Welcome to the first installment of a series on risk management for the laboratory. We begin with two definitions of “risk” that we will use throughout our discussion. Risk is harm to a patient or a loss in resources, finances or time; resulting from inadequate or failed processes, people and systems or from external events.
For example, there is a risk of reporting out an incorrect CBC due to drawing the wrong patient. Another useful definition of risk is “the chance of something happening that will have an impact on objectives.” For example, if we define a risk as mis-identification of a patient’s samples, then a project to reduce or even eliminate such errors is risk management (RM). We might define RM as the identification, analysis, assessment, control and avoidance, minimization or elimination of unacceptable risks.
In several respects, RM is closely related to project management (PM). If you have been exposed to PM or even studied it, that will be of help in discussion and applying RM to your laboratory.
In order to manage risks, they must be identified and then quantified. It is difficult, if not impossible, to manage a risk if the incidence of risk events (e.g., drawing the wrong patient) is not known. Thus, once the risk is identified and quantified, a review process by one single person, or better a group, is formed to find all of the variables that could generate the risk event (e.g., drawing the wrong patient). This group or team should as an entity have a good understanding of the tasks and objectives of the risk being scrutinized and analyzed.
Here is a sketch of how the group may begin their attack on the risk:
Identify the risk: As a group, list those things or events that might obstruct your ability to meet the objectives (In our case, the objective is to eliminate all mis-identifications of patient samples. Or, if our objective is to reduce the turn-around-time [TAT] for a troponin from the ER, we will need to determine the TAT as it is now). At this step in RM, you may examine the things that would actually enhance your ability to meet those objectives (e.g. implementing bar codes on the patient and the tube or in the case of the TAT, consider an instrument in the ER).
- Identify the causes that create the risk: In the example of TAT, one cause might include simply the time it takes the instrument to generate the value (Take a minute or two and name at least three other impediments to achieving a better TAT).
- Identify the controls: There may be certain factors now in place that exist to reduce the risk. If so, list these. Ask if those controls can be improved. In our example of patient ID, a solution might be to ask the patient his or her name and birth date, as opposed to asking is your name Francis Johnson?
- Establish the risk rating descriptors: What is meant by a Low, Moderate, High or Extreme Risk needs to be decided upon ahead of time (e.g., in the case of TAT, the time on the instrument could be rated extreme for it is permanent. Or you may rate it as low as being fixed — there is nothing the team can do to reduce it.)
- Likelihood and consequences: Once all the parameters have be identified, discuss what changes for each might be made. Early in this step, we suggest that any possible change should be put up on the board. Once all the possible changes are listed, estimate the effect (In our example of TAT, adding more staff is the possible change and the effect would be to reduce the TAT by a certain time). Then rank them in respect to the likelihood that change could be made (hire more people may have a likelihood of 0!).
- Monitor and review: The monitoring of all the risks and a regular review of the unit’s risk profile is a critical component for a successful RM program. List the manner that monitor and review will be done.
The flow chart below is a graphic approach to RM.
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Another approach is the cycle shown here. This is called a PDCA or a Deming or Shewhart cycle. Note that it begins with a plan and after acting returns to (a revised) plan. Obviously this can go on and on — until the risk has been eliminated or the resources needed for the new plan are not (currently) available.
| Activity Number or Time |
Plan Start |
Plan Duration Weeks |
Actual Start |
Actual Duration |
Percent Complete |
| Which Patients |
1 |
4 |
1 |
x |
? |
| 1. 0000-0600 |
1 |
4 |
1 |
x |
? |
| No. of Staff |
1 |
4 |
1 |
x |
? |
| Order to Draw |
1 |
4 |
1 |
x |
? |
| Draw to Lab |
1 |
4 |
1 |
x |
? |
| Accession to Instr |
1 |
4 |
1 |
x |
? |
| Instr to ER |
1 |
4 |
1 |
x |
? |
