Preventing diagnostic errors by uniting the clinical laboratory with direct patient care

Doctoral programs are preparing experts to lead diagnostic management teams at hospitals, with promising early results

Brandy Gunsolus and Jennifer Pine
Dr. Brandy Gunsolus, who leads the Diagnostic Management Team at Augusta University Medical Center in Georgia, reviews a complicated fluorescence scope pattern with Jennifer Pine, a medical laboratory scientist in immunology. (Photo by Isaac Green)

Brandy Gunsolus has witnessed diagnostic errors as a patient as well as a professional.

Brandy Gunsolus, DCLS, MLS(ASCP)CMA decade ago, she started experiencing headaches, a rash – and repeated miscarriages. She went to different specialists for two years before one of them realized that the initial test she was given was not broad enough to cover the condition he suspected.

At the same time, she was a laboratory manager for a large medical practice, working closely with a group of family medicine physicians. Her training as a medical laboratory scientist gave her the foundation she needed to do her job well. However, she still experienced challenges:

They would frequently ask me questions about what test they should order for certain conditions or how to interpret a result on an uncommon test. I realized very quickly that I didn’t have the knowledge necessary to answer some of these questions.

Her drive to give doctors the best possible advice led her to pursue a master’s degree in Clinical Laboratory Science, followed by a doctorate that had just been created in that field.

Now, as the first person to complete a DCLS, Dr. Gunsolus is at the forefront of a movement that is expected to reduce diagnostic errors while uniting the clinical laboratory and direct patient care.

Nearly every adult American has been the victim of at least one diagnostic error, according to a 2015 report by the National Academy of Medicine. At least one in seven times a diagnostic error is made, the patient is treated ineffectively as a result, often with severe consequences. A recent study from Johns Hopkins points to medical error – the largest component of which is diagnostic error – as the third leading cause of death in America.

A promising plan to improve the situation involves a unique kind of medical collaboration.

The National Academy of Medicine in the US has endorsed the increased use of expert diagnostic teams in providing two important services to all treating healthcare providers:

  • Recommendations for the appropriate tests to evaluate a patient.
  • A patient-specific, expert driven interpretation of the test results within the clinical context of the patient.

These expert groups, which unite people from clinical practice and the medical laboratory, are sometimes known as diagnostic management teams, or DMTs. These teams could be key to halting trends in diagnostic error. Leading them, however, requires people who work at the intersection of research and practice – and recognizing laboratory medicine and the people that practice it as a vital component of today’s complex healthcare system.

The complexity of a medical examination and a specific patient’s clinical course means that healthcare analysts had simply not been able to track the number of delayed or misdiagnoses until they recognized the problem and introduced new queries in the review of medical records.

Which experts can lead these diagnostic management teams?

Co-author Dr. Rodney E. Rohde, Professor and Chair of the Clinical Laboratory Science Program at Texas State University, discusses a morphological and specific staining reaction of a bacterial species with Joanna Miranda, a senior Medical Laboratory Science major and Student Forum Chair of the Texas Association for Clinical Laboratory Science.

One obviously qualified group would be pathologists with expertise in clinical areas. They could meet regularly, review clinical cases with laboratory data, and make recommendations on further testing, and provide a clinically actionable narrative interpretation. However, for a variety of historical reasons, from varying standards of reimbursement across different areas, combined with rising pressure in the form of higher medical school debts, there is a limited number of experts for a large number of clinical areas.

“While clinical pathologists are certainly capable of fulfilling this role, there are too few of them,” Dr. Gunsolus added, “and those out there are so overworked that they simply don’t have the time to do these types of consults.”

For a diagnostic management team to exist, multiple experts must be available. This has produced a major challenge for those in healthcare to create DMTs in individual institutions because it is hard enough to find single experts in a clinical area.

Another group of DMT leaders could be PhD qualified laboratory directors. What limits this group of capable individuals is that there are so few of them. The number of programs for fellowship training in clinical chemistry and clinical microbiology is about 20 to 30 each. Many of these programs only accept one fellow every other year. As a result, they’re simply not enough of these individuals in the pipeline to fulfill the need for DMT leaders. Looking to the future, we would want to see more advocacy for awareness and eventual funding to build DMT programs across the globe. But there is also the opportunity to find and fund a new group of experts for these diagnostic management teams.

Creating a new group of experts to lead diagnostic management teams

Dr. Michael Laposata, Professor and Chair of the Department of Pathology at the University of Texas Medical Branch-Galveston, is a co-author of this story. His clinical and research expertise is in the field of blood coagulation, and he has published extensively in this area.

Nearly 20 years ago, an idea arose to create doctoral level individuals trained as clinical laboratory scientists. The analogy was made to those who earned the doctor of pharmacy degree, which had proven to be a significant step forward. Why not have doctoral level individuals become leaders of some kind in the clinical laboratory?

When this clinical doctorate was conceived, it was not clear what these individuals would do with the additional training that took them beyond the performance of assays at the bench in the laboratory, and even beyond supervising individuals who are performing lab tests.

A new role came into focus as diagnostic management teams continued to grow in number and impact. About 10 years ago, as a pathology professor at Vanderbilt University School of Medicine, I (Michael Laposata) proposed that these professionals could lead DMTs.

National leaders in the education of clinical laboratory scientists conferred with pathologists and reached an important conclusion: individuals with a doctorate in clinical laboratory sciences (DCLS) could learn much diagnostic medicine through additional coursework and clinical experience, including participation in diagnostic management teams. There are currently three schools that have DCLS programs: Rutgers University, the University of Kansas Medical Center, and the University of Texas Medical Branch (UTMB) in Galveston. Each of these are 3- to 4-year programs that involve participating in diagnostic management teams, rounding with clinical teams in the hospital, and taking courses to understand diagnostic testing in areas outside the clinical laboratory.

Dr. Gunsolus completed her DCLS at Rutgers in 2018 to become the first DCLS in the nation, and additional graduates are expected from the UTMB program in August. These individuals are being groomed to lead diagnostic management teams. The requirement for graduation is a thesis advancing clinical laboratory consultation, which can include the development of a DMT in one clinical area. Additional research includes impact on patient outcomes from bedside rounding with clinical teams as well as interdisciplinary collaboration with other areas, such as pharmacy and nutrition. This research experience leading to a thesis develops the qualifications of DCLS graduates for leadership of diagnostic management teams.

For her research, Dr. Gunsolus documented the cost savings and improved outcomes that can result from DMTs. She has presented her paper “Innovations to Improve Laboratory Test Utilization” at the International Federation of Biomedical Laboratory Scientists World Congress in Florence, Italy, and last month as the keynote speaker at the 2019 Alabama-Georgia Medical Laboratory Symposium, and she will publish it later this year.

If each DCLS program graduates five to 10 individuals per year, most of the individuals leading diagnostic management teams will be DCLS graduates. They will have started by performing tests on patient samples at the bench, typically have developed into supervisors, and then obtained a doctoral degree. The clinical experience during their training focuses on building the knowledge and confidence to provide consultations on laboratory test selection and patient-specific result interpretation.

To put it plainly, these individuals are medical pioneers. The DCLS and other similar roles will fill the gap between physicians and laboratory medicine.

That connection – and the connection with the patient – is what Dr. Gunsolus has been experiencing in her new role.

“Having the feeling as a patient, I understand what our patients our going through,” Dr. Gunsolus said. “I completely feel the DCLS addresses a critical gap between clinicians and the laboratory.”

Early gains as a DCLS

Dr. Brandy Gunsolus and Chief Clinical Pathologist Dr. Gurmukh Singh discuss an article and its applicability on a patient case. (Photo by Patricia Pilcher)

So how does this connection between medical lab work and medical practice work? After finishing her DCLS, Dr. Gunsolus established a coagulation Diagnostic Management Team at Augusta University Medical Center in Georgia, which she leads. She is also establishing other DMTs, including an autoimmune DMT and a newborn genetics DMT, all of which she will lead.

She has done significant work in clinician education on laboratory medicine and promoting both appropriate test utilization and Choosing Wisely initiatives. Besides being requested by many clinicians to be a regular member of their bedside patient rounding team, she is working with several non-pathology physicians in researching outpatient laboratory test ordering patterns and developing standardization of care.

There is also underway a non-pathology physician study evaluating patient outcomes differences between when a DCLS is present for bedside rounding versus when a DCLS is not present for bedside rounding, with the hypothesis that patient outcomes are more favorable when a DCLS is present. So far, Dr. Gunsolus has documented over $1.3 million in savings from test order optimization and ensuring correct test interpretation by clinicians. This provides evidence that, while there is currently no mechanism for payment for DCLS practitioners, there is certainly value to medical institutions to add a DCLS to their clinical laboratory staff for improving both facility finances and patient care.

The move to DMTs is also reducing the time it takes to diagnose patients and reduces unnecessary testing.

It’s been amazing to see the response and changes that have come about directly because of the integration of the DCLS,” Dr. Gunsolus said.

Meanwhile, she experienced relief as a patient when she finally got the right diagnosis. After ordering the correct test, her doctor diagnosed her with antiphospholipid antibody syndrome, an autoimmune disease that causes abnormal blood clotting, posing a high risk for deep vein thrombosis, pulmonary embolism and stroke. Finally, her symptoms made sense and she could get treatment to prevent these dangerous blood clots.

Should you pursue a DCLS?

“The DCLS is not for everyone. You must understand that you will be the face of the laboratory outside of the laboratory. This will require that you interact with lots of people and receive criticism about the laboratory. When individuals are frustrated with the situation, they are venting to you so that you can improve the situation, which often requires you to educate the individual on process, protocols, appropriateness of the test, interpretation of the test, interferences that can occur with the test, etc. If you are not comfortable with working in an interdisciplinary group environment or interacting with many different individuals, some who may be frustrated with the laboratory, this is not for you.

“The path is also challenging, as is any doctoral degree. However, if you are passionate about the laboratory and are willing to work with many different people to improve laboratory diagnostics, this is a very rewarding career path!” — Brandy Gunsolus, DCLS, MLS(ASCP)CM

Listen to Prof. Rodney Rohde talking about the DCLS on Outbreak News Radio.

Many unanswered questions

There are operational issues that need to be resolved before DCLS graduates can lead DMTs: there is no mechanism for payment for their activity by insurance companies using established codes, and the people concerned need to agree to take on the same consultative role as MD and non-MD specialists and go beyond the traditional roles of clinical laboratory scientists. It is a major cultural change for individuals who have previously focused on the performance of the assay and not the clinical significance of the assay result as it pertains to specific patients. But the expertise is there: the DCLS programs are attracting very highly qualified individuals. Surveys of pathologists, internists, and others who interact with them in training all indicate that they play an important role in the laboratory evaluation of patients, and that there is clearly a place for them as the laboratory test menu grows in complexity and cost. A major change in the past 10 to 20 years has been a recognition by most practicing physicians that a test menu with thousands of options, many of which are extremely expensive at hundreds to thousands of dollars, and often with a large genetic component which is poorly understood by most physicians, requires the input of experts that are available when needed, and that the need is large.

Based on the work of the initial DCLS graduate, the interaction of the DCLS with a pathologist may act as intermediate care provider in the diagnostic arena, much like a physician assistant in a clinical setting.

DMTs and the DCLS professional will revolutionize the medical laboratory profession by placing the focus on upstream care and diagnostics versus downstream data. It will place a face on our professionals which will impact understanding of clinical laboratory science by all students at all levels of education because they “will see us” in patient care. We will no longer be a hidden profession. Importantly, the medical laboratory has significant shortages that rival or exceed nursing and others in healthcare professions.

Conclusion

Diagnostic errors affect all of us often with severe consequences. Diagnostic management teams that focus on recommendation of appropriate tests result in quicker and more accurate diagnoses – and a dramatic cost savings to obtain a diagnosis. The concept of using such teams has been endorsed by the National Academy of Medicine. There is a shortage of diagnostic management team leaders among pathologists and PhD laboratory directors. These are highly qualified individuals, but there are too few of them. Clinical and medical laboratory scientists willing to move beyond the performance of tests at the bench, learn in detail the diagnostic requirements for disorders within a clinical category, and become available at all times like other clinicians will reduce diagnostic error and the costs associated with it. It is now timely for these individuals to take their place as leaders among us in the clinical laboratories.

Clinical Laboratory Week 2019 with Rodney Rohde, PhD

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