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Chapter 18

Collection of Blood - General

18.1 As discussed in Chapter 25, Screening of Donated Blood for Hepatitis B, the development and application of screening tests for the presence of Hepatitis B antigen and antibody, perceived at the time to be increasingly effective, had a central role in mitigating the risks of transmission of viral infection during the first decade of the reference period. The limitations of the technology available were noted at the time. Though the predicted effectiveness of the screening tests available improved over that period, tests never achieved detection rates for Hepatitis B of more than about 50% even in the best circumstances. Other means had to be relied on as they became known, not only for detection of Hepatitis B infection, but for other risks of transmission of viral infection. This chapter examines the procedures adopted. It is important to note, however, that in the perceptions of the time, reliance on screening technology defined the context in which other measures were put in place, at least from the end of 1972 when screening for Hepatitis B surface antigen (HBsAg) became general throughout the UK. Whatever their limitations, they were the best tools available.

18.2 This chapter discusses blood donation collection practice generally, leaving topics relating to the acceptance of blood from 'higher risk' donors for separate discussion. Inevitably, increasing knowledge of the risks of transmission of disease was a further factor in changes in practice. Most of the chapter will deal with the earlier part of the reference period, taking account of changes in practice related to specific risks and noting technological change relevant to those changes, where appropriate.

Blood collection: the voluntary principle

18.3 Well before the beginning of the reference period, both within the UK and internationally, there was a widely held view among government and specialist organisations, that purchased blood carried a relatively high risk of transmitting hepatitis. The report of the World Health Organization Scientific Group on Viral Hepatitis, Viral Hepatitis, Number 512 of the Technical Report Series in 1972, recognised a wider range of factors relating to the risk of transmission of the Hepatitis B virus (HBV):

Great variations in the prevalence of hepatitis B antigen in apparently healthy blood donors have been found in different parts of the world. Prevalence also varies with such factors as the socioeconomic status and sex of the donor, whether he is a volunteer or paid, and whether he lives privately or in an institution. Antigen has been detected most frequently in males in the younger age-groups.[1]

Some of these factors, in particular gender and socioeconomic status, would have been unlikely to have influenced donor selection in the UK at any period. However, payment was a factor that could be dealt with as a matter of general policy.

18.4 As noted in Chapter 17, Blood and Blood Products Management, paragraph 17.13, with the formation of the Scottish National Blood Transfusion Association (SNBTA) in 1940, voluntary donation became the rule throughout Scotland, and funding and collection procedures took on the character of voluntary charitable activities. In war time, voluntary donation was an obvious response to the call to assist the blood transfusion service. The programme had considerable success: see Chapter 17 at paragraph 17.15.

18.5 By 1975-76, when the Scottish National Blood Transfusion Service (the SNBTS) had largely superseded the SNBTA in the collection and supply of blood for clinical use, the scale of the activities had increased dramatically, and a high level of blood collection was maintained thereafter.

18.6 At the beginning of the reference period, the voluntary nature of blood donation was universally accepted and admired. Dr Brian McClelland reflected a common view among Blood Transfusion Service personnel:

I think people in the UK were extremely proud of the voluntaryism [sic] and the voluntary system and they knew it was morally better and they probably felt also that it was microbiologically safer. It was safer.[2]

18.7 The World Health Organization (WHO) was a prominent supporter of the voluntary principle internationally. It published guidance in 1971: Guide to the Formation and Operation of a Transfusion Service, aimed specifically at countries lacking a developed blood transfusion service.[3] According to its preface:

The present book is intended to help physicians and pathologists who, after receiving a basic training in blood transfusion, are entrusted with the responsibility of establishing and developing transfusion services in their own countries, either under the ministry of health or through the agency of a voluntary organization, such as a Red Cross Society.[4]

The relevance of the book to developing knowledge of hepatitis is discussed in Chapter 14, Knowledge of Viral Hepatitis 1.

18.8. The Guide encouraged voluntary donation, identifying concealment of previous illnesses like jaundice as a risk associated with paid donation, implicitly recognising that a history of jaundice was a contra-indication to receiving blood from individuals who had been infected.[5] The guidance commented that paid donors were mostly 'from the lowest social strata where alcoholics and drug addicts are often found'. That, and the risk that paid donors might form syndicates and from time to time demand an increase in financial recompense, were said to have brought paid blood donations into disrepute in many places.[6] As regards voluntary unpaid donors, the Guide stated:

'The voluntary unpaid blood donation is a humanitarian act towards the sick by the healthy .... Under this system it is easier to verify the donor's state of health, since - unlike some paid donors - he has no reason to try to conceal illness'.[7]

18.9 In May 1975, the WHO passed Resolution 28.72: Utilization and Supply of Human Blood and Blood Products.[8] The resolution urged Member States to promote the development of national blood services based on voluntary non-remunerated regular blood donation; to enact effective legislation governing the operation of blood services; and to take other actions necessary to protect and promote the health of blood donors and of recipients of blood and blood products. In January 1987, the 79th session of the WHO at Geneva reiterated its support for resolution WHA28.72.[9] Subject to qualifications relating to developing countries, from the outset of the reference period the WHO advice was consistent: Member States should adopt the voluntary principle and take steps to embed it in effective legislation. The picture that emerges is of consistent support for the voluntary principle.

18.10 There is perhaps no better way of characterising the voluntary donor in the systems in place in the UK at about the beginning of the reference period than by reference to what Professor Richard Titmusss, author of The Gift Relationship, said in a presentation to a joint symposium held by the Royal Society of Edinburgh and the Royal College of Physicians in February 1972:

[T]he primary characteristics of the voluntary donor ... [are]: the absence of tangible immediate rewards in monetary or non-monetary forms; the absence of penalties, financial or otherwise, for not donating; and the knowledge among donors that their donations were for unnamed strangers without distinction of age, sex, medical condition, income, class, religion or ethnic group.

No donor type can, of course, be said to be characterised by complete, disinterested, spontaneous altruism. There must be some sense of obligation, approval and interest; some awareness of need and of the purpose of the blood gift; perhaps some organised group rivalry in generosity; some knowledge that fellow-members of the community who are young or old or sick cannot donate, and some expectation and assurance that a return or reciprocal gift may be needed or received at some future time. Nevertheless, in terms of the free gift of blood to unnamed strangers there is no formal contract, no legal bond, no situation of power, domination, constraint or compulsion, no sense of shame or guilt, no gratitude imperative, no need for penitence, no money and no explicit guarantee of or wish for a reward or a return gift however many donations are made. They are acts of free will; of the exercise of choice; of conscience without shame.

Virtually all donors in Britain ... fall into this category.[10]

18.11 As is clear from international guidance, the generally accepted view was that blood collected from unpaid volunteers was inherently safer than blood collected from individuals paid for their blood. While it was logically indefensible to infer that blood collected from unpaid volunteers was safe, adherence to the voluntary principle gave a high degree of confidence in the safety of donated blood, and that clearly had an influence on the practices adopted in the management of the collection process.

18.12 The events that created the risks of transmission of the infections with which the Inquiry is concerned (HIV/AIDS and HCV) happened during the period up to 1991 when there was continuing growth in the volume of donations. The pattern of blood collection in Scotland from 1975-1990 is shown in Figure 18.1.[11] The data reflected in this graph are net of rejections or deferrals.[12] The values in the graph rose from 212,061 usable donations of blood in the year ended 31 March 1975 to 301,741 usable donations in the year ended 31 March 1990. The picture overall is one of steady growth. Technological innovations contributed to the developing picture. Plasmapheresis helped boost total blood collection. Data on plasmapheresis are not available on a consistent basis across this period, but there was a steady rise throughout the 1980s, reaching over 15,000 donations in 1990.

Figure 18.1 Blood Donations 1975 to 1990

Figure 18.1 Blood Donations 1975 to 1990

18.13 For immediate purposes, Figure 18.1 illustrates the success of the SNBTS in recruiting donors and maintaining growth in the volume of blood collected for direct clinical use in transfusion, and for the manufacture of blood products, during the critical part of the reference period. It is impossible to say to what extent individual donors were aware of the many uses to which their donations were put, but it appears that to generate these increasing levels of donation, there must have been confidence generally in the benefits conferred on others by the effective use of donated blood. There was clearly, in Professor Titmuss's words 'some awareness of the need and of the purpose of the blood gift'.[13]

18.14 Regular donors always were, and remain of, considerable importance to the effectiveness of blood collection in Scotland. As illustrated in the Preliminary Report, data for the mid-1970s indicates some turnover in donors.[14] That seems to have been inevitable, and to be a continuing feature of voluntary donation, given the peripatetic nature of collection and basic human nature. Individually, donors' patterns of activity would have varied and still do vary. Apart from regular donors called up for a specific session, there must inevitably be an element of chance in matching the timing and place of a session to the availability and needs of prospective donors. Perhaps there is also a variability of response inherent in the voluntary principle, given the variability of donors' circumstances. Seasonal shortages occurred in some areas from time to time, while emergencies created exceptional demand. Viewed broadly, however, the data illustrate a reasonably steady state of commitment. The total figures imply a high percentage of return donors: Approximately 80% of the donors bled were not 'new'. At the present time, return donors contribute about 85% of all donations.[15] Consistency in total supply was achieved notwithstanding these levels of variation.

18.15 Dependence on a high proportion of regular donation was a general phenomenon related to increasing demand for blood for transfusion and therapeutic application. Professor Titmuss commented in 1972 that it was becoming clearer to those responsible for organising recruitment programmes that:

[E]ffective transfusion services cannot be run on the basis of dramatic and 'crisis' appeals to transient or sporadic givers or suppliers of blood.[16]

18.16 Professor Marc Turner emphasised that the importance of voluntary donors went beyond maintaining the volume of blood available to the service. Regular donors were registered and could be called upon to form a core for planned sessions, ensuring a structured approach to the collection of human blood and its components. In addition, because they were subject to regular screening, returning donors had a much lower deferral rate than new donors.[17] Donor selection practice and procedures would be expected to reflect the characteristics of the donor population, and in particular the high proportion of return donors comprised in it. The lower deferral rate among return donors supported confidence in the safety of most of the supply.

18.17 The corollary of donor commitment was reflected in the transfusion service's recognition of an obligation of care for the health of donors, as well as the health of recipients of blood and blood components. Recognition of this obligation was a further factor that had a significant bearing on donor selection practice. In a discussion on recruiting methods, the WHO Guide to the Formation and Operation of a Transfusion Service stated:

The motto of the medical director should be: "Without the donor panel there would be no blood transfusion service; therefore the convenience, comfort, and wishes of the donors should be given every consideration." For the donor organizer the motto should be: "The blood must be available in the quantity needed, at the place and time required. All other considerations are subservient to this."[18]

18.18 Within the UK's blood transfusion services, and the SNBTS in particular, the implications of relying on a voluntary system were recognised:

Firstly, the goodwill of the donor population is essential and the utmost care is necessary to ensure that no individual nor collective causes for dissatisfaction arise. To a large extent this depends on a high state of morale and dedication on the part of all members of the SNBTS, including voluntary workers, and it is essential that this be kept to the forefront in any discussions on transfusion policy and its implementation.[19]

18.19 In its submission to the Royal Commission on the National Health Service, dated February 1977, the SNBTS said:

16. A fact so obvious that it is often overlooked by clinicians and NHS management is that human blood and its constituents cannot be manufactured but must be obtained from members of the general public ....

17. The benefits of a voluntary donor system, in terms of purity of blood and reliability of the donor, were recognised in resolution No. WHA 28.72 passed at the 28th World Health Assembly in 1975 which fully endorsed the principle of voluntary donation and urged the governments of all nations to adopt the highest standards in providing a safe blood service to their citizens, formulating those standards on the concept of non-remunerated donors.

18. It is strongly felt in this service that the Central Departments in England and Scotland should be asked to pronounce publicly their support for voluntary blood donation and to consider its implications for the management and finance of the blood transfusion service. SNBTS feels that the indispensability of blood donors should be recognised by their being given an opportunity to participate once more in the management of the service as was the case before NHS reorganisation. Equally, the Central Departments should be taking active steps to counter the threat to voluntary blood donation posed by those multi-national pharmaceutical companies who are marketing in Scotland products, made from the blood of paid donors, which the blood transfusion service also manufactures from voluntary blood donations. This can be done by acknowledging the value of SNBTS products and investing in the service.[20]

18.20 As indicated in Chapter 17, Blood and Blood Products Management, there was during this period a degree of concern among senior SNBTS officials related to structural changes in the Blood Transfusion Service at the time and the tone of the comment probably reflects that concern.[21] It is likely that the need for express political commitment to the voluntary principle indicated a lack of confidence on the part of SNBTS senior management that the principle was entirely secure at the material time. However, despite these observations, the voluntary principle remained intact, and universal support for it has been assured. Occasional threats of intrusion into the UK blood supply system by commercial pharmaceutical companies failed to materialise.[22] The collection of blood in Scotland remained, and remains, in the hands of the SNBTS, supported by the Scottish National Blood Donors Association (the successor to the SNBTA) as a voluntary donation scheme.

Collection procedures

18.21 Despite the reassignment of the management of the SNBTS to the CSA in 1974, the Regional Transfusion Centres remained largely autonomous entities as far as many professional matters were concerned. The SNBTS said:

In respect of blood donor selection, the Regional Transfusion Director (RTD) and his/her consultant colleagues determined their own local policies and issued guidance to medical and nursing staff. Documents, for example information for donors, session records, publicity materials etc, were designed and printed locally, albeit with a national logo. Discussions between RTDs at national level were just that, and consensus was not always achieved.[23]

Dr John Gillon, searching through the SNBTS archive, could find no specifically Scottish documents containing details of donor selection procedures prior to about 1982. It appears that such documentation relating to donor selection criteria before 1982 had either been destroyed or lost with the passage of time.

18.24 There was a progressive shift away from this position from the mid-1980s.[24] The SNBTS characterised this shift as a move from 'more of a federation of collaborating centres than a national service', towards general management and ultimately a national service with (generally) common systems, after re-organisation in 1999.[25]

18.25 The position in respect of collection of donations can be contrasted with the approach adopted to transfusion and to manufacture of blood products. Notes on Transfusion were intended primarily for use by medical staff in hospitals.[26] They were not prescriptive. But they were issued by the DHSS, the SHHD and the Welsh Office jointly for the NBTS and the SNBTA, and carried the authority of the departments. The fifth edition was published in 1973. Standards for the Collection and Processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids was first published in 1979.[27] Revised editions were produced from time to time thereafter. The Standards were compiled by: the Department of Health and Social Security (DHSS) in England and Wales in consultation with the Regional Transfusion Directors (RTDs) of the NBTS and the SNBTS; the Directors of the fractionation laboratories - the Blood Products Laboratory (BPL) and Protein Fractionation Centre (PFC) - and the Scottish Home and Health Department (SHHD). The Standards were focused on aspects of collection and processing that might have a bearing on the safety and quality of blood products. Certain illnesses and conditions were identified as disqualifying a person from being a donor, including illicit drug taking, current jaundice or hepatitis or the presence in the blood of HBsAg. Deferment, or discretionary disqualification, applied where the person reported jaundice or hepatitis in the preceding year or contact with 'a case' within six months. Temporary deferment applied to an individual who had tattooing, acupuncture or ear-piercing within six months or who had a transfusion within that period. It was stated that the Standards should not be construed as comprehensive guidance on donor selection. Though not prescriptive or comprehensive, the Standards also had the authority of the health departments involved.

18.26 In England and Wales, the National Blood Transfusion Service (NBTS) produced a Memorandum on the Selection, Medical Examination and Care of Blood Donors. The SNBTS Directors 'noted' the final version of the original document on 8 May 1978 when they expected that the document would be incorporated into the Standards.[28] However, it remained an independent document. The Inquiry has found versions of the Memorandum produced in 1977,[29] 1983,[30] 1985[31] and 1987.[32] Scottish Regional Directors used the 1977 Memorandum as guidance, and participated in its revision. Professor Stan Urbaniak indicated that his predecessor, Dr Brodie Lewis, used it and that he used it during his own tenure as Regional Director from 1983 onwards. Dr Ewa Brookes found it in use when she became the Regional Director at Dundee in 1981 and continued its use. Dr McClelland stated that his understanding was that 'all the SNBTS regions had based their procedures on the 1977 guidance document'. Dr Ruthven Mitchell indicated that he also used the Memorandum. The extent to which the guidance was adapted for local use was not explored.

18.27 Specific questions relating to the health of the donor were included in the Memorandum from 1977 onwards. It was stated that the donor's medical history should be coupled with a careful assessment of the donor's appearance:

'The experienced doctor can detect at a glance the potentially unsuitable donor. Those of poor physique or who are underweight, the debilitated, the undernourished, the mentally unstable, and those bearing the obvious stigmata of disease should not be bled'.[33]

However, dependence on the donor was emphasised. The 1977 iteration stated:

A donor is the best judge of whether he is in normal health and truthful answers to simple questions concerning his medical history and general health form the main part of the examination.[34]

This was said against the background of recognition that a complete medical examination was impractical and that superficial medical examination, by auscultation (examination by stethoscope) and percussion of the chest, and measuring pulse and blood pressure, was in most cases of no great value. In some respects, the Memorandum repeated the Standards. Directions relating to tattooing, acupuncture or ear-piercing or those donors who had had a transfusion were the same in both publications.

18.28 In relation to jaundice or hepatitis (then treated for many purposes as the same condition), the 1977 Memorandum provided:

Individuals who give a history of jaundice or hepatitis or in whose blood anti-HBsAg is present may be accepted as donors providing that they have not suffered from jaundice or hepatitis in the previous twelve months, have not been in house contact with hepatitis or received a transfusion of blood or blood products in the previous six months, and providing their blood gives a negative reaction for the presence of HBsAg when tested by a sensitive method (R.P.H[35] or R.I.A[36]). An accepted test for hepatitis B surface antigen shall be performed each time a donor is bled; donors whose blood reacts positively shall be excluded permanently from the donor panel.[37]

It was also repeated that illicit drug taking, if admitted or suspected, should debar a person from donating.

18.29 A move away from use of the NBTS Memorandum began in about 1982. A revised guide to donor selection was prepared by Edinburgh and South East Scotland Blood Transfusion Service (ESESBTS) in 1982, in response to a comment by the Medicines Inspectorate on the consistency of decision-making regarding which donors to accept or reject.[38] In their response to the Medicines Inspectorate dated 12 January 1983, the ESESBTS noted that a new comprehensive guide to donor selection had been prepared and was in routine use by donor selection staff.[39]

18.30 The ESESBTS guide comprised three documents: a Guide to selection of blood donors,[40] an Alphabetical Guide to Medical Assessment,[41] and a health check for new donors.[42] The first of these set out the general conditions to be met before a donation could be accepted. These dealt with the donor's age and weight, distinguishing new first-time donors and return donors, and prescribing the required haemoglobin level. It also restricted frequency of donation. In relation to hepatitis it provided that detection of HBsAg at any time excluded all donations except with the approval of the Transfusion Director. There were general directions related to medical conditions which might exclude donation, permanently or temporarily.

18.31 The Alphabetical Guide contained an extensive list of specific conditions which might affect the acceptability of a donation, with guidance on the response of the session team and in particular the circumstances requiring reference to the doctor in charge. Under 'Hepatitis', the Alphabetical Guide provided generally that the doctor should be consulted. Further guidance was:

Defer for one full year after recovery. Check if donor knows he/she is a carrier for serum hepatitis, and if so, put off service. Otherwise, at their first donation 1 year after their recovery record 'Hepatitis' on donor's name slip and inform Hepatitis lab.[43]

In the case of 'Hepatitis contact' donors, where the donor and contact lived together, used the same towels, crockery, etc, the donor was to be deferred for six months after close contact. Recipients of blood transfusion were acceptable as donors six months after transfusion. The directions required staff to check the reason for the transfusion and to consult the doctor or nursing Sister if in doubt.

18.32 The health check questionnaire was designed to elicit information relating to these and other issues.[44] There was a question on whether the donor had ever had a serious illness or operation, and questions related to piercing, acupuncture and tattoos. There was not a specific question relating to transfusion. But the information required by these guides required discussion and follow-up where the prospective donor gave a positive answer to any of the questions asked. These guidance documents were prepared in response to the Inspectorate's concerns which the ESESBTS said it shared. It seems reasonable to infer that until 1982 there was no similar, well-structured interview routine in place in that region.

18.33 In 1985 the SNBTS considered that The Guidelines on the Care and Selection of Blood Donors, issued by NBTS (the updated version of the Memorandum), required adaptation. Accordingly, the National Medical Director and the Regional Directors requested Dr Gillon, of ESESBTS, to prepare a report comparing donor selection practice in the five regional centres in an attempt to assess the significance of the existing differences between the SNBTS centres and the NBTS guidelines. In his report, dated 11 November 1985, he advised that there was general agreement that the NBTS Guidelines were unsatisfactory in format, and that, in addition, each centre criticised particular (and different) items, which he listed. His conclusion was that, having looked at donor selection criteria in the five regions, 'major differences of opinion are few', and that differences related to local factors could be accommodated. He had formed the impression that all centres were willing to attempt to reach a consensus and he commented that the 'evidence suggests that this would be relatively easy to achieve'.[45]

18.34 In his oral evidence Dr Gillon explained the position as at 1985:

There was a core of consistency .... So really we were working at the margins, largely on issues of donor safety rather than patient safety. By and large I think as far as recipient safety was concerned, there was greater commonality. But for the central core significant issues of patient safety, I don't think there was any significant difference.[46]

18.35 The report was considered at a co-ordinating group meeting of the SNBTS Directors on 30 April 1986. It was agreed that there was a need for an SNBTS set of criteria to serve as a framework for use by medical officers and team staff, with specific agreement that it was for each centre to decide who should take clinical decisions on donor acceptance. The Directors present agreed to recommend to the full co-ordinating group that a 'standard guide' should be produced, and that the ESESBTS donor selection document provided the basis for that.[47] In November 1988, Guidance for the Selection of Blood Donors was eventually agreed and issued.[48] In a note on the front page it was said to 'represent the collective opinion of SNBTS'.

18.36 Use of the 1977 Memorandum on the Selection, Medical Examination and Care of Blood Donors, and its revised versions, by the Regional Directors of the SNBTS provided RTDs in Scotland with a common base for developing their own donor selection procedures. A former Regional Transfusion Director has provided the Inquiry with a description of a typical donor session. Session Medical Officers received training and a copy of the 'Guidance' at the start of their work with the Blood Transfusion Service. The donor team included a clerical officer, donor assistants and a team leader together with assistants to carry out the haemoglobin check. The prospective donor was welcomed and asked to read the donor questionnaire. It included the phrase 'Please tell us if you have ever suffered from Hepatitis (jaundice) or been in contact with a case in the past six months'. The donor was then interviewed by the clerk who went through a health check with the donor, the donor signing to confirm that they had read and understood. The haemoglobinist then carried out a finger stick test to exclude anaemia. When a medical query arose, if the Medical Officer could resolve it a note was made on the donor's record card and the donation accepted or temporary deferral advised, as appropriate. If the Medical Officer could not resolve it, the donation was temporarily deferred, GP details were obtained and the query referred to the Regional Centre medical staff. If the reply to the hepatitis/jaundice question was positive the donor was referred to the session Medical Officer, donation was deferred, GP details obtained and the report referred back to the Regional Centre staff. After a satisfactory history and blood check, the donor was made comfortable on the donation bed and the donation was taken. Accordingly, the donor's memory was prompted at three points and sometimes donors then mentioned something, for example, during the donation procedure or during the bed rest period afterwards. The team leader continuously scanned all donors in the premises, principally for signs of nausea or fainting but also for other things, sometimes sufficient to refer to the Medical Officer for another check. Consequently, the assessment of donors did not end until they were fully recovered and left the premises.

18.37 In the ESESBTS, the conduct of donor sessions followed a similar pattern whatever the location, subject to necessary adaptation in institutions which will be discussed later. Routine donor sessions were arranged well in advance, usually between 12 and 15 months ahead, to allow for all necessary planning.[49] Dr McClelland described the approach in the late 1970s and early 1980s.[50] Donor sessions were conducted by a team. A doctor was always present at the session. There was a senior nurse or team leader and a group of what were then called 'donor attendants'. The donors would be welcomed to the session. In this period they would have been given an information card, which was fairly standard across the UK, which set out a series of exclusion criteria. A donor who had any of the listed features was asked not to donate. Those who were proceeding were seen by a clerical member of staff, who would take them through that card again and ask them questions to confirm that they had read it, record some of the information about the donor and then pass the donor on to another person who, using a finger prick technique, would take a sample of blood which was tested for haemoglobin. Provided the donor passed that test, they would be moved to another waiting area from which they would be taken to lie on the couch and have their blood taken.

18.38 The interview routine was supplemented by observation. Dr McClelland commented that the donor would be seen, talked to and observed by SNBTS staff throughout the whole process of donation. If something struck a member of staff, perhaps even when the donor was giving blood, which caused them to be uncomfortable about the donor's suitability, that issue would be noted and acted on.[51]

18.39 Matters of interest to staff would include whether a donor was heavily tattooed, which for some reason might not have been noticed at an earlier stage. Further, when the donor's arm was exposed to take a sample, evidence of needle injection tracks might be disclosed. It was not unheard of for a donor to appear to be inebriated. However, Dr McClelland emphasised that there was almost certainly a fair amount of individual variation in the way that individual members of staff assessed donors. He said that it was, and remains, extremely difficult to control practice with a very large team of people operating peripatetically. While the ESESBTS had always striven for consistency in the application of donor session standards, he said that that was very difficult to achieve.[52]

18.40 Dr Mitchell thought that factors related to donor care and maintenance militated against questions that placed the donor in a position in which they would have to self-exclude on grounds of health.[53] He thought it impossible to challenge a donor who asserted that they were healthy, when it appeared that was not true or reliable. In this, and in other aspects of his approach to practice, Dr Mitchell reflected most fully the dedication to the interests of the donor noted in paragraphs 18.15 to 18.17 above.

18.41 The best evidence of the initial stages in donor procedure in the west of Scotland at the beginning of the reference period was provided by Mrs Rosalind Prior, who was employed by the SNBTS as a Mobile Team Assistant in the region between 1969 and March 1974. She described normal practice in the early 1970s as follows:

The normal practice was that after the donor had passed the haemoglobin test they would move on to another team assistant who would go through a series of questions with them. We didn't have a sheet concerning the questions that we read to the donor and we didn't have a sheet containing the questions which we handed to the donor and asked them to read. We were taught the questions which we had to remember and go through them with the donors. The first question was, "Have you given blood before". If the donor said "Yes" then we would ask "Is it over three months since the last time you donated". If the donor said "Yes" then we would ask, "Is there any reason why you shouldn't donate blood? For example, do you have a cold, flu, boils, abscesses or ulcers?" If the answer was "No", we would ask if they had recently had any injections or vaccinations. If they answered "No" to that we would ask if they had had mumps, measles, chickenpox, shingles or jaundice or been in contact with anyone who had had jaundice or had they had any recent illnesses or operations in the last two years. If the person said yes to any of these questions we would have to go and advise the doctor of this. In the case of jaundice the doctor would tell us that we had to inform the donor that they could donate blood that day but that it would be used for research purposes only. They were also informed that they had to be clear of jaundice for five years before they would be able to donate blood again ....

The procedure never changed in the five years I worked for the Blood Transfusion Service. We were never told to ask any donors if they had ever used intravenous drugs or had tattoos or piercings. At that time HIV was not known and we were not instructed to ask any questions about hepatitis ....

Just before I finished working with the Blood Transfusion Service they produced the questions that donors had to be asked on a sheet that we used but as far as I can recall the questions weren't any different from what we had previously asked donors.[54]

Mrs Prior's employment ceased at the very start of the reference period, some three years prior to the issuing of the 1977 Memorandum. However, Dr Mitchell's evidence noted at paragraph 18.40 suggests that it is unlikely that there would have been any change in the instructions to session staff in the West of Scotland relating to questioning about health.

18.42 Full compliance with the requirements set out in the Standards and the 1977 Memorandum would have changed the procedure described by Mrs Prior to some extent. However, the most detailed evidence about what happened in a donor session came from her. The descriptions given by the former Regional Transfusion Director and Dr McClelland of donor sessions in their regions were very similar. Dr Gillon found differences in practice, sometimes a higher standard being applied, sometimes a lower one. His ultimate conclusion was that as far as recipient/patient safety was concerned there was not any 'significant difference'. However, as noted in paragraph 18.35, the view of the members of the co-ordinating group who discussed Dr Gillon's report was that there was a need for a Scottish framework for use by medical officers and team staff, in relation to decisions on donor acceptance, and that a 'standard guide' should be produced based on the ESESBTS donor selection document.

18.43 At the start of the reference period there was confidence in the ability of medical staff to identify donors presenting risk. The authors of the 1971 WHO Guide reflected that confidence, commenting that 'the medical officer should be able to pick out those prospective donors who may be, for example, undernourished, crippled, mentally unstable, alcoholics, or drug addicts'.[55] As grounds for distinguishing acceptable from unacceptable potential donors, the comments use the language of the times but apart from that they reflect, in retrospect, an unsophisticated approach to the assessment of risk. It has to be noted, however, that in 1971 general medical knowledge of the risks that later came to be identified and understood, was equally unsophisticated.

18.44 It is unlikely that there was questioning on sensitive personal matters. Obtrusive questioning, or questioning not felt to be appropriate, could have proved unacceptable to return donors and might have threatened the core supply on which the service depended.

18.45 Dr Mitchell's relatively extreme attitude to these matters may have emphasised the risk of upsetting donors over the risk to recipients of potentially infected blood or blood products. The lack of systematic questioning of prospective donors about hepatitis, for example, might have led to the failure to identify donors whose donations would have been rejected if true and reliable answers had been given to questions about matters indicating or suggesting high risk of transmission of infection. A focus on the best interests of the donor panel appears to have reflected the emphasis placed by the WHO on the convenience, comfort and wishes of the donor (paragraph 18.17 above). That is understandable, at least so long as the risk to the recipient of blood reflected the view that hepatitis was generally a low-risk infection. His was one of the range of views acceptable in a context that gave high priority to the practitioner's autonomy at a period when knowledge of risk was relatively undeveloped.

18.46 Relevant risk factors were more focused following the acceptance that AIDS probably presented a transfusion risk.[56] This brought a step change in the rigour of the donor selection procedures, beginning in the spring of 1983,[57] and in the desire to have national consistency in proper documentation of the procedures as they evolved.[58] However, direct oral questioning on sexual matters was not introduced even then,[59] although whether the incidence of transmission of hepatitis would have been reduced by more active questioning, remains speculative. It has to be borne in mind that there was no screening test for Hepatitis C until after the discovery of the virus in 1988, and until 1985 non-A, non-B Hepatitis (NANB Hepatitis) was considered to be generally benign, largely because in most cases there were few clinical signs of infection that could be identified. It is not clear that there were questions that could have been formulated that would have elicited relevant information from donors. And up-to-date methods of screening for HBV were adopted, using the technology available at the time.

Grounds of exclusion: medical history

18.47 As is clear from the preceding discussion, from time to time particular groups of potential donors have been perceived to present a high risk of transmitting disease. These have included people with a record of parenteral (injecting) drug abuse. In addition, people detained in penal institutions were thought to present relatively high risks. It has been suggested to the Inquiry that US servicemen were relatively high risk donors. These groups are discussed separately in Chapter 26, Donor Selection - Higher Risk Donors. More generally, individuals with a history of hepatitis and individuals who had at some stage received blood transfusion, whatever their status otherwise, were perceived to present an unacceptable risk. This part of the discussion deals with these general issues.

Exclusion on grounds of jaundice or hepatitis

18.48 As discussed in Chapter 25, Screening of Donated Blood for Hepatitis B, practice relating to exclusion on grounds of hepatitis was closely related to technological changes in screening for hepatitis in blood donations. In the absence of contemporaneous documents setting out practice guidance it is difficult to relate changes in practice to changes in technology with any degree of precision. This section seeks to identify some stages in the evolving scene and to comment particularly on blood collection practice.

18.49 As noted already, in the period up to the early 1970s the terms 'hepatitis' and 'jaundice' were often used indiscriminately: in general understanding, infection with hepatitis was typically evidenced by the clinical symptoms and signs of jaundice. It was known that there was a risk of transmission, but there was little understanding of that risk or of the clinical course and effects of infection. Initially, a conservative approach was taken to donor exclusion where there was evidence of exposure to hepatitis. By the mid-1960s, prospective donors giving a history of ever having had infective hepatitis, which almost always equated with a history of having had transient jaundice, were excluded from donor panels.[60] At this stage, before the Hepatitis A and B viruses were identified, the practice in the UK of excluding from donation any prospective donor with a history of jaundice, appears to have been common in Western countries.

18.50 For many prospective donors, giving an accurate history of previous jaundice would have been challenging. Jaundice in infancy, jaundice many years previously at a time of other more serious illness, anicteric hepatitis and other conditions not noted at the time would have militated against disclosure, except perhaps on detailed investigation of medical records. The interview procedures discussed above were in many cases unlikely to succeed in eliciting a relevant history. It appears very unlikely that reporting would have been significantly distorted by purported disclosure of jaundice that had not been experienced. The consequence of relying on donor recollection is more likely to have been under-reporting of jaundice and, for that reason, a flawed understanding of the risks presented. The prevalence of anicteric forms of hepatitis, and in particular of NANB Hepatitis, further hampered understanding of the risks presented by hepatitis in the widest sense.

18.51 The 1971 WHO Guide to the Formation and Operation of a Transfusion Service reflected a changed understanding of risk. It pointed to the risks of transmission of a number of diseases including hepatitis. The clinical signs and symptoms of infectious and serum hepatitis as then understood were described, and it was observed that:

Patients with clinical jaundice are not the main source of the disease; far more significant sources are the mild anicteric case [that is, mild cases without overt jaundice], the convalescent carrier, those incubating the disease, and the healthy contact carrier, all of whom at one time or another may be viraemic [carry the virus in their blood].[61]

18.52 At that stage, NANB Hepatitis was unknown and inferences were drawn as to the nature of risk that subsequently proved to be seriously flawed. While there began to be references to other forms of hepatitis, attention was focused on Hepatitis B and the relationship, if any, between HBV antigen or antibody positivity and a past history of jaundice. A positive test for HBsAg indicated current viraemia. However, the relevance of a history of jaundice was undermined. A WHO expert group report of 1973 observed:

Limited surveys have also shown that the prevalence of hepatitis B antigen is no higher amongst donors with a past history of jaundice than in those without such a history.[62]

18.53 The 1973 report also noted that it was generally agreed that not all cases of post-transfusion hepatitis were caused by Hepatitis B infection and that 'as more hepatitis B carriers are eliminated from serving as blood donors, the proportion of cases due to other types of hepatitis will increase'.[63] In relation to the exclusion of donors on grounds related to hepatitis, however, it was Hepatitis B that was discussed and the report marked the beginning of a change of attitude. The 1973 report developed the discussion of risk from the position set out in the 1971 report.[64] Firstly, it was observed that the exclusion from blood donation of individuals with a clinical history of Hepatitis B infection, but who did not have detectable antigen, might not materially reduce the frequency of hepatitis among the recipients of blood. Secondly, it was observed that the exclusion from blood donation of those with serological evidence of previous infection with Hepatitis B, indicated by the presence of antibody, might not be justified.

18.54 In international guidance, this was the start of a move away from excluding all donors with a history of hepatitis, towards excluding more limited groups with a relevant recent history.[65] Only Hepatitis B was relevant in the context of contemporaneous knowledge. The 1973 WHO report noted that the existence of a chronic carrier state following Hepatitis A (HAV) infection had not been proved.[66] That turned out to be correct: there is no chronic carrier state for HAV. It is now clear that most of the individuals with a history of hepatitis were carriers of NANB Hepatitis virus and could not have been identified by the tests for HBV then becoming available.

18.55 Leaving aside HBV screening results, the restriction of exclusion criteria related to a donor's history of jaundice or hepatitis appears questionable on logical grounds. The 1973 report recognised that post-transfusion hepatitis was not solely associated with HBV: there were thought to be a variety of causes of hepatitis. It was to become known that NANB Hepatitis was not generally associated with a history of jaundice. But that was not known in 1973, and there was no exhaustive analysis of the historical antecedents of any other transmissible agent of hepatic disease. The explanation appears to be that there was a strand of belief that was prevalent up to the early 1970s that once Hepatitis B had been dealt with, the problem of Post-Transfusion Hepatitis (PTH) would be solved.

18.56 The same approach to donor exclusion, as expressed in the WHO report, appeared in a letter from Dr John Wallace of the Glasgow and West of Scotland BTS published in the British Medical Journal of 11 August 1973. Dr Wallace reported the findings of a study in his region that 'volunteers with a history of jaundice or of recent contact with a case of jaundice do not have a higher incidence of positivity for [Hepatitis B antigen and antibody] than in donors lacking this history'.[67]

18.57 The Advisory Group on Testing for the Presence of Australia (Hepatitis Associated) Antigen and its Antibody (the Maycock Group),[68] originally set up in September 1970, was re-convened on 6 December 1973.[69] In its second report, published in September 1975, it recommended that the practice of excluding donors with a history of jaundice should be discontinued, provided that HBsAg was not detected using a sensitive test and the donor had not suffered from hepatitis or jaundice during the previous 12 months.[70]

18.58 Increased understanding of Hepatitis B had driven the change. But there was still no means of limiting the risk of transmission of other viruses causing post-transfusion hepatitis. The existence of long-incubation post-transfusion hepatitis unrelated to Hepatitis B, postulated by Dr Alfred Prince and colleagues in The Lancet published on 3 August 1974, was not noted in the Maycock Group's discussion of the topic of exclusion on grounds of jaundice or hepatitis history.[71]

18.59 An internal DHSS memorandum dated 16 March 1976 noted that some RTDs in England and Wales 'express[ed] reservations about discontinuing (within prescribed safeguards) the practice of excluding from the panel donors with a history of jaundice but the majority favour admitting such donors from a given date'.[72] That became established advice.[73]

18.60 Consistent advice was published by the WHO in 1975. Recommendations included:

6 At present blood donors should not be excluded on the evidence of previous hepatitis alone, whether it is based on a past history of infection or on the findings of hepatitis B surface antibody, provided that they have had no attack of hepatitis during the previous year and their blood has been found negative for hepatitis B surface antigen by a very sensitive test.

7 There can be no categorical designation of high risk blood donor groups; the situation is likely to vary from country to country from time to time and within countries. Any subpopulation with specific characteristics shown to have a continuing carrier rate of HBsAg at least three times that of the total potential blood donor population may be considered for exclusion. However, such decisions should be made on a local basis with due regard to the needs and availability of blood.[74]

18.61 Dr McClelland said that paragraph 7 of the WHO report was relevant to the question of taking blood from donors in Scotland.[75] The advice was probably a reflection of the growing awareness at the time of the variability of the prevalence of Hepatitis B surface antigen carriage in the populations of different countries. But it was relevant to the assessment of the suitability of any population.

18.62 The three WHO papers referred to reflected developments in opinion that coincided, in time, with growing knowledge of the hepatitis viruses and with the development of HBsAg assays. It would be unrealistic, however, to think that this increased knowledge would lead to the rapid production of new assays, or to the instant adoption of tests as they became available. In 1972, Dr Wallace commented:

The phenomenon of a long latent period between significant experimental observations and their application in clinical practice is not confined to blood transfusion. Part of the delay is caused by the need to develop new technical capabilities, and by having to await adequate financial support. Even more important is a human reluctance to depart from the familiarity of old habits and a natural suspicion of things new. In some respects progress in blood transfusion is being retarded because new ideas are not easy to sell to old heads.[76]

18.63 General advice was developed in 1976 with the publication of the International Society of Blood Transfusion (ISBT) Guide Criteria for the Selection of Blood Donors.[77] Some of the guidance is relevant to later topics, but it is helpful to note the full range at this point, since it emphasised the need for general precautions notwithstanding developments in screening. In this respect the Guide marked a significant development in re-assessing general exclusion policy and practice. The Guide stated:

In spite of recently developed tests for the detection of HBsAg, only a relatively small proportion of carriers can presently be detected. No routine screening test is presently available for the detection of hepatitis A virus, or of other viral agents that cause transfusion-associated hepatitis. It follows, therefore, that some general precautions should be taken in an attempt to reduce the risk of such viral agents being transmitted from donor to recipient.

Prospective donors should be excluded if it is known that they:

1. Give a history of viral hepatitis at any time, except during the first months of life ...

2. Have received a transfusion of blood or blood products within the last six months.

3. Have been in close, household contact with a case of "infectious hepatitis" in the last six months.

4. Have donated blood which was strongly suspected of having been responsible for a case of post-transfusion hepatitis.

5. Are suspected to be parenteral drug addicts.

6. Have been tattooed, had their ears pierced, or experienced acupuncture within the past six months.

7. Are inmates of a correctional institution.

8. Are HBsAg positive.

9. Are working in high-risk areas such as haemodialysis centres.[78]

18.64 The 1977 NBTS Memorandum on the Selection of Donors provided for exclusion in the same terms as items 2 and 3 of the ISBT Guide. Item 1 was not followed. The Memorandum reflected the advice of the Maycock Group and stated that those with a history of jaundice or hepatitis could be accepted as donors provided they had not suffered from jaundice or hepatitis in the previous 12 months and provided they tested negative for Hepatitis B surface antigen using a sensitive test (RPHA or RIA). Item 8 was reflected in a positive stipulation that an accepted test for HBsAg be performed each time a donor was bled, and that donors whose blood reacted positively should be excluded permanently from the donor panel.[79]

18.65 In his evidence to the Inquiry, Dr McClelland stated that he believed that the SNBTS adopted a similar approach to the acceptance of donors with a history of jaundice as that set out in the 1977 NBTS Memorandum, albeit that some regions may have restricted acceptance to cases where the donor had only experienced jaundice before the age of 12 years.[80]

18.66 The pattern of infection in Scotland was a factor underlying changes introduced to the 1977 guidance.[81] The restriction on accepting donors with a history of jaundice was relaxed in the case of donors infected under the age of 12 years because, where there was evidence of infection, it was almost always found to be an antibody to HAV. Dr McClelland thought that this was based on work done by Dr Brian Dow in Glasgow, who reported that many patients who had jaundice in childhood had been infected with Hepatitis A, a transient infection which was for all practical purposes considered not to be transmissible by transfusion. He suspected that the decision to restrict the acceptance of a donor with a jaundice history in later life was related to concern that jaundice occurring later might not be due to Hepatitis A, but due to NANB Hepatitis.[82]

18.67 Dr Wallace's book, Blood Transfusion for Clinicians, was published in 1977. It noted, without criticism, the 1975 WHO recommendation that volunteers with a history of clinical hepatitis could be accepted as donors provided the clinical illness occurred more than 12 months previously, and the serum of the donor was shown not to contain HBsAg when tested by a sensitive method.[83]

18.68 The topic continued to generate study and correspondence in professional publications. In October 1978, Renton and others, of the Manchester BTS, reported their findings on whether the inclusion of donors with a history of jaundice had led to an increased incidence of HBsAg positive tests.[84] Donors with a history of jaundice were 3.5 times as likely to be HBsAg positive as donors without such a history. The sensitivity of the test influenced their conclusion:

[T]he rate of HBsAg positives amongst these people is still small, and with the sensitive tests at present in use we do not believe that these figures mean that such donors ought to be excluded from the panels.

18.69 Despite that, it was a challenge to the accepted understanding. Contrary views were also expressed. On 21 July 1979, The Lancet published a letter from Dr Robert Crawford and colleagues at the Glasgow and West of Scotland BTS reporting on their study into blood donors with a history of jaundice. The authors found that a history of jaundice was not materially higher in donors who tested positive for HBsAg than in those who did not. They stated:

We conclude from these results that a history of jaundice does not materially increase the prevalence of HBsAg among blood-donors and is likely to imply previous infection with [Hepatitis A virus] rather than with [Hepatitis B virus].[85]

18.70 The findings of the Glasgow BTS study were reported more fully in The Lancet on 2 February 1980. The authors stated:

The findings suggest that in a country with a low incidence of hepatitis-B carriage a history of jaundice is much more likely to equate with prior hepatitis-A infection than B infection. There is no evidence to support the practice of regarding blood donors or patients with a history of jaundice as a special group with more prior exposure to hepatitis B virus and thus more likelihood of being long-term carriers of hepatitis-B virus.[86]

18.71 On 15 March 1980, The Lancet published a letter from Dr Robert Hopkins and colleagues at the ESESBTS on the topic of blood donors with a history of jaundice. The letter stated:

The former policy of the Scottish Blood Transfusion Service was to reject as donors all persons admitting a history of jaundice. Lately this policy has been modified to exclude only would-be donors with a history of jaundice within the previous twelve months: donations are now accepted from most persons with a history of jaundice, provided they are HBsAg negative upon routine testing.[87]

18.72 After reporting the findings of their study the authors stated:

We conclude that in the donor population of South-East Scotland a history of jaundice is not associated with an increased risk of HBsAg carriage. This is in agreement with findings in the West of Scotland reported by Dr Follett and colleagues. The prevalence of antibody to hepatitis A in our region is similar in donors with and without a history of jaundice (84% and 78%). This suggests that the viruses of "non-A, non-B hepatitis" may be a significant cause of jaundice in this population.[88]

18.73 This too was controversial. In his evidence to the Inquiry, Dr Dow stated that the finding in the Edinburgh study of a similar incidence of Hepatitis A in donors with a history of jaundice and in donors without such a history, was at variance with the findings in the west of Scotland where the incidence of Hepatitis A was much higher in donors with a history of jaundice. Dr Dow considered that one would need to know how many donors were tested in the Edinburgh study and considered that the suggestion in the last sentence about NANB Hepatitis was 'pure speculation'.[89]

18.74 On 23 October 1982, the British Medical Journal published a letter by Mr Archie Barr and colleagues at the Glasgow BTS on the topic of blood donors with a history of jaundice. They reported:

We have now studied a group of donors according to the age at which the jaundice occurred. Almost all the episodes of jaundice occurring before the age of 13 years were due to hepatitis A infection, but about 20% of those with jaundice in adolescence or later had no markers for hepatitis A or B. Other viruses can cause jaundice - for example, Epstein-Barr virus, cytomegalovirus, Coxsackie virus, adenovirus - and many other agents can cause liver problems. We cannot, therefore, equate unexplained jaundice with infection by the elusive non-A, non-B viruses. Indeed, it is uncertain whether sporadic non-A, non-B hepatitis is caused by the same agent as the form of the disease transmitted by transfusion, and it is not known how often a carrier state follows sporadic infection. Furthermore, it is possible that, as with hepatitis B, clinical jaundice may be an indicator of elimination of virus rather than carriage ....

In the last three years this region has transfused nearly 400,000 donations of blood and their derivatives. Only 12 cases of overt post-transfusion hepatitis possibly attributable to non-A, non-B agents have been notified .... None of the donors involved in the eight cases associated with red-cell transfusion had given a history of jaundice ....

The present British policy appears to be correct, and any change could cause a serious loss of blood products when some regions are still struggling to make 80% of the blood plasma they collect available for factor VIII production ....[90]

18.75 In May 1986, Dr Dow presented a Special Report to the SNBTS Directors on Surrogate Tests for Non-A, Non-B Hepatitis. The report noted that:

In the USA individuals with a history of prior jaundice are excluded because of the possibility of their jaundice episode being due to NANB and subsequently becoming chronic carriers of NANB agent(s). Exclusion of such individuals in the West of Scotland population would incur a loss of around 2 to 3% of donors.[91]

18.76 After commenting on the three NANB Hepatitis surrogate screening tests then under consideration, namely, excluding donors who had a history of jaundice, who were positive for antibodies to the Hepatitis B core antigen or who had an elevation of the liver enzyme ALT, the report stated:

The effect of these strategies in identifying implicated donors involved in NANB PTH cases.

The "acid" test for either of these three means of identifying potential NANB carrier donors is to examine the effect, if any, they would have in identifying such donors amongst those implicated in reported cases of NANB PTH.

Of the 65 donors implicated in 18 NANB PTH cases, only 2 had histories of jaundice and both were involved in the cases in which jaundice may have been caused by the effects of drugs rather than transfused blood.[92]

18.77 The report concluded:

The present UK policy of accepting donors with raised ALT levels .... anti-HBc or histories of jaundice would appear to be correct. It would appear from the study that the introduction of such surrogate screening procedures would have little impact on reducing the already low level of NANB PTH cases at present reported within the West of Scotland region.[93]

18.78 Continuing controversy over these matters clouds the issue as to whether interview practices in the 1970s and early 1980s were likely to provide relevant and reliable information about the risk that an individual prospective donor's blood might be infective for Hepatitis B, or any other transmissible infection. As some of the evidence shows, the debate tended to move from Hepatitis B to NANB Hepatitis over this period. There was no test for any NANB Hepatitis virus before 1988. The use of surrogate testing in that context is discussed in Chapter 27, Surrogate testing of Donated Blood for Non-A, Non-B Hepatitis.

18.79 In November 1987 the NBTS advice was modified.[94] Donors reporting jaundice or hepatitis in childhood followed by full recovery were to be accepted. Item 1 of the ISBT guidance was now reflected in the NBTS advice. Donors reporting adult jaundice or hepatitis were to be deferred pending additional information from their general practitioners. If it proved not to be Hepatitis B, they were to be accepted one year after full recovery. Donors known to have had Hepatitis B and who wished to donate were to be referred to their NBTS Centre for individual consideration. Hepatitis contacts were to be deferred for six months after close contact. It was recognised that defining high risk donor populations by means of fixed HBsAG prevalence rates could cause problems, and that it was necessary to have regard to the impact of guidance on the availability of blood supplies.[95] This was consistent with the Maycock report,[96] and in turn with the 1977 guidance.[97] That version of the NBTS Memorandum on the Selection, Medical Examination and Care of Blood Donors (1977) embodied the Maycock recommendation on exclusion. There was a change towards accepting donors with a history of jaundice or hepatitis, as long as the attack had been more than 12 months previously and the donor was proven negative for Hepatitis B surface antigen using a sensitive test.

18.80 The progressive reduction in the range of individuals excluded would probably have improved to some extent the prospects of obtaining relevant information on interviewing potential blood donors. More recent episodes of hepatitis, particularly involving jaundice, would have been likely to have been recalled by donors. A person who had had no overt signs or symptoms of infection might be wholly unaware of his or her infection but, where there was a known infection, disclosure still depended on the ability and willingness of the individual presenting as a donor to provide a history. Some donor sessions, in factories or other work places and in public places such as shopping centres, were less than private, and a donor might prefer to conceal a relevant fact rather than explain to colleagues why no donation had been taken.

Exclusion on the ground's of NANB Hepatitis and jaundice

18.81 Developing knowledge of NANB Hepatitis and the development of tests indicative of infection with that disease are dealt with in detail elsewhere. For the purposes of this discussion, the question is whether the interview techniques, focussed as they were on prior hepatitis and in particular on the signs of jaundice, were effective means of identifying potential donors infected with the NANB Hepatitis virus, as an incidental result of exploring the potential donor's exposure to HBV.

18.82 The letter by Dr Hopkins and colleagues, referred to at paragraph 18.71 above, suggested an association of jaundice and the NANB Hepatitis/Hepatitis C (HCV) viruses. Dr Dow thought that was speculative. Mr Barr and colleagues considered that one could not associate unexplained jaundice with 'the elusive non-A, non-B viruses'. Dr Dow and colleagues thought that using histories of jaundice would have little impact on reducing NANB PTH cases. Two sources of evidence deal conclusively with the issue.

18.83 In his written evidence to the Inquiry, Dr McClelland stated:

With respect to antibody to hepatitis C virus, Crawford et al 1994,[98] found that only 5.9% of the donors who had been found to be HCV positive gave a history of jaundice, suggesting that the result of this questioning would not be an effective screening test. This is consistent with observations that the natural history of hepatitis C infection does not typically include early episodes of jaundice. The infection can be asymptomatic for a long period after exposure, so it cannot be assumed that donors carrying the virus would recall any episode of jaundice or hepatitis ....

I am unable to estimate the size of any possible impact of an exclusion of donors with a history of jaundice on the incidence of post transfusion hepatitis, but I think it is unlikely that any effect would have been large.[99]

18.84 Professor Juhani Leikola gave the following evidence:

On the basis of what was known at the time, in my opinion it was a reasonable policy to accept otherwise healthy individuals (after a quarantine time) but who gave a history of jaundice. In the past it was natural to think that the cause of jaundice would have been hepatitis A (after recovery blood is not infectious) since hepatitis B would have been detected in the laboratory. However, once it became clear by mid-1970s ... that after clinical hepatitis B the patient may become chronic carrier of the virus with HBsAg levels below detection limits and that there could be another hepatitis virus causing first jaundice and chronic carrier state without clinical symptoms, the policy could have been reconsidered. However, I think that precluding all donors giving a history of jaundice would not have had a major effect on the blood transfusion safety.[100]

18.85 Professor Leikola was asked why the exclusion of donors with a history of jaundice was unlikely to have had a major effect on blood transfusion safety. He replied:

What we know about these diseases right now is that the vast majority of the carriers of either Hepatitis B or Hepatitis C virus, they have not had any jaundiced phase in their disease. The vast majority is really subclinical and maybe not causing any symptoms at all. On the other hand, some people with acute infectious hepatitis, especially Hepatitis A, they recover completely from that jaundice and they are not hazardous to the blood transfusion matter. So in light of what we know now, I don't think that precluding people giving a history of jaundice would have very much influenced the final blood safety.[101]

18.86 From what is now known, it seems unlikely that the practice of accepting donors with a history of jaundice did materially increase the risk of recipients developing post-transfusion NANB Hepatitis/HCV. Firstly, the vast majority of donors with a history of jaundice were likely to have been jaundiced as a result of causes other than Hepatitis C, for example:

  • Hepatitis A (from which donors will have long since recovered and which is generally not transmissible by blood).
  • Hepatitis B (in respect of which any donors carrying the antigen at the time of donation are likely to have been detected by the Hepatitis B screening tests and excluded).
  • Non-hepatitis viruses (such as cytomegalovirus or Epstein Barr virus).
  • Non-viral causes (including alcoholic liver disease, gallstones, and adverse reaction to medication).[102]

Secondly, only a small proportion of individuals who contract Hepatitis C develop jaundice, with the result that most donors with Hepatitis C would not have been excluded by a policy that excluded donors with a history of jaundice.[103] Thirdly, it appears that individuals who contract Hepatitis C and who have an acute episode of jaundice, are more likely to clear the virus, and no longer be infective, than individuals who contract Hepatitis C and who do not experience an acute episode of jaundice.[104]

18.87 On the basis of what was known at the time, and in light of the recommendations contained in the 1975 WHO report and the second report of the Maycock Advisory Group, it seems reasonable for the Scottish Blood Transfusion Service, from around the mid-1970s, to have accepted donors with a history of jaundice and who were negative for HBsAg. Indeed, no suggestion to the contrary was made to or by any of the witnesses at the Inquiry. The policy of the SNBTS from around the middle of the 1970s to accept donors with a history of jaundice (and who tested negative for HBsAg) appears unlikely to have materially increased the risk of transfusion-transmitted Hepatitis C.

18.88 Shortcomings in collection procedures, and in particular interview techniques, cannot be said to have had any material bearing on the outcome for recipients of blood products so far as NANB Hepatitis is concerned. There were no known signs and symptoms of infection that could have been elicited by interview of the potential donor, and the information that may have been elicited pointing to a history of Hepatitis B infection would not have alerted the transfusion service to the possibility of infection with NANB Hepatitis.

Previous transfusion

18.89 A prospective donor who had previously had a transfusion of blood or blood components, or who had been treated with blood products, might have acquired disease on that occasion, transmitted by the blood from the original donor, and that was considered to be a risk leading to exclusion, at least within certain time limits.[105] The risk of that person transmitting infection was the same, however the donor of the source blood came to be infected.

18.90 Item 2 in the section of the 1976 ISBT Criteria for the Selection of Blood Donors quoted in paragraph 18.63 above had provided for exclusion where the transfusion had been received within the previous six months.[106]

18.91 In 1978 the WHO Expert Committee on Biological Standardization published a report.[107] The report noted that it had been agreed that it would be useful to have a single set of requirements applicable to all organisations and laboratories involved in the collection or fractionation of blood and blood products. The report included an Annex on Requirements for the Collection, Processing and Quality Control of Human Blood and Blood Products.[108] In respect of the medical history of donors and, in particular, infectious diseases, the report contained a similar recommendation to the ISBT Guide:

Donors shall have a negative history ... of receipt within six months of human blood or any blood component or fraction that might be a source of transmission of viral hepatitis.[109]

18.92 The Memorandum on the Selection, Medical Examination and Care of Blood Donors, produced by the Transfusion Directors in England and Wales stated, since at least 1977, that donors should be temporarily deferred who, within the last six months, had either undergone a transfusion with blood or plasma or had undergone acupuncture or ear piercing.[110]

18.93 As noted at paragraph 18.25 above, the 1979 edition of the Standards for the Collection and Processing of Blood etc stated that transfusion within the last six months should result in temporary deferment.[111]

18.94 Two factors changed the context for exclusion on the grounds of prior transfusion. The first was an appreciation of the risks associated with AIDS, which brought about material changes in procedures in about 1983. These changes are dealt with in Chapter 28, Donor Selection - AIDS.

18.95 The second was the risk posed by variant CJD. In current practice, individuals who might have received a blood transfusion since 1980 are not accepted as donors.[112] That decision was taken in 2004 when the first documented clinical case of transmission of variant CJD by a red cell component was described.[113] The intention was to avoid the risk that individuals who themselves had variant CJD through a blood transfusion, might carry on donating and continue recycling the infection in the community. The decision excluded about 3.5% of the donor population at that time (2004), and a higher percentage of the blood donated because people who themselves had received blood transfusions in the past, or whose relatives had benefited from transfusion, were often very keen to contribute something to the community, so that they were often amongst the most dedicated donors. The Services may defer about 1% of donors on this ground on an ongoing basis.[114] As some people do not know whether they have been transfused, if it is inferred from other history that they probably have been transfused they will then be excluded on a precautionary basis.


18.96 The general policy of voluntary donation at the beginning of the period put emphasis on the exclusion of particular groups of potential donors, permanently or temporarily, from donating blood for clinical or therapeutic application as a means of limiting risk. The five regions of the SNBTS drew on the Standards and the 1977 Memorandum on the Selection, Medical Examination and Care of Blood Donors, as updated, and were involved in the development of the 1989 UK Professional Guidelines for the Care and Selection of Blood Donors. Until the advent of AIDS the questioning of donors was less rigorous, being both less direct and less personal. There were also differences of approach apparent between the Regional Centres in relation to donor selection as reported by Dr Gillon in 1985. As late as the early 1980s, a form in use in Glasgow and the West of Scotland identified certain infectious diseases and asked whether the individual had had contact with or had recently recovered from any of them; identified other serious illnesses and asked whether the individual had had such an illness. It also asked whether the individual had had inoculations, surgery or had worked or taken part in sports involving unusual hazards. It did not refer to drug abuse or any aspect of sexual orientation or behaviour.[115]

18.97 Inhibitions on discussion of the previous medical history of the prospective donor affected the group of individuals that had received previous transfusions, as it did those with a history of jaundice. There were similar problems of recollection. Perinatal transfusion (that is, transfusion in the period immediately after birth, generally up to four weeks) is unlikely to have been known to the recipient. Some patients would never have known that they had been transfused in later life, or understood that the procedures they observed and recollected were transfusions of blood components, for example. If there was jaundice, all of the previous factors would have applied. If the hepatitis was NANB Hepatitis and there was no jaundice, there may have been no other sign or symptom to alert the individual to the need to disclose the event. By comparison, in current practice, questioning is more rigorous, and testing procedures reinforce the safety of the supply.

18.98 In reality, there were few if any known clinical signs and symptoms of infection with NANB Hepatitis/Hepatitis C that could have been elicited on interview of a prospective donor. Indeed, until a late stage in the development of disease there were a few clinical signs that could have been found by a competent physician on discussion with the individual. Developments in knowledge to the mid-1980s are discussed in Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985. Until the end of that period there were substantial deficits in knowledge of the disease and its natural history.[116] Few of the patients studied in the period had any specific symptoms.[117] In the event, whatever deficits may have existed in the interview procedure, it is unlikely that they had any material impact on the transmission of the infections with which this Inquiry is concerned.

18.99 Infected blood entered the system up to the mid-1980s primarily because screening of blood for virus infection was ineffective and not because of poor interviewing practices, or donor routines. Screening was recognised as essential to the safety of transfusion, but methods developed up to that time could not identify the main causes of post-transfusion hepatitis efficiently (in the case of Hepatitis B until the late 1970s) or at all (in the case of Hepatitis C).

18.100 In summary, and having regard to earlier discussion of developing knowledge of NANB Hepatitis/HCV, considerations that had a bearing on the development and application of policies and practices relating to the collection of blood included the following:

  • The voluntary principle acknowledged a long-held view that freely donated blood presented a lower level of risk of transmitting infection than blood collected commercially from paid donors.
  • Voluntary donors performed a valuable service to society.
  • Mutual trust was implicit in the voluntary principle, imposing on the transfusion services obligations of care towards donors, for their safety, and more particularly for present purposes for their general well-being in the course of management of donation procedures; and imposing on donors obligations of care for the ultimate recipients of donated blood.
  • The emphasis on jaundice in determining the suitability of a donor to give blood for clinical use was generally irrelevant to the risk of transmission of NANB Hepatitis/Hepatitis C, but that was not understood until the prevalence of anicteric HCV infection began to be appreciated after the introduction of anti-HCV screening in the early 1990s.
  • So far as a risk of transmission of NANB Hepatitis was understood to exist, until the second half of the 1980s the disease was generally understood to be benign in its progression.
  • A donor's infection with NANB Hepatitis could not have been discovered by interview: medical knowledge did not provide a basis for relevant questioning.


  • By the spring of 1983 it was accepted that AIDS presented a transfusion risk. This resulted in a step change in the rigour of donor selection procedures. Until then it is unlikely that generally recognised interview procedures at donation collections in Scotland were fully effective to elicit information about social or medical histories of donors in general which was relevant to risks of transmission of viral hepatitis.
  • The emphasis on Hepatitis B reflected generally accepted views among medical experts until the end of the 1970s that HBV infection presented the most significant risk of transfusion-related transmission of viral hepatitis.
  • Even after Regional Transfusion Directors introduced more rigorous interview practices in and after 1983, there were no procedures that could have elicited information indicative of asymptomatic NANB Hepatitis infection.
  • Until the second half of the 1980s, NANB Hepatitis was generally understood to pose a lower risk to the recipient of an infected donation, than the underlying cause of medical or surgical treatment giving rise to the transfusion.
  • Ignoring later scientific developments, so far as general members of the public offering blood donation were concerned, there was no method of identifying with interview those potential donors who were infected with NANB Hepatitis, but who remained asymptomatic at the donor session. No such interview could have been conceived at the time.

1 'Viral Hepatitis: Report of a WHO Scientific Group', World Health Organization Technical Report Series, 1973, No. 512 [SGH.002.9746] at 9761

2 Dr McClelland - Day 9, page 72

3 Blood Transfusion: a Guide to the Formation and Operation of a Transfusion Service [PEN.002.0462]. The guide was edited by CC Bowley, KLG Goldsmith and W d'A Maycock on behalf of the International Society of Blood Transfusion and the League of Red Cross Societies, with contributions from experts from England, Canada, France, the Netherlands and Switzerland.

4 Ibid [PEN.002.0462] at 0466

5 Ibid [PEN.002.0462] at 0472

6 Ibid [PEN.002.0462] at 0472

7 Ibid [PEN.002.0462] at 0473

8 Twenty-Eighth World Health Assembly, Geneva, 13-30 May 1975, WHA28.72 [DHF.003.0764]

9 World Health Organization Executive Board, Seventy-Ninth Session, Geneva, 12-23 January 1987: EB79.R1 Blood and Blood Products [PEN.019.1382]

10 Titmuss, 'The Blood Donor' Proceedings of The Royal Society of Edinburgh, section B (Biology) 1972; vol 71 Supplement. s. 59 at s. 61 [PEN.002.0570] at 0571. Professor Titmuss was Professor of Social Administration, The London School of Economics and Political Science.

11 The data have been derived from extant SNBTS and PFC records that were not maintained on a consistent basis over the whole period. The data reflected in Figure 18.1 were published in the Preliminary Report paragraph 5.52 and were not challenged in later evidence. As at 1990, the total for donations before deferrals was 332,236. Data on donations from 1991 to 2009 are summarised in SNBTS Infection Surveillance Report No. 11 [PEN.001.0053] at 0055 and 0056. Donations in 1991 totalled 358,359. Total annual volume remained over 300,000 until 1995 after which it fell progressively to about 250,000 donations per annum.

12 Donations before rejections and deferrals for part of the period are presented in Chapter 26, Donor Selection - Higher Risk Donors, at Appendix 2.

13 Titmuss, 'The Blood Donor' Proceedings of The Royal Society of Edinburgh, section B (Biology) 1972; vol 71 Supplement. s. 59 at s. 61 [PEN.002.0570] at 0571

14 Preliminary Report, paragraphs 5.50 and 5.51, based on the SNBTS Annual Report for 1975-1976: [SNB.010.3921]

15 Professor Turner - Day 7, Page 15

16 Titmuss, 'The Blood Donor', Proceedings of The Royal Society of Edinburgh, section B (Biology) 1972; vol 71 Supplement. s.60. [PEN.002.0570] at 0571

17 Professor Turner - Day 7, pages 15-23

18 Blood Transfusion: a Guide to the Formation and Operation of a Transfusion Service [PEN.002.0462] at 0474

19 SNBTS Annual Report 1975-76 [SNB.010.3921] at 3922

20 Royal Commission on the National Health Service: Evidence from the SNBTS, January 1977 [SNB.003.4592] at 4599

21 See Chapter 17, Blood and Blood Products Management, at paragraphs 17.28 to 17.47

22 Dr Wallace, regional director of the Glasgow and West of Scotland BTS, reflected his general concern in a letter dated 24 November 1976: [SNB.003.4539]. In September 1980, there was a proposal in England that Beechams should take over BPL: [DHF.003.0329]

23 Collection of Blood in Prisons, SNBTS, 2011 [PEN.018.1521] at 1525. See similar comments by Dr McClelland in his statement [WIT.003.0072]

24 See Chapter 17, Blood and Blood Products Management, at paragraph 17.77

25 Collection of Blood in Prisons, SNBTS, 2011 [PEN.018.1521] at 1525

26 Notes on Transfusion, DHSS etc, 1973 [DHF.001.2039] at 2041

27 The 1979 edition of the Standards etc are [PEN.002.0249]. The Medicines Division, through the DHSS, also produced a Guide to Good Pharmaceutical Practice (known as 'the Orange Book'), the first edition of which appeared in 1971. The second edition of the Orange Book was published in 1977 [DHF.001.2933] and the third edition in July 1983 [DHF.001.4990]. The current edition is Rules and Guidance for Pharmaceutical Manufacturers and Distributors, published in 2007 by the Medicines and Healthcare Regulatory Agency (MHRA). The guide still has an orange cover.

28 Minutes of SNBTS Directors' meeting held on 8 May 1978 [SNB.002.5319] at 5320

29 1977 Memorandum [SNB.002.5348]

30 1983 Memorandum [SGF.001.0377]

31 1985 Memorandum [DHF.001.8931]

32 1987 Memorandum [SNB.006.6410]. The Memorandum was superseded in 1990 by the guidance published by the Department of Health on behalf of the UK Blood Transfusion Services and the NIBSC, Guidelines for the Blood Transfusion Services in the UK. These guidelines are more fully discussed in Note on the various guidance documentation produced by the Inquiry team [PEN.012.0347].

33 1977 Memorandum [SNB.002.5348] at 5351

34 Ibid [SNB.002.5348]

35 Reversed passive haemagglutination

36 Radioimmunoassay. The use of these tests is discussed in Chapter 25, Screening of Donated Blood for Hepatitis B

37 1977 Memorandum [SNB.002.5348] at 5350

38 Report by the Medicines Inspectorate following their visit to the Edinburgh and SE Scotland BTS on 10-11 March and 10-12 May 1982 [SGF.001.0351], at 0352, para 11(a). In that paragraph the Inspectors also asked 'whether donors really read the questionnaire' and 'Just how comprehensive is the questionnaire?'

39 Response to Medicines Inspectors Report [SGH.003.5059] at 5063

40 Ibid [SGH.003.5059] at 5089

41 Ibid [SGH.003.5059] at 5093

42 Ibid [SGH.003.5059] at 5123

43 Ibid [SGH.003.5059] at 5105

44 Ibid [SGH.003.5059] at 5123

45 Report on Donor Selection Criteria by Dr Gillon dated 11 November 1985 [SNB.003.9864] at 9867

46 Dr Gillon - Day 11, page 48

47 Minutes of SNBTS Co-ordinating Group meeting on 30 April 1986 [SNB.003.9905] at para 2

48 Guidance for the Selection of Blood Donors, November 1988 [PEN.016.0479]. The document was re-issued in August 1990 [SNB.006.6484] and revised in early 1991 [SNB.011.7435]

49 Dr McClelland - Day 9, page 18

50 Ibid pages 19-20 The description related to prisons sessions specifically, but was said to operate identically at any other session.

51 Ibid page 20

52 Ibid pages 20-21

53 Dr Mitchell - Day 9, page 167

54 Mrs Prior's written statement [PEN.019.0107] at 0108

55 Blood Transfusion: a Guide to the Formation and Operation of a Transfusion Service [PEN.002.0462] at 0488

56 Dr McClelland - Day 9, page 24

57 See Chapter 28, Donor Selection - AIDS, paragraph 28.2

58 Dr McClelland - Day 9, page 23

59 See Chapter 28, Donor Selection - AIDS,. In some areas leaflets, of varying specificity, were used to inform donors of potential risks.

60 The Practitioner: No 1166 (August 1965) pp 184-5 [LIT.001.4394]

61 Blood Transfusion - A Guide to the Formation and Operation of a Transfusion Service [PEN.002.0462] at 0481

62 'Viral Hepatitis: Report of a WHO Scientific Group', World Health Organization Technical Report Series, 1973, No. 512 [SGH.002.9746] at 9761

63 Ibid [SGH.002.9746] at 9754 and see also at 9762

64 Ibid [SGH.002.9746] at 9761

65 Dr McClelland - Day 9, page 106

66 'Viral Hepatitis: Report of a WHO Scientific Group', World Health Organization Technical Report Series, 1973, No. 512 [SGH.002.9746] at 9761

67 Wallace, 'Hepatitis B antigen VD clinic patients', British Medical Journal, 1973; 347 [PEN.002.0821]

68 See Chapter 25, Screening of Donated Blood for Hepatitis B, paragraphs 25.21 and 25.22

69 Second Report of the Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen and its Antibody [SGH.003.0079] at 0081

70 Ibid [SGH.003.0079] at 0084

71 Prince et al, 'Long-incubation post-transfusion hepatitis without serological evidence of exposure to hepatitis-B virus', The Lancet, 1974; 241 [LIT.001.0363]. Professor Cash explained that 'I saw Alfred Prince in my 1969 visit to the States, he gave me a small vial of Australia antigen in New York and I brought it back, and that was the first beginnings of testing for Australia antigen, certainly in Scotland. This was an outstanding group'. Day 10, page 101

72 Memorandum from TE Dutton to Dr Waiter dated 16 March 1976 at para 4, item 104A [SGF.001.2841] at 2842. South West Thames Regional Health Authority were also noted to have 'Reservations about including or readmitting donors with a history of jaundice' (para 4, item 102A).

73 See Chapter 25, Screening of Donated Blood for Hepatitis B, paragraphs 25.38-25.39

74 World Health Organisation - Technical Report Series - Report of a WHO Meeting [LIT.001.3272] at 3298

75 Dr McClelland - Day 9, page 111

76 Wallace, 'New approaches to the supply of blood and plasma', Proceedings of the Royal Society of Edinburgh, Section B (Biology) 1972; vol 71: Supplement: S.13 [PEN.018.1026] at 1032

77 Criteria for the Selection of Blood Donors [DHF.001.2672]

78 Ibid [DHF.001.2672] at 2683

79 1977 Memorandum [SNB.002.5348] at 5350. A similar provision was contained in the 1983 Memorandum ([SGF.001.0377] at 0388), the 1985 Memorandum ([DHF.001.8931] at 8943) and the 1987 Memorandum ([SNB.006.6410] at 6418)]. For completeness, it is noted that the Standards for the Collection and Processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids, published by the DHSS in 1979, stated that, 'The following diseases may lead to acceptance, deferment or disqualification as donors ... jaundice or hepatitis in the last year' [PEN.002.0249] at 0253.

80 Dr McClelland - Day 9, pages 90-91

81 Ibid pages 91-92

82 Ibid pages 90-92

83 Wallace, Blood Transfusion for Clinicians, 1977 [LIT.001.3058] at 3107

84 Renton et al, 'Blood donors with a history of jaundice', The Lancet, 1978:833 [PEN.002.0851]

85 Crawford et al, 'Blood donors with a history of jaundice', The Lancet, 1979:155 [LIT.001.2155]

86 Follett et al, 'Viral hepatitis markers in blood donors and patients with a history of jaundice', The Lancet, 1980:246 [LIT.001.0430]

87 Hopkins et al, 'Blood donors with a history of jaundice', The Lancet, 1980:596 [LIT.001.0429]

88 Ibid [LIT.001.0429]

89 Day 24, page 149

90 Barr et al, 'Blood donors with a history of jaundice', British Medical Journal, 1952:285 [PEN.014.0067]

91 Surrogate Tests for Non-A - Non-B Hepatitis - Special Report to Regional Transfusion Directors [SNF.001.1109]

92 Ibid [SNF.001.1109] at 1110.

93 Ibid [SNF.001.1109] at 1111. Dr Dow's research and the error inherent in the approach of relying on reported cases of post-transfusion jaundice to estimate the prevalence of post- transfusion NANB Hepatitis are more fully discussed in this Report in the chapter on surrogate testing.

94 Guidance for the Selection, Medical Examination and Care of Blood Donors 1987 [SNB.006.6410] at 6418

95 Dr McClelland - Day 9, page 111

96 Second Report of the Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen and its Antibody [SGH.003.0079]

97 Dr McClelland - Day 9, page 110; Memorandum on the Selection, Medical Examination and Care of Blood Donors - Section 1 - Selection of Donors [SNB.002.5348]

98 Crawford et al, 'Prevalence and epidemiological characteristics of hepatitis C in Scottish blood donors', Transfusion Medicine, 1994; 4:121-124 [PEN.002.0582]

99 Dr McClelland's written statement, [WIT.003.0072] at 0089

100 Professor Leikola's written statement, [WIT.003.0027] at 0030

101 Professor Leikola - Day 13, page 87

102 Dr Dow - Day 24, Pages 161-162

103 In his evidence to the Inquiry, for example, Dr Gillon stated that he had looked at the literature and, while it is very difficult to get a figure, 'It is a very small figure and I think most authorities accept that jaundice is an occasional but rare feature in non-A non-B hepatitis': Day 11, pages 15-16

104 Professor Thomas - Day 52, page 69

105 Memorandum on the Selection, Medical Examination and Care of Blood Donors - Section 1 - Selection of Donors 1977 [SNB.002.5348] at 5349

106 Criteria for the Selection of Blood Donors [DHF.001.2672] at 2681

107 WHO Expert Committee on Biological Standardization - Twenty-ninth Report [LIT.001.3627]

108 Ibid [LIT.001.3627] at 3640

109 Ibid [LIT.001.3627] at 3651. As regards the last recommendation quoted, relating to the avoidance of donor population showing a higher prevalence of acute or chronic hepatitis than in the general population, Professor Leikola explained in his evidence to the Inquiry that he would not place much weight on that recommendation because direct markers of disease (eg the presence of antigen) should be used when identifying a group with a higher prevalence of disease rather than indirect markers such as 'acute or chronic hepatitis'; the recommendation does not say how much higher the prevalence of disease should be in a donor group for that group to be excluded and the committee who produced the recommendation comprised biologists, virologists and fractionators rather than those with practical experience of blood collection or transfusion: Day 13, pages 57-58

110 Memorandum on the Selection, Medical Examination and Care of Blood Donors - Section 1 - Selection of Donors 1977 [SNB.002.5348] at 5349. Similar guidance appeared in the 1983 Guidance [SGF.001.0377] at 0381, the 1985 Guidance [DHF.001.8931] at 8936 and the 1987 Guidance [SNB.006.6410] at 6411, 6413 and 6427

111 Standards for the Collection and Processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids - Section 1 - Selection of Donors 1979 [PEN.002.0249] at 0253 and 0254

112 Professor Turner - Day 7, page 17

113 Ibid page 18. Professor Turner's evidence included a detailed explanation of modes of transmission. The 'infective agent' of vCJD, a prion protein, is not removed from blood by the conventional methods used to remove viruses, including HCV and HIV.

114 Professor Turner - Day 7, Pages 19-20

115 Glasgow & West of Scotland Blood Transfusion Service Questionnaire (1983) [PEN.013.1395]

116 Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985, paragraph 15.166

117 Ibid paragraph 15.164

19. Production of Blood Products - Facilities >