The Impact of Inpatient Point-Of-Care Blood Glucose Quality Control Testing

Corl, Dawn E.; Yin, Tom S.; Hoofnagle, Andrew N.; Whitney, JoAnne D.; Hirsch, Irl B.; Wisse, Brent E.

doi:10.1111/j.1945-1474.2012.00149.x

Cited by 6 publications

(2 citation statements)

References 15 publications

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“…1 Incorrect results may cause serious harm and change clinical decisions. 2,3 To ensure reliable results, POC devices and test strips should be stored and operated according to manufacturer specifications. In tropical settings, temperature and relative humidity may exceed specified ranges.…”

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confidence: 99%

The Effects of Temperature and Relative Humidity on Point-of-Care Glucose Measurements in Hospital Practice in a Tropical Clinical Setting

Pratumvinit

Charoenkoop

Niwattisaiwong

et al. 2016

J Diabetes Sci Technol

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Inaccuracy of glucose monitoring may derive from test strip, patient, pharmacological, environmental, and other factors. Incorrect results may cause serious harm and change clinical decisions. 2,3 To ensure reliable results, POC devices and test strips should be stored and operated according to manufacturer specifications. In tropical settings, temperature and relative humidity may exceed specified ranges.Our goal was to assess the effects of storage temperature, operating temperature, and operating relative humidity (RH) when ambient conditions in patient ward areas naturally exceeded manufacturer limits because of the tropical setting of Siriraj Hospital. During ISO 22870 4,5 certification inspection, we discovered out-of-limit temperature and RH discrepancies that had to be investigated and corrected. Methods Glucose Meters and Test StripsWe evaluated the photometric SureStep®Flexx meter, SureStep™ Hospital glucose test strips, and control solutions Background: Hospitals in tropical countries experience conditions that exceed manufacturer temperature and humidity limits for point-of-care (POC) glucose reagents. Our goal was to assess the effects of out-of-limits storage temperature, operating temperature, and operating humidity on POC glucose measurement reliability.Methods: Quality control measurements were performed monthly using glucose test strips stored under controlled conditions and in inpatient wards under ambient conditions. Glucose test strips were evaluated in groups organized by operating temperatures of 24-25 (group 1), 28-29 (group 2), and 33-34°C (group 3), and relative humidity (RH) of ≤70 (group A), ~80 (group B), and ~90% (group C). Results:Glucose results for different storage conditions were inconsistent. Measurements at higher operating temperatures had lower values with mean differences of -2.4 (P < .001) and -36.5 (P < .001) mg/dL (28-29 vs 24-25°C), and -3.6 (P < .001) and -37.4 (P < .001) mg/dL (33-34 vs 24-25°C) for low and high control levels, respectively. Measurements at higher RH had lower values with mean differences of -4.0 (P < .001) and -13.2 (P < .001) mg/dL (~80 vs ≤70% RH), and -5.8 (P < .001) and -16.6 (P < .001) mg/dL (~90 vs ≤70% RH) for low and high levels, respectively. Conclusions:High temperature and high RH decreased glucose concentrations for the POC oxidase-based system we evaluated. We recommend that individual hospitals perform stress testing, then determine if maximum absolute differences, which represent highest risk for patients, are clinically significant for decision making by using error grid analysis.

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confidence: 99%

The Effects of Temperature and Relative Humidity on Point-of-Care Glucose Measurements in Hospital Practice in a Tropical Clinical Setting

Pratumvinit

Charoenkoop

Niwattisaiwong

et al. 2016

J Diabetes Sci Technol

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“…The frequency of quality control checks are outlined by regulatory authorities for that country in addition to the manufacturer’s guidelines. 81…”

Section: Advantages and Disadvantages Of Point-of-care Testing For Blmentioning

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Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients

Rajendran

Rayman

2014

J Diabetes Sci Technol

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Glycemic control in hospitalized patients with diabetes requires accurate near-patient glucose monitoring systems. In the past decade, point-of-care blood glucose monitoring devices have become the mainstay of near-patient glucose monitoring in hospitals across the world. In this article, we focus on its history, accuracy, clinical use, and cost-effectiveness. Point-of-care devices have evolved from 1.2 kg instruments with no informatics to handheld lightweight portable devices with advanced connectivity features. Their accuracy however remains a subject of debate, and new standards for their approval have now been issued by both the International Organization for Standardization and the Clinical and Laboratory Standards Institute. While their cost-effectiveness remains to be proved, their clinical value for managing inpatients with diabetes remains unchallenged. This evidence-based review provides an overall view of its use in the hospital setting.

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