Clinical Labs: Part of the Diagnostic Team

What follows is an interview with Reynolds M Salerno, PhD, Director of the Division of Laboratory Systems at the US Centers for Disease Control and Prevention (CDC). He is also the Designated Federal Official of the US Clinical Laboratory Improvement Advisory Committee.

When did the CDC Division of Laboratory Systems (DLS) become interested in diagnostic excellence?

Reynolds M Salerno, PhD, Director of the Division of Laboratory Systems at the US Centers for Disease Control and Prevention

DLS has a long-standing history and leadership role at CDC to engage clinical and public health laboratory professionals and to support the continual advances in the practice of clinical laboratory medicine, including diagnostic quality and safety.

In 2008, CDC established the Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) team to improve clinical care decision-making by encouraging laboratory and healthcare professionals to work together. In 2014 and 2016, the CLIHC team published findings from a survey of laboratory professionals and clinicians that supported the need for diagnostic teams to improve communication among healthcare professionals to ensure the use of appropriate tests. This early diagnostic excellence initiative paved the way for other initiatives (such as the Next Generation Sequencing Quality Initiative and the Extension for Community Healthcare Outcomes Project) that we developed to tackle the challenges of diagnostic errors.

DLS has also participated in the Coalition to Improve Diagnosis from its inception and played an important role in supporting the development of the Institute of Medicine report, Improving Diagnosis in Healthcare, which promoted efforts to address a major gap in healthcare delivery.

Why does the CDC consider this an important issue?

Diagnostic error is an essential issue for CDC because it causes harm to patients and drives many other public health problems, including antibiotic resistance, inappropriate antibiotic use, and sepsis (the body’s extreme reaction to an infection). For example, without timely treatment with antibiotics, sepsis can rapidly lead to tissue damage, organ failure, and death.

CDC is well-positioned to help improve diagnoses through engaging laboratory and healthcare expertise, providing and using better data, and developing and promoting best practices.

A high-profile example of diagnostic error with profound public health implications was when the United States experienced its first case of Ebola virus infection in 2014. The diagnosis was initially missed, and the patient was inappropriately discharged. Then after the patient deteriorated and was readmitted to the hospital, the laboratory test sent to CDC provided definitive confirmation of Ebola infection. This example illustrates how a missed or delayed diagnosis could result in significant public health consequences. Improving diagnosis is often addressed from a disease- or institution-specific perspective. However, it is a systems issue and should be approached with systems solutions.

What is the ECHO (Extension for Community Healthcare Outcomes) Project?

While each clinical and public health laboratory is different, with a unique combination of tests, equipment, and resources, there are challenges shared by many laboratories, including an abundance of non-value added activities, lack of workflow efficiencies, and so on, that may contribute to diagnostic errors. To try to address the many similar challenges that laboratories face, we wanted to connect subject matter experts who have developed innovative laboratory solutions to these challenges at their institutions with laboratory professionals in both rural and community hospital settings. In 2020, DLS piloted a laboratory community of practice on diagnostic excellence based on an adaptation of ECHO Model™. The goals of the ECHO project were to:

  • Connect laboratory professionals and clinicians who work in rural areas or small community hospitals with subject matter experts at larger academic institutions;
  • Use case-based learning from subject matter experts to educate and train laboratory and healthcare professionals on innovative practices to reduce diagnostic error; and,
  • Examine cross-cutting issues in clinical and anatomic pathology.

Each month DLS hosted 60 to 90-minute sessions during which participants shared best practices, tools, and resources to reduce existing laboratory errors and to improve diagnostic excellence. Listen to previous sessions here.

How did you decide what areas of discussion to focus on in the ECHO sessions?

We planned to pilot this program for a year, so we selected twelve specialties in anatomical and clinical pathology based on our knowledge of interest and needs of the laboratory community. We identified and invited subject matter experts in each of those specialties from large academic institutions. Examples of topics included:

  • Overview of diagnostic excellence
  • Clinical pathology (hematology, microbiology, clinical chemistry, transfusion medicine)
  • Point-of-Care testing
  • Clinical informatics/Machine learning/Artificial intelligence
  • Anatomic and surgical pathology
  • Laboratory quality improvement/Patient safety
  • Clinical Lab 2.0
  • Public health laboratories

What are a few key findings or takeaways from the sessions so far?

Based on surveys and the feedback we’ve received during the sessions, we’ve learned that participants were interested in learning how other organizations overcame their own process challenges across all topics. Some participants were reassured, realizing that they weren’t the only ones facing the same challenges. They also liked that speakers presented information with a real-life case and demonstrated how they worked through their challenges. We also learned that providing continuing education credits (i.e., P.A.C.E.®) motivated some participants to attend our sessions.

If you are interested in listening to some of our previous ECHO sessions, they are available, along the transcript, on our website.

What other tools and resources has the CDC developed for clinical laboratories with diagnostic improvement in mind?

CDC, specifically DLS, conducts other activities to improve diagnostic performance by engaging the laboratory community throughout the nation. Some of our current activities include:

  • Advancing laboratory quality management systems (QMS), technical guidance, and training materials based on the Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements.
  • Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC), which provides scientific/technical advice on clinical laboratory quality improvement.
  • Co-leading the Next Generation Sequencing (NGS) Quality Initiative by developing an NGS-focused quality management system (QMS) to address the many challenges public health and clinical laboratories encounter when they develop and implement NGS-based tests, by providing ready-to-implement guidance documents, customizable standard operating procedures, and other tools. When laboratories use a QMS to ensure high-quality NGS data, they can deliver more accurate and reliable test results, which positively affects diagnosis, prognosis, and the health of patients and communities.
  • The Laboratory Medicine Best Practices (LMBP) Initiative to develop an evidence-based process for developing laboratory practice recommendations. These best practices support high-quality healthcare delivery and diagnostic safety. DLS has published nine systematic reviews as part of the LMBP initiative.
  • In 2021, DLS published Bringing the Clinical Laboratory into The Strategy to Advance Diagnostic Excellence to highlight opportunities for clinical laboratory professionals and organizations to be part of strategies to improve diagnoses.

How has your work tried to reinforce the fact that laboratory professionals are part of the diagnostic team?

We recognize that laboratories are on the frontline for protecting our communities’ health. In our recent publication, Bringing the Clinical Laboratory into The Strategy to Advance Diagnostic Excellence, we acknowledge the role clinical laboratory professionals and organizations play in improving patient diagnoses. Many of DLS’ activities promote the need for laboratory professionals to actively participate in the diagnostics decision-making process, but more work in this area is needed.

What does being a Federal Liaison for the Coalition mean to CDC DLS? Has it shaped any of your diagnostic improvement work?

Improving diagnostic excellence requires a systems solution that involves finding opportunities for laboratory and clinical professionals to identify better ways to work together to improve diagnostic performance. The Coalition has improved our ability to foster those connections between clinicians and laboratory professionals. We are eager to continue to work with our partners in the Coalition to identify solutions to enhance diagnostic quality and safety, reduce harm, and ultimately ensure better health outcomes for patients.

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