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Friday, February 16, 2007

Going Solo?: How to start a lab.

As a physician, whether you are solo or part of a group, you will need access to laboratory services. One year ago, when I was first venturing off into my new, grand experiment, I had no clue about the most basic of basics: how I was going to order tests such PSAs or urine cultures or cytologies or a CBCs or anything for that matter, because in my prior offices, where I was an employee, I just told someone to do it and it got done, usually. Now, I would have to make it happen. Fortunately, we have a free market economy and numerous commercial labs exist and they compete for your business. All you need to do is set up an account with them. This is quite easy, and if the lab is good, at least with regard to business development, they will send a representative to you without you even having to ask, and the lab rep will do all the work. The lab itself will supply you with equipment needed to collect the specimens, such as blood tubes and specimen cups and tourniquets, and some sort of mechanism to get your patients’ clinical specimens to their lab for processing and reporting, be it a drop box or a UPS Bag, etc. Often, they will even supply a centrifuge. It is really quite easy, and you will find that after setting up accounts with 1 or 2 labs that you can function as a doctor. Pretty cool, eh? National labs include Quest Diagnostics and LabCorp, among others.

Of course, setting up an account with a lab like Quest Diagnostics is not really what I mean when I talk about setting up a lab. At some point, you may decide that you need to bring certain tests that you rely upon heavily in-house. In my case, as a male infertility specialist, I felt the need to do semen analyses on-site. Blood work I could send out, but the semen analysis, well, this needed to be done by me since it is the cornerstone of the male infertility evaluation. In addition, as a urologist, I needed to do urine analysis dip sticks. Urine cultures could go out, but UA’s need to be done while the patient is in the examination room. You may have your own reasons to bring a certain test in-house, but this decision should not be taken lightly since running a lab can be challenging and expensive, and yes, a pain in the unowhat. But it can also be profitable and can help you transition your medical practice into a medical enterprise that can serve as a source of income in and of itself, independent from your own physical labor.

In the USA, physician office labs are classified into several categories; waived, moderate complexity, and high complexity. Getting into the details of each is way outside the scope of this post, but suffice it to say that most physician office labs (POLs) fall into the waived or moderate complexity umbrellas. Waived tests actually include a subset of tests known as the PPM, which stands for physician performed microscopy. You can just perform waived tests in your office without having to go through any licensing or credentialing paperwork from a federal agency known as CLIA. Waived tests do not require a CLIA number. Everything else does. A dipstick UA is a waived test, as is a urine pregnancy test or a home blood glucose kit, among others. You can find a list on CLIA’s website. Basically, any test that is so easy to do and so difficult to misinterpret that a lay person can do it may be classified as waived. PPM’s include looking at a urine sediment for red blood cells or looking at semen sample for the presence or absence of sperm. Again, you can find a list of other PPM’s on CLIA’s website. Google, CLIA.

High complexity tests include things like cell culture and PCR and FISH and certain blood smears etc. High complexity tests demand a tremendous degree of expertise to perform and the outcome of these tests may result in major impact on a patient’s care. These tests require that you have a CLIA license that allows you to do high complexity tests. In order to get this authority, you must have either a PhD in that particular field, be a Board Certified Pathologist, or have 12 months or more of continuous basic science lab experience doing the type of work you plan to do in your office lab. Or you can hire one of the above people. Very few physicians have high complexity labs in their offices.

Most physician office labs fall into the moderate complexity sphere. Examples of moderate complexity tests include automated CBC’s and SMA’7s and my test, the semen analysis. Similar to performing high complexity labs, in order to perform moderate complexity labs in your office, you must have a CLIA authorization, ie a CLIA ID number.

Obtaining a CLIA ID is not difficult. All you need to do is locate CLIA’s website (Google) or via your state’s department of health website, and download an application. You fill it out, pay a $100 fee, and several weeks later you have a CLIA ID number. With that CLIA ID number, you can then legally do the tests and bill insurance companies for them. Sometimes, the insurers will even pay!

Of course, having a CLIA ID number does not mean that you do the tests well or that you have a good quality lab. It just means that you jumped through a licensing hoop. You do, however, want to run a high quality lab. It is important. I believe that you should strive to maintain high standards of quality in your lab for the following reasons; because it is just plain right, because you take pride in your work, because patient care requires it, and because referring physicians rely upon it. It is also the law. Agencies exist that can help you in this regard and after you enroll in their courses and follow their recommendations, these agencies will provide your lab with accreditation. I used an agency named COLA. I don’t know what COLA stands for, but you can google, COLA, and you’ll find it. COLA accredited my lab and through their 20 hour Lab Director Course I learned how to run and maintain a high quality andrology lab. I learned lessons on topics such as quality control and quality assurance; lessons that have spilled over into how I run my entire office. Having my own lab has been not only profitable for me, but has been a marvelous professional growth experience. I recommend it.

Now there is a new system on the market, and I recommend it highly. You know why, I designed it. Here is the link www.ilabtqm.org.

Good luck.