A successful physician office lab starts with three fundamentals – people, places and things.
We often needlessly complicate the work required to set up and maintain a physician office lab that creates great patient results and runs smoothly for the lab staff, management and the patients they serve.
On the other hand, there are strict CLIA requirements, particularly for non-waived labs, which must be met and, if they’re not, can lead to a deficiency citing by an inspector in the event of a lab inspection.
As distributor sales professionals working with our trusted lab manufacturers, it is important to remember that when we help a customer set up or expand their laboratory, our job is not to avoid deficiencies during a lab inspection. Rather, our job is to provide the products, software and guidance our customers need to comply with CLIA requirements and create a good work environment for the staff and to create excellent lab results.
The question I have always asked myself of every lab I worked with has been “Would I want my family’s lab work done here?” If the answer is “no”, you and your lab manufacturer have work to do to make it so.
There are only three things your POL needs to manage to be CLIA compliant and produce excellent patient results.
1. People
Your lab needs to recruit qualified individuals with the appropriate experience to fill the roles based on the CLIA classification of their lab. Your trusted lab manufacturer should have this information on hand and should be your first resource.
Knowing the initial qualifications for lab personnel associated with their role along with the assessments required put you and the laboratory in an excellent position to initiate and maintain a quality laboratory.
2. Places
CLIA “place” requirements (the physical requirements for a safe and effective lab) may also be complemented by state and local regulations.
It is prudent to review these requirements with your trusted lab manufacturer and their technical team to ensure that any system including chemistry, immunoassay and hematology systems, in particular, meet this broad range of regulations:
- Space and layout must be adequate with proper ventilation and utilities to permit effective lab test performance.
- Temperature and humidity must be controlled and monitored as required by manufacturer instructions.
- Facilities must have effective safeguards against fire, chemical and electrical hazards.
- The lab must have policies and physical systems in place for safe containment, decontamination and disposal of hazardous and biohazard waste.
- Work areas must be clean, well-lit and organized.
3. Things
Any “thing” subject to CLIA regulations must be strictly managed and controlled by the laboratory. This not only includes the lab instruments that must meet strict performance standards, but also lab accessories including centrifuges, rockers, rotators and any specimen handling or storage systems.
When in doubt, your trusted lab manufacturer should be able to guide you and your customer. There are several requirements with testing systems that the customer must adhere to in order to assure the system conforms to manufacturer performance claims and that continued performance is tested to assure ongoing quality. There are also quality control and proficiency testing requirements for these systems.
Your trusted lab manufacturer knows their instruments, reagents and accessories better than anyone. They should always be your first resource and counted on as the most experienced source of information for our lab customers. They know and understand the performance characteristics of their systems, their maintenance requirements, QC and PT requirements so much better than any other source. They should be with you and your customer during the sales process, system set up, quarterly business reviews and any time questions about system performance or CLIA compliance come up.
Be sure to create and maintain a strong relationship with these lab manufacturers and your reward will be more sales, better customer satisfaction and a stronger flow of after-sale reagent and consumable sales.
What about general CLIA questions?
While your trusted lab manufacturer is an excellent source, there are other resources you should get to know. COLA has helped a wide variety of physician office labs become comfortable with CLIA and to be confident they understand the basic CLIA requirements to say “yes” when you ask them to consider in-office testing. They are an objective source of information and have been trusted for their advice for nearly 40 years and can be counted on as a trusted source of general CLIA information.
There are also a few suites of lab software that contain all the CLIA requirements in a simple and easy-to-understand format, and walk the customer through all the tasks they need to perform to set up, manage and maintain their lab, no matter their CLIA classification. Some even have QC and system maintenance modules built in and can act as an overall lab management system for the physician office lab.
Your trusted lab manufacturer or your home office may have recommendations for these types of systems. Their unique value is the level of simplicity they provide for initial lab set up and for guidance once the lab is up and running. These systems, along with the guidance from your lab manufacturer, can be a very effective two-part solution to general and specific lab management and CLIA compliance. It is worth your time to understand these types of software solutions.
HIDA offers excellent training modules through its AMS training program. Ask your experienced colleagues what they think of this program. Chances are they will give it a strong recommendation and suggest that you ask to participate in it.
There are also general and specific lab training modules offered by virtually every medical specialty which are appropriate for your customers. In addition, the three entities that manage CLIA – CMS, the CDC and the FDA – also offer multiple resources.
Some are essentially links to CLIA documents and can be challenging to read, interpret and understand. Others are designed to be used at the novice laboratorian and lab salesperson level. I recently found the CDC One Lab training modules and was really excited to see the level at which they provide information.
Check with your sales manager, but I recommend them highly for you and for customers on the fence about setting up a POL lab or that just want to quickly brush up on a topic or two. I took two courses through One Lab and found the material fun and easy to work with, and provided the right level of information you and your customers can use.
Last points
So, what’s the bottom line in understanding CLIA well enough to sell lab effectively?
First, don’t try to be an expert. That’s why you have experienced lab manufacturers.
Second, don’t be afraid. It’s really as simple as people, places and things.
Third, research software suites that manage the lab for your lab customers and ask around. I think you will find them a good complement to your trusted lab manufacturers’ information.
Fourth, check out One Lab. I was pleasantly surprised and I think you will be also.
Finally, make sure you are having fun while you sell lab.
Lab testing in the physician office provides the right information at the right place and the right time to provide the best healthcare to our patients. Once you become confident, you will find lab fun to sell and that will build your confidence and lab customer base.
Key Takeaways
- Successful physician office labs come down to three essentials: people, places and things.
- Distributor reps don’t need to be CLIA experts – they need to connect customers with the right
manufacturers, software and educational resources to ensure compliance and quality results. - By relying on trusted partners and focusing on creating safe, efficient labs that deliver accurate patient testing, reps can strengthen customer relationships while growing long-term reagent and consumable sales.
- Lab management software and trusted educational resources help physician office labs stay organized, meet CLIA requirements and operate more efficiently.