Development of a District Cord Blood Bank: a Model for Cord Blood Banking in the National Health Service
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Bone Marrow Transplantation (2000) 25, 899–905 2000 Macmillan Publishers Ltd All rights reserved 0268–3369/00 $15.00 www.nature.com/bmt Development of a district Cord Blood Bank: a model for cord blood banking in the National Health Service C Donaldson1, R Buchanan2, J Webster2, V Laundy1, H Horsley1, C Barron1, N Anderson3, B Bradley1 and J Hows1 1University of Bristol Division of Transplantation Sciences, 2Department of Women’s Health Services, Southmead Hospital and 3National Blood Service, Bristol Centre, Bristol, UK Summary: personal communication).4 Transplants performed world- wide show that low cell dose significantly decreases post- The Bristol Cord Blood Bank was established as a pilot transplant survival.4,5 Therefore, to date, most cord blood project within existing health services to establish cost- transplant recipients have been small children under effective recruitment, collection and processing suitable the age of 10 years. for use in the NHS should cord blood become a routine The Bristol Cord Blood Bank (BCBB) was developed as source of haemopoietic stem cells for transplantation in a pilot research project to optimise recruitment, collection the UK. An important aim of the project was to evaluate and processing of cord blood donations, with future incor- the feasibility of establishing a midwifery-based collec- poration of cord blood banking into the NHS in mind. An tion network, thus utilising expertise already in place. important aim of the project was to evaluate the feasibility Collection was performed on the delivery suite immedi- of establishing a midwifery-based collection network, thus ately after the placenta was delivered. The clinical utilising expertise already in place within the NHS. experience of the midwife collector/counsellors allowed rapid pre-collection assessment of the condition of the cord and placenta. This prevented collection attempts Establishment of the Bristol Cord Blood Bank from diseased or otherwise damaged placentas, leading to conservation of resources by preventing collection of The district most small volume donations. The bank was established within the National Blood Service, Bristol Centre to The North Bristol NHS Trust provides community and hos- achieve Good Manufacturing Practice standards and pital services to 500 000 people living in north Bristol and ensure that processing was subject to the same strin- South Gloucestershire. Community midwives provide the gency required for other sources of haemopoietic stem majority of antenatal care in the community, with referral cells. Cord blood is an expensive resource. By utilising to the hospital antenatal assessment unit when necessary. existing expertise in district Obstetric and National During the 1997/1998 financial year there were 88 116 Blood Services, the Bristol Cord Blood Bank may serve community midwife/patient visits compared with 16 000 as a model for health economic evaluation of cord blood maternity-related admissions to Southmead Hospital, which banking of volunteer donations within the NHS. Bone included 5500 births. Marrow Transplantation (2000) 25, 899–905. The National Blood Service, Bristol Centre, provides Keywords: cord blood; collection; banking; obstetric processing and storage facilities for bone marrow and per- factors ipheral blood stem cell harvests. The cord blood bank was established within this facility to achieve Good Manufactur- ing Practice (GMP) standards and ensure that processing was subject to the same stringency and underlying prin- Haemopoietic stem cells from human umbilical cord blood ciples required for other sources of haemopoietic stem cells. can be transplanted in place of bone marrow to treat chil- dren with leukaemia and other potentially fatal marrow dis- eases.1–3 The future of cord blood as a practical source of Staffing haemopoietic stem cells for transplantation is uncertain and Central Delivery Suite (CDS) at Southmead has a core staff research is still ongoing. A cohort controlled study from the of 40 full-time equivalent midwives working in shifts, as International Bone Marrow Transplant Registry comparing well as four teams of community midwives on rotational banked cord blood with bone marrow donations from regis- attachment.There was concern that if all midwives were tered unrelated volunteers is still awaited (John Wagner, asked to collect cord blood, there would have to be constant retraining in the collection procedures and an increased possibility of small volume collections and higher bacterial Correspondence: Dr C Donaldson, University of Bristol, Division of Transplantation Sciences, Southmead Hospital, Westbury-on-Trym, contamination rates, as the frequency of collections perfor- Bristol BS10 5NB, UK med by any individual midwife would be low. Received 18 August 1999; accepted 15 December 1999 The collection system was therefore developed around Cord blood banking in the NHS C Donaldson et al 900 senior core midwifery staff. Two senior midwives were labour as previously described by the New York Cord seconded for 40% of their time to the cord blood bank as Blood Bank.7 Briefly, the obstetric team in charge of the midwife counsellors. Their role was to organise the recruit- delivery passed the placenta out of the delivery room to ment system, perform the collections, counsel and consent one of the midwife counsellors whose clinical experience mothers for donation and organise the collection of allowed rapid pre-collection assessment of the condition of maternal blood samples 6 months post partum for ‘follow- the cord and placenta. This assessment, which was based up’ virology screens. For the remaining 60% of their time on the findings of a pre-clinical study,8 took into account they were midwives in charge of CDS. Cord blood banking the size, health and condition of the placenta, the size of was therefore seen by all staff as a development within the infant, length of labour, and time of cord clamping. This midwifery services, not as an outside research project. With prevented collection attempts from diseased or otherwise this arrangement it was possible to build up expertise and damaged placentas, leading to conservation of resources by enthusiasm for the project within the obstetric department. preventing collection of most small volume donations. The placenta was placed on a collection stand with the Recruitment foetal surface positioned ventrally. The cord was cleaned with an alcohol spray. A venesection site was selected on A two-stage recruitment and counselling procedure was the umbilical vein as near to the distal cord clamp as poss- developed within National Blood Service guidelines6 antici- ible. The umbilical vein was cannulated with the needle of pating a central role for the NBS should cord blood become a standard Baxter Optipac triple blood collection pack a routine source of haemopoietic stem cells in the UK. (Baxter Healthcare Ltd, Newbury, UK); the volume of anti- Community midwives recruited healthy pregnant women coagulant having been reduced to 23 ml for cord blood col- during the third trimester by giving them information about lection by the removal of 40 ml by sterile technique. The the project and a leaflet highlighting lifestyle exclusion cri- cord blood drained into the collection bag which was placed teria. Certain aspects of the expectant mother’s health and on a blood collection mixer (Baxter Optimix) throughout lifestyle are routinely discussed between the midwife and the collection to prevent clotting. The donation was labelled the mother to enable the best management of the preg- in the collection room with a maternal hospital label and nancy, delivery and immediate care of the newborn. Com- placed in an insulated blood transport box on the delivery munity midwives performed an initial ‘pre-selection’ and suite until collected for processing. did not give the information to women whose known social By the end of the research period, 749 donations had history or personal and family medical history would been collected for banking with a mean volume of 98 ml warrant exclusion. (s.d. 35), excluding the volume of anticoagulant. This com- After reading the leaflets women either gave written con- pares favourably with other reports. In one study, collection sent for cord blood to be collected after delivery of the by obstetricians during the third stage of labour was com- placenta, or were free to decline without giving a reason. pared with collections by cord blood bank technicians after Signed consent forms were placed in the mother’s ante- placental delivery.9 The mean volume collected during the natal notes. third stage of labour was 81 ml (n ϭ 293), and after pla- There were 8267 births on CDS between September cental delivery was 75 ml (n ϭ 41). In a smaller study of 1997, when clinical cord blood collection commenced, and 42 collections,10 a mean volume of 83 ml (s.d. 7.9) for 23 the end of the pilot research project in March 1999. In the donations collected during the third stage compared with first 6 months successful collections averaged 33% of those 48 ml (s.d. 4) for 19 donations collected after placental possible during the midwife counsellors’ shifts (Table 1). delivery. Therefore our decision to collect after placental Improvements were made to the recruitment and collection delivery did not obviously compromise the volume of procedures following an audit by the midwife counsellors donations. in February 1998. These changes, combined with greater Four hundred and sixty-four donations were from vaginal availability of processing facilities, enabled us to increase deliveries, mean volume 92 ml (s.d. 32), and 285 after Cae- the collection rate to 53% for the following year. sarean sections, mean volume 107 ml (s.d. 36), P Ͻ 0.001. In the pre-clinical observational study8 factors found to sig- Collection nificantly enhance total nucleated count of the donation included the total volume collected. Therefore we used Local hospital ethics committee approval was obtained for minimum volume as the most practical variable to decide cord blood collection for clinical banking.