Jim Poggi
By Jim Poggi
I’d rather get an injection!
Fear of a lab inspection is one of the most common reasons customers do not invest in CLIA moderate lab testing, or choose to reduce testing to CLIA waived tests, even if they know they need many of the CLIA moderate tests available to help them initiate or modify a patient’s treatment plan.
There are several reasons, including lack of knowledge of CLIA moderate complexity requirements, how to manage a lab, or ignorance of resources available to help the practice. Fear of failure to pass an inspection, lack of confidence in the practice’s ability to successfully manage the lab, concerns about the time needed to manage the lab or concerns about staff turnover and continuity of lab management are also factors. Each of us knows a potential lab prospect who heard the story of a peer or colleague whose lab ran into inspection issues and ultimately stopped testing.
Myths and ignorance typically fuel reluctance to initiate CLIA moderate complexity testing or panic when the lab is informed that an inspection is planned. A few of the classics are below. Each of us could add a few more, I am sure.
Myths vs. reality
| Myth | Reality |
| Few labs get inspected; why waste time planning and organizing? | Failure to plan is planning to fail; this attitude spells disaster when an inspection takes place. |
| Managing a lab to be ready for inspection is hard and time consuming | It takes knowledge of what you need to do, commitment to success and some effort EVERY DAY |
| The lab staff needs to do all the work to be ready for an inspection | The best managed labs have thoughtful engagement and oversight from the lab director |
| Drag out the “books” when the inspector shows up to dazzle them with paper | Be prepared and have key documents ready (personnel training records, QC, policies and procedures). Know where your records are; take out what you need WHEN you need it. Newer solutions are software based. |
| Inspectors are out to find problems and cite the lab | Inspectors want to find evidence of on-going planning and management of the lab consistent with CLIA and the lab’s policies and procedures |
| One “bad inspection” and the lab gets shut down | Big deficiencies can be problems, but most labs are simply asked to correct deficiencies on a timely basis |
So, knowing this and knowing how much value your customers can get from initiating and properly managing a CLIA moderate lab, what can you do in order to help them confidently manage their new lab and be ready for an inspection?
SUBHEAD Knowledge
Arm yourself with knowledge of CLIA requirements and the available resources your company offers. Local lab consultants with good reputations and publicly available resources like COLA can also help organize the lab and keep it running smoothly.
Understand the help available from your key lab suppliers; they are the experts and many companies offer assistance with applicable CLIA standards, compliance manuals, understanding of how to write policies and procedures, quality control and other important elements of managing a lab successfully.
Traditional CLIA compliance tools have been paper documents, but newer electronic solutions are software based “fill in the blanks” solutions that guide the client through CLIA requirements and help them prepare appropriate documentation. These new tools offer a level of expertise and guidance that greatly simplifies daily lab operation and makes preparation for an inspection far easier. It adds confidence for you and your customers.
Some publicly available resources can be found by using the following links:
- CLOA http://www.cola.org/
- American College of Physicians https://www.acponline.org/system/files/documents/running_practice/mle/clia-and-your-lab.pdf
- American Academy of Family Practice https://www.aafp.org/practice-management/regulatory/clia.html
Share the information openly and completely with your customers
As a friend of mine likes to observe, “Hope is not a strategy”. So, sharing the planning needed to implement and maintain a physician office laboratory as you prepare to move a customer from CLIA waived to moderate is critical. Physician offices need to understand what is involved, be committed to daily management of the lab and have policies and procedures in place to assure the smooth functioning of their lab. Nothing manages itself, and lab is no exception.
I recommend setting aside time with the practice and your key moderate complexity suppliers early in the implementation process to review the key actions needed to conform to CLIA moderate complexity lab management practices. Make a check list, assign activities such as developing QC testing practices, procedure manuals and personnel records to the right members of the practice and diligently work to assure all the open action items get resolved satisfactorily. Time spent now reaps rewards in increased confidence, reduced anxiety and more efficient operation of the laboratory over time.
The lab that starts out with a patient-centric mission to improve care and use lab tests to create or modify patient treatment plans combined with a well thought out process for managing the lab is in a much better position to deal with the inevitable challenges that managing a lab as part of the physician practice encounters.
Monitor performance of your current customers’ POL
The best account managers are known and respected as consultants to their customers and their help and expertise is expected. This is certainly the case with a CLIA moderate complexity physician office lab. For your established customers, periodic check-ins to review operation of the lab and address issues head on is as important as high-quality implementation as they begin testing.
Many of the most successful account managers I know include a review of the lab’s operation with their quarterly business reviews. Key suppliers should be a welcome addition to the attendees at these meetings. Keeping all the resources available to you in mind makes issue resolution far more efficient and assures experts are ready to step in as needed. Probe for issues, ask the right questions and openly discuss improvement needs. This business review is no substitute for a “mock inspection”, but it is part of your commitment to your customer’s success.
Do you know how prepared your customers are for an inspection?
You should. Using the tips provided, all of your company’s and supplier resources and researching newer compliance solutions is in your best interests as well as those of your customers. Make it a practice to provide needed resources and consultative efforts to help your customers manage their labs smoothly and efficiently. Your reward will be fewer headaches, no surprises at inspection time and customers who confidently manage their labs for the health and wellness of their patients. There are over 15,000 CLIA moderate complexity labs in primary care. How are yours doing?