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包括的リスク管理とプロセス分析による検査室の質の向上

Shobha C Ramachandra1, Venkatesha Madegowda1, Manish Kumar Pandey1

  • 1BiochemistryJSS Medical College.

Annals of clinical biochemistry
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まとめ

失敗モードと影響解析（FMEA）とシグマ指標を統合することで、臨床検査室のエラーが効果的に減少し、患者の安全性が向上しました。このアプローチは、臨床検査室における継続的な品質改善のための堅牢なフレームワークを提供します。

キーワード:
検査室管理検査室方法品質保証・管理

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科学分野:

  • 臨床検査科学
  • ヘルスケアにおける品質管理
  • 医療診断

背景:

  • 検査室のエラーは、患者の安全性と臨床的意思決定に大きな影響を与えます。
  • 既存の品質システムは、検査室プロセスエラーの防止において限界があります。
  • 検査室のリスク評価のために、失敗モードと影響解析（FMEA）とシグマ指標を統合することに関する研究は限られています。

研究 の 目的:

  • 失敗モードと影響解析（FMEA）とシグマ指標を組み合わせたアプローチを用いて、検査室のエラーを評価すること。
  • NABL認定の三次医療病院の検査室内の失敗モードを特定し、優先順位を付けること。
  • エラー削減とシグマ指標向上のための是正措置の効果を評価すること。

主な方法:

  • 総検査プロセスにおけるエラーを特定するためにFMEAを利用した2.5年間の後向き観察研究。
  • 四半期ごとのエラー率を計算し、100万あたりの欠陥数（DPM）に変換し、シグマ指標として表現しました。
  • 四半期ごとにリスク優先度数（RPN）を計算して失敗の優先順位を付け、介入前後のシグマ値を比較しました。

主要な成果:

  • 23種類のエラーが特定され、その中で溶血サンプル、凝固サンプル、およびクリティカル値の非通知が最も高いリスク優先度数（RPN）を示しました。
  • 溶血サンプル（0.97%から0.49%）および凝固サンプル（0.24%から0.06%）で有意な減少が観察されました。
  • クリティカル値の非通知の減少（2.63%から2.18%）が認められましたが、統計的には有意ではありませんでした（p=0.065）。

結論:

  • FMEAとシグマ指標の統合は、検査室のエラーの体系的な特定、優先順位付け、および削減のための強力なフレームワークを提供します。
  • 継続的な監視と是正措置の実施は、検査室の質の改善を維持し、患者の安全性を向上させるために不可欠です。
  • この組み合わせアプローチは、臨床検査室の設定における堅牢なリスク管理の可能性を示しています。