|Centrifuges are one of the low-level lab equipment items that fall under a biomed’s purview.|
Biomeds have traditionally found clinical laboratories intimidating places—a view justified by the large amount of biohazardous materials, technical scientific jargon, and sophisticated pieces of equipment. But just as gloves and goggles can offer physical protection, education and knowledge provide a mental armor that makes servicing the lab less daunting.
Biomeds already handle preventive and corrective maintenance for many of the smaller, less complicated pieces of laboratory equipment, but more frequently, they are assuming more responsibility for the sophisticated equipment found in the lab. This opens opportunities not only for clinical/biomedical engineering departments, but for the lab and the hospital as well.
In-house technicians can potentially fix problems much more quickly than techs from manufacturers or third parties who are not on-site and may need up to a day to arrive. Yet, service contracts, reagent rental agreements, and laboratorian mistrust have often stood in the way of this more convenient and more cost-efficient arrangement. That is changing, in part because of the convenience and cost-efficiencies, but also because biomeds have won laboratorians over, having proven at some facilities that they are more than capable of handling laboratory equipment.
“Once you establish a little bit of trust, they [laboratorians] are open to letting you work on the bigger machines,” says James Houp, a biomed with Philips Healthcare, Andover, Mass.
That little bit of trust is often established through the work done on less sophisticated pieces of equipment. Mike Speer, CBET, supervisor of the clinical engineering department at Simi Valley Hospital Adventist in Simi Valley, Calif, estimates that of the 2,200 pieces of equipment in the facility, 143 of them are in the laboratories. Biomeds, however, have not been historically responsible for all of that lab equipment.
“Traditionally, the biomed department handles only the low level equipment in the lab,” says James Scheffel, MBA, CEO/CFO of Pinnacle Service Consulting LLC, Spring Hill, Fla. OEMs and third-party providers cover the rest through warranties, service contracts, and reagent rental agreements.
The exact division of labor varies with each facility and each biomed. “There are definitely facilities where biomeds stay out of the lab entirely, and others where they work on the more sophisticated equipment,” says Jonathan T. Sears, CLES, a BMET III and lab specialist at the Baltimore VA Medical Center.
Houp notes that when he first started at one facility, the laboratory relied primarily on service contracts, but by the end of his tenure, biomeds held responsibility for much of the equipment, “or at least first look,” Houp says.
The lab equipment that typically falls under a biomed’s purview can include centrifuges, incubators, vortexers, rockers, microscopes, microtomes, tissue stainers, and/or blood gas analyzers—items with basic motors and a belt or two, according to Sears.
Biomeds will perform both preventive and corrective maintenance on these devices, work that is often straightforward. “On the general side, the simpler devices—centrifuges, incubators, shakers, spinners, and timers—require just basic mechanical and troubleshooting skills, like being able to review a service manual or knowing how motors work, or when a switch is bad,” Speer says.
Though these devices are not difficult to work with, they may require more frequent maintenance than other hospital equipment because of high-volume use. Speer finds that centrifuges require attention about two or three times per year because they process such a large number of specimens.
Understanding how the equipment works and what it does can help with the maintenance. For instance, Sears recommends using healthy blood samples and keeping them capped when working on blood gas analyzers. “Always look for the healthiest blood possible because it will provide normal results,” he says. “As you use it, the sample is consumed. The smaller volume absorbs oxygen when the cap is removed and it is mixed, which can produce a varying result, so you want to keep it capped as much as possible.”
Complexity Made Simple
Knowing how to run the sample will also make the biomed’s job easier, particularly on the more sophisticated pieces of equipment where controls must produce the proper results before the device receives a clean bill of health. High-end laboratory equipment includes the larger automated devices such as chemistry and hematology analyzers as well as preanalytic and postanalytic information systems.
These devices are complicated pieces of equipment with many moving parts and sections that perform different functions. This equipment requires varying degrees of maintenance, from daily tasks handled by the laboratory technologists to preventive maintenance (PM) requirements to repairs.
The Clinical Laboratory:
A New Frontier for Biomeds?
By James Scheffel, MBA
Traditionally, the clinical laboratory arena in most hospital facilities has been essentially ignored by the biomedical industry. This is a reactive position, primarily driven by three biomedical department beliefs:
- Lab organizations are very loyal to their instrument OEMs.
- Labs will not accept biomedical technicians as legitimate service providers for most of their complex instrumentation.
- Most lab instrumentation is acquired through reagent rental agreements, virtually shutting out any opportunity for a biomed service option.
The first two of these beliefs are mere perceptions—not reality—and have been addressed in the accompanying article.
The third point—regarding reagent rental acquisition programs—was very real in the past but is rapidly changing for the better. Historically, reagent rental programs (RRPs) were conceived by OEMs to create loopholes that allowed laboratories to acquire leading-edge technology without the approval of the hospital’s capital oversight committees. The RRP option enabled OEMs to place more instrumentation and generate years of significant revenue streams afterward. In the process, RRPs have essentially eliminated all other service options for the hospital. Is this acquisition method good for the fiscal health of the hospital? Once the details are broken down, the answer is no. Equipment acquired under RRP has a higher total cost of ownership. Additionally, since title to the instrumentation remains with the OEM, the hospital cannot take advantage of capital depreciation.
So … where is the good news? In the past few years, savvy hospital CFOs have begun uncovering and blocking these programs. Many hospitals are now even eliminating existing RRP (and long-term lease with service) programs, converting them into capital purchases, for all the reasons noted above.
There has never been a better time for our biomedical industry to leverage its service model and take on instrumentation service in the clinical lab. Through active membership on the hospital’s capital oversight committee, through the use of comprehensive introductory lab training, effective relationship building, followed by well-constructed technical training, the clinical laboratory can become the new frontier the biomedical industry sorely needs to advance its partnership with the hospital—all in the interest of improved patient care.
If not the lab, what? If not now, when?
—James Scheffel, MBA, is CEO/CFO
of Pinnacle Service Consulting LLC,
Controls help to ensure that the system is operating properly. Daily controls run by the laboratorians can indicate when a problem exists as well as when it has been fixed. Although the lab technologists can help with this, biomeds who are able to run samples themselves have an advantage. “Being able to run a sample and knowing how to operate the machine has helped to accelerate the repair process and enabled me to go into the lab and do whatever I needed to do without interrupting the lab’s day,” Houp says.
In busy labs, when a machine is down, the technologists must sometimes complete the sample analyses in other, more time-consuming and manually intensive ways. “Many technologists don’t have a lot of time to stand there and walk you through how to do something. They will, but it’s not a luxury they can afford,” Houp says. “Understanding how to run samples means the biomed can go to a machine if there is a problem, run the sample themselves, and get to the bottom of the problem with little or no help.”
Knowledge of the machine can also help to more quickly identify the problem than simply running samples. “In these analyzers, the blood or serum sample may get split up and go to different parts of the machine,” Speer says. So if the system is supposed to produce four results but is only providing three correctly, then that related section is likely the problem. “If the hemoglobin is messing up, then you know to go to the hemoglobin flow cell rather than the fluorometer,” Houp says.
Yet even with this knowledge, finding and repairing the exact source can be a challenge. Sears, who has worked for one of the device manufacturers, recalls many times when he spent 3 to 6 hours working on equipment. “I have seen vendors come in for days at a time trying to trace a problem and fix the equipment,” he says. “It will test your troubleshooting skills, especially when it comes to fluidics and pressures.”
Simply powering the machine up or down can be a 15-minute to 20-minute process, and maneuvering inside may also require patience. “There might be 100 tubes crisscrossing in a section which you need to get below,” Speer says. “You have to take apart five things just to get to a spot and then put them all back together properly.”
Newer devices may reduce the number of parts but not the complication. “I have one instrument with a sample tip that has sensors built into it to gauge depth, and I can’t do anything with it,” Speer says.
PMs can be equally as complicated with lots of little tubings, pumps, and needles that need to be replaced. Filters and fluid from leaks must be cleaned, and corrective action may be needed. Lines need to be bleached periodically to remove bacteria, which can cause readings to drift if left to grow. “It is important not to take shortcuts,” Houp says. “If there is a step in the PM that needs to be done, the biomed needs to do it. These components may have problems that can’t be seen with the naked eye.”
Learning the Lab
Basic biomed training addresses the issues seen in simpler equipment, while opportunities to develop the necessary skills and knowledge needed to work on the complex analyzers exist through vendors, specialty training centers, and work experience. Just learning the language of the lab can be a big help.
“They have a lot of acronyms and a lot of tests—CBC, ABG, CSF—little things like that which you may not know,” Speer says. “They also have reagent names you may have never heard before. So there is a certain amount of a language barrier.”
Laboratorians may also refer to parts of the machine in sophisticated terminology. “They won’t say blood sampling but hemoglobin flow cell,” Houp says. “You won’t have someone saying my syringe is bad—they’ll refer to my sample flow cell.” Education can help bridge this divide, and vendors are one of the best sources. If negotiated at the time of the equipment’s purchase, the necessary knowledge and software can be arranged and at a better price than if requested later. “It’s important to recognize that your power to negotiate training and technical support is at the front end,” Scheffel says. “When the hospital is in the negotiation process for capital equipment, the biomed organization should be there, helping to ensure that the hospital is negotiating a fully comprehensive deal with the vendor of choice.”
That deal should include operator training and manuals, technical service manuals, access to onboard diagnostic software, and the option for technical training and support. “Should the biomed staff decide after the warranty expires to bring the service in-house, the hospital can then exercise its option to get the technical training and support required to be successful,” Scheffel says.
Although many biomeds, like Sears, believe that factory training is best, there is a lot to be learned on the job. “Depending on how you approach the field service rep, you can learn more about the instrument from them,” Sears says.
Laboratorians can also provide a significant amount of information, from running the instruments to sourcing problems. “They perform daily maintenance, which involves breaking the machine down and cleaning it, so they have a lot of knowledge about the maintenance of the machine, sometimes without even knowing it,” Houp says.
And, despite the apparent complexity of analyzers, the basics are often the same. “When you strip all the automation away, the analytical elements are fundamentally the same,” Scheffel says. “If you understand the basic methodology of analysis, then it is just a matter of learning the automation that surrounds it. In many cases, troubleshooting instrument problems relative to the analytical process is the same today as 10 or 20 years ago.”
There is, however, more to laboratory equipment maintenance than the technical aspects. Without proper documentation, any service delivered may mean nothing. Clinical laboratories are regulated and/or accredited by a number of organizations, including Clinical Laboratory Improvement Amendments, or CLIA; the College of American Pathologists; The Joint Commission; and the American Association of Blood Banks—all of whom require significant documentation that is often reviewed during inspections.
“You have to document what you do, probably in triplicate, because the lab is required to have detailed descriptions of everything that has been done, even on centrifuges,” Houp says. “These organizations perform tense inspections, and they’ll notice if you’ve just stuck jargon in there.”
For instance, if the biomed performs a PM and replaces tubing, he or she must note exactly which tubing. “If I checked the speeds on a centrifuge and they were all OK, I can’t just summarize that,” Sears says. “I have to specify that I checked it at 2,000 RPM and here were the results, and I checked it at 3,000 RPM with these results, and so on.”
This documentation will also need to be accessible to the lab so that when it undergoes an inspection, the lab director can produce whatever is needed. Although most biomed departments will keep these records in their filing systems (often electronically), where they can be pulled when needed, some will also automatically provide copies to the lab. “We generate a report that is sent to the lab as an electronic e-mail attachment,” Speer says.
These reports help to provide protection from regulatory action, but this is not the only safeguarding needed—biomeds must also remain aware that the lab is a biohazardous area that handles blood and body fluids. Appropriate safeguards include gloves, goggles, and lab coats, particularly if handling samples. “You always want gloves and goggles when running samples and dealing with pressures and fluidics,” Sears says. “You can pop off a piece of tubing and have it splash or fling a drop of fluid, and if you are not wearing goggles, it can get in your eye.” Body substances are not the only concern; some of the chemicals and reagents used can be caustic.
Biomeds should not be afraid. Proper protection can ensure safety while proper education can provide confidence. The lab can be a demanding place. There is a lot of variety in the equipment, and laboratorians hold high expectations for service, but it is nothing biomeds cannot handle, as they have proven in other areas of the hospital such as radiology. Houp offers three simple words of advice: “Don’t be intimidated.”
Renee Diiulio is a contributing writer for 24×7. For more information, contact .