Managing the risk - three conceptions of risk
While there were differences in labelling what was happening, there were none in terms of prognosis (likely outcome), seen universally as the removal of unsafe product. In other words, expert opinion converges with respect to the goal - safe blood - but on how and why this might be done there is divergence, thus revealing differences in management perspectives. We identify three approaches to managing the risk from this organisational threat: risk as hazard, risk as liability and risk and precaution.
Risk as hazard emphasises the potential adverse consequences to patient well-being. Such an approach demands immediate removal and the full disclosure of what is happening to patients. Furthermore, it suggests that those notifying patients should be as close to the patients as possible, usually the treating or transfusing physician. This risk is almost a given and most comments refer to the importance of physician notification to allay any or all fears about hazard, the physician being seen as trusted, knowledgeable and close to the patient. There is agreement on who is central in this immediate task of ensuring blood safety, the blood supplier, but different stakeholders hold the risk as hazard view for different reasons. The blood supplier itself sees a distinctive chain of responsibility and action if blood may be unsafe - from themselves to the physician to the patient.
"... you know we are in this era of informing the patient, but I think to some extent the pendulum can go too far ... and that we need to be careful about not giving patients information that's no of value... I think we can overdo some of the informing of patients, it's almost like we're passing the buck and not kind of letting the responsibility stop somewhere along the way with a physician..." (Blood Supplier-07)
This discussion on the need to notify seems supported by all stakeholders. Hospitals see that any notification from the blood supplier highlights a concern and the need for action.
"Now, I would anticipate that if the blood... supplier... was concerned enough to notify us as an organization to recall a product, then the degree of risk is always such that it would be important for us to notify the patient. You know what I mean. Like, the risk assessment has already taken place at the blood supplier" (Hospital-Risk Management-02)
"I guess from my perspective there is either risk or there is no risk, and if there's no risk they're not notifying us. If they're notifying us it's because there is risk" (Hospital-PR-01)
Physicians tend to agree but see themselves and are seen as those best positioned to make patients aware of potential problems as 'they know' their patients best.
"In my opinion, it's the role of the clinician who's caring for the patient to manage those things" (Physician using blood products-05)
"It's useful to have a well-informed recommendation from the Blood Supplier but the hospital always has to use its discretion and the difference there is that we know our patient population" (Physician using blood products-07)
"I think ultimately the physician always has that, you know, discretion. And that's clear in case law" (Blood Supplier-04).
Others feel that the physician may not have all the skills necessary to manage risk as hazard, especially if their style is based on a confident, medical approach to the issue.
"So I would be perfectly supportive, of a hospital system or provincial system or even a nation-wide system that developed advisory guidelines. But I don't think it's a situation where if it is ... that a physician doesn't want to notify her patients that, that somehow some other agency needs to get involved and compel that notification" (Physician- Blood Bank-03)
"I don't know whether there would be a place for a third party to come in, where a third party would contact the recipient and say 'I know that your physician spoke with you, or that you received a letter, this is just a reminder that you might need to go for further testing'" (Laboratory Technician-04)
"Well I don't know if everybody has them but a patient representative would be one option. I think somebody with those sets of skills. Like not just the technical skills but the people with counselling skills and discussion. I mean they'd have to have some kind of knowledge about blood and risk" (Provincial Health Ministry-02)
Risk as hazard was the best articulated of the discourses on how to manage. Yet risk as liability, where the potential consequences for system integrity of specific practices were central, received greater expression from respondents. Patient well-being is of course still vital but now disclosure to patients of events that might affect their well-being protects the blood supply institution as well. Such management is seen particularly at the supplier and hospital levels. The identification of the risk and its disclosure were closely related. But under many comments lies an often implicitly stated concern over liability, i.e. what is our liability if we do not act (disclose) and something happens? In other words, their responses are anchored around current operational characteristics of the healthcare system and their legally demarcated roles within that system.
Liability is often framed in terms of outside perceptions, specifically and not unusually, on how public perceptions of expertise and expert response may be framed. In this discourse, the role of the blood supplier is central but responses to their notices may vary depending on how others see the issue and their liability. The blood supplier must always give an opinion.
"We [Blood Supplier] would always give our opinion as to follow up." (Blood Supplier-01)
The importance of local circumstances and their possible impact on liability are recognised by the blood supplier. It must balance its obligations with that of the independence (and discretionary action) of institutions such as hospitals and doctors.
"What we do in our centre is... we take a look at the reason for the recall, we may provide that information. The hospital doesn't do much with it, and they know they'll get a supplementary letter from me if I think recipient notification is required so that decision whether recipient notification is required is made here. I think that ... works better in our environment because I have more experience in this than the regional lab tech ... and we don't have experienced blood bank directors in most of the blood banks." (Blood Supplier-02)
Yet circumstances at the local level may affect response to this opinion.
"But the Blood Supplier has their own ideas about what, in what situations do recipients need to be notified so they advise us. In our opinion, you do or do not have to notify the recipient if this product has been transfused already and we sometimes do what the Blood Supplier asks, although we're a little more aggressive about notifying patients than what the Blood Supplier does." (Physician using blood products-01).
"I think you know, some hospitals are in a position where they absolutely must rely on the expertise of the Blood Supplier. I mean, they, you know, primary care hospitals that I assume are somewhat more comfortable just saying, 'Look, just tell us what you want to do. Tell us what you want to say and we're not gonna do any independent analysis. Just, you know, provide us with what your recommendation is.' Other hospitals are saying, 'okay Blood Supplier, thanks for the information. We're gonna consider this independently. We have the expertise to do so, you know. The only thing we want you to do is provide as much information as you can on the risk and we're all consider it at our Transfusion Committee and we'll all decide ultimately what we think our physicians should do in terms of patient notification.' ... that kind of thing. You know, so there's quite a difference. So that is a part that we're struggling with a little bit in terms of how do we fulfill our obligations? We never want to be, we never want to fetter anyone's discretion in terms of notification. That's for sure. Though part of us is saying, you know, part of the time we think, okay, we can provide all of the, all of the information, all of the risk information as clearly as we can, and that's it and then the hospital can sort of make their decisions. But there's another component then because we don't want to be in a position of... we don't want to abdicate our responsibility and thrust the decision making on hospitals, you know, so there's sort of a tension there between those two" (Blood Supplier-04).
The hospital is perhaps in a position of having to respond to local pressures before the full facts are known because they are local institutions and have explicit liability concerns.
"I believe in full disclosure even if all you can say is here's what we think happened, here's why it happened, here's what we know and don't know, and here's a mechanism for either monitoring or what have you down the road. So in the absence of that, in the event that there's some new novel research finding in the not so distant future, I've never been told about this, I didn't know I had exposure, some marvellous new technology or technique comes along that would perhaps allow me to be more definitive. Well I don't even know about it to pursue that or include it in my own medical history" (Hospital Adminstrator-02)
While some groups which are closest to the patient that is being transfused with blood see most recalls as leading to minimal risk, perhaps displaying an overconfidence in the role of scientific assessment, others are concerned about outside perceptions and what these might do to the situation.
" ... we couldn't identify what the risks were and the risks were minimal, therefore we should not disclose, and [the Chief of Governance] was adamant that we needed to ... I was really surprised that the recommendation by the Transfusion Committee was totally disregarded" (Transfusion Safety Officer-01)
Waiting for an assessment can lead to much time thinking through the issue. This may result in an affect response, especially with respect to the media. This may be exacerbated by public attention being roused before a system-based announcement can be made.
"And sometimes we've got no, we don't have an assessment yet... so we're sitting ... waiting, you know and there's a time delay there so... my biggest fear is in the meantime it hits the media, now we've got an issue" (Laboratory Manager-03)
"But the problem is, is that you have media that's watching, and so then, then there's a different spin put on this when it hits the newspaper. You know... another bloody scandal. So are you more concerned about your public relations or are you more concerned about the effect you're going to have on patient care?" (Laboratory Manager-01)
Much of the liability discourse takes into account the perceptions and roles of other stakeholders, both inside and outside the blood supply system. The third discourse - risk as precaution - does that too but also seems to treat problems on a case-by-case basis as uncertainty cannot be fully removed or explained. It is a view of risk often held and articulated by system administrators. A precautionary approach has been based on a changed perspective toward patients and institutional/professional partners. And precaution - taking care - is necessary as interests and ways to achieve them may be dissimilar. The blood supplier sees precaution as necessary because of these dissimilarities.
"I don't know how much a hospital's disclosure policy would vary from one hospital to another. I mean one would hope that there's some uniformity in that or else disclosure of things is going to be a problem for very much more than recalls and withdrawals because I think there's all kind of things in a hospital that one might decided you disclose or you don't disclose" (Blood Supplier-07)
"I'm not looking at it in the capacity of disclosure and our disclosure policy and for us it's not as simple as just telling people something went wrong. We have to ... weigh out what the risk of telling someone versus the benefit of telling someone ... we very much are very strong proponents of disclosure and do it unless the risk of advising is significantly worse than not we certainly learn towards advising patients" (Hospital Administrator-03)
Furthermore, the blood supplier argues for precaution because of the need to respect the different needs and sensibilities of different types of patient.
"Because right now, the decision whether to inform a patient is based upon the doctors and the doctors in hospitals alone. The patient has no input whatsoever.... now the CJD thing was a perfect example of some people probably didn't want to know all the recalls, because what good could this have done. But some people did. So that there has to be a choice made by the patients... and my view and most patients' view on that is that they have no business making that decision for patients. Now, it's just the whole attitude of the health system, it's not anyone's particular fault, but it's just the attitude of you know, it's your responsibility and we'll make the decision. I think patients feel you know a little ticked with that" (Transfusion Recipient-02)
Often, agencies lack information about these patients: the recipients of the transfused products.
"We only have part of the story when we do these recalls and withdrawals which is the information from our end about the donor or about the component but we don't know anything about the recipient at the other end. And the importance of the information and about what should be done has to be determined in the context of the recipient" (Blood Supplier-03)
"I know our medical staff has a problem with the word recommendation because, I think it centres around the fact that they are dealing with facts about the unit and have no facts about the patient. Certainly, if you go to the level of individual patients, you can, I think justify different actions because of the different situations of patients" (Blood Supplier-01)
Precaution on the part of local system administrators is weighed not only with respect to hazard but also institutional and patient autonomy.
"For us it's not as simple as just telling people that something went wrong. We have to, we like to, weigh out what the risk of telling someone versus the benefit of telling someone ... so I think there needs to be a way to bring hospitals together and recognising the hospitals are independent and are free to make their own choices to the extent that that can be coordinated goes a long way because ... we have to have a plan B that while we didn't think disclosure was appropriate, in the event that another hospital chose to disclose, we had to be prepared for how we would respond to that" (Hospital Adminstrator-03)
"It's a very paternalistic approach to say 'oh well we know it's bad for you and so you know we want to spare you the pain of having to you now think about things like this so just let us do it.' That has not worked well in the past and we are a sort of newer generation of people where the attitude has changed... So, give the sort of transition in the social more that is out there.... I think trying to take that paternalistic approach that we will hide things from you for your own best interest it just won't sell" (Transfusion Recipient-01)