Centre by Procedure for requesting a Search for a Donor and/or Cord Blood Unit if the HLA Testing of the patient is performed at the Anthony Nolan Laboratories. When Anthony Nolan provides a HLA typing report for a patient, it will also ask the Transplant Centre whether it requires Anthony Nolan to carry out a search for an unrelated Donor. If the Transplant Centre requires such a search, the Anthony Nolan Laboratories will forward a copy of the patient s HLA typing report to the Search and Selection Team of Anthony Nolan. There is no need for the Transplant Centre to complete any other search request. 3.6 Procedure for requesting a Search for a Donor and/or Cord Blood Unit, if the HLA Testing of the patient is not performed at the Anthony Nolan Laboratories If the HLA typing of a patient is carried out at a laboratory other than the Anthony Nolan Laboratories, the Transplant Centre 6

7 must complete a search request: SDAP002 Search Request Form and send it, either by fax or , to the Transplant Centre s own Anthony Nolan or to the Anthony Nolan search staff at searchteam@anthonynolan.org. to Anthony Nolan or send a similar form which contains the information set out in the Clause 3.9 below If sufficient information is not provided on the form, Anthony Nolan will ask the Transplant Centre to provide further details. The Transplant Centre must also send Anthony Nolan the HLA Typing Report, as described below, for each patient for whom it requests a search. 3.7 HLA Typing Report The Transplant Centre must send a HLA Typing Report with each search request. It is recommended that the HLA typing is performed to the second field level for HLA-A, B, C and DRB1 and to the first field level for other loci or serological split level, whichever gives the higher resolution. This level of typing expedites the search process. Low resolution HLA typing slows down the search procedure by identifying Donors who, on subsequent analysis, may prove to be mismatches. As some International Registries require HLA typing to second field level of patients before they will provide a Donor, high resolution patient typing is recommended at the beginning of the search process. Information on HLA typing requirements can be found in the Anthony Nolan Histocompatibility Laboratory User Guide. 3.8 Procedure for an International Registry which is Requesting a Search for a Donor and/or Cord Blood Unit An International Registry may request a search electronically, or by fax. Users authorised by their affiliated International Registry may request a search using the European Marrow Donor Information System ( EMDIS ). If EMDIS is not used, such users may fax a search request: SDAP002 Search Request Form 7

8 3.9 Information to be contained in a Fax Search Request from an International Registry Patient s name Patient s gender Patient s date of birth Diagnosis and current status of patient HLA typing of patient (minimum HLA-A, B and DRB1) If homozygous HLA loci given at low resolution (e.g. serology), molecular (DNA) typing or family data confirming homozygosity) Registry reference Invoice Address If a Cord Blood Unit search is required the fax must also state the patient weight Checking of Data on Search Requests Anthony Nolan will check all search requests to ensure that appropriate and adequate data is given before the search is initiated. If any information is illegible or missing, Anthony Nolan will ask the Transplant Centre or International Registry to resubmit the request. 8

9 4 THE SEARCH PROCESS 4.1 Search of the Anthony Nolan Register and the NHSBT Database for UK patients On receipt of a search request as referred to in Chapter 3 of this User Guide, Anthony Nolan shall search the Anthony Nolan Register and the NHSBT Database for each UK patient. Anthony Nolan shall also search the Anthony Nolan Cord Blood Bank and the NHSBT Cord Blood Bank for each UK patient unless otherwise advised by the Transplant Centre. Anthony Nolan will perform a mismatch search if necessary. 4.2 Worldwide Search for UK Patients BMDW Anthony Nolan shall perform a worldwide search of adult Donors on the Bone Marrow Donors Worldwide ( BMDW ) database for all UK patients. 4.3 Search for a Cord Blood Unit Anthony Nolan shall also perform a worldwide Cord Blood Unit search for each child patient and for an adult patient if the Transplant Centre or International Registry specifically requires this. The Transplant Centre must provide details of the weight of each patient for whom a Cord Blood Unit is requested. 4.4 Forwarding Search Requests to the Welsh Bone Marrow Donor Registry Upon receipt of a search request for a UK patient, Anthony Nolan will immediately forward a sequentially numbered copy of the search request to the Welsh Bone Marrow Donor Registry ( WBMDR ), unless the Transplant Centre states that the search request has already been sent to WBMDR. Similarly, WBMDR will forward all search requests which it receives to Anthony Nolan. 4.5 Search Report UK Patients Anthony Nolan will prepare a search report consisting of the Anthony Nolan and NHSBT Donor listings, the details of the Cord Blood Units if these have been requested by the Transplant Centre, a BMDW summary and a covering letter recommending an appropriate course of action. Anthony Nolan will send this search report to the Transplant Centre by fax within approximately two business days of the receipt of the search request. 4.6 Search of the Anthony Nolan Register and the Anthony Nolan Cord Blood Bank for Overseas Patients Anthony Nolan will search the Anthony Nolan Register for overseas patients. It will also perform a Cord Blood Unit search of the Anthony Nolan Cord Blood Bank if the International Registry specifically requests this. 9

10 6 Anthony Nolan will send the International Registry a search report, consisting of the Anthony Nolan Donor listings and details of Cord Blood Units from the Anthony Nolan Cord Blood Bank, within two working days of receipt of the search request. 4.7 Search of International Registers: Request for Further Information UK Patients If the initial BMDW search produces details of possible adult matching International Donors and/or suitable Cord Blood Units about whom the Transplant Centre would like further information, the Transplant Centre must, by , request Anthony Nolan, to obtain such additional information from the relevant International Register and/or Cord Blood Bank. Such additional information shall include matters such as the age and gender of the proposed adult International Donor. Forms: Additional Information on a Cord Blood Unit Form CBAP003 and Additional Information on a Cord Blood Unit and a DNA Sample CBAP001 The Transplant Centre may also request additional information about the Donor, by Results of Search of International Registries and International Cord Blood Banks 4.9 First Repeat of Search On request, Anthony Nolan shall rerun a search, for the same patient, after an interval of three months, or such shorter period, which may, in exceptional circumstances, be agreed by Anthony Nolan. This initial repeat search is free Additional Repeat Searches If the Transplant Centre requires further repeat searches (in addition to the initial repeat search referred to in the preceding paragraph) the Transplant Centre must submit a new repeat search request together with supporting notes from the Transplant Centre physician giving clinical details and the reason for the new repeat search. The Transplant Centre must pay for these additional repeat searches at the rate specified in the Fee Schedule. No Transplant Centre may request more than 2 repeat searches a day Cancellation of search To cancel a search, the Transplant Centre or International Registry must complete Form SDAP004 Search cancellation. Anthony Nolan will send the Transplant Centre, by fax, an initial report of each adult International Donor and each international Cord Blood Unit within three working days of receipt of request. The turn around times of International Registries and international Cord Blood Banks vary so some results may not be available when Anthony Nolan sends out this initial international search report. Anthony Nolan will forward these other results to the Transplant Centre promptly after receiving them. 10

11 6 5 MATCHING OF PATIENTS AND DONORS Advice and Responsibility: Anthony Nolan is willing to provide advice on matching Donors and patients. The final decision, however, on Donor suitability is always the responsibility of the Transplant Centre. 5.1 Matching Programme - Anthony Nolan Laboratories The matching programme developed at Anthony Nolan includes the HLA A, B, and DRB1 molecular typing data in the sorting algorithm. Where ambiguities exist, resulting in intermediate resolution results, the allele codes developed by the National Marrow Donor Program, USA are utilised to enter data onto the computer ( de_lists.html). Anthony Nolan will extend searches to look for Donors with a single mismatch at the HLA-A, -B or DRBI locus if Anthony Nolan deems this appropriate. The standard sort format for Donor listings is male Donors before female and younger before older, within degree of HLA match. Additional information provided on matching Donors, if known, includes ABO and RhD, blood group, cytomegalovirus (CMV) status, ethnic group and weight. Most of these factors may be applied as optional filters to reduce a long list of matching Donors e.g. a list of CMV negative matching Donors only may be requested. Donors who are known to be temporarily unavailable are marked Unavailable with a release date, those in test for another patient are marked In Test, and those who have already donated to another patient are marked Donated. The higher the HLA typing resolution provided on the patient, the more informative the donor listing will be. 5.2 Verification Typing As soon as the Transplant Centre selects a potential matched Anthony Nolan Donor, or NHSBT or International Donor, such Donor must provide a fresh blood sample. This testing is necessary to ensure that the Donor is still willing and available to donate, and still fulfills the medical requirements for donation. Anthony Nolan will notify the Transplant Centre of all Anthony Nolan or NHSBT Donors who are unavailable to proceed further, or if Anthony Nolan or NHSBT is having difficulty in locating a Donor for longer than 21 calendar days. A Transplant Centre or an International Registry may request a sample to be tested in the Transplant Centre s designated laboratory SDAP001 Confirmatory Typing Sample Request Form. Request Forms must be sent by fax to the Anthony Nolan Operations Administrator. Anthony Nolan will confirm receipt by fax. In addition, an International Registry may submit these Requests by EMDIS. If an Anthony Nolan Donor is selected, and a fresh sample is needed, the Anthony Nolan CT coordinators will discuss donation procedures and availability with the Anthony Nolan Donor. Once arrangements have been made, Anthony Nolan will notify the Transplant Centre and/or International Registry of when to expect the blood sample from the Anthony Nolan Donor, together with details of Donor availability, medical issues which could affect the donation and preference of method of donating the stem cells, if known. This notification will be made by fax, or in the case of notification of an International Registry, may be made by EMDIS. 11

12 6 If an International Donor is selected, Anthony Nolan shall, as requested by the Transplant Centre, facilitate shipment of the International Donor blood sample to the designated UK Transplant Centre Laboratory for verification typing. If an NHSBT Donor is selected by a UK Transplant Centre, Anthony Nolan will liaise with NHSBT regarding arrangements for the blood sample shipment. Anthony Nolan will notify the Transplant Centre once the date of the sample arrival is known. 5.3 Extended Typing If the Transplant Centre or International Registry needs additional information on a Donor s HLA Typing, extended typing can be performed on a stored DNA sample, if such sample is available. lf the typing of an Anthony Nolan Donor is to be performed on stored material, Anthony Nolan will still make every effort to contact the Donor to discuss the typing which is being carried out. Anthony Nolan will inform the Transplant Centre/ International Registry if Anthony Nolan has been unable to contact the Donor. If the Transplant Centre requests extended typing of a NHSBT or International Donor, Anthony Nolan can not guarantee that such International Donor will be available to provide a further sample. The policies of other Registries vary. If the Transplant Centre requires extended typing on an Anthony Nolan, NHSBT or International Donor it should complete Form DAP007 Extended Typing Request Form, and send such form by fax or CTTeam@anthonynolan.org or send it to the sender s allocated 5.4 Virology Screening If the Donor has not been tested for virology within the last three months Anthony Nolan will also perform Virology Screening (Hep B, Hep C, HIV and CMV) on samples provided for verification typing, and on samples provided for extended typing. Please see the Anthony Nolan Histocompatibility Laboratory User Guide for further details of sample requirements associated with particular test requests. If the Transplant Centre requires NHSBT to perform virology screening on an NHSBT Donor such a test should be requested and paid for separately as set out in the Fee Schedule. Virology tests of International Donors are usually part of the standard verification typing request. 5.5 Results Extended Typing Performed in Anthony Nolan Histocompatibility Laboratories If the testing is carried out in the Anthony Nolan histocompatibility Laboratories, Anthony Nolan will send the report of the test results to the Transplant Centre s designated laboratory, or to the International Registry, approximately seven business days after Anthony Nolan receives the blood sample. 5.6 Results Verification Typing Performed in the Transplant Centre s Designated Laboratories If the testing is carried out in the Transplant Centre s own designated Laboratory, the Transplant Centre must arrange for this Laboratory to return the results of Donor typing to Anthony Nolan as soon as possible, by fax indicating whether the Donor should be released or reserved. If the Transplant Centre does not instruct Anthony Nolan to reserve a Donor, Anthony Nolan will hold the Donors for 60 days after the date on which the verification typing samples were shipped and then release them. In the case of an International Donor, if the Transplant Centre does not instruct Anthony Nolan to reserve such Donor, Anthony Nolan will give instructions to the International Registry to release the Donor within 60 days. 12

13 6 5.7 Reporting of Discrepancies in HLA Typing Results The Transplant Centre must report all discrepancies in HLA typing results to Anthony Nolan as soon as possible. 5.8 Cancellation A Transplant Centre or International Registry may cancel requests for further typing, or for blood sample procurement or blood sample shipment, at any time. A Transplant Centre must give Anthony Nolan not less than two business days notice of cancellation of requests for blood samples, to enable Anthony Nolan to contact the Donor and cancel the Donor s appointment. If notice of cancellation is received by Anthony Nolan when the typing, sample procurement or sample shipment is underway, the Transplant Centre or International Registry must still pay the full fee for such typing or sample. 13

14 6 EXAMPLE OF AN ANTHONY NOLAN SEARCH REPORT 14

15 6 6 GRAFT IDENTIFICATION ADVISORY SERVICE 6.1 Graft Identification Advisory Service (GIAS) GIAS consists of professional help to the Transplant Centre selecting Donors and/or Cord Blood Units for verification and extended typing in a time efficient and cost effective way. GIAS will be provided by Anthony Nolan if the Transplant Centre has requested GIAS by ticking the relevant box in the separate Service Level Agreement, which is signed by both parties. 6.2 Search If the Anthony Nolan Laboratories are not providing HLA testing, Anthony Nolan will initiate an unrelated search as soon as the search request, which gives details of the patient s typing, has been received. If the Anthony Nolan Laboratories are providing HLA testing, Anthony Nolan may initiate an unrelated search as soon as the patient s typing has been completed at the Anthony Nolan Laboratories. Anthony Nolan may, at its discretion, extend the standard search to any additional level, including mismatching, international and Cord Blood Units search. 6.3 Search Results and Recommendations If the Transplant Centre requires only a search of the Anthony Nolan Register and the NHSBT Register, Anthony Nolan will endeavour to send the results of all searches within one business day of receipt of the search request. If extended searches are required Anthony Nolan will endeavour to send the results of such searches within three business days of receipt of the search request together with Anthony Nolan s recommendations for Donor or Cord Blood Unit selection. Recommendations will include three Donors to be requested for verification and/or extended typing together with three back up Donors, and, if required, up to ten Cord Blood Units on which reports should be requested. Anthony Nolan will make its recommendations based on the patient information and matching requirements supplied by the Transplant Centre, and shall apply Anthony Nolan expertise. Recommendations will be authorised by the Head of Search and Selection or other appropriate members of staff. 6.4 Verification/Extended Typing Requests 15

16 6 If initially agreed, Anthony Nolan may proceed to verification /extended typing requests immediately after the search and will notify the Transplant Centre of such typing requests in the covering letter which is sent with the search results and recommendations. If the Transplant Centre disagrees with such requests, it must its designated Search Coordinator to stop the request. Such must be received by Anthony Nolan within three business days of Anthony Nolan sending the search results. Any delay may incur a cancellation payment. Such must be received by Anthony Nolan within three business days of Anthony Nolan sending the search results. Any delay may incur a cancellation payment. Such must be received by Anthony Nolan within three business days of Anthony Nolan sending the search results. 6.5 Back-Up List If a Donor or Cord Blood Unit is unavailable or there is an unacceptable mismatch, Anthony Nolan will immediately proceed to the verification and/or extended typing request of another Donor or Cord Blood Unit from the back-up list agreed with the Transplant Centre. 6.6 Reporting On a regular basis (once a week or fortnightly) Anthony Nolan will an updated GIAS spread sheet to the Transplant Centre. This will include current information about arrangements for shipping samples, the progress of the Donor s extended typing and the progress of the typing the Donor s siblings, if applicable. 6.7 Fees The Transplant Centre must pay for GIAS. Fees are set out in the Fee Schedule. 16

17 6 7 COLLECTION OF PERIPHERAL BLOOD STEM CELLS (PBSC) OR BONE MARROW FROM AN ANTHONY NOLAN DONOR HWAP028. Product Request: 7.1 Forms to Be Completed by the Transplant Centre/International Registry If the Transplant Centre/International Registry requires PBSC or bone marrow from an Anthony Nolan Donor the Transplant Centre must send Anthony Nolan the following completed work-up request forms. PBSC Forms: HWAP028 - Formal Request for Blood Stem Cell Collection ( Product Request ). HWAP029A - Prescription for Peripheral Stem Cell Collection and/or Bone Marrow Forms: HHWAP029B - Prescription for Bone Marrow Harvest. HWAP032 - Confirmatory HLA Typing Result Sheet (or legible lab HLA typing reports for both patient and Donor). 7.2 Details of Forms The Transplant Centre/International Registry must complete each section of each form. If there are any gaps this may delay processing the request. Put 1 next to the preferred stem cell source, and 2 if the other stem cell source will also definitely be accepted, or 0 if the other source is not an option (i.e. the Transplant Centre would prefer to use another Donor if the selected Donor will not donate via option 1). HWAP029A Prescription (PBSC) and HWAP029B Prescription (BM): Dilution of Prescription. Unless otherwise instructed by the Transplant Centre/International Registry on the relevant prescription form: PBSC collections will be diluted with autologous plasma to get an approximate final concentration of less than 200x10^6/ml TNC. Bone Marrow will be diluted with ACD at a dilution of 1:7 vol ACD/vol BM. If the Transplant Centre/International Registry requires different dilutions, the Transplant Centre/International Registry must specify this on the relevant prescription form. 17

18 6 7.3 HWAP032 Confirmatory HLA Typing Result Sheet The following infectious disease markers:- HBsAg, anti-hbc, HTLV 1 and 2, anti-hiv1 and HIV2, anti-, anti-hcv, HCV RNA, anti- CMV IgG and IgM, Anti Toxo IgG and IgM, Trepenoma Pallidum serology VZV IgG. EBV (Anti-VCA IgG and IgM) are HTA/WMDA mandatory requirements and are routinely tested for in all Anthony Nolan Donors. Anthony Nolan also performs HBV DNA & HIV RNA NAT Testing. If the Transplant Centre/International Registry requires any other tests it should request additional pre-collection samples. 7.4 Confirmation of Receipt of Work - Up Request Anthony Nolan will confirm receipt of each work-up request by fax or to the Transplant Centre or International Registry. 7.5 Checking of Work-Up Request and Patient Criteria Anthony Nolan will check all work-up requests for an Anthony Nolan Donor to ensure that the appropriate (HLA matched) Donor has been selected for the patient, by verifying initial Donor eligibility based on HLA requirements, age, previous medical and social history and information provided by the Donor. Anthony Nolan will also check that the patient s criteria (age, diagnosis, disease status) and transplant protocol comply with Anthony Nolan s standards. Anthony Nolan will notify the Transplant Centre/International Registry by fax or the name of the Harvest Coordinator responsible for the patient s work-up request. 7.6 Anthony Nolan s Contact with the Donor If the transplantation is imminent Anthony Nolan will notify the Donor by telephone immediately. If the requested dates for transplantation are several weeks away, Anthony Nolan will send the Donor a letter and a Donor information booklet. If the Donor does not respond to either letter or telephone call, the Donor will be passed as an extremely urgent case to the Donor Tracing team and the Transplant Centre/International Registry will be informed of the potential delay. 7.7 Checking Dates The Harvest Coordinator shall check with the selected Donor that he or she is still willing to proceed and is available on the dates requested by the Transplant Centre/International Registry. If the Donor is not available on the requested dates, this information, with alternative dates proposed by the Donor, will immediately be relayed to the requesting Transplant Centre/International Registry. 7.8 Preferred Method of Donation Anthony Nolan will make the Donor fully aware of the options regarding the two methods of donating, which are PBSC and bone marrow. Anthony Nolan will tell the Donor of the Transplant Centre s preferred method of donation but Anthony Nolan will never put pressure on the Donor to select such preferred method. If the Donor s chosen method of donation is not the Transplant Centre s first preferred choice, but it is its second, Anthony Nolan will proceed with making the arrangements for donation and will notify the Transplant Centre/International Registry accordingly. If the Transplant Centre/International Registry only wants the alternative method, Anthony Nolan will not persuade or coerce the Donor into changing his or her mind. Anthony Nolan will tell the Transplant Centre/ International Registry of the Donor s choice to see if the Transplant Centre/ International Registry is still willing to proceed with such Donor. 18

19 6 7.9 Booking the Medical, Counselling, Consenting and Harvest Procedure at the Collection Centre When the dates for the transplantation have been agreed by the Donor and the Transplant Centre, Anthony Nolan will book the Donor a full medical at one of Anthony Nolan s Collection Centres to ensure that the Donor is medically fit to donate. Anthony Nolan will arrange all the logistics of the medical examination and the donation, including all necessary travel arrangements and the reimbursement of any out-of-pocket expenses, including subsistence, for an accompanying relative or friend. Also, Anthony Nolan will arrange the following appointments, and will notify the Transplant Centre/International Registry of the confirmed dates for: (i) the Donor s medical examination, consenting and counselling for the donation procedure. (If pre collection samples are required by the Transplant Centre, this examination will not take place on a Friday), (ii) the estimated date on which the results of the Donor s clearance will be received, (iii) if the method of donation is PBSC, the dates and times of the G-CSF injections, (iv) the date(s) of the donation, and (v) the date and time(s) for expected delivery of the donated PBSC or bone marrow No Donor/Patient Contact Donors will never donate in the same hospital as the hospital in which the patient is being treated. Donors will never be treated by a physician who is involved in the care of the patient Donor Clearance When all the Donor s tests and reports have been accepted as suitable for the Donor to proceed with donation, Anthony Nolan s Medical Officer will complete: HWAP009 -Donor Final Clearance Form. Anthony Nolan will send the clearance form and HWAP019/HWAP020 - Verification Form to the Transplant Centre/International Registry. The Transplant Centre/International Registry will sign these forms and return them to Anthony Nolan to confirm that the Transplant Centre/International Registry is happy with the dates and the proposed donation/collection regime. The Transplant Centre must check that Anthony Nolan has received this Donor clearance before patient conditioning begins Procedure if a Donor Fails Medical If any tests or examination results are not within the normal range, such results will be reviewed immediately by Anthony Nolan. If any condition is uncovered which prevents the Donor from donating, Anthony Nolan will notify the Transplant Centre/ International Registry of this decision immediately. Anthony Nolan will not give the Transplant Centre/International Registry any details of the reasons why the Donor has failed his or her medical. Occasionally, the Medical Officer may decide that further medical investigations are required before a final decision on the Donor s suitability to donate can be made. The Anthony Nolan Harvest Coordinator will inform the Transplant Centre/International Registry in writing that the Donor requires further testing before a decision regarding the Donor s suitability to donate can be given. Details of the further testing will not be given to the Transplant Centre/ International Registry but the expected date on which the results will be available will be given in order for the proposed transplant date to be 19

20 6 changed if necessary and/or other appropriate actions to be taken Postponements and Cancellations of Transplants The Transplant Centre/International Registry must immediately notify Anthony Nolan, both by telephone and in writing, of all postponements and cancellations of a scheduled transplant. examination of the Donor is required and will be arranged by Anthony Nolan Material Change in Staffing The Transplant Centre must notify Anthony Nolan immediately of the departure of any senior member of staff, including, but not limited to, the Transplant Director, whose loss may adversely affect the running of the programme. If these cancellations or postponements require urgent action by Anthony Nolan and occur outside office hours the Transplant Centre/International Registry must call the Anthony Nolan emergency number on: Postponements and Cancellations of Donations Anthony Nolan will immediately notify the Transplant Centre/International Registry, both by telephone and in writing, of all postponements and cancellations of the scheduled donation. The Transplant Centre/International Registry must provide a 24 hour telephone number for this purpose. In rescheduling a donation, if the last virology testing was performed on a Donor sample taken more than thirty days prior to the donation date, Anthony Nolan will ensure that repeat virology testing is performed. If the transplant has been postponed by more than eight weeks, repeat haematology and biochemistry tests will also be performed. If the transplant has been delayed by more than three months, a repeat full medical 20

21 6 8 FACILITATING THE COLLECTION OF PERIPHERAL BLOOD STEM CELLS (PBSC) OR BONE MARROW FROM AN INTERNATIONAL DONOR 8.1 Forms General A Transplant Centre must send Anthony Nolan the following completed (i) HWAP028 - Formal request for blood stem cell collection ( Product Request ) (ii) HWAP029A - Prescription for Peripheral Stem Cell Collection and/or (iii) HWAP029B - Prescription for Bone Marrow Harvest (iv) HWAP032 - Confirmatory HLA Typing Result Sheet (or legible lab HLA typing reports for both patient and Donor) Each section must be completed. If there are any gaps this may delay processing the request. 8.2 Form HWAP028 Product Request Put 1 next to the preferred stem cell source, and 2 if the other stem cell source will also definitely be accepted or 0 if the other source is not an option (i.e. the Transplant Centre would prefer to use another Donor if this Donor will not donate via option 1). 8.3 Form NMDP Donor Request. Anthony Nolan Form F Fillable Donor Workup Request together with high resolution HLA typing for both patient and Donor. 8.4 HWAP029A - Prescription (PBSC) and HWAP029B - Prescription (BM) Unless otherwise instructed by the Transplant Centre on the relevant prescription form, PBSC collections will be diluted with autologous plasma to get an approximate final concentration of less than 200x10^6/ml TNC; and Bone Marrow will be diluted with ACD at a dilution of 1:7 vol ACD/vol BM 8.5 HWAP032 Confirmatory HLA Typing Result Sheet Most International Donors are tested for the following infectious disease markers: HBsAg, anti-hbc anti-htlv 1 and 2,,anti- HIV1 and HIV2, anti-hcv, HCV RNA, anti- CMV IgG and IgM, Anti Toxo IgG and IgM, Trepenoma Pallidum serology VZV IgG and EBV (Anti-VCA IgG and IgM). If the Donor is an NMDP Donor, (not including Caitlin Raymond or Gift of Life Donors) the Transplant Centre will send 21

22 8.6 Confirmation and Checking of Work-Up Requests Anthony Nolan will confirm receipt of each Work-Up Request by fax or to the Transplant Centre. If Anthony Nolan is providing clinical services, Anthony Nolan will check all workup requests for an International Donor to ensure that the appropriate (HLA matched) Donor has been selected for the patient, by verifying initial Donor eligibility based on HLA requirements. Anthony Nolan will also check that the patient s criteria (age, diagnosis, disease status) and transplant protocol comply with the relevant International Registry s standards (where known). If Anthony Nolan is not providing clinical services, Anthony Nolan will not provide any of the checks referred to above. 8.7 Contact with International Registry Anthony Nolan will forward each request for an International Donor to the respective International Registry. Such International Registry will then proceed to contact the International Donor and will confirm availability and dates with him or her. Anthony Nolan will notify the Transplant Centre by fax or of the name of the Anthony Nolan Harvest Coordinator who will be responsible for the patient s work-up request. The time frame for confirmation of dates and availability of an International Donor will vary but Anthony Nolan will maintain contact with the International Registry and Transplant Centre to ensure that all information is received at the appropriate times to allow the transplant to proceed on schedule. Anthony Nolan will forward information to the Transplant Centre when it receives it. The written information which will be passed on to the Transplant Centre by Anthony Nolan will include: (i) the date of the Donor s medical, (ii) the date of donation, (iii) the date on which pre-harvest samples will be delivered to the Transplant Centre,(if applicable) and (iv) the expected date and time(s) of the delivery of the donated PBSC or bone marrow. Anthony Nolan will forward this information to the Transplant Centre when it receives it. If the dates do not suit the Transplant Centre, Anthony Nolan will attempt to obtain new dates from the International Registry until a mutually acceptable date is found. 8.8 Donor Clearance When Anthony Nolan receives the International Donor Clearance and results of virology screening from the International Registry, Anthony Nolan will fax or these to the Transplant Centre, before the date on which patient conditioning begins. 8.9 Donors on Reserve The various International Registries have different reservation policies. The Transplant Centre should ask Anthony Nolan for this information when it requires it Postponements and Cancellations The Transplant Centre must notify Anthony Nolan immediately, by telephone and in writing of any postponements and cancellations of a scheduled transplant. If these cancellations/ postponements require urgent action by Anthony Nolan and occur outside office hours the Transplant Centre must call the Anthony Nolan emergency number on

23 Anthony Nolan will immediately notify the Transplant Centre, both by telephone and in writing, of all postponements and cancellations of the scheduled donation. The Transplant Centre must provide Anthony Nolan with details of an emergency 24 hour phone number on which Anthony Nolan can contact the Transplant Centre s transplant team. The Transplant Centre will pass on all information received from Anthony Nolan to the relevant departments of the Transplant Centre, and where necessary, third parties, immediately upon receipt of such information. 23

24 9 SUBSEQUENT DONATIONS FROM ANTHONY NOLAN DONORS AND INTERNATIONAL DONORS 9.1 Requesting a Subsequent Donation The Transplant Centre must send Anthony Nolan the following completed forms for every subsequent donation from the original Donor, who can be either an Anthony Nolan Donor or an International Donor (including NMDP Donors): (i) HWAP031 Formal Request for Subsequent HPC and T-CT Donation and, depending on the type of product being requested, either: (ii) HWAP029A- Prescription for Peripheral Stem Cell Collection and/or (iii) HWAP029B Prescription for Bone Marrow Harvest and/or (iv) HWAP030 Prescription for T-CT collection 9.2 Request for Subsequent Donation of PBSC or Bone Marrow from an Anthony Nolan Donor On receipt of the HWAP031 form, the request will be reviewed by the Anthony Nolan Medical Director (or their deputy) and, where deemed necessary, Anthony Nolan s Medical Advisory Board. 9.3 Consideration of Request for Subsequent Donation from an Anthony Nolan Donor Anthony Nolan will endeavour to provide an interim decision soon after receipt of the request for a subsequent donation from an Anthony Nolan Donor. Anthony Nolan may request further information. If the request is not approved, Anthony Nolan will provide a brief summary of the reason(s) for deferral. The decision of the Medical Director is final. 9.4 Frequency of Subsequent Donations from an Anthony Nolan Donor An Anthony Nolan Donor may only donate haemopoietic stem cells on a total of four occasions. Any further donation will be considered on a case by case situation by Anthony Nolan s medical board. Lymphocytes may be requested from one Anthony Nolan Donor a maximum of four times. Any further lymphocyte requests will be considered on a case by case basis. An Anthony Nolan Donor may only donate to two patients. A Donor who has undergone a PBSC or bone marrow donation, and despite repeated contact attempts is not participating in the post donation follow-up procedures required by Anthony Nolan, may not be considered for any further PBSC or bone marrow collections. A Donor will not be approached to provide PBSC on a second occasion if the Donor did not mobilise at the time of the primary donation. 24

25 9.5 Timings of Second Donations from an Anthony Nolan Donor After the donation of PBSC, bone marrow or lymphocytes, a Donor will not be available for other patient searches for a period of 24 months after donation. Anthony Nolan usually requires a period of four weeks to elapse between any primary donation and a subsequent donation for the same patient. 9.6 Procedure for Approval of Subsequent Donation Requests for a Cell Product from an International Donor If a Transplant Centre requires a further donation from the same International Donor, the Transplant Centre must complete: Subsequent Donation Form HWAP031 referred to Clause 9.1 and return it to Anthony Nolan via fax. Anthony Nolan will forward this form to the relevant International Registry. The rules regarding frequency of subsequent donations from an International Donor vary between International Registries. These rules can be requested from an Anthony Nolan Harvest Co-ordinator when required. 25

26 10 PROVISION OF CORD BLOOD UNITS FROM THE ANTHONY NOLAN CORD BLOOD BANK 10.1 Quality Specification of Anthony Nolan Cord Blood Bank Anthony Nolan s strategy for cord blood is to build its banked inventory to match the unmet demand for Cord Blood Units from UK and overseas Transplant Centres. Anthony Nolan aims to reduce UK Transplant Centre reliance on Cord Blood Units imported from overseas, and to reduce the costs to the NHS, by providing a well stocked inventory of high quality Cord Blood Units. This quality approach is based on four criteria: Security Extensive range IDM virology assays including NAT testing on HBV, HCV, HIV and HTLV Bacteriology assays for aerobic and anaerobic bacteria and fungi presence to ensure sterility Haemoglobinopathy Strict donor eligibility criteria and screening Identity High resolution HLA Typing on HLA- A,-B,-C, -DRB3, -DRB4, -DRB5 and - DQB1 loci and allelic level typing on DRB1 Verification typing from an attached segment from CBU and maternal haplotype matching with CBU. Cord tissue sample also available for DNA testing. Purity Pre-processing threshold for clinically suitable units 1400 x 10 6 Total Nucleated Cells (TNC) Pre-processing threshold for clinically suitable units to 3.2 x 10 6 CD34 + Potency Colony Forming Unit assay to confirm CD34 + potency, ClonE (CFU/CD34) > 10% prior to cryopreservation Viability protocols 7AAD and Annexin V On receipt of a Unit Reservation Request for a Cord Blood Unit, referred to in Clause10.3 below, the Anthony Nolan Cord Blood Bank will initiate its quality assurance tests in accordance with Netcord FACT standards. These tests usually take two weeks. If the Transplant Centre needs the Cord Blood Unit urgently, or when full testing has not been completed, the Transplant Centre must complete a written declaration that it is willing to receive the Cord Blood Unit before these quality and infectious disease marker tests have been completed. HWAP039 Confirmation of Acceptability of Cord Blood Unit. The form, including the declaration, may be sent by fax Cord Blood Selection Cord Blood Unit selection is a complicated and often controversial subject. Anthony Nolan has prepared an article for health professionals about this. See 26

27 10.3 Forms - Requests for Cord Blood Units, Reservation of Cord Blood Units and Requests for Cord Blood Unit Shipment. If the Transplant Centre requests a Cord Blood Unit(s) it shall send:- Form CBAP 003 Cord Blood Unit Report Request to the Anthony Nolan Search team (CTTeam@anthonynolan.org) If, after reviewing the Cord Blood Unit Report, the Transplant Centre decides to reserve such Cord Blood Unit, the Transplant Centre shall send Anthony Nolan:- CPAP004 Cord Blood Unit Reservation Request Each section of the form must be completed, particularly the date of the proposed transplantation Confirmation of Acceptance of Cord Blood When a date for shipment of a Cord Blood Unit has been confirmed and agreed, the Transplant Centre shall complete and return the form:- HWAP039 Confirmation of Acceptance of Cord Blood Unit to the Anthony Nolan Harvest team. The Cord Blood Unit can not be shipped until this form has been received by Anthony Nolan. Anthony Nolan strongly advises that the Cord Blood Unit is shipped and reaches the Transplant Centre before the patient begins their conditioning regime. The Transplant Centre may also consider identifying domestically banked back up units Transportation of Cord Blood The Anthony Nolan Cord Blood Bank will book the courier for the transportation of the Cord Blood Unit to the address stipulated on the request form, and for the return of the dry shipper post delivery. Anthony Nolan will notify the Transplant Centre of the courier details, and shall liaise with the courier in order to arrange a delivery date and time. Anthony Nolan shall notify the Transplant Centre of the courier details and will liaise with the courier to arrange a delivery time and date. Anthony Nolan will notify the transplant centre of the waybill details (for tracking). The Transplant Centre must ensure there is a person waiting at the Transplant Centre to receive the Cord Blood Unit at the stipulated time Storage of Cord Blood The Transplant Centre must have the ability to store the Cord Blood Unit on delivery and prior to transplant. Cord Blood Units are cryopreserved at -150 C Receipt of Dry Shipper On receipt of the dry shipper the Transplant Centre must check the integrity and data logger and complete Form CBB-F-59-2 Reception Form and return such form with the courier or fax it to Anthony Nolan Thawing of Cord Blood Units When thawing the Cord Blood Units the Transplant Centre must check the seals very carefully and thaw all Cord Blood Units precisely in accordance with the instructions given by the Anthony Nolan Cord Blood Bank. The Transplant Centre must thaw the Cord Blood Units in a sterile zip lock type bag. 27