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Formation and Evaluation of Complete Blood Count Proficiency Testing Program.

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Summary
This summary is machine-generated.

This study developed stable complete blood count (CBC) external quality assessment (EQA) samples meeting ISO standards. The EQA materials demonstrate good homogeneity and stability for up to 16 weeks, ensuring reliable quality assurance in haematology.

Keywords:
ISO 13528:2015completed blood countexternal quality assessmenthomogeneitystability

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Area of Science:

  • Medical Laboratory Science
  • Clinical Chemistry
  • Haematology

Background:

  • External Quality Assessment (EQA) is crucial for laboratory quality assurance.
  • Developing cost-effective and high-quality complete blood count (CBC) EQA materials presents challenges for organizers in Vietnam.
  • Ensuring the reliability of CBC EQA samples is vital for accurate patient diagnostics.

Purpose of the Study:

  • To evaluate the homogeneity, long-term stability, and peer-group performance of 10-parameter stabilised CBC EQA samples.
  • To assess the suitability of these EQA materials for use in Vietnam's haematology EQA schemes.
  • To determine if the prepared EQA samples meet international quality standards like ISO 13528:2015.

Main Methods:

  • Preparation of stabilised CBC EQA material by adjusting erythrocyte, leukocyte, and platelet levels, followed by batch mixing and cold storage (2-6 °C).
  • Homogeneity and long-term stability testing using randomly selected specimens according to ISO 13528:2015.
  • Distribution of EQA samples to participants for analysis on automated cell counters and subsequent peer-group performance evaluation.

Main Results:

  • The 10-parameter stabilised CBC EQA materials achieved homogeneity and stability within 12 weeks at 2-6 °C.
  • Five specific parameters (RBC, Hb, MCH, MCV, MPV) maintained stability for up to 16 weeks under storage conditions.
  • Peer-group analysis indicated increased coefficient of variation (CV) at low concentrations, particularly for platelet counts.

Conclusions:

  • The stabilised CBC EQA samples, prepared using a partial fixation method with aldehyde and glutaraldehyde, meet ISO 13528:2015 requirements for homogeneity and long-term stability.
  • The developed EQA materials are suitable for use in haematology EQA schemes, offering a reliable quality assurance solution.
  • Categorizing participant methods into peer groups is recommended for analytical performance evaluation to account for variations.