labman g2 Documentation Management Flashcards
it involves the organization, storage, and retrieval of documents
Documentation Management
it ensures that important information is easily accessible, properly maintained, and protected from loss or unauthorized access
Documentation Management
it includes categorizing documents, implementing security measures, and using software systems to manage digital files
Documentation Management
it involves converting paper documents into digital formats and managing these digital documents efficiently
Documentation Management
converting paper documents to digital formats for easier storage and access
Digital Storage
categorizing and indexing documents for quick retrieval
Organization
ensuring only authorized users can access sensitive documents
Access Control
Facilitating teamwork by allowing multiple users to access and edit documents simultaneously
Collaboration
reduces time spent searching for documents and eliminates the need for physical storage
Improved Efficiency
protects documents with encryption and access controls
Enhanced Security
helps meet legal and regulatory requiremets
Better Compliance
Cuts costs related to paper, printing, and storage
Cost Savings
a set of rules, guidelines, or principles that an organization or individual follows to ensure consistent decision-making and behavior
Policy
every document, including test data, quality control logs, patient records, and instrument calibration records, must be full and error-free
Accuracy
use standard formats for every document to maintain consistency and clarity
Standardization
label each record with a unique identifier
Traceability
it specify how long each sort of document should be retained.
Retention Period
when documents reach the end of their retention period, they should be disposed of securely, especially if they contain sensitive or confidential information
Secure Disposal
HIPAA
Health Insurance Portability and Accountability Act
a U.S. law that protects health information and reduces fraud and abuse
HIPAA (Act of 1996)
specifically focuses on the unique requirements of medical laboratories
ISO 15189:2022
regular audits help ensure that documentation procedures adhere to internal and external requirements
Internal and External Audits
may be conducted by lab personnel
Internal audits
frequently performed by regulatory organizations or accreditation agencies
External Audits
guide users on how to identify and resolve common issues, enhancing operational uptime
Troubleshooting and Maintenance
Diagrams, flowcharts, and images that facilitate understanding of complex processes
Visual Aids
for operational and maintenance tasks
Technicians
to ensure compliance and operational efficiency
Managers
as a training tool during onboarding
New Employees
for easy navigation
table contents
each section typically includes objectives, procedures, responsible parties, required tools, and evaluation metrics
Standardized Sections
regular updates are essential to reflect changes in processed or technology
Updates and Version Control
manuals play a key role in regulatory compliance, providing documentation that can be critical during audits
Compliance and Standards
new employees often rely on these manuals for understanding their roles and responsibilities, making them integral to effective training programs
Training and Onboarding