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EPIDEM model promotes culture of quality, patient safety
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By Yaolin Zhou, MD
The oncology landscape is rapidly evolving with new biomarker discoveries and potential targeted treatment options.
Consequently, the medical community must work together to develop timely and relevant quality improvement initiatives that advance cancer patient care.
Cancer care increasingly relies upon genetic and biomarker testing to ensure appropriate diagnoses and treatment decisions. Collaboration between oncologists and those who have technical expertise in molecular diagnostics is essential.
Ideally, laboratory testing is done on a local level, but the task of bringing on new assays is no small endeavor. Assay validation begins with understanding clinical medicine, as well as the laboratory science.
A grand rounds presentation showcased this newly developed BCR-ABL algorithm.
The selection of a platform or instrument requires some business calculations, such as test volumes, reimbursement, reagent and instrument costs, overhead costs and personnel time.
The validation itself must prove clinical validity and utility, and it requires extensive testing to account for analytic sensitivity, specificity, reproducibility, repeatability and accuracy. Further downstream, the factors of how and what to report are critical to ensure the test results are conveyed in a clear and timely fashion.
Unfortunately, as the field and market evolve rapidly, it is not uncommon for a competing laboratory to have a newer, faster option at any point during this new test development process. Steps must be taken to ensure that the health care provided is effective, efficient, patient-centered, safe and timely.
To do this, we can approach launching evidence-based biomarker testing as quality improvement initiatives.
Quality improvement in health care
Quality improvement is distinct from quality control and quality assurance.
Quality control focuses on error detection and assay performance, and quality assurance focuses on compliance with accepted standards.
In contrast, continuous quality improvement is a collegial approach to improving systems and processes, increasing health care value and, ultimately, improving patient outcomes. It encompasses broader goals like shaping a culture of quality. It values teamwork and views errors as opportunities for learning.
Existing quality improvement models have had mixed success in the health care system. Successful implementation is challenging because patients, organizations and individuals are complex, and a continuous improvement mindset is needed.
We developed a quality improvement model to better equip laboratorians, pathologists and other health care providers and promote a culture of quality and patient safety.
The EPIDEM model — an acronym that stands for Exploration, Promotion, Implementation, Documentation, Evaluation, Modification — is a flexible model for all levels of users. It is simple enough for individuals without formal quality improvement training to understand, and those with formal training will find it compatible with other models.
Think of EPIDEM as a bare-bones framework for the steps of quality improvement and the structure upon which other quality improvement tools and methods can be incorporated.
We first used the EPIDEM model at University of Oklahoma Health Sciences Center Molecular Pathology Laboratory to improve testing for BCR-ABL, a fusion gene found in chronic myelogenous leukemia and occasionally in acute lymphoblastic leukemia or acute myelogenous leukemia.
Exploration: Relevant issues and contextual factors
The most important step in quality improvement is the initial exploration step. Problems and potential solutions need to be explored, and neither can be taken for granted.
EPIDEM uniquely emphasizes understanding culture, context and resources. Some key considerations include understanding contributing factors, the scope of the problem, potential solutions and pitfalls.
Based on incorrect orders the molecular pathology laboratory was receiving, we suspected BCR-ABL was not consistently being tested appropriately. In contrast to patients with CML — who often have t(9;22)(q34;q11.2) BCR-ABL major — patients with BCR-ABL-positive ALL are more likely to have BCR-ABL minor.
For patients with BCR-ABL minor-positive disease, we were finding that the error rate for ordering BCR-ABL tests had increased steadily since 2011 and was close to 60% by 2016. We discovered that the in-house assays and send-out tests had similar names, likely contributing to the increasing error rate.
After numerous conversations with hematopathologists and the treating hematologists/oncologists, we determined the best solution would be to validate an in-house BCR-ABL major quantitative (Qiagen) and to modify our BCR-ABL qualitative assay (DNA Diagnostic A/S) to reflex to BCR-ABL major if appropriate.
Promotion: The right people
Once a situation is understood and explored, the promotion step of the EPIDEM model entails identifying relevant stakeholders and building a collaborative team to help improve quality improvement initiatives and make the positive change.
When solving the BCR-ABL testing issue, we met one-on-one with hematologists and participated in hematology tumor boards. We then gave a grand rounds presentation showcasing the newly developed BCR-ABL algorithm (Figure 1).
Implementation: Timely solutions
The implementation phase must be thoughtfully rolled out with ample feedback from relevant stakeholders. Prior to our official live date, we had discussed this process for several months and allowed stakeholders to provide input on how results would be reported.
Documentation: Successes and challenges
Every step of the initiative must be documented, including successes and challenges.
When we implemented the new ordering system for BCR-ABL, we emailed ordering providers with the results of the individual patients to provide them opportunities to ask any questions. We continued to document ordering errors and sent a lab customer service survey.
Evaluation : Meaningful measures
The evaluation phase — an extension of the documentation step — involves measuring our success, which can include adherence rates, cost savings, patient satisfaction and improvement of patient outcomes.
We found that the ordering error rate for BCR-ABL decreased significantly after the new approach was implemented. After reaching an error rate of nearly 60% in early 2017, the incorrect ordering error rate for patients with BCR-ABL minor fusions had been reduced to nearly 30% by the end of that year.
Modification: Further improvement
Although modification is listed as the last step of EPIDEM, changes may be needed at any point in a quality improvement initiative.
Flexibility throughout the exploration, promotion, implementation, documentation and evaluation of quality improvement projects is critical to the success of any initiative.
For example, despite a dramatic reduction in the error rate in testing, clinicians still were having trouble ordering the tests because of confusion in the electronic ordering system. We further shortened the list of tests to only include the three order names that best reflected the available tests.
Overall, the feedback we received from the lab survey in 2017 was overwhelmingly positive, with several key stakeholders requesting that we develop more testing pathways.
Future directions
Quality improvement activities are critically important for health care providers in the 21st century, and they may seem like a lofty and unattainable goal set by hospital administrators.
What niche can our laboratory fulfill in order to maintain its relevancy? Our goal is to continue offering critical tests that are the bread and butter of our laboratory services while validating clinically actionable next-generation sequencing panels.
Small academic laboratories like University of Oklahoma have limited resources and experience when it comes to conducting larger gene panels, but we feel there is still a role for our laboratory in reporting the immediate clinically actionable molecular variants.
We explored several available options, including QIAGEN’s GeneReader NGS System, which includes target enrichment, library preparation, clonal amplification, sequencing and analysis.
Our goal is to provide oncologists with key information to make early treatment and management decisions for their patients.
As we demonstrated here, when implemented effectively, quality improvement measures can have wide-reaching implications. As described above with the EPIDEM model, we realize that quality improvement goes beyond hospital administrators and can be implemented every day, by all members of the health care team, to ensure that our efforts will produce the highest-quality patient care.
A more detailed description of the EPIDEM model — including tables with useful questions — was published earlier this year in Laboratory Medicine.
Please consider trying the EPIDEM model and let us know what you think. Let’s create an EPIDEMic of health care providers working together to improve patient care!
References:
Agency for Healthcare Research and Quality. Practice Facilitation Handbook. Module 4: Approaches to quality improvement. Available at: www.ahrq.gov/ncepcr/tools/pf-handbook/mod4.html. Accessed on Oct. 6, 2019.
Reed JE, et al. BMJ Qual Saf. 2016;doi:10.1136/bmjqs-2015-005076.
Taylor MJ, et al. BMJ Qual Saf. 2014;doi:10.1136/bmjqs-2013-001862.
Yin F, et al. Am J Clin Pathol. 2019;doi:10.1093/ajcp/aqy089.
Zhou Y. Lab Med. 2019;doi:10.1093/labmed/lmy066.
For more information:
Yaolin Zhou, MD, is assistant professor of pathology at University of Oklahoma Health Sciences Center and chair of the University of Oklahoma Physicians Quality Committee. She can be reached at yaolinz@gmail.com.
Disclosure: Zhou reports no relevant financial disclosures.