Regulatory Compliance

Laboratories are full of potentially hazardous minefields, and they don’t include just chemicals.

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Dedication, Resources, and Manpower Required

On December 29, 2008, a young research assistant working at a University of California, Los Angeles (UCLA) lab used a syringe to transfer tert-Butyllithium from one container to another. The syringe came apart and the contents of the pyrophoric reagent, which spilled on the assistant, Sheharbano Sangji, combusted and instantly engulfed her in flames. Sangji suffered severe burns and died days later.

Many of those who examined the incident blamed it on lack of proper training and said it was one that could have been avoided if the victim were wearing protective gear. The California Division of Occupational Safety and Health considered the case a result of regulation violations.

“That was definitely one of the worst tragedies during my career that I could remember, and it had pretty severe consequences across the academic scene in terms of tightening up, making sure that we get everybody trained that we need to, especially when you’re dealing with extremely hazardous substances like that,” says Vince McLeod, a consultant who recently retired after 28 years as a senior industrial hygienist for the environmental health and safety division at the University of Florida, responsible for all Occupational Safety & Health Administration (OSHA) health and safety regulations in more than 3,500 laboratories at the university.

Laboratories are full of potentially hazardous minefields, and they don’t include just chemicals. Physical hazards are equally abundant. In 2011, a 22-year-old Yale University astronomy and physics student was working in a lab when she was killed after her hair was caught in a lathe.

Upon hearing of this and other incidents of students operating heavy machinery in laboratories and material engineering shops and sustaining serious physical injuries operating equipment without proper training, knowledge, and experience, McLeod and his team went on a mission to further ensure that such accidents are avoided at their facilities. “We started a heavy emphasis on going through all our laboratories and finding those that had equipment like lathes, table saws, and other heavy machinery that can cause severe injury, making sure we had shields and guards in place and that operators were properly trained and that students did not work alone,” he says.

OSHA is a federal agency that regulates safety and health in the workplace. The agency not only sets standards for workers to follow but also enforces them. These standards—which could be learned through training and education and are to be followed by personnel across the nation—help avoid risks. To that end, laboratory managers and employers should train their workers to deal with potential hazards and provide protective gear along with chemical information and safety sheets for substances used.

“If you reviewed the safety data sheets associated with those [pyrophoric] substances, [they indicate] proper measures to protect against those types of hazards,” says Kevin Slates, industrial hygiene laboratory director at the Indiana School of Public Health-Bloomington and former OSHA inspector, of the UCLA incident. “Accidents don’t just happen, they’re caused, and there’s initial intervention that instructors or managers should have been aware of.”

Staying compliant

The route to staying compliant differs for each institution and company laboratory, depending on the type of work and hazards specific to the setting.

For example, Sherrill Gelsomino, president of J&S Environmental Laboratories LLC in Union, New Jersey, runs a lab where the primary analyses consist of testing building materials and air samples for the presence of asbestos.

Related Article: A Preventive Approach

She’s particularly aware of the five major federal asbestos statutes and regulations used by states for asbestos testing. These are OSHA’s Construction Standards (OSHA 29 CFR 1928.58), the OSHA General Industry Standards (OSHA 29 CFR 2910), the Environmental Protection Agency’s (EPA’s) Worker Protection Rule (EPA 40 CFR 763), the EPA’s National Emission Standard for Hazardous Air Pollutants (EPA 40 CFR 61), and the EPA’s Asbestos Hazard Emergency Response Act and Asbestos School Hazard Abatement Reauthorization Act rules (EPA CFR 763).

J&S currently conducts the Environmental Laboratory Approval Program (ELAP) for the state of New York and the National Environmental Laboratory Accreditation Program (NELAP), developed by the NELAC Institute.

“The NELAC standards for laboratories are modeled after similar ISO standards that all laboratories accredited must adhere to,” Gelsomino says. “Both the ELAP and NELAP accreditations require at least a biannual site assessment to ensure that the laboratory stays in compliance with the above regulations.”

As the industrial hygiene laboratory director, Slates is concerned with OSHA standards for laboratory safety, specifically the chemical hygiene plan under OSHA 29 CFR 1910.1450. Examples of what falls under that standard include personal protective equipment, storage of flammable and combustible chemicals, ventilation requirements for fume hoods, and hazard communication.

To ensure compliance, his university uses an institutional system. “We have a department of environmental health and safety, and they have safety specialists or inspectors [who] go out to assist in educational training whether or not they’re conducting mock audits and an assessment,” Slates says. “They will [then] write up a technical report and send [it] to the department chair so there’s accountability at the university and department levels to ensure that these laboratories are meeting requirements. They will also publish resources to graduate students, faculty, and lab instructors, and will provide resources for each laboratory to make those programs more site-specific based on what’s done in the lab with regard to research or analytical work.”

For J&S, strict quality assurance and control requirements are also in place and performed daily to ensure the integrity of the sample analytical testing and that it stays in compliance. Additionally, whenever there is an update with regard to regulations, employees are informed of pertinent information via either email or weekly meetings. Furthermore, courses and in-house training are provided to ensure that employees are kept up to date with the changing regulations. In-house standard operating procedures are also updated if necessary, explains Gelsomino, who oversees all compliance requirements.

Inspections

In order to ensure that laboratories are safe, government and sometimes health and safety entities within an organization routinely and randomly inspect laboratories.

At J&S, the agencies, ELAP, and NELAP conduct inspections at least twice a year. The agencies typically provide a one-month notice prior to a scheduled visit. Should the lab fail inspection, it could be subject to suspension and is given ten days to provide a rebuttal. “In my opinion,” Gelsomino says, “ELAP is one of the most stringent accrediting authorities out there.”

For the University of Florida labs that work with hazardous waste, it works a bit differently. Representatives from the Florida Department of Environmental Protection conduct large annual hazardous waste inspections. “They usually send out a team of inspectors [that includes] both state inspectors as well as at least one federal inspector,” McLeod says.

For other types of labs at the university, inspectors from other agencies come in. For example, “There’s an agency that inspects all your animal handling and animal care facilities, and [others, such as the DEA,] that come if you’re dealing with controlled substances,” McLeod says. “So there are a lot of agencies [involved], especially for a larger institution where you have a great diversity of research going on.”

Although these agencies don’t have to give the labs any warning and could show up unannounced, they often do notify them and will give labs about a week’s notice. If they’re planning a large inspection and intend to be present at a lab for several days, they usually let managers know a week ahead so they can plan accordingly.

Yet government inspectors never visit some labs. “I’ve been at Indiana University for ten years and the industrial hygiene laboratory director for eight of those years, and we have yet to have a government [inspection],” says Slates. “We haven’t had a probable cause.” Probable cause would be a programmed inspection, a catastrophic event that would initiate an inspection, or an employee complaint.

In industry, they often inspect labs randomly, Slates explains. However, many academic or university laboratories are considered lower priority in terms of risk and because there are “just so few inspectors available that it’s not feasible for a university lab to expect a government representative to show up,” says Slates. “That’s why at [the] university level they’ll conduct mock inspections to look at the same things that government inspectors look for.”

Best practices

Staying compliant takes resources and manpower, but it pays back its weight in gold in terms of safety and efficiency. Managers each have their own take on what constitutes best practices for their lab or institution. For example, for Gelsomino, staying in compliance with quality assurance and quality control every step of the way means keeping abreast of compliance. “If [you are performing reviews] daily and complying with the checklists provided by the accrediting authorities, you are doing well as a testing facility,” she says.

At the University of Florida, where there are many labs and it could be challenging to keep track of compliance, there’s a designated person in each lab or division who handles all health and safety aspects. That person works with local environmental health and safety representatives to make sure the facility stays up to date.

It’s important, McLeod says, to have a written program in place. The Department of Health and Safety provides a test bed for labs to use in light of their specific safety requirements based on a general template. “Also, we maintained and helped them keep up with their chemical inventories and things of that nature,” he says. “You all have to work together, [and] looking at the lab standards that OSHA has—29 CFR 1910.1450—is a very good starting place in terms [of] helping your overall program.”

Slates also recommends implementing OSHA’s chemical hygiene plan, 29 CFR 1910.1450, within which other standards are integrated. “Examples,” he explains, “would be fire protection plans, hazard communication, protective equipment hazard assessment, requirements for fume hoods, and even access to first-aid kits.”

“Another recommendation that I’d make is to become members of professional organizations or societies,” he says. “Within those societies, they’ll have groups that will primarily focus on laboratory safety issues—it could be assessment, it could be program development or implementation—and from a management perspective you’re managing programs, people, resources, and hazards. I think it’s important that laboratory managers tie into existing associations, that way they’re able to benchmark what other successful programs are doing and save time and resources in the process.”

Such practices not only help avoid tragic accidents by protecting the health and safety of individuals and property, but could also increase lab productivity.

“[When] people feel as if their personal welfare is being considered and risks are reduced, they really focus on issues like quality in terms of what they’re doing in the laboratory,” Slates adds.

Categories: Lab Health and Safety

Published In

Regulatory Compliance Magazine Issue Cover
Regulatory Compliance

Published: March 11, 2016

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