Risk Management in the Clinical Laboratory

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Author: Garland E. Pendergraph, PhD, JD, MLS(ASCP)SM, HCLD/CC(ABB)

In 1999 the Institute of Medicine (IOM) published a study entitled "To Err Is Human: Building a Safer Health System." Its estimate of the number of deaths and adverse outcomes caused by medical errors sent shockwaves throughout the healthcare community as well as the general population. Perhaps for the first time members of the healthcare community began to seriously look at the way healthcare is delivered and how the process could be improved to enhance patient safety.

Thus, one of the most beneficial results from the IOM study was that hospital workers and other healthcare providers realized that they urgently needed to fully and more effectively incorporate "risk" as a crucial component of their management.

This course discusses the ways that risk can be detected and managed, both within the healthcare facility and specifically within the laboratory. Several tools are presented for proactively and reactively responding to situations affecting patient safety.

Continuing Education Credits


  • Define "risk" and discuss why risk management is important in healthcare.
  • Identify laboratory and hospital accrediting bodies and regulations that impact laboratory risk management.
  • Identify risk management concerns associated with the laboratory's pre-examination, examination, and post-examination phases of testing.
  • Describe some of the tools used in risk management processes.

Course Outline

  • Introduction to Risk Management
      • Introduction to Risk Management
      • Introduction to Risk Management, continued
      • Definitions of Risk and Risk Management
      • Why Manage Risk?
      • Risk management, as it applies to the clinical laboratory, is most accurately defined in which of the following ways?
  • Phases of Testing and Risk Exposures
      • Risk Assessment
      • Pre-Examination Phase
      • Examination, Phase
      • Post-Examination Phase
      • The majority of all laboratory errors occur during which phase of laboratory testing?
  • The Risk Management Process
      • Introduction to the Risk Management Process
    • Identify and Analyze Loss Exposure
      • Risk Management
      • Model of Accident Causation
      • Root Cause Analysis (RCA)
      • Team Approach
      • Mapping the Process
      • The Flowchart
      • Five Whys
      • The Fishbone Diagram
      • Examining Alternative Risk Management Treatments
      • Select the Best Risk Management Treatment(s)
      • Errors Related to Risk Management
      • Which of these methods should be used when an adverse event occurs that results in patient injury (negative patient outcomes) to prevent a recurrence?
    • Monitor and Improve Risk Management Treatment(s)
      • Monitor and Improve Risk Management Treatment(s)
      • Failure Mode and Effect Analysis
      • Following a patient injury event, the facility's risk manager is solely responsible for monitoring the implemented risk management treatments and iden...
    • External Laboratory Assessment as a Risk Management Tool
      • Accrediting Organizations
      • Accrediting Organizations: The Joint Commission
      • Accrediting Organizations: The College of American Pathologists
      • Accrediting Organizations: COLA (Formerly Commission on Laboratory Accreditation)
      • Accrediting Organizations: The American Association for Laboratory Accreditation (A2LA)
  • Risk Management and Employment Practices Liability
      • Introduction to Risk Management and Employment Practices Liability
      • Pre-Employment Screening
      • Employee Performance Evaluation
  • Healthcare Standards and Regulations
      • Federal Regulations for Risk Management
      • Clinical Laboratory Improvement Amendments of 1988 (CLIA)
      • Health Insurance Portability and Accountability Act of 1996
      • Occupational Safety and Health Administration (OSHA)
      • Safe Medical Devices Act of 1990 (SMDA)
      • The Patient Safety and Quality Improvement Act of 2005
      • State Regulations for Risk Management
      • Which Amendment or Act describes the quality standards that all laboratories must meet in order to ensure testing accuracy, reliability, and timelines...
  • Legal Concerns and Risk Management
      • Legal Concerns and Risk Management
  • References and Recommended Reading
      • References and Recommended Reading

Additional Information

Level of Instruction: Intermediate
Intended Audience: Medical laboratory professionals
Author Information: Garland E. Pendergraph, PhD, JD, MLS(ASCP)SM, HCLD/CC(ABB) received his MSPH from the University of Kentucky in Lexington, his PhD in medical parasitology and mycology from the University of North Carolina in Chapel Hill, and his law degree with a concentration in health care law from Concord Law School, Purdue University. He also did a Fellowship in Tropical Medicine at Louisiana State University School of Medicine. He is the author of a textbook in phlebotomy, a number of scientific articles, plus internet training programs. He is licensed as a laboratory director in the States of Georgia and Florida.
Reviewer Information: Joy Gould, MS, SBBCM(ASCP)CCM,BB, MLT, CQIA(ASQ), CPHQ received a Master of Science from Thomas Jefferson University in Philadelphia, PA and a Bachelor of Science from Rowan University in Glassboro, NJ. She is a Teaching Assistant Professor and the Director of Academic and Corporate Initiatives for the Department of Medical Laboratory Sciences and Biotechnology at Thomas Jefferson University. She held the position of Transfusion Medicine Supervisor for both Thomas Jefferson University Hospital and Jefferson Methodist Hospital for 12 years. Joy has been a Medical Technologist for over 37 years, 23 in a blood bank supervisory capacity.

This course is part of:
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The “Swiss Cheese” Model of Accident Causation (1).
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Risk management and the responsibilities included.