Risk Management in the Clinical Laboratory (Online Course)

(based on 1022 customer ratings)

Author: Garland E. Pendergraph, PhD, JD, MLS(ASCP)SM, HCLD/CC(ABB)
Reviewer: Edward J. Gruber, MT(ASCP), CLS(NCA)

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.

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Continuing Education Credits

  • P.A.C.E.® Contact Hours: 1 hour(s)
  • Florida Board of Clinical Laboratory Science CE - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)


  • 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 preanalytic, analytic, and postanalytic phases of testing.
  • Describe some of the tools used in risk management processes.

Customer Ratings

(based on 1022 customer ratings)

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
      • Preanalytic Phase
      • Analytic Phase
      • Postanalytic 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)
      • 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: Commission on Laboratory Accreditation
  • 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) is Laboratory Director & Director of Laboratory Operations, Quest Diagnostics-Valdosta RRL. Dr. Pendergraph is the laboratory director for Quest Diagnostics in Valdosta, GA and Miller County Hospital in Colquitt, GA. Dr. Pendergraph 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, Kaplan 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. Dr. Pendergraph serves on the advisory committee for medical technology program at Thomas University. He is licensed as a laboratory director in the States of Georgia and Florida.
Reviewer information: Edward J. Gruber, MT(ASCP), CLS(NCA) held the position of Technical Specialist in the laboratory accreditation program (LAP) of the College of American Pathologists for 13 years before his retirement from that position in 2007. He was the primary technical specialist for handling participant inquiries related to anatomic pathology, cytopathology, and immunohistochemistry. He also worked as a technologist at Lutheran General Hospital prior to and during his time at CAP. Mr Gruber is currently pursuing a Master's degree in training and development from Roosevelt University.
Course description: Risk Management is an important discipline for medical laboratory professionals as it is our responsibility to understand and follow the vast number of rules and regulations governing our profession.

http://www.lanl.gov/news/albums/events/K_Chalmers_Keith_Tucker_2.jpg (3-31-2010)

www.opm.gov/hrd/lead/images/diverse.jpg (4-1-10)

The “Swiss Cheese” Model of Accident Causation

Source: Reason J, Carthey J, deLeval M. Diagnosing “vulnerable system syndrome”: An essential prerequisite to effective risk management. Qual Health Care, 2001; 10(Suppl. II):ii21–ii25. Reprinted with permission of the BMJ Publishing Group.