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Are you thinking about opening your own POL? With a lab designed exclusively to serve your patients, your practice can offer faster, often same-day service and superior patient care. It’s a great investment for your patients’ health, but it does represent a big change for you. You will need to invest in space, staff, technology, accreditation, and more.
The first things to understand—even before developing your business plan—are the specific CLIA regulations that will apply to your physician office lab. In the US, laboratory testing is regulated by CLIA legislation, so you’ll need to apply for your CLIA license and meet the national standards for compliance.
Drawing on 30 years of experience as the lab manager for a start-up POL in Princeton, Indiana, Beth Schmitt is an account manager for the lab division at CompuGroup Medical who has experienced the logistical challenges that come with running and growing a successful laboratory.
“You’ll have to develop and write detailed policies and procedures,” Beth said. “Your consultant can help.”
Your employees must be trained and checked to make sure they’re doing things the correct way. If your procedures are adequate, someone brand new should be able to follow your instructions and perform their tasks correctly the first time.
Before you get too far along with your planning, ensure that your plan for opening a POL is a feasible one. One of the biggest hurdles may simply be finding the physical space within your practice to get something started.
“When our practice decided to open a lab, they imagined that a former supply closet would be enough to get started. That was never going to work. I moved into a small exam room, but even that wasn’t adequate,” Beth said. “By the time we put cabinets on both sides of the room and brought in a refrigerator, the analyzers, and the workstation, I was out of space and looking for places to expand.”
Without enough physical space available, Beth’s lab sprawled out with analyzers and workstations in different rooms, hallways, and closets.
“It took 20 years to get the space I needed when we finally converted a larger exam room that wasn’t in use,” she said.
Starting a POL is like opening a business within a business, and the best way to get started is to bring in some help.
You need to find your own Beth. The person that helps you plan your laboratory should be the person you’ve picked to be your lead technician, scientist, or lab manager. You may also consider getting help from a laboratory consultant. Your current medical supplies distributor or another distributor partner such as Henry Schein, Medline, or McKesson can offer invaluable advice.
Relying on this newly acquired expertise, you’re ready to start planning your testing menu and making the decisions that will benefit your practice and your patients the most.
Beth recommends tailoring your menu of diagnostic lab tests to your patient population. This is a crucial consideration for a successful lab.
“Tailor your testing menu to the needs of your patients,” she said. “A pediatric practice won’t offer tests for congestive heart failure, and a geriatric practice wouldn’t offer newborn screens.”
Don’t be afraid to start small. It’s possible to begin with manual tests or kit tests that don’t require instruments. Then you can expand with a chemistry analyzer, realize the benefit, and add more tests over time.
Your lab will require counter space, a refrigerator, storage, and a lab sink with running water.
The costs will multiply as you turn your attention to analyzers, but leasing may be an affordable option for you. South Carolina’s Vessel Medical reports that the cost of medical equipment has been declining thanks to competition among manufacturers and distributors.
CompuGroup Medical can help you with your workstations and with finding the laboratory information system that’s best for you. The unique configuration of your software can be a real time-saver for your staff, especially with interfaces to streamline ordering, testing, and billing.
Interfaces between the LIS and your instruments help streamline and automate your testing workflow.
“One big thing—and this is where the EMR interface would come in—is how are you going to order the tests and get the results to the chart? Without the interface, you’ll need paper requisitions that meet CLIA requirements, which invites human error and delays,” Beth said.
An interface to your practice management system or billing software eliminates repetitive data entry, too, since testing information can pass easily from the lab to a clearinghouse like eMEDIX.
When you’re ready to grow your lab team beyond just the lab manager, you may find the process difficult, especially if your practice struggles to match the pay offered by area hospital labs, for example.
This was the case for Beth, as well.
“We couldn’t pay what hospitals were paying, but we could offer a Monday-through-Friday shift with no nights or weekends,” she said.
As you consider applicants, look for individuals who will be able to multi-task. Although experienced, some lab technicians may be used to sitting in front of one machine and doing the same task all day long. Beth recommends looking for associate-degree graduates from an MLT school. A trained phlebotomist or medical laboratory technician can be taught how to do the testing specific to your POL.
As you find yourself closer to opening a new physician office lab, remember that a POL’s strength is in improving the quality of patient care and providing results quickly.
“A doctor could order a test at the patient visit and have the results available during the examination,” Beth said. “The patient gains a clear understanding of their health with a face-to-face review of the results, and can go pick up their prescription, all in one trip.”
Once everything comes together, your POL will deliver faster care and promote better patient compliance.
As Beth says, POLs make a difference.