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Ireland Army Community Hospital. CLSI Quality Series. CLSI Quality Series. Set of documents designed for healthcare managers who wish to improve their Quality system through quality management activities - HS1-A2 A Quality System Model for Healthcare - PowerPoint PPT Presentation
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Ireland Army Community Hospital
CLSI Quality Series
CLSI Quality Series
• Set of documents designed for healthcare managers who wish to improve their Quality system through quality management activities
- HS1-A2 A Quality System Model for Healthcare
- GP26-A3 Applications of a Quality System Model for Laboratory Services
- GP 22 Continuous Quality Improvement
- GP27 Using Proficiency Testing to Improve the Clinical Laboratory
- GP2 Development and Control, Lab documents
- C24 Statistical Quality Control
CLSI Quality SeriesPatient
ClinicianAssessment of patient
ClinicianAction on
resultLaboratory Services
Paths of Workflow
Documents and RecordsOrganization
PersonnelEquipment
Purchasing & InventoryProcess Control
Information ManagementOccurrence Management
AssessmentProcess Improvement
Customer Service & SatisfactionFacilities & Safety
CLSI Quality Series
Preanalytic Processes >>> Analytic Processes >>> Postanalytic Processes
Test Ordering>> Specimen Collection>>Transport>>Specimen Receipt/Processing>>
Clinical Laboratory Key Processes
Testing>>Results Review/FU>>Interpretation>>
Result Reporting & Archiving>>Specimen Mgmt
CLSI Quality Series
Quality Manual
System Level Procedures
Instructions
Records, FormsReports
Description of system
Commitment to Quality
Definition of policy
Authority and Responsibilities
The Documented Quality System
Flows and Controls
System Implementation
CLSI Quality Series
Intended for: primarily for Lab directors, managers, and supervisory personnel
Goal: systematic implementation of Quality management approaches
TQM- customer oriented, team focused decision making, anticipatory planning
CQI- ongoing quality improvement
CLSI Quality Series
Why: systematically maximize efficiency, effectiveness, and adaptability
1. licensing and certifying agencies
2. demands to handle more volume with fewer resources
3. changing trends
CLSI Quality Series
• Quality System Essentials: coordinated management activities to direct and control an organization with regard to quality
•The quality system must be managed with a focus on Continuous Quality Improvement
CLSI Quality Series
QSEs
•Document and Records: creation, review, approval
change control
master file
retention, storage and retrieval•Organization: org chart, leadership review, strategic planning•Personnel: hiring, training, competency•Equipment: selection, calibration, maintenance•Purchasing & Inventory: vendor selection, receiving & inspection,
vendor evaluation•Process control: design, validation, QC, PT•Information Management: data issues, security, pat. related info
CLSI Quality Series
•Occurrence Management: detection, documentation and remedial action
investigation and analysis•Internal & External assessment: external assessment, quality
indicators, internal audit, quality reporting•Process Improvement: preventive action, corrective action•Customer Service: needs & satisfaction assessment•Facilities and safety: design, safety surveillance
CLSI Quality SeriesQuality Management, Why it Fails
• Three identifiable phases to implementation
1. Startup: struggle to learn (all levels)
Commitment vs Involvement
Justification and Timing
Too much focus on short term activities
2. Alignment: must align organizational systems and practices
3. Integration: quality - how we do things, not something we do
CLSI Quality Series
Leadership:
“Determine the direction
Set the Pace
Applaud the spirit”
Coordination and Implementation
Facility Department of Pathology
US Army Medical Department Activity Fort Knox, Kentucky 40121-5520
Procedure Procedure No.: Revision Date: Information Title: Total Pages: Date Implemented:
Coordination Signatures
This procedure has been reviewed by the following individuals at the local facility:
Coordinated with... Signature Date Medical Technologist
Technical Supervisor
OIC, Laboratory
Medical Director
Document Control
The total number of copies made for local use is ____ and their locations are:
Copy # Location Copy # Location Master 6
1 7 2 8 3 9 4 10 5 11
Date Rescinded This procedure was rescinded on _____________. All copies listed above
have been retrieved and archived/destroyed as appropriate.
