To err is human; to get a LIMS, divine

by Sam Kim on March 22, 2016 in Genomics

Who first said “To err is human”?  Many would say Alexander Pope, but this in itself would be an error. It was Seneca the Younger, a Roman philosopher, who actually first spoke those words. Undeniably, mistakes happen and they exist wherever people do. In some fields, mistakes are more tolerated than others.  Healthcare is not one of these fields.  A landmark study of the same name “To Err is Human: Building a Safer Healthcare System” exposed just how common mistakes are. This report was one of the first to bring the issue of medical errors and patient safety to the mainstream.  For the public, the report may have been a bit alarming; for those in healthcare, it verified the elephant in the room. Task forces were formed and numerous efforts were implemented to find strategies for reducing errors in patient care.

When people think of healthcare mistakes, they often picture the bedside – perhaps the wrong medication or the wrong dose of medication is administered. There have even been highly publicized cases in which patients have incorrect surgical procedures performed. The healthcare industry is actively engaged in eliminating all mistakes, no matter how big or small.

But healthcare isn’t what it used to be. We now live in the era of personalized and precision medicine, where patients and their physicians have access to a myriad of genetic tests. Genetic testing is currently available for about 2,500 conditions, including cancers and communicable diseases, and it is estimated to be growing by double digits annually. With these test results, clinicians can better diagnose, treat, prevent, and understand disease.

Unfortunately, since genetic testing it is an endeavor that involves humans, it too is prone to error. With any test, there are multiple phases in the process in which mistakes can be made. These are generally classified as pre-analytical, analytical, or post-analytical errors.  Pre-analytical errors take place after the test has been ordered but before the specimen arrives in the lab. Analytical errors are those that happen while the sample is being prepared and processed.  Post-analytical errors, of course, have to do with the reporting, interpreting, and communication of the result to the clinician and the patient. Although it is reported that most lab testing mistakes occur outside of the lab – in either the pre-analytical or post-analytical stage, they do occur in all three phases.

Notably, patients don’t care in which stage a mistake occurs. They simply want and expect accurate test results. And with so many tests now available, how can errors be minimized or eliminated all together?

The industry is scrutinizing all phases of care in light of genetic testing, and is devising strategies to reduce error.  Some of these strategies include:

There are multiple stakeholders involved, and they are all playing their respective parts to apply pressure, refine the system, and reduce inaccuracy. Patients are more educated and engaged than ever before. Rightfully, they demand these new tests, research what their results mean, and hold their physicians and testing labs accountable.  Payers want evidence that testing methods are safe and reliable and data that demonstrate the tests save time and money. Physicians and caretakers are learning to navigate an evolving system by learning about the newest tests, all while being sandwiched in between patients and payers.

Labs that conduct these tests have challenges to contend with as well. They must invest in and rely on process and infrastructure that supports the reduction of error in every phase. Many labs are using a laboratory information management system (LIMS) to manage the intake, processing, and results-stages of samples that come into their labs.  These systems can help labs to dramatically reduce error and prevent it from happening in the first place, through use of robotics and automation.

For labs considering the purchase of a LIMS, some important features for error reduction include:

Without a doubt, a LIMS should be a crucial component in the effort to drive down error. With features such as automation and validation, they can help labs prevent errors before they have chance to occur.

For more information about reducing errors in your lab, contact us.

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References

  1. Donaldson MS. An Overview of To Err is Human: Re-emphasizing the Message of Patient Safety. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 3.Available from: http://www.ncbi.nlm.nih.gov/books/NBK2673/
  2. Pulkkinen, L. Court: $50M verdict in Seattle-area ‘wrongful birth’ doesn’t shock the conscience. Seattle PI. August 26, 2015. http://www.seattlepi.com/local/article/Court-50M-verdict-in-Seattle-area-wrongful-6465297.php#photo-5580968 Accessed March, 2016.
  3. United Health Group. New Report Finds Greater Use of Genetic Testing, but Half of Physicians Concerned About Their Lack of Familiarity with Genetic Tests. http://www.unitedhealthgroup.com/newsroom/articles/news/unitedhealth%20group/2012/0312genetictesting.aspx. Published March 12, 2012. Accessed March, 2016.
  4. Wians, F. Clinical Laboratory Tests: Which, Why, and What do the Results Mean?  Laboratory Medicine. DOI: http://dx.doi.org/10.1309/LM4O4L0HHUTWWUDD
  5. Doctor’s Mistakes in Genetic Test Orders is Warning Signal to Pathologists and Clinical Laboratories. http://www.darkdaily.com/doctors-mistakes-in-genetic-test-orders-is-warning-signal-to-pathologists-and-clinical-laboratories-1029#axzz3uJU0b8YU. Published October 29, 2012. Accessed March, 2016.
  6. Don’t Do it AMA. http://yalecancergeneticcounseling.blogspot.com/. Published May 29, 2017. Accessed March, 2016.
  7. Langreth, R. Fumbled DNA Tests Mean Peril for Breast Cancer Patients. Bloomberg Business. September 9, 2012. http://www.bloomberg.com/news/articles/2012-09-10/fumbled-dna-tests-mean-peril-for-breast-cancer-patients.
  8. Ravine, D. and Suthers, G. Quality standards and samples in genetic testing. J Clin Pathol. doi:10.1136/jclinpath-2011-20051.
  9. de Gruyter, W.Plebani. Review of Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44(6):750–759. DOI 10.1515/CCLM.2006.123.

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