How to Start a Clinical Laboratory

The decision to start your own clinical laboratory is an exciting one. You may be brimming with ideas for your clinical lab, but before you begin your business venture, take the following steps into consideration.

The decision to start your own clinical laboratory is an exciting one. You may be brimming with ideas for your clinical lab, but before you begin your business venture, take the following steps into consideration.

 

1.Determine what your lab will offer.

Determining what specific tests your laboratory will offer is the first step in building your lab. A common mistake is attempting to offer every type of testing your potential customer base may need. It’s important to realize being everything to everyone is not financially feasible – at least in the beginning. Focusing on a small number of tests your team can perform efficiently and effectively is a much better way to go.

 

2. Hire a Laboratory Director

Every clinical lab needs a lab director in order to ensure smooth day-to-day operation. The tests menu you choose to offer will determine at what complexity level your lab will be classified. This will the determine the level at which your lab director will need to be educated, and if it would be more beneficial to hire a full-time or part-time lab director.

 

3.Location

Again, the list of tests you decide to offer when your starting a clinical lab will inform the amount of space you will need to have, as well as the other building requirements (access to adequate plumbing for sink and eyewash stations, reliable HVAC for consistent temperature, appropriate ventilation, proper incoming voltage for large equipment and dedicated lines and so on. Cost per square footage is a consideration, but so is proximity to a science community, universities and industrial centers to help attract high caliber candidates to help your research flourish.

 

4.Instrumentation and Management Systems

Selecting the necessary equipment to conduct the tests in your clinical laboratory is key. Buying gently used lab equipment that’s been properly vented, such as those offered by The Lab World Group, is a great way to stretch your start-up laboratory dollars further. You can save sometimes as much as 50% or more off market value, and bonus, you’re keeping instruments from becoming land fill. Going hand in hand with sourcing lab equipment is selecting the proper Laboratory Information Management System (LIMS). This is the system your employees will use to enter new specimens for tracking and to enter results that will be reported back to the physician.

 

5.Accreditation and Application

There are a few different choices for laboratory accreditation. Whether it’s a federal agency like CLIA or a non-profit like COLA, passing inspection and earning accreditation is key. Once this is determined, it’s time to file a CMS 116 application. There are fees involved in this filing process, which can take anywhere from 4 weeks to 6 months, so the earlier these applications are filed, the better.

  

6.Staffing

This is the most important investment you will make when starting a clinical laboratory. Hiring highly qualified and experienced staff to run the laboratory is key. Clinical laboratories are highly regulated, so credentials and certifications are very important. It’s also important to realize that one person can fill multiple roles, so being strategic with your hiring is key to getting the most bang for your buck.