RPL Laboratory Solutions Inc, Corona, Calif, helps laboratory clients achieve goals with compliancefocused, business-oriented consultative services.
Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), and Matt Stewart, director, IT Systems
In theory, any clinical laboratory should be ready for an inspection at any time. In reality, there are many requirements that can vary with each inspecting organization. Laboratory administrators may not be aware of the differences between the regulatory bodies—some may have more stringent requirements than CLIA—or they may not have the tools or resources to properly meet all of the specific needs. The situation can be made more difficult as the regulations tend to be dynamic.
It can take time to determine what is needed for a specific inspection and pull the material together. With unannounced inspections, the time may not be enough. In some cases, small errors can lead to a fail.
“Laboratories don’t have the guidance,” says Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), founder, president, and CEO of RPL Laboratory Solutions Inc, Corona, Calif. They may lack the resources to hire outside help, or they may not have hired the right individual (in-house or contracted) to handle the process.
“Failed inspections are a primary driver for why we are contacted by new clients,” Stewart says. Working as an Expert CLIA Surveyor for CMS (formerly HFCA) and dealing with failed inspections was also what drove Stewart to found RPL in 1986. They are certainly not the only factor driving the growth of the laboratory consulting firm today, but they are a constant issue for the industry.
COMPLIANCE-FOCUSED
The situation has been that way for some time. In the late 1980s, regulations tightened, particularly for physician-office laboratories (POLs). “I was approached by several manufacturer reps who were finding themselves having to consult with doctors, and it wasn’t their expertise. So they asked if I would do it, and I did it, a bit reluctantly. But once I started doing it, I really enjoyed it,” Stewart says.
Her experience as an Expert CLIA Surveyor for CMS gave her further motivation. “I didn’t like just going in and telling laboratories what I saw them doing incorrectly, particularly when I realized they were really struggling trying to comply. But as a Surveyor, you’re not allowed to offer guidance,” Stewart says.
So she completed her tenure and devoted herself full-time to RPL, where she could help labs achieve compliance rather than merely point out their flaws. RPL’s mission is “to provide essential expert professional assistance to the health care community in the specialty arena of laboratory medicine, simplifying the process of maintaining regulatory compliance while maximizing efficiencies, thereby empowering the health care provider with the ability to deliver quality lab testing.”
The operating philosophy is that “every kind of model should be able to offer lab services, if they choose, and control the quality, turnaround time, and availability of testing for their patients,” Stewart says.
BUSINESS-ORIENTED
These maxims apply to new laboratories as well, a growing segment of RPL’s business. “We’re seeing a lot of R&D groups that are developing genetic testing and want to move into the clinical arena,” Stewart says, estimating an average of one to two calls a month from new clients with that goal this year.
The trend repeats a pattern Stewart observed 20 years ago as manufacturers reposition themselves. “I’m seeing almost the same market protocol model emerge,” Stewart notes in regard to the genetic R&D companies.
When helping any client with a new venture, Stewart calls on her extensive corporate experience (she holds a graduate degree in business administration). “Finances and operations are always going to be a major factor, so we want to incorporate lab into what they’re doing without reinventing the wheel and staying attentive to cost,” Stewart says.
RPL Laboratory Solutions Inc
Corona, Calif
www.rplLaboratorySolutions.com
RPL offers a comprehensive program designed for new and existing labs to help meet regulatory requirements. Additional services include maintenance programs for long-term compliance, spot checkups, feasibility analyses, document and correspondence preparation, LIS/EMR project management, safety services, and other consultative expertise. The team is fluid and hired in response to market needs.
Stewart relies on this nationwide group to gather information out in the field on trends, issues, and new models, and to discuss it with an eye toward client needs. “Is it something we can implement across the board that will benefit everybody? Is it a trend laboratories need to prepare for? Is it misinformation we can raise awareness about?” Stewart asks. If the answer is yes, RPL will turn theories into reality.
Renee Diiulio is a contributing writer for CLP.
