The healthcare in the United States is a lot like dining out. Sometimes you can experience a restaurant with great service and have a fantastic meal, but other times, the food is cold or not what you ordered. In healthcare, patients can have a great experience, and other times errors occur. Incorrect procedures, wrong site/wrong surgeries, and lapses in judgment happen. You might think it is all about cost. More expensive healthcare must be better, since fine dining restaurants are more expensive than fast food. No, just like in dining, higher cost doesn’t necessarily buy you higher quality! Everyone has occasionally overpaid for a bad meal even at a fine restaurant. Good food and service can come at any price, just like quality healthcare.

The determining factors between good and poor quality are the management systems in place. A good restaurant has a total quality vision and a management system to deliver that vision. The kitchen is well organized, everyone knows their roles and responsibilities, and a recipe sets the standard for food preparation. Plates are prepared according to the recipes by the line chefs. But, before the plate leaves the kitchen to be delivered to the customer, it is checked by the head chef to ensure that it meets minimum standards for quality and presentation. There are multiple control processes in place to ensure quality both during preparation as well as the final check before the plate goes out the kitchen. This restaurant is an example of risk management in action. The kitchen has mapped their processes, knows their weaknesses and has put controls and checks in place to ensure consistency of results.

Implementing risk management in the laboratory follows similar strategies. We must map our processes so that the staff understands how a test result is produced. From physician order to patient preparation, sample collection, transportation to the lab, processing, analysis and reporting of results, the laboratory must know the detailed operations and where the process can go wrong. What are the weak steps in the process? What can the laboratory do to prevent or detect errors before they impact the test result, affect clinical action and harm the patient?

This is the heart of risk management, understanding our processes, weaknesses and taking steps such as implementing controls, checks or policies/procedures to prevent and detect error. In the clinical laboratory, staff may not realize that manufacturers conduct risk management before submitting for new device approval through the FDA. Manufacturers consider not only what could fail on a device during operation, but also define use or “misuse” scenarios of how consumers will utilize that device in practice. Much of this risk information is summarized in the package insert and operations manuals (particularly in the limitation sections). However, as consumers of laboratory instrumentation, we should routinely partner with our manufacturers, ask how devices can fail, and what the laboratory can do to prevent such failures.

Newer advances in instrumentation have control processes engineered into the device that lower the probability of certain errors occurring. Features like automated calibration and expiration dates barcoded into the lot specific information on reagent packaging can enhance the detection of compromised specimens and prevent mistakes in calibration factors or use of reagents past their expiration date. While we can never get to zero risk, such features help the laboratory ensure quality results by lowering risk to a clinically acceptable level.

Risk management should not be a new concept to laboratories. We perform a number of activities that could be considered risk management in our daily laboratory operation, but we may not formally call these activities risk management. Laboratories validate tests before patient use to document initial performance, analyze quality control specimens to look for shifts in assay performance and drift, and trouble-shoot when controls fail or other problems occur. As future devices become more of a “black box” to the staff, laboratories should learn to partner more closely with manufacturers to determine what laboratories can do to reduce risk and the probability of medical error.

The Clinical and Laboratory Standards Institute (CLSI) has published EP23-A: Laboratory Quality Control Based on Risk Management that introduces risk management principles to clinical laboratories. EP23 presents an overview of risk management and provides guidance for laboratories to map their processes, define weaknesses and identify control processes that can manage risk. This guideline can help laboratories define what can go wrong, and how to control those risks.

Laboratories and regulatory agencies have struggled with a one-size fits all, two levels of controls each day of testing, being the minimum requirement for good laboratory practice in the face of newer technologies. For unit-use tests, the performance of liquid controls consumes the entire, single-use test and is no guarantee of performance with next cartridge or test. Newer devices have a variety of built-in and engineered chemical and biological controls performed with each test, like the internal controls on pregnancy, drugs-of-abuse or occult blood guaiac tests. Risk management can help laboratories find the right control processes and frequency for their tests, based on how the test functions, what can go wrong with the device, the effectiveness of the control processes, their laboratory environment, and most importantly how the test will be utilized by the physician in the care of a patient. Some laboratories may have to analyze more frequent liquid controls or take additional competency steps compared to other laboratories because of high staff turnover or low levels of staffing. Performance of liquid control samples may not be practical for some technologies, like arrays and chips, with hundreds of individual markers on a single cartridge, since no single control can detect and monitor performance of every marker on that cartridge in a single test. A more practical approach may be to control for the most common failure points in that device, like sample, enzyme activity and signal detection. Managing noninvasive bilirubin meters and in-vitro sensors may require still other types of controls, since a liquid sample cannot even be analyzed by these devices. Thus, risk management allows the laboratories to define the right control for their specific device.

As I think about risk management, I can’t help wonder about the many ways that risk management can help us better define our limitations and get to that next level of quality both in people, processes and instrumentation. Whenever I make my next reservation for dinner or my next doctor’s appointment, I am certainly going to consider how their systems are working and if they are using risk management principles in their day-to-day activities.


CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI Document EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.