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Research ArticleOriginal Research

Verification of Assayed Blood Gas Quality Control Ranges

Jeffrey M Haynes and Robert G Fishwick
Respiratory Care April 2022, 67 (4) 428-432; DOI: https://doi.org/10.4187/respcare.09342
Jeffrey M Haynes
Pulmonary Function Laboratory, Elliot Health System, Manchester, New Hampshire.
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  • For correspondence: [email protected]
Robert G Fishwick
Respiratory Care Department, Elliot Health System, Manchester, New Hampshire.
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Abstract

BACKGROUND: Blood gas quality control (QC) is an essential and mandatory part of a laboratory’s quality plan. The acceptable QC range should be 2 SD from the mean value. The use of assayed QC material does not negate the responsibility of the laboratory to calculate the mean and 2 SD ranges of QC measurements for verification. Verifying assayed QC ranges is a Clinical Laboratory Improvement Amendment (CLIA) requirement. This study shows the results of assayed QC mean and 2 SD range verification from a blood gas analyzer.

METHODS: QC data from a blood gas analyzer were compared to manufacturer-provided mean and ranges. The percent difference between the measured mean and the manufacturer-provided mean was calculated to assess agreement. The measured SD was used to determine how many SD the manufacturer-provided ranges were from the measured mean.

RESULTS: The largest difference in mean values was 2.27% > the manufacturer-provided mean. Forty-eight percent of all mean value comparisons showed a difference of 0%, and 71% were < 1%. The manufacturer-provided ranges were considerably wider than the measured 2 SD range, ranging from 2.4–75 SD. None of the manufacturer-provided ranges were deemed acceptable for clinical use.

CONCLUSIONS: Our analysis validates the CLIA mandate and American Association for Respiratory Care Clinical Practice Guideline recommendation that laboratories must verify manufacturer-provided QC means and ranges and adjust QC means and ranges to match the performance of their blood gas analyzer.

  • quality control
  • laboratory errors
  • quality events
  • blood gas analysis
  • patient safety
  • quality assurance

Footnotes

  • Correspondence: Jeffrey M Haynes RRT RPFT FAARC, Pulmonary Function Laboratory, Elliot Health System, 185 Queen City Avenue, Manchester, New Hampshire 03101. E-mail: jhaynes{at}elliot-hs.org
  • Mr Haynes discloses a relationship with Morgan Scientific. Mr Fishwick has disclosed no conflicts of interest.

  • Copyright © 2022 by Daedalus Enterprises
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Respiratory Care: 67 (4)
Respiratory Care
Vol. 67, Issue 4
1 Apr 2022
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Verification of Assayed Blood Gas Quality Control Ranges
Jeffrey M Haynes, Robert G Fishwick
Respiratory Care Apr 2022, 67 (4) 428-432; DOI: 10.4187/respcare.09342

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Verification of Assayed Blood Gas Quality Control Ranges
Jeffrey M Haynes, Robert G Fishwick
Respiratory Care Apr 2022, 67 (4) 428-432; DOI: 10.4187/respcare.09342
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Keywords

  • quality control
  • laboratory errors
  • quality events
  • blood gas analysis
  • patient safety
  • quality assurance

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