CIQAP (Canadian Immunology Quality Assessment Program)

CIQAP is the Public Health Agency of Canada’s domestic external quality assurance (EQA) program for CD4+ T-cell enumeration, located at the National Laboratory for Sexually Transmitted and Bloodborne Infections in Winnipeg, Canada. CD4+ T-cell enumeration by flow cytometry remains an important indicator of a patient’s immune and clinical status, as well as a critical indicator of immune status at time of diagnosis to assess the risk for development of opportunistic infections.

The panel consists of three fresh whole blood specimens (1.5mL) obtained through blood donor programs and characterized using the Navios flow cytometer. for leukocyte phenotyping.

Determination of assigned value: Statistical analysis defines the limits of acceptability of results obtained from participants according to a group mean value.

Evaluation of performance: Each laboratory is required to report lymphocyte T-cell subset percentages of CD3+, CD3+CD4+ and CD3+CD8+. Absolute count values can also be reported as whole numbers (cells/µL), but are not required. For single platform users, this is to be obtained using absolute count beads such as Flow-Count or TruCount. All submitted data are tabulated to obtain the group robust mean value, robust standard deviation and Z-score for each lymphocyte subset; both percentage and absolute count. The performance of the laboratory is assessed using an SD index. If the reported percent or absolute count value is within ±2 SD of the mean, this is marked as “Proficient”. If the reported value is within ±3 SD of the mean, this is marked as “Attention”. If the reported value is greater than 3 SD or less than -3 SD of the mean, this value would be marked as “Fail” and this would require corrective measures.

Report distribution: A performance report is provided for each participant within 2 weeks of the shipment date. This report is available on the CIQAP website and is accessible confidentially to the participant after logging in using their unique user name and password. A final, aggregate report will be distributed to all participants within three weeks of the shipment date.

Additional information can be found in the CIQAP Information Booklet below.

CIQAP provides EQA through administration of proficiency testing (PT) panels and comprehensive corrective and preventative action as required in English and French. The primary objective of CIQAP is to ensure reproducible and accurate T-cell subset measurements by flow cytometry.

Corrective action is a critical component of CIQAP. Participants are contacted with requests for electronic files and a copy of their flow cytometry printouts for analysis when further investigation is required and guided in corrective actions needed for performance improvement. Due to the interactive nature of the program, participants are encouraged to communicate any concerns to the quality improvement team.

There is no fee to enrol or participate in the CIQAP program. 

Eligible participants are those hospitals and laboratories actively performing testing for CD4+ T cell enumeration by conventional flow cytometry.

Confidentiality of testing results and performance is maintained using a password protected online database and numerical laboratory IDs to distinguish testing sites.  Summary data from each session is released to all participants, though the participant anonymity is maintained through the use of their specified laboratory IDs.  Participants will be notified via email prior to sending any results from past or present CIQAP sessions to regulatory authorities or interested parties.

Policy on collusion and/or falsification of data: The CIQAP program takes any accusation of collusion or falsification of data very seriously and has a zero tolerance policy.  Any report of this nature will be thoroughly investigated and if founded, participants can face suspension from the CIQAP program.

To apply to participate in the CIQAP program please contact ciqap@phac-aspc.gc.ca.

Appeals process: Participants have the right to appeal the results of any proficiency test (PT) in which they are enrolled.

Any appeals received will be acknowledged, validated, and investigated, with the outcome communicated to the participant.

If any participant would like to appeal their results, they can email this request to ciqap@phac-aspc.gc.ca.