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Step # 1. Review the Course Content Outline

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    Steps To Prepare For And Obtain One Or both Of Our Accredited Certifications:

  • Step # 1. Review the Course Content Outline:
    • While The Accreditation and Quality Doctor (TAAQD) recommends the use of its own preparatory materials to study, prepare, and take the exams, it does not mandate that you do so. You may study on your own from any source you like and take the exam. See below for more information.
    • Furthermore, while the use of the TAAQD materials and or resources by the candidates to prepare for the exams covers all areas of the exam and will make it easy on candidates to pass the exam, it does not guarantee that they will pass the certification exam(s). Candidates with clinical laboratory background should plan to spend about 1-2 months in preparation.
    • Each question on the exam could be linked directly to one or more of the tasks listed in the content / topics outline, see below for detailed content outline for the CCLQP and CCLSP exams. In addition, each question is designed to test if the candidate possesses the knowledge necessary to perform the task and/or has the ability to apply it to a job situation.
    1. Certified Clinical Laboratory Quality Professional (CCLQP):

      2. Detailed Content Outline For The CCLQP Examination:

      Chapter One: Quality Assurance In Clinical Laboratories:

      1. What is Quality?
      2. What is Quality Assurance (QA)?
      3. What is the Difference Between Total Quality Management (TQM), Quality System (QS), Quality Assurance (QA), and Quality Control (QC)?
      4. How Does It Work?
      5. Why Do You Need Quality / QA In Your Laboratory?
      6. How Do You Achieve Quality / QA in Your Laboratory?
      7. Who is Responsible for Quality / QA in Your Laboratory?

      Chapter Two: Specimens Stages:

      1. Introduction
      2. The Specimens’ Stages: Preanalytical, Analytical, Postanalytical
      3. Possible Errors During The Specimen’s Stages
      4. What Causes These Errors
      5. How to Avoid or Control Specimens’ Errors?
      6. What Happened If We Reduce Specimens’ Errors?
      7. What Happens If We Do Not?

      Chapter Three: Quality Control (QC) In Clinical Laboratory:

      1. What Is A Control?
      2. What Is Quality Control (QC)?
      3. What Is The Difference Between Standards (Calibrators) and Controls?
      4. What Are The Differences Between Controls And External Quality Assessment?
      5. How To Handel Controls Safely?
      6. What Are the Properties of Good Controls Materials?
      7. Why Run Controls?
      8. What Is the Difference Between Assayed And Unassayed Controls?
      9. For New QC Lots, Do You verify Or Establish The QC Ranges And How?
      10. Establishing / Calculating The QC Ranges Using:
      11. The Mean, SD, and CV
      12. Histogram / Gaussian (Bell) Curve
      13. The Levy-Jennings (L-J) Charts
      14. When Do You Run QC, How Often, And By Whom?
      15. How To File And Organize Your QC Data?
      16. QC Errors:
        1. Random Errors
        2. Systematic Errors
      17. QC Trends & Shifts
      18. How to Use Westgard Rules To Evaluate And Identify QC Problems?
      19. Simple QC Rules to Follow in Your Laboratory
      20. QC Troubleshooting:
        1. Reasons Why QC Out of Control
        2. Possible Corrective Actions
      21. How To implement an Internal QC Program?
      22. QC Do’s and Don’ts

      Chapter Four: Writing Policies/Procedures (Standard Operating Procedures-SOPs / Internal Policies & Procedures-IPPs):

      1. What Kind of SOPs / IPPs Do You Need To Have In Your Laboratory?
      2. What Is The Difference Between a Policy and a Procedure?
      3. Who Can Write IPPs? Who Can Review Them? And, Who Must Approve Them? How Often?
      4. How Do You Organize Your IPPs?
      5. What Is The Staff Responsibility Toward These IPPs?
      6. What Do You Do With Retired / Discontinued IPPs?
      7. What Are The Elements of IPPs?

      Chapter Five: Quality Management Program (QMP) For Clinical Laboratories:

      1. Why Do You Need a QM Program?
      2. Who Is Responsible For It?
      3. Define Key Elements Of a QMP Per CLSI & CAP Requirements
      4. What Are The Criteria For Evaluating The Effectiveness Of Your Own QMP; How Often?

      Chapter Six: Implementing A Document Control Program In Your Laboratory:

      1. What Is Document Control Management (DCM)?
      2. What Are CAP’s requirements For Document Control Management?
      3. Discuss How Policies, Procedures, Records, And Forms Come Under The Document Control Requirements
      4. Discuss Strategies And Issues In Implementing An Excellent Document Management System

      Chapter Seven: Training Checklists Vs. Competency:

      1. What Does Competency Assessment Mean? Is Competency The Same as Training?
      2. Why Must We Assess Competency?
      3. What Are CAP’s Requirements for it?
      4. When Must Competency be Assessed?
      5. What Must Be Assessed?
      6. Who Must Be Assessed? By Whom?
      7. How Do You Assess The Performance Of Supervisors / Consultants?
      8. How Must We Assess Competency?

      Chapter Eight: Introduction to CAP (College of American Pathologists) Accreditation:

      1. What Is CAP?
      2. Why CAP Accreditation?
      3. How Can You Become CAP Accredited?

      Chapter Nine: External Quality Program-Proficiency Testing (PT):

      1. What Is PT (Proficiency Testing)?
      2. What Are The CAP (College of American Pathologists) Requirements For PT? How Does It Work?
      3. What Do You Do When You Receive You PT Shipments?
      4. How To Enter Your PT Results In CAP E-Lab Solution?
      5. How To Check For and Print Your CAP PT Evaluation Reports?
      6. How To Evaluate and Investigate Your CAP PT Evaluation Reports?
      7. Graded Results:
        1. Acceptable With No Bias Or Exceptional Codes (Ungraded)
        2. Acceptable, But Shows Trends (Bias Results)
        3. Unacceptable (Counted Against You)
        4. Ungraded Results (Exceptional Codes)
      8. PT Referral: What Does It Mean? How Can You Comply With It?
      9. Alternative Assessment (AA)

      Chapter 10: Instruments / Equipment Maintenance:

      1. What Kind Of Equipment / Instruments Are We Talking About?
      2. How Do You Know If An Equipment / Instrument Need Maintenance?
      3. How Do You Know What Type Of Maintenance Needs To Be Done On Your Equipment / Instruments?
      4. How Do You Prove That Your Maintenance Is Done On Your Equipment / Instruments?
      5. What Would You Do If The Maintenance Is Not Done On Your Equipment / Instruments
      6. What Would You Do About Maintenance If Your Equipment / Instrument Is Down?
      7. Who Should Be Reviewing Your Maintenance In Your Laboratory?
      8. How Often Should Your Maintenance Be Reviewed?
      9. How Long Do You Keep Your Maintenance Records?

      Chapter 11: Panic (Critical Values) / LIS (Lab Information System) / Quality of Water / Specimens / Records Retention:

      1. Panic (Critical Values):
        1. What Is It?
        2. What is Required?
      2. LIS (Lab Information System)
      3. Quality of Water
      4. Specimen / Records Retention

      Chapter 12: Verification / Validation for Qualitative Instruments / Methods / Tests:

      1. What Is The Definition Of Analytical Validation And Verification?
      2. Who Is Responsible For Performing Analytical Validation & Verification?
      3. What Are CAP Requirements for The Analytical Validation for Modified FDA-Cleared/Approved & LDTs Tests?
      4. What Are CAP Requirements For Analytical Validation And Verification For Laboratories Subject To USA Regulations?
      5. What Are CAP Requirements For Analytical Validation And Verification For Laboratories NOT Subject To USA Regulations (Non-USA Labs)?
      6. How Do You Meet These requirements For Qualitative Methods/Tests? How Do You Perform Them?
      7. Waived Test Implementation (Validation / Verification) And Approval

      Chapter 13: Verification / Validation for Quantitative Instruments / Methods / Tests:

      1. Introduction
      2. How Do You Meet These requirements For Quantitative Methods/Tests? How Do You Perform them?
        1. Analytical accuracy
        2. Analytical precision
        3. Reportable range
        4. Reference Interval (Normal Ranges)
        5. Any Other Performance Characteristic Required To Ensure Analytical Test Performance:
          1. Specificity (Lower Detection Limit) And
          2. Analytic Specificity (Interferences) If It Is Required By The Laboratory Policy, And Or The Test Manufacturer
          3. Or Establish (Validate) Them If The Test Manufacturer Has Not Documented These Test Characteristics.
      3. Waived Test Implementation (Validation / Verification) And Approval
      4. Calibration Verification:
        1. What Is Calibration Verification?
        2. When Is It Required?
        3. How Do You Perform It?
        4. What is the difference between It, AMR, and Linearity?
      5. When & How Do You Perform New Lots Studies?
        1. New Reagent Lot to Lot Verification
        2. New QC Lot Verification or Establishment
      6. How & How Often Do You Perform Method To Method Comparison?

      Chapter 14: Starting A POCT (Point Of Care Testing) Program-What Do You Need To Know?

      1. What Is POCT?
      2. What Is Required For POCT?
      3. What Do You Need In Order To Establish A POCT Program?
      4. How To Achieve Quality In POCT Program?

      Chapter 15: Quality Indicators (Key Performance Indicators-KPIs):

      1. What Is A Quality Indicator?
      2. What Are The Key Characteristics Of An Ideal Indicator?
      3. What Are The Types Of Indicators?
      4. Why Measure? How Many?
      5. Where Do You Start?
      6. Implementing Your QI Plan.
      7. How To Choose Specific Strategies To Make Your QI Program Succeed.
      8. How To Evaluate?
      9. How To Use Information Collecting To Fuel Your QI Process?

      Chapter 16: CAP Calibration Verification & Linearity (CVLs) Surveys:

      1. What Is Calibration Verification?
      2. When And How Often Is Calibration Verification Required?
      3. What Is The Difference Between Calibration Verification, AMR (Analytical Measurement Range), And Linearity?
      4. Which Laboratory Sections Are Required To Preform Calibration Verification And AMR, And How Often?
      5. What Materials Can You Use To Perform Calibration Verification / Linearity And To Verify The AMR?
      6. How Do You Perform Calibration Verification / Linearity / AMR?
        1. An In House (Available In The Laboratory) Method
          1. How Do You Interpret The Results And Prepare Your Report?
          1. Commercial (Purchased) Method:
            1. Where Do You Buy Your Calibration Verification Linearity (CVL) Materials?
            2. How Do You Perform CVL Using CAP CVL Surveys Materials?
            3. How Do You Interpret / Read The CVL Results (Report)?
            4. How To Evaluate And Investigate (Troubleshoot) Your CVL Results (Report)?
            5. How To Prepare Your Own Calibration Verification Reports? &
            6. How To Prepare Your Own Linearity Reports?

      Chapter 17: Equipment / Instruments Performance Qualification / Validation / Verification:

      1. What Is The Definition Of Equipment / Instruments Performance Qualification / Validation / Verification?
      2. What Is The Difference Between Equipment / Instruments Performance Qualification / Verification and Analytical Method (Test) Validation And Verification?
      3. Who Is Responsible For Performing Equipment / Instruments Performance Verification?
      4. What Is the Classification of Equipment and Instruments?
      5. What Are CAP (College of American Pathologists) Requirements For Equipment / Instruments Performance Verification?
      6. What Are CBAHI (The Saudi Central Board for Accreditation of Healthcare Institutions) Requirements For Equipment / Instruments Performance Verification (Not Applicable For Non-Saudi Labs)?
      7. How Do You Meet These requirements? How Do You Perform Them?
      8. What Is The Acceptable Criteria Per CAP & CBAHI For Equipment / Instruments Performance Verification?
      9. When Do You Repeat The Performance Qualification Or Part Of It?
      10. How Long Do You Keep Your Performance Verification Record For?

      Chapter 18: CAP Inspection Stages: Before, During, & At The End Of The Inspection:

      1. Inspection Stages:
        1. Before The Inspection;
        2. On The Day Of The Inspection;
        3. During The Inspection;
        4. At The End Of:
          1. Your Section’s Inspection;
          2. The Lab Inspection; And
          3. After The Inspection
      2. What Inspectors Will Be Looking For / Focusing On During The Inspection?

      Chapter 19: How To Be CAP Ready Every Day In Your Laboratory:

      1. If You Are CAP Accredited:
        1. For Any Revised Checklist, You Need To Review:
          1. New Standards
          2. Revised, Merged Standards
          3. Deleted Standards
        2. For Existing Checklists, You Need To Review / Take Care Of Any:
          1. Weekly,
          2. Monthly,
          3. Semiannual,
          4. Annually, And Or
          5. Biannual (Biennial) Standards
        3. If You Are Not CAP Accredited:
          1. Everything Is New To You. You Need To Take Care Of Every Standard On The Checklists If Applicable To You

      Chapter 20: How To Become An Excellent CAP Inspector?

      1. How Do You Qualify To Become An Inspector?
      2. What Are The Process Or Steps Of An Inspection?
        1. What To Do Before The Inspection?
        2. What To Do During The Inspection?
        3. What To Do At The End Of The Inspection?
          1. Finished With Your Assignment Section(s)
          2. Pre-Summation Meeting
          3. Summation Conference
          4. Summation Conference Do’s and Don’ts

      Chapter 21: The Most Common CAP Inspections Deficiencies (Citations) & How To Avoid Them:

      1. CAP Checklists
      2. What Do We Mean By Deficiencies Or Citations and What Are Their Types?
      3. Are Deficiencies & Recommendations The same?
      4. What Are The Most Commonly Cited Standards By CAP? And How To Avoid Them?
      5. How To Respond To Deficiencies (Citations)?
      6. When And How To Challenge A Deficiency (Citation)?
      7. What To Send To The CAP If You Get Cited?

      Chapter 22: Individualized Quality Control Plan (IQCP) Made Simple:

      1. Brief Quality Control (QC) History
      2. What Is IQCP (Individualized Quality Control Plan)?
      3. What Are The Rationale For Moving To IQCP?
      4. Why Do You Need IQCP In Your Laboratory?
      5. What Are CAP Requirements For IQCP?
      6. What Are The Elements Of An IQCP?
      7. How Do Implement Or Develop Them?
      8. Where Do You Begin?

      Chapter 23: Introduction to Safety in Clinical Laboratories:

      1. What Is Safety?
      2. Why Safety?
      3. What Are The General Hazards In A Laboratory?
      4. Safety Policies And Procedures (IPPs/SOPs)
      5. Safety Training
      6. Safe Work Practices Review By Risk Assessment? Why? How Often? By Whom? How?
      7. Safety And Lab Accidents:
        1. Why Accidents happen?
        2. How to Manage and Minimize accidents / Risk?
      8. General Safety Rules In The Laboratory
      9. Disaster Preparedness
        1. Internal
        2. External
      10. Evacuation Plan
      11. Bloodborne Pathogens
      12. TB Exposure Plan
      13. Infectious Disease Reporting
      14. PPE Provision, Instructions, And Usage:
        1. Introduction
        2. Selection
          1. Latex Allergy
      15. Training
      16. When To Wear Gloves & Dirty Lab Coats
      17. When NOT to Wear Gloves
      18. When NOT to Wear Dirty Lab Coats

      Chapter 24: Effective Leadership Skills:

      1. What Is The Definition Of Leadership?
      2. What Is The Difference Between A Leader & A Manager?
      3. What Are The Qualities And Skills Of Leaders?
      4. What Are The Different Types / Styles Of Leaders?
      5. How Can I Become A Great & Effective Leader? A Leader That People Follow!

      Chapter 25: Effective Communication Skills:

      1. What Is The Definition Of Communication?
      2. Why Is Communication Important?
      3. What Are The Different Types Of Communication?
      4. What Is The Communication Process?
      5. How Do Improve Your Communication Process / Skills?
      6. What Are The Barriers To Effective Communication & How Can You Overcome Them?

      Chapter 26: How to Provide Exceptional Customer Service?

      1. What Is The Definition Of Exceptional Customer Service?
      2. Who Are Our Customers?
      3. What Do Customers Want?
      4. How Do You Provide Exceptional Customer Service?
      5. How Do You Deal With Difficult / Complaining / Customers / Patients?
      6. How Do You Reduce Complaints?

      Note: The exam questions might have one or more item that will require recall, application of knowledge, and analysis on the part of the candidate The exam is a multiple-choice examination consisting of 100 multiple choice questions. Candidates will have 2.5 hours to complete the examination. The examination will terminate if testing exceeds the time allowed. To pass the exam, a candidate must earn 80% on the exam.

    2. Certified Clinical Laboratory Safety Professional (CCLSP):

      3. Detailed Content Outline For (CCLSP) Examination:

      Chapter One: Introduction to Safety in Clinical Laboratories:

      1. What Is Safety?
      2. Why Safety?
      3. What Are The General Hazards In A Laboratory?
      4. Safety Policies And Procedures (IPPs/SOPs)
      5. Safety Training
      6. Safe Work Practices Review By Risk Assessment? Why? How Often? By Whom? How?
      7. Safety And Lab Accidents:
        1. Why Accidents Happen?
        2. How To Manage And Minimize Accidents / Risk?
      8. General Safety Rules In The Laboratory
      9. Disaster Preparedness
        1. Internal
        2. External
      10. Evacuation Plan
      11. Bloodborne Pathogens
      12. TB Exposure Plan
      13. Infectious Disease Reporting
      14. PPE Provision, Instructions, And Usage:
        1. Introduction
        2. Selection:
          1. Latex Allergy
        3. PPEs Training
        4. When To Wear Gloves & Dirty Lab Coats
        5. When NOT To Wear Gloves
        6. When NOT To Wear Dirty Lab Coats
      15. Summary of Practices for Handling Biohazards Materials:

      Chapter Two: Fire Safety:

      1. Fire Prevention Policies and Procedures
      2. What Are The Common Causes Of Fires In Laboratories?
      3. How Do You Prevent, Predict, And Detect Fires?
      4. Why Should You Fight A Fire?
      5. When Should You Fight A Fire?
      6. How Do You Fight A Fire?
      7. What Should You Do If You Or Someone Get Caught On Fire?
      8. Fire Extinguishers Types And Training
      9. Annual Fire Drill, Who Needs It?
      10. Fire Exit

      Chapter Three: Chemicals Safety In Clinical Laboratories:

      1. Purpose
      2. Principles of Chemicals Handling & Storage:
        1. Creating An Inventory List:
          1. How Do You Create an Accurate Chemicals Inventory List?
          2. How Do You Develop A Plan To Maintain The Accuracy Of This List?
      3. Chemicals Storage:
        1. General Guidelines For Chemicals Storage
        2. Storage Containers And Cabinets
      4. Segregation, Classification, And Storage Of Chemicals With Respect To Hazard Class,/
      5. Chemicals Storage Don’ts
      6. Chemicals Precautionary Labels:
        1. Major Labeling Systems
        2. Employers Responsibilities
        3. Employees Responsibilities
      7. Safety Data Sheets (SDS)
      8. Chemicals Hygiene Plan (CHP):
        1. Introduction
        2. Acceptable CHP Per CAP (College of American Pathologists)
      9. Chapter Summary

      Chapter Four: Waste Management in Clinical Laboratories:

      1. Introduction
      2. Definitions
      3. Waste Classifications
      4. Chemicals Waste:
        1. Chemicals Waste Classification
        2. Chemicals Waste Management & Disposal
      5. How to Manage, Contain, & Dispose Chemicals Waste:
        1. Sorting / Classifications
        2. Containers
        3. Labeling
        4. Storage / Packaging
        5. Disposing
      6. Chapter Summary

      Chapter Five: Biomedical Waste Management (BMWM):

      1. Definitions
      2. Biomedical Waste (BMW) Classification
      3. Magnitude Of The BMW (Global Problem)
      4. Who Generate BMW?
      5. When Did The Concern About BMW Started?
      6. Why Do You Need BMW Management?
      7. What Are The Problems Associated With BMW?
      8. Who Is At Risk Of Infection?
      9. What Are The Routes Of Transmission?
      10. Biomedical Waste Management (BMWM) Steps:
        1. Willingness
        2. Investments (Person, Place, Financial)
        3. Assign Responsibilities (BMWM Committee)
        4. Policies And Procedures (IPPs)
        5. Survey Of Waste Generated
        6. Waste Generation
        7. Waste Segregation & Labeling
        8. Waste Collection & Storage
        9. Waste Transportation:
          1. In House
          2. Off Site
        10. Waste Treatment & Disposal
      11. Sharps Disposal (GEN.78000)
      12. The Do’s And Don’ts Of BMWM
      13. BMW Management Action Plan
      14. Waste Minimization
        1. Definition
        2. The Difference Between Waste Management and Waste Minimization
        3. Why Minimize Waste?
        4. How To Minimize Waste?
        5. The 3 R’s of Waste Reduction
      15. Chapter Summary

      Chapter Six: Spills Handling:

      1. Introduction
      2. Spills’ Types Based On Size
      3. Spills Treatment Methods / Kits
      4. What To Do When A Spill / Accident Happen?
      5. How Do You Clean Spills?
      6. Specific Spills Situations And How To Deal With Them

      Chapter Seven: Miscellaneous Topics (The Use Of Biosafety Cabinets, Fume Hoods, Eye Wash And Safety Shower, Electrical Safety, Radiation Safety, Laser Safety, And Ultraviolet (UV) Light Exposure:

      1. Biosafety Cabinets:
        1. What Is A Biosafety Cabinet?
        2. Use Of Biosafety Cabinet
        3. Levels Of Biosafety Cabinets
        4. Testing Of Biosafety Cabinets
        5. The UV Light Exposure Safety
      2. Fume Hoods:
        1. What Is A Fume Hood?
        2. The Use Of A Fume Hood
        3. Dos and Don’ts Of Fume Hoods.
        4. How Does It Work?
        5. Parts Of Fume Hoods
      3. Eye Wash And Safety Shower:
        1. The Use Of Eye Wash And Safety Shower
        2. Specification Of Eyewash Facility
        3. Testing Of Eye Wash And Safety Shower
      4. Electrical Safety:
        1. Electrical Testing Requirements For Laboratory Instruments And Equipment
        2. Electrical Safety Checklist For Laboratory Instruments And Equipment
        3. First Aid For Electrical Shocks
      5. Radiation Safety:
        1. Policies and Procedures For Radiation Safety
        2. Types Of Radiation Emissions
        3. How To Handle Radiation Waste
      6. Laser Safety and Ultraviolet (UV) Light Exposure:
        1. Policies And Procedures For Laser Safety
        2. General Rules For Laser Safety

      Chapter Eight: Ergonomics:

      1. What Is It?
      2. Policies And Procedures
      3. Neutral Postures Vs. Awkward Postures
      4. Common Laboratory Procedures Associated With Ergonomic Problems
      5. Most Common Ergonomic Disorders And How To Avoid Them?

      Note: The exam questions might have one or more item that will require recall, application of knowledge, and analysis on the part of the candidate The exam is a multiple-choice examination consisting of 40 multiple choice questions. Candidates will have 1 (one) hour to complete the examination. The examination will terminate if testing exceeds the time allowed. To pass the exam, a candidate must earn 80% on the exam.

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