Vox Sanguinis (2015) © 2015 International Society of Blood Transfusion DOI: 10.1111/vox.12228
ORIGINAL PAPER
A clinical governance framework for blood services L. M. Williamson,1 R. J. Benjamin,2 D. V. Devine,3 L. M Katz,4 J. Pink5 & for the Alliance of Blood Operators Medical Directors Group* 1
NHS Blood and Transplant, Watford, UK American Red Cross, Rockville, MD, USA 3 Canadian Blood Services, Vancouver, BC, Canada 4 America’s Blood Centers, Washington, DC, USA 5 Australian Red Cross Blood Service, Melbourne, VIC, Australia 2
Background and Objectives The elements of clinical governance, which ensure excellence in clinical care, can be applied to blood services. In this survey, their application in a range of blood providers was gauged, with the aim of identifying best practice and producing a generalizable framework. Materials and Methods The Medical Directors of members of the Alliance of Blood Operators surveyed how different elements of clinical governance operated within their organizations and developed recommendations applicable in the blood service environment. Results The recommendations that emerged highlighted the importance of an organization’s culture, with the delivery of optimal clinical governance being a corporate responsibility. Senior management must agree and promote a set of values to ensure that the system operates with the patient and donor at its heart. All staff should understand how their role fits into the ‘journey to the patient’, and a culture of openness promoted. Thus, reporting of errors and risks should be actively sought and praised, with penalties applied for concealment. Systems should exist to collect, analyse and escalate clinical outcomes, safety data, clinical risk assessments, incident reports and complaints to inform organizational learning.
Received: 1 September 2014, revised 2 November 2014, accepted 4 November 2014
Conclusion Clinical governance principles from general health care can be applied within blood services to complement good manufacturing practice. This requires leadership, accountability, an open culture and a drive for continuous improvement and excellence in clinical care. Key words: blood services, clinical care, clinical governance, culture, quality.
Introduction The concept of clinical governance emerged from the National Health Service (NHS) in the UK, as a system through which NHS organizations are accountable for continuously improving their standards by creating an Correspondence: Lorna Williamson, Medical and Research Director, NHS Blood and Transplant, Oak House, Reeds Crescent, Watford, WD24 4QN, UK E-mail: [email protected] *Study particpants details are given before the Acknowledgements section.
environment in which excellence in clinical care will flourish [1]. This approach consolidated previously fragmented policies and approaches to clinical quality [1]. Clinical governance is essentially a quality framework that is patient (and in our environment, donor) centred. It comprises all the elements of clinical planning, care and monitoring, which, when taken together, should deliver the best outcomes for patient and donor (see Box 1: Ten Commandments of Clinical Governance, [2]). There are several key features of good clinical governance. Leadership and accountability of both clinical and non-clinical staff are critical, with ultimate responsibility for delivery of clinical excellence resting with the chief executive.
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Box 1. The ten commandments of clinical governance. Modified from Harrison et al., 2003 [2]: Getting to grips with Clinical Governance. An organization intent on achieving clinical governance will ensure that: Clinical quality improvement processes are in place and integrated with the quality programme for the organization as a whole Leadership skills (the ability to inspire and implement the ways of working which underpin clinical governance) are developed at a clinical team level Evidence-based practice is in day-to-day use with the infrastructure to support it Good practice, ideas and innovations (which have been evaluated) are systematically disseminated and taught within and outside the organization Effective clinical risk reduction programmes are in place Adverse events are detected and openly investigated and the lessons learned are promptly applied Lessons for clinical practice are systematically learned from complaints make by patients Problems of poor clinician performance are recognized at an early stage and dealt with to prevent harm to patients All professional development programmes reflect the principles of clinical governance
Reporting, collection and analysis of data, along with an open culture and a willingness to learn from errors are also critical. Evidence-based decision making is essential, and innovation is fundamental to developing transformative ways of working, for example to drive out errors. The focus is therefore proactive as well as reactive to harmful events, the overall aim being to improve services and prevent adverse outcomes. Clinical governance would seem to be particularly relevant to blood services, with their historical focus on product quality. This provides a solid platform on which to build the growing consensus that transfusion safety is dependent on every step from the donor to patient. As elsewhere in health care, the patient and donor should therefore be at the heart of blood service thinking and planning. However, blood services are regulated as manufacturing organizations, and have to maintain licensure in order to be able to operate. There is therefore an understandable emphasis on regulatory compliance, with highly developed quality systems. It might be assumed that the quality system would meet all requirements of best practice in clinical governance. There is indeed considerable overlap, but an organization can be compliant without adopting all the best elements of clinical governance. Although blood services determine quality processes using a risk-based decision making approach,
regulatory compliance regarding product specifications and Good Manufacturing Practice requirements is dichotomous – products and services either comply with regulatory standards or they do not. Therefore, although in some Blood Services Good Manufacturing Practice does promote continuous improvement, it may not always give due emphasis to holistic continuous improvement which is a goal of clinical governance. Specifically, clinical governance considers the whole donor experience, including aspects such as waiting times, confidentiality, bruising and the staff’s attitude, so organizations with mature systems of governance would have such performance indicators for clinical teams. In addition, promotion of optimal blood use by hospitals is increasingly becoming within the remit of blood services, but is not generally considered within a quality system. Finally, services which treat patients directly, such as therapeutic apheresis, are not covered by manufacturing regulation, but would be included in clinical governance systems. It should be noted that in general health care, clinical governance predominantly considers the activities of doctors, nurses and scientists. Within a blood service, however, most staff working in blood collection, manufacturing and transport are not healthcare professionals, yet their roles have an important impact on the final quality and timeliness of the treatment provided for a patient. Thus, the induction and training of such staff must constantly emphasize the ultimate aim of treating a patient. This paper reports a study undertaken by the Medical Directors of members of the Alliance of Blood Operators (ABO), an international group of blood providers. The objective was to establish which elements of clinical governance were in place within each blood service, and to build on those to produce a framework and recommendations which could be implemented in any developed blood service.
Materials and methods Participating blood services Participating ABO members were America’s Blood Centers (ABC), American Red Cross (ARC), Australian Red Cross Blood Service (ARCBS), Canadian Blood Services (CBS), European Blood Alliance and National Health Service Blood and Transplant (NHSBT, England and North Wales). The Japanese Red Cross Blood Service (JRCBS), although not an ABO member, kindly agreed to take part. EBA and ABC are themselves groupings of many different blood providers, either in USA (ABC, 67 Blood Centres), or in different European countries (EBA, 25 national members). CBS, ARCBS, JRCBS and NHSBT are monopoly not-forprofit suppliers tasked by their governments with national © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
© 2015 International Society of Blood Transfusion Vox Sanguinis (2015) ARCBS
NHSBT
JRCBS
Quality incidents summarized. National Concern line for anonymous reporting (ARC). Annual surveillance report (CBS).
Receive and manage complaints from donors, hospitals. Annual hospital customer survey. Donors & recipients can give feedback on public website and a 1-800 number (ARC) or cards in clinics (CBS). CBS contracts a professional organization for donor polling, focus groups.
Complaints and recommendations?
Required reporting to FDA (ARC) or Health Canada (CBS).
Severe outcomes reported to National Blood Authority. Also to regulator, CEO, CG committees, Board. Review by CG Committee. Reported to Board. Annual surveillance report (in partnership with the Kirby Institute). Complaints, compliments and information requests captured by electronic customer feedback system Customer satisfaction surveys conducted by an external company. Regular donor satisfaction and other customer satisfaction surveys undertaken.
To each CARE group and senior management team; serious events to national CARE/ Executive team/Board.
Serious Untoward Incidents and Potential for serious harm (i.e. near miss) escalated to Board in real time. Also report to SHOT. Quality incidents/patient reactions collated and sent to CARE, then Executive/Board.
Donor complaints dealt with at collection site, with medical support if necessary. Complaints from hospitals/ patients dealt by medical representatives, with medical support if necessary.
Accidents reported immediately to HQ. Collated data reported and reviewed by the Safe Operation Committee in HQ.
System in place – division managers are assigned as incident report managers.
CG committee (chair: CMO). National CARE committees (chair: Adherence to Japanese National Blood Transfusion Medical & Research Director). Pharmaceutical Affairs and Committee (chair: external Specialist sub-CARE groups (3). Blood Laws, subject to clinician). Medical and Reports on infection prevention, government inspection, scientific Board submedico-legal claims, research & internal audit for all committee, Ethics committee, information governance, Serious operations (clinical and QA). customer satisfaction survey, Untoward Incidents. haemovigilance. No formal programme. Diagnostic laboratories, donor Yes. External audit (non-clinical Yes: Topics chosen by each CARE Internal blood collection audit testing programmes are proficiency tested and accredited. but also clinical topics chosen group based on incidents/ conducted with QA audit. by Exec.). Internal audit (CG changes/clinical risk, prioritized Revised based on past committee-approved topics). though the 3 Directorate CARE frequent/important issues. Laboratory: QAP and NATA groups. Work is ongoing to audited. Not linked to quality align clinical and quality audit. audits. No structured or consistent review at any organization, but varying levels of involvement (e.g. physicians signing off on CAP audits, local review groups that sometimes include a clinician, etc.). ARCBS now formalizing this process.
CBS
Reports on adverse events, surveillance, lookback/traceback. Hospital satisfaction surveys. CBS: Also annual R&D report.
ARC
Incident reporting, escalation and collation?
Incidents and events Overall arrangements?
Are clinicians involved in review of QA data (locally/ nationally)?
Clinical audit programme: Do you have one? How are topics chosen? Is it connected to the quality audit programme?
Overall arrangements
Clinical effectiveness
Table 1 Current clinical governance arrangements in alliance of blood operators blood services: survey questions and summarized responses
Clinical governance for blood services 3
NHSBT
Managed by R&D Executive Director. Yes, physicians appointed as national clinical leads for different laboratories.
Managed according to policies and procedures. Extreme cases could include suspension.
(A) Yes. (B) Yes – When inventory falls below a certain level or there are severe shortages, physicians are involved.
Yes: sign off by Medical Director (if blood centre involved) or VP. Yes – each regional laboratory has a physician.
All formal staff: annual performance plan (work objectives/development) and review. No similar obligation for physicians on contract. Routine issues: mentoring and coaching. More severe issues: probation and suspension.
Done within each CARE group based on national policies. Varied; protocols define what can be signed off by a physician or scientist. (A) Yes. (B) Yes (platelets/FFP). Minimal involvement unless shortage is severe (RBCs).
Managed according to formal, publicized procedures (General Medical/Nursing Council). Can include referral to remediation, suspension
Yes, time and fund allowance for continuing education. Clinical staff encouraged to apply for senior leadership development programme. All formal staff: annual performance plan (work objectives/development) and review.
Yes, continuing education for all clinical staff, funding to attend conferences, training opportunities.
Regularly reviewed at CG committee.
ARCBS
Reviewed within each CARE group and at national CARE/ Executive Team/Board. All blood service organizations report varying levels of clinical involvement in assessment of donor and patient outcomes.
CBS
No formal mechanism, but usually medical involvement.
ARC
(A) NA. (B) No.
National guidelines not yet issued. When sensitive, test results are supported by a physician.
Usual job performance review applied with no special appraisal for clinical staff.
Yes, for health check doctors, but not staff medical doctors.
Education/training twice yearly for doctors conducting donor health check/interview.
–
JRCBS
ARC, American Red Cross; ARCBS, Australian Red Cross Blood Service; CAP, College of American Pathologists; CARE, clinical audit, risk and effectiveness; CBS, Canadian Blood Services; CEO, chief executive officer; CG, clinical governance; CMO, chief medical officer; FDA, Food and Drug Administration; FFP, fresh frozen plasma; HQ, head quarters; JRCBS, Japanese Red Cross Blood Service; NA, not applicable; NATA, National Association of Testing Authorities; NHSBT, National Health Service Blood & Transplant; QA, quality assurance; QAP, quality assurance program; R&D, research & development; SHOT, Serious Hazards of Transfusion; VP, vice president.
Role of doctors in inventory management? (A) Release of non-conforming product? (B) Management of shortages?
Other Review of requests for samples/ data for research? Role of doctors in diagnostic laboratories
Mechanisms for handling poor performance in clinical staff?
Regular appraisal arrangements?
Effective workforce Development Programme for clinical staff?
Assessment of donor/patient outcomes?
Review of medico-legal claims?
Clinical effectiveness
Table 1 (Continued)
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© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 5
provision of blood. ARC and members of ABC are all notfor-profit companies, while many EBA members are national blood services of their respective countries.
Survey A survey was conducted to determine which elements of clinical governance were in place at each ABO member blood service. The survey covered overall arrangements for: (1) Clinical effectiveness: overall arrangements, clinical audit, the role of clinicians in reviewing quality assurance data; (2) Incidents and Events: reporting, collating and escalating incidents and events, including complaints, commendations and medico-legal claims (3) Effective workforce: professional development programmes, appraisal and handling poor performance in clinical staff. (4) Other clinical activities: handling of requests for research data/samples, in diagnostic laboratories and in inventory management The Medical Directors from the blood services involved then compiled recommendations based on guidelines for good clinical governance and the practices already in place.
Results and recommendations Survey results were returned by all the single blood operators: ARC, ARCBS, CBS, JRCBS and NHSBT. Due to the large number of individual members, neither ABC nor EBA could complete the survey, but were actively engaged in formulating the recommendations. A summary of the responses to the survey is shown in Table 1, and the full dataset is available at Vox Sanguinis on line. Most participants already had systems for most or all of the elements identified as contributing to good clinical governance. Incident reporting with clinical involvement was well established in all participants. Establishment of clinical audit programmes was variable, as was clinician involvement in reviewing QA data. One common theme, however, was for review of different data sets to be carried out by different parts of the organization, which, in a recent report into a substandard UK hospital, was not considered best practice [3]. It is important that key data are reviewed by a single group. The following elements were considered essential in ensuring best practice in clinical governance (summarized in Box 2).
Clinical Governance is a corporate responsibility Responsibility for delivery of the right clinical outcomes must start at the most senior level of leadership, who © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Box 2. Features of good clinical governance in a blood service. Good clinical governance in blood services should encompass: Corporate arrangements for clinical governance, including regular reports to Board/Executive team, who must show commitment and ultimate responsibility for clinical outcomes Monitoring measures of patient and donor safety, including surveillance for emerging infections, new trends and technical developments Assessment of potential risks to donors and patients, at a local, regional and national level Clinical effectiveness and appropriate use of donated material, including research uses The patient and donor experience, through satisfaction surveys, focus groups and review of complaints/legal claims Incident reporting, particularly where a donor or patient is involved Quality assurance/Quality improvement An effective clinical workforce, including personal development, appraisal and handling of poor performance Clinical audit of practice against external clinical guidance
should develop and promulgate an agreed set of values for the organization – these should be known and adhered to by all staff, for example ‘Caring, Expert, Quality’ is used in NHSBT. One tangible way to demonstrate this could be a written statement that the Board/Executive Team of the organization operates with a donor and patient focus, and a commitment by Board members, both Executive and Non-Executive, to ‘walk the floor’ and maintain their contact with staff, although this can be a challenge in a national organization. Equally, all staff should be aware of their individual role and its importance in the ‘journey to the patient’. A set of values also have to be real at the front line. For example, Blood Centre management could make it clear to staff that they will reward people who escalate an error (even their own) up the line, but may discipline concealment of an error or purposeful violation of procedures. Likewise, concerns, complaints and suggestions should be nurtured and fully investigated as means to improve performance. A corporate focus on clinical risks is also critical, so the system of risk management should identify clinical risks, with mitigations and assurances well-documented. Risk registers should be established and regularly reviewed, with a clear system for escalating the highest scoring risks to the next management level. Appropriate clinical representation at a senior level is essential in ensuring that the clinical focus is maintained. Therefore, blood services should ensure, if necessary by influencing upwards to Ministries or nominations committees who may make the appointments, that external
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board members include experienced individuals from clinical professions. In addition, the Medical Director must be a full member of the Executive Team, reporting to the Chief Executive, be expected to provide regular reports on clinical issues and events and have overall responsibility for all donor, product and patient safety policies. Senior management teams responsible for operational business areas must include a senior clinician, and discussion of clinical issues should be a standing agenda item at meetings. A clinician should be a member of any group overseeing change of service provision or configuration. Horizon scanning is an important activity to ensure a systematic approach to new developments, and certain posts/individuals should be identified as having this responsibility. Finally, where a blood service might be considered to have a potential conflict of interest, the ability to refer clinical/ethical issues to a group of external expert clinicians should exist.
Operational implementation of good clinical governance The survey revealed that although most elements of clinical governance operate in many of the blood services, recommendations were developed to expand these and bring them to greater maturity. Firstly, it is recommended that a named director (usually the Medical Director or Director of Nursing) has lead responsibility for ensuring that systems of clinical governance are in place. This director could enact this responsibility by chairing a high level Clinical Audit, Risk and Effectiveness (CARE) or Clinical Governance group, reporting to the Executive Team. This group should comprise senior clinical, operational and quality staff, covering all products and services, and with an annual calendar of regular reports, for example from viral epidemiology, infection control, outcomes from any direct clinical services and medico-legal claims. Such groups are already in place in ARCBS and NHSBT. The mandate of such a group centres on review of different types of information, which, taken together, indicate the clinical ‘health’ of services. It is recommended that the following types of information are collected, collated and escalated:
Patient and donor outcomes Patient outcomes can be challenging to obtain, as outcomes for success of transfusions are not internationally defined. If ongoing collection of this data is not possible, periodic audits should be performed. Donor outcomes such as faints, bruises and more serious complications should be monitored at both a collection team and orga-
nizational level. Donor and patient haemovigilance systems are a critical part of outcomes assessment and these should be promoted within a clinical governance framework.
Complaints/legal claims There should be an easily accessible system to receive donor/patient/hospital complaints, with timelines for initial and final responses defined and monitored. An appropriate review and escalation process should be in place to ensure recurring themes are identified and addressed and to facilitate organizational learning.
Clinical audits These can provide assurance regarding adherence to external/internal clinical policies, the impact of operational change, the functioning of systems designed to prevent adverse outcomes and the quality of clinical advice. A powerful approach is for the clinical audit team to work closely with quality staff to produce a programme of clinical audits that is complementary to the quality audit programme, with combined quality/clinical audits in some areas, for example reference diagnostics. Clinical audit topics should be prioritized based on risk registers, incidents, guidelines, etc.
Donor/patient satisfaction surveys Donor satisfaction surveys should be conducted to capture the experience of previous donations. Donor input on operational changes affecting them could be sought through local donor liaison groups that feed into a national liaison committee. Patient input is also increasingly shown to be useful, and although it can be difficult to identify appropriate individuals, development of ongoing relationships with patient advocacy groups is recommended.
Data from hospitals Information from hospitals is extremely powerful in demonstrating safe and appropriate blood usage, a responsibility we have to donors and the healthcare system. Many countries now have national haemovigilance schemes to collect the most serious types of incidents and adverse events, but there remains a role for local or national data collection on topics such as wastage rates, use of O negative red cells and audits of component usage against national guidance. Even in countries where the blood collectors are not responsible for the transfusion services, they are increasingly involved in the promotion of patient-centred blood management programmes, where a central tenet is monitoring of wastage and inappropriate clinical use of products. © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 7
Incidents involving donors or patients Adverse event reporting is an important sentinel to indicate a process that may cause clinical harm, and while most blood services have good arrangements for adverse event reporting, systems should be in place to identify overall trends and the benefits of mitigating actions.
Clinical risk assessments Local and national service delivery areas should develop risk registers, with escalation of the highest risks to the next management level.
Monitoring impacts of organizational change Change projects such as consolidation of testing laboratories or production sites should include clinically agreed performance metrics before and after the change, for example sample turnaround times, order fill rates, donor deferral rates. This may require specific data collection of the ‘before’ situation.
External guidelines Systems should be in place for identifying new clinical guidelines and their relevance to the organization, with a follow-up process to ensure that new guidance is reflected in internal policies and SOPs.
Information governance incidents These errors can lead to serious breaches of privacy as a result of donor or patient (or staff) identifiable data being lost or falling into the wrong hands, either within the organization or externally. Increasingly, such incidents will be electronic and potentially impacting large numbers of records, and so this area overlaps with IT security, requiring close working between clinical and IT staff. Identification of named clinical posts as ‘owners’ of donor and patient data will help clarify responsibilities. Legal requirements may require a responsible Director and systems to deal with information governance incidents. The Clinical Governance committee or equivalent should review these at agreed intervals. The larger issue of IT failures that put the entire operation at risk is part of organizational risk management and require a corporate approach to mitigation.
Approval of release of Information/materials for research A system of approval should be in place with periodic review though clinical governance. Horizon scanning: blood services must engage in monitoring for infectious disease agents that may pose an actual or potential risk to the blood supply. The approach should be systematic, with clarity regarding who undertakes the monitoring function and escalation require© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
ments. The approach may include daily monitoring of sources that provide a rapid turnaround for information on outbreaks and threats that may require an immediate response (such as ProMED-mail), regular scanning of sources that provide information that may take some weeks to gather (such as Eurosurveillance data) and monitoring of sources based on longer term trends and developments (such as publications and strategic supplier meetings).
Benchmarking Systems should be in place to benchmark performance as a means to identify performance improvement opportunities. One important aspect is to ‘join the dots’ by ensuring that different types of information on the same area of activity are considered together. Sometimes, only weak signals are generated from single sources of data, for example clinical audits, but if combined with poor donor experience, low performance measures and poor morale in a staff survey, these can indicate that action is needed in a particular area to prevent a major clinical incident.
Incident reporting The ultimate aim of incident reporting is so that the organization can recognize recurring themes and develop solutions for reducing their likelihood. Therefore, it is critical that blood services develop a culture where reporting of incidents is praised and concealment penalized. It should be clear to all staff what the escalation process and timescales are for different types of event, as sometimes staff work diligently for too long trying to resolve a problem without the help of their managers. A useful backstop is a ‘whistle-blowing’ policy, which allows the top layer of the organization to be alerted to unresolved problems which may be affecting patient or donor care. Quality systems have ways of grading incidents and events, but such classifications may not cover all clinical possibilities. For example, the UK healthcare system defines a ‘Serious Untoward Incident’ as death or serious harm due to error, and has also produced a list of socalled Never Events which are situations where particular care is needed to prevent serious harm, for example ABO incompatible transfusion. These ‘sentinel events’ should be handled according to a specific protocol, with early escalation to the Executive/Board, involvement of the communications team in case of media interest and wide dissemination of the learning across the organization. Much learning can also come from ‘near miss’ events. All serious incidents, not only sentinel events, should be
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subject to thorough root cause analysis, in which key staff should be trained. Regular collated reports of incidents should be presented regularly to senior management teams and the Executive/Board at agreed intervals. If Board meetings are held partly in public, then such reporting should be in the open part of the meeting, although care should be taken to anonymize reports such that individual patients/ hospitals cannot be identified.
An effective clinical workforce Delivery of optimal services depends on employment of a clinical team that drives excellence in a blood service’s core business of serving patients and donors. As recruitment and retention of high quality clinical staff can sometimes be a challenge for blood services, medical staff job descriptions should be formulated to ensure their roles are attractive and add value to the organization. Joint posts with hospitals and universities provide a useful bridge to wider clinical communities. The potential for other healthcare professionals to take on day-to-day tasks should be reviewed regularly within the context of a clinical governance framework. Standard operating procedures should clearly state when a nurse/doctor/clinical scientist needs to be involved, for example in times of stock shortage, or in signing off diagnostic results. Provided a clear system is in place, signing off on other routine activities/negative results can be delegated to others. A mandatory system of continuing professional development is required to ensure that clinical staff are kept up to date, and employers must ensure sufficient time and funds are available for staff to meet these requirements. Development programmes should also be in place to ensure that clinical staff acquire leadership skills as they move into managerial roles.
Patient/donor involvement in decision making Many healthcare systems now place great emphasis on patient involvement in policy and organizational change. Having lay members on a committee or board can add value, but is not always easy to get right. There are risks of tokenism, or of appointing lay people who have strong feelings about a single issue. A better approach might be to develop donor or patient focus groups of people willing to be contacted on a range of issues.
Discussion There is no doubt that a mature system of clinical governance can drive continuous quality improvement, and provide assurance to the Board, the public, regulators,
health funders and other stakeholders that optimal outcomes are bring provided. There are, however, a number of potential pitfalls. The first is the risk of adding another layer of reporting on top of quality and performance reporting, with the same information being sent to multiple committees. This is not only inefficient, but can result in a system where data go round and round with no clarity as to whose responsibility it is to act on it. A second risk is that so much data are generated that no one can see the wood for the trees. Good analysis with clinical input and demonstration of trends over time is therefore essential, as is identification of outliers, be they laboratories or blood collection teams. This must be complemented by clear lines of accountability for remedial action. Finally, a quality culture takes time to mature, so a system to feed back key messages regularly to frontline staff is therefore essential. There are additional challenges to establishing a fully mature system. There will be some, albeit modest, extra costs for clinical audit and administrative staff, as well as senior oversight, but these can be minimized by building a data-driven culture, and instilling a sense that everyone needs to contribute to provision of data and continuous improvement. Obtaining data from hospitals, for example on blood usage is not easy, due to limitations of hospital information systems, even when there is a close working relationship between the blood supplier and the hospital. Nevertheless, blood collectors should promote the active reporting of patient haemovigilance data by hospitals to either regional or national databases, so that outcomes can be benchmarked and utilized for improvement purposes. Similarly, active engagement and promotion of patient-centred blood management programmes between hospitals customers and blood collectors may provide an avenue for data collection and assessment. The infrastructure and processes described in this paper are focussed on continuous improvement without quantum leaps in safety steps. A complementary piece of work is being undertaken by the Alliance of Blood Operators to develop a framework for risk-based decision making on matters of blood safety policy [4].
Alliance of Blood Operators (ABO) Medical Directors Group Members Alex Aquilina, European Blood Alliance, Valetta, Malta. Celso Bianco, America’s Blood Centers, Washington, DC, USA. Richard Benjamin, American Red Cross, Rockville, MD, USA. Dana V. Devine, Canadian Blood Services, Ottawa, ON, Canada. Louis Katz, America’s Blood Centers, Washington, DC, USA. Joanne Pink, Australian Red Cross Blood Service, Melbourne, Victoria, Australia. Lorna Williamson, NHS Blood and Transplant, Watford, UK. © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 9
Blood Services Scientific Writer, for assistance with manuscript editing.
ABO observer Kenji Tadokoro, Japanese Red Cross Blood Service, Tokyo, Japan.
Funding
Acknowledgements
This work was supported by funding from the Alliance of Blood Operators.
All authors contributed to the study design, generating and reviewing the results, formulating the recommendations and in production of the manuscript. The authors gratefully acknowledge Dr. Geraldine Walsh, Canadian
Conflict of interest The authors have no conflicts to declare with respect to the content of this manuscript.
References 1 Scally G, Donaldson LJ: Clinical governance and the drive for quality improvement in the new NHS in England. BMJ 1998; 317:61
2 Harrison S, Pollock C, Symons S: Getting to grips with clinical governance. Tfm Pub Ltd 2003 3 Mid Staffordshire NHS Foundation Trust Public Inquiry. http://www.midstaffspublicinquiry.com
© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
4 Menitove JE, Leach Bennett J, Tomasulo P, et al.: How safe is enough, who decides, and how? From a zerorisk paradigm to risk-based decision making Transfusion 2014; 54:753–757
ORIGINAL PAPER
A clinical governance framework for blood services L. M. Williamson,1 R. J. Benjamin,2 D. V. Devine,3 L. M Katz,4 J. Pink5 & for the Alliance of Blood Operators Medical Directors Group* 1
NHS Blood and Transplant, Watford, UK American Red Cross, Rockville, MD, USA 3 Canadian Blood Services, Vancouver, BC, Canada 4 America’s Blood Centers, Washington, DC, USA 5 Australian Red Cross Blood Service, Melbourne, VIC, Australia 2
Background and Objectives The elements of clinical governance, which ensure excellence in clinical care, can be applied to blood services. In this survey, their application in a range of blood providers was gauged, with the aim of identifying best practice and producing a generalizable framework. Materials and Methods The Medical Directors of members of the Alliance of Blood Operators surveyed how different elements of clinical governance operated within their organizations and developed recommendations applicable in the blood service environment. Results The recommendations that emerged highlighted the importance of an organization’s culture, with the delivery of optimal clinical governance being a corporate responsibility. Senior management must agree and promote a set of values to ensure that the system operates with the patient and donor at its heart. All staff should understand how their role fits into the ‘journey to the patient’, and a culture of openness promoted. Thus, reporting of errors and risks should be actively sought and praised, with penalties applied for concealment. Systems should exist to collect, analyse and escalate clinical outcomes, safety data, clinical risk assessments, incident reports and complaints to inform organizational learning.
Received: 1 September 2014, revised 2 November 2014, accepted 4 November 2014
Conclusion Clinical governance principles from general health care can be applied within blood services to complement good manufacturing practice. This requires leadership, accountability, an open culture and a drive for continuous improvement and excellence in clinical care. Key words: blood services, clinical care, clinical governance, culture, quality.
Introduction The concept of clinical governance emerged from the National Health Service (NHS) in the UK, as a system through which NHS organizations are accountable for continuously improving their standards by creating an Correspondence: Lorna Williamson, Medical and Research Director, NHS Blood and Transplant, Oak House, Reeds Crescent, Watford, WD24 4QN, UK E-mail: [email protected] *Study particpants details are given before the Acknowledgements section.
environment in which excellence in clinical care will flourish [1]. This approach consolidated previously fragmented policies and approaches to clinical quality [1]. Clinical governance is essentially a quality framework that is patient (and in our environment, donor) centred. It comprises all the elements of clinical planning, care and monitoring, which, when taken together, should deliver the best outcomes for patient and donor (see Box 1: Ten Commandments of Clinical Governance, [2]). There are several key features of good clinical governance. Leadership and accountability of both clinical and non-clinical staff are critical, with ultimate responsibility for delivery of clinical excellence resting with the chief executive.
1
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Box 1. The ten commandments of clinical governance. Modified from Harrison et al., 2003 [2]: Getting to grips with Clinical Governance. An organization intent on achieving clinical governance will ensure that: Clinical quality improvement processes are in place and integrated with the quality programme for the organization as a whole Leadership skills (the ability to inspire and implement the ways of working which underpin clinical governance) are developed at a clinical team level Evidence-based practice is in day-to-day use with the infrastructure to support it Good practice, ideas and innovations (which have been evaluated) are systematically disseminated and taught within and outside the organization Effective clinical risk reduction programmes are in place Adverse events are detected and openly investigated and the lessons learned are promptly applied Lessons for clinical practice are systematically learned from complaints make by patients Problems of poor clinician performance are recognized at an early stage and dealt with to prevent harm to patients All professional development programmes reflect the principles of clinical governance
Reporting, collection and analysis of data, along with an open culture and a willingness to learn from errors are also critical. Evidence-based decision making is essential, and innovation is fundamental to developing transformative ways of working, for example to drive out errors. The focus is therefore proactive as well as reactive to harmful events, the overall aim being to improve services and prevent adverse outcomes. Clinical governance would seem to be particularly relevant to blood services, with their historical focus on product quality. This provides a solid platform on which to build the growing consensus that transfusion safety is dependent on every step from the donor to patient. As elsewhere in health care, the patient and donor should therefore be at the heart of blood service thinking and planning. However, blood services are regulated as manufacturing organizations, and have to maintain licensure in order to be able to operate. There is therefore an understandable emphasis on regulatory compliance, with highly developed quality systems. It might be assumed that the quality system would meet all requirements of best practice in clinical governance. There is indeed considerable overlap, but an organization can be compliant without adopting all the best elements of clinical governance. Although blood services determine quality processes using a risk-based decision making approach,
regulatory compliance regarding product specifications and Good Manufacturing Practice requirements is dichotomous – products and services either comply with regulatory standards or they do not. Therefore, although in some Blood Services Good Manufacturing Practice does promote continuous improvement, it may not always give due emphasis to holistic continuous improvement which is a goal of clinical governance. Specifically, clinical governance considers the whole donor experience, including aspects such as waiting times, confidentiality, bruising and the staff’s attitude, so organizations with mature systems of governance would have such performance indicators for clinical teams. In addition, promotion of optimal blood use by hospitals is increasingly becoming within the remit of blood services, but is not generally considered within a quality system. Finally, services which treat patients directly, such as therapeutic apheresis, are not covered by manufacturing regulation, but would be included in clinical governance systems. It should be noted that in general health care, clinical governance predominantly considers the activities of doctors, nurses and scientists. Within a blood service, however, most staff working in blood collection, manufacturing and transport are not healthcare professionals, yet their roles have an important impact on the final quality and timeliness of the treatment provided for a patient. Thus, the induction and training of such staff must constantly emphasize the ultimate aim of treating a patient. This paper reports a study undertaken by the Medical Directors of members of the Alliance of Blood Operators (ABO), an international group of blood providers. The objective was to establish which elements of clinical governance were in place within each blood service, and to build on those to produce a framework and recommendations which could be implemented in any developed blood service.
Materials and methods Participating blood services Participating ABO members were America’s Blood Centers (ABC), American Red Cross (ARC), Australian Red Cross Blood Service (ARCBS), Canadian Blood Services (CBS), European Blood Alliance and National Health Service Blood and Transplant (NHSBT, England and North Wales). The Japanese Red Cross Blood Service (JRCBS), although not an ABO member, kindly agreed to take part. EBA and ABC are themselves groupings of many different blood providers, either in USA (ABC, 67 Blood Centres), or in different European countries (EBA, 25 national members). CBS, ARCBS, JRCBS and NHSBT are monopoly not-forprofit suppliers tasked by their governments with national © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
© 2015 International Society of Blood Transfusion Vox Sanguinis (2015) ARCBS
NHSBT
JRCBS
Quality incidents summarized. National Concern line for anonymous reporting (ARC). Annual surveillance report (CBS).
Receive and manage complaints from donors, hospitals. Annual hospital customer survey. Donors & recipients can give feedback on public website and a 1-800 number (ARC) or cards in clinics (CBS). CBS contracts a professional organization for donor polling, focus groups.
Complaints and recommendations?
Required reporting to FDA (ARC) or Health Canada (CBS).
Severe outcomes reported to National Blood Authority. Also to regulator, CEO, CG committees, Board. Review by CG Committee. Reported to Board. Annual surveillance report (in partnership with the Kirby Institute). Complaints, compliments and information requests captured by electronic customer feedback system Customer satisfaction surveys conducted by an external company. Regular donor satisfaction and other customer satisfaction surveys undertaken.
To each CARE group and senior management team; serious events to national CARE/ Executive team/Board.
Serious Untoward Incidents and Potential for serious harm (i.e. near miss) escalated to Board in real time. Also report to SHOT. Quality incidents/patient reactions collated and sent to CARE, then Executive/Board.
Donor complaints dealt with at collection site, with medical support if necessary. Complaints from hospitals/ patients dealt by medical representatives, with medical support if necessary.
Accidents reported immediately to HQ. Collated data reported and reviewed by the Safe Operation Committee in HQ.
System in place – division managers are assigned as incident report managers.
CG committee (chair: CMO). National CARE committees (chair: Adherence to Japanese National Blood Transfusion Medical & Research Director). Pharmaceutical Affairs and Committee (chair: external Specialist sub-CARE groups (3). Blood Laws, subject to clinician). Medical and Reports on infection prevention, government inspection, scientific Board submedico-legal claims, research & internal audit for all committee, Ethics committee, information governance, Serious operations (clinical and QA). customer satisfaction survey, Untoward Incidents. haemovigilance. No formal programme. Diagnostic laboratories, donor Yes. External audit (non-clinical Yes: Topics chosen by each CARE Internal blood collection audit testing programmes are proficiency tested and accredited. but also clinical topics chosen group based on incidents/ conducted with QA audit. by Exec.). Internal audit (CG changes/clinical risk, prioritized Revised based on past committee-approved topics). though the 3 Directorate CARE frequent/important issues. Laboratory: QAP and NATA groups. Work is ongoing to audited. Not linked to quality align clinical and quality audit. audits. No structured or consistent review at any organization, but varying levels of involvement (e.g. physicians signing off on CAP audits, local review groups that sometimes include a clinician, etc.). ARCBS now formalizing this process.
CBS
Reports on adverse events, surveillance, lookback/traceback. Hospital satisfaction surveys. CBS: Also annual R&D report.
ARC
Incident reporting, escalation and collation?
Incidents and events Overall arrangements?
Are clinicians involved in review of QA data (locally/ nationally)?
Clinical audit programme: Do you have one? How are topics chosen? Is it connected to the quality audit programme?
Overall arrangements
Clinical effectiveness
Table 1 Current clinical governance arrangements in alliance of blood operators blood services: survey questions and summarized responses
Clinical governance for blood services 3
NHSBT
Managed by R&D Executive Director. Yes, physicians appointed as national clinical leads for different laboratories.
Managed according to policies and procedures. Extreme cases could include suspension.
(A) Yes. (B) Yes – When inventory falls below a certain level or there are severe shortages, physicians are involved.
Yes: sign off by Medical Director (if blood centre involved) or VP. Yes – each regional laboratory has a physician.
All formal staff: annual performance plan (work objectives/development) and review. No similar obligation for physicians on contract. Routine issues: mentoring and coaching. More severe issues: probation and suspension.
Done within each CARE group based on national policies. Varied; protocols define what can be signed off by a physician or scientist. (A) Yes. (B) Yes (platelets/FFP). Minimal involvement unless shortage is severe (RBCs).
Managed according to formal, publicized procedures (General Medical/Nursing Council). Can include referral to remediation, suspension
Yes, time and fund allowance for continuing education. Clinical staff encouraged to apply for senior leadership development programme. All formal staff: annual performance plan (work objectives/development) and review.
Yes, continuing education for all clinical staff, funding to attend conferences, training opportunities.
Regularly reviewed at CG committee.
ARCBS
Reviewed within each CARE group and at national CARE/ Executive Team/Board. All blood service organizations report varying levels of clinical involvement in assessment of donor and patient outcomes.
CBS
No formal mechanism, but usually medical involvement.
ARC
(A) NA. (B) No.
National guidelines not yet issued. When sensitive, test results are supported by a physician.
Usual job performance review applied with no special appraisal for clinical staff.
Yes, for health check doctors, but not staff medical doctors.
Education/training twice yearly for doctors conducting donor health check/interview.
–
JRCBS
ARC, American Red Cross; ARCBS, Australian Red Cross Blood Service; CAP, College of American Pathologists; CARE, clinical audit, risk and effectiveness; CBS, Canadian Blood Services; CEO, chief executive officer; CG, clinical governance; CMO, chief medical officer; FDA, Food and Drug Administration; FFP, fresh frozen plasma; HQ, head quarters; JRCBS, Japanese Red Cross Blood Service; NA, not applicable; NATA, National Association of Testing Authorities; NHSBT, National Health Service Blood & Transplant; QA, quality assurance; QAP, quality assurance program; R&D, research & development; SHOT, Serious Hazards of Transfusion; VP, vice president.
Role of doctors in inventory management? (A) Release of non-conforming product? (B) Management of shortages?
Other Review of requests for samples/ data for research? Role of doctors in diagnostic laboratories
Mechanisms for handling poor performance in clinical staff?
Regular appraisal arrangements?
Effective workforce Development Programme for clinical staff?
Assessment of donor/patient outcomes?
Review of medico-legal claims?
Clinical effectiveness
Table 1 (Continued)
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© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 5
provision of blood. ARC and members of ABC are all notfor-profit companies, while many EBA members are national blood services of their respective countries.
Survey A survey was conducted to determine which elements of clinical governance were in place at each ABO member blood service. The survey covered overall arrangements for: (1) Clinical effectiveness: overall arrangements, clinical audit, the role of clinicians in reviewing quality assurance data; (2) Incidents and Events: reporting, collating and escalating incidents and events, including complaints, commendations and medico-legal claims (3) Effective workforce: professional development programmes, appraisal and handling poor performance in clinical staff. (4) Other clinical activities: handling of requests for research data/samples, in diagnostic laboratories and in inventory management The Medical Directors from the blood services involved then compiled recommendations based on guidelines for good clinical governance and the practices already in place.
Results and recommendations Survey results were returned by all the single blood operators: ARC, ARCBS, CBS, JRCBS and NHSBT. Due to the large number of individual members, neither ABC nor EBA could complete the survey, but were actively engaged in formulating the recommendations. A summary of the responses to the survey is shown in Table 1, and the full dataset is available at Vox Sanguinis on line. Most participants already had systems for most or all of the elements identified as contributing to good clinical governance. Incident reporting with clinical involvement was well established in all participants. Establishment of clinical audit programmes was variable, as was clinician involvement in reviewing QA data. One common theme, however, was for review of different data sets to be carried out by different parts of the organization, which, in a recent report into a substandard UK hospital, was not considered best practice [3]. It is important that key data are reviewed by a single group. The following elements were considered essential in ensuring best practice in clinical governance (summarized in Box 2).
Clinical Governance is a corporate responsibility Responsibility for delivery of the right clinical outcomes must start at the most senior level of leadership, who © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Box 2. Features of good clinical governance in a blood service. Good clinical governance in blood services should encompass: Corporate arrangements for clinical governance, including regular reports to Board/Executive team, who must show commitment and ultimate responsibility for clinical outcomes Monitoring measures of patient and donor safety, including surveillance for emerging infections, new trends and technical developments Assessment of potential risks to donors and patients, at a local, regional and national level Clinical effectiveness and appropriate use of donated material, including research uses The patient and donor experience, through satisfaction surveys, focus groups and review of complaints/legal claims Incident reporting, particularly where a donor or patient is involved Quality assurance/Quality improvement An effective clinical workforce, including personal development, appraisal and handling of poor performance Clinical audit of practice against external clinical guidance
should develop and promulgate an agreed set of values for the organization – these should be known and adhered to by all staff, for example ‘Caring, Expert, Quality’ is used in NHSBT. One tangible way to demonstrate this could be a written statement that the Board/Executive Team of the organization operates with a donor and patient focus, and a commitment by Board members, both Executive and Non-Executive, to ‘walk the floor’ and maintain their contact with staff, although this can be a challenge in a national organization. Equally, all staff should be aware of their individual role and its importance in the ‘journey to the patient’. A set of values also have to be real at the front line. For example, Blood Centre management could make it clear to staff that they will reward people who escalate an error (even their own) up the line, but may discipline concealment of an error or purposeful violation of procedures. Likewise, concerns, complaints and suggestions should be nurtured and fully investigated as means to improve performance. A corporate focus on clinical risks is also critical, so the system of risk management should identify clinical risks, with mitigations and assurances well-documented. Risk registers should be established and regularly reviewed, with a clear system for escalating the highest scoring risks to the next management level. Appropriate clinical representation at a senior level is essential in ensuring that the clinical focus is maintained. Therefore, blood services should ensure, if necessary by influencing upwards to Ministries or nominations committees who may make the appointments, that external
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board members include experienced individuals from clinical professions. In addition, the Medical Director must be a full member of the Executive Team, reporting to the Chief Executive, be expected to provide regular reports on clinical issues and events and have overall responsibility for all donor, product and patient safety policies. Senior management teams responsible for operational business areas must include a senior clinician, and discussion of clinical issues should be a standing agenda item at meetings. A clinician should be a member of any group overseeing change of service provision or configuration. Horizon scanning is an important activity to ensure a systematic approach to new developments, and certain posts/individuals should be identified as having this responsibility. Finally, where a blood service might be considered to have a potential conflict of interest, the ability to refer clinical/ethical issues to a group of external expert clinicians should exist.
Operational implementation of good clinical governance The survey revealed that although most elements of clinical governance operate in many of the blood services, recommendations were developed to expand these and bring them to greater maturity. Firstly, it is recommended that a named director (usually the Medical Director or Director of Nursing) has lead responsibility for ensuring that systems of clinical governance are in place. This director could enact this responsibility by chairing a high level Clinical Audit, Risk and Effectiveness (CARE) or Clinical Governance group, reporting to the Executive Team. This group should comprise senior clinical, operational and quality staff, covering all products and services, and with an annual calendar of regular reports, for example from viral epidemiology, infection control, outcomes from any direct clinical services and medico-legal claims. Such groups are already in place in ARCBS and NHSBT. The mandate of such a group centres on review of different types of information, which, taken together, indicate the clinical ‘health’ of services. It is recommended that the following types of information are collected, collated and escalated:
Patient and donor outcomes Patient outcomes can be challenging to obtain, as outcomes for success of transfusions are not internationally defined. If ongoing collection of this data is not possible, periodic audits should be performed. Donor outcomes such as faints, bruises and more serious complications should be monitored at both a collection team and orga-
nizational level. Donor and patient haemovigilance systems are a critical part of outcomes assessment and these should be promoted within a clinical governance framework.
Complaints/legal claims There should be an easily accessible system to receive donor/patient/hospital complaints, with timelines for initial and final responses defined and monitored. An appropriate review and escalation process should be in place to ensure recurring themes are identified and addressed and to facilitate organizational learning.
Clinical audits These can provide assurance regarding adherence to external/internal clinical policies, the impact of operational change, the functioning of systems designed to prevent adverse outcomes and the quality of clinical advice. A powerful approach is for the clinical audit team to work closely with quality staff to produce a programme of clinical audits that is complementary to the quality audit programme, with combined quality/clinical audits in some areas, for example reference diagnostics. Clinical audit topics should be prioritized based on risk registers, incidents, guidelines, etc.
Donor/patient satisfaction surveys Donor satisfaction surveys should be conducted to capture the experience of previous donations. Donor input on operational changes affecting them could be sought through local donor liaison groups that feed into a national liaison committee. Patient input is also increasingly shown to be useful, and although it can be difficult to identify appropriate individuals, development of ongoing relationships with patient advocacy groups is recommended.
Data from hospitals Information from hospitals is extremely powerful in demonstrating safe and appropriate blood usage, a responsibility we have to donors and the healthcare system. Many countries now have national haemovigilance schemes to collect the most serious types of incidents and adverse events, but there remains a role for local or national data collection on topics such as wastage rates, use of O negative red cells and audits of component usage against national guidance. Even in countries where the blood collectors are not responsible for the transfusion services, they are increasingly involved in the promotion of patient-centred blood management programmes, where a central tenet is monitoring of wastage and inappropriate clinical use of products. © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 7
Incidents involving donors or patients Adverse event reporting is an important sentinel to indicate a process that may cause clinical harm, and while most blood services have good arrangements for adverse event reporting, systems should be in place to identify overall trends and the benefits of mitigating actions.
Clinical risk assessments Local and national service delivery areas should develop risk registers, with escalation of the highest risks to the next management level.
Monitoring impacts of organizational change Change projects such as consolidation of testing laboratories or production sites should include clinically agreed performance metrics before and after the change, for example sample turnaround times, order fill rates, donor deferral rates. This may require specific data collection of the ‘before’ situation.
External guidelines Systems should be in place for identifying new clinical guidelines and their relevance to the organization, with a follow-up process to ensure that new guidance is reflected in internal policies and SOPs.
Information governance incidents These errors can lead to serious breaches of privacy as a result of donor or patient (or staff) identifiable data being lost or falling into the wrong hands, either within the organization or externally. Increasingly, such incidents will be electronic and potentially impacting large numbers of records, and so this area overlaps with IT security, requiring close working between clinical and IT staff. Identification of named clinical posts as ‘owners’ of donor and patient data will help clarify responsibilities. Legal requirements may require a responsible Director and systems to deal with information governance incidents. The Clinical Governance committee or equivalent should review these at agreed intervals. The larger issue of IT failures that put the entire operation at risk is part of organizational risk management and require a corporate approach to mitigation.
Approval of release of Information/materials for research A system of approval should be in place with periodic review though clinical governance. Horizon scanning: blood services must engage in monitoring for infectious disease agents that may pose an actual or potential risk to the blood supply. The approach should be systematic, with clarity regarding who undertakes the monitoring function and escalation require© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
ments. The approach may include daily monitoring of sources that provide a rapid turnaround for information on outbreaks and threats that may require an immediate response (such as ProMED-mail), regular scanning of sources that provide information that may take some weeks to gather (such as Eurosurveillance data) and monitoring of sources based on longer term trends and developments (such as publications and strategic supplier meetings).
Benchmarking Systems should be in place to benchmark performance as a means to identify performance improvement opportunities. One important aspect is to ‘join the dots’ by ensuring that different types of information on the same area of activity are considered together. Sometimes, only weak signals are generated from single sources of data, for example clinical audits, but if combined with poor donor experience, low performance measures and poor morale in a staff survey, these can indicate that action is needed in a particular area to prevent a major clinical incident.
Incident reporting The ultimate aim of incident reporting is so that the organization can recognize recurring themes and develop solutions for reducing their likelihood. Therefore, it is critical that blood services develop a culture where reporting of incidents is praised and concealment penalized. It should be clear to all staff what the escalation process and timescales are for different types of event, as sometimes staff work diligently for too long trying to resolve a problem without the help of their managers. A useful backstop is a ‘whistle-blowing’ policy, which allows the top layer of the organization to be alerted to unresolved problems which may be affecting patient or donor care. Quality systems have ways of grading incidents and events, but such classifications may not cover all clinical possibilities. For example, the UK healthcare system defines a ‘Serious Untoward Incident’ as death or serious harm due to error, and has also produced a list of socalled Never Events which are situations where particular care is needed to prevent serious harm, for example ABO incompatible transfusion. These ‘sentinel events’ should be handled according to a specific protocol, with early escalation to the Executive/Board, involvement of the communications team in case of media interest and wide dissemination of the learning across the organization. Much learning can also come from ‘near miss’ events. All serious incidents, not only sentinel events, should be
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subject to thorough root cause analysis, in which key staff should be trained. Regular collated reports of incidents should be presented regularly to senior management teams and the Executive/Board at agreed intervals. If Board meetings are held partly in public, then such reporting should be in the open part of the meeting, although care should be taken to anonymize reports such that individual patients/ hospitals cannot be identified.
An effective clinical workforce Delivery of optimal services depends on employment of a clinical team that drives excellence in a blood service’s core business of serving patients and donors. As recruitment and retention of high quality clinical staff can sometimes be a challenge for blood services, medical staff job descriptions should be formulated to ensure their roles are attractive and add value to the organization. Joint posts with hospitals and universities provide a useful bridge to wider clinical communities. The potential for other healthcare professionals to take on day-to-day tasks should be reviewed regularly within the context of a clinical governance framework. Standard operating procedures should clearly state when a nurse/doctor/clinical scientist needs to be involved, for example in times of stock shortage, or in signing off diagnostic results. Provided a clear system is in place, signing off on other routine activities/negative results can be delegated to others. A mandatory system of continuing professional development is required to ensure that clinical staff are kept up to date, and employers must ensure sufficient time and funds are available for staff to meet these requirements. Development programmes should also be in place to ensure that clinical staff acquire leadership skills as they move into managerial roles.
Patient/donor involvement in decision making Many healthcare systems now place great emphasis on patient involvement in policy and organizational change. Having lay members on a committee or board can add value, but is not always easy to get right. There are risks of tokenism, or of appointing lay people who have strong feelings about a single issue. A better approach might be to develop donor or patient focus groups of people willing to be contacted on a range of issues.
Discussion There is no doubt that a mature system of clinical governance can drive continuous quality improvement, and provide assurance to the Board, the public, regulators,
health funders and other stakeholders that optimal outcomes are bring provided. There are, however, a number of potential pitfalls. The first is the risk of adding another layer of reporting on top of quality and performance reporting, with the same information being sent to multiple committees. This is not only inefficient, but can result in a system where data go round and round with no clarity as to whose responsibility it is to act on it. A second risk is that so much data are generated that no one can see the wood for the trees. Good analysis with clinical input and demonstration of trends over time is therefore essential, as is identification of outliers, be they laboratories or blood collection teams. This must be complemented by clear lines of accountability for remedial action. Finally, a quality culture takes time to mature, so a system to feed back key messages regularly to frontline staff is therefore essential. There are additional challenges to establishing a fully mature system. There will be some, albeit modest, extra costs for clinical audit and administrative staff, as well as senior oversight, but these can be minimized by building a data-driven culture, and instilling a sense that everyone needs to contribute to provision of data and continuous improvement. Obtaining data from hospitals, for example on blood usage is not easy, due to limitations of hospital information systems, even when there is a close working relationship between the blood supplier and the hospital. Nevertheless, blood collectors should promote the active reporting of patient haemovigilance data by hospitals to either regional or national databases, so that outcomes can be benchmarked and utilized for improvement purposes. Similarly, active engagement and promotion of patient-centred blood management programmes between hospitals customers and blood collectors may provide an avenue for data collection and assessment. The infrastructure and processes described in this paper are focussed on continuous improvement without quantum leaps in safety steps. A complementary piece of work is being undertaken by the Alliance of Blood Operators to develop a framework for risk-based decision making on matters of blood safety policy [4].
Alliance of Blood Operators (ABO) Medical Directors Group Members Alex Aquilina, European Blood Alliance, Valetta, Malta. Celso Bianco, America’s Blood Centers, Washington, DC, USA. Richard Benjamin, American Red Cross, Rockville, MD, USA. Dana V. Devine, Canadian Blood Services, Ottawa, ON, Canada. Louis Katz, America’s Blood Centers, Washington, DC, USA. Joanne Pink, Australian Red Cross Blood Service, Melbourne, Victoria, Australia. Lorna Williamson, NHS Blood and Transplant, Watford, UK. © 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
Clinical governance for blood services 9
Blood Services Scientific Writer, for assistance with manuscript editing.
ABO observer Kenji Tadokoro, Japanese Red Cross Blood Service, Tokyo, Japan.
Funding
Acknowledgements
This work was supported by funding from the Alliance of Blood Operators.
All authors contributed to the study design, generating and reviewing the results, formulating the recommendations and in production of the manuscript. The authors gratefully acknowledge Dr. Geraldine Walsh, Canadian
Conflict of interest The authors have no conflicts to declare with respect to the content of this manuscript.
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© 2015 International Society of Blood Transfusion Vox Sanguinis (2015)
4 Menitove JE, Leach Bennett J, Tomasulo P, et al.: How safe is enough, who decides, and how? From a zerorisk paradigm to risk-based decision making Transfusion 2014; 54:753–757
