Manage risk better with a team approach By Leslie A. Glynn, AIA      Risk assessment and risk management are fundamental, daily concerns of all laboratory managers and personnel. However, when new or renovated labs are being designed, risk management should also become the purview of the lab architects and engineers. Involving these design professionals in risk management discussions brings a valuable, facilities-based perspective to a project, and takes advantage of their expertise: from facilitating the flow of lab operations to proposing proper lab support, storage, and safety considerations. Proficient lab designers will draw from the breadth of their experiences to generate new solutions tailored to the current project. For the purposes of this discussion, the term “risk assessment” means providing a professional and experienced review of hazardous materials handling, scientific operations, and processes to evaluate and document the risk of harm. The term “risk management” means determining and documenting safe and appropriate protocols to mitigate and manage potential harm. Successfully programming and designing new or renovated lab facilities requires that lab architects take an active role in the owner’s discussions about risk management. Photo: Warren Jagger for Tsoi/Kobus & Associates. Click to enlarge. Since the risk of a hazardous operation can be practically nullified if the operation is performed within an appropriate facility by trained personnel, risk assessment and management can be regarded as relative rather than absolute studies. A combined scientific, operational, and facilities approach to risk management should use a 360° review by a diverse team of professionals. This team will discuss concerns and propose solutions that will form the basis of an organization’s risk management protocols. Risk assessment and management became the cornerstone of laboratory protocols after 1980, when the U.S. Supreme Court ruled on a landmark case involving the Occupational Safety and Health Administration (OSHA). That decision stated that an assessment of risk is necessary to establish occupational health standards, and prompted federal regulatory agencies involved in handling hazardous materials or agents to predicate their compliance requirements on documented risk assessments. In light of this legal precedent—and the acknowledged prudence of this policy—institutions and corporations have followed suit and used a risk assessment and management approach to keep their workplaces safe. Risk assessment details A risk assessment usually lists all hazardous materials and processes with regard to the nature and degree of potential harm. Hazardous materials may be classified within one or several categories, including: toxic, flammable, reactive, explosives, cryogenic, radioactive, and biohazard. The hazardous properties and toxicities of known materials are normally derived from Material Data Sheets (MDSs), product labels, the Agent Summary Statements in the Centers for Disease Control’s “Biosafety in Microbiological Laboratories” (BMBL), and a number of other well-thumbed lab references authored by OSHA, the National Fire Protection Assn. (NFPA), and the National Institutes of Health (NIH), to name just a few. Safe laboratories are created when those who are trained for the work understand and implement safety precautions as a natural course of their daily activities. Photo: Greg Premru for Tsoi/Kobus & Associates. Click to enlarge A person can be harmed or killed by sufficient exposure to hazardous materials through inhalation, contact with the skin or eyes, ingestion, or injection. These are referred to as the routes of exposure. The physical state in which the material or agent is handled (e.g., solid, liquid, aerosol, or gas) is also a significant consideration. Lab procedures routinely require several changes of state, and these different states require varying types and levels of protection and containment. In addition to the materials themselves are the hazards posed by processing them, which may involve electrical danger, high-pressure reactions, vacuum work, compressed gas, UV, near-infrared light, lasers, radio frequency, microwaves, and magnetic fields, not to mention the all-too-frequent injuries caused by falling, tripping, slipping, and lifting that often occur during material handling and storage. Safe laboratories are created when those who are trained for the work understand and implement safety precautions as a natural course of their daily activities. Depending on the nature of both the hazard and the venue, compliance may be monitored at the laboratory level through programs and committees such as the Chemical Hygiene Program (CHP) and the Institutional Biosafety Committee (IBC), and on-site through Environmental, Health, and Safety (EH&S) inspections. At the heart of lab safety, however, lies risk assessment and risk management. Understand risk for flexibility Successfully programming and de-signing new or renovated lab facilities requires that lab architects take an active role in the owner’s discussions about risk management. Although experienced lab designers will have expertise in general laboratory protocols, practices, guidelines, and codes, there are enough variations in process—not to mention the dynamic nature of technique and instrumentation—that a proper review of “routine” lab protocols as well as specialized lab procedures and processes should be conducted. Post-9/11 safety concerns, which have resulted in increased lab security and personnel access requirements, also need to be considered. Involving lab architects and engineers in risk management discussions brings a valuable, facilities-based perspective to a project, and takes advantage of their expertise in everything from facilitating the flow of lab operations to proposing proper support, storage and safety considerations. Photo: Bruce Martin for Tsoi/Kobus & Associates. Click to enlarge. It can be easy to fall into inexact jargon and broad-based descriptions for lab environmental specifications based on “hearsay” scientific protocols. Only when the design team fully understands the hazard source and sequence of lab operations can an organization be sure that a facility will be designed to provide the most appropriate and flexible spatial layouts and building systems. The critical aspects include proper ventilation, filtration and containment; remote and direct visual supervision; alarms; communication devices; fire suppression systems; safety equipment; waste treatment; maintenance procedures; and other considerations. Accordingly, the designers’ review should include but not be limited to: • Incoming regulated materials. Are there biohazardous, toxic, or radioactive materials? What forms are they: liquid, gas, or solid? What are their container types and sizes? • Outgoing regulated waste streams. Will wastes be disposed through an acid neutralization system, collected separately for licensed disposal, or red-bagged for sterilization on- or off-site? • Exhausted fumes. Are they required to be filtered, scrubbed, or incinerated? • Drain disposal. If there is an acid neutralization system, how is it monitored? What can be put down the drain, and what requires collection and disposal elsewhere? • Access. Who is allowed where, and when? Consider researchers, visitors, maintenance personnel, vendors, inspectors, lab support staff, and, in many cases, graduate and undergraduate students. For an illustration of this kind of review in action, consider chemical storage. Many health risks can be better managed through proper oversight of the quantities, concentrations, and container size of chemicals. Maintaining the smallest practical inventory of chemicals can not only lessen laboratory hazards but also reduce waste in chemical usage, as well as unproductive building space and wasted energy (both with respect to utilities and staff time). It can also mitigate the need for extensive fire-rated separations that can increase costs in engineering systems as well as architectural partitions. Organizations should take a coordinated team approach to risk management when building or renovating scientific facilities. Photo: Tsoi/Kobus & Associates.Click to enlarge. This practice regarding chemical usage has led to the “JIT” (“just in time”)—or lean—approach of supply and demand. By working with researchers, EH&S, insurers, purchasing, and other relevant parties, it is possible to determine the chemical usage of a lab on a weekly basis and coordinate with the vendor (and, as necessary, waste removal agency) to calculate how much product is actually needed on hand. This exercise can not only lower the hazard level by reducing quantities of materials but also cut costs. The location of chemical storerooms is another factor in managing a building’s risk. It may be more expeditious to place satellite chemical rooms central to each floor rather than putting a large central storage room near a building’s loading dock. Storerooms adjacent to the loading dock tend to cause staff to load up on supplies when they are “in the neighborhood,” often leading to hoarding. These private caches are potentially dangerous since hazardous materials accumulate in spaces that were not designed to house them. They also are wasteful, since they can cause a purchasing and/or inventory system to falsely assume that a product is in use and that additional supplies are needed. If such hoarding becomes a habit, it can also result in unproductive storage in lab spaces, where every available square inch should be used for viable research operations. Designing a facility using satellite storerooms places the concentration of chemicals where researchers can have ready access and provides for proper fire ratings, exhaust ventilation, fire protection, and spill containment. When designed in combination with a chemical inventory system, this solution can reduce the building-wide hazard management effort and even streamline purchasing. New science requires new strategies So far, we have assumed known hazards to which well-established protocols can be applied. Unknown agents or chemicals pose a far more complex challenge. Such cases call for a conservative approach to risk assessment and management in which worst-case scenarios are thoroughly explored. Science is continually discovering new materials and processes that may involve potential hazards, both immediate and long-term. The handling and manipulation of these unknowns require that a risk assessment and management approach make the best extrapolation of known phenomena and derived characteristics. Even with the Internet, information about new materials and processes requires time to review, substantiate, and document before it can become a legitimate addition to the body of scientific knowledge and recommended protocols for safe handling. I recently worked on a BSL-3 project for a confidential client that involved the use of select agents. This project was the first in which the institution, the city, the architects, and the engineers worked with the new federal regulations. Consequently, the diverse forum of experts—researchers, lab managers, EH&S, laboratory architects, and engineers—spent a series of meetings proposing and outlining protocols using the floorplans to walk through different scenarios. In addition, we solicited the input and expertise of vendors representing sterilizers, bubble dampers, decontamination systems, kill systems, glove boxes, and other products. Good vendors understand the operational context in which their products work safely and know how other institutions are using them. Many even have in-house PhDs to assist with the ever-evolving needs of the scientific community. Together, our group identified and planned the path and treatment of all personnel, materials, and waste as they entered and exited the facility, in routine and extraordinary circumstances. Our concerns addressed safety for the researcher, lab, building, neighborhood, and “global village.” Our review list highlighted proper containment, usage, redundancy, and security. Beginning with normal procedures, we discussed issues such as: • Access. Would a key or card be used to access the facility? Would a camera be activated by the swipe? Would a keypad also be needed in case the card is lost? Should a timed alarm be put on the door to prevent it from being held open too long? • Drain disposal. What can go down the drain to the kill tank, and how much? What is the agent in the kill tank, its kill time, and the concentration required? How is the effluent monitored before discharge to the acid neutralization system? • Laboratory support services. How are the labs stocked, serviced, and cleaned? Can laboratory support services staff access the anteroom only to pick up waste and stock disposables and chemicals? Are the researchers responsible for servicing and cleaning the biosafety lab itself? What about access by maintenance and calibration staff? Next, we investigated normal but infrequent procedures, such as facility shutdowns due to routine maintenance or proscribed decontamination. How long could the facility be down, and how does that coordinate with the recommended maintenance plans of the MEP and scientific equipment, calibration specifications, and other considerations? Finally, we proposed emergency situations to assess worst-case scenarios. Significant harm often derives from a sequence or combination of events involving materials, process, and facilities design, rather than a single incident. If an alarm fails, what happens next? And after that? And after that? How do we design a fail-safe facility? Fail-safe design relies heavily on careful interface and sequencing between building systems in combination with appropriate operational and maintenance protocols. Accordingly, we spent considerable effort working out the appropriate balance of redundancy in the mechanical systems, building controls, alarms, and security that comprise the primary and secondary biocontainment environment, with the understanding that the addition of multiple “belts and suspenders” does not automatically produce the safest design. The result was a narrative that outlined the staff operational protocols integrated with the mechanical systems, controls, alarms, and security. This document had two purposes. First, it was the basis of the risk management plan. Second, we planned to use this document to write the building systems performance criteria and the controls integration and sequencing criteria, which are required for the construction documents. Our work on the project was stopped at this point due to a reprioritization of funding by the institution. Although it meant that this particular BSL-3 facility was never built, the risk management discussions proved valuable to all of the parties involved. Raising many complex concerns and considerations in a multidisciplinary forum provided a process that optimized safety in the laboratory design. Leslie A. Glynn, AIA, is a senior project architect and laboratory planner with Tsoi/Kobus & Associates, Cambridge, Mass. (www.tka-architects.com). TK&A has a national practice providing planning, architecture, and interior design services for research, healthcare, academic, and commercial facilities. Many of the firm’s projects involve large multidisciplinary teams, multiple stakeholders, intensive programs and systems, and complex siting, permitting, operational, budgetary, and scheduling challenges.