ENUMERATION II Flashcards
characteristic of organizational systems
- HOLISTIC AND SYNERGISTIC WITH CLEARLY DEFINED BOUNDARIES
- PURPOSELY ACTIVITY AND A PRIMARY TASK
- HIERARCHY OF SYSTEMS
- OPERATES AS AN OPEN SYSTEM
- SEEK A STATE OF STABILITY AND EQUILIBRIUM
- SELF-REGULATING
the manual should contain the following:
- ALL QUALITY POLICIES OF THE LABORATORY
- A REFERENCE TO ALL PROCESSES AND PROCEDURES
- A TABLE OF CONTENTS
the quality system plan
- OBJECTIVES AND TASK
- RESPONSIBILITIES
- TIMELINE
- BUDGET AND RESOURCE NEEDS
- BENCHMARKS
principles of organizational structure and authority
- DEPARTMENTALIZATION
- DECENTRALIZATION
- UNITY OF COMMAND
- SCALAR PRINCIPLE
- SPAN OF TIME
- EXCEPTION PRINCIPLE
- EXCEPTIONAL PRINCIPLE
problems commonly identified in laboratories using a gap analysis include:
• TEST ORDERING
• SAMPLE MANAGEMENT
• INCOMPETENT TECHNICAL STAFF
• QUALITY CONTROL
• ANALYTICAL PROCESS
• RECORDING AND REPORTING RESULTS
• REAGENT AND EQUIPMENT MANAGEMENT
Elements of structure
- PATH OF WORKFLOW
- AN ACCURATE AND COMPLETE ORGANIZATIONAL CHART IS NECESSARY.
- A QUALITY MANAGEMENT SYSTEM MUST HAVE A QUALITY MANAGER.
- RESOURCE ALLOCATION MUST BE SUFFICIENT TO ENSURE THAT PERSONNEL AND INFRASTRUCTURE NEEDS ARE MET.
purpose of quality indicators
- GIVE INFORMATION ABOUT THE PERFORMANCE OF A PROCESS
- DETERMINE QUALITY OF SERVICE
- HIGHLIGHT POTENTIAL QUALITY CONCERNS
- IDENTIFY AREAS THAT NEED FURTHER STUDY AND INVESTIGATION
- TRACK CHANGES OVER TIME
developing successful indicators
- OBJECTIVES
- METHODOLOGY
- LIMITS
- INTERPRETATION
- LIMITATION
- PRESENTATION
- ACTION PLAN
- EXIT PLAN
CHARACTERISTICS OF GOOD QUALITY INDICATORS
Measurable
2. Interpretable
3. Actionable
4. Balanced
5. Engaging
6. Timed
Advantages of computerized systems (LIMS or LIS)
- ERROR REDUCTION
- QUALITY CONTROL MANAGEMENT
- PROVISION OF OPTIONS OF DATA SEARCHING
- ACCESS TO PATIENT INFORMATION
- GENERATE REPORTS
- ABILITY TO TRACK AND ANALYSE TRENDS
- IMPROVE CAPABILITY FOR MAINTAINING PATIENT CONFIDENTIALITY
- FINANCIAL MANAGEMENT
- INTEGRATION WITH SITES OUTSIDE THE LABORATORY
- MANUFACTURER-PROVIDED TRAINING
Disadvantages
- Training
- Time to adapt to a new system
- Cost
- Physical restrictions
- Need for backup system
Disadvantages
- Training
- Time to adapt to a new system
- Cost
- Physical restrictions
- Need for backup system
A GOOD SOP SHOULD BE:
- Detailed, clear and concise
- Easily understood by new personnel or students in training;
- Reviewed and approved by the laboratory management- approval is indicated by a signature and a date
- Update on a regular basis.
PREPARING SOPs
.
- TITLE
- PURPOSE
- INSTRUCTIONS
- NAME OF THE PERSON PREPARING THE SOP;
- SIGNATURES OF APPROVING OFFICIALS AND DATES OF APPROVAL
ELEMENTS OF DOCUMENT CONTROL
- A uniform format that includes a numbering system,
- A process for formal approval of each new document,
- A master log or inventory of all documents of the laboratory;
4.A process to ensure that the documents are available to all who need them
- A method for archiving documents that become out-dated but need to be kept for future reference.