I want to start my own in-office laboratory. What is my first step?
Your first step will always be determining your patient's needs. Which test will benefit your patients the most be giving you access to results at the time of their visit. Your next step is determining whether the tests you want to run are economically feasible and the level of complexity involved in performing those tests.
How do I apply for a CLIA certificate?
After determining which tests are right for your practice, and detemining the complexity level of these tests, you are then ready to apply for a CLIA certificate. (Remember, if applying for a non-waived status, you must meet the qualifications of a Medical Director for a Non-Waived Laboratory. Moreon that further down.) You can go to www.cms.hhs.gov/cmsforms/downloads/cms116.pdf and download an application and instructions for completion.
How do I qualify for Laboratory Director if I choose to perform non-waived tests?
You must meet the guidlines listed for Laboratory Director found HERE.
If you do not, you can utilize COLA's online Laboratory Director course found HERE to meet the guidelines. This course also counts 20 hours towards your annual CME requirements.
My lab only runs waived test. So basically, I don't have to worry with CLIA, right?
Applying for a Certificate of Waiver does not guarantee a CLIA-free life. Did you know:
1. Quality control is always required on waived tests.
2. Once the testing personnel review the manufacturer's instructions for a test, it is always necessary to review them again.
3. Documented training is required of testing personnel in a waived lab.
4. A waived lab cannot perform CBCs, even if the test is not billed.
5. Quality assurance is required for PPM labs.
See my ARTICLE here for more information.
Why pay your company for a lab system? Can't I do it myself?
The simple answer is this. My system works. Period. It is documented by 100% scores on inspection after inspection. Yes, you can do it yourself, but why try to re-invent the wheel? I put five years into the design of this system and then had it copyrighted. With all the time consuming task involved with running a practice, let Laboratory Consulting, LLC take on the laboratory portion and save you the headache.
I have a research or blood donation facility. I do not fall under CLIA, right?
Technically, your facility is not subject to CLIA if the testing performed does not diagnose or treat a patient. However, even if you perform test for screening or research, the participants of the research or screening are legally entitled to their results. If even one patient demands the results of any testing you perform, your facility immediately falls under CLIA regulations.
