2020 Joint Annual Meeting

Virtual, Affordable, Convenient

Read More


Becoming a member is easy and fast!

Join Today!

CONNECT Communities

Virtually network with your colleagues.

Read more

Do No Harm: Diagnostic Errors and the Laboratory

“Do no harm” is the mantra that healthcare providers live by. Doctors, nurses and laboratory professionals alike enter into the business of healthcare because they are motivated to help people. Why then do 5% of adults in the United States experience diagnostic error annually in outpatient settings at the hands of these well-meaning providers?1 Humans work in healthcare. Where humans are involved, there will be mistakes. There is also a certain level of trial-and-error that is acceptable in the diagnosis of patients. Laboratory professionals often feel removed from the actual diagnosis of the patients that they serve. Laboratories play a critical role as laboratory testing is often used to confirm initial impressions or rule out differential diagnoses. It is estimated that 70% of all health care decisions affecting diagnosis or treatment involve laboratory testing2 and at least 10% of all diagnoses are not considered final until laboratory testing is complete3,4.
We can all agree that the identification of diagnostic errors in medicine is critical to improving patient safety, however, it is easier said than done. Historically, the laboratory industry and its professionals have focused quality improvement efforts within boundaries of the laboratory. We have been laboratory-centric in this respect and have not focused on collaboration with other members of the care team or patient outcomes. Laboratory professionals have been very good at detecting and eliminating errors in the analytical phase. Less focus has been placed on identifying and remedying errors outside of the analytical phase, particularly those that occur outside the boundaries of the laboratory (pre- and post-analytical).
For laboratory professionals to have a positive impact on diagnostic errors, it is necessary to become part of the interdisciplinary patient-centered care team. Laboratory professionals need to view their services as contributing to patient outcomes, not just generating results.  Research on diagnostic errors and the laboratory’s role has found that failure to order appropriate diagnostic tests, including laboratory tests, makes up 55% of missed and delayed diagnoses in the ambulatory setting and 58% of errors in emergency departments 5. We know that healthcare providers don’t understand our tests as well as laboratory professionals do. This statistic underscores the need for Medical Laboratory Scientists to interact with and provide education to ordering providers on the proper use of the testing we provide. One way that medical laboratory professionals can affect positive change is by collaborating with other healthcare providers to establish evidence-based decision-making guidance for ordering tests. Providing feedback to providers detailing improper test utilization patterns, both over- and under-utilization, is another way that laboratory professionals can help to reduce diagnostic errors. Other ways to help reduce diagnostic errors includes reflexive testing, consultative services and improved test reporting.
Unfortunately, standardized feedback systems and reliable evidence-based decision support mechanisms do not yet exist on a large scale. In the meantime, we are reliant largely on our non-conforming event management systems to capture diagnostic errors. The success of these systems, whether you choose a manual or electronic option, is contingent on the establishment of a reporting culture. A reporting culture is a culture of trust where employees feel safe, supported and comfortable pointing out errors, which may include their own, in the interest of patient safety and continuous improvement. The types of errors captured will include laboratory errors, errors generated outside the confines of the laboratory, and near misses. A near miss is “any event that could have had an adverse patient consequence, but did not, and was indistinguishable from a full-fledged adverse event in all but outcome”6.  A near miss is the perfect quality improvement opportunity, as we have the opportunity to eliminate the root cause before a patient is harmed. It is only after we are made aware of an event or near miss that a root cause analysis and corrective action can be formulated to prevent the event’s recurrence.
The identification of diagnostic errors to which Laboratory Medicine has contributed is a crucial piece of the puzzle in our effort to improve patient safety and outcomes. The lack of comprehensive information on the incidence of diagnostic errors should not prompt us to conclude that these errors are uncommon or unavoidable7. In addition to the patient safety benefits, the shift from fee-for-service to value-based purchasing is already requiring us to become more patient-centric and outcome-focused. This way of thinking is in line with the way we will be reimbursed in the future. Laboratory professionals can help to reduce diagnostic errors by focusing on becoming more patient-centered, educating providers on laboratory testing, providing consultative services, initiating feedback loops that extend beyond the walls of the laboratory and ensuring that we have an effective non-conformity management system.


  1. Singh, H., Meyer, A. N. D., & Thomas, E. J. (2014). The frequency of diagnostic errors in outpatient care:estimations from three large observational studies involving US adult populations. BMJ Quality & Safety, 1–5.
  2. Badrick T. (2013) Evidence-Based Laboratory Medicine. Clin Biochem Rev. 2013 Aug; 34(2): 43–46
  3. Peterson MC, Holbrook JH, Von Hales D, et al. Contributions of the history, physical examination, and laboratory investigation in making medical diagnoses. The Western Journal of Medicine. BMJ 1992;156:163–5.
  4. Wahner-Roedler DL, Chaliki SS, Bauer BA, et al. Who makes the diagnosis? The role of clinical skills and diagnostic test results. J Eval Clin Pract 2007;13:321–5.
  5. Plebani M. Diagnostic errors and laboratory medicine – causes and strategies. EJIFCC. 2015 Jan; 26(1): 7–14
  6. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting. BMJ 2000;320:759-63
  7. Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine; Balogh EP, Miller BT, Ball JR, editors. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015 Dec 29. 9, The Path to Improve Diagnosis and Reduce Diagnostic Error. Available from: https://www.ncbi.nlm.nih.gov/books/NBK338589/


Author:  Jennifer Dawson, MHA, DLM(ASCP)CMSLS, ASCLS Patient Safety Committee Member

Reprinted with Author’s and LabTesting Matters Permissions, Original Publication:  (http://www.labtestingmatters.org/do-no-harm-diagnostic-errors-and-the-lab/)


Additional Resources

LabTestingMatters.org: An online community for laboratorians, allied health professionals and patients to exchange ideas and experiences demonstrating the importance of quality laboratory medicine.  This site offers many excellent educational blogs and videos on various quality and patient safety topics.  The ASCLS Patient Safety Committee is a contributor to educational blogs related to Patient Safety on the ‘ASCLS: Patient Safety & the Lab’ section.
Society to Improve Diagnosis in Medicine (SIDM): SIDM's “Vision and Mission is "Creating a world where no patients are harmed by diagnostic error.  SIDM catalyzes and leads change to improve diagnosis and eliminate harm from diagnostic error, in partnership with patients, their families, the healthcare community and every interested stakeholder.”
ACT for Better DiagnosisTM (An initiative of the Society to Improve Diagnosis in Medicine) “Improving diagnosis will not happen overnight, but the most prominent organizations in healthcare and patient advocacy are working together to identify how to improve diagnosis and make care safer." Lead by SIDM, the Coalition to Improve Diagnosis increases awareness and promotes actions that can improve diagnosis.  The organizations behind the ACT for Better DiagnosisTM initiative represent healthcare providers and patients- as well as the leading organizations involved in patient care.  Together, the coalition is working to find solutions that enhance diagnostic safety and quality, reduce harm, and ultimately ensure better health outcomes for patients.”

What is Patient Safety?

To define ‘what is patient safety?’, it is critical to distinguish the difference between ‘patient safety’ and ‘Laboratory safety’.  ‘Patient safety’ focuses on preventing errors associated with the provision of laboratory services and striving to improve care for the patient.  ‘Laboratory safety’ focuses on keeping laboratory professionals safe as they perform their assigned duties.  Both forms of safety are extremely important, however they are not the same nor are the terms interchangeable.
Patient Safety is focused on ‘Do No Harm’ which includes avoiding harm to patients from the care that is intended to help them.  “Medical Laboratory Professionals are stewards of patient safety and must promote a culture of safety and quality defined by the Institute of Medicine (IOM, now the National Academy of Medicine) as safe, effective, patient-centered, timely, efficient, and equitable practice.”1

IOM's Six Quality Aims For Healthcare 2

6 Quality Aims for Healthcare

How do these quality aims directly relate to the practice of Laboratory Medicine?

With each of the six quality aims, there exists tremendous opportunity for medical laboratory professionals to not just work towards ‘error prevention’ but to focus all phases of laboratory services on improving patient outcomes.  Studies have been published that demonstrate the importance of strategically assessing and improving all phases of the ‘total testing process (TTP)’ (e.g. preanalytical, analytical, postanalytical phases).  Laboratory professionals and technological advancements have improved the analytical phase of the TTP so that it now harbors the least amount of error.  It is now important for laboratory professionals to focus efforts on the preanalytical and postanalytical phases of the TTP.  In these phases, the current most vulnerable and error prone processes include: selecting the correct test to order (preanalytical); accurately interpreting test results (post analytical); reporting test results to the patient (postanalytical).3
With each required laboratory process included in the separate phases of the TTP, the process may be evaluated based on how it meets each of the six aims.  Through in-depth evaluation, weaknesses in process may be identified and allow for development of new or revision of current process that will improve outcome, quality and patient safety.  Many of the processes in the preanalytical and postanalytical phases will require laboratory professionals and laboratory teams to step out from the boundaries known as ‘under direct laboratory control’.  Actions should include requesting to form or volunteering to serve on interdisciplinary teams.  Success will happen through direct partnerships which are focused on building trust and open, positive lines of communication with physicians, nurses, other healthcare professionals, patients and families.  All healthcare leaders and professionals must feel compelled and empowered to uphold mutual accountability and speak up for safety.

How can I, as a laboratory professional, positively impact patient safety?

  • Ensure that patient safety is recognized as a core value in the mission of your laboratory and is a top priority for you as a practicing healthcare professional
  • Assist in and support building a laboratory culture in which all leaders and professionals understand the basic principles of patient safety and assure that patient safety continuing education is available for all staff
  • Commit to and support the principles of a ‘just culture’ within the laboratory.  A ‘just culture’ “focuses on identifying and addressing system issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior.” (AHRQ PSNet 2016)
  • Commit to and support behavior expectations for the workforce that contribute to improving patient safety (e.g. transparency, effective teamwork, open communication, just culture, respect, and direct and timely feedback)
  • Incorporate the IOM identified patient safety competencies4 into your daily practice:
    • Provide patient-centered care – recognize the patient is the focus of your practice
    • Employ evidence-based laboratory practice to facilitate and support change
    • Apply quality improvement principles to processes to reduce opportunities for error and improve service delivery
    • Use informatics as an essential component of your practice and to enhance communication to provide safe healthcare delivery
    • Work on interprofessional healthcare teams to provide laboratory expertise in developing innovative and improved healthcare services


  1. ‘Patient Safety and Clinical Laboratory Science’ ASCLS Position Paper
  2. Committee on Quality of Health Care in America. Institute of Medicine.  Kohn L, Corrigan J, Donaldson M., eds. To err is human:  building a safer health system.  Washington DC:  National Academy Press; 2000.
  3. Plebani,M. Diagnostic errors in laboratory medicine-causes and strategies; The Journal of the International Federation of Clinical Chemistry and Laboratory Medicine; eJIFCC 2015; Vol 26 No1; pp007-014
  4. Committee on the Health Professions Education Summit, National Academies Press. Greiner AC, Knebel E, eds.  Health Professions Education: A Bridge to Quality. Washington DC: National Academies Press; 2003.

Additional resource articles on ‘What is Patient Safety’





Helpful Links