Start a GI Lab

Opening an in-house clinical laboratory can transform the way wound centers, dermatology clinics, and podiatry practices deliver care. With rapid advances in molecular testing, practices can now offer precise, same-day diagnostics that improve patient outcomes and streamline treatment decisions. If you’re considering starting a clinical lab for your specialty practice, here’s what you need to know.

Why In-House Molecular Testing Matters

Traditional culture-based testing can take days to identify pathogens and determine antimicrobial resistance. In contrast, molecular PCR-based solutions provide rapid and precise identification of pathogens, allowing for targeted therapy and improved patient care. For wound centers, dermatologists, and podiatrists, this means:

• Faster diagnosis and treatment of infections
• Improved antibiotic stewardship
• Better patient satisfaction and outcomes
• Increased revenue to your practice

Step 1: Assess Your Practice’s Needs

Begin by identifying the most common infections and diagnostic needs in your specialty. For example:

• Wound Centers: Chronic wounds are prone to polymicrobial infections. Rapid detection of bacteria and fungi is essential for effective management.
• Dermatologists: Skin and soft tissue infections require accurate identification to differentiate between bacterial, fungal, and viral causes.
• Podiatrists: Foot ulcers and nail infections often involve hard-to-treat pathogens that benefit from precise identification.

Step 2: Choose the Right Molecular Testing Services

Molecular testing, such as PCR-based assays, can detect a broad range of pathogens—including bacteria, fungi, and antimicrobial resistance markers—in a single test. This technology, similar to the molecular testing services offered by PathMD Labs, delivers results within 24 hours, enabling swift clinical decisions.

Key benefits include:

• Comprehensive Pathogen Panels: Identify multiple organisms in one test.
• Antimicrobial Resistance Detection: Guide therapy with real-time resistance data.
• Rapid Turnaround: Results typically available within one business day.

Molecular Testing Labs Typically Ordered

Pathology Tests Typically Ordered

*ROI values are estimates based on average insurance and Medicare reimbursement rates for in-house clinical labs. Actual reimbursement may vary based on payer contracts, coding, and local market factors.

Want to learn more about maximizing your ROI by bringing these tests in-house? We can run the numbers for your practice or center for 2 months to show you the actual ROI’s.

Contact Cadence Lab Services for a free consultation and personalized analysis or your practice.

Step 3: Navigate Regulatory Compliance

Setting up a clinical lab involves obtaining the proper licensure and accreditation (such as CLIA and COLA). Work with experienced consultants to ensure your lab meets all federal and state requirements, including:

• Facility and equipment standards
• Personnel qualifications
• Quality control and assurance procedures
• Documentation and reporting protocols

Step 4: Design Your Lab Workflow

Efficient workflow is critical for high-quality results. Plan for:

• Sample Collection: Train staff on proper techniques for wound, skin, and nail specimens.
• Specimen Processing: Invest in validated molecular testing equipment and ensure proper storage and handling.
• Data Management: Implement a Laboratory Information System (LIS) for secure results reporting and integration with your EMR.

Step 5: Train Your Team

Your lab’s success depends on well-trained personnel. Provide ongoing education on:

• Molecular testing methodologies
• Quality management systems
• Interpretation of results and clinical integration
• Cadence Lab Services can hire your lab manager and staff for you.

Step 6: Partner with Experts

Launching a clinical lab is a significant investment. Partnering with a team like Cadence Lab Services ensures you have guidance through every step—from initial planning and regulatory compliance to equipment selection and ongoing quality management.

By bringing molecular testing in-house, wound centers, dermatologists, and podiatrists can deliver faster, more accurate care while improving operational efficiency. If you’re ready to elevate your practice with a clinical lab, Cadence Lab Services is here to help you succeed—every step of the way.

Contact us today to learn more about starting up your own specialty clinical lab.

Frequently Asked Questions

What are the main benefits of having an in-house clinical lab for my practice?

An in-house lab allows for faster diagnostic turnaround, improved patient care, greater control over testing quality, and the potential for increased revenue through reimbursement for laboratory services.

What types of tests should I offer in my specialty clinical lab?

Wound centers, dermatologists, and podiatrists commonly offer molecular tests (such as PCR panels for wound pathogens, skin and nail infections, and antimicrobial resistance) as well as traditional pathology tests (like tissue biopsies, punch biopsies, and direct immunofluorescence).

How do I determine which molecular tests are most relevant for my practice?

Start by assessing the most frequent infections and diagnostic needs of your patient population. Consulting with a laboratory expert can help you select the most clinically and financially valuable tests for your workflow.

What are the regulatory requirements for opening a clinical lab?

You must obtain CLIA certification and, depending on your state, additional licensure or accreditation (such as CAP or COLA). You’ll also need to comply with federal and state regulations regarding lab operations, quality assurance, and personnel qualifications.

How much space and equipment do I need?

Lab size and equipment will depend on your test menu and patient volume. Most specialty practices can start with a compact molecular testing platform and basic histopathology equipment. An experienced consultant can help you design an efficient layout.

What is the typical investment and ROI for starting an in-house lab?

Startup costs vary, but many practices see a positive ROI within the first year due to improved reimbursement and operational efficiencies. See our charts above for potential reimbursement rates for common tests.

How do I ensure quality and compliance in my new lab?

Implement robust quality control and assurance procedures, provide ongoing staff training, and consider partnering with a lab management service for ongoing compliance support.

Can I integrate lab results with my existing EMR?

Yes, most modern laboratory information systems (LIS) can interface with electronic medical records, providing seamless ordering and results reporting.

Who can help me plan and launch my in-house clinical lab?

Cadence Lab Services specializes in helping wound centers, dermatologists, and podiatrists plan, launch, and manage successful in-house clinical labs. Contact us to get started.

Read Next

We have more guides to inspire you to start your own clinical lab.

Join the antibiotic stewardship movement and champion accurate diagnosis by starting your own molecular lab.

Learn more about the costs associated with running your own clinical lab. Cadence Lab Services can run the numbers for the current labs your practice or center orders for free, so you have a real-time estimate of your return on investment.

Learn more about Cadence Lab Services and how we can help you with all your lab management needs.

Read our step by step guide to starting your own clinical lab. You don’t have to do it alone—Cadence Lab Services is your one stop shop for the startup of your in-house turn-key lab.

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