A Risk-Based Approach to Lab Errors

March 2017 - Vol. 6 No. 2 - Page #22


Over 98,000 people die each year of preventable medical harm, including harm caused by laboratory errors. Laboratory error is the cause of approximately one of every 330–1000 occurrences equating to 900–2074 patients and 214–8316 laboratory results.1 These statistics have led to the development of quality improvement programs to minimize error and improve patient safety.

Standards such as ISO 9001:2015 Quality Management Systems – Requirements specifically address risk management and actions to address risk, and ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence requires risk assessments to evaluate the impact of work process changes on patient safety.2

Error reduction in the laboratory relies heavily on proper clinical governance—a framework for improvement that takes an evidence-based approach of error trend analysis and an integrated approach to prevent error reoccurrence. By flipping from reactive thinking with a focus on repairing errors, to proactive thinking with a focus on analyzing trends and applying risk mitigation strategies and corrective-action plans, the lab can do its part to place the patient at the center of health care.


Reducing errors is a primary and constant goal of clinical laboratories. The demand for quality improvement programs to reduce errors increased with the publication of To Err Is Human: Building a Safer Health System in 2000.3 In the US and Canada, the report initiated a series of events to reduce errors and improve patient safety, such as the development of increased leadership expertise in patient safety protocols, error reporting systems, and methods for raising performance standards and expectations for safety improvements through the assistance of oversight organizations such as regulatory agencies.

Since this landmark publication, laboratory requirements and regulations have grown in scope and capacity, with an increased focus on the quality management system (QMS) and the accompanying expectation that QMS programs increase lab quality and patient safety by ensuring errors are detected, corrected, and prevented.

The introduction and utilization of laboratory error reporting systems (eg, non-conforming event reporting) was the beginning of a shift from a culture wherein errors were not reported (for fear of blame and punitive action) to a patient-centric culture that views errors as opportunities for improvement and encourages reporting and tracking, and the implementation of corrective action plans to minimize future reoccurrence.

Determining error type is key to this process, but more so is the ability to understand the cause of errors, develop improvement plans for error mitigation or elimination, and empower staff leaders to modify work processes when required to affect positive change:

  • Understanding types and frequencies of both common clinical lab errors and institution-specific errors is the necessary first step to creating improvement plans that apply risk mitigation strategies.
  • Further development of improvement or corrective-action plans leading to the modification of work processes requires the incorporation of evidence-based error trend analysis.

Addressing the risks of error by reviewing trends, determining what caused the error, and measuring the outcome severity is known as a reactive strategy. Alternatively, proactive strategies apply trend analysis to the development of improvement plans, which in turn modify workflow processes to reduce or eliminate the risk.4 In a QMS, clinical governance is a risk management framework that incorporates both proactive and reactive strategies with the goal of enhancing the overall delivery of laboratory services and improving patient safety.

Changes in Laboratory Requirements

Several regulatory bodies have put forth standards in order to ensure laboratories comply with and operate within a quality system framework. As the landscape of laboratory medicine continues to evolve along with the greater changes to health care delivery, the requirements related to quality programs are becoming more sophisticated in response. In 2015, the International Standard Organization (ISO) released ISO 9001:2015 Quality Management Systems, marking the first time the word risk was incorporated in these requirements. Clauses 6.1.1 and 6.1.2 present requirements indicating that organizations must determine the risks and opportunities in lab workflow as part of its QMS to reduce or prevent undesired effects and achieve continual process improvement (see SIDEBAR).

Further to the recognition of risk in ISO 9001, ISO 15189:2012 has received updates regarding risk; specifically, the addition of risk assessments:

- 4.13.6: Risk Management: The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken. [ISO 15189:2012]2

As regulations continue to emerge, laboratories must plan ahead and imbed risk management tools and risk assessments into workflow processes during planning, design, and implementation.

Clinical Governance and the Benefit of Evidence

Clinical governance serves as the link between the development of structured processes and their implementation as health care improvement initiatives,5 including laboratory medicine. While reducing laboratory errors requires a systematic approach of preventive (or risk-based) thinking, the process must begin with clear and expeditious error reporting. The application of an occurrence management program is one approach. Occurrence reporting and management, root cause determination, error identification, and the implementation of corrective actions are all important to assuring that errors are properly handled such that they do not reoccur. These are quality system essentials and are key to continuous process improvement. The goal of occurrence management is to correct errors and processes in a trend toward error elimination.

Reporting and analyzing errors to determine trends is a preventive action in building the evidentiary data framework required to modify processes. Accordingly, these trends should be seen as opportunities to improve laboratory systems. Error risk in the clinical laboratory setting cannot be eliminated, but defining error causes and implementing evidence-based corrective action plans will improve patient safety.

Evaluate the Success of Improvement Plans

Risk mitigation is vital to assessing the effectiveness of improvement plans that address error trends. This approach highlights potential problems that could arise as a result of improvements and seeks to avoid them. The probability and frequency of the effect of each event is then calculated. A failure modes and effects analysis (FMEA) can then be applied prioritizing each event according to impact, followed by the implementation of contingency plans.


Reducing and eliminating errors should be among the permanent goals of clinical laboratories in pursuit of ever-improving patient safety. Many commercially available systems have been developed to facilitate error reporting and the documentation of corrective actions, but the landscape of laboratory medicine continues to shift and the lab must adapt. Using evidence-based error trend analysis, laboratories will be able to see the potential consequences and opportunities and modify plans as appropriate to reduce laboratory errors.


  1. Plebani M, Lippi G. To err is human. To misdiagnose might be deadly. Clin Chem. 2010;43(1-2):1-3. doi: 10.1016/j.clinbiochem.2009.07.002.
  2. ISO. ISO 15189:2012 Medical laboratories – Requirements for quality and competence. Retrieved January 31, 2017: www.iso.org/iso/catalogue_detail?csnumber=56115
  3. To Err is Human: Building a Safer Health System. Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. Washington DC: National Academies Press (US); 2000.
  4. Spath PL, ed. Error Reduction in Health Care: A Systems Approach to Improving Patient Safety. 2nd ed. San Francisco, CA: Jossey-Bass; 2011:153.
  5. Mugglestone M, Maher L, Manson N, Baxter H. Accelerating the improvement process. Clin Govern Int J. 2008;13(1): 19-25. doi: 10.1108/14777270810850599

Andrea Park is the manager for quality and regulatory affairs at LifeLabs in Toronto, Canada. She received a BS from the University of Toronto in 2003, followed by her medical laboratory registration and laboratory quality manager certification in 2009 from the Michener Institute of Applied Health Sciences in Toronto. Andrea obtained her certified quality improvement associate certificate from ASQ in 2010.


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