Making the leap from CLIA-waived testing to moderate complexity testing in your laboratory can be a game-changer for your practice. While it will initially involve making a more substantial commitment to your testing business, making the transition to moderate complexity testing ultimately offers greater control over patient outcomes, test quality, and revenue generation.  

But what are the key considerations to help physicians with office labs, hospitals, urgent care centers, and pharmacies navigate this transition successfully? Read on below to learn about the differences between the two levels of testing and the benefits that come with expanding to moderately complex testing. 

Understanding the Difference: CLIA-Waived vs. Moderate Complexity Testing 

CLIA-Waived Testing: These most often are simple tests that provide quick, reliable results with minimal training and regulatory oversight. Examples include glucose monitoring, pregnancy tests, and some urine tests. Laboratories performing these tests need only a CLIA certificate of waiver and must follow manufacturer instructions. Often, these tests are performed in point-of-care settings. 

Moderate Complexity Testing: This category includes tests that are more sophisticated and require higher levels of training and regulatory compliance. Common tests in this category include complete blood counts (CBCs), chemistries, thyroid function tests, and infectious disease screenings. Labs performing these tests must have a CLIA certificate of compliance or accreditation, undergo regulatory inspections, and meet more stringent quality standards. 

Neil Gerber, Director of Business Development

Neil Gerber, Director of Business Development for Lighthouse, says his team often encounters practices that are running waived tests and are interested in expanding that portion of their business, but may be hesitant to do so due concerns about meeting additional regulatory burdens. These concerns are why he recommends working with regulatory experts who intimately understand the requirements labs must meet. 

“Our program for moderately complex labs not only makes adding this testing easy, but it is also a cost-effective way to grow your practice efficiently,” Gerber adds.  

Benefits of Transitioning to Moderate Complexity Testing

• Expanded Test Menu: 

• • Broadens your lab’s capabilities, allowing for a wider range and diversity of diagnostic tests. 

• • Enhances patient care by providing more comprehensive and detailed results. 

• Increased Diagnostic Accuracy: 

• • Offers higher precision in test results, improving the quality of diagnoses and treatment plans. 

• Professional Development: 

• • Provides opportunities for staff to gain advanced training and expertise with different lines of testing. 

• Revenue Growth: 

• • Keeps more of the testing revenue in-house by reducing the need for outsourced lab services. 

• • Can lead to higher insurance reimbursements for meeting the unique needs of a payer’s patient population. 

Key Considerations for Making a Successful Transition 

Volume and Demand: Assess whether your patient volume justifies the investment in moderate complexity testing. Higher volumes will help to provide consistent testing opportunities and make the transition financially viable. 

Regulatory Compliance: Understand and prepare for the regulatory requirements, including obtaining the necessary CLIA certifications and meeting quality standards. You will also want to understand whether there are specific state-level requirements your lab must meet. 

Staff Training and Competency: Evaluate your current staff’s skills and determine the additional training needed to comply with testing guidelines. Hiring new personnel with the required expertise might also be necessary. 

Infrastructure and Resources: Ensure your lab has the physical and technological infrastructure to support more complex testing. This may involve investing in new or refurbished equipment and upgrading facilities. 

Physicians seeking to expand their office labs will also want to ensure they have the space necessary to expand their current POL setup. 

Financial Planning: Conduct a cost-benefit analysis to understand the financial implications, including initial setup costs and ongoing operational expenses versus the potential for increased revenue. Consulting with billing experts can help you understand the payer reimbursement landscape and potential up front before you begin filing claims. 

Quality Assurance: Implement robust quality assurance and control measures to maintain accuracy, reliability, and consistency in test results. 

Steps to Transition to Moderate Complexity Testing 

• Needs Assessment: 

• • Evaluate the specific clinical needs of your patient population. 

• • Identify relevant moderate complexity tests. 

• Financial Planning: 

• • Perform a thorough cost-benefit analysis. 

• • Plan for both initial and ongoing financial requirements. 

• Regulatory Compliance: 

• • Familiarize yourself with CLIA and other federal and state regulatory standards. 

• • Ensure your practice is prepared for necessary inspections. 

• Staff Training: 

• • Identify training needs and gaps in current staff competencies. 

• • Develop a comprehensive training plan or hire skilled personnel. 

• Infrastructure Assessment: 

• • Evaluate your current lab setup and identify needed upgrades. 

• • Ensure your lab can support the expanded test menu and complexity. 

Conclusion 

Transitioning from CLIA-waived to moderate complexity testing can significantly enhance your laboratory’s capabilities and improve patient care. By carefully considering the factors involved, meeting regulatory requirements, and following a structured implementation plan, you can make this transition smoothly and successfully. This strategic move can position your practice for better patient outcomes, increased operational efficiency, and enhanced revenue potential. 

Curious about next steps? Contact us today for a free consultation. 

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