Determining whether to add in-office laboratory testing to your physician’s office can be a challenge, with many items to consider. This one question will help you decide whether performing lab tests in house could benefit your practice.
The decision for medical practices to add laboratory testing to their services has been a subject of spirited debate even since before CLIA ’88 lab regulations took effect more than 25 years ago. Several opportunities, such as revenue generation, patient counseling and control of test results, have been balanced against challenges including lab license requirements, personnel qualifications, which tests to offer, staff (dis)satisfaction and many others.
So many factors have been put into play that it seems like there is no simple, objective way to determine whether to test in house or to send test results out. But, especially due to appropriate emphasis on patient outcomes, there is a simple path to determine whether your practice could benefit from performing tests in house, and three simple criteria to decide how to implement a physician office laboratory.
The only question you need to ask when determining whether you should perform laboratory testing in house: “Can I dramatically improve the quality of my patient care by knowing now instead of later?” In others words, will a treatment plan be initiated or modified based upon what you learn from having test results available during the patient visit?
If the answer to this question is “yes”, which is likely in most primary care practices, urgent care centers and many specialty practices, including oncology, pediatrics, internal medicine and family practice, then you need to consider the scale of testing you desire and a plan to implement it.
As a point of reference, the number of practices that have chosen to offer laboratory services of any scale (from certificate of Waiver to Moderate Complexity) has been stable overall for the past several years. The chart below details data collected and published by the Centers for Medicare and Medicaid Services and shows a slight decline in moderate complexity labs over time, and a similar trend for Provider Performed Microscopy lab licenses. But it also shows an increase in CLIA certificate of waiver labs during the same time frame.
Chronic Conditions & Laboratory Testing
So, which chronic conditions are of concern to practicing physicians, and which have a valuable laboratory testing component? The graph to the right outlines the top ten causes of morbidity and mortality in the US in 2015, in order, according to the CDC Morbidity and Mortality Monthly Report.
Even by conservatively removing Alzheimer’s disease (where lab tests help “rule out” other disorders) and both intentional and unintentional injuries, lab tests have a role in 90% of the leading causes of mortality in the US. Given the chronic nature of heart disease, cancer, diabetes and lower respiratory ailments, there may be a substantial percentage of daily patient visits present for treatment for these disorders. And, during the annual peak of influenza season, CDC data shows that between 3.5 and 6.0% of all patients seeking medical attention, presented with “influenza like illness” in the past three influenza seasons. During this time period testing for common respiratory illnesses including influenza, group A streptococcus and RSV are commonplace in primary care, urgent care and emergency room settings.
So, Where Does This Data Lead Us?
Let’s test our question, “Will a treatment plan be initiated or modified based upon what I learn from having test results available during the patient visit?”
|Disease||Lab screening test available?||Is screening waived?||Lab monitoring test available?||Is monitoring waived?|
|Heart disease||Yes||Yes; e.g. BNP||Yes||Yes; e.g. BNP|
|Cancer||Yes||Yes; e.g. iFOBT in particular||Yes||No|
|Chronic lower respiratory disease||Yes; electrolytes, blood gas||Some electrolytes||Yes||Some electrolytes|
|Cerebrovascular (stroke)||Yes||Some; d-dimer, PT/INR||Yes||Some; d-dimer, PT/INR|
|Alzheimer’s disease||N/A||Rule out tests exist||N/A||N/A|
|Diabetes mellitus||Yes||Yes; glucose||Yes; A1C||Yes|
|Pneumonia & influenza||Yes||Rapid pneumonia strep & flu tests||N/A; microbiology CAN determine clearance of the organism||N/A|
|Kidney disease||Yes||Yes; creatinine, BUN||Yes; creatinine, BUN||Yes|
It is clear from a number of perspectives that treatment programs will be created or modified based on either screening or monitoring lab tests for 7 of the 10 top causes of morbidity and mortality in the US.
The patient population being served (average patient age, disease incidence, nutritional habits, socioeconomic status and other factors) influence the percentage and severity of these diseases that present daily to the average primary care practice. Each practice must examine their data and make their own determination whether they should test. Once that is done, they can move on to the three big picture criteria they need to consider before implementation of a practice-based lab.
Continue your learning. Read more about in-office laboratory testing.
Getting Ready to Implement In-Office Laboratory Testing
Is your physician office actually ready to implement laboratory testing? Explore these three key criteria to find out.
Determining In-Office Laboratory Testing Options
Now that your physician office is ready to implement in-office lab testing, how do you know which test options you should offer? Learn how the 80/20 rule can help.
Expanding Laboratory Testing in Medical Practices
Explore how expanding point-of-care lab testing or transitioning from CLIA-waived to moderately complex lab testing can help address some of the needs generated from an outcomes-based approach.
Our Laboratory Implementation Team helps with initial lab setup and implementation, ensuring you have enough space for lab equipment, verifying hazard protocols, validating and testing equipment and more. This team can help set up single pieces of lab equipment or help build an entire new lab. Email us today to get started.
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1: Medical Laboratory Sciences. Mayo Clinic School of Health Sciences. Retrieved from http://www.mayo.edu/mayo-clinic-school-of-health-sciences/careers/laboratory-sciences
2: 70% of Medical Decisions Are Based on Lab Results. Quest Diagnostics. Retrieved from http://www.questdiagnostics.com/dms/Documents/PLS/35841-FIN-WP-Hospital_Lab_Management-WP4289.pdf
3: (April 17, 2014). Importance of Clinical Lab Testing Highlighted During Medical Lab Professionals Week. American Clinical Laboratory Association News. Retrieved from http://www.acla.com/importance-of-clinical-lab-testing-highlighted-during-medical-lab-professionals-week/
4: 2016-2017 Influenza Season Week 37 ending September 16, 2017. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/flu/weekly/index.htm