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Computerization of clinical laboratory procedure manuals
The American Journal of Medical Technology
|September 1, 1978
Summary
A new computerized system helps federally licensed clinical laboratories manage standard operating procedure manuals for all tests. This system meets regulatory criteria for generating, revising, and excerpting essential laboratory documentation.
Area of Science:
- Clinical laboratory science
- Regulatory compliance
- Information management
Background:
- Federally licensed clinical laboratories are mandated to maintain comprehensive standard operating procedure (SOP) manuals.
- Accurate and up-to-date SOPs are critical for ensuring test quality and regulatory adherence.
- Manual management presents challenges in generation, revision, and dissemination.
Purpose of the Study:
- To introduce a computerized system designed for the management of clinical laboratory SOP manuals.
- To assess the system's compliance with federal regulatory requirements.
- To describe the system's features, manual format, and user feedback.
Main Methods:
- Development of a computerized system for SOP manual creation, modification, and extraction.
- Generation of both hard copy and microfiche outputs.
- Evaluation of the system against federal regulatory standards.
Main Results:
- The developed computerized system effectively generates, revises, and excerpts laboratory manuals.
- The system appears to meet all pertinent federal regulatory criteria for SOP documentation.
- User experience with the system and its output format was documented.
Conclusions:
- The computerized SOP manual system offers a viable solution for clinical laboratories.
- The system facilitates compliance with federal regulations for laboratory testing documentation.
- This technology enhances the efficiency and accuracy of manual management in clinical settings.