News Story #18557

Safety

By Nicolas Borgert

New products, new processes and automation are reducing risks in the clinical laboratory
Well-equipped facilities, more protective attire and the presence of advanced technology can’t hide the fact that clinical labs remain a threatening setting where care and caution are paramount in importance. Injuries from glass specimen tubes, capillary tubes, pipettes and slides account for nearly 4 of every 10 injuries to clinical lab workers.

Clinical lab workers comprise 20 percent of all healthcare-worker occupationally acquired HIV cases — second only to nurses. Such infections will kill approximately 300 healthcare workers this year. Between 600,000 and 800,000 needlestick and other percutaneous injuries occur yearly among healthcare workers (NIOSH). Available medical devices could prevent up to 90 percent of the needlestick injuries, according to the CDC.

Needlestick law is helping
Passage of the Needlestick Safety and Protection Act in 2000 added specificity to the bloodborne pathogen standard written by OSHA in 1991, according to Amber Hogan, Industrial Hygienist with OSHA’s Office of Health Enforcement. Melody Sands, Director of the OSHA office, said that while the number of inspections has remained about the same since the new law took effect, the number of violations is trending upward. OSHA inspections are both planned and conducted in response to employee complaints. Regional OSHA programs are focused on increasing awareness among lab workers. “We’re getting the word out that lab employees have the right to work safely, which includes the use of safer devices that reduce their exposure to bloodborne pathogens,” Hogan said.

In addition to workers, that outreach is targeting professional organizations. “Healthcare is a relatively new industry for OSHA,” Sands said. “People tend to think of OSHA in terms of industrial plants and mills. But our standard for healthcare organizations is very performance oriented, requiring yearly evaluations by employers and engineering controls to reduce or eliminate exposure.”

Jane Perry, Communications Director for the International Healthcare Worker Safety Center at the University of Virginia, said her group is encouraged by the impact of the revised needlestick law. The law required OSHA to streamline the revision and enforcement of Bloodborne Pathogen Standard for safer sharps devices. Also required: input from frontline healthcare employees in the evaluation of safety devices, full documentation of a facility’s exposure control plan and logging of all sharps-related injuries.

“We don’t think the initial standards (set in 1991) were enforced as vigorously as they might have been,” Perry said. “It is clear that OSHA has stepped up enforcement and we applaud that.” Center data show that 33 percent of sharps injuries in clinical labs involve glass tubes, so it recommends immediate transition to plastic ones.

Perry said other data indicate that about 45 percent of needle injuries in lab settings are connected to blood drawing. Rather than use syringes for venous blood drawing —- a high-risk procedure for bloodborne pathogen transmission — labs are urged to use safety-engineered phlebotomy devices.

Mike Gannon, one-time lab manager and now Director of the Beckman Coulter Clinicon Consulting Group, says exposure to risk and error is much higher for patients than for operators. Lab staff safety has experienced measurable improvements in recent years, he said.

“Walking into a lab and finding people who are not properly attired for safety, with face shields, gloves and buttoned up lab coats is becoming increasingly rare,” he said. He credits sheathed needles, plastic sampling tubes, closed tube sampling and automated sample processing as key factors in reducing operator risk and exposure in labs.

Labs are by nature a risk- and error-prone environment, Gannon said. Two persistent problem areas: exposure to biohazards during aliquotting (when an operator transfers blood samples from a primary to secondary tube) and the increasing disappearance of dedicated, lab-controlled phlebotomy teams. This pool of highly trained personnel traditionally performs the drawing of blood samples for hospital inpatients. As a cost cutting exercise, labs and hospitals are increasingly eliminating their phlebotomy teams in favor of nurse-drawn specimens. According to Gannon, because nurses are not as proficient as lab trained and controlled phlebotomy teams in collecting specimens, nurse-drawn specimens are associated with higher error rates — such as insufficient sample amounts, incorrect or mislabeled specimens and needlestick injuries. While the risk of needlestick injury will likely continue to decrease as institutions continue the transition to safer, sheathed needles, the risk of specimen errors that could potentially affect patient safety remains troublingly high, Gannon said. “Laboratory specimen reception areas”, Gannon says, “must increasingly implement strong error trapping controls to insure that externally-generated specimen defects do not enter the analytical process.”

Another concern involves lack of medical technologists and the difficulty many labs have in finding qualified personnel to replace operators that move, retire or leave the profession. “Staff shortages lead to increased operator workload and stress which contributes to the risk of increased error,” Gannon said. To solve this shortage, many labs are using medical laboratory technicians.

This allows labs to concentrate their medical technologists on high-complexity testing and in the exercise of supervisory or oversight functions which is the “highest and best use” of an increasingly rare and valuable resource. Even in California — the most highly regulated state in the country — a law enacted this fall will permit medical laboratory technicians to assume many of the tasks previously reserved only for state certified MTs.

Gannon looks for process inefficiencies, including defects that affect patient as well as operator safety. Some signs of a lab with increased risk and error exposure are a disorganized work environment with unduly complex workflow or a lab that performs a lot of manual aliquotting. His goal is to help a lab identify process inefficiencies and draw up a plan using Beckman Coulter’s proprietary Six-Sigma based Powerlab program to enhance efficiency as it lowers risk exposure for both patient and lab staff. “The safest labs tend to be the cleanest labs where proper processes and policies are in place and being followed,” Gannon said.

Promoting safe and sensible laboratory practices is also the concern of Dr. W. Emmett Barkley, Ph.D., director of Howard Hughes Medical Institute’s Office of Laboratory Safety. His work with research and clinical labs encompasses many years. “I think laboratories are as safe as they have ever been,” Dr. Barkley said. Two documents, he said, have played a pivotal role in lab safety. The first came in 1984 when a joint CDC/NIH document (which Barkley helped write) established the first comprehensive guidelines on the handling of human pathogens. The guidelines were voluntary and represented vast input collected from the scientific community on controlling risks and selecting appropriate safeguards on human pathogen handling.

Seven years later, OSHA introduced regulations for bloodborne pathogens. The standards covered safe handling practices and mandated that laboratories develop infection control programs to protect their personnel.

Dr. Barkley says many of the safety enhancements adopted by today’s laboratories were driven by the scientific community rather than through regulatory fiat. OSHA, he said, is the only agency to establish specific regulations for safe labs relating to bloodborne pathogens. “Maintaining recent gains in lab safety will require continuous promotion, review and training,” he said. “There are very real hazards in the laboratory. A vigorous training program in safe practices and hazard awareness is required if we are to attract more competent scientists and technical staff needed to work with emerging dangerous pathogens.”

The first guidelines related to recombinant DNA, Dr. Barkley said, were adopted by the NIH in 1976. “That technology has allowed scientists to work with genomic materials at the molecular level without handling pathogens and exposing them to risk,” he said.

Power of automation
Developing safer lab products is an ongoing effort, said Dr. Berend Houwen, M.D., Ph.D., medical director at Beckman Coulter. The original Coulter Corporation’s cap piercing devices solved problems of blood splattering on hematology analyzers in the 1980s. Then came the twist cap. Later, the company’s modular Power Processor reduced exposure even more by automating sample-handling tasks, such as aliquotting and centrifuging. That freed lab staff from these preanalytical tasks. Eventually, Dr. Houwen said, today’s open system will advance further into an enclosed system.

What will the clinical laboratory of the future look like? Dr. Houwen sees technology that could be miniaturized, fewer people in the actual analytical environment and more IT staff involved with analyzing data. “A continuing move toward automation and further development of enclosed analyzers,” Dr. Houwen said. “We still see fairly high risks of infection among lab personnel from hepatitis C which we don’t have a vaccine for,” he added.

Major manufacturers have made the move to closed tube sampling, and the newest technologies continue to reduce specimen handling and splitting requirements. In addition to improving operator safety, this decreases risks of sample contamination due to air exposure and evaporation.

Plastic evacuated blood collection tubes are also an option. Plastic tubes are virtually unbreakable. There have been no reported accidents to date involving breakage of plastic evacuated blood collection tubes.

European-based Greiner bio-one Vacuette pioneered plastic evacuated blood collection tubes in the mid-80s. Demand for plastic evacuated blood collection tubes has been doubling every year, according to Doug Harris, the company’s vice president of marketing & sales. Worldwide, Greiner is the leading supplier of plastic tubes and the number two supplier among all types of tubes.

Harris said that in addition to a full line of plastic collection tubes, Greiner has a series of needle safety devices in the pipeline for introduction in the near future. A major challenge is helping those institutions that depend on decentralized blood sample collection. With that loss of direct laboratory process control comes the risk of poor sample handling, errors and unnecessary risk of exposure.

Kevin Shively, MT (ASCP), MHA, assistant director for clinical laboratories at the Ohio State University Medical Center, says automation is the single most important investment his lab has made to improve safety. “Three years ago, we introduced a complete automation system. Today, we have eliminated 90 percent of our manual loading,” he said. Even when complete automation is not immediately feasible, Shively said, automating even the preanalytical phase can improve safety and efficiency in large measure. The OSU lab has made the transition to butterfly needles, and uses plastic tubes for all but coagulation testing involving sodium citrate. In the near future, the lab will be converting to a plastic tube that has a shelf life of one year, he said. In addition to minimizing breakage, plastic tubes reduce chatter in centrifugation modules.

Nicholas Borgert is a freelance writer based in Charlotte, N.C.