Reports published by the Institute of Medicine (IOM), a part of the National Academies of Sciences, Engineering and Medicine (NAS), are the foundation of research on medical errors1 and how to improve patient safety. These reports established six aims that define healthcare quality: safety, patient-centeredness, efficacy, efficiency, equity and timeliness2, and five core competencies for healthcare professionals: work in interprofessional teams, use information technology, apply quality improvement techniques, practice evidence-based medicine, and provide patient-centered care3.

Many health professional educational programs have incorporated patient safety principles in training, practice, and competencies after the reports were released.  The clinical laboratory profession is behind in adopting these principles in its preparation of practitioners and in its practice.  Perceived as being “behind-the-scenes”, many clinical laboratory professionals have had difficulty recognizing the role they play in keeping patients safe from harm by the care that is meant to help them.  When the NAS published “Improving Diagnosis in Medicine” in 2015, clinical laboratory professionals were specifically identified as critical partners in addressing a specific type of medical error: diagnostic error4.

Diagnostic error is “the failure to (a) establish an accurate and timely explanation for the patient’s health problem(s) or (b) communicate that explanation to the patient.”4 Diagnostic error received relatively little attention in earlier years of research on medical errors, but it is now recognized as one of the most common types of medical error, accounting for 6%-17% of all hospital adverse events5, and is the leading reason for paid medical malpractice claims6.

The report acknowledges the complexity of the diagnostic process, describing a detailed conceptual model to showcase the many different “players” in the process and the cyclical decision-making going on in a physician’s brain.  Once a patient experiences a health problem and connects with the healthcare system to investigate, a circle of information-gathering and interpretation begins, based upon health history, diagnostic tests, physical examination, and consultations.  A working diagnosis is considered, and more information is gathered as needed until a final diagnosis is reached and communicated to the patient.  Subsequent appropriate treatment and follow-up commences until the health problem is resolved or ameliorated.

The diagnostic process occurs within the context of a work system, workplace culture, and physical environment, and includes multiple team members performing specific tasks within their scope of practice, using tools and technologies, all of which can impact the accuracy, timeliness, and communication of a diagnosis.  The clinical laboratory professionals are members of the team, particularly during information-gathering and interpretation during the investigative process.

Many laboratory professionals consider their involvement and role in the Total Testing Process (TTP), the conceptual framework for the laboratory testing process, to begin at the receipt of the specimen in the laboratory (perhaps with some involvement in the collection of the specimen), through the analysis of the specimens in the laboratory, and ending with the reporting of an accurate result to the clinician who ordered the test.

There is a “call-to-action” in “Improving Diagnosis in Medicine” that recommends clinical laboratory professionals expand their participation and role in the TTP. It specifically recommends that laboratory professionals provide assistance and expertise to physicians when they are choosing which test to order, and incorporate interpretative consultation for the test results.  These “pre-pre-analytic” and “post-post-analytic” activities require laboratory professionals to engage in interdisciplinary conversations, often outside the four walls of the laboratory, on a regular basis.

The authors of the 2015 report suggest eight goals to improve diagnosis in medicine:

“(1) Facilitate more effective teamwork in the diagnostic process among healthcare professionals, patients, and their families;

(2) Enhance healthcare professionals’ education and training in the diagnostic process;

(3) Ensure health information technologies support patients and healthcare professionals in the diagnostic process;

(4) Develop and deploy approaches to identify, learn from, and reduce diagnostic errors and near misses in clinical practice;

(5) Establish a work system and culture that supports the diagnostic process and improvements in diagnostic performance;

(6) Develop a reporting environment and medical liability system that facilitates improved diagnosis by learning from diagnostic errors and near misses;

(7) Design a payment and care delivery environment that supports the diagnostic process, and

(8) Provide dedicated funding for research on the diagnostic process and diagnostic errors.”

Clinical laboratory professionals have a role to play in every single one of these goals. With increased attention on diagnostic errors, recognition that a robust, multifaceted approach is required to reduce diagnostic errors, and acknowledging that an interdisciplinary team is essential in this process, it is a pivotal and exciting time to be a clinical laboratory professional.

Over the course of the next several months, additional articles on improving diagnosis in medicine will be presented, all with a clinical laboratory perspective.



  1. Kohn, L. T., Corrigan, J., & Donaldson, M. S. (2000). To err is human: Building a safer health system. Washington, DC: National Academies Press.
  2. Committee on Quality Health Care in America, Institute of Medicine. (2001). Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academies Press.
  3. Institute of Medicine. (2003). Health Professions Education: A Bridge to Quality. Washington, DC: The National Academies Press.
  4. National Academies of Sciences, Engineering, and Medicine. (2015). Improving Diagnosis in Health Care. Washington, DC: The National Academies Press.
  5. Leape, L.L., Brennan, T.A., Laird, N., et. al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324:377-384.
  6. Saber Tehrani, A.S., Lee, H., Mathews, S.C., et. al. 25-year summary of US malpractice claims for diagnostic errors 1986-2010: an analysis from the National Practitioner Data Bank. BMJ Qual Saf 2013;22:672-680.

About The Author

Stacy Walz is the current Chair of the American Society for Clinical Laboratory Science (ASCLS) Patient Safety Committee.  She has taught immunohematology, hematology, coagulation, phlebotomy, and laboratory management in MLS/MLT programs for over 10 years, and has delivered several poster and oral presentations on the topic of the laboratory’s involvement in patient safety at state, national, and international conferences.  She is currently the Department Chair and an Associate Professor of Clinical Laboratory Sciences at Arkansas State University, overseeing a dual MLS/MLT program.

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