Role of laboratory medicine in collaborative healthcare

Introduction

A high percentage of all clinical decisions are influenced by laboratory medicine results. Therefore, specialists in laboratory medicine have a professional responsibility to facilitate optimal use of the laboratory [1]. Collaborative healthcare occurs when health workers from different professional backgrounds provide comprehensive services by working with patients and carers to deliver high-quality care across traditional settings. Collaborative healthcare adds a new dimension to the responsibility of specialists in laboratory medicine.

Patient-centered health care as a concept has been recognized for some time. However, a recent opinion paper asserts that information and technological revolutions have increased patients’ engagement such that practice in future will be based on collaboration between patients and the healthcare team [2]. The new paradigm is enabled by online health activities, including making appointments, repeat prescription requests and accessible healthcare records. Three core principles have been proposed: shared information, shared engagement and shared accountability [2]. There is evidence that such an approach improves patients’ ability to manage their health and are better informed [3]. Clarity is needed on accountability and responsibility as personal health records have legal implications [4].

What are the implications of collaborative healthcare for laboratory medicine? In the DECISIONS survey of patients’ decision making for three cancers, it was found that although patients considered themselves well informed about screening tests, the reality was different with most patients failing to meet the criteria for being informed [5], and those with poorer education and income were less able to appreciate information [6]. This highlights a need for better patient knowledge, perhaps addressed through enabling more patient-orientated informatics [7], but also an understanding of the limits that some individuals will face. The robustness of such systems, effective data-exchange, privacy and security and use of data for public health will all need consideration [7].

The comprehension of test results by patients is linked to numeracy and literacy [8]. Understanding is improved by using pictorial and color formats [9]. Such outputs may assist the understanding of a personal result in the context of population values, but they do not convey an understanding of the significance of the result as a health indicator. Such a role is the traditional responsibility of that patient’s physician, as the individual that has the contextual health information.

Pressures on physicians, especially in primary care, challenge their ability to cope with more time-consuming patient enquiries to facilitate accurate understanding [10]. The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Patient Focused Laboratory Medicine (WG-PFLM) has found a willingness by appropriately qualified specialists in laboratory medicine to provide direct support to patients [11] and that some patients would be willing to receive interpretation from such a source [12], provided this was done in conjunction with their physician.

There are examples of laboratory medicine embracing patient-centered care, including an authoritative resource for patients and physicians, which is moderated by the global profession [13]. Self-testing in a system overseen by laboratorians has been shown to be successful for patients with long-term needs such as those on warfarin [14] or diabetics [15]. However, if laboratory medicine is to help to deliver collaborative healthcare, it needs significantly greater engagement with patients and with their clinicians. Tripartite collaboration is the new dimension of responsibility for specialists in laboratory medicine.

This article suggests ways in which laboratory medicine support may be provided to patients and clinicians, in both primary and secondary care settings, to develop tripartite collaboration. It also considers the information required by managers of laboratory medicine services to support collaborative healthcare and emphasizes the growing importance of point of care testing (POCT) and new sources of information. The approach adopted in the article is summarized in Figure 1.

Figure 1:

Knowledge management roles contributing to collaborative healthcare.

The contribution of specialists in laboratory medicine to supporting tripartite collaborative healthcare is depicted in the boxes labeled “patient” and “clinician”. The information required by managers of laboratory medicine services to enable their support for collaborative healthcare is depicted in the box labeled “manager”.

Supporting the needs of patients

In 1978, the WHO adopted the recommendations of the Alma-Ata Declaration [16], including “that people have a duty and a right to participate individually and collectively in the planning and implementation of their health care” and that primary health care “requires and promotes maximum community and individual self-reliance … and develops through appropriate education the ability of communities to participate”. Implementation enables patients to have accurate and up to date information about their health so that they can become partners in their treatment and make informed shared decisions with clinical colleagues.

Patients do not form a homogeneous group. We are all now being encouraged to take more responsibility for our own health. However, many patients live with several chronic lifelong conditions and must learn to self-manage [17].

Information about the illness must include information about pathology and laboratory medicine tests. This means that patients need to have general information about work in a lab, what investigations are carried out there and where they can get information so that they can fully participate in the management of their illnesses.

For patients to be involved in their own care, they need to know the following:

• What investigations or tests are being suggested?

• What are these for and which illnesses can they identify?

• What are the limits of such tests or are they definitive?

• Have they been asked to consent to all possible investigations? This is particularly important if the illness is serious. Consent needs to consider what is important to the patient [18].

• How is the test interpreted? Including an explanation of measurements and risk [19], [20], [21]

• How long do results take? This may vary from area to area and country to country, but it may also depend on the time needed for the culture of the specimen.

• Who is responsible for giving patients the results?

Patients need to be helped to understand the language used in the explanation of test results. For example, what does “normal” mean? Is this normal for the individual patient, normal for the population? Good practice would suggest that the patient is told of the actual reading/result rather than just a description [13] or possibly both. This also includes giving a negative result, especially since research has shown that it is important to patients to know results even when they are negative [22].

Shared decision making is best achieved through health care professionals both sharing with and discussing with the patient their medical records. This ensures that the patient is part of the team and has a contemporary record of dates of diagnoses of illnesses, investigations carried out and the results, treatments and medications [23]. In the electronic era, this is neither difficult nor costly.

Specialists in laboratory medicine should respond to the needs of patients by

• Providing educational support, including information on reference intervals, result interpretation and managed POCT

• Implementing agreed policies and practices on patient-centered care, shared decision making and access to the laboratory.

Supporting General Practitioner (GP) users of laboratory medicine services

GP practices are now able to offer online services that are quick, easy and secure [24]. This enables patients (and or their carers with appropriate consent) to book or cancel appointments, order repeat prescriptions, view parts of their GP electronic health record including test results and view clinical correspondence. In the UK, this is a free service for patients and is available to everyone who is registered with a GP. However, take up by patients is typically less than 1%, although in the practice of a co-author of this article (AH), 60% of patients can currently view their whole electronic health record [25].

These online services offer opportunities for GP practices to

• Support the understanding of the healthcare needs of individual patients and their carers

• Know what their doctor, nurse or other health professional is saying

• View results as soon as they become available

• Improve shared decision making

• Improve the partnership of trust between patient and clinician

• Empower patients to be more in control of their health and take greater responsibility for their own health

This approach could lead to improved quality of care and patient safety. Educating patients and carers to understand test results can reap rewards [26]. However, GPs have fears too, including risk of litigation, increased workload, poor understanding of what the benefits may be and risks related to privacy and confidentiality [27].

“Responsible sharing” has been advocated to improve further uptake of online services in a GP setting. This entails the following:

• A robust, explicit consent process that ensure patients understand the risks and benefits and helps them to know what the service involves. Patients need to be able to view their records and understand them [28].

• A support service so that patients know who to turn to for help for technology problems and for clinical problems. An active Patient Participation Group helps with this.

• Building practice-based resources for patients and staff to help understand the practice records better and healthcare needs [29].

• A different kind of conversation with patients, which encourages greater use of online services to help manage their care and explore the use of IT as part of the care process during the consultation itself where the Partnership of Trust is formed [30].

• Reporting tools that help to inform when online services are used and by whom and identify when problems arise – continuous learning must be part of the process of quality improvement.

• Funding for the change management and ongoing support to enable far greater usage of online services. Providing exemplar sites will help to identify possible solutions and provide examples that others can learn from and share too.

There is a key role for specialists in laboratory medicine in helping GPs to develop and deliver “responsible sharing”. Support may include the following:

• Educational resources aligned with that available for patients

• Reporting tools and online services

• Access to interpretation and clinical liaison

• Managed POCT

Supporting hospital clinician users of laboratory medicine services

Hospital clinician users largely determine the repertoire of tests and investigations offered by a laboratory medicine service and so are major stakeholders in collaborative healthcare. Factors influencing the repertoire include the specific clinical specialisms supported and the balance between acute and non-acute clinical services. Optimization of service provision to hospital clinicians requires that specialists in laboratory medicine develop close working relationships with the clinical leads for each specialism. Such collaboration will facilitate repertoire modernization and lead to joint proposals to increase the value of laboratory medicine to patients [31].

As part of tripartite collaboration, the clinical laboratory should consider methods of service delivery. Supporting POCT provision in acute medical receiving (A&E), the intensive care unit (ICU) and the clinic can enable a quicker delivery of patient results than the central laboratory can provide.

Hospital clinicians expect clinical laboratory results to be delivered to a high level of analytical quality. However, they do not always appreciate the importance of the pre-analytical phase, over which they have control, as a component of quality [32]. They are unlikely to appreciate that between-method variability may compromise the transferability of results and the local application of national clinical practice guidelines. The importance of method harmonization [33] and traceability in laboratory medicine [34] should be communicated to hospital clinicians by specialists in laboratory medicine as part of collaborative healthcare.

Senior hospital clinicians will have a good understanding of the clinical relevance of laboratory results in their specialism. However, junior doctors and other healthcare workers may require support with the interpretation of results. That support may take several forms, including interpretive comments on reports, telephone alerts from the laboratory and the availability of laboratory specialists to discuss results on demand. There is evidence that interpretive support improves the timeliness and quality of diagnosis [35]. The details of interpretive support should be agreed between the clinical laboratory and its hospital clinician users, such activity is a core competency [36]. There is a need for agreement as to the consistency with which this is delivered [37]. One specific area where the laboratory should be proactive is in critical results management [38].

Effective communication is the key to optimizing the working relationship between the clinical laboratory and its hospital users. As part of collaborative healthcare, specialists in laboratory medicine should seek to be part of multidisciplinary clinical teams or networks [39] that can agree policy and practices, review case studies, agree the implementation of clinical practice guidelines, support clinical audit of the available service and consider development and research opportunities.

The importance of managers of laboratory medicine services

The generic term “manager” is used to describe the individual or group responsible for the governance, commissioning and business management of laboratory medicine services in the host institution. Managers are unlikely to have a background in clinical laboratory services and so may not appreciate the importance of laboratory medicine in collaborative healthcare. Managers are not full stakeholders in the tripartite collaboration, but their involvement is vital because they have a role in overseeing the laboratory medicine services required to deliver collaborative healthcare. Therefore, effective communication and partnership working with the head of the laboratory medicine service is essential.

Laboratory medicine service provision varies considerably across the world [40] in terms of service specification, delivery systems and reimbursement models [41]. The implementation of collaborative healthcare will require even greater flexibility and devolved responsibility, and a key joint decision for the manager and the head of laboratory medicine service is to agree the detailed service specification, considering the needs of all stakeholders, and to keep this under review through regular clinical audit.

As part of his/her governance role, the manager will require evidence of quality across the spectrum of the laboratory medicine service. The accepted international standard of quality is accreditation in line with the requirements of ISO 15189:2012 [42]. Therefore, joint agreement is required to maintain, attain or work towards laboratory accreditation within a defined timescale as part of the laboratory commitment to collaborative healthcare.

The clinical value of the laboratory medicine service (clinical effectiveness) is a high-profile topic with growing importance for the “appropriateness” of testing, or “utilization management” as it is termed in North America [43]. Both overutilization (too many inappropriate tests) [44] and underutilization (too few appropriate tests) occur with the latter at least as important as the former [45]. Management decisions, such as changing the hospital test request panel, can have a significant impact [46]. To address this topic in a rational manner, a “value proposition” [31] and a “value framework” have been developed [47]. These value tools may facilitate management support for collaborative healthcare.

The manager will require reassurance about the operational efficiency and cost-effectiveness of the service. These may be influenced by national policy. Increasing adoption of LEAN principles can provide evidence of improving operational efficiency [48], and there is a least one independent national benchmarking service for laboratory medicine [49]. Cost containment measures may include competitive tendering, shared facilities across laboratory medicine, laboratory networking and matching staff skill mix to the required functions. As part of collaborative healthcare, managers and the clinical laboratory lead have a role in enabling innovative usage of the service to improve both clinical outcomes and cost effectiveness. An example is the use of high-sensitivity troponin to improve the management of patients with acute coronary syndromes [50].

Managers are currently overseeing the consolidation of laboratories that is occurring across the globe enabled by technological advances. The result is core laboratories linked to satellite laboratories, typically a hub and spoke arrangement with increasing use of managed POCT. The outcome is expected to be more cost-efficient and no less clinically effective. Such reconfigurations have the advantage of providing a more harmonized service, which benefits collaborative healthcare.

In summary, the manager may not be a full stakeholder in the tripartite collaboration but he/she has a major supporting role in its delivery.

The growing role of POCT

POCT is developing rapidly [51] and will play an increasing role in patient-centered care [52] as part of collaborative healthcare. POCT is useful for immediacy; ensuring maintenance of the necessary standards of analytical and pre- and postanalytical quality is a significant challenge given the disseminated nature of POCT. Regrettably the focus in the literature is principally on the analytical performance and speed of POCT, with little on impact on patient outcomes [53], although evidence for its effectiveness and comparability indicates that with appropriate training, quality procedures and oversight, it is effective [54]. The economics of POCT compared to laboratory-based testing are complex [55]. A randomized controlled trial has revealed patient satisfaction with POCT in general practice [56], and patients and healthcare workers perception of improved access to diagnosis a dengue fever outbreak was improved by using POCT [57].

Managed POCT for blood gases, glucose and electrolytes is well established in hospital A&E and ICU departments and is a good example of collaborative healthcare. Access to investigations for patients in remote and rural areas, where access to activities is poor due to distance or lack of resource, is made possible using POCT [54]. The key to POCT is that it be performed within a quality environment conforming to ISO 22870 [58]. Maintaining quality through quality assurance schemes has been successful; these may be developed locally, regionally or nationally through laboratory medicine departments. Commercial POCT suppliers also provide schemes with reports back to local organizers.

Diabetic patients and those on INR anticoagulation have self-tested successfully using POCT for many years as part of their health management with professionals. There is increasing marketing of self-test POCT for a range of disease markers as well as genomics. This area of testing is unregulated and not subject to professional oversight, so there are neither quality systems associated with use nor authoritative advice on what the results mean posing risks of either complacency in the event of a false-negative result or undue concern in the event of a false-positive result. Therefore, medical professionals have called for regulation [59].

In short, POCT has potential for providing rapid results and can be clinically safe used in a quality assured environment; POCT is useful in patients that are remote from or reluctant to engage with central health care. Specialists in laboratory medicine have a responsibility to facilitate the rational use of POCT as part of collaborative healthcare.

Sources of available information and support

Understanding the clinical significance of a laboratory test result may be challenging, even for healthcare professionals. Specialists in laboratory medicine are expected to help, but training in clinical interpretation is not always a priority in training curricula, as it should be. Participation in external quality assessment schemes for interpretive comments can assist as part of continuing professional development [60].

Patients generally rely on their clinician to provide information on test results [11], although increasing numbers of patients with chronic disorders can interpret their test results as part of self-management. A range of information sources may be used. A survey in Germany in 2012 listed the following: pharmacists 34%, internet and print 74%, mobile apps 18%, physician friends 41% and television 54% [61]. There is no guarantee that these sources provide correct, relevant information; the internet and mobile apps as self-generated queries provide no quality criteria as to the information provided.

Lab Tests Online was launched by the American Association for Clinical Chemistry and has now been disseminated and customized to local needs in over 17 countries in 13 languages [13]. More general sites also exist; some are government supported, e.g. NHS Choices [62], others are commercial, e.g. e-Santé [63].

The EFLM WG-PFLM has identified nearly 40 mobile apps that utilize laboratory medicine data to provide either data handling or advice, the latter ranging from reference ranges to health monitoring. The effectiveness or otherwise of such sources is unevaluated, although publications on their potential are optimistic. Apps can link with other devices; some wearable devices offer the possibility of continual monitoring of parameters of interest.

There are attempts to develop standardized interfacing for substitutable web applications such as SMART that can retrieve a range of data, including laboratory results [64]. This will be key to ensuring seamless data exchange.

Reinforcement or advice can be provided through professionally mentored Skype or Google groups. Full record access and interaction through a smartphone is now available in a range of countries [12]. The growing popularity of such approaches would seem to attest to user satisfaction, but whether there is an effect on outcomes remains to be seen.

The above developments are general rather than patient specific, as the section on GPs reveals personalized support can be available. As part of collaborative healthcare, specialists in laboratory medicine have a future lead role in working with clinicians and other healthcare workers to provide such personalized support, which is likely to be acceptable to patients [11], [12].

The way forward

It is some 40 years since the Alma-Ata Declaration [16], and there is now the real prospect through technology and the awareness this has caused that individuals are more able than ever to take ownership of their health and the associated records; how this may be best achieved is still the subject of debate [2].

An illustration of this direction of travel may be seen at the integrated, managed care consortium, Kaiser Permanente^® in the USA, where for the first time the number of virtual visits with providers, using telehealth, has surpassed the number of face-to-face appointments [65]. Also in the USA, huge investment into telehealth means that hospitals and nearly 80% of office-based practices use certified electronic health records. Most providers can share health information between systems, and 87% of patients report having access to their electronic health information [66]. However, the full support of clinicians is still required to realize the benefits of this technology [67]. This latter point reinforces the need for collaborative healthcare.

National solutions will vary, but all are focused around electronic health records as well as being key to cross-border health initiatives. Although patients having access to their records is progressive, the challenge is clearly to ensure that they comprehend the significance of the data. Although the issues of literacy and numeracy [8] impinge on understanding and the adoption of graphical and color coding provide indicators of significance [9], there remains the need to understand what test results mean to that individual.

In considering personalization of information, the legal and ethical issues need to be carefully considered in the context of the legal framework that pertains. It is particularly important to recognize patients’ comprehension of why and what investigations are being done and what they mean to them is effectively addressed [18].

The constraints on clinicians of available time and resources present a challenge should their patients become more engaged with their healthcare, but suitably motivated practitioners can provide online individualized access [26].

Effectively, the route to understanding for patients is education. The responsibility of healthcare professionals is to facilitate this as part of the wider concept of the “partnership of trust” [30]. The added value that specialists in laboratory medicine should add [1] is through knowledge management that is directed at patients, clinicians and managers. For patients, there seems to be a willingness to embrace this [11], [12], and specialists in laboratory medicine have specific knowledge to help patients understand their results. Additional effort and structures would be necessary to reach out beyond the healthcare framework where patients are self-testing [15].

Examples of these knowledge management roles are summarized in Figure 1. These will be new to many specialists in laboratory medicine, and so there are implications for the content of training curricula, with the inclusion of practice-based training beyond the laboratory. International harmonization of these knowledge management roles should be a target, and a move in this direction would be for all international organizations involved with laboratory medicine to adopt the promotion of collaborative healthcare as a strategic priority area. This will facilitate continuing professional development opportunities at local, national and international level with patients, clinicians and specialists in laboratory medicine sharing good practice at clinical and scientific workshops, symposia and clinical guideline writing groups.

Progress in engaging in the tripartite partnership of trust, patient-physician-laboratory specialist, will require clear understanding of the aims and limitations of such a relationship. There is a real opportunity to create a meaningful paradigm shift in the understanding of patients, GPs and hospital clinicians with the benefit of repositioning laboratory medicine as a more outward-facing profession.