Clinician test choice

The ethical duty of a pathologist is distinct from other patient-facing specialties. It goes beyond the patient’s physical being to the very basis of life and humankind—organs, tissues, cells and genetic material. As physicians, pathologists share many of the same ethical duties as their patient-facing colleagues, but there are differences that have yet to be explored and need to in order to further investigate their role in the healthcare system. In their unique moral position, pathologists and laboratorians serve as a guardian of patient data, a fiduciary consultant in patient care, a steward for shared resources and an advocate which, when taken together, support the assertion that pathologists and laboratories have the ethical duty to share their expertise in an attempt to improve clinician test choice, test interpretation and test utilisation at the system level.

All members of the patient care team are guardians of patient data and fiduciary consultants; but pathologists, in particular, deal with some of the most protected patient information—raw genetic data, and it is their safe, informed analysis that yields an intelligible report to guide patient care. Additionally, as a fiduciary consultant, the pathologist has the duty to make the most accurate diagnosis—just as any physician does, but the pathologist–patient relationship’s unique unidirectional flow of communication and inability to participate in the psychosocial aspect of medicine makes their moral position particularly vexing. The psychosocial conversations that would benefit the pathologist or laboratory director might include conversations about coverage of laboratory tests and provider-performed microscopic analyses, ethnic or cultural beliefs surrounding communication of dire medical results, and some of the challenges faced by pathologists in this position have been explored, but in general, the ethical challenges all come down to the particularities in how communication is mediated in the data garnered from patient’s pathology report that includes a whole spectrum of information ranging from laboratory test values to biopsy reports.3

Their third role as a steward of resources becomes vital when, on a health system scale, clinicians do not properly understand the utility of various clinical tests leading to result misinterpretation or inappropriate/unneeded/dangerous ordering of tests. In their role as a steward, pathologists have the duty to engage with their patient-facing colleagues in an attempt to decrease unnecessary costs to the patient and healthcare system which is why there needs to be enhanced focus on education, communication with clinicians and active intervention. These materials should be based on the statistical viability of screening and testing methods but must be continually updated and even researched at the health system level to gain better insight into community-specific diagnostic and screening needs.

A particularly challenging moral and economic position for the pathologist is the role as a diagnostic commodity. This position has been extensively debated in the pathology community and understandably so.4 5 However, the pathologist, unlike other physicians, is the physical entity delivering the final diagnosis in addition to participating in patient care through suggesting the next best steps in treatment. This puts the pathologist in a difficult situation. Their ability to look at a histological slide and diagnose a patient’s condition is indispensable and cannot be replaced by another specialty or a machine. In this sense, the pathologist is a commodity, but unlike those who argue against the commoditisation of pathology, embracing the indispensable nature of the profession could lead to an enhanced presence in health policy, for without pathology and laboratory medicine, a hospital and health system could not deliver any safe and effective patient care.

Taking into consideration the moral obligations pertaining to diagnostic expenses, test utilisation and the intricacies of serving as a diagnostic means and an end, laboratorians must properly communicate the importance of the field, interpretation of laboratory results and their role in patient care. Not only does this communication fulfil the final moral position as an advocate, but it also helps address the aforementioned challenges of clinician test choice by breaking the barrier between the clinic and the lab. However, the role of advocacy should go beyond communication with fellow medical professionals and into the public sphere. In order to address the systemic issues plaguing the pathology community, there must be continued advocacy for the profession and for their patients. The most pressing of which would be advocating for a voice in hospital programmes that involve the development of just healthcare practices involving diagnostic laboratory services.

Quality improvement in the laboratory

In addition to attempting to educate improved physician test choice, laboratories continually strive to improve financial margins to help distribute the limited resources across a broader patient population. In part, this continual improvement is born out of the duty to improve patient care, but it has also been necessitated by unfavourable investment in the field and stagnant or declining reimbursement schemes.6 Without altering the current healthcare system in the USA, reimbursement for pathology services is largely determined by (1) the payment schedules determined by the Centers for Medicare and Medicaid Services (CMS), (2) the number of pathology services absorbed by the hospital as a factor of the number of uninsured patients seeking care at the facility who cannot afford to pay their bill, and (3) the availability of the requested test at the facility.7 8

The CMS reimbursement schedules for pathology and laboratory services have been either stagnant or declining in recent years, leading to laboratories having to handle a growing number of complex cases with declining reimbursement for said cases.6 As a result, laboratories have become some of the ‘leanest’ departments in the hospital—continually striving to decrease the margins in order to care for more patients with fewer funds. The duty to improve efficiency is not unique to the field of pathology and laboratory medicine. In fact, many healthcare ethicists including Paul Menzel and Jon Tilburt have written extensively that efficiency is not only a goal for medical care but a moral obligation.9 10 This moral obligation cannot be understated in diagnostic medicine as it has the ability to dramatically alter the cost of patient care as well as the distribution of diagnostic care at the health system or even the national level. The second issue pertaining to cost is also addressed by the quality improvement and lean projects in the laboratories, but the more pertinent factor in the hospital absorption of uninsured patient laboratory bills would be more effectively addressed at the clinician level with fewer unneeded tests and statistics-based, data-driven lab test ordering. At this point, the final check on proper test utilisation is on the pathology and laboratory medicine department. Many pathology departments have taken it on themselves to be good stewards of healthcare dollars by implementing mechanisms to triage testing. At the outset, this seems counterintuitive, since limiting testing (to only appropriate tests) reduces revenue for the pathology. However, appropriate testing leads to happier patients and a leaner system with the technical and professional allowance to provide more appropriate testing without burdening existing systems. This is also important as without such committees and triage procedures in place, hospitals often need to cover the expenses of tests that are deemed unnecessary by the payer or not covered by the in-hospital payment (ie, diagnostic-related group coverage). These bills become the responsibility of the department of pathology, since they handled the specimen and sent out the test. Accountable Care Organizations determine what is needed for a particular ‘service line’ in medicine (eg, hip replacement surgery). This determination is optimally done with all interested parties at the table, including pathology and laboratory medicine. Clinicians are then held responsible for significant deviations from tests/procedures that are acknowledged as covered. While a team effort, patient-facing physicians need to bear some of the responsibility for their actions, particularly when they are outside of the standard of care for a particular disease. As a result, pathologists across the country have started implementing the use of novel programmes such as Diagnostic Management Teams11 and pathology organisations are committed to programmes such as ‘Choosing Wisely’12 to bridge gaps of understanding and to make pathology and laboratory medicine have a more robust inclusion within healthcare decision-making policies.

In order for any substantive improvements to be made, pathologists need to educate their patient-facing colleagues, and pathologists must be at the centre of system-level decisions because of their extensive expertise and front-line experience.

Molecular pathology and advanced diagnostics

The challenges faced by pathology laboratories mentioned above are only compounded by a wave of changes that have dramatically altered how pathologists practise medicine. These advances have enhanced diagnostic capabilities and accuracy but with these changes comes an increased cost. The inclusion of advanced molecular diagnostics, genome sequencing, multiple fluorophore biomarker flow cytometry, digital slide scanning, immunohistochemical analysis, and their accompanied computation and analysis have led to patients getting truly individualised treatment and more precise, definitive diagnoses. However, the implementation of these technologies has been far from uniform across the country with large, academic medical centres holding a majority of the technologies and therapies leaving rural and underserved communities from getting access to these advanced techniques.13 In some areas, this distribution makes administrative sense; however, this may lead to unequal access to care, but it may also contribute to unequal representation in advanced therapeutic/diagnostic research and participation in biobanking.14 In addition, some diagnostic methods have become ‘reflex’, meaning they will be automatically added to the testing suite if a certain condition is on the differential diagnosis. This leaves patients having to pay the bill for numerous tests for which they were not expecting to be held accountable. Of course, most insurance companies will cover advanced reflex testing when provided with evidence for the use of that specific test. However, for uninsured patients, that extra test could run the patient further into debt or be taken-on by the hospital without administering a drop of treatment.

For these reasons, some have called for a moratorium on or slowing of advanced diagnostic research until a more just system of distribution can be attained.15 However, as a fiduciary consultant in clinical management, the pathologist has the moral obligation to continually strive to improve patient care by defining the patient’s disease to the current level of care. In the current landscape, that level of care continues to shift toward increasingly individualised disease states. In cancer, many of the treatments available now target specific surface markers that can only be assessed with ancillary tests like flow cytometry or molecular pathology. For these reasons, pathology cannot simply wait for a more just system to be formulated—the proposed reform policies must rapidly catch up to the healthcare system in which it serves which continues to progress without it.

The medical laboratory workforce

Policies aimed at improving patient access to care in the USA might mention diagnostic care using one or more of the aforementioned foci, but very few in the policy realm mention the longstanding shortage of qualified laboratorians who perform the advanced testing in the lab to get patients the results they need. Because the medical laboratory science degree is not a common choice and pursuing medical laboratory science after receiving a bachelor’s degree is difficult, many bright, potential medical scientists are lost to the current academic machine. That is, not adapting to the trends in higher education ends up precluding students from pursuing medical laboratory science because either they did not know about the field or they did not find out about the field until it was too late to pursue during their undergraduate career. Having a strong medical laboratory workforce does not only help promote healthcare justice, but it also enhances our country’s ability to respond to public health threats16 ranging from metabolic diseases, like diabetes and obesity, to infectious diseases, like COVID-19 and pandemic influenza strains. Unfortunately, the COVID-19 pandemic has only highlighted the strain17 experienced by the already fragile clinical laboratories across the nation. During this pandemic, many laboratorians and lab directors have resorted to sleeping at the hospital, pulling multiple shifts, coming out of retirement or leaving the field altogether due to burnout.17

Though an improvement in the laboratory workforce would not result in a comprehensive solution to the problem of access to care, a strong public health response in all communities could lead to fewer inequities in pandemic response leading to improved healthcare justice and the promotion of community health. Having qualified personnel in community hospitals and local health systems would give those organisations the ability to perform better. Adding more tests to a hospital’s catalogue is one example where the conversation surrounding an appropriately trained medical workforce takes on multiple layers of discussion. When there is redundancy in well-trained personnel (qualified medical laboratory scientists cross-trained at various benches and procedures) and the number of full-time equivalent allocations allow increasing testing, bringing in newer tests has the potential to lead to fewer tests being sent to private testing facilities. Providing tests within the patients’ health system lowers the financial burden on the patient, reduces turnaround time and provides the opportunity for these organisations to offer the molecular assays required to administer personalised therapies to patients without the samples being sent out of the laboratory. However, in the case that increasing in-house testing seems to be a burden on the existing laboratory workforce of a community hospital, a more robust national laboratory workforce would also enable private testing facilities (such as reference centres) to bring more test results to more patients leading to an enhancement and strengthening of the already standing connection between these hospitals and the large, reference laboratories. Having more accessibility to laboratory tests required to receive personalised therapies would allow patients who do not have the ability to drive to a large academic centre the ability to receive the current standard of care in their own community.

Addressing injustice in pathology

Taking into account the moral duties of pathologists, clinicians, laboratorians and payers, the issues of justice in pathology and laboratory medicine can be understood as a multifaceted and complex issue which requires enhanced advocacy and physician education on the part of the pathologist/laboratory director, selective test ordering on the part of the clinician, continual improvement on the part of the laboratorian, amended reimbursement schemes on the part of the payer and growth of the laboratory workforce. For just formulation of healthcare policies, physicians need to be at the forefront of communicating their knowledge and expertise with policymakers. Additionally, physicians, and pathologists, in particular, need to communicate their expertise to the public to (1) foster trust and bolster a more robust community base and (2) better inform the public on which subjects each specialist is most suited to tackle.

The foundation of any informed, just policy is communication which is an area scientists and clinicians have been struggling to address for years. However, the physician’s voice is one that is, historically, taken with great regard by the public despite the ongoing erosion of trust in science and public health institutions foddered by people in political power. For this reason, having pathologists and non-pathologists come forward to talk about the importance of the clinical laboratory could spark enough interest at the state, local and federal level to begin to incorporate the clinical laboratory into the conversation surrounding access to care and healthcare justice. Aside from formal interactions, pathologists need to reach out to local schools, particularly high schools, to inform students about a career in medical laboratory science. Furthermore, pathologists in hospitals and health systems have the moral obligation to serve as a steward for the precious diagnostic and blood components of which they safeguard. As the steward of these valuable resources, pathologists need to inform their patient-facing colleagues about changes in best practices, so these resources could be more optimally used at the population level and lower direct costs to the patient.

Many of the aforementioned issues are addressed on a case-by-case basis over the phone or even in person, but hospitals and political think-tanks need to start recognising the utility of having a pathologist as a member of management boards or health policy committees. However, at this point, there may not be enough trained personnel who feel comfortable partaking in these tough conversations. For this reason, an enhanced level of conflict resolution, policy participation and communication training in pathology residencies through a mix of objectively scored encounters, training modules and project-oriented assignments could be a start. Such communication training programmes have been implemented at select pathology residencies with great success.18 A more global implementation of these programmes with broader emphasis focused on long-term professional development aimed at improving communication at all levels mentioned above could be very beneficial in the short term.

Taken together, addressing patient access to and cost of diagnostic care need to be taken into account as conversations on healthcare reform continue; but in order to make these conversations more commonplace at the state and federal level, pathologists and laboratorians need a place at the table. Laboratorian involvement in policymaking is far more than ‘clinician test choice, test interpretation and test utilisation’—while these three things are important, they serve as but a starting point for programmatic development in pursuit of just care (table 3). In the early stages of this transition, there will need to be non-pathologist champions of this change in order for any change to take effect. But after years of continued advocacy and alterations to training, pathologists should start to become a more public-facing field with invaluable experience and understanding of one of the most vital aspects of clinical medicine. If anything, the COVID-19 pandemic offered the opportunity for this field to join the conversation because of enhanced publicity they have faced as a result of being the force behind a robust test and trace response. However, it is up to senior pathologists and policymakers to realise the importance of this line of communication, so a more just, equitable healthcare system can be formulated and implemented in a realistic manner.