At least once a year, perhaps when least expected, every lab will encounter the inevitable: an inspection. The unannounced arrival of a designated lab inspector can inspire anxiety in even the most experienced and diligent managers. If one worker happens to forget his or her safety glasses or walks into the lab with a cup of coffee on the day of inspection, citations will occur — no matter if the error is simply a poorly timed aberration.
Keeping track of the minutia related to lab work can be taxing. Jonathan Moore, MS, CHP, oversees the lab safety inspection program at the University of North Carolina Chapel Hill and faces the arduous task of enforcing compliance within laboratories across the entire campus. He has witnessed many of the things that can go wrong in a lab, so he compiles a list of the top 20 violations every year.
“Everything is based on OSHA [Occupational Safety and Health Administration] regulations, fire codes, safety codes, and guidance documents from agencies like the CDC’s Biosafety in Microbiological and Biomedical Laboratories,” he explains. These long lists of rules can be difficult to remember, but the most common errors tend to be the most obvious.
Laboratories across the country and even the world consistently miss the mark on seemingly basic steps. The problem, Moore says, stems in part from the frequent turnover at labs, but the root of most issues seems to come from the No.1 violation: failing to complete compliance training. He has found it very challenging to obtain universal participation from those who work in labs.
“The training contains the very hazards they will experience in their everyday work,” Moore explains. Total participation is a distant dream for the average lab. Fortunately, the advent of online testing has made it easier to complete the requirement. “We are finally seeing improvement.” Moore’s experience proves that even the best labs must stay vigilant, and increased compliance with training should better the status of inspections overall.
Among the other top 20 violations, hazardous waste management, labeling, and chemical storage consistently appear. “We see acids and bases next to each other and flammable materials stored improperly all the time,” Moore says. A myriad of less common violations do occur, but generally have a smaller impact on lab performance.
Check it Out
Most labs are inspected annually, aside from labs involving radiation. Usually, no prior warning is provided to ensure realistic conditions. Moore claims that the best way to prepare for a surprise inspection is to run through a checklist of regulations on at least a monthly basis. His office provides a standard list to the entire university that covers every point of inspection divided up into 18 sections, from documentation to physical hazards.
Signage and labeling is also a recurring theme across the checklist sections. Lab entrance signs with current contracts and emergency numbers, “No food or drink” signs, expiration date labels, properly marked waste bins, and biohazard symbols on the correct containers are a few of the necessary steps to reach compliance. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) must also be adhered to, which means no chemical formulas or abbreviations on labels.
For truly realistic practice, the person running through the checklist should have training specific to the type of lab they are in. An individual without the necessary expertise might miss the details that a regulatory agency representative is looking for. Interviews with employees should also be conducted to make sure they know the answers to safety questions. Once again, completion of training is crucial to succeed on these exams of a lab.
When a lab inspection is prescheduled, labs have the opportunity to make special preparations. The best place to start is with documentation. Reviewing paperwork and files will remind lab managers of the day-to-day activities of the lab and any notable recent occurrences. Any misfiled documents can be correctly placed, and those who are behind on training can be reminded to catch up with posthaste, as all training must be documented.
Among the many files that lab managers keep track of, a quality control plan is one of the most crucial. Each laboratory must complete regular checks into the consistency and caliber of its tests. Whenever results seem awry, new chemical lots are introduced, or an instrument undergoes repair, a quality control check should take place.
According to the CDC, a good quality assurance program achieves four central goals: “establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation; defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs; specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and sustains high-quality employee performance.”
Attaining these markers requires the mapping and analysis of activity in each area. For clinical tests, patient results should be carefully monitored to ensure precision. A large number of unusual outcomes is a red flag that something is amiss in the testing process. The remaining three goals focus mostly on staff, which reinforces the importance of keeping all employees trained and compliant with rules and regulations. Human error, after all, tends to be the largest contributor to violations. When everyone is thoroughly educated on the quality control plan, mistakes are far less likely and corrections will occur more quickly.
Of course, the best way to prepared for an inspection is to always be prepared. Constant vigilance with paperwork, standards, and daily issues is the only way to cultivate a world-class laboratory. As the CDC likes to remind us, the results that come out of medical and research labs influence both policy and everyday clinical decisions. That responsibility alone should provide the necessary motivation to run a well-regulated lab.
— Mapes is a freelance writer in Washington D.C. She wrote about obesity and dementia in the February issue.