External Quality Assessment (EQA) National Cancer Institute
HLA Typing

The External Quality Assessment Service at the BMT lab, National Cancer Institute provide an external quality assessment (EQA/EPT) service for clinical laboratories. EQA monitors laboratory performance using ‘blind’ samples analyzed as if they were patient samples to ensure testing is comparable, safe and clinically useful to a patient no matter where the testing is performed.

 Introduction

H&I laboratory support is required for:

(i) Solid organ transplantation

(ii) Hematopoietic stem cell transplant programs

(iii) HLA typing as an aid to disease diagnosis, e.g. HLA-B27 and the spondyloarthropathies

(iv) Unrelated hematopoietic stem cell door panels

(v) The provision of HLA/HPA matched blood products

The primary laboratory investigations are:

(vi) Determination of HLA allele type

The purpose of EQA:

• Allow labs to monitor, evaluate and improve all aspects of service provision.

• Allows participants to compare their assay performance across time, across method, across networks

• Give insight into individual lab performance in a national setting helping to drive improvements.

• May reveal unsuspected areas of weakness and can also act as a check on the efficacy of internal quality control procedures.

• Can be used as a tool for competency assessment of lab staff.

• Independent

• Highlights best practice, common errors or poor practice, up-to-date guidance and clinically relevant performance issues.

• EQA participation demonstrates that your laboratory is committed to providing the highest quality of analysis for all patients.

Our EQA Schemes

BMT Lab at NCI, Cairo University Egypt is proud to offer a wide variety of external quality assessment (EQA/EPT) schemes. We use expert knowledge and experience, coupled with a vision for innovation  to continually review our schemes in order to maintain their clinical relevance and convenience for our participants.

  Contact Details

Contact Address: BMT LAB UNIT, National Cancer Institute

                            1 Kasr Elaini st. Foum elkhalig sq. Cairo ,Egypt

Email: webmaster@nci.cu.edu.eg

Website: https://nci.cu.edu.eg/

  Scheme staff:

Director: Prof.Dr. Ghada Mossallam

Operations Manager: Prof.Dr Sally Elfishawi

Deputy Manager: Prof. Dr. Eman Omar

QA officer: Prof..Dr Randa Osman

Scheme Purpose: 

To assess participants’ ability to use molecular methods to correctly identify HLA specificities

        Material                                                  Whole Blood

   Volume of Sample                                              2mL
               
    Distributions per Year                                            1

   No. Samples per Distribution                                5

   Total Samples per Year                                          5

    Assessment Options                                              HLA- A, B, DR

         Consensus                                                             75% agreement

    Satisfactory Performance                 Obtaining 4 or more complete HLA typing in agreement
                                                                           with the consensus typing in a distribution year

Scheme timetable schedule:

Scheme fees:
Scheme                                                     Fees
HLA typing 3 loci/ resolution                     ------
HLA typing 6 loci                                      ------

Performance Reports

Individual laboratory performance reports will be available to view on the Participant’s Portal in line with the published report timetable. Participants will also be able to view performance tables detailing the assessment of all participants for a particular distribution.  Detailed summaries of methodology used by all Participants in each Scheme will also be available to view.
At the end of each distribution year, an annual performance certificate will be available on the Participant’s Portal for each laboratory, detailing your overall performance for each Scheme you participated in.

Performance Criteria

In general, performance assessment is based on establishing a consensus result for HLA alleles or all test samples.

Scheme assessment and satisfactory performance criteria are reviewed by the Steering Committee each year and take into account current Standards for Providers’ established by ISO 17043:2023.

The method used to test the samples is generally not considered during scheme assessment. Schemes are generally analyte driven and different methods should give comparable qualitative results. 

Consensus

To establish the consensus result, 75% or more of participant’s results must be in agreement. If there is less than 75% agreement, consensus is not established and that result is not assessed.

A reference result will be used for assessment in the event that a consensus result is not achieved.

Reference typing, will be performed in an ISO15189/CAP accredited laboratory. A laboratory of a Steering Committee member may also be used for a reference result if alternative/additional testing is required.

Non-submitted Results

Participants that have informed the PT Scheme support of a valid reason for not testing EQA sample(s) are marked as ‘Not Tested’ and are not assessed. In these instances, the total number of samples tested on the report is reduced.

Participants that do not submit results without notification are assessed as ‘Unacceptable’. Where a choice of categories for assessment is provided at registration (e.g. HLA loci for HLA Typing) all categories must be reported.

 Failure to report a registered assessment category will result in unsatisfactory performance.