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Biochemical Measurement of Neonatal Hypoxia
Published on: August 24, 2011
Quality assurance program for neonatal screening of glucose-6-phosphate dehydrogenase deficiency
Szu-Hui Chiang1, Kuei-Fen Wu, Tze-Tze Liu
1Department of Medical Research and Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Insights
Taiwan
Area of Science:
- Clinical Diagnostics
- Public Health Screening
- Biochemistry
Background:
- Taiwan initiated a nationwide neonatal screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency in 1987.
- The program achieves over 96% newborn collection rate, with an overall incidence of approximately 2% G6PD deficiency.
- The screening network includes 3 centers and 18 hospitals across Taiwan and its outlying islands.
Purpose of the Study:
- To develop and assess an external quality assurance (QA) program for G6PD assays.
- To evaluate the reliability and accuracy of both screening and confirmatory G6PD tests used in the program.
- To identify and rectify analytical errors in participating laboratories.
Main Methods:
- Developed lyophilized red blood cell and whole blood QC materials for quantitative and screening G6PD assays.
- Periodically distributed QC materials to 21 referral laboratories and 8 screening centers (including international sites).
- Evaluated QA results against median reports and reference values, with troubleshooting for detected errors.
Main Results:
- Over 104 quantitative QA surveys (1988-2001), 12.6% of reports showed abnormal results, primarily due to instrumental (46.4%) and experimental (17.2%) errors.
- Screening QA (1999-2001) identified 1 false negative and 14 false positive results among 1,110 tests (3.6% of reports).
- Errors often correlated with inadequate internal QA practices in participating labs.
Conclusions:
- The external QA program effectively monitors G6PD testing performance in hospitals and screening centers.
- The program provides crucial guidance for correcting analytical errors, enhancing diagnostic accuracy.
- Implementing robust internal QA is vital for minimizing errors in G6PD testing.
Abstract:
The nationwide neonatal screening of glucose-6-phosphate dehydrogenase (G6PD) deficiency in Taiwan was started on July 1, 1987. The effective collection rate has reached more than 96% of all newborns since 1993 and the overall incidence rate of G6PD deficiency was about 2%. This screening program has 3 screening centers and 18 referral hospitals, distributed around Taiwan including outlying islands. To assess the reliability of the confirmatory and screening tests, an external quality assurance (QA) program for G6PD assay was developed. For quantitative assay of G6PD activity, lyophilized quality control materials with different G6PD activities were prepared from red blood cells. For G6PD screening, quality control materials with different G6PD activities were prepared from whole blood and spotted onto the blood collecting filter paper. Periodically (1-2 months), the QC materials were sent to each of the referral hospitals and screening centers by speed post delivery. The external QA results were evaluated and compared to the median of all the reports and the reference values determined by our laboratory. Whenever an analytical system error was detected in any participating laboratory, troubleshooting was carried out either by contacting by phone or visiting in person. Twenty-one referral laboratories and 8 screening centers (3 in Taiwan, 2 in Mainland China, and one each in the Philippines, Thailand and Lebanon) participated in the QA program. Three to 5 QC specimens were sent to every participating referral laboratory for each quantitative survey. From January 1988 to June 2001, 104 QA surveys were carried out and 1,891 reports were received. Two hundred and thirty-nine (12.6%, 239/1,891) QA reports had abnormal results, attributed to clerical (13%, 31/239), experimental (17.2%, 41/239), and instrumental errors (46.4%, 111/239). Most of the experimental and instrumental errors were found in those laboratories that did not execute internal QA properly. For the screening QA program, 10 QC blood spots were delivered to every participating screening center for each survey. From March 1999 to June 2001, 15 screening surveys were performed with 111 reports received. One false negative (1/1,110) and 14 (14/1,110) false positive results were found in four (3.6%, 4/111) of the screening QA reports. The external quality assurance program proved useful for monitoring the performance of G6PD tests in referral hospitals and screening centers, and provided guidance for correcting analytical errors.
