Internal Quality Control Program (IQC) for Neonatal G6PD Screening Test

Introduction:

  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 G6PD 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 ). 

Procedure:

The program provides two activity levels 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 laboratory using quantitative methods.  In addition to use these IQC result 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 the real-time and long term cumulative statistic result after each run .  Or you can reported 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 more than 9 months.

Results:

( I ) 2019~

1. January 2019

2. February 2019

3. March 2019

4. April 2019

5. May 2019

6. June 2019

7. July 2019

 

( II ) January 2018 ~ December 2018

( III ) January 2017 ~ December 2017

( IV ) January 2016 ~ December 2016

( V ) January 2015 ~ December 2015

( VI ) January 2014 ~ December 2014

( VII ) January 2013 ~ December 2013

( VIII ) May 2012 ~ December 2012

Application:

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 club 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: <nsiqc@pmf.tw>