Expanding an onsite point-of-care (POC) CLIA waived lab to a moderately complex facility is a significant consideration for busy practices. While this upgrade promises faster turnaround times and enhanced patient service, it also entails various investments and expenses, both anticipated and unforeseen.
Initially, CLIA waived testing suffices for basic cholesterol or glucose screening in limited onsite testing scenarios. However, practices handling a high volume of bloodwork tests daily may benefit from conducting more complex tests in-house, enabling quicker result delivery. The decision to upgrade labs originates not only from convenience or reimbursement potential but also from the aim to improve facility offerings and raise the quality of patient care.
Here’s a breakdown of the costs and benefits involved in expanding your CLIA waived lab to a moderately complex facility.
Launch Delays: Transitioning to a moderately complex lab requires time, depending on geographical location, staff requirements, and equipment procurement. The most common delays in the buildout process are the result of purchasing and receiving equipment, as well as scheduling manufacturer training sessions, necessitating flexible planning and contingency measures.
Lab Space Modifications: Reconfiguring lab space to accommodate new equipment entails considerations like electrical requirements, deionized water hookups, and additional storage and refrigeration for supplies, accessories and specimen storage.
Supplies Procurement: Besides equipment costs, ongoing expenses for replenishing supplies and consumables, along with adequate storage solutions, must be factored in. Be sure to assess the reagent requirements for an instrument before purchasing. Many analyzers require reagent that’s exclusively sold by a manufacturer or distributor and their contractual terms may require a minimum purchase amount for reagent each month, which may become very expensive and wasteful for your new lab that’s below the volume threshold for that amount of reagent.
Staffing: Labor costs may vary based on equipment caliber and state-specific regulatory requirements, potentially affecting staffing plans and overall operational expenses.
Regulatory Compliance and Startup Costs: Moderately complex labs incur regulatory fees, including CLIA certification fees and bi-annual inspection expenses. Additionally, proficiency testing fees, varying based on test types and frequency, contribute to startup costs.
Accelerated Turnaround Times: Onsite moderately complex labs enable same-day test results, facilitating prompt treatment decisions and enhancing patient care in urgent or emergency care settings.
Enhanced Patient Satisfaction and Outcomes: Access to immediate results during the initial visit reduces patient anxiety, improves satisfaction levels, and promotes treatment adherence, ultimately leading to better clinical outcomes.
Quality Control and Return on Investment: Direct oversight of testing quality minimizes uncertainties associated with reference labs, ensuring optimal patient care. Investing in advanced technology optimizes workflows, enhancing efficiency and reducing labor costs over time.
Streamlined Patient Follow-up: Conducting lab tests onsite eliminates logistical barriers associated with scheduling separate lab appointments, leading to improved patient compliance and continuity of care.
Revenue Optimization Opportunities: Operating a moderately complex lab potentially opens avenues for additional reimbursement opportunities, particularly through initiatives like the Medicare Access and CHIP Reauthorization Act (MACRA), rewarding providers for improved outcomes and quality of care.
Public Health Benefits: In-house labs contribute to reducing community spread of infectious diseases by minimizing patient exposure to external facilities, particularly relevant amid the COVID-19 pandemic.
Deciding to upgrade to a moderately complex lab involves careful consideration of these costs and benefits. Partnering with our experienced laboratory consultants at Vyzorb can help you make a more informed and cost-effective decision. Reach out for a free estimate today!
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