Ireland Army Community Hospital

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Ireland Army Community Hospital
CLSI Quality Series
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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

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CLSI Quality Series
Patient
Laboratory Services
Clinician Assessment of patient
Clinician Action on result
Paths of Workflow
Documents and Records Organization Personnel Equip
ment Purchasing Inventory Process
Control Information Management Occurrence
Management Assessment Process Improvement Customer
Service Satisfaction Facilities Safety
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CLSI Quality Series
Clinical Laboratory Key Processes
Result Reporting ArchivinggtgtSpecimen Mgmt
Preanalytic Processes gtgtgt Analytic Processes gtgtgt
Postanalytic Processes
TestinggtgtResults Review/FUgtgtInterpretationgtgt
Test Orderinggtgt Specimen CollectiongtgtTransportgtgtSp
ecimen Receipt/Processinggtgt
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CLSI Quality Series
The Documented Quality System
Description of system Commitment to Quality
Definition of policy Authority and
Responsibilities
Quality Manual
System Level Procedures
Flows and Controls
System Implementation
Instructions
Records, Forms Reports
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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

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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

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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

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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

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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

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CLSI Quality Series

• Quality 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

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CLSI Quality Series

• Leadership
• Determine the direction
• Set the Pace
• Applaud the spirit

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