By Jim Poggi
Understanding regulations, prioritizing the right tests and knowing when to call in expertise are critical to becoming a top-tier lab consultant.
In last month’s Physician Office Lab column, we made the case that even in a rapidly evolving diagnostic landscape, success in the physician office lab still comes down to mastering the fundamentals – starting with trust and truly knowing your customers.
Building on that foundation, this installment turns to three more essentials every lab sales professional must command: understanding CLIA requirements, focusing on the core tests that drive daily care, and knowing when – and who – to rely on for expert support.
CLIA requirements and test categorization
At the end of the day, we are still talking about selling lab. So, our knowledge and understanding of key lab concerns your customers are likely to have is basic information you need to master. To be a well-respected lab consultant, you need to know which products are waived, moderate complexity and highly complex.
You also need to know the personnel and testing requirements for each level of CLIA. Your trusted lab manufacturers are a great source, but it is useful to learn the basics on your own. It keeps you sharp, keeps your lab manufacturers on their toes and assures you are providing the right information to your customers if the question comes up and your key lab manufacturer is not with you. Distributor account managers that know lab well get more productive ride with days than anyone else. You are not alone in your quest for this information.
There are many tabs associated with this link and they cover most of what you need to know about CLIA. If your specific need is to find the CLIA categorization of a specific product, go to the “FDA registration and Listing Data Base” section of this link. The FDA registration database is not the easiest database to navigate, but if you take a little time to get used to it, you will be able to get around successfully. I promise you that if you take advantage of the main elements of the information in this link, you will know more than the majority of your competitors. Looking to be the most well-respected lab consultant in your area? This link has everything you need to become a top tier source.
The top 20 POL tests
Why should you care? After all your respected lab manufacturers MAKE these products and should know this information. Besides, your customers are more likely to ask for lab products used frequently than for esoteric products, right?
Wrong. I have met more customers with stars in their eyes and a burning desire to try out the latest technology than I care to admit to. Sometimes it’s the cool factor that drives this behavior. “My lab is the only one in our city that offers (insert esoteric lab test name here).”
What usually happens is that limited demand for this test usually leads to the POL to stop offering it. And YOU get the blame for their failure.
The other ugly reality is the POL offering tests “because they offer the highest reimbursement and I need that level of revenue to support my lab.” In this case, higher levels of personnel requirements and lab oversight become a hurdle these labs are unwilling to consistently follow. The result? Either the lab or the inspector decides that this test will no longer be offered. And, once again you are the “goat,” as in scape goat.
Looked at another way, the top 20 POL tests are the basics. They are the tests that offer the highest level of daily diagnostic utility, and they are the tests needed to initiate or modify a patient treatment program.
Remember that your customer’s patients and the type of their practice will dictate which tests make sense and which do not. An OB/GYN practice is likely to have some fertility tests and hormone tests not on this list and would not have any need for PSA as an example.
So it is always important to ask questions before offering advice.
- What does a typical day in your practice look like?
- Who is your typical patient?
- Are you seeing any changes in your patient make up?
- What are they? Which lab tests do you usually send out?
It is likely that you will find some sexually transmitted infections and human papilloma virus testing becoming more important to this customer. Talking to a rheumatology practice? With recent immune system inhibiting prescription drugs becoming more common, tests for tuberculosis are likely to be on their minds.
Knowing the basic tests provides you with an outstanding foundation for discussions on more esoteric tests. Is TB a test the practice needs or just one getting a lot of media attention? The same holds true of a wide variety of tests including HPV, and others. You will find that the media and interaction with their peer group will create interest in several tests the practice does not do. It is your job working alongside your trusted lab manufacturer to turn interest into a practical recommendation to test or not to test.
Know who you can count on to be your consultant
The lab business encompasses so many diverse and rapidly changing products and technologies that it is virtually impossible to be an expert in every area. Know the topics you are confident in and know the ones where you need help. This keeps your communication thoughtful and on point.
When you do not know, it is a simple matter of letting your customer know that you need to check and get back to them. The successful distribution lab sales professional has contacts that cover CLIA requirements, lab personnel requirements, leasing and financial topics as well as knowing and understanding which products make sense for specific customers. It is better to know who you can count on for expert advice than to try to become an expert on every element of lab. Keep your consultant list up to date and be sure to contact them to understand what is new and important in their specific field.
Like so many other topics on selling lab, knowing your customer and their needs is the foundational element. I believe it is better to have a smaller number of well-established, happy customers who are loyal to you than to juggle a larger group of customers you barely know.
You and your respected lab manufacturers can provide better service to customers you know well than to others you may not know so well. Add to that, the other basic elements I have provided for your consideration and you will be in a better position than your competition. Knowing and mastering the basics is the gateway to a better, more successful business than any other option I can think of. And it is not easy.
Make mastery of the basics and adherence to your key professional objectives the guiding principles of your professional life. Then, watch your business and your confidence grow.
The Top 20 POL tests
- Complete blood count (CBC)
- Comprehensive metabolic panel (CMP)
- Basic metabolic panel (BMP)
- Lipids
- Hemoglobin A1C
- Thyroid Stimulating Hormone
- Urinalysis
- Rapid Strep Test
- PT/INR
- Vitamin D
- Prostate specific antigen (PSA)
- C Reactive Protein
- FLU
- Pregnancy
- Ferritin
- Magnesium
- Erythrocyte Sedimentation Rate
- Rapid COVID test
- Liver function tests (primarily ALT and AST)
- Creatinine/Microalbumin
Key takeaways
- Mastering CLIA requirements and test categorization helps lab sales professionals become trusted consultants and better support physician office labs.
- Focusing on high-utility, commonly used POL tests leads to better long-term customer success than chasing niche or trendy diagnostics.
- Strong lab reps know when to rely on expert partners and consultants instead of trying to be experts in every area themselves.
CLIA Categorizations
Click here to see what the FDA offers as an excellent resource that provides this information for every test cleared under 510(k).