Supporting the Nation’s Laboratories

What follows is an interview with Donna Sweet, MD, AAHIVS, MACP, chair of the COLA, Inc., Board, Master in the American College of Physicians, professor of internal medicine at the University of Kansas School of Medicine-Wichita, and director of internal medicine education at Via-Christi Health – St. Francis Campus.

Why is COLA, Inc. focused on diagnostic quality improvement?

“As a physician-directed organization, it was an easy decision for COLA to join the efforts of the Society to Improve Diagnosis in Medicine (SIDM) and the Coalition,” said Dr. Donna Sweet. “The laboratory plays a pivotal role in the diagnostic process by providing information to aid in the formation of a diagnosis and a treatment plan for patients.”

COLA Inc. accredits more than 7,000 medical laboratories nationwide to meet the federal Clinical Laboratory Improvement Amendments of 1988 that regulate all testing for the diagnosis, prevention, or treatment of diseases and other health problems, as well as state-specific regulatory requirements.

“As we accredit laboratories across the country, every COLA staff member is committed to making a positive impact on quality and patient care every day. Our mission is rooted in knowing that a sustained focus on adhering to best laboratory practices makes all the difference,” stated Dr. Sweet.

Why is diagnostic quality and safety more important now more than ever?

“These are certainly not normal times. As we work together to contain the coronavirus pandemic and save lives, the significance of the availability, accuracy, and quality of laboratory testing, an essential component of the diagnostic continuum, takes on a whole new meaning,” stated Dr. Sweet. “Key to the treatment of any disease, including COVID-19, is an accurate, timely, and communicated diagnosis, which often relies on the results of laboratory tests. The team at COLA is doing everything it can to ensure that clinical laboratories wanting to perform COVID-19 testing are supported with the latest technical information and regulatory guidance as it becomes available from the key government authorities, so we can test, diagnosis and treat patients with COVID-19 in a timely manner.”

How does the COLA, Inc. Lab Testing Matters website encourage the care team to share best practices?

COLA’s Lab Testing Matters (LTM) website is an online community for laboratorians, allied health professionals and patients to exchange ideas and experiences demonstrating the importance of quality laboratory medicine. The blog is designed to share personal and professional stories that showcase the impact that the laboratory can have on ensuring an accurate and timely diagnosis, leading to positive patient outcomes.

This educational forum includes patient stories; practices in quality and safety in laboratory testing; information about the importance of inclusion, teamwork and communication throughout the care team; and the latest breakthroughs in science, technology and informatics.

“Through the forum, we’re learning more about the essential role that the laboratory community and accurate, up-to-date testing technologies play in the diagnostic team framework,” said Dr. Sweet. “We would like to extend an invitation to the broader healthcare community, including members of the Coalition to Improve Diagnosis, to contribute articles to the LTM forum.”

Guest articles to the forum can be contributed by contacting Tammy Zinsmeister, COLA Inc.’s Chief Innovation Officer, by email at tzinsmeister@cola.org.

Tell us about the near patient testing research initiative. What is it?

Near Patient testing, also known as point-of-care testing, are tests taken during trips to the doctor’s office or a hospital stay with results delivered instantly.

This form of testing is a focus of today’s advancements in clinical laboratory science enabling clinicians to perform real-time testing in a diversity of care settings, including clinics, nursing homes, patient-centered medical homes, and accountable care organizations. These tests are invaluable to chronic disease management and early diagnosis, in lieu of tests that could take days to deliver results, particularly in rural areas, thereby delaying the onset of treatment.

The Near-Patient Testing Matters Portal initiative began as an evaluative study to gather quantitative and qualitative data on the value of physicians performing near-patient testing, i.e., tests taken at the time of consultation with availability of instant results—particularly in rural settings.

The evaluative study included interviews with physicians in very rural areas and a national practice survey. The preliminary data emerging from this first study and the related literature review was summarized on the Near-Patient Testing Matters Portal in patient vignettes, e-books, and other educational materials.

What tools or products, if any, have you developed to improve diagnostic processes and safety?

COLA offers a wide range of educational tools via its online platform for laboratories accredited through its Laboratory Accreditation Program. Through the accreditation from COLA, laboratories not only meet federal and state regulatory guidelines, they also benefit from COLA’s educational approach to accreditation.

“Each step in the accreditation process is an opportunity to gather the information labs need to improve the quality of the results they provide,” said Dr. Sweet. “Diagnostic errors, despite the hard work and professionalism shown by those on the diagnostic team, are prevalent throughout the healthcare system, including the testing community. Our goal is to prevent errors that are preventable and help labs improve when they do contribute to diagnostic errors.”

“Everyone in health care wants to do the best they can for our patients. Our focus on good laboratory medicine, continuous improvement, and quality management is what is needed to run an excellent laboratory which, in the end, helps support getting the right diagnosis as quickly as possible,” stated Dr. Sweet.

How do you measure success?

“To measure our own performance in serving clinical laboratories nationwide, we made the strategic decision to implement a Quality Management System for COLA’s Laboratory Accreditation Program, and to pursue third-party certification of that system,” said Dr. Sweet.

Through COLA’s standards of accreditation, laboratory testing errors are reduced, improving diagnostic accuracy in the process; weaknesses in workflow, processes, and procedures are addressed; and overall operations are aligned with accepted practices. By implementing and sustaining best practices, clinical laboratories can contribute to the diagnostic process with accurate, high-quality test results.

“We’re also witnessing improvement anecdotally through the stories laboratory scientists, other health professionals and patients share on the Lab Testing Matters forum,” said Dr. Sweet. “We’re encouraged by the advances the field has made and its willingness to learn from and improve upon the errors of the past. Accurate and timely test results are essential to the diagnostic process and COLA is committed to supporting laboratory professionals and their role in the diagnostic team.”

What were the barriers you overcame to advance this work?

“One challenge we continuously focus on is educating testing personnel about the importance of good laboratory practice and the need to comply with regulations,” said Dr. Sweet.

COLA surveyors have extensive experience and in-depth knowledge about compliance, quality, and laboratory management. COLA also invests in continual education for its surveyors to equip them with the latest relevant information about changes impacting clinical laboratories.

“Laboratories serving on the front line of the coronavirus, the incredible technological and scientific shifts in our field, and the reconfiguration of the healthcare delivery system under value-based care are all a central focus for COLA,” said Dr. Sweet. “One of the many benefits of being part of the Coalition is that we can explore ways to work together for greater impact to overcome challenges.”

What have you learned that might be helpful to other organizations implementing diagnostic quality and safety work?

“Education and the need for open communication across disciplines to ensure that the safest and highest quality of care is delivered to every patient is very important,” said Dr. Sweet. “We need to recognize that improvement work is never finished. Only by focusing on what really matters and what can have the biggest impact—while understanding and valuing the unique motivation of every person involved in the improving diagnosis movement—can we accomplish a great deal, together.”

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