Setting up a new lab can be a daunting task for the uninitiated. Here are a few important steps you must take before you start your first experiment.
Physicians and researchers rarely encounter the opportunity to design a new state-of-the-art laboratory from the ground up. Themore likely scenario is assignment to a decades-old lab in need of updates and reorganization. Either way, the same universal principles for effective lab set-up can be applied to any workplace to ensure maximum safety, productivity, and quality control.
April Barts, MT, executive director of Clinical Laboratory Consulting, led an endocrinology lab for 10 years before becoming a nation-wide consultant. She recommends checking state regulations as the crucial first step for anyone working on a lab. “Depending on your state, you may have specific regulations that a lot of physicians are not aware of,” she explains. “We call those ‘regulatory states,’ which have their own criteria outside of the federal.”
Rules & Regulations
National regulations originate from the Centers for Medicaid & Medicare Services (CMS), which oversee all lab testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). These lengthy federal rules require a lot of paperwork and technical knowledge, as do the additional state requirements, which can all be found on the CLIA website.
“You definitely need to educate yourself,” Barts says. “And make sure that whoever oversees these regulations has lab experience.” In her consulting work, Barts has encountered numerous scenarios where an office administrator without proper credentials was placed in charge of CLIA and state compliance. Because the administrator did not understand the technical language, the lab failed to meet regulations and was forced to bring in an outside expert for help.
As a result of such costly foibles, Barts emphasizes the importance of hiring a qualified lab director. She also says to ensure that the qualifications of all staffmembers are well documented. “The guidelines are set very clearly on the CLIA website as to what they require for a laboratory director and stafffor training,” she says.
Documentation, in general, is a crucial part of creating and managing a lab successfully. All relevant activities laid out in CLIA and state regulations should be recorded and organized. Devising a filing system is step three, but Barts also recommends obtaining accreditation from a CLIA-approved entity, like the Commission on Office Laboratory Accreditation (COLA) or the College of American Pathologists (CAP). Accreditation brings peace of mind to physicians and staffabout the quality and compliance of their lab, and helps to avoid government penalties for any regulatory oversights. “COLA has a wonderful manual that gives everything you need step-bystep for a start-up lab,” Barts says.
Bit by Bit
Once staffing, regulations, and paperwork are in place, the physical arrangement of the lab can begin. Science magazine claims in its article series, “TheArt of Laboratory Feng Shui,” that a prioritized list of equipment and other resources is necessary. Base this list on the tests and experiments that will be conducted in the lab. Most practices and hospitals negotiate discounts or startup specials from retailers to buy these items in bulk. Work with the department’s purchasing staff to find out which stores carry the relevant inventory and then place initial orders.
A floor plan should be developed around the same time. Th ink about the workfl ow of each test and the stations that the lab will need, while also considering safety. Improper placement of chemicals or tools can result in disastrous consequences, such as explosions. Although it is common sense to keep acids and bases separate, it would not be the first time that a lab technician without proper training made the mistake of placing the two near each other. If the gases from ammonia and nitric acid intermingle, they will form an explosive dust akin to the ammonium nitrate concoction used in the Oklahoma City bombing in 1995.
Rob Bossio, PhD, scientist at Cabot Microelectronics and former Organic and General Chemistry lecturer at University of Michigan Dearborn, told Science that he has seen water-sensitive materials like alkali metals stored under and around sinks in labs. He recommends storing these materials in cool, dry places or desiccators with a tight seal to prevent contamination. “Science is only going to get more expensive, there’s no need to waste money on buying materials and reagents again because of negligent care,” he says.
Generally, lab equipment costs around $10,000 per year, but researchers can save on set-up by buying basic tools, like timers, from a grocery store rather than a bio supply house. If working at a university, other departments may be willing to share tools, which can also save a lot of cash.
Tests and experiments may begin after collecting and arranging all laboratory resources, but there is still much work to be done. Barts says that monthly quality assurance tests and continued documentation of activities and training are essential. With any luck, the qualified lab director hired during step two will be able to take the reins on such projects and allow physicians to focus on their work.
After all, the most important resource for any lab is, of course, the staff. The money saved from borrowing lab equipment and negotiating discounts should be invested in the recruitment of dedicated, well-trained employees who will ensure the laboratory runs safely, efficiently, and within regulations for many years to come.
— Mapes is a freelance writer in Washington, D.C., and a regular contributor to Endocrine News.