SERUM-ALBUMIN CONCENTRATION-RELATED HEALTH-CARE FINANCING ADMINISTRATION QUALITY ASSURANCE CRITERION IS METHOD-DEPENDENT - REVISION IS NECESSARY

The objective of this study was to examine quantitative differences between the two commonly used methods for determining serum albumin concentration, bromcresol green (BCG) and bromcresol purple (BCP), in normal subjects and in 235 unselected dialysis patients in view of recently established Health Care Financing Administration (HCFA) quality assurance review criteria. The mean of normal results by the BCG method was 4.4 g/dL, and 97.5% of values were 3.8 g/dL or higher. The mean of normal results by the BCP method was 3.9 g/dL, and 97.5% of values were 3.3 g/dL or higher. Serum albumin concentrations in samples from the dialysis patients had respectively lower mean values by both methods. For the BCG method, the mean was 3.8 g/dL, and 82% of values were 3.5 g/dL or higher; for the BCP method, the mean was 3.3 g/dL, and 82% of values were 3.0 g/dL or higher. Likewise, for the reference immunonephelometric procedure, the mean value for the dialysis patients was 3.3 g/dL, and 82% of values were 3.0 g/dL or higher. For the samples from the dialysis patients, in comparison with the immunonephelometric method, the BCG method exhibited both constant (intercept = 9.3 gIL) and proportional error (slope = 0:87). The mean albumin value for the BCG method was 3.8 g/dL, 15% higher. In contrast, the BCP method compared closely with the reference method: slope = 1.00, intercept = 0.8 gIL, mean x = 3.3 g/dL, mean y = 3.3 g/dL. The HCFA quality assurance criteria are valid only for the BCG method. New criteria, 3.0 g/dL for hemodialysis patients and 2.5 g/dL for peritoneal dialysis and all pediatric dialysis patients, must be included for the more specific BCP method. Each dialysis facility must be aware of the specific albumin method used by its clinical laboratory and, based on the particular method, determine appropriate quality assurance limits. These findings also have implications for the use of serum albumin concentration in comparing dialysis patient and other patient populations. Finally, this report vividly illustrate one of the problems when government regulators develop screening criteria for clinical situations without adequate input and testing. © 1993, National Kidney Foundation. All rights reserved. All rights reserved.