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Outside the Lab Profession, Training and education, Laboratory management, Clinical care

Let’s Take Control

As we know, laboratory investigations are essential for diagnostic, preventative and therapeutic purposes and it is widely believed that the majority of clinical decisions are made based on data produced by the clinical laboratory. Nevertheless, I believe the real importance of laboratory medicine lies in the bridging of the knowledge gap at the clinician/laboratory interface.

According to a report by Research & Markets, the global in vitro diagnostic market was valued at US$49 billion in 2012. It represents 3 to 5 percent of all healthcare costs and is expected to grow by 7 percent over the period of 2012 to 2017. However, it has been estimated that US$6.8 billion of medical care in the US involves unnecessary testing and procedures that do not improve patient care and may even harm the patient (1)! We need to help reverse this worrying trend.

Users of the clinical laboratory want information that enables them to make better decisions about their patients. They want assurance that the investigations they order will be quick, accurate, and inexpensive and that they’ll get the right investigation on the right patient at the right time, with the results reaching the right clinician at the right time and in the right format. And the right interpretation is essential to ensure optimum patient outcome (2). So, we laboratory professionals need to be involved, not only in the analytical process, but also at the pre- and post-analytical points of laboratory utilization.

Not surprisingly, the use of laboratory diagnostics varies between countries and, according to Research & Markets, it was estimated to be five times greater in the USA than in the UK in 2006. Understandably, there are also large differences in laboratory utilization between individual practitioners. Indeed, many factors determine a physician’s test-ordering practice. In literature surveys (3,4), physicians mostly cite fear of legal (malpractice) complaints as a primary driver of over-testing. Hoffman et al. (5) state the main driver of overdiagnosis and overtreatment is zero tolerance for error and uncertainty.

An analysis of 307 malpractice claims in the USA (6) found the primary cause of misdiagnosis in 55 percent of patients was the failure to order the appropriate diagnostic/laboratory test. And, there is growing recognition that errors in both test selection (inappropriate ordering) and result interpretation can have significant or adverse clinical consequences to patients and financial consequences to healthcare institutions (7).

Inappropriate test utilization is increasing the clinical burden for the health economy, as Moynihan et al. (8) wrote, “Medicine’s much heralded ability to heal the sick is fast being challenged by its propensity to harm the healthy. Too many people are being overdosed, overtreated and overdiagnosed.”

We, the laboratory professionals, play a crucial role in ensuring that laboratory utilization programs should not be exclusively based on reducing the number of tests, but also consider the clinical outcomes and change to patient management.

So what drives overutilization? Causes include patient pressure, duplicate ordering, lack of understanding of the diagnostic value of the test, ordering the wrong test, failure to understand the consequences of overutilization, defensive testing, perverse financial incentives and “availability creating demand.” In fact, resources wasted on unnecessary diagnosis and care can be much better spent treating and preventing genuine illness.

If we look at some of the statistics; Zhi et al. in their systematic review of the literature from 1997 to 2012 (9) found mean rates of testing overutilization to be 20.6 percent. Importantly, overutilization of low-volume tests was higher at 32.2 percent. Both Laposata and Plebani (7,10) showed the highest incidence of error in laboratory testing is in test selection by clinicians and interpretation of test results by clinicians. Others have concurred and recognize that not ordering an appropriate test is also an important cause of 
diagnostic error.

We, the laboratory professionals, play a crucial role in ensuring that laboratory utilization programs should not be exclusively based on reducing the number of tests, but also consider the clinical outcomes and change to patient management. Worryingly, Zhi et al. (9) found the mean rate of underutilization of testing to be almost 45 percent.

We play a key role in implementing strategies to support physicians in test ordering and providing guidelines, education, auditing, use of formularies, electronic order systems (CPOE), use of a minimum of resting intervals, and request vetting. Feedback to users with activity data and costs has also been shown to be important (2). The best approach to improving laboratory utilization therefore comprises 
multiple interventions.

I urge all laboratory professionals to refocus their efforts on the total testing process, rather than simply on the analytical aspects. This is fundamental, and requires input into appropriate test utilization, accurate results and interpretation. In addition, there is no point in ordering a test if no one looks at the results or acts on them. The impact of the failure to follow up and act on results also needs reviewing. We must be involved in implementation of policies to improve laboratory utilization, which will improve patient outcome and avoid patient harm.

Finally, we must not forget that “the target of requesting of the test and of the results should be the patient. It is the person who actually, in the end, is going to have to change their lives and start adopting new behaviors 
[…]” (11).

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  1. E B Holliday, “Test right”, Critical Values, 5:3 (2012).
  2. DB Freedman, “Towards better test utilization – strategies to improve physicians ordering and their impact on patient outcome”, eJIFCC, 26, 1, 15–30 (2015).
  3. HK Kanzaria et al, “Emergency physician perceptions of medically unnecessary advanced diagnostic imaging”, Acad Emerg Med, 22(4), 390–398 (2015). PMID: 25807868.
  4. DM Studdert et al., “Defensive medicine among high risk specialist physicians in a volatile malpractice environment”, JAMA, 293, 2609–2617 (2005). PMID: 15928282.
  5. JR Hoffman, HK Kanzaria, “Intolerance of error and culture of blame drive medical excess”, BMJ, 349, g5702 (2014). PMID: 25315302.
  6. TK Gandhi et al., “Missed and delayed diagnosis in the ambulatory setting: a study of closed malpractice claims”, Ann Intern Med, 145, 488–496 (2006). PMID: 17015866.
  7. M Laposata, “Putting the patient first – using the expertise of laboratory professionals to produce rapid and accurate diagnoses”, Lab Med, 45, 4–5 (2014). PMID: 24719977.
  8. R Moynihan et al., “Preventing over diagnosis – how to stop harming the healthy”, BMJ, 344, e3502 (2012). PMID: 22645185.
  9. M Zhi et al., “The landscape of inappropriate laboratory testing: a 15-year meta-analysis”, PLoS ONE, 8(11), e78962 (2013). PMID: 24260139.
  10. M Plebani, “The detection and prevention of errors in laboratory medicine”, Ann Clin Biochem, 47, 101–110 (2010). PMID: 19952034.
  11. R Goetz, “The decision tree: taking control of your health in the new era of personalised medicine”, Rodale Books, Emmaus, Pennsylvania, USA (2010).
About the Author
Danielle Freedman

Danielle Freedman is Consultant Chemical Pathologist and Associate Physician in Clinical Endocrinology, and Director of Pathology at Luton & Dunstable University Hospital NHS Foundation Trust, UK.

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