A quality assurance program for the measurement of capillary blood cholesterol levels in private pediatric practices. The Children's Health Project
M. J. Bennett, A. M. Tershakovec, J. A. Cortner and B. M. Shannon
Lipid Heart Research Center, Children's Hospital of Philadelphia, Pa.
OBJECTIVE--To develop an easy to use quality assurance program for the
measurement of capillary blood cholesterol levels in private pediatric
practices. The program needed to comply with the guidelines laid down by
the National Cholesterol Education Program. DESIGN--Intervention study.
SETTING--Nine private pediatric practices in and around northern
Philadelphia, Pa. PARTICIPANTS--The analysts included clinic staff members
with laboratory expertise ranging from none to some previous experience.
None of the participants had previous experience with a quality assurance
program. INTERVENTIONS--Progress was reported monthly to the Lipid Research
Laboratory, Philadelphia, and action was taken to correct inaccuracies in
bias or variance. MAIN OUTCOME MEASURE--Compliance with the analytical
guidelines laid down by the National Cholesterol Education Program in that
the coefficient of variation was no greater than 5% and the bias was no
greater than +/- 5% in the first year of the study. RESULTS--Within the
first year of the study, there were 152 monthly quality assurance returns
for each of two lyophilized control materials. On four occasions the
coefficient of variation was greater than 5% while the overall bias was
within the desired +/- 5% on 143 (94%) of 152 occasions. After the first 3
months of the study, as user confidence increased, intervention by the
Lipid Research Laboratory became minimal. The internal quality assurance
was further evaluated by a successful performance in a quarterly external
quality assurance program. CONCLUSIONS--It is possible to devise an easy to
use quality assurance program for extra laboratory measurement of
cholesterol levels in children, and, with minimal assistance, maintain
acceptable standards of cholesterol analysis. The quality assurance
improved following the first 3 months of training and education. Subsequent
continuous quality improvement was maintained with minimal involvement of
the specialist center. Should the controversial issue of private office
measurement of blood cholesterol levels become universally acceptable, the
implication from our study is that standards acceptable to the National
Cholesterol Education Program and the Clinical Laboratory Improvement
Amendments of 1988 are possible using a suitable quality assurance program.
