ENUMERATION II Flashcards

1
Q

characteristic of organizational systems

A
  1. HOLISTIC AND SYNERGISTIC WITH CLEARLY DEFINED BOUNDARIES
  2. PURPOSELY ACTIVITY AND A PRIMARY TASK
  3. HIERARCHY OF SYSTEMS
  4. OPERATES AS AN OPEN SYSTEM
  5. SEEK A STATE OF STABILITY AND EQUILIBRIUM
  6. SELF-REGULATING
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2
Q

the manual should contain the following:

A
  • ALL QUALITY POLICIES OF THE LABORATORY
  • A REFERENCE TO ALL PROCESSES AND PROCEDURES
  • A TABLE OF CONTENTS
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3
Q

the quality system plan

A
  • OBJECTIVES AND TASK
  • RESPONSIBILITIES
  • TIMELINE
  • BUDGET AND RESOURCE NEEDS
  • BENCHMARKS
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4
Q

principles of organizational structure and authority

A
  • DEPARTMENTALIZATION
  • DECENTRALIZATION
  • UNITY OF COMMAND
  • SCALAR PRINCIPLE
  • SPAN OF TIME
  • EXCEPTION PRINCIPLE
  • EXCEPTIONAL PRINCIPLE
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5
Q

problems commonly identified in laboratories using a gap analysis include:

A

• TEST ORDERING
• SAMPLE MANAGEMENT
• INCOMPETENT TECHNICAL STAFF
• QUALITY CONTROL
• ANALYTICAL PROCESS
• RECORDING AND REPORTING RESULTS
• REAGENT AND EQUIPMENT MANAGEMENT

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6
Q

Elements of structure

A
  1. PATH OF WORKFLOW
  2. AN ACCURATE AND COMPLETE ORGANIZATIONAL CHART IS NECESSARY.
  3. A QUALITY MANAGEMENT SYSTEM MUST HAVE A QUALITY MANAGER.
  4. RESOURCE ALLOCATION MUST BE SUFFICIENT TO ENSURE THAT PERSONNEL AND INFRASTRUCTURE NEEDS ARE MET.
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7
Q

purpose of quality indicators

A
  1. GIVE INFORMATION ABOUT THE PERFORMANCE OF A PROCESS
  2. DETERMINE QUALITY OF SERVICE
  3. HIGHLIGHT POTENTIAL QUALITY CONCERNS
  4. IDENTIFY AREAS THAT NEED FURTHER STUDY AND INVESTIGATION
  5. TRACK CHANGES OVER TIME
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8
Q

developing successful indicators

A
  1. OBJECTIVES
  2. METHODOLOGY
  3. LIMITS
  4. INTERPRETATION
  5. LIMITATION
  6. PRESENTATION
  7. ACTION PLAN
  8. EXIT PLAN
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9
Q

CHARACTERISTICS OF GOOD QUALITY INDICATORS

A

Measurable
2. Interpretable
3. Actionable
4. Balanced
5. Engaging
6. Timed

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10
Q

Advantages of computerized systems (LIMS or LIS)

A
  1. ERROR REDUCTION
  2. QUALITY CONTROL MANAGEMENT
  3. PROVISION OF OPTIONS OF DATA SEARCHING
  4. ACCESS TO PATIENT INFORMATION
  5. GENERATE REPORTS
  6. ABILITY TO TRACK AND ANALYSE TRENDS
  7. IMPROVE CAPABILITY FOR MAINTAINING PATIENT CONFIDENTIALITY
  8. FINANCIAL MANAGEMENT
  9. INTEGRATION WITH SITES OUTSIDE THE LABORATORY
  10. MANUFACTURER-PROVIDED TRAINING
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11
Q

Disadvantages

A
  1. Training
  2. Time to adapt to a new system
  3. Cost
  4. Physical restrictions
  5. Need for backup system
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12
Q

Disadvantages

A
  1. Training
  2. Time to adapt to a new system
  3. Cost
  4. Physical restrictions
  5. Need for backup system
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13
Q

A GOOD SOP SHOULD BE:

A
  1. Detailed, clear and concise
  2. Easily understood by new personnel or students in training;
  3. Reviewed and approved by the laboratory management- approval is indicated by a signature and a date
  4. Update on a regular basis.
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14
Q

PREPARING SOPs
.

A
  • TITLE
  • PURPOSE
  • INSTRUCTIONS
  • NAME OF THE PERSON PREPARING THE SOP;
  • SIGNATURES OF APPROVING OFFICIALS AND DATES OF APPROVAL
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15
Q

ELEMENTS OF DOCUMENT CONTROL

A
  1. A uniform format that includes a numbering system,
  2. A process for formal approval of each new document,
  3. 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

  1. A method for archiving documents that become out-dated but need to be kept for future reference.
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16
Q

PURPOSE OF DOCUMENT CONTROL

A
  1. Ensure that the most current version of any document is the one that is in use;
  2. Ensure availability and ease of use when a document is needed;
  3. Provide for the appropriate archiving of documents when they need to be replaced
17
Q

COMMON PROBLEMS

A
  1. Out-dated documents in circulation.
  2. Distribution problem
  3. Failure to account for documents of external origin