Proficiency testing materials for pH and blood gases. The California Thoracic Society experience.

The California Thoracic Society Blood Gas Proficiency Testing Program distributed ampules from three separate lots of quality control products every three months as unknowns to participating clinical (survey) laboratories and ten selected reference laboratories. For eight quarters, aqueous buffers were distributed. For each lot, PCO2 and pH measurements varied within narrow ranges between laboratories. Concurrently, the PO2 measurements varied widely between reference laboratories as well as survey laboratories, but varied minimally when repeatedly assessed on each reference laboratory machine. Change to a fluorocarbon-containing emulsion as a testing medium resulted in a significant reduction in within model and overall variability for PO2. We attribute this reduction in variability to the higher O2 content and decreased temperature sensitivity for PO2 of the fluorocarbon-containing emulsion. Because we have no evidence that the magnitude of the interinstrument differences in PO2 found with these materials would be found with fresh human blood we recommend that regulatory agencies use the results of proficiency testing for PO2 cautiously.

Inter-instrument comparison of blood gas analyzers and assessment of tonometry using fresh heparinized whole human blood.

Because of limitations associated with commercial blood gas quality controls and tonometry of stored blood, fresh heparinized blood was used to compare PO2 and PCO2 performance of ten blood gas analyzers. Function of nine gas mixer/tonometer systems was evaluated. These were used to create blood samples with target values for PO2 and PCO2. All ten analyzers had high precision; this magnified small differences between observed results and target values. Grand mean results from all ten analyzers were within 0.8 mm Hg of the target for PO2 of 40.0 and 100.0 and for PCO2 of 20.0 and 70.0 mm Hg. Eight automated blood gas analyzers gave clinically indistinguishable results for PO2 and PCO2 that were sufficiently accurate for clinical purposes. Also reported is the practicality of using tonometry of fresh heparinized blood in a per shift quality control program for PO2 and PCO2.

Evaluation of the Ciba Corning 840 blood gas analyzer.

BACKGROUND: Because our laboratory had used the Ciba Corning 200 series blood-gas analyzers for a number of years, we were asked to participate in the evaluation of a premarket unit of the Model 840 analyzer (C840). DESCRIPTION OF DEVICE: The C840 is a bench-top instrument that combines a menu-driven user interface with an automated sampler and integrates software for data management and system diagnostics. EVALUATION METHODS: We compared the performance of the C840 to a laboratory-based Ciba Corning 278 (C278), analyzing a total of 325 blood samples. We also evaluated the software for routine laboratory applications. EVALUATION RESULTS: The bias and imprecision (+/- 2 SD) between the C840 and C278 was calculated for pH (+0.004 +/- 0.014 pH units), PCO2 (+1.8 +/- 3.3 torr), and PO2 (+0.01 +/- 9.0 torr for all PO2 ranges; -0.17 +/- 4.8 torr for PO2 < 150 torr). CONCLUSIONS: We conclude that the analytical performance of the C840 is comparable to the C278, and its data storage and interface capabilities should help laboratories meet CLIA-88 requirements.

Carboxyhemoglobin as measured by gas chromatography and with the IL 282 and 482 CO-Oximeters.

We measured the concentration of carboxyhemoglobin (HbCO) in original and CO-tonometered blood samples from 53 intensive-care patients with IL 282 and IL 482 CO-Oximeters and by gas chromatography (GC), finding very strong correlations among the three methods for HbCO concentrations greater than 2.5%. For concentrations within the normal reference interval (less than or equal to 2.5%), however, the correlation between CO-Oximetry and GC is poor (r2 less than 0.26). The capillary mode of the IL 482 has a consistently lower correlation with any other method or mode. The correlations of measurements between the CO-Oximeters for total hemoglobin and oxyhemoglobin were excellent (r2 greater than or equal to 0.98). Correlations for methemoglobin were lower, owing to its low concentrations in the samples. We conclude that the IL 482 and the IL 282 are analytically equivalent for all analytes measured, but that both instruments differentiate poorly between HbCO values that fall within the reference interval.

Measurement of carboxyhemoglobin and total hemoglobin by five specialized spectrophotometers (CO-oximeters) in comparison with reference methods.

We measured total hemoglobin (CtHb) and carboxyhemoglobin (COHb) in 100 patients' blood samples by using five specialized spectrophotometers (CO-oximeters)--IL 482 CO-Oximeter, Corning 2500 CO-oximeter, Radiometer OSM 3 Hemoximeter, Corning 270 CO-oximeter, and the AVL 912 CO-Oxylite--and compared the results with those obtained with the manual cyanmethemoglobin method and a gas-chromatographic (GC) method, respectively. For the CtHb measurements, the differences between the cyanmethemoglobin method and the CO-oximeters were not clinically important for any model. For the blood COHb measurements, the direction of the bias relative to GC was dependent on COHb concentration. In general, the CO-oximeters underestimated COHb concentration for COHb > 2.5% of total hemoglobin but overestimated COHb concentration for COHb < or = 2.5%. We conclude that all five CO-oximeters compared favorably with the reference methods for CtHb and for high concentrations of COHb. However, the inaccuracy of CO-oximeters for low-concentration (< or = 2.5%) COHb measurements may make these instruments unsuitable for some applications.

Changes in oxygen measurements when whole blood is stored in iced plastic or glass syringes.

Tonometered whole-blood and plasma specimens were tested in plastic and glass syringes to determine whether clinically significant changes in gas tensions occur during sample storage. When whole blood was tonometered with 60 and 100 mL/L (6% and 10%) oxygen and then stored for 30 min in iced plastic syringes, the pO2 of the samples remained stable (mean change = +0.4 and +0.8 mmHg, respectively). However, for 140 mL/L (14%) oxygen tonometry, the pO2 increased significantly (mean change = +8.4 mmHg; P less than 0.0001). When tonometered plasma was stored in iced plastic syringes, the pO2 increased progressively at all three concentrations, with the smallest change occurring at 140 mL/L (mean change = +12.6 mmHg) and the greatest at 60 mL/L oxygen (mean change = +20.9 mmHg). In contrast, when iced glass syringes were used for storing plasma or whole blood, no clinically significant changes in pO2 were found at any of the tonometered oxygen values for 60 min. When whole blood was stored in plastic syringes at ambient temperature for 30 min, again no clinically significant changes in pO2 were found at these tonometry conditions. Apparently, some blood gas samples stored in iced plastic syringes may yield clinically significant errors in oxygen tension.

StatPal II pH and Blood Gas Analysis System evaluated.

We evaluated a new portable instrument, the PPG StatPal II pH and Blood Gas Analysis System, designed for "point-of-care" measurements of blood gases and pH. Inaccuracy (% of target value) and imprecision (CV%) were assessed by blood tonometry and comparison with a Corning 178. Within-day results for PCO2 inaccuracy and imprecision ranged from 98.2% to 102.9% and 3.3% to 3.9%, respectively; for PO2, these were 95.5% to 102.3% and 2.3% to 3.0%, respectively. Between-day results for PCO2 inaccuracy and imprecision ranged from 99.2% to 99.3% and from 2.9% to 3.2%, respectively; for PO2, the ranges were 96.2% to 98.2% and 2.6% to 3.0%, respectively. Two PCO2 outliers (in 645 samples = 0.3%) were observed. In general, tonometry recovery, measurement stability, and pH bias results for the StatPal II and Corning 178 were comparable. We conclude that the StatPal II performs within acceptable ranges of inaccuracy and imprecision.

Evaluation of blood gas quality control and proficiency testing materials by tonometry.

Because of consistent differences found by other investigators and by us, we systematically tonometered, sampled, and measured PO2 and PCO2 concentrations of fresh blood, plasma, and several commercial quality control materials in three models of semiautomated blood gas machines. We found no significant differences between materials or machines for PCO2 between 25 to 72 mm Hg. For tonometered PO2 of approximately 25 to 100 mm Hg, the measured PO2 concentrations were accurate for blood, high for materials with hemoglobin or fluorocarbon (high O2 capacity), and very high for other materials (low O2 capacity). A low O2 capacity material tonometered to a PO2 of 0 mm Hg gave very high values in semiautomated machines and gave correct values only when injected repeatedly without interrupting rinse cycles into a manual machine. These findings indicate significant contamination of blood gas machines with fluids other than the sample so that low O2 capacity quality control materials are inadequate for proficiency testing at degrees of PO2 below 100 mm Hg.

Reduced bovine hemoglobin solution evaluated for use as a blood gas quality-control material.

We evaluated a new commercially available partially purified reduced bovine hemoglobin solution (RBHS) and a new tonometer for use in the quality control of blood gas analyzers. RBHS is manufactured in three different formulations, each corresponding to three different bicarbonate-buffering capacities and concentrations of total hemoglobin (ctHb). The P50 for each formulation of RBHS was determined to be as follows: 30.6 mmHg (4.08 kPa) for Level 1, 29.1 mmHg (3.88 kPa) for Level 2, and 28.2 mmHg (3.76 kPa) for Level 3. When RBHS and human blood samples were tonometered at three clinically significant values of PO2 and PCO2, the recovered values for PO2 and PCO2 in RBHS were comparable with those of the tonometered whole blood. Each level of RBHS also produced precise pH (SD < or = 0.006 pH units) and ctHb (SD = 1.0 g/L) values. In addition, when the temperature of a sample chamber was intentionally altered, the changes in RBHS blood gas values closely approximated the changes seen with human blood. RBHS shows more thermal sensitivity than either perfluorocarbon emulsions or aqueous buffers, which are currently being used as quality-control and proficiency testing materials.

Portable blood gas and electrolyte analyzer evaluated in a multiinstitutional study.

A recently introduced blood gas/electrolyte analyzer (SenDx 100((R)), renamed ABL70) intended for point-of-care, near-patient, or stat laboratory use was evaluated simultaneously in four different institutions and compared with three different laboratory bench analyzers with respect to imprecision, inaccuracy (assessed by tonometry), and patient-sample analyses. The analyzer is equipped with a sensor cassette and a reagent cartridge for 50, 100, or 200 analyses and 100 or more traditional quality-control measurements. One analysis requires 170 microL of whole blood and takes <90 s. Statistically, the instrument performed somewhat better (lower CVs) for PO2 and potassium and somewhat worse for pH, PCO2, and ionized calcium than the respective comparison analyzers. However, the overall performance (in terms of CV and accuracy) was satisfactory in terms of clinical (e.g., CLIA '88) goals in all institutions. The mean difference and the CV of that difference in some 400 patient-sample comparisons were as follows: 0.010 (+/- 0.002%) for pH, -0.65 mmHg (+/- 4%) for PCO2, -0.49 mmHg (+/- 6%) for Po2, 0.44 mmol/L (+/- 1.2%) for sodium, -0.013 mmol/L (+/- 2.9%) for potassium, -0.016 mmol/L (+/- 2.6%) for ionized calcium, and -0.016 L/L (+/- 7. 1%) for the hematocrit. Its acceptable analytical performance and ease of operation make the SenDx 100 suitable for the analysis of blood gases and electrolytes.

Effectiveness of a purified human hemoglobin as a blood substitute in the perfused rat liver.

The efficacy of purified cross-linked human hemoglobin solution in maintaining the metabolic integrity of perfused livers from fed rats was determined and compared with that of livers recirculated with red blood cells, perfluorocarbon, and Krebs' Ringer bicarbonate buffer media at normal and accelerated flow rates. The data indicate that oxygen utilization was comparable in livers perfused with red blood cell medium (53.5 +/- 4.0 microL.g liver-1.min-1), hemoglobin (45.7 +/- 1.9), and perfluorocarbon (57.2 +/- 6.1) and less in livers perfused with Krebs' Ringer bicarbonate buffer solution at normal (17.4 +/- 1.4) and high (27.7 +/- 1.4) flow rates. Bile flow, the outflow of glucose and lactic acid, and residual glycogen levels were similar when livers were perfused with red blood cells (hematocrit, 19) and hemoglobin solutions containing 7 g hemoglobin/dL at flow rates of 1.1-1.2 mL.g liver-1.min-1. However, livers perfused with perfluorocarbon at 1.1 mL.g-1.min-1 showed a significantly greater (P less than 0.01) decline in bile flow and outflow of glucose and lactic acid. Livers perfused with Krebs' Ringer bicarbonate buffer at normal (1.3 mL.g-1.min-1) and accelerated flow rates (3.0 mL.g-1.min-1) also showed a progressive decrease in bile flow and marked glycogenolysis as well as depletion of adenosine triphosphate content. In addition, morphological studies (light and electron microscopy) showed more vacuoles, membrane alterations, and increased mitochondrial swelling in livers perfused with Krebs' Ringer bicarbonate buffer and perfluorocarbon. These findings suggest that hepatocyte function in livers from fed rats is maintained equally well with hemoglobin solutions and with red blood cell medium, suggesting that cross-linked hemoglobin solution may serve as an effective blood substitute for maintaining adequate oxygenation and metabolic integrity of the isolated perfused rat liver.

International Federation of Clinical Chemistry (IFCC), Committee on pH, Blood Gases and Electrolytes: approved IFCC recommendation on definitions of quantities and conventions related to blood gases and pH.

Terminology in blood pH and gas analysis can be confusing, both because more than one name has been used for the same quantity, and because the same name has been used for more than one quantity. In addition, several calculated quantities are commonly used, but in some cases many different algorithms have been published for a single quantity. This document contains definitions of the most useful quantities in blood pH and gas analysis, and presents algorithms for the most useful calculated quantities. Use of these should lessen confusion among users and should also result in data that are more comparable among laboratories.

Recommendations on whole blood sampling, transport, and storage for simultaneous determination of pH, blood gases, and electrolytes. International Federation of Clinical Chemistry Scientific Division.

Pre-analytical variables, e.g., specimen collection, transport, and storage, can contribute significantly to inaccurate pH, blood gas, and electrolyte values. The International Federation of Clinical Chemistry (IFCC), through its Committee on pH, Blood Gases and Electrolytes, has developed specific recommendations to minimize the undesirable effects of pre-analytical variables. The Committee has drawn upon the experiences of its own members as well as published data by others. Specifically, the Committee has included pertinent guidelines and suggestions by the IFCC Working Group on Selective Electrodes (WGSE), the National Committee on Clinical Laboratory Standards (NCCLS), and the Electrolyte/Blood Gas Division of the American Association for Clinical Chemistry (AACC). This paper will familiarize the reader with the effect of different types of specimen containers and anticoagulants. It discusses important aspects of specimen collection procedures including patient status and special precautions during specimen collection from indwelling catheters or cannulae. The paper also identifies different requirements in storage and transport of specimens for blood gas and electrolyte analysis.

International Federation of Clinical Chemistry (IFCC). Scientific Division. Committee on pH, Blood Gases and Electrolytes. Approved IFCC recommendations on whole blood sampling, transport and storage for simultaneous determination of pH, blood gases and electrolytes.

Pre-analytical variables, e.g., specimen collection, transport, and storage, can contribute significantly to inaccurate pH, blood gas, and electrolyte values. The International Federation of Clinical Chemistry (IFCC), through its Committee on pH, Blood Gases and Electrolytes, has developed specific recommendations to minimize the undesirable effects of pre-analytical variables. The Committee has drawn upon the experiences of its own members as well as published data by others. Specifically, the Committee has included pertinent guidelines and suggestions by the IFCC Working Group on Selective Electrodes (WGSE), the National Committee on Clinical Laboratory Standards (NCCLS), and the Electrolyte/Blood Gas Division of the American Association for Clinical Chemistry (AACC). This paper will familiarize the reader with the effect of different types of specimen containers and anticoagulants. It discusses important aspects of specimen collection procedures including patients status and special precautions during specimen collection from indwelling catheters or cannulae. The paper also identifies different requirements in storage and transport of specimens for blood gas and electrolyte analysis.