THE PENROSE INQUIRY
Final Report

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Chapter 17

Blood and Blood Products Management

17.1 This part of the report deals generally with questions related to the collection of blood and its adaptation for clinical use. Some information about the administrative and management structures set up for the provision of blood services in Scotland is required, as background to that discussion, to introduce relevant bodies and to provide an indication of the scope of their responsibilities. It is not necessary for the purposes of the Inquiry, however, to attempt to provide a comprehensive account of the history of these bodies or their legal background. For the early stages in the history the Inquiry has drawn on two monographs describing the organisation of blood collection and management: Dr W N Boog Watson's The Scottish National Blood Transfusion Association 1940 - 1965^[1] and Professor Ronald Girdwood's Fifty Years of an Organised Blood Transfusion Service in Scotland^[2] written in the early 1990s. Together these provide fascinating insights into aspects of the story which cannot be developed in this report.

Early history of blood organisation: the SNBTA

17.2 The Scottish National Blood Transfusion Association (SNBTA) was formally constituted on 5 March 1940. The need for a national organisation had been advocated by the Blood Transfusion Sub-Committee of the Department of Health's Scientific Advisory Committee, which had been set up at the beginning of 1939 as part of a review of emergency medical preparations in Scotland in anticipation of war following the Munich crisis in 1938.^[3]

17.3 The remit of the Blood Transfusion Sub-Committee had included review of existing facilities and the consideration of necessary changes in securing the provision of blood for emergency use. More particularly the Sub-Committee was instructed 'to advise on the storage of blood in selected centres'. The practice of storing blood in blood banks was novel. It had started in Madrid in 1937 during the Spanish Civil War. Spanish experience influenced the sub-committee and led to a preliminary recommendation, before publication of its report, that stores of blood should be established in the principal population centres. By 3 September 1939, when war was declared, small blood banks had been established at the Royal Infirmary of Edinburgh (RIE) and Stobhill Hospital, Glasgow.^[4]

17.4 The start of the war coincided with other changes in blood transfusion that pointed to a need for central administration of the service. Professor Girdwood recalled:

[T]he situation was that there was a major war in progress just at the time when knowledge about blood transfusion problems and techniques was increasing and clearly some form of Scottish national organization was speedily required.^[5]

17.5 Donor centres had already been set up in Edinburgh and Glasgow. The Edinburgh operation had started in 1929 and had grown over the intervening period as a result of a number of initiatives, the last of which, in 1936, had been promoted by the Lord Provost. In Glasgow, the Lord Provost convened a meeting in June 1939 which led to the organisation of a panel of donors and, shortly thereafter, to the establishment of a regional donor centre. In other areas practice was less developed. Following on the sub-committee's report, letters were sent to the Lords Provost and civic leaders throughout the country urging the development of transfusion services. Against the background of enthusiastic but varying response, it was decided that a national council was required to take central control and form a more permanent Blood Transfusion Association. On 9 February 1940, the Department of Health for Scotland invited Lord Rosebery to chair the national organisation in Scotland.^[6]

17.6 From the outset it was intended that the transfusion service would remain a voluntary service, supported by voluntary donations, but it was anticipated that generous central government grants would be required to support the range and scope of services the Association would be expected to provide. During the war, the service was enthusiastically supported by members of the public, both as donors and in raising funds by collections, fairs and other events. That changed after the war. Dependence on the Exchequer grant grew rapidly, to the extent that by 1952 voluntary donations accounted for less than 0.5% of the SNBTA's revenue.

A step change in service provision

17.7 Over the war period there were major changes in the scope of the blood transfusion service. The SNBTA took over a miscellany of local services including the blood banks in Edinburgh and Glasgow, and small lists of donors in other areas. It also set about establishing some common policies. Five regional centres were established at Dundee, Edinburgh, Glasgow, Aberdeen and Inverness.

17.8 The introduction of blood banks was a major development. Until 1939 some districts had no storage facilities at all. In some smaller hospital areas relatives were called in when a transfusion was required and, subject to compatibility, were bled immediately before treatment of the patient. Some hospitals had lists of professional donors who would give blood for a fee. Some favoured voluntary donation, recruiting donors by public appeal or with the help of charitable organisations.^[7] The SNBTA developed new procedures for the organisation of blood collection and new facilities for handling and processing the blood collected. In the future, only exceptionally would a volunteer be called on to provide blood for a single patient. Donor sessions would be organised and blood collected to build up and replenish blood banks. Blood banks would store whole blood or plasma to be called down by hospitals in the region for clinical use. Storage required refrigeration equipment and support services. Funds were required immediately and were raised with such efficiency that by July 1940, the chairman of the SNBTA technical committee could claim that the various services could cope with any demands which might be made on their resources.^[8]

17.9 However, technological changes were imminent. It became clear that plasma had considerable value since it obviated the need for cross-matching in an emergency situation, and was particularly effective in treating shock. There was a considerable demand from the armed forces. Unrefrigerated plasma was shipped from the United States (before the USA entered the war), but often arrived with bacterial contamination. Casualties in the war brought home the need for local supplies to be available.^[9] In August 1941, central depots were organised in Edinburgh and Glasgow, to prepare raw material collected locally and from other regions of Scotland and to store plasma for use. This removed the risk of contamination associated with imported plasma. It was agreed that a predetermined quantity of blood for processing would be regularly provided from each blood bank in the country.^[10]

17.10 It was then shown in England that plasma could be dried and reconstituted. In its dried state plasma could be preserved for a much longer period. There arose a great demand for the product, especially from the armed forces, but also for emergency use in civilian practice.^[11] A unit for the production of dried plasma was required. The necessary apparatus was installed in Edinburgh at the beginning of 1943 to meet all Scottish needs. Edinburgh was thought to be in less danger of bombing than the west of Scotland. For the next 12 years, it continued to be the processing centre for the whole of Scotland for the production of dried plasma.^[12]

17.11 In the meantime, in the early months of the war, the Department of Health (DoH) funded the provision of a 'saline infusion fluids centre' for the preparation of saline glucose and other solutions used for intravenous injection. It had been located in Glasgow where the clinician selected by the Department to take charge of the operation worked. These early decisions were reflected in the location of the major laboratory and production facilities in the Glasgow and Edinburgh regions as they developed. The laboratory at Edinburgh was expanded to handle the fractionation of plasma when that process was introduced in 1952, initially for the production of immunoglobulin.^[13] As demand grew for the specialist services provided in Glasgow, civil defence considerations led to the relocation of its facilities to Law Hospital, Carluke. The western service became responsible for plasma drying in 1956 for the whole of Scotland except the Edinburgh and south-east region.^[14] The provision of laboratory and other facilities required for the development of the service is discussed in Chapter 19, Production of Blood Products - Facilities.

17.12 The war years saw huge changes in the transfusion service, in its organisation and in its facilities and, more particularly, in the scope and range of the blood and blood components it managed and provided. There were also changes in the relationships between the service and its donors.

Donor organisation

17.13 Before March 1940, donor organisation was a strictly local concern and policies varied across the country. Small payments and other forms of reward had been made to donors in some areas of Scotland. The newly formed SNBTA favoured the use of voluntary donations and decided to bring an end to payments. This was one of the first acts of the new body and helped to bring about consistency in the practice of recruiting and dealing with donors throughout Scotland. It came to characterise the Scottish system in popular perception and in the representations made about the system domestically and internationally. In The Gift Relationship,^[15] published in 1970, Richard Titmuss, a United Kingdom social scientist, described the British system of blood management as following the social welfare model, with blood treated as a free community resource, collected and distributed by the State. In Scotland the State provided financial support, but did not have a significant managerial role before the National Health Service was established on 5 July 1948, when the National Health Service (Scotland) Act 1947 (the 1947 Act) came into force.^[16]

17.14 The SNBTA took over a service that had grown in a piecemeal fashion. Operational units had a strong sense of local identity. The SNBTA developed a network of blood transfusion centres and panels of volunteer blood donors, in the modern sense, that reflected practice throughout the United Kingdom after the Second World War.^[17] In general, however, Titmuss's characterisation applied to Scotland from 1940: the developing service conformed to the social welfare model.

17.15 From 1940, the service continued to be based on the voluntary donor. War conditions affected the operation of the service. Many potential donors were on active service in the armed forces. Others were employed in occupations remote from collection centres. Mobile collection teams were necessary in some areas to meet the growing demand for blood in 1943 and 1944. There was a strong public response. In 1943 the number of donors rose from 43,000 to 57,000 and in the first half of 1944, as 'D-Day' approached, a further 10,000 donors were recruited. The invasion of France created increased demand in the third quarter of 1944. However, after the war the transition to peace was difficult. Staff changes followed the return of personnel to civilian life. Premises had to be returned to civilian use. Public enthusiasm waned and donor attendances at sessions fell.^[18]

17.16 The wider environment had changed with peace. The requirements of hospitals treating service personnel decreased after the war. However, changes in the therapeutic application of blood and blood components and products in civilian hospitals continued to increase with the growing importance of the use of blood in maternity work and in the treatment of burns and other accident damage. Transfusion was no longer a near- desperate measure in the face of emergency: it had become a well-established form of treatment with ever widening possibilities. The incentive to support the service financially by private donation had changed. In the meantime, the work of the SNBTA was made more difficult by uncertainty about its future. It was increasingly dependent on public funding and, as a corollary, exposed to the influence of government policy. There was a possibility in 1948 that the Association would be merged with the National Health Service. That did not happen.

17.17 The Association's property and staff were transferred to the Secretary of State when the National Health Service was established but the SNBTA itself continued as an independent body.^[19] A proportion of the officers and members of the Association were now nominated by the Secretary of State or by regional hospital boards. But the regime established by agreement with the Secretary of State provided the stability the Association required to get on with its work. An early task was revision of the lists of donors in every region to reduce the registered donors to those who were 'live', who could be expected to attend donor sessions when asked to do so. The work of recruiting new 'live' donors was vigorously pursued.^[20]

17.18 The need for review of the donor system varied across the individual regions. Before the war, Edinburgh was the only place in Scotland with an established blood transfusion service. In other places some hospitals had worked with small lists of donors. The drive to recruit more donors had been managed in various ways across Scotland. In certain areas the population was concentrated around major settlements, while in others the scattered population led to a greater reliance on mobile teams that often had to travel considerable distances. The western service, based round Glasgow, had been able to recruit many donors from the work forces of large industrial employers. An early task for the SNBTA had been to establish a suitable network of blood banks, taking account in some regions of the need to equip smaller, more remote, hospitals that could not easily be served by the larger regional centres.

17.19 The heterogeneity of the regions was largely a reflection of geography, population spread and employment. This did not change after the war, nor with the establishment of the National Health Service. Blood collection had to take account of the realities. Regional organisers, appointed in each region in 1940 with responsibility for raising the money required to maintain the service, to recruit donors and to arrange blood donation sessions, depended for success on voluntary local organisers. Dr Boog Watson said:

In every rural parish, country town and city district in which donors were recruited the regional organisers by personal search and personal approach secured their local organisers, often through such channels as the Red Cross, W.V.S., or Women's Rural Institutes.^[21]

This produced a diverse group of men and women from all walks of life who maintained contact with donors. The collection of blood had the character of a voluntary charitable activity. Effective organisation depended on the goodwill of the organisers and the donors and their personal commitment. These characteristics would continue.

The role of ministers

17.20 The National Health Service (Scotland) Act 1947 provided that it would be a function of the Secretary of State to promote the establishment of a comprehensive health service and provide or secure the provision of services, which necessarily included the provision of blood for clinical use. Accordingly:

• From 1948, the principal duty of providing effective health care in Scotland, including promoting the effective provision of blood transfusion services, has been the responsibility of the Secretary of State for Scotland and now the Scottish Ministers.
• The Secretary of State assisted by Scottish Office Health Ministers, and now Scottish Ministers and in particular the Health Ministers, supported by their respective civil servants, have operational control of health care policy.

17.21 Central government provided increasing funding of the SNBTA's operations by Exchequer grant. The sum provided in 1944 was £7250. By 1964 that had risen to £363,368.^[22] There was ever-increasing need for funding of the service, including the funding of major capital projects. These included facilities for the production of coagulation factor products for the treatment of haemophilia and other coagulation disorders. It was probably inevitable that the SNBTA's role would be reduced.

17.22 Professor Girdwood commented:

When the war ended the need for Government financing became much greater and the coming of the National Health Service necessitated a complete reconsideration of the organization of blood transfusion services in Scotland. It was decided not to make this a responsibility of Regional Hospital Boards .... The notion that the Association could continue to administer the Service was not realistic ....^[23]

However, change did not come as quickly as it might. Legislation was not in place until 1972.

17.23 Section 19 of the National Health Service (Scotland) Act 1972 provided for the constitution of the Common Services Agency for the Scottish Health Service (the CSA) with effect from 1 April 1974.^[24] It provided that:

(2) The Secretary of State may by order delegate to the Agency such of his functions as he considers appropriate.

And

(8) In carrying out its functions the Agency shall act subject to and in accordance with such directions as may be given by the Secretary of State.

The CSA

17.24 The functions of the CSA were initially set out in the National Health Service (Functions of the Common Services Agency) (Scotland) Order 1974^[25]. Article 3 of the Order, as regards blood, provided:

It shall be the duty of the Agency to undertake the following functions:-

....

(e) the provision of supplies of human blood for the purposes of carrying out blood transfusion and related services, including the production of blood fractions.

Formally, the CSA took over most of the functions of the SNBTA in 1974. In structural terms, the CSA operated through a management committee and a series of sub-committees including, in time, the (CSA) Blood Transfusion Sub-Committee.

17.25 Accordingly, in terms of the successive Health Acts and subordinate legislation:

• From 1974, the CSA had delegated responsibility for the operational management of blood services.
• The CSA was subject to, and was obliged to act in accordance with, such directions as might be given by the Secretary of State.

17.26 The 1947 Act was repealed by the National Health Service (Scotland) Act 1978 (the 1978 Act) which continued the general duties of the Secretary of State, including the provision or securing the provision of services. The CSA was reconstituted under the 1978 Act and section 19 of that Act repeated the provisions of section 19 of the 1972 Act as quoted above. Under the 1972 and 1978 Acts the members of the Management Committee of the CSA were appointed by the Secretary of State.

17.27 That remained the position until, with effect from 1 October 2008, the 1974 Order was revoked by the National Health Service (Functions of the Common Services Agency) (Scotland) Order 2008.^[26] So far as relevant for present purposes, the 2008 Order removed the production of blood fractions from the functions of the CSA, but continued to provide for delegation of the provision of supplies of human blood for transfusion and related services.

The CSA and the Blood Transfusion Service

17.28 Scottish Home and Health Department (SHHD) circular HSR(72)C2^[27] which dealt specifically with the CSA, narrated under the heading 'Functions' that the purpose of the new organisation was to provide the SHHD and the Health Boards with a variety of services which could be provided most efficiently by a single agency. It also stated, under the heading 'Central Organisation' that:

The main responsibility for the day to day running of each service within the allocated expenditure and in accordance with broad policies will fall to the chief officer or director of that division of the CSA; and he will in most cases be directly responsible to the Management Committee or to any sub-committee which may be set up for the particular service. It is unlikely that the Management Committee as such will normally have to concern itself with the detailed running of any of the services provided by its operational divisions or that it could attempt to do so over a wide range of services.

....

As indicated, regulations made by the Secretary of State may provide, where appropriate, for sub-committees which include persons not members of the Management Committee. It will be open to the Management Committee to propose such sub-committees for those services where it seems necessary to do so....^[28]

17.29 The government's intention to transfer responsibility for the Blood Transfusion Service to the CSA was set out in the Scottish Home and Health Department (SHHD) circular HSR(73)C40. It stated under the heading 'Reorganisation';

On the appointed day, the Blood Transfusion Service will become a division of the CSA; operational arrangements, based on the five centres and the Protein Fractionation Centre will not be affected. Staff employed by the Association will transfer to the employment of the CSA, although this will not affect the work or organisation of the centres. ^[29]

17.30 That operational control was intended to remain with the SNBTS was recognised by the CSA Management Committee as reflected in an extract from the minutes of its second meeting on 14 March 1974:

It was noted that the operational responsibility for the Blood Transfusion Service would rest with each Regional Director within his region. So far as operational problems affecting Scotland as a whole were concerned it was agreed that a Co-ordinating group should be set up consisting of the National Medical Director, the five Regional Directors, the Scientific Director of the Protein Fractionation Unit, and the Administrative Officer. The National Medical Director would act as spokesman for the group to the Management Committee.

17.31 SHHD circular HSR(73)C40 was greeted with concern among transfusion specialists. They were worried that the CSA would lack the technical competence to manage the highly specialised transfusion service that was envisaged as the replacement for the SNBTA and that the Regional Directors would lose the autonomy they had enjoyed under the SNBTA.

17.32 These concerns were expressed by a member of the South-East Scotland Regional Blood Transfusion Service (probably Dr Robert Cumming),^[30] in a paper circulated on 29 November 1973 commenting on the circular. His concern was that circular HSR(73)C40 lacked information about future arrangements. It did not show 'evidence of policy', nor did it make adequate provision for 'representation by those who best understand the clinical, scientific and technical complexities of blood transfusion practice'. ^[31]

17.33 From a different point of view, Mr John Watt, Scientific Director of the Protein Fractionation Centre (PFC), sent proposals for restructuring the service to all Regional Transfusion Directors in December 1973.^[32] He proposed a centralised management arrangement, which he argued would be compatible with the new overall organisation, but would operate through a committee comprising administrators, transfusion and scientific directors, donor representatives, and representatives of user interests. The bias in his proposals was towards management by experts and those intimately concerned with the quality of delivery.

17.34 Writing on the eve of the restructuring of the Blood Transfusion Service in January 1974, Dr John Wallace, Glasgow and West of Scotland BTS, said:

S.N.B.T.A., apart from its financial control, has allowed each regional director comparative freedom in developing the transfusion service within his region. I am now afraid that we are likely to feel the iron hand of central management, unless we exert professional influence.^[33]

Dr Wallace was concerned that integration would undermine community health at local level, in view of the wide diversity of the service requirements within individual regions.

17.35 Differences of approach among the Directors were resolved early in 1974. On 16 January the Regional Transfusion Directors and Mr Watt wrote to the secretary of the SNBTA commenting on the restructuring of the service.^[34] They repeated concern about the information in circular HSR(73)C40. They drew attention to the far-reaching changes taking place in the clinical, scientific, technical and organisational spheres of blood transfusion practice; proposed that the arrangements for the transfer to CSA be held in abeyance; and argued that SNBTA should continue in office pending an acceptable solution for the effective management of the Blood Transfusion Service. They asked for more time to be given to the development of proposals, and for discussion.

17.36 Meetings followed that letter,^[35] but the government's policies were implemented against the opposition of the Directors. It was an inauspicious start to new arrangements intended to provide an integrated service. Some practical steps were taken. The service had been transferred. A National Medical Director had been appointed.

17.37 Even after the establishment of the CSA and the SNBTS, Transfusion Directors continued to be exercised by the lack of transfusion expertise on the CSA's Management Committee and to press for alternative arrangements. During the later part of 1976 the Directors were in touch with Dr McIntyre, SHHD.^[36] They reiterated their initial anxiety and stated:

The anxiety... has been realised. The Management Committee does not have within, or available to, it, such independent specialist and other advice as was available within its predecessor, the Executive Committee of SNBTA. This lack of professional expertise and clinical user involvement is considered by the Transfusion Directors to be a retrograde step in the management of the service.^[37]

They proposed the transfer of the management of the Blood Transfusion Service to a management committee, independent of the CSA and directly responsible to the Secretary of State, with a wide representative membership including transfusion specialists, donor interests and user interests.^[38]

17.38 Regional Directors continued to be apprehensive that the centralised management arrangements of the CSA were in conflict with what they understood to be the 'responsibilities and authorities' of their roles.^[39]

17.39 The Directors' proposals and representations were given short shrift in a reply by Dr McIntyre dated 2 December 1976. He wrote:

It is only fair to say ... that the SNBTS is now formally a part of the NHS and can therefore only be administered in the existing health service framework. On a number of occasions General Jeffrey^[40] raised with officers of the Department the question of the SNBTS being taken outside the framework of the CSA and on each occasion it was made quite clear that there would be no question of this.^[41]

General Jeffrey was formerly Chairman of the SNBTA, and was appointed the first National Medical Director of the SNBTS in 1975. He served in that post until his death in 1977. Dr Cash was appointed to replace General Jeffrey in October 1979.

17.40 Dr McIntyre's letter was not the end of the matter. The Regional Directors had understood that there might be a review of management after three years. A meeting of Regional Directors and the SHHD took place on 18 May 1977 at which there appears to have been a frank exchange of irreconcilable views.^[42] Leaving aside personal comments, there were two complaints: the CSA management structure was costly, inefficient and counter-productive; and there was a lack of professional expertise on or available to the CSA committees which had responsibility for the management of the Blood Transfusion Service. The Inquiry has not investigated and cannot form or express views on the detailed complaints and comments made on behalf of the Directors, principally by Professor John Cash. It is sufficient to note that they were extensive, and appeared to reflect the apprehensions the Directors had expressed in 1974, and were further reflected in a loss of harmony, and acute disquiet. From the Directors' point of view, there appeared to be no progress.

17.41 On 15 June 1977, however, a step was taken towards establishing a framework for managing the service. The CSA Management Committee agreed to establish an ad hoc committee, 'to examine and report to the Management Committee on the management arrangements for the Blood Transfusion Service within the Common Services Agency'. The ad hoc committee in turn set up a working party in which representatives of the SNBTS Directors participated.^[43]

17.42 On 20 December 1977, Professor Cash reported to the SNBTS Directors Co-ordinating Group that the CSA Management Committee had proposed a remit for a blood transfusion sub-committee of the Management Committee. He reported:

This met most of the aims which the Directors had sought in their meetings before the Working Party began and the Director representatives hoped that further progress would be made.^[44]

The Working Party met and made proposals to the ad hoc committee.

17.43 Thereafter a draft report of the ad hoc committee's proposals was circulated and reported to the Co-ordinating Group on 14 March 1978. At this stage, there was concern that the proposals departed in some respects from the Working Party's report to the ad hoc committee. Among representations agreed to be made on the proposals, the following were material:

• The National Medical Director should be a non-voting member of the proposed blood transfusion sub-committee.
• Transfusion Directors should receive sub-committee papers and have the right to attend if they wished.
• The National Medical Director was to receive the agenda for meetings of the Management Committee and its sub-committees.
• The National Medical Director should be able to nominate a deputy to attend meetings of the proposed sub-committee.^[45]

17.44 After further discussion, the ad hoc committee reported its recommendations that a sub-committee of the Management Committee should be set up specifically to deal with Blood Transfusion Service matters with specified terms of reference. These recommendations were accepted by the Management Committee on 26 April 1978. The Regional Directors also accepted the recommendations.^[46]

17.45 The terms of reference of the CSA Blood Transfusion Service Sub-Committee defined as at July 1978 included:

(1) The review of the operational activity of the Blood Transfusion Service to ensure that the services provided are efficient and economic and within approved financial allocations.

(2) The formulation of proposals for the development and improvement on the services given by the Blood Transfusion Service and to make recommendations of the priority and proposed programming of such developments and improvements.

(3) Liaison with other authorities on developments in the Blood Transfusion Service and on operational matters.

....

(8) The provision of medical and operational equipment required for the efficient and economic operation of the Blood Transfusion Service.

(9) The preparation of a capital programme (including accommodation and vehicles) for the Blood Transfusion Service...

....

(10) The appointment of such ad hoc advisory committees and working parties as may be necessary to advise on specific matters relating to the services provided by the Blood Transfusion Service.

(11) Any other matters relating to the Blood Transfusion Service which the Management Committee [of the CSA] may refer from time to time.^[47]

In formal structural terms there was significant delegation to the sub-committee of the functions listed, and this would continue to be the case.

17.46 The membership of the sub-committee was specified. The Management Committee was to be represented by six members. In addition there were to be two specialists in clinical medicine, two specialists in laboratory medicine, one SHHD medical officer, and one representative of donor interests. The National Medical Director was not to be a member of the sub-committee. It was provided that that officer should receive the agenda and all papers for each meeting of the sub-committee and be entitled to attend or be represented at meetings. Other Transfusion Directors might attend with the agreement of the Convenor. Three of the four representations listed in paragraph 17.43 above were met.

17.47 The terms of reference of the sub-committee delegated control of the establishment, appointment and dismissal of staff, with the following exceptions: the National Medical Director and Regional Directors, the Scientific Director of the Protein Fractionation Centre, and other consultant medical staff. The National Medical Director was to be responsible to the Management Committee for the efficient operation of the service, including the Protein Fractionation Centre, and, within the resources available to the CSA, for the implementation of national policies with regard to the supply of blood and blood products to the National Health Service.^[48] The job description of the National Medical Director agreed on 26 April 1978 outlined the duties and responsibilities of the office, including:

1. Ascertainment of the needs of clinicians for blood products and for ensuring in consultation with the Regional Directors and the Scientific Director of the [PFC] that adequate supplies of plasma are made available and processed accordingly at the [PFC] to meet these needs.

2. Co-ordination of the distribution of supplies of blood products.

....

5. Advising the [SHHD] on national policy questions affecting the development of the Blood Transfusion Service.^[49]

Various administrative matters also formed part of the job description. There was no definition of any relationship between the National Medical Director and the sub-committee.

17.48 The constitution of the CSA Blood Transfusion Service sub-committee went a considerable way towards meeting the objections to the lack of expertise available to the Management Committee in relation to blood transfusion matters. However, neither the sub-committee nor the National Medical Director had executive control of the management of the service. By inference, that was left with the Regional Transfusion Directors and the Scientific Director of the PFC. The reasoning of the Management Committee in specifying the role of the National Medical Director was set out in the minutes of the meeting of 26 April 1978, as an aspect of the constitutional arrangements for the sub-committee:

[T]o provide the most suitable management structure for maintaining and developing the highest standards within the Blood Transfusion Service, the National Medical Director should be responsible to the Management Committee for the efficient operation of the Blood Transfusion Service in Scotland, including the Protein Fractionation Centre ....^[50]

17.49 The National Medical Director's direct responsibility to the Management Committee for the efficient operation of the service was not qualified by any requirement for reference to the sub-committee. The sub-committee's overview role included review of activities falling within the job description of the National Medical Director, however, as an officer of the Management Committee. Relationships among the several participants in the management structure were poorly defined, from a modern perspective. One element in the job description of the National Medical Director should be noted. It was part of the duties of the office to advise the Scottish Home and Health Department on national policy questions affecting the development of the Blood Transfusion Service, apparently directly and without involving the Management Committee or its sub-committee.

CSA oversight of the Blood Transfusion Service: the formal position

17.50 The formal arrangements for CSA oversight of the SNBTS that were established in 1978, continued throughout the remainder of the reference period and beyond. In 2002 a review was undertaken of 180 public bodies including 49 NHS bodies, one of which was the CSA. The review of the CSA looked at all aspects of its role, including its management of the SNBTS and the management structures in place.^[51] The conclusions of that Review noted general satisfaction with the CSA:

[A]part from SNBTS where stakeholders and staff alike feel relocation of SNBTS to another organisation is preferred.^[52]

17.51 The narrative of the report identified three causes of dissatisfaction, two of which related to strategic planning and finance in 1999, and a third which is of greater relevance for present purposes:

A perception in SNBTS that the performance of the organisation is managed by the Medicines Control Agency, the Clinical Pathology Association and SNBTS Clinical User group, and CSA is not qualified to manage the performance of SNBTS.

17.52 The report commented that the critical views identified in the course of the review perhaps reflected:

[A]n inadequate understanding of the role of the NHS Boards across Scotland in supporting, developing and holding to account specialist services to ensure they meet the needs of the public. Whatever organisational arrangements apply, there needs to be a proper system of corporate and clinical governance, and a Board providing a focus for efficient, effective and accountable governance and strategic leadership and direction.^[53]

17.53 The SNBTS plea for re-organisation, which had been repeated, was dismissed, but it was observed in the conclusions of the Review:

There is some justification for their concerns because of the lack of a developed system of clinical governance in CSA; a lack of clarity about the role and purpose of the Board, and therefore a lack of clarity about how CSA and its component Divisions support and add value to each other's activities.^[54]

17.54 It is not part of the remit of this Inquiry to provide a critique of the management or management structure of the CSA in relation to the SNBTS. It is, however, helpful when looking at the work of the SNBTS during the reference period to understand the views of senior SNBTS staff at the time, given the conclusion of the Review concerning the CSA's lack of a developed system of clinical governance and its failure to establish a clear understanding of its role and purpose in the minds of SNBTS staff and other stakeholders.

17.55 Whether justified or not, there was a deep-rooted view among transfusion professionals until at least 2002 that the CSA did not make a positive contribution to the delivery of the service.

17.56 The 2002 Review reflected the reality of (a) the statutory framework governing the NHS, and (b) the importance of public accountability, as factors underlining the existing governance structures. The Scottish Government has submitted that:

While the utility of CSA in the management structure was at some stages questioned, it is important to emphasize that its role was part of the general arrangements under which both special and territorial health boards exercised the principal responsibility for the day to day running of the health service in Scotland. Those arrangements devolved responsibility from SHHD as the central department and distanced the NHS from political interference.^[55]

17.57 For present purposes, it is sufficient to note this view. The Transfusion Directors' concern that the management structure lacked specialist membership and advice necessary for effective clinical governance clearly continued notwithstanding the 1978 changes. The authority of the National Medical Director was less well defined than his responsibilities. Those background factors may throw light on some of the events that will be discussed in this report.

CSA oversight of the Blood Transfusion Service: the factual position

17.58 The delivery of the service in the 1970s had become challenging. The activities of the SNBTS at or about the beginning of the reference period were described in evidence submitted to the Royal Commission on the National Health Service, in January 1977.^[56] In relation to management, the evidence was perhaps aspirational rather than reflective of practical reality. In the 1970s, and perhaps reflecting its limited role, the SNBTS headquarters was a tiny organisation comprising the National Medical Director, one national administrator, a secretary and a clerical assistant, with little practical influence over regional operations.^[57] But the evidence of the regional services operated from regional transfusion centres provided a clear explanation of the scope of the work done at that period:

The Protein Fractionation Centre is sited in Edinburgh ... It serves the whole of Scotland, and at some future date may serve part of England. Its principal function is the fractionation of human blood plasma supplied by the regional services and the return of finished blood products to them.^[58]

The National Headquarters, [responsible for the co-ordination of work within the SNBTS,] is also based in Edinburgh.^[59]

The functions of the SNBTS ... the following are carried out by all or some of the regional services, in conjunction with the PFC:

(a) Donor recruitment and the organisation of blood-collecting sessions.

(b) Medical selection of blood donors and the collection of blood, either as single donations, or by plasmapheresis.

(c) Collection of blood from selected donors for the preparation of blood-grouping anti-sera; and the immunisation of animals to provide other laboratory reagents.

(d) Immunisation of volunteers for the production of anti-D immunoglobulin.

(e) Tests on each donation to determine its blood groups, and tests for transmissible disease.

(f) Compatibility testing of donations for transfusion to individual patients.

(g) Antenatal and neonatal blood group serology in relation to the prevention and treatment of haemolytic disease of the newborn.

(h) Blood group serological reference services, including the investigation of cross-matching problems and transfusion reactions.

(i) Leucocyte and platelet typing; compatibility testing for organ transplantation.

(j) Separation of blood into its cellular elements; and the fractionation of plasma to produce a wide range of therapeutic substances (below).

(k) Clinical blood transfusion, including the management of haemostatic defects, the use of cell separators, and advice on the use of blood and blood products.

(l) Research and development, and participation in training programmes for postgraduates, undergraduates, medical laboratory technicians, and nurses.

The products prepared for transfusion include:

Whole blood

Concentrated red cells:

fresh

frozen

Platelets

Plasma:

dried

fresh dried

fresh frozen

Albumin solution

Stable plasma protein solution

Normal immunoglobulin

Specific immunoglobulins:

anti-D

anti-tetanus

anti-vaccinia

anti-hepatitis B

anti-varicella/zoster

anti-rubella

Coagulation factors:

fibrinogen

factor VIII - as cryoprecipitate (frozen) - as 'intermediate factor' (dried)

factors II, IX, X

factors II, VII, IX, X^[60]

17.59 This was the range of activities at about the start of the reference period that were, at least nominally, delegated by the Secretary of State to the CSA to manage. It had developed against the background of significant and sometimes dramatic changes in the therapeutic application of blood and blood products, in the scientific and technological developments that enabled their production, and in the facilities provided for research and development and for the manufacture of blood products. That would continue throughout the reference period: scientific and technological change drove changes in the use of blood and in the production and application of blood products.

17.60 While the management structures put in place by the CSA clearly generated considerable debate, it is reasonably clear that they did not have the significant impact on the autonomy of local transfusion directors that had been feared. Taking over practical responsibility for the wide-ranging activities of the service would have been a major logistical exercise. In the event, notwithstanding the formal structural changes, the Blood Transfusion Service would continue to be characterised by a high degree of local autonomy, until substantial restructuring of the SNBTS on a national functional basis began in the late 1990s, long after the period in which the events of importance in this Inquiry had happened.^[61]

17.61 Before the CSA was established and the management structures described above had been put in place, the SNBTS Regional Directors and the Scientific Director of the PFC had met on a regular basis with representatives of the SHHD to discuss operational matters. The work of the Regional Directors as a group continued after the developments in 1978. In addition, as noted in paragraph 17.47 above, the National Medical Director's role as specified in the job description of 26 April 1978 expressly included advising the SHHD on national policy questions affecting the development of the Blood Transfusion Service.

17.62 Regional autonomy was maintained among the Regional Directors, In the course of the Inquiry Professor Cash, who was appointed National Medical Director, commented on what he perceived to be deficiencies in his position. He commented that he had no authority over the Regional Directors. For example, in relation to a topic discussed later, the collection of blood from prisons, on which consensus was not achieved, he said:

My main recollections were that I was not the boss, that all consultants are equal, that I was merely there to co-ordinate and chair; that individual regional directors had the authority to stick to their view and so on and so forth.

....

So I was there chairing a meeting, and if we didn't get consensus and all agreeing there was no way on a particular issue we could go forward.^[62]

17.63 The view of an operational director was expressed by Dr Perry, the Scientific Director of PFC. He commented on the CSA situation as he found it:

[I]n terms of giving any direction to a strategy for producing products ... they had no role in that at all and had very little knowledge - I think they almost totally deferred to SNBTS managers and also the Scottish Home and Health Department, where they did have medics and scientists that really understood to an extent what we were doing.^[63]

The regular meetings of SNBTS Regional Directors were attended by representatives of the SHHD, substantially reflecting the reality of Dr Perry's views.

17.64 In one area, the control of expenditure, delegated management appears to have been effective at least in formal terms. The SNBTS Management Sub-Committee made an application for funding as part of the CSA's bid in the course of the annual Public Expenditure Survey (the PES). The SNBTS bid, supported by the best evidence available to the Sub-Committee and by information and submissions from the SNBTS Directors and the National Medical Director, was passed to the CSA Management Committee. There it was subjected to scrutiny and amalgamated, so far as acceptable, with other applications, before submission to the SHHD. In practice, recurrent expenditure was generally inflated annually by a percentage uplift. New expenditure required more particular justification. Accountability for expenditure followed the same route. However, this appears to have been more of a paper exercise than a reflection of substantial financial control.

17.65 Dr Perry said that, in addition to matters of finance, the CSA took an interest in recruitment, promotion and discipline of staff, ensuring compliance with Whitley Council^[64] rules, for example.^[65] But that interest did not extend to review of performance. Dr Perry said that his contract required him to report to a committee of management, but 'in practice very little reporting went on'.^[66] He looked on the National Medical Director as the closest he had to an operational manager, a de facto relationship.^[67] He said:

[A]s far as the CSA is concerned, I had no experience of - either personally or as group - of the CSA being closely involved in any of the complex decision-making that accompanied the operational management of a blood transfusion service.^[68]

17.66 Dr Perry commented further on contact with SHHD officials:

I think there was quite a regular dialogue between particularly the national medical director but also to an extent regional directors as well if there was a specific topic. There would have been a direct discussion between managers in the SNBTS and officials from the Scottish Home and Health Department particularly if there was a major area of funding that was required or a building development or a major new development, such as heat treating of Factor VIII that required significant funding. Then the Scottish Home and Health Department will have discussed that directly with experts within the Scottish Blood Transfusion Service. And those discussions would not necessarily have included managers or officials from the Common Services Agency. My impression at the time was that the Common Services Agency, if there had been an agreement reached between the Scottish Home and Health Department and the SNBTS on a particular issue, then the CSA would not have interfered or intervened in that because they did not have the expertise or knowledge.^[69]

17.67 Dr Perry's evidence reflects the position adopted by other SNBTS officials. The CSA and its committees and sub-committees were not involved in any significant way in the delivery of the service over the major part of the period with which the Inquiry is concerned. It appears clear that their independence of active CSA management in the operational aspects of the service continued notwithstanding the structural changes of 1974, 1978 and later years.

17.68 In substance, central government delegated responsibility to the CSA for certain management functions that, in the event, fell short of operational control over the technical aspects of the delivery of the Blood Transfusion Service. Since the SHHD, and therefore Ministers, controlled funding and health policy, devolution would never have been complete. SHHD officials were involved in technical discussions throughout the period, and those took place in direct contact with the National Medical Director and the Regional Directors. In addition, from 1973 the SHHD organised and chaired annual meetings with Scottish Haemophilia Centre Directors and SNBTS Directors to consider the provision of blood products for the treatment of people with haemophilia. Those meetings provided opportunities to influence decisions. The SHHD also maintained close links with the Department of Health and Social Security (DHSS) and its predecessors in London.

17.69 In the course of the reference period, decisions were taken and implemented that had important consequences for the delivery of the service, wholly without the participation of the CSA, its committees or sub-committees. Two examples illustrate this in relation to scientific developments, which will be discussed in greater detail later. In November 1984, scientists from the PFC heard at a conference in Groningen that HIV could be inactivated by being dry heated to 68°C for one hour. On return to Scotland they implemented the process changes necessary to test the suggestion, found that the Scottish product would sustain heating at 68°C for two hours and proceeded to implement the changes, with great advantage to National Health Service patients dependent on Factor VIII therapy. At the end of 1985, PFC scientists abandoned research on pasteurisation of Factor VIII concentrate, and adopted a dry heat-treatment process for virus inactivation. They were again successful. Objectively, the process changes involved real and significant policy decisions relating to the delivery of the service. They were implemented without reference to the CSA and its committees.

17.70 In relation to medical matters, in 1991-93 the Edinburgh and South-East Scotland Region undertook a look-back exercise relating to the transmission of Hepatitis C, that was not referred to the CSA or its committees, and was arguably a direct challenge to SHHD policy. It proved the practicality of look-back, and contributed significantly to the UK Government's decision in 1995 to adopt look-back for the whole country.

17.71 These are examples only and do not tell the whole story. Some elements of the blood transfusion function have changed over time, and central policies have had a direct impact. For example, fractionation of human blood and the production of coagulation factors ended in 2006. That was the result of a strategic review by the Board of NHS National Services Scotland on the future of the Protein Fractionation Centre and Diagnostics Scotland which was initiated in 2004. The review resulted in the closure of the Protein Fractionation Centre in 2007 and the removal of the production of blood fractions from the functions of the CSA in 2008. Other functions have been added, some reflecting technological changes in the use of human cells and tissue which are not relevant to the Terms of Reference. Again, policy decisions have played a part in such innovations. However, as expressed on its web page 'Meeting the transfusion needs of patients in Scotland', the SNBTS perceives its role to be comprehensive:

Our key priority is to ensure that NHS Scotland has enough blood to meet the transfusion needs of patients in Scotland. It is our responsibility to make sure that blood tissues and cells are available when patients need them.^[70]

17.72 Delegation of the functions of the Secretary of State, and later the Scottish Ministers, for the provision of blood for transfusion remains in place, much as it was under the 1974 Order. But until the end of the last century the reality of SNBTS management was often very different from what the formal structures would have suggested. Apart from a few specific situations, which will be noted in context, the formal management structure was irrelevant to the functioning of the service. That structure provided a route for setting budgets and for financial accounting, but did not impinge on the medical, scientific or technical operations of the SNBTS. On one view, it cloaked an underlying failure to integrate fully the operational activities of the Blood Transfusion Service in Scotland, perhaps until the re-organisation in the late 1990s. On another, it was a pragmatic response to the reality that while governance required a management structure within NHS norms, effective delivery of the transfusion service depended on the regional and functional autonomy of the specialist directors and staff of the SNBTS.

17.73 In considering, the role and structure of the CSA from its formation onwards, and, in particular, its oversight of the Blood Transfusion Service, it has to be borne in mind that the concept of corporate governance did not start to develop in the UK until reports such as the Cadbury Report and the Nolan Report on Standards in Public Life were issued in 1992 and 1995, respectively. Clinical governance also began to develop around the same time. Its introduction into the NHS in Scotland was announced in 1998 in NHS MEL (1998) 75 as one of the commitments contained in the 1997 White Paper, Designed To Care. The 2002 Review of the CSA made a number of recommendations including that the purpose, function and structure of its Board should emulate that of NHS Boards. Those changes were implemented and are reflected in current governance arrangements. Blood, Tissue and Cells (SNBTS) is one of the six Strategic Business Units of the CSA. The Strategic Business Units incorporate most of the divisions that were part of the CSA (now renamed NHS National Services Scotland) since its inception, along with others that have joined or been established over the years. The Board's Clinical Governance Sub-Committee provides strategic oversight and scrutiny of the SNBTS. SNBTS has a Clinical Governance and Safety Group to ensure effective clinical governance at a tactical and operational level. It reports to the Board's Clinical Governance Committee and its role is to ensure the safety and consistent quality of blood, tissues and cells and that service requirements are being met.

17.74 The Scottish Government's Closing Submission to the Inquiry about the functioning of the system was:

The formal lines of communication were followed in so far as submission of funding bids was concerned. It does not appear from the evidence, however, that there was strict adherence to the formalities in relation to issues of medical or scientific policy; nor indeed was there rigidity about the level at which communications took place between SHHD and CSA .... [T]he reporting system ought to have led from SNBTS to the managing committee of CSA, and the formal position was that SNBTS directors were responsible to the Blood Transfusion Service subcommittee of the CSA management committee. But in practice this route was evidently not always taken .... Thus while there were clearly established lines of communication, these were not slavishly adhered to, ensuring that where appropriate matters could be raised and resolved with reasonable speed and at the appropriate level.^[71]

17.75 It is not clear that SNBTS directors were formally responsible to the Blood Transfusion Service sub-committee of the CSA until the later 1990s. Otherwise, it is a masterly and restrained summary. How far it reflects the realities of the situation will best be seen in relation to the disposal of particular issues relating to management which will be discussed in context. At this stage it is sufficient to note that in some contexts, the formal structure was ignored as irrelevant to the delivery of the service, and SHHD officials were complicit with SNBTS professionals in the development of practical expedients which implicitly acknowledged the unsuitability of the formal structure for management of a highly specialised service.

17.76 However, the problems that arose were not wholly attributable to the management structure of the CSA. There were other issues that arose from the independence of the Regional and National Directors.

The role of the Transfusion Director and the National Medical Director

17.77 The scope of the Regional Transfusion Directors' responsibilities was described by Dr Brian McClelland.^[72] Dr McClelland held a number of progressively more senior posts in Edinburgh and the South-East of Scotland BTS and at Edinburgh University from 1977 to 2001.^[73] In 1979 he was appointed Regional Director. Dr McClelland's job description as Regional Director contained no reference to managerial accountability. It imposed overall responsibility for ensuring that the full range of the service was efficiently carried out. It stated that in practice the responsibility for the administration of budgets was delegated to Regional Transfusion Directors. In terms of national management of the service, it was stipulated that the director would be expected to share with the other Transfusion Directors the responsibilities involved in coordinating the national service as a whole. The director was expected to attend the regular meetings of the Transfusion Directors to discuss matters of common interest, usually under the chairmanship of the National Medical Director.

17.78 The job description did not require the post holder to report to or accept review by a line manager. Subject to the obligation to co-ordinate the service with other Regional Transfusion Directors, each director was autonomous to a significant degree.

17.79 Dr McClelland pointed to change from the mid-1980s. The appearance of AIDS, the commencement of regulatory inspections of the transfusion services, the enactment of the European Directive on consumer protection and the development of the guidelines for the transfusion services in the UK led to progressive convergence of practices among the UK transfusion centres.^[74] Until then the service was characterised by its history: it was composed of distinct regional services, each with a strong sense of local identity and under its own director. Dr McClelland noted that:

Despite the reassignment of management of SNBTS from the SNBTA to the CSA, the Regional Transfusion Centres (RTCs) remained largely autonomous entities. In respect of blood donor selection, the Region Transfusion Director (RTD) and his/her consultant colleagues determined their own local policies and issued guidance to medical and nursing staff ....

Discussions between RTD's at national level were just that, and they often agreed to disagree. Moreover, the concept of clinical freedom was sacrosanct ....^[75]

Dr McClelland said:

[I] would simply like to explain that ... looking at it now, it does seem rather odd that an organisation which calls itself a national organisation did appear to be behaving in many respects as a series of regional organisations. And you know, the truth is that at this period, at the time that I joined it, it very much was a series of regional organisations and that was where it had come from and the level of sort of autonomy that at that time rested with the regional directors was not actually particularly unconventional. The health service in its totality was a very different place in the 70s and 80s from what it is now.^[76]

17.80 From 1979 Dr, later Professor, John Cash held the post of National Medical Director.^[77] His views on his role have already been noted. In addition to the comments already quoted he said:

[T]here are documents, plenty of documents, available .... in which I write to the CSA and the department and we have letters back from them. In actual fact, trying to get clarification as to my management role in the SNBTS at that time, and what clearly came back -- and I had long discussions with .... the deputy chief medical officer -- was that I was the first among equals.

Eventually, I took the view -- this is much later in the 1980s -- that this wasn't .... going to work and we needed a general manager and they changed the management structure .... So I was there chairing a meeting, and if we didn't get consensus and all agreeing there was no way on a particular issue we could go forward. Looking back, the wonderful thing is in the main we nearly always did get consensus, as a result of which we were enormously successful in many .... areas.^[78]

17.81 Notwithstanding Professor Cash's view of the practical success of the service, which differed to some extent from Dr McClelland's, it is clear that for much of the reference period the service lacked a coherent strategic control structure and the guidance that might reasonably have been expected to flow from that. Given prevailing opinion on clinical autonomy, devising and enforcing an effective structure would have been challenging at any time in the 1970s and early to mid 1980s. The arrival of AIDS changed attitudes, and provision of guidance on practice became more acceptable. However, there was lack of a developed system of clinical governance, as found by the 2002 Review, and the issue was never put to the test.

17.82 As is clear from the selection of written comments referred to above, from the beginning those with professional responsibilities for delivering the service had reservations about the management structure. By 1990, when the radical changes already mentioned were introduced, many of the events that gave rise to the issues related to the transmission of infection with which the Inquiry is concerned had largely passed into history.

The role of the clinician

17.83 RTC medical staff did not have direct clinical responsibility for the care of patients and were not clinically responsible for the transfusion of patients before or after the inception of the SNBTS. Those responsibilities remained with the individual consultants who had under their care patients requiring transfusions of blood or blood products. The concept of clinical freedom was important to the medical and surgical consultants. A surgeon, for example, would decide on the likely need for transfusion for a given procedure, without reference to a transfusion specialist. The transfusion specialist or haematologist would give advice, if asked, on difficult cases, either in difficult serological or difficult clinical cases.^[79] As history was to unfold, clinical freedom extended to the choice of therapeutic blood product, which was to become an issue.

PFC

17.84 The main functions and functional departments of the PFC are described in Chapter 19, Production of Blood Products - Facilities. In addition to its manufacturing function, the PFC had a research function. The Director of the PFC and other senior personnel provided information and advice on matters of plasma fractionation requested by the SHHD, DHSS and other national and international bodies, as required.

17.85 The Scientific Director of the PFC, who was responsible for the management of all the activities of the PFC, was accountable to the Management Committee of the CSA until 1991. Thereafter the post was accountable to the SNBTS General Manager/National Medical Director. The PFC Scientific Director was independent of the National Medical Director (for most of the material time Professor Cash). As Dr Robert Perry indicated, accountability was not enforced in review of the Scientific Director's operations. The effective independence of the scientists at the PFC will be discussed in context.

The modern service

17.86 It is unnecessary to trace in detail the development of the modern service. All administrative organisations change. Issues for the Inquiry that emerge from the position in the 1970s and early 1980s as it has been described here will include whether the characteristics of the organisation increased risk to NHS patients. For example, the collection of blood in prisons, and the approach to donor selection with regard to high risk donations generally, provide a focus for part of this discussion which is dealt with separately in Chapter 26, Donor Selection - Higher Risk Donors. But it is appropriate to note that there have been significant changes over the reference period, and that the service as it exists today is rather different from the service in the 1970s and 1980s.

17.87 From the beginning of the reference period until 1990, the SNBTS National Medical Director/National Medical and Scientific Director and the Regional Transfusion Directors were not formally accountable to the CSA Blood Transfusion Service Sub-Committee of the CSA Management Committee. In 1990 the post of SNBTS General Manager was created and the directors were made accountable to the General Manager on managerial aspects, and were professionally accountable to the National Medical and Scientific Director. There was one central body, the Management Board, through which all policy and strategic decisions passed.^[80] The Management Board comprised the General Manager, the National Medical and Scientific Director, the Regional Directors, the Director of the PFC, the Director of the National Science Laboratory, the National Finance Manager, the National Donor Services Manager and the National Administrator.^[81] The CSA Management Board met for the first time on 19 June 1990 to finalise its remit in the new structure.^[82] A Medical and Scientific Committee (the MSC) was established to provide a scientific and professional forum for the SNBTS.^[83] The MSC would present its recommendations on medical and scientific matters to the Management Board, reducing the need for detailed discussion of such matters by the Board. From this time on there was a greater degree of centralised management.

17.88 Re-structuring of the SNBTS into a national functional organisation was put in the hands of the National Director, Angus Douglas, in about 1997-98, soon after he took up office. Public consultation followed in 1998, and a major re-organisation of the SNBTS was implemented.^[84] The five regional centres continue, but with less autonomy than before, and some services are now managed on a national basis, such as red cell preparation, tissues and the clinical directorate. The directors of the national services are accountable to the SNBTS National Directorate and the Management Board.^[85] Part of the reasoning behind the changes was:

[To] allow clinicians to concentrate on closer working with local hospitals in delivering more effective clinical care via the use of blood and blood products .... ^[86]

17.89 As a result of the re-organisation, overall coordination, strategy, senior staff appointments, succession planning, representation within CSA and some external relationships, audit and quality audit became the responsibility of the National Director. The National Medical and Scientific Director became responsible for clinical services, blood bank management, clinical apheresis, clinical laboratory services, research and development, and relationships with external medical organisations. Other national directorates, as set out in the SNBTS Annual Report for 1999-2000 were:

• Blood Supply Chain
• Plasma Products (PFC)
• Diagnostics Scotland
• Bone and Tissue Products
• Products and Clinical Services^[87]

17.90 The Regional Transfusion Directors were re-designated Clinical Directors reporting to the National Medical and Scientific Director. Some services remained local. Hospital blood banking, the provision of advice and information on transfusion medicine to hospitals and some diagnostic services remained based in the regional centres, but generally the service was centrally controlled.

17.91 The Directorates have changed from time to time. For present purposes it is unnecessary to trace these changes. They continued to reflect changing demands for effective management structures within the SNBTS, starting from the 1998 re-organisation. For present purposes, the importance of these developments lies in the contrast they provide with the situation that obtained throughout the material part of the reference period - when decisions were required that had an impact on the functioning of the Blood Transfusion Service in face of many and fundamentally changing demands.

17.92 The management structure of the Blood Transfusion Service inevitably forms part of the context in which the delivery of blood, blood components and blood products for clinical use has to be discussed. The critical period arising from the Terms of Reference ends in the early 1990s, by which time blood for clinical use was effectively screened for infection with HIV and HCV and blood products were effectively treated to inactivate virus infection.

Conclusions

17.93 From the inception of the National Health Service:

• The Secretary of State for Scotland, Scottish Health Ministers, and Scottish Home and Health Department civil servants had control of health care policy.
• Until 1974 operational control of the delivery of the service was not exercised in relation to the operations of the SNBTA which provided blood transfusion services as an independent body, increasingly funded by Exchequer grant.
• In 1974 the Secretary of State delegated to the CSA responsibility for the provision of supplies of human blood for the purposes of carrying out blood transfusion and related services, including the production of blood fractions.
• In practice, the CSA did not exercise operational control over the Blood Transfusion Service.
• Both before and after 1974 the Regional, and latterly the National Medical and PFC Scientific Directors, of the Service had largely autonomous control of their respective operations, exercised independently of the CSA.
• In general, in relation to operations of the Blood Transfusion Service requiring specific funding or policy decisions, there was much direct contact between Regional, Medical and the PFC Scientific Directors of the Service and officials of the SHHD that did not involve the CSA.

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18. Collection of Blood - General >