COLA has acknowledged the findings of a recent Johns Hopkins University study which concludes that if medical errors were tabulated similarly to diseases, they would rank as the third-leading cause of death in the United States, with more than 250,000 deaths each year, behind only heart disease and cancer. The clinical laboratory accreditor has called upon the medical community to begin addressing the concerns raised by the study, and issued a series of recommendations to help laboratories reduce the potential for medical errors.

The Johns Hopkins study indicates that most medical errors represent systemic problems that include the absence of standard protocols and safety nets, poorly coordinated care, and human error.1 Moreover, the researchers conclude, shortcomings in the International Classification of Diseases coding system for cause of death have concealed the severity of the problem, and hinder the ability of healthcare professionals to both cultivate and fund systemwide solutions.

In 2015, the Institute of Medicine (now the Health and Medical Division of the National Academies of Sciences, Engineering, and Medicine) issued a similar report, which asserted that most people will experience at least one diagnostic error in their lifetime.2

Douglas Beigel, COLA.

Douglas Beigel, COLA.

“While these medical errors are a result of inefficiencies throughout the entire system, the laboratory can play a significant role in preventing many of these errors,” says Doug Beigel, CEO of COLA. “It is estimated that laboratory testing influences approximately 70% of all medical decisions. Ensuring quality and excellence in the practice of laboratory medicine can go a long way in reducing overall adverse patient outcomes.”

COLA has issued a series of recommendations to help laboratories reduce the potential for medical errors, and to help build a systemic solution that focuses on ensuring the best quality care for patients:

Interprofessional Teamwork and Communication. Improved patient outcomes require an understanding of how the testing process involves institutional systems beyond the laboratory. Laboratorians can embrace teamwork and collaboration by working with clinicians to develop appropriate protocols for not only ordering tests but also providing interpretation of the test results. A universal transformation of the clinical laboratory from a passive service to an active participant is needed in patient diagnosis, treatment, and management.

Laboratory Training and Education. Specimen collection, labeling, storage, and other steps of the preanalytical testing phase account for 46% to 68% of laboratory errors in the total testing process.3 Yet, allied health professionals with limited laboratory experience or training are often responsible for these functions. Furthermore, point-of-care testing for more than 120 unregulated analytes that contribute to diagnostic decisions require no specialized laboratory training at all. Maintaining and following the highest quality standards should be a universal priority, regardless of the complexity of the test being performed, and regardless of the level of education possessed by the person doing the testing. The laboratory should promote increased education and training about laboratory quality for all individuals performing any part of the testing process.

Transparency in Reporting. Both the Johns Hopkins study and the 2015 Institute of Medicine report include a focus on the reporting of medical errors. Such errors are often concealed in fear of potential reprisals and legal action. The healthcare industry as a whole needs to build a sustainable culture of quality, recognizing that errors create opportunities for improvement. In order to usher in such a societal transformation, the laboratory can begin on the ground level by encouraging staff to feel comfortable self-reporting errors, conducting root cause analysis, crafting long-term solutions, and teaching others how to avoid the same errors in the future.

Increased Research. All professionals should urge colleagues in government and the broader healthcare system to conduct further research into the extent of the problem posed by medical errors. The research conducted by Johns Hopkins and the Institute of Medicine opens the door for further exploration into the prevalence and significance of medical errors stemming from all sectors of the healthcare system. In particular, COLA believes that increased research into the nearly 180,000 largely unregulated certificate-of-waiver laboratory sites could provide valuable information to reduce medical errors and enhance patient safety. The more that research reveals about the existence of a systemic problem, the greater the potential for knowledge and subsequent funding to cultivate long-term and sustainable solutions.

For more information, visit COLA.


  1. Makary MA, Daniel M. Medical error: the third leading cause of death in the US. BMJ. 2016;353:i2139; doi: 10.1136/bmj.i2139.
  1. National Academies of Sciences, Engineering, and Medicine. Improving diagnosis in healthcare. Balogh EP, Miller BT, Ball JR, eds. Washington, DC: The National Academies Press, 2015. Available at:
  1. Plebani M. Errors in clinical laboratories or errors in laboratory medicine. Clin Chem Lab Med. 2006;44(6):750–759; doi: 10.1515/CCLM.2006.123.