Basic QC Practices

A new IFCC survey of global practices highlights some old problems.

IFCC Global Survey of QC Standards and Practices

July 2023
James O. Westgard and Sten A. Westgard

In a recent publication [1], the IFCC Task Force on Global Laboratory Quality (TF-GLQ) reported the results from a survey of IQC practices and TQM management in member and affiliate countries. The survey documents the “variability in TQM and IQC practices and highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.”

In this survey, participants represented the following areas:

• 3 countries from AFCC, African Federation of Clinical Chemistry
• 1 country from AFCB, Arab Federation of Clinical Biology
• 9 countries from APFCB, Asian-Pacific Federation of Clinical Chemistry and Laboratory Medicine
• 27 countries from EFLM, European Federation of Clinical Chemistry and Laboratory Medicine
• 6 countries from COLABIOCI, Latin-American Confederation of Clinical Biochemistry
• 0 countries from NAFCC, North America Federation of Clinical Chemistry and Laboratory Medicine

Respondents represented 46 of 110 recipients of the survey. Because each member country counts as 1 respondent, it somewhat difficult to interpret the overall results. For example, EFLM was represented by 27 countries, whereas the North America Federation of Clinical Chemistry and Laboratory Medicine (NAFCC) represents just 2 countries – US and Canada. Furthermore, there was no response from NAFCC, probably because it isn’t really an active organization and is just represented by 1 individual for purposes of voting on IFCC matters. Nonetheless, the survey was considered to provide “…a reasonable estimate of current practices in TQM and IQC practices globally.”

A Note about NAFCC

What is NAFCC? Googling NAFCC provides results for the National Association for Family Child Care. Entering the complete name reveals that NAFCC is an organization that represents the AACC (now known as Association for Diagnostic and Laboratory Medicine, ADLM) and CSCC on the IFCC Executive Board. It was created in 2014 in response to changes in the structure of the IFCC organization. Prior to that time, the US and Canada participated informally in IFCC activities, even as officers of the organization. Now there is an official structure and relationship where ADLM and CSCC alternate, every two years, in appointing a representative to the IFCC Executive Board.

The lack of information about QC practices in the US and Canada would seem like a significant shortcoming, however both countries have extensive regulatory and accreditation requirements that assure well documented quality policies and procedures. Furthermore there exists a recent survey of QC practices in medical laboratories at large academic medical centers [2], as well as a follow-up paper that provides recommendations for improvement [3].

Difficulties with Global Surveys

Westgard Web also conducted global surveys of QC practices in 2017 and 2021. The 2021 survey provided some 613 total responses, with 119 from the US, 110 from Asia-Australia, 63 from the middle-east, 73 from South and Latin America, and 189 from Europe. That leaves about 60 “others” who don’t fit these categories. It is interesting that the authors of the IFCC study cited the results from the 2017 survey, but not those from our 2021 survey.

But, the point we want to raise here is the difference in survey outcomes that could occur when 1 person represents a country vs multiple respondents from an individual country. Our survey results were obtained from volunteers who frequent the Westgard Web whereas the IFCC survey results were from those individuals who represent an IFCC member country (or affiliate). There are difficulties with both approaches in terms of how the “weigh" the influence of participants on the survey results. With our use of volunteer participants, an enthusiastic response from individual countries will greatly influence the survey results. With the IFCC use of individual representatives of each country, large countries with many laboratories will not be weighted appropriately. For example, what would happen if Europe were considered as a single participant rather than 27 countries.

In our 2021 survey, we attempted to deal with this issue by describing the results for all participants and then breaking out the results for 5 subgroups. [You can access the results starting with The Top Ten Findings of the 2021 Global QC Survey then follow the links at the end of that article.]

IFCC Survey Findings

The predominate QC practice globally is the analysis of two levels of controls every 24 hours. This probably reflects the impact of early regulatory programs, such as the US CLIA program that formally set the minimum requirement to analyze two levels of controls every day.

• In two-thirds of the countries, the controls are provided by the manufacturer, whereas the other third use independent control materials.
• Half of the laboratories claim to use Westgard Rules, one-fourth 2 SD rules, and the remaining a “combination” of rules.
• Approximately 80% of countries have “laboratory quality standards” (regulatory and/or accreditation guidelines), but use is mandatory in only about half of those countries. The result is that many laboratories do not have formal policies and procedures to guide their QC practices.

Variability in IQC Practices

The observed variability in practices should actually be expected due to the variability in the quality required for intended medical use of different tests, which depends on the medical practices, patient population, and local treatment guidelines, as well as the imprecision and bias observed for the wide variety of analytical methods in use globally, and the operating parameters to effectively manage laboratory workload and service requirements (such as Turn Around Time). As the authors themselves acknowledge:

“Assessing ongoing assay reproducibility necessitates defining the IQC frequency and levels. This survey was limited in that it queried these questions as a composite of laboratory practice, though frequency and levels of IQC should be assay specific.”

“Running appropriate IQC materials, at appropriate concentrations and intervals is only the first step in truly utilizing IQC for quality management. Establishing performance criteria and follow-up processes for unacceptable results is also critical.”

“Two levels of IQC run every 24 h would be sufficient for high performance assays but inadequate for other [poorer performing] assays.”

“The likely variation in application of IQC rules coupled with the gap in implementation of policies and procedures represents an important area of future education and work to improve laboratory TQM.”

While variability in practices is expected, there is still a right practice for each individual test based on its particular performance parameters. What needs to be constant is a laboratory’s planning process that identifies the appropriate control rules, number of levels of controls, and frequency of IQC. The CLSI guideline for statistical QC provides a “roadmap” for planning risk-based SQC strategies [4]. Practical implementation of this planning approach is aided by the availability of graphical and calculator programs that translate the rather complicated mathematics into user friendly tools [5-7].

IFCC Survey Conclusions and Recommendations

• “This survey represents the current state of global TQM and IQC practices. It demonstrates variability in practices globally,… it shows there is ample room for improvements in the quality management of medical laboratories.
• "These survey results lay the groundwork for the IFCC TF-GLQ to develop training and education programs to increase harmonization and improve quality practices in medical laboratories around the world.
• "Moreover, this highlights an opportunity for the IFCC and other laboratory professional societies to develop guidance on medical laboratory quality strategies and practical approaches with the ultimate goal of improving patient care and outcome."

What’s the point?

There is a need for additional education and training for IQC in medical laboratories, according to this global survey. The authors of the US survey of academic medical laboratories came to the same conclusion. Variability of practices, however, is not the real issue that must be resolved!

What is needed is a standardized IQC planning process that takes into consideration the important variables such as the quality required for intended use, the observed imprecision and bias of individual laboratory methods, as well as laboratory workload and goals for the turnaround time for patient test results. IQC strategies for individual methods are expected to vary, but there still is a right way to do IQC for each test in each laboratory.

References

1. Wheeler SE, Blasutiz IM, Kumer Dabla P, Giannoli J-M, Vassault A, Lin J, Cendejas KA, Perret-Liaudet A, Bais R, Thomas A, Amann EP, Meng QH. Quality standard and internal quality control practices in medical laboratories: an IFCC global survey of member societies. Clin Chem Lab Med 2023; https://doi.org/10.1515/cclm-2023-0492
2. Rosenbaum MW, Flood JG, Melanson SEF, Baumann NA, Marzinke MA, Rai AJ, et al. Quality control practices for chemistry and immunochemistry in a cohort of 21 large academic medical centers. Am J Clin Pathol 2018;150:96-104.
3. Westgard JO, Westgard SA. Establishing evidence-based statistical quality control practices. Am J Clin Pathol20018;151:364-70.
4. CLSI C24-Ed4. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. Clinical and Laboratory Standards Institute, Wayne PA; 2016.
5. Bayat H, Westgard SA, Westgard JO. Planning risk-based SQC strategies: Practical tools to support the new CLSI C24Ed4 guidance. J Appl Lab Med 2017;2:211-221.
6. Westgard JO, Bayat H, Westgard SA. Planning risk-based SQC schedules for bracketed operation of continuous production analyzers. Clin Chem 2018;64:289-296.
7. Westgard JO, Bayat H, Westgard SA. Advanced QC Strategies: Risk-Based Design for Medical Laboratories. Madison WI:Westgard QC, Inc.; 2022.