On Q for Transfusion Services

Deviation Management
Upon completion of this section you will be able to:
Define the terms associated with management of errors, deviations and unexpected events
Structure an effective system for processing of deviations
Outline the steps of Biological product Deviation Reporting
Describes reportable event versus a non reportable event
Describe a fatality submission to FDA
Define a JCAHO sentinel event and be able to outline the steps of reporting

Document Control
Identify the regulatory requirements for document control
Recognize and implement Good Documentation Practices
Describe how policy, process and procedures are developed and controlled retained and archived
Review formats for document development

Equipment
Review regulatory requirements for equipment
Discuss equipment selection considerations
Discuss equipment monitoring and maintenance
Define documentation requirements

Process Control –Change Control
Define change control
Describe factors that make individuals resist change
Describe ways to help manage change
Describe the benefits of managing changes
Describe Project Management as a tool for managing change

Process Control-Risk Management
Define risk management
Describe types of risks and potential losses in a hospital blood bank or donor center.
Apply basic risk management techniques and components to operations

Process Control -Validation
Define Validation and the terms used in validation process
Describe the elements of validation
Differentiate between validation and verification/qualification.
Define Prospective and Retrospective Validation
Develop a Validation Plan

Process Improvement
Define Regulatory Requirements for Process Improvement
Define Process Improvement
List the Common Steps involved in Process Improvement Methods
Identify Available Tools for Process Improvement and how and when to use them

Quality Basics
To explain why quality is important
Define the core concepts of Total Quality Management (TQM) and Process Improvement
To review the regulatory and accreditation impact on the transfusions service

Regulatory and Accreditation Requirements
Discuss the regulatory and accrediting agencies that impact Transfusion Services
Discuss the differences between registered and licensed establishments
Discuss the registration requirements for a Transfusion Service

Resources
List the blood bank regulations that govern human resources
Examine various methods to deliver training
Examine various methods for performing competency testing
Discuss the required records

Supplier and Customer Requirements
Discuss the regulatory requirements of supplier-customer issues
Outline the elements of a supplier qualification program
Define terms associated with Supplier-Customer requirements
Define critical supplies and services
Discuss contract management
Describe elements of managing critical supplies and services
Describe elements of managing nonconforming supplies

Internal Assessments
Define principles of auditing
Describe elements of an effective audit program
Describe the basic steps or phases of an audit
Develop audit tools
Review an audit report and follow-up
Perform an audit

Quality Monitoring
Define a Quality Indicator(QI)
Understand how to select a QI
Identify measurement tools for data collection
List priorities that determine which QI are monitored
Identify requirement for tracking QI’S
Recognize difference between benchmarking and establishing thresholds
Determine the criteria for ongoing monitoring of QI