The National Academies of Medicine, formerly the Institute of Medicine, recently published a report that concludes that “diagnostic errors – inaccurate or delayed diagnoses – persist throughout all settings of care and continue to harm an unacceptable number of patients.” In reviewing the evidence, the committee concluded that most people will experience a diagnostic error in their lifetime.

COLA,a national laboratory accreditor and long-time advocate for quality in laboratory medicine and patient care, strongly supports the report’s findings, as well as calls for increased research into the adverse patient outcomes as a result of diagnostic errors, and in particular laboratory tests such as those granted a Certificate of Waiver under CLIA ’88. Additionally, more effective teamwork in the diagnostic process among allied health care and laboratory professionals can have significant and positive impacts on reducing diagnostic error and enhancing the quality of patient care.

Study Highlights

The study cited the following statistics regarding diagnostic errors:

  • An estimated 5 percent of U.S. adults seeking outpatient care each year experience a diagnostic error
  • Postmortem research spanning decades indicates that diagnostic errors contribute to about 10 percent of patient deaths
  • Medical record reviews suggest that diagnostic errors account for 6-17 percent of hospital adverse events
  • Diagnostic errors are the leading type of paid medical malpractice claims, are almost twice as likely to have resulted in the patient’s death compared to other claims and represent the highest proportion of total payments

While the report asserts that causes of these diagnostic errors can stem from a variety of different circumstances – such as inadequate communication among clinicians; a healthcare system that is not optimized to support the diagnostic process; and a culture that discourages transparency and disclosure of diagnostic errors – the effects are the same.  These errors can leave lasting impacts both physically and emotionally; sometimes they can even be fatal.

The report included eight broad goals for reducing diagnostic errors and improving diagnosis, including:

  1. Facilitate more effective teamwork in the diagnostic process among health care professionals, patients, and their families
  2. Enhance health care professional education and training in the diagnostic process
  3. Ensure that health information technologies support patients and health care 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
  8. Provide dedicated funding for research on the diagnostic process and diagnostic errors

Following are COLA recommendations for enhancing the role of the laboratory to help to achieve these goals:


Laboratorians can embrace teamwork and collaboration among all healthcare professionals by working with clinicians to develop appropriate protocols for not only ordering but also providing interpretation of the test results.

The medical laboratory is an integral component of the health care diagnostic process. It is essential that the laboratory recognize their role in this process and engage with their health care counterparts across all disciplines with the ultimate goal of improving patient outcomes.  As the report recommends, this includes “collaboration throughout the testing process, including the ordering of appropriate tests or images, analysis and interpretation, the reporting and communication of results, and subsequent decision making.”

It is not possible for any one individual to have fingertip information on the utility and interpretation of each and every clinical laboratory test available; therefore, laboratories have an obligation to provide decision support tools for test ordering.

To do this effectively, laboratorians need to work with clinicians directly to develop appropriate protocols for not only ordering tests but also in providing interpretation of the results, particularly when multiple integrated tests have been ordered. Reference laboratories —  including hospitals, health systems, ACO’s, and regional reference and national reference laboratories — have LIS systems possessing the ability to facilitate knowledgeable ordering and test interpretation that can include evidence-based guidelines for diagnosis and disease management.


Increased education and training on laboratory quality should be provided to allied health professionals and all individuals performing any component of laboratory testing, regardless of the complexity of the testing.

Enactment of the Affordable Care Act, the rise of retail medicine, documented shortages in the laboratory workforce, the emergence of alternate healthcare delivery models and other factors have launched a movement towards expanding the role of nurses and other allied health professionals in performing a large and growing percentage of laboratory testing.

Often allied health professionals are also responsible for specimen collection and other steps of the pre-analytical testing process, the most error-prone phase of testing. Yet, often these professionals have limited experience and training on the tests they are performing. Regardless of the complexity of the test being performed, and regardless of the level of education possessed by the person doing the testing, maintaining and following the highest quality standards should be a universal priority.

COLA also believes that increased education for Certificate of Waiver site personnel is essential to ensure quality testing. In its white paper, Federal Government Questions Quality in Waived Testing, COLA documented the growing role of waived testing (which consists of simple tests performed at the point-of-care that are “waived” from most federal oversight), and shared CDC and CMS evidence that demonstrates that mounting quality problems exist in the largely unregulated labs relying on these tests, with the potential to contribute to diagnostic errors leading to patient harm.

COLA believes that more education is needed for Certificate of Waiver site directors and all personnel performing laboratory testing. In particular, the importance of following manufacturers’ instructions, adhering to expiration dates, performing Quality Control testing, and proper documentation and recordkeeping.


Laboratorians and healthcare professionals everywhere should share their stories to encourage a new culture of transparency in reporting of diagnostic and laboratory errors.

COLA believes there is a need to open a larger discussion about ushering in a new culture of transparency in the reporting of diagnostic and laboratory errors.  The key to creating a sustainable culture of quality is recognizing that errors create opportunities for learning.  Errors should not be opportunities for shaming or reprisals.  Rather, the goal for the laboratory and other health professionals is to feel comfortable self-reporting errors, and to treat mistakes as teachable moments that can be used to craft solutions, and to teach others how to avoid the same errors in the future.

To further the goal of industry transparency, COLA recently launched a website,, a community for laboratorians, allied health professionals and patients alike, to exchange ideas, experiences and stories demonstrating the importance of quality laboratory medicine.  An outgrowth of the recent COLA Leadership Summit, which included healthcare leaders from across all disciplines, the online community encourages lab professionals, doctors, consumer patients and others to share personal stories about how lab results have helped doctors make critical diagnoses; how patient outcomes (both good and bad) have been affected by lab results; and how lab teams are committed to patient safety and quality.

By telling stories of how lab testing has made an impact on the care of a patient, we as a community can create that culture of quality that encourages transparency and elevates the perception of the value of laboratory medicine. Once that value is clear, the need for empirical evidence that quantifies the impacts of laboratory and diagnostic errors will be palpable.


All professionals should urge colleagues in government and the broader healthcare system to further research the relationship between diagnostic and laboratory (particularly waived testing) errors and patient outcomes.

COLA continues to advocate for increased research into clinical outcomes of diagnostic errors.  It already has begun sharing patient outcomes as a result of laboratory testing on and urges its colleagues in government and the healthcare community to also begin exploring the relationship between testing errors, in particular waived testing, and patient outcomes. While anecdotal evidence exists, without adequate and current data depicting a causal relationship between adverse patient outcomes to waived testing quality lapses, the industry cannot begin to design effective solutions to the problems it faces.

In 2005, The CDC published a Morbidity and Mortality Weekly Report called “Good Laboratory Practices for Waived Testing Sites” that cited CMS data from surveyed Certificate of Waiver sites in 2002-2004 finding that among Certificate of Waiver sites:

  • 12% did not have the most recent instructions for the waived test systems they were using
  • 21% reported they did not routinely check the product insert or instructions for changes to the information
  • 21% did not perform QC testing as specified by manufacturer’s instructions
  • 18% of the sites did not use correct terminology or units of measure when reporting results.

The findings of this report are profound. It is clear that there are quality concerns in these largely unregulated testing sites that have the potential to harm patients, as results from waived tests can be used to adjust treatment and medication in those undergoing anticoagulation therapy, diabetics, HIV patients and more.

As we reach the 10-year anniversary of this report and the number of waived testing systems has skyrocketed to over 4,000, it is time for government and industry leaders to take a renewed look at the potential patient implications of errors in waived testing.

In addition to waived testing-specific research, COLA believes that a need for more research on the overall clinical outcomes of errors in the diagnostic process and to further explore the findings of the recent IOM study and ensure the patients we serve are receiving the best quality care possible.

About The Author

As the Chief Executive Officer at COLA, Mr. Beigel leads a dynamic team responsible for helping nearly 8,000 laboratories across the country fulfill their accreditation obligations under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988. He has received numerous awards including the “Edwards Medal” from The American Society for Quality (ASQ) in recognition of his leadership and contributions to the field of quality methodology and The “Award of Excellence in Finance and Administration” from the American Society of Association Executives (ASAE) which honors extraordinary efforts to solve intricate problems through creative technology applications. Mr. Beigel is a member of ASAE, the American Association of Medical Society Executives (AAMSE), and Sigma Iota Epsilon. A resident of Howard County, Maryland for over 30 years, Mr. Beigel is active in the community, serving on the Board of Trustees for both the Howard Hospital Foundation and the Howard County Police Foundation. In addition, he also serves as a member of the Chamber of Commerce of Howard County and the Howard County Leadership program. He received his MA from Loyola College and an MBA from the Merrick School of Business at the University of Baltimore.

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