There are a number of advantages of setting up your own Physician Office Laboratory (POL). One is that you get test results much faster rather which is very helpful to patients. Another advantage is that you are able to perform more tests thanks to advances in lab technology. Thirdly, you cut down on follow up calls to patients, extra visits from patients coming to pick up results and the paperwork required.
Many physicians put off or opt not to set up their own POL because they believe that the federal standards and cost of doing so are prohibitive. This is not the case. The following is a rundown of what you would need to set up your own POL.
It is not true that the Clinical Laboratory Improvement Amendments (CLIA) of 1992 make it difficult or impossible to set up a POL. CLIA sets the standards of every aspect of a POL including test management procedures, quality control, personnel, inspections and proficiency tests.
If your practice is a small one, you have the option of engaging a qualified medical technologist to offer consultancy services on CLIA compliance. A consultant can also help you to get the lab running and they can train a lab technician for you. There are certified medical technologists at local hospitals who offer consultancy services. You can also find them through the American Medical Technologists website.
Another misconception is about compliance costs. It actually quite affordable. CLIA fees for mid to high complexity labs is about $450 every two years including the CLIA certificate and inspection. It is higher depending on test volume. Labs that perform simple tests and don’t have many regulations to comply to pay $150 every two years. You can see the CLIA Certificate fee schedule online.
There is also an annual $200 to $2,000 fee payable for proficiency testing which is testing done to ensure that your lab can do accurate testing. The fee is determined by the complexity of a lab and its test volume. The American College of Physicians can give you proficiency tests and advice on the same at no cost. You can also get lab management assistance. This is offered without charges.
In total, CLIA compliance takes up about 5% of total lab tests. This includes the fees, inspection fees, proficiency testing fees and staff time.
This is another set up cost that is widely believed to be prohibitive. The fact is that thanks to improved technology and competition among manufacturers and distributors, the cost of medical equipment has been declining steadily over the last few years.
The equipment needed will vary from lab to lab but there are three machines that are standard. This are an immunoassay machine, a chemistry analyzer and a hematology analyzer. A small practice with up to three physicians can buy other machines depending on test volumes or area of specialty.
The cost varies but a new chemistry analyzer for about $9,995 such as the one from Careside Inc located in Culver City, California that has a cartridge that gives automated results in just 12 minutes. A hematology machine between $12,000 and $20,000 or less. Manufacturers will usually provide immunoassay machines at no cost so you will only have to pay for the reagents which cost between $2 and $10 per test.
If this amounts are beyond your reach, consider leasing or purchasing used equipment that is still in good condition. If you go for the second option, test equipment thoroughly and get a one-year warranty.
Once you get the equipment, you’ll need personnel. You can opt to train a nurse or medical assistant on your staff. CLIA have it that a moderately complex lab can be run by a high school diploma holder who has adequate training. Manufacturers typically provide training on using their equipment.
However, the recommendation is have a trained lab technologist in your lab. It doesn’t cost so much more and a professional will understand and comply with CLIA requirements.
Another worry about setting up a POL is that Health Maintenance Organizations (HMOs) chasing volume discounts won’t compensate for lab services. However, this is not true. While thy do sign national contracts with big labs, even a small one with the capability to perform the tests in-house can write to them and request to be paid at the Medicare rate. They usually send an affirmative response.
Once you get a health plan to reimburse you for lab services, keep checking the contracts for changes in regard to the covered services.
A lab that is being run well should have a profit margin of at least 40%. A practice that has four to five physicians has the potential to bring in at least $200,000 a year in profit. Returns depend on how busy a lab is and the number of tests offered. Small labs can maximize profits by offering only common tests and outsourcing others. A consultant can help you do perform an analysis of your lab’s test volume and costs. You can also do so using software. One good one is Office Laboratory Check Up from ACP-ASIM. It can determine how viable it is for you to set up a POL, to maintain one or to offer particular tests. It can help you determine the most profitable tests to offer and those that best to outsource. It can be done you can get more information on setting up your POL from State Survey Agencies or Regional Offices.
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