Why reps must be mindful of the challenges customers face when they commit to a moderate complexity lab.
By Jim Poggi
CLIA should be on the minds of every distribution account manager who has helped his customers implement a CLIA moderate complexity or high complexity lab. Well managed, these point-of-care labs provide exceptional value to both the patient and the care giver. With needed lab information available during the patient visit, a treatment program can be initiated or modified with confidence, saving time and providing better quality of life and improved health outcomes for the patient.
While that is all true, a poorly managed physician office lab can be inefficient, produce less than satisfactory patient results and create frustration for both the care givers and their lab staff. Concerns about CLIA compliance are a key factor in customers deciding not to embrace lab testing in their office or discontinuing testing down the road.
As of 2021, there were over 34,000 CLIA moderate or high complexity labs operating in the physician office market. This number is a tribute to the recognition of the value of onsite testing by the provider community as well as your efforts to educate your customers on the importance of lab testing while providing consultative assistance in establishment and maintenance of high quality physician office labs. It is not an easy task.
As proof, in 2021, CMS reported it found over 18,000 deficiencies in surveys of over 9,000 moderate labs. The top 10 deficiencies are all associated with core CLIA compliance requirements. No. 1 involves labs with inadequate written policies and procedures, with almost 19% of the labs cited for this specific deficiency. Improper storage of reagents and specimens was No. 2 cited in 17.5% of the labs. Failure to verify performance of tests was cited in No. 3 and No. 4 and resulted in a total of 32% of the deficiencies cited.
The list goes on and includes procedure manual deficiencies of multiple kinds as well as failure to properly perform proficiency testing as required.
The common thread
In my opinion, it is that CLIA regulations encompass a broad range of requirements for the lab, including personnel qualifications and training, proficiency testing, maintenance of a quality control program and monitoring test performance data to assure proper patient results. In addition, there are requirements for test calibration, verification of performance and maintenance of policies governing how the lab assures adherence with these requirements and actions needed when failures are observed. Bottom line: policies and procedures must cover EVERY CLIA requirement, be rigorously enforced and personnel standards must be set and managed through on-going training over time. Even in the well-organized lab, there are a significant number of factors to control. Yes, no lab is perfect, but each lab must perform to a high standard or risk being cited for deficiencies with the need to demonstrate effective corrective action.
While a complete listing of CLIA requirements is available online and our key lab systems manufacturers are an excellent source of information related to test performance, quality control, sample and reagent management and even proficiency testing, most labs do not have a comprehensive, up to date system that they review and consult daily to make sure they are compliant in every way, every day. And, over time, even the more thorough paper systems become out of date and insufficient when personnel changes take place, or the test menu changes in response to the needs of the physician practice.
Some labs attempt to meet these challenges by engaging outside lab consultants to provide assistance, though the quality of consultants varies considerably across the country. To be CLIA compliant and prepared for the inspection labs are subject to every two years, the lab must have a comprehensive, well documented, easy to understand policy and procedures system that provides guidance and direction to lab personnel required to meet EVERY CLIA requirement. And, the system needs to be friendly enough and easy enough to use that the lab’s personnel can find the information they need quickly and understand action required for routine testing tasks, periodic activities such as monthly QC review, proficiency testing, and on-going personnel recruitment and training.
For most labs, this is a dream state rather than a reality. Many tend to make do with paper documentation which is not always up to date and may not cover every element of lab operation mandated under CLIA. More likely than not, these paper documents are not consulted daily as they should be. Lack of attention here, hoping for the best or lack of understanding of the myriad CLIA requirements can have everyday impacts and eventually lead to the lab being cited for deficiencies and possibly even failing to correct the deficiencies and closing down.
Customer feedback
Customer experiences prove the point:
“Our moderate complexity lab opened in 2018,” Myra M, Virginia wrote. “We began with hematology and thought our documents for testing were good, but knew we needed to do a better job on personnel training. We managed OK until we started chemistry testing. Then the wheels fell off due to the larger number of activities we needed to manage. It took months for our lab staff of three to come up with reasonable documents, but we were never really sure we covered everything.”
While lab manufacturers, consultants and COLA all offer a range of solutions, it is a rare physician office lab director who does not wonder whether their documentation is complete, easy to use and able to direct the staff to manage daily tasks and handle testing difficulties as they arise. With online resources available for virtually every aspect of daily living, many labs would consider an electronic document system as a preferred way to manage their lab.
Another customer, Bob R, NY wrote: “We order supplies online, communicate within the lab via text messaging and with our manufacturers and distributor online, and even conduct online searches to compare lab products before buying. We live in the real world, but most of our information is housed in the virtual world. We find online solutions preferable to paper documents on shelves.”
From AACC to manufacturer websites to proficiency testing sites, there are a wide variety of partial solutions to lab information gathering and documentation. But, the average lab lacks the time, expertise or knowledge to patch together these disparate bits of information into a single source to be used by the lab staff as a CLIA compliance reference source. And the average physician office lab lacks the IT staff to combine these individual bits of information into a single system. However, by combining a comprehensive list of CLIA requirements, an expert system to guide user input to create needed documents and even templated policy and procedure documentation, there is a solution available today.
Fred A, MN, wrote: “Addressing challenges head on is clearly the best way to overcome them. Managing a lab under CLIA is no different from any other significant business challenge faced by today’s physician office lab. Our lab muddled along until we found a simple, easy to use online solution. This solution leads to a more organized and efficient lab where management of patient results, quality control and personnel is made simple. It teaches the fundamentals of managing a lab as it organizes the work to be done and documents the important licensing and personnel requirements of the lab staff. It has made our lives so much easier and we work more confidently every day. The staff and physicians love it.”
In our role as consultants, we need to be ever mindful of the challenges our customers face when they commit to a moderate complexity lab. We are all aware of the benefits of point-of-care testing, but we do not always know where to turn for help to guide our customers to create a smooth and efficient lab operation. And, we also know that as the lab’s testing menu grows, so does the level of complication in managing compliance. Keep up to date on the tools your key manufacturers offer to assist with lab management, know local consulting resources and keep an eye out for new innovative products that can bring CLIA complexity challenges the 21st century ease and simplicity they deserve. CLIA is here and not going away. Your preparation now will ensure your customers’ confidence and competency in the future!