The relevance of the Medical Act to the diagnostic laboratory and new technologies

In Laboratory Medicine (clinical pathology), complex processes in a medical laboratory can be dissected into many small segments starting from the request form or electronic order for obtaining the patient’s sample up to the issuing of the medical report and discussion about how these results might influence patient management. It is obvious that many of these small segments can be performed by persons who are trained for individual specific tasks, irrespective of their educational background. This situation is like the division of work in an operating theatre between physicians (surgeons and anaesthetists), nursing staff, semiskilled healthcare workers and trainees, where nobody would question that the whole process of surgery requires rigorous medical training as enshrined in the Medical Act. It is indisputable that safe medical practice requires a solid grounding in the basic sciences underpinning clinical medicine coupled with knowledge and experience of disease states. All of these attributes are relevant to physicians in Laboratory Medicine in addition to active engagement in research, development and innovation.14

Ideally, the patient’s well-being should be explicitly stated within this definition independent of financial resources and the availability of pathology services. However, there are differences in how healthcare has evolved between different nations, federations and regions. Harmonisation in healthcare such as the delegation of subtasks to certain professions should consider such differences in the healthcare systems between countries. Laboratory physicians work in collaboration with other personnel at the laboratory who are responsible for patient hospitality, sample collection, pre-analytical, and postanalytical and analytical phases of sample management and provide their medical expertise to the whole process. Reliable laboratory results are the result of complementary interaction between physicians and non-medical biomedical scientists/technologists in the medical laboratory. Heterogeneity and cost constraints in healthcare systems in different countries result in differences in the role of these professions.9 However, in many countries, it is the clinical pathologist who carries ultimate responsibility for provision of a high-quality service, with some countries legally mandating this.

In recent decades, technological advances have transformed virtually all fields of medical practice, bringing with it an important role for scientists, physician assistants and IT specialists. These developments contrast with the historic context of the Medical Act with its pre-eminent role for physicians responsible around the clock for patients with very little assistance from co-workers.13

These changes in the perception of medicine as a vocation to that of a commodity are also calling into question the Medical Act, notably challenging the grey zone between qualified and non-qualified practitioners from a medical perspective. Why should the patient see a physician to get an ultrasound when they can go to a physician assistant trained specifically in sonography? Why should the patient see a radiologist to get a CT scan when a radiographer can perform and email the image files for interpretation to a call centre somewhere else in the world? Why should the patient see a cardiologist when the smart watch (‘wearable’) or the smart phone automatically interprets his or her ECG? It is without doubt that some simple, brief and clearly defined processes of the Medical Act such as performing routine vaccinations, administering certain drugs (eg, analgesics for headaches) or taking the blood pressure can be delegated and even substituted by non-physician professionals. The delegation of these Medical Acts poses only a very limited risk for the patient once proper processes to ensure oversight are in place; as a result, the employer’s liability insurance will usually cover the risk of the non-physician healthcare professionals. Directive 2001/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare states ‘systems of professional liability insurance, or a guarantee or similar arrangement that is equivalent or essentially comparable as regards its purpose and which is appropriate to the nature and the extent of the risk, are in place for treatment provided on its territory’. As a result of this, all UK state registered professional groups must have indemnity insurance though some state registered professional groups have had difficulty in obtaining such indemnity insurance for private practice independent of physicians or hospitals with physicians.15

The relevance of the Medical Act in clinical pathology is particularly challenged by these new developments. The situation gets even more complicated since the complexity and the volume of testing differs markedly between laboratories. While the level of direct intervention by the clinical pathologists in many cases is not as prominent as in the example of surgery and the personal contact between clinical pathologist and patients in most cases is indirect and often invisible to the patient; nonetheless, laboratory physicians play an important role in improving clinical outcomes for individual patients16 (box).

Developments in IVD marketing have led to direct selling to physicians and also to consumers (direct-to-consumer testing, DTC).17 As a result, IVD diagnostics could potentially be performed by non-qualified practitioners or even by lay persons in the future if there are no regulations concerning the professional qualification of staff employed by laboratories. The patient could just submit his sample to any laboratory for testing. Consequently, in some laboratories, Laboratory Medicine would no longer be a part of healthcare as we know it. The medical aspects of oversight and interpretation would be removed and only an analytical service would remain. The most prominent example of DTC was Theranos, a company that tried to revolutionise the US market for Laboratory Medicine by testing capillary samples drawn in the neighbourhood pharmacy and transmitting the test results directly to the patient.18 It is worth noting that Theranos received sanctions from the Centers for Medicare and Medicaid Services in July 2016 including the revocation of its Clinical Laboratory Improvement Amendments certificate and prohibition of the owners and operators from owning or operating a laboratory for 2 years for multiple deficiencies, including producing inaccurate results.19 While some believe that the regulatory framework is too lax in the USA,20 it is noteworthy that some countries such as the UK have no specific laws or regulations governing the ownership of a laboratory (with the exception of blood transfusion and embryology), requiring only registration with the devolved national independent regulator of health and social care services.

This argument, however, focuses only on a few selected aspects of analytics and does not consider the whole complex process associated with IVDs. This whole in vitro testing process has been aptly conceptualised as the ‘brain-to-brain loop’21: this loop covers the entire process from obtaining the patient’s sample to selection of appropriate test(s) and through to the analytical and postanalytical processes, including interpretation, which then contributes to patient management—all key elements described in the Medical Act. In addition, there are legal issues which prohibit delegation of certain tasks in clinical pathology to non-qualified practitioners or lay persons: blood transfusion, genetic testing22 and investigation of contagious diseases in most countries are restricted to physicians only and certain diagnostic kits can only be obtained by a physician’s prescription.

The consequences highlighted here of unfettered marketing of IVD have parallels with indiscriminate testing across medicine. By their training, physicians in Laboratory Medicine are well placed to address these issues by ensuring provision of appropriate test repertoires, guiding test selection and audit, thus ensuring cost-effective use of finite resources.23–25

Personalised medicine and patient autonomy

Closely related to DTC testing are proposed initiatives from the EU legislation to empower patients by direct transmission of results. This is done in the context of P3 medicine (predictive, personalised, preventive), a concept, however, which to date has had only limited success. Extension of this view to include active participation of the patient would lead to the concept of P4 medicine (predictive, personalised, preventive, participatory), which is likely to have a greater chance of success. It also lends itself to salutogenesis, an approach focusing on factors that support human health and well-being, rather than on factors that cause disease.26 27 The concept of P4 medicine heavily relies on technology, big data and on social networks for commenting on the data of consumers (the word patient is avoided intentionally) by peers in the general public. An immediate challenge to conventional thinking is the difference between classical laboratory medicine which could be called decision diagnostics (figure 1) and the concept of big data which focuses heavily on statistical associations. The imminent danger of false interpretation of health data is obvious. The P4 medicine concept is based on the idea that the patient collects his data in a data cloud to be used effectively to optimise wellness and minimise disease.26 The consumer/patient is not left alone, without professional help. Supporters of P4 medicine see a strong requirement for trusted interpreters of these data clouds for each patient,26 in regard to laboratory testing and the correct interpretation of IVD results. This interpretation should ideally be done soon after the analytical step since the release of raw analytical data (ie,the uninterpreted test results) may pose a risk to some patients28: for a very limited number of tests such as blood glucose in diabetics with self-monitoring29 or luteinising hormone-based ovulation tests—classical DTC, the interpretation of laboratory results can be done by patients themselves. However, for most tests, medical interpretation should ideally be done either by a physician such as the clinical pathologist (especially for more complex laboratory tests) or, for basic tests, by the attending physician (figure 1) rather than by individuals without appropriate training such as a ‘healthcare and wellness’ coach.26 28–31

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Figure 1

Laboratory testing is pivotal at numerous time points during a single patient episode. The laboratory reports of clinical pathologists of (mostly) panels of laboratory tests as well as the results of single tests in point of care testing (POCT) and direct-to-consumer testing (DTC) are used for necessary medical decisions by the general practitioner (GP) as well as from the outpatient (OP) and inpatient department (IP) of the hospital. The patient-specific selection of the best suited biomarker as well as the medical interpretation of the test results relies heavily on medical knowledge.

Focus on medical interpretation instead of analytical evaluation

With the exception of very few tests mentioned above, it is obvious that all other tests need medical interpretation, both in patients and in consumers.28 Medical interpretation goes far beyond flagging up a result outside defined reference ranges and, as a part of the Medical Act, should be done by a physician.1 In the ideal world, this physician should know the limits of the analytical phase (ie, the testing process) and should be experienced in the consequences of a certain test result, in the context of other diseases, certain therapies and in the clinical course of the disease. It is debatable whether this task is better done by a medical laboratory specialist who subspecialises in certain areas of clinical pathology (such as endocrinology or blood coagulation) or by a generalist covering all subjects of in vitro testing (ie, haematology, clinical chemistry, immunology, laboratory genetics and often microbiology).1 In our experience, depending on the local situation both specialists and generalists can give adequate advice to requesting physicians and patients. From the patient’s perspective, proliferation of subspecialties in clinical pathology could potentially be confusing in contrast to having unified advice from a generalist. In certain situations, however, in particular in very complex patients, the expertise of two or even more laboratory specialists is likely to be in the best interests of such patients. It is not unusual for specialist clinical scientists and biomedical scientists/technologists to participate in clinical rounds and share their advice, like nurse consultants or pharmacist consultants. In hospitals with clinical rounds, there is a long tradition of sharing knowledge between different professions with mutual respect. However, in these clinical rounds, the final responsibility as envisaged in the Medical Act for integrating advice given by non-medical specialists and consequent management decisions remains with the attending physician.

The biggest evolution in the laboratory over recent decades has occurred in the supply of robust tests, technologies and instruments: huge improvements in instrument design together with the successful standardisation of reagents and instruments allow IVD companies to offer nearly perfect diagnostic systems for most areas of the clinical laboratory. Because of these rigorous improvements in the analytical process, many technical chores such as the preparation of reagents or tedious adjustments of instruments regularly performed in the laboratories in the past have been transferred to the IVD companies. With the widespread use of CE-marked or equivalent reagents, problems associated with assay verification are less frequent than previously. In addition, a wide array of improvements in the pre-analytical processes (such as electronic orders, diagnostic pathways, barcode coding of primary samples, robot-assisted aliquoting, permanent temperature control of reagents and samples, automatic checks for clots, haemolysis, lipaemia and icterus),8 analytical processes (in particular by using highly standardised techniques with low intra-assay and inter-assay variation) and postanalytical processes (such as autovalidation and sending reports electronically directly in the health record) have occurred in the last years.32 These improvements enable clinical pathologists to spend less time with analytical processes and assign most of their time to being a partner to treating physicians (and to patients) for selecting and interpreting laboratory tests and advising on appropriate therapies. Extensive practical and theoretical medical expertise is essential for these tasks, which is reflected in recent modifications to the curricula for clinical pathology in different European countries, with a special focus on medical knowledge and practical experience, in particular in Internal Medicine and laboratory management skills rather than on analytical techniques.33

Patient versus customer

Justifiable moves to empower patients have led to a change in the dynamics of the doctor–patient relationship, with the patient frequently being regarded as a consumer. This has led to the promotion of inexpensive appliances such as smart watches and fitness trackers (wearables) capable of monitoring physiological data previously only accessible by sophisticated medical equipment under medical supervision. The overall value of these wearables is currently under intense discussion. Notwithstanding possible benefits in the context of P4 medicine, self-monitoring contains the risk of potential harm.34 For example, in diabetics, intense self-monitoring has been shown to increase depressive symptoms.35 In addition, sophisticated regulations safeguard the patient but not the customer. In general, the patient–physician (such as a clinical pathologist) relationship is based on trust. For example, the patient can rely on very high levels of data protection regulated by the declaration of Geneva. On the contrary, the relation between a customer and a vendor (such as the vendor of DTC tests) is markedly influenced by competition, the law of the marketplace and even the interests of others, such as buyers of consumers' health data (‘big data’).26 36 In this context, consumer rights are often used as false pretences to eliminate essential barriers currently present in healthcare. Instead, many perceived or apparent restrictions of trade may be necessary to guarantee quality and competence. For example, one important aspect of healthcare performed by clinical pathologists is the obligation to use only tests with proven medical value,2 37 in contrast to the many unvalidated lifestyle tests that are offered to customers (quackery) without regulatory control.

Direct access of patients to bioanalytical specialists (non-medical laboratory specialists)

In the interests of empowerment, it has been proposed that patients should be able to obtain laboratory test results directly without the involvement of physicians, with efforts to allow non-medical laboratory specialists direct access to patients in the outpatient setting.30 However, offering patients bald numerical values without appropriate individualised clinical interpretation of results is counterproductive and could be considered to be unethical.28 38 In this setting, the patient’s safety would rely primarily on the medical knowledge and medical skills of the non-medical laboratory specialist, an obvious oxymoron. The safeguards to patients of the Medical Act are further compromised when considering the type of clinical sample for analysis. Except for saliva and urine testing, potentially risky and or invasive sampling (like phlebotomy, bone marrow aspiration or a spinal tap) precedes the testing process. For this reason, most countries stipulate that clinical samples for analysis should only be performed by a physician or under a physician’s supervision.

Substitution of clinical pathologists by bioanalytical specialists

If fundamental elements of the Medical Act in Laboratory Medicine to be carried out by non-clinical pathologists,30 then a rigorous system of standardised, supervised and structured training complemented by formative and summative assessment of competencies would be required to ensure patient safety. In fact, the possibility of clinical training for non-medical laboratory specialists is under intense discussion. To overcome the current lack of necessary knowledge and skills in non-medical specialists in the pre-analytical and postanalytical phases, a separate graduate programme for Laboratory Medicine might be an option, like the brief human medicine curriculum taught in dentistry to provide assurance that the required theoretical and practical skills have been obtained. However, unlike with dentistry which has a limited interface with medicine, Laboratory Medicine is integrally involved in decision-making across Internal Medicine and related subspecialties. For a non-medical specialist to be accepted as an equal peer by other physicians, the clinical training should be at a similar level of competence as that obtained by physicians in Laboratory Medicine. The challenges of doing so should not be underestimated given the statutory length of undergraduate and postgraduate training required for attaining competence by specialists in Laboratory Medicine in the EU.10

In a multifaceted and innovative specialty such as clinical pathology, continuing professional development (CPD) or continuing medical education (CME) is a crucial plank of patient well-being: physicians are obliged to participate successfully in life-long learning CPD-CME programmes both to ensure high standards and their fitness to practice in medicine. These unique CPD-CME programmes are well structured with standards in regard of content (both covering clinical leadership and specialty knowledge) and conflict of interest.39

In some countries, participation in an appropriate and accredited scheme is a legal requirement for registered doctors,40 including physicians in Laboratory Medicine, with statutory consequences for those who fail to comply. While this requirement for mandatory participation is not universal for non-medically trained laboratory specialists, it is clear that the trend is definitely in this direction.

Therefore, current efforts to develop curricula for non-medical laboratory specialists should take into account the wide-ranging knowledge base and interpretative skills required for these individuals to function independently as effective substitutes for physicians. Political pressures to use free movement of professionals across the EU to plug workforce shortfalls should not be used as an excuse to dilute the rigour of training.