Point of Care Testing in Primary Care

If you’ve ever considered enhancing your primary care practice with in-office point-of-care testing (POCT), it’s essential to have a thorough grasp of laboratory management before proceeding. The incorporation of physician office lab testing offers numerous advantages for both patients and practices.

Benefits for Patients

1. 1. Accelerated treatment plans based on promptly received lab results during office visits, leading to tailored treatments.
   2. Convenient access to routine lab tests during office visits, eliminating the need for separate trips to external labs.
   3. Simplified billing through the integration of office visits and in-house lab services.

Advantages for Practices

1. 1. Enhanced patient compliance with treatment plans due to reliance on in-office test results.
   2. Revenue growth and retention facilitated by in-house testing services.
   3. Improved operational efficiency by minimizing the need for communication regarding outsourced lab results.
   4. Reduction in unnecessary antibiotic prescriptions for suspected bacterial infections.

Running a Laboratory

Before establishing your POCT lab, it’s crucial to familiarize yourself with current office-based lab requirements. Key considerations include regulatory obligations, physical prerequisites, and test selection.

Regulatory Requirements

The Clinical Laboratory Improvement Amendments (CLIA), introduced in 1988, govern all human testing labs in the United States. To begin testing patient samples, obtaining a CLIA license is mandatory. Most POCT labs qualify for a Certificate of Waiver, permitting the performance of CLIA waived laboratory procedures on-site. However, it’s imperative to adhere to specific guidelines:

• • • Compliance with manufacturers’ instructions for waived tests without alterations.
    • Notification to the state agency regarding any changes in the POCT lab, including ownership, name, address, or addition of non-CLIA waived tests.
    • Willingness to undergo on-site inspections by representatives of the Centers for Medicare & Medicaid Services (CMS) upon request.

It’s essential not to cut corners in obtaining CLIA licensing, and seeking guidance from distributors and lab equipment suppliers can aid in navigating this process efficiently.

To gain insights into CLIA waived testing within your practice, refer to our article, “How to Run a Laboratory: Understanding CLIA Waived Office-Based Lab Requirements.”

Physical Requirements for POCT Labs

Creating a conducive physical environment is vital to ensure the reliability of test results. Factors to consider include:

• • • Provision of a clean workspace with adequate space for patient privacy.
    • Safety measures for sample collection and testing procedures.
    • Installation of essential utilities such as electricity and water, possibly through hiring contractors.
    • Adequate lighting, ergonomic workspace setup, and adherence to safety protocols for equipment handling and waste disposal.

Furthermore, procuring necessary lab supplies such as refrigerators, centrifuges, and phlebotomy consumables is essential for seamless lab operations.

For guidance on preparing your staff to implement physician office lab testing, refer to our article, “How to Run a Laboratory: Preparing for Physician Office Laboratory Testing.”

Test Selection

Initiating CLIA waived tests involves assessing previous send-out testing patterns to identify frequently conducted tests. Focus on tests suitable for discussion during brief patient visits (15 minutes or less), primarily consisting of CLIA waived tests. Commonly conducted CLIA waived tests include:

• • • Glucose
    • Urinalysis
    • Lipids
    • Comprehensive metabolic panel (CMP)
    • Basic metabolic panel (BMP)
    • Hemoglobin

Consideration may also be given to risk-based screening tests and those utilized in acute onset disorder detection. Additionally, exploring molecular diagnostics for infectious disease diagnosis presents a promising avenue for expanding testing capabilities.

To learn more about selecting tests for POCT labs, including product recommendations, consult our article, “How to Run a Laboratory: Evaluating Point-of-Care Testing Options.”

Anticipating Complex Testing

Once comfortable with CLIA waived testing, practices may contemplate offering moderately complex laboratory services. Consultation with trusted sources is advisable to address technical concerns such as licensing, staffing, and equipment selection based on available resources.

Factors to consider when selecting test systems

• • • Compatibility with physical space limitations.
    • Adherence to manufacturer specifications.
    • Cost-effectiveness and user-friendliness.
    • Comprehensive test menus and minimal maintenance requirements.

By adhering to these guidelines and continuously assessing practice needs, primary care physicians can effectively integrate point-of-care testing into their practice, enhancing patient care and practice efficiency alike.