Some insights and resources to help you and your customers get more comfortable with CLIA compliance.
By Jim Poggi
CLIA ’88 has been in place now since 1992 and is still probably one of the most misunderstood obstacles to a creating and managing a successful moderate complexity physician office lab. While manufacturers and distributors have deployed an increasingly impressive range of specialist sales personnel and a broad range of consultative resources to help the distributor account manager, customer concerns and reluctance continue to provide a daily struggle for all of us involved in the physician office laboratory market. In this article, I intend to review some of the laboratory license statistics and take a fresh look at the array of resources available to help you and your customers become comfortable with compliance with CLIA, and to manage an outstanding, profitable, and productive physician office laboratory.
What does the CLIA lab license data tell us?
The total number of laboratory licenses has grown from about 207,000 in 2008 to 262,000 in 2018, an increase of over 26%. That’s the good news.
What about the moderate and high complexity licenses? In 2008, there were 35,673 of them. In 2018, the number dropped to 33,674, a decrease of about 6%.
What are some of the reasons? There are a number of factors in play, and it’s not easy to determine which are the most influential. But, they include factors ranging from consolidation of some physician practices to physician retirements and purchase of practices by IDNs as well as shut downs related to PAMA reimbursement cuts and inability to keep current with CLIA regulations. While we cannot influence the more macro trends including practice consolidation and IDN practice purchases, we can assure we actively support our current customers and support new customers considering investing in a moderate complexity lab.
Managing and coaching the current customers
This should always be our first priority. In last month’s column, I addressed how to prevent the current customer from making the decision to cease testing. Simply stated, you need to work with your key laboratory suppliers and stay in close touch with your customers to assess their lab quality, personnel satisfaction and technical performance. To do so successfully really requires a commitment to thoughtful and frequent business reviews, drawing out small issues before they become significant roadblocks that could endanger the future of your customer’s lab. Once you know the lab’s overall performance, you and your key manufacturing partners can develop a program that addresses technical performance, workflow and test menu customization to optimize lab quality and staff satisfaction.
Along the way, be sure to gain guidance and recommendations from your lab specialists and home office laboratory product team. You have three key levers to manage: financial results, clinical performance and workflow. If you see each current customer’s concerns through this lens, you can quickly create a list of addressable items that fall under each element of value. In the process, you can also seek to gain customer agreement that these three pillars of value and the most important ones and create programs to provide a better solution.
As always, as you propose and implement solutions, seek agreement from the customer that you have selected the key items to resolve and that the proposed solution has created improvements without causing new issues. Most frequently this process involves understanding the training needs of the lab staff, helping them to get the most out of the lab instruments they have invested in and to review technical performance with your key supplier’s technical staff. It also helps to review their testing pattern to help assure they are performing tests that are both needed for patient treatment programs and performing those tests that as a full test menu keep the lab profitable. From time to time, it will result in retiring an older piece of lab equipment and investing in new equipment more suited to changes in their patient mix and treatment program requirements.
Working to develop new customers
While you may at first think it is a matter of you and your key lab supplier “going it alone” to understand the customer’s needs and develop a solution, there are, in fact, a surprisingly large number of other sources of help.
As examples, many professional medical associations including the American Academy of Family Physicians manage a library of resources designed to train and coach physicians desiring to manage a physician office laboratory including on line programs to guide physicians on how to qualify as a lab director. Some, including AAFP also provide their own proficiency testing programs designed to reduce concerns about how to properly assure test performance.
One resource I find that is often overlooked is the Centers for Disease Control and Prevention (CDC). They have an exceptional range of helpful documents and training materials covering the gamut from applying for a license to personnel requirements. The link to their information can be found here www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.
COLA has also been a third party educational resource for a number of years. They provide customer training and development resources aimed at developing a quality oriented POL. The link to their home page: www.cola.org.
Many experienced distributor account managers have relied on COLA as one of their key customer assistance sources for years. There are also a number of independent lab consultants available. Be sure to check with your colleagues and customers to understand which consultants offer the greatest value for our POL customers.
In addition, don’t overlook the assistance your LIS and EMR providers can provide. Their sophisticated range of result management tools can help with storage and retrieval of patient data, quality control program result management and even workflow tools. Some of the more sophisticated LIS providers even offer a turn key program specifically intended to support on line CLIA compliance for the POL. This is becoming a more popular option for a number of customers due to its ease of use and comprehensive but simple method of assuring the POL knows what it needs to do and has the tools required for successful CLIA compliance.
When the physician office laboratory is properly implemented and well managed, it is a powerful tool for management of patient treatment programs. Like any other tool, it requires thoughtful attention to detail and refinement over time to maintain its effectiveness. Stay engaged, stay informed, and grow your physician office laboratory business. Your customers will thank you and their patients will benefit.