Áp dụng thang Sigma trong đánh giá chất lượng xét nghiệm tại khoa sinh hóa - Bệnh viện Bệnh nhiệt đới Trung ương

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Tác giả: Văn Đại Hà, Thị Hạnh Hoàng, Hoàng Phương Nguyễn, Thị Thanh Hải Nguyễn, Thị Thu Hà Nguyễn, Ngọc Thạch Phạm, Thị Thanh Nhàn Phan

Ngôn ngữ: vie

Ký hiệu phân loại: 542.1 Laboratories

Thông tin xuất bản: Truyền nhiễm Việt Nam, 2023

Mô tả vật lý: 16-23

Bộ sưu tập: Metadata

ID: 502414

Thêm vào giỏ

Áp dụng Sigma metric đánh giá hiệu năng phân tích của các xét nghiệm hóa sinh tại Bệnh viện Bệnh Nhiệt đới Trung ương, từ đó lập kế hoạch kiểm soát chất lượng (QC). Đối tượng và phương pháp: Nghiên cứu mô tả cắt ngang, 24 chỉ số xét nghiệm hóa sinh từ tháng 2/2022 đến tháng 5/2022 tại Khoa Sinh hóa, Bệnh viện Bệnh Nhiệt đới Trung ương. Độ lệch được tính dựa trên kết quả ngoại kiểm của RIQAS (%DEV). Hệ số biến thiên mô tả độ phân tán của các dữ liệu nội kiểm ở hai cấp độ trong ba tháng và TEa là giới hạn chấp nhận cho từng xét nghiệm. Trong nghiên cứu của chúng tôi sử dụng bộ tiêu chuẩn của CLIA (Clinical Laboratory Improvement Amendment - Tổ chức tiêu chuẩn cải tiến phòng xét nghiệm lâm sàng) làm mục tiêu chất lượng. Giá trị sigma của từng xét nghiệm sinh hóa được tính theo dữ liệu trên. Kế hoạch nội kiểm và cải tiến chất lượng đã được điều chỉnh theo quy tắc Westgard Sigma. Kết quả: Hầu hết các xét nghiệm trên cả hai máy đều có giá trị Sigma lớn hơn 3 (ngưỡng giá trị tối thiểu được chấp nhận): trên máy AU400 có 81,25% xét nghiệm, trên máy C501 là 97,78% xét nghiệm. Dựa vào hiệu năng phương pháp, lựa chọn quy trình nội kiểm phù hợp với từng xét nghiệm theo quy tắc Westgard Sigma. Kết luận: Công cụ Six Sigma là phương pháp hữu ích, mang tính định lượng giúp đánh giá nhanh, chính xác chất lượng xét nghiệm từ đó đưa ra kế hoạch cải tiến hiệu quả.Objectives: Apply the sigma metric to evaluate the of the analytical performance of biochemical tests at the National Hospital for Tropical Diseases to design a quality control (QC) strategy. Subjects and methods: Across-sectional descriptive study was conducted on 24 biochemical indicators on Beckman Coulter AU400 and Roche Cobas C501 at the Biochemistry Department of the National Hospital for Tropical Diseases from February 2022 to May 2022. Bias was calculated based on the results of RIQAS external quality assessment (%DEV). The coefficient of variation was calculated using three months of internal quality control measurements at two levels, and desirable specification derived from acceptance limits for proficiency testing of CLIA (Clinical Laboratory Improvement Amendment) was used as the quality goal. The sigma value for each biochemistry test was calculated using the above data. The internal quality control scheme and measure improvements were adjusted according to the Westgard Sigma rules. Results: The sigma value for almost biochemistry tests on Beckman Coulter AU400 and Roche Cobas C501 for two quality control levels were greater than 3 (the minimum acceptable threshold) with the corresponding ratio of 81.25% and 97.78%. Appropriate internal control scheme was selected for each assay based on Westgard Sigma rules. Conclusions: Sigma metrics is a rapid quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides quantifiable data for the laboratory to design an internal quality control scheme, indicate poor assay performance, and evaluate the efficiency of existing laboratory procedures.

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