Rhetoric Versus Reality? Laboratory Surveys Show Actual Practice Differs Considerably from Proposed Models and Mandated Calculations

https://doi.org/10.1016/j.cll.2016.09.004Get rights and content

Section snippets

Key points

  • There is a large difference between the scientific debate about goals, measurement uncertainty, and analytical goals and the reality of how laboratories routinely operate.

  • Online surveys of laboratory professionals in the United States and around the world were conducted in 2014, 2015, and 2016.

  • Most laboratories that implement measurement uncertainty do so only because of regulatory mandate by ISO (International Organization for Standardization) 15189. They do not have a practical use for the

Materials and methods

In late 2014 through 2016, Westgard QC sent out invitations to online surveys on MU, analytical goal setting, and IQCPs. The survey requests were sent to more than 24,000 laboratory professionals who had voluntarily joined the electronic newsletter list of westgard.com and nearly 15,000 LinkedIn connections who had voluntarily connected with one of the authors. Surveys were conducted on the SurveyMonkey site and consisted of a variety of single-choice, multiple-choice, and free-form comments.

Limitations

The surveys were subject to several biases common to voluntary polling. Although the authors sent out survey requests to more than 24,000 laboratory professionals and 15,000 LinkedIn connections in 2016, both of those are opt-in, self-selecting groups; the type of laboratory professional who chooses to subscribe to a Westgard newsletter may have already expressed a preference and thus results will be affected by self-selection bias. It is also possible that the authors did not search widely

The real state of analytical goal setting

At the end of 2014 and early 2015, Westgard Web conducted a survey, announcing it in an electronic newsletter, which reached more than 20,000 laboratory professionals.1 Similar announcements were made via Twitter, LinkedIn, and various electronic mailing lists that are dedicated to the medical laboratory profession. The authors received more than 450 responses from more than 80 countries.

The most common type of analytical goal used by nearly 2 out of 3 laboratories is the TEa. Target MU was

The real state of measurement uncertainty

In 2015, Westgard Web conducted a global survey of analytical goal setting. This survey obtained more than 550 responses from more than 85 countries, which is the largest response we have had to date. The results were significantly different within the United States, where MU is almost unknown as a concept and rarely implemented save by a handful of laboratories. Thus the authors broke out the responses for non-US or rest of world into 1 set of results, and then the US responses were collected

The real state of individualized quality control plan implementation

In early 2016, after a 2-year educational period, IQCPs became a matter of law in US laboratories. The previous EQC protocols became illegal. For many laboratories, despite 2 years of advanced notice, the details of IQCP implementation remained vague, and it was also a mystery how IQCPs were going to be interpreted by inspectors.

After 6 months of implementation, the authors initiated a survey of laboratories that had implemented IQCPs. Of the surveys we conducted, this one had the smallest

Discussion

In the scientific literature, because of the ISO 1518915 mandate, MU is supreme. In reality, it is a calculation that even compliant laboratories find virtually useless. In the marketing of IQCP, it was promised that this approach would help laboratories choose the right QC and right-size their QC, when in practice it has been mostly used to justify exactly the same QC and same QC frequency. In the scientific literature, there are continuing attacks on the TEa approach, despite its

Summary

There is a common saying about academic debates, that the arguments are so large because the differences are so small. In this case, the differences are significant, but the reason the debate is so loud is because the reality is so unforgiving. Despite all the articles published on the superiority of MU and IQCP, or the imperfections of TEa, laboratories still use the TEa instead of MU and IQCP, and prefer the TEa approach to the forced implementations of MU and IQCP. When laboratories are

First page preview

First page preview
Click to open first page preview

References (15)

  • Analytical global goal survey results. 2015. Available at: https://www.westgard.com/global-goal-results.htm. Accessed...
  • Measurement uncertainty survey results. 2015. Available at: https://www.westgard.com/mu-global-survey.htm. Accessed...
  • IQCP survey results 2016. 2016. Available at: https://www.westgard.com/iqcp-user-survey.htm. Accessed August 22,...
  • IQCP homepage. Available at:...
  • Equivocal QC. Coming soon to a laboratory near you. 2007. Available at: https://www.westgard.com/essay119.htm. Accessed...
  • R.H. Laessig et al.

    CLIA 2003’s new concept: equivalent quality control

    MLO Med Lab Obs

    (2005)
  • EP23–A. Available at: http://shop.clsi.org/method-evaluation-documents/EP23.html. Accessed August 22,...
There are more references available in the full text version of this article.

Cited by (5)

  • Development and implementation of evidence-based laboratory safety management tools for a public health laboratory

    2019, Safety Science
    Citation Excerpt :

    In addition to hazard types, there is a growing body of knowledge about various contributors to workplace safety (e.g. the effects of mental workload (Charles and Nixon, 2019); the need for leadership training (Gravina et al., 2019); the importance of occupational ergonomics (Fasanya and Shofoluwe, 2019) and the effects of worker personality on safety behavior (Jong-Hyun et al., 2018), which have not been well-studied in the laboratory setting. While laboratory safety has long been a priority in public health laboratories (Moskowitz, 1948; Cook, 1961; Fuscaldo et al., 1980), multiple gaps remain between published best practices and the actual implementation of these practices in laboratories (Westgard, 2017; Herrmann-Werner et al., 2013; Van Noorden, 2013). There are many regulations, guidelines and standards relevant to the work performed in laboratories, but strategies for implementation of these guidelines are left to individual laboratories to develop (World Health Organization, 2004; Chosewood and Wilson, 2009; Richmond and Nesby-O'Dell, 2002; Ned-Sykes et al., 2015; 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73 - Select Agent Regulations, 2018; International Organization for Standardization, 2017; Miller et al., 2012; 42 CFR 493, 2018; United States Code, 1988; International Organization for Standardization, 2018; International Organization for Standardization, 2003; International Organization for Standardization, 2012; 29 USC, 1910, 2018).

  • The utility of measurement uncertainty in medical laboratories

    2020, Clinical Chemistry and Laboratory Medicine
View full text