WS/T 347-2024 in English
VALIDGuideline for the calibration of complete blood cell count
- Issued on:2024-04-02
- Implemented on:2024-09-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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本标准规定了血细胞分析校准的技术要求。
本标准适用于医疗机构临床实验室进行血细胞分析的校准。
Introduction
Core changes in the standard revision
| Revision dimensions | 2011 version | 2024 version |
|---|---|---|
| Calibration procedures | Basic requirements | Detailed documentation requirements (4.1) |
| Sampling mode | Undefined | Added comparability verification (4.3) |
| Quality control management | General requirements | Quality control charts need to be reset after adjusting the coefficients (4.5) |
Analysis of key technical requirements
1. Specifications for selection of calibrants
The standard specifies two types of calibrants: manufacturer-provided calibrants (7.1.1) and fixed value fresh blood (7.1.2). Non-matching detection systems must be calibrated with fresh blood, and the fixed value must be traceable to the reference method.
Implementation case:
When a tertiary hospital used the Sysmex XN-9000 hematology analyzer, it used the calibrants (batch number XC-A123) provided by the manufacturer and the matching reagents for calibration. After calibration, the WBC bias was reduced from 3.2% to 0.8%.
2. Calibration laboratory qualifications
Added dual system certification requirements of ISO 17025 and ISO 15195 (4.6), and the calibration report must include measurement uncertainty (4.7).
| Key indicators | Technical requirements |
|---|---|
| Background count | Meet the requirements of the instrument manual (5.1) |
| Precision | Take the higher requirement of the manual and WS/T 406 (5.2) |
Optimization of calibration operation process
1. Calibration material handling specifications
Revise the calibrant standing time to 30 minutes (8.2.3.1.2), delete the mixing and dispensing operations, and require the use of independent tube verification (8.2.3.1.5).
2. Calibration Verification Standards
The bias is calculated by taking the average of the last 10 out of 11 tests (8.2.7). The verification standards are shown in Table 2:
- WBC allowable bias ≤1.5%
- Hb allowable bias ≤1.0%
- Plt critical value 3.0%
Implementation Suggestions
- Establish dual-track records: Paper calibration reports and electronic original data are archived simultaneously (kept for ≥2 years)
- Engineer Collaboration Specifications: Outsourced calibration requires signature confirmation from the laboratory director (4.8)
- Environmental Monitoring: Maintain a calibration environment of 18-25℃ (Chapter 6)
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