IQC program for Neonatal Phe Screening Test


The internal quality control (IQC) is very important for the laboratory quality assurance system.  To assist newborn screening laboratories in maintaining the high quality of screening tests, Preventive Medicine Foundation provides “Internal Quality Control Systems for Neonatal Phe Screening Test” for laboratories to monitor with-in laboratory test quality performance.

The systems use independent third-party control materials which could assist newborn screening laboratories meet the requirements recommended by international standards (cf. ISO 15189 and CLSI C24-A3: 2006) that the IQC samples need to be different from the calibrator materials and reagent kits to ensure that the QC procedure provides an independent assessment of system performance.   The control ranges were compatible with range in neonatal bloods.  The quality control samples are prepared from human whole blood spotting on Guthrie cards ( Whatman 903 ). 



The program provides two concentration levels of quality control samples to the newborn screening laboratories for routine internal quality control (IQC) of neonatal screening test, which can also be used for long term interlaboratory comparisons between participating laboratories.

As soon as each participant online submits the IQC result, the real-time statistic result (including mean, SD, CV, TE and σ) and Shewhart QC Chart will be available online immediately for those laboratories using quantitative methods.  In addition to using these IQC results to monitoring with-in laboratory test quality performance, each participant can also use these results for inter-laboratory comparison with other participating laboratories.

Online MIS systems provide real-time and long-term cumulative statistic results after each run.  Or you can report monthly at the end of the month (not later than the 3rd of next month)

The certificate of participation ( or annual certification label  ) will be issued to whom has participated in the IQC program of the year and reported results for more than 9 months.



Peer Group Statistics (Table 1) Month vs. Cumulative (Table 2) QC Chart of Individual Lab



All the IQC programs provide several options.  Each option contains different sets of internal quality control samples.  For details and prices, please contact our Quality Control Center.

After completing the application, the QAP center will provide internal quality control and operation-related materials and instructions according to the plan selected by the applicant.

If you have any questions about the internal quality control programs, please contact Project Manager Ms. Alice Shiau, Tel: +886-2-2703-6080; Fax: +886-2-2703-6070; e-mail: <>