The Full Value of Laboratory Risk Assessments

December 2020 - Vol.9 No. 11 - Page #8


The US Occupational Safety and Health Administration (OSHA) requires that laboratories perform a job risk assessment for each position in the laboratory and update it annually. This includes determining each employee’s risk level for exposure to bloodborne pathogens as part of their general duties. Task and instrument assessments for risk likewise are required by OSHA. Individual laboratory processes should be reviewed annually in order to determine what level of exposure risk exists, and what methods can be taken to mitigate those risks. These two types of risk assessments—to staff and to instruments—are equally important and there are ways to utilize risk assessments that go above and beyond what is required in order to ensure safety throughout the laboratory staff in all circumstances. Herein we will look at a few hypothetical, yet common, risk examples and discuss ways in which risk assessments can benefit laboratories in the short and long term.

Take a Comprehensive View of Risk

Case Example 1. A hospital laboratory has just installed a new preanalytical specimen handling line that takes in racks of tubes, de-caps them, and performs any necessary aliquots based on individual sample need as determined by the system IT and the LIS. The instrument is placed on a counter in the processing area, next to the location where full racks of tested specimens are kept awaiting archival storage as permitted by staff time. Shortly after the front-end equipment is put in place, a tech places a rack of specimens on the new equipment to process and leaves for a break, noting multiple racks of tested tubes from earlier in the day still sitting on the nearby counter. Assuming these specimens can be archived later, the tech takes lunch in the break room. A few minutes later, the tech hears a loud crash in the lab, and upon investigation, discovers that an entire rack of tested specimen tubes has fallen off of the counter and spilled all over the floor, creating a large biohazard spill.

Given the loss of specimens (thankfully after testing), a root cause analysis is performed. It is discovered that the new preanalytic equipment has a metal arm that extends out to the side and slides forward each time a rack of specimens is placed on board. The incident occurred because a storage rack was placed on the counter next to the new equipment, and the metal arm pushed forward, knocking the specimens rack onto the floor. While numerous other parameters were resolved prior to implementing this instrument, full consideration was not given to the total mechanical action in its surroundings.

Mastering Required Risk Assessments

The first step for any laboratory safety program is gaining an understanding of all risks that may be encountered as work is performed throughout the department. In fact, the international standard that describes the requirements for the competent and consistent operation of laboratories—ISO/IEC 17025—was updated in 2017 and it contains a strong focus on assessing risk. This update to the General Requirements for the Competence of Testing and Calibration Laboratories1 requires laboratories to implement a risk-management approach to all activities in the department.

Laboratories should begin by focusing on regulatory requirements. Examine each job title or position in the lab and consider the amount of exposure to bloodborne pathogens each person might encounter in the course of their work.2 Document these assessments and schedule for an annual re-evaluation (see FIGURE 1). The required task and instrument assessments may take more time. Look at the individual tasks that are performed in the lab and make a scientific judgement about the potential exposure risk for each (see FIGURE 2). One way to bundle these assessments is to look at all of the work performed in a particular work area (ie, the gram stain area, the chemistry analyzer bench, etc), consider the exposure hazards, and document the existing protections (eg, engineering controls, PPE, etc). These assessments should be reviewed annually as well.


Furthermore, OSHA requires laboratories to assess employee risk to airborne pathogens, such as tuberculosis. This assessment is made in order to determine what type of respiratory protection (if any) may be required while working with such pathogens or within the workspace of these pathogens. Keep in mind, while these assessments are important and necessary, they do not cover all the types of risks lab staff may encounter. Thus, reviewing these potential risks does not necessarily close the loop on hazard mitigation in the laboratory.

The Risk Assessment 5-Step Process

Case Example 2. An operating room assistant comes to the histology laboratory every day to fill specimen containers with formaldehyde, then delivers them up to the OR on a cart. One day, when exiting the elevator with a full cart, another employee accidentally bumps it, knocking it over. About two gallons of formaldehyde spill all over the corridor floor. With no spill kit nearby and no immediate staff trained on spill clean-up, the area has to be evacuated until lab staff can bring supplies upstairs and clean up the volatile chemical spill.

Routine risk assessments should be used for any process related to the laboratory where hazards are present. There are several other types of hazards besides bloodborne and airborne pathogens, so including risk assessments that go above and beyond the requirements is vital. Consider chemical hygiene, electrical issues, radiation contamination, ergonomics, fire safety, compressed gases, and waste handling concerns, among others.

Although there are variations on this theme, general agreement dictates that there are 5 essential steps to performing a basic risk assessment (see FIGURE 3):

  • First, identify the known risks and hazards of a specific work area or of specimens/samples being handled. While not every potential risk can be identified at first, focusing on obvious hazards is a good starting point when placing new equipment or introducing a new lab process.
  • Second, perform an evaluation of those risk elements including the likelihood of occurrence for each risk. Classify the consequence of each identified, potential occurrence on a rating scale using terms such as insignificant, minor, moderate, major, and critical.
  • Third, rank each risk assessment in order of criticality (highest to lowest). Calculate the overall risk level for each process step using the information in the previous step.
  • Fourth, list the risks according to severity (top down) and determine individual actions that can be taken to mitigate each one. For example, if placing a new centrifuge means an electrical cord will cross a lab walkway, consider methods to remove that known trip hazard, such as relocating the equipment or securing and covering the cord with a walking mat.

    As the fourth step goes into practice, it is important to consider what is known as “residual risk,” or the danger/hazard that may remain after risk mitigation steps are put into place. For example, if a lab must perform an aerosol-generating process with a COVID-19 respiratory specimen and no biological safety cabinet (BSC) is used, the risk of exposure is high. Mitigation of risk here could include the use of a safety shield and N95 respirators (per CDC guidelines), which would minimize the residual risk. If the residual risk level is not lower than the original risk, that may mean that the task should not be performed or that more safety controls will be necessary in order to proceed.

  • The fifth and final step of the risk assessment process is to implement the risk controls and to continually monitor the process. Look for any exposures or injuries that may occur as the process is adopted and regularly review the risk assessment to make sure any process changes that may occur over time are considered and addressed.

A Complete Risk Assessment Model

Case Example 3. A new analyzer was purchased so the lab could quickly onboard COVID-19 PCR testing. With insufficient space to install the analyzer in the current lab layout, a storage area was repurposed to the department for use. However, the area did not have negative pressure and there was no door on the room separating it from the hallway where employees walked to the break room. Staff working with the new analyzer had to vortex the samples, but there was no room for a biological safety cabinet (BSC) in the new testing space. To resolve this, a tech could vortex samples while donning a protective shield and full PPE (ie, lab coat, gloves, N95 respirator). A door would need to be installed with negative pressure established.

As the coronavirus pandemic proliferated in the first half of 2020, the CDC provided substantial resource information to help laboratories navigate the new and somewhat unknown risks of working with COVID-19 patient samples. Many laboratories were tasked with the rapid implementation of new testing, new analyzers, and new work practices, and this introduced new types of risks for exposures and injury to lab staff across the country. These scenarios perfectly illustrate the need for documented risk assessments throughout the laboratory.

Among the CDC’s Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)3 is a resource for laboratory risk assessments. There are a variety of models available to use, but most follow the 5-step process listed previously. Use this resource to create a standard document unique to your laboratory such that risk assessments are automatically enabled as new instruments, methodologies, and processes are implemented. Even if there is an emergent need to perform testing, a formatted risk assessment will be of value and can be performed reasonably quickly. See the Appendix for one possible format. Use the examples provided by The Association of Public Health Laboratories (APHL)4 and the CDC to create a format that works for your laboratory.


Case Example 4. The laboratory has an unused floor drain that requires a weekly check by a member of building facilities staff who adds water to the trap if necessary to prevent the release of any possible fumes. A new hematology analyzer is acquired and is slated to be placed near the drain so the waste line can feed into it. While performing a complete risk assessment, the safety officer notes that the drain line is not secure and when waste is flushed from the analyzers, splashes occur around the drain. This poses a danger to the facilities staff member who inspects the drain, so the tubing is secured and tested to ensure against splashing. Equally important, information on safety and proper PPE is provided to those who service the drain and operate the analyzer.

Clinical laboratories can be inherently dangerous places to work. Thus, the primary purpose of OSHA in laboratory practice is to ensure staff are protected from all potential hazards. While this is required, it is also the right thing to do. Knowing and following the regulations regarding risk assessments in the laboratory is beneficial, but those regulations alone do not paint an entire picture for maintaining safety in your specific department. Conduct a complete risk assessment as new instruments and procedures are implemented to reveal unknown hazards and allow them to be handled before the risk manifests.

Keeping staff safe from exposures and injuries in the laboratory is a comprehensive task, but it needs to be a top priority for lab leadership and safety professionals alike. When used properly and completely, risk assessments can be powerful tools to initiate, discover, and close the loop on laboratory safety hazards.

Daniel J. Scungio, MT(ASCP)SLS, CQA(ASQ), has over 25 years’ experience as a certified medical technologist. He worked as a laboratory generalist in hospitals ranging from 75 to 800 beds before becoming a laboratory manager, a position in which he served for 10 years. Dan is now the laboratory safety officer for Sentara Healthcare, a system of more than seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. As “Dan the Lab Safety Man,” he also serves as a professional speaker, trainer, and lab safety consultant. Dan received his BS in medical technology from the State University of New York at Buffalo.


  1. International Organization for Standardization (ISO). General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:2017. Accessed 11.12.20:
  2. US Department of Labor. Occupational Safety and Health Administration. Toxic and hazardous substances; bloodborne pathogens. Washington, DC: US Government Printing Office, 1999(Jul 1): [29CFR1910.1030]. Accessed 11.12.20:
  3. US Centers for Disease Control and Prevention. Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Accessed 11.12.20:
  4. Association of Public Health Laboratories. Risk Assessment Best Practices. 5.5.16. Accessed 11.12.20: Risk Assessment Best Practices and Examples.pdf

For CDC Information for Laboratories about Coronavirus (COVID-19), visit:

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