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Should spirometer quality control be treated like other laboratory devices?

Jeffrey M. Haynes, Gregg L. Ruppel
ERJ Open Research 2019 5: 00249-2018; DOI: 10.1183/23120541.00249-2018
Jeffrey M. Haynes
1Pulmonary Function Laboratory, St Joseph Hospital, Nashua, NH, USA
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Gregg L. Ruppel
2Division of Pulmonary, Critical Care, and Sleep Medicine, St Louis University, St Louis, MO, USA
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Abstract

The ATS/ERS spirometer calibration standards may not be adequate http://ow.ly/Pqdq30nwAmb

To the Editor:

Spirometry plays an important role in the diagnosis and management of obstructive and restrictive lung disease [1–4]. To help ensure the accuracy of spirometry testing the American Thoracic Society (ATS)/European Respiratory Society (ERS) recommend that the calibration of spirometers be verified daily with a 3-L syringe and the recorded value should be 3 L ±3.5% [5]. This recommendation is based on expert opinion, not evidence. The following case describes a situation where a significant spirometer malfunction was not detected by the ATS/ERS spirometer calibration limits and offers an alternative approach to spirometer quality control.

Calibration verification of a pressure differential pneumotach with a 3-L calibration syringe produced a value of 3.07 L. This reading falls within the ATS/ERS range of acceptability (2.90–3.10 L), but is historically an unusual reading for this device. Closer inspection of the pneumotach performance including repeat calibration verification, which included pauses between strokes, revealed a positive zero-flow error [6]. A positive zero-flow error can falsely elevate spirometry indices and preclude the achievement of end-of-test criteria [5, 6].

Following this incident, spirometer calibration data from the preceding 6 weeks was used to create a Levey–Jennings chart displaying the mean±2sd calibration value (figure 1). Plotting the 3.07 L calibration value showed that the reading was nearly 6sd away from the mean value for this device, while still satisfying the ATS/ERS quality control standard. Using the mean±2sd as a quality control range is common in laboratory medicine, but not in pulmonary function laboratories. A value outside of these limits is an unusual finding for a properly functioning analyser and should prompt close inspection and troubleshooting of the device. Indeed, in this case using the mean±2sd was sensitive to a significant positive zero-flow error where the ATS/ERS recommended range was not. We believe that the performance of modern spirometers allows for tighter calibration ranges [7], including the use of mean±2sd. For example, one approach would be stipulating that the mean calibration value should be 3 L ±1.5% (2.95–3.05 L) for accuracy and the 2sd range should not produce a coefficient of variation >3% for precision. Spirometer calibration limits could be established by the manufacturer and integrated into the software for each model such that continuous statistics for every calibration are recorded. Alternatively, the software could determine calibration limits for each individual device after clinical testing has begun. Measurements used to calculate the mean and sd of spirometer performance should be carried out on different days. If the pneumotach uses single patient use flow sensors, a different sensor should be used for each calibration. If the precision of a device is too narrow to use sd ranges, a fixed error tighter than the current 3.5% should be used. Calibration limits based on performance rather than fixed arbitrary values may provide better quality control of spirometer devices.

FIGURE 1
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FIGURE 1

Spirometer calibration data plotted as a Levey–Jennings graph. The final datapoint was the product of a positive zero-flow error. Mean±sd value: 2.98±0.02 L. ATPS: ambient temperature and pressure saturated with water vapour; ATS/ERS: American Thoracic Society/European Respiratory Society calibration limits.

Footnotes

  • Conflict of interest: J.M. Haynes reports personal fees from Morgan Scientific Inc. (paid Consultant), outside the submitted work.

  • Conflict of interest: G.L. Ruppel has no other disclosures except for speaking fees from MGC Diagnostics, outside the submitted work.

  • Received December 18, 2018.
  • Accepted December 21, 2018.
  • Copyright ©ERS 2019

This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

References

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    3. Brusasco V, et al.
    Interpretative strategies for lung function tests. Eur Respir J 2005; 26: 948–968.
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  2. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2018. www.ginasthma.org
  3. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, 2018 report. www.goldcopd.org
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    1. Raghu G,
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    An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med 2011; 183: 788–824.
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    1. Miller MR,
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    Standardisation of spirometry. Eur Respir J 2005; 26: 319–338.
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    Is my lung function really that good? Flow-type spirometer problems that elevate test results. Chest 2004; 125: 1902–1909.
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    OpenUrlAbstract/FREE Full Text
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Should spirometer quality control be treated like other laboratory devices?
Jeffrey M. Haynes, Gregg L. Ruppel
ERJ Open Research Feb 2019, 5 (1) 00249-2018; DOI: 10.1183/23120541.00249-2018

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Should spirometer quality control be treated like other laboratory devices?
Jeffrey M. Haynes, Gregg L. Ruppel
ERJ Open Research Feb 2019, 5 (1) 00249-2018; DOI: 10.1183/23120541.00249-2018
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