1. What are the quality indicators I should establish for my lab to monitor?
   
   Each facility needs to develop their own Quality Indicators. To be effective and truly impact quality improvement for each individual facility, this can't be established across the board by COLA or its assessors. The Quality Indicators should be related to those processes within your operation that are critical to ensuring the right thing gets done right at the right time. You may select items or services that if not properly followed could cause serious harm to patients or staff. Consider the level of significance of potential outcomes. You may wish to select process or services where there have been documented problems, or new processes have recently been instituted.
   


2. What is the purpose of collecting and reporting data (monitoring) Quality Indicators?
   
   Laboratory Management should be using this data to evaluate operational processes and outcomes, identify areas for improvement, and develop plans to address improvement areas, and monitor the outcome following implementation. This data is critical to the Plan Do Study Act model for continuous improvement.
   


3. Where do I start?
   
   The first activities you pursue should be:
   
   • Identifying critical laboratory processes
   • Inventorying existing process flow documents
   • Developing a purpose, objectives, and goals,
   • Developing policy statements for each QSE
     


4. What should I include in my Quality Manual?

• Purpose ( mission)
• Objectives
• Goals
• Policy for each QSE
  • The policy statement should describe the expectations of management as they relate to the key components of this QSE
  • Identify party(ies) responsible for oversight of this QSE
  • An outline or list of key processes that convert the expectations set by policy into actionable activity within the organization or laboratory
  • List of associated documents & records that support this QSE
• Organizational Chart
• Path of Workflow (flow charts, tables, outlines)
• Description of Quality Report (sample if possible)
  • What to include
  • How often produced
  • Responsible parties
  • Distribution