With physician practices assuming more clinical and financial risk for the overall health of their patients, many are considering expanding their point-of-care, in-office diagnostic laboratory testing services.
However, making the leap from CLIA-waived testing to moderately complex laboratory testing is not easy. It takes careful consideration and execution in two primary areas, including equipment and personnel, and also requires a business mindset, test volume and clinical decision making.
Chronic disease and population health management drive change in test philosophy
Most physician practices perform at least some CLIA-waived diagnostic lab tests in their offices to help them diagnose and treat medical conditions that need immediate attention. CLIA-waived lab tests are simple, FDA-approved diagnostic tests that pose little or no risk to the patient. The tests are exempt, or waived, from the Clinical Laboratory Improvement Amendment, the law that sets and oversees clinical performance standards for labs, tests and testing equipment. Examples of common CLIA-waived tests used by doctors in their offices are:
- Dipstick urinalysis to test for diseases or infections
- Urine pregnancy tests to determine pregnancy
- Stool samples to screen for diseases or infections
- Blood tests to screen for anemia or determine blood glucose levels
With the rise in chronic disease rates and the need for effective population health management tactics, many physician practices feel the clinical and financial need to expand into what CLIA calls moderately complex laboratory testing. Such tests and their results help doctors develop care plans to manage the long-term health of their patients.
But, moderately complex diagnostic lab tests are more sophisticated and require specialized testing equipment and expertise. Physician practices that offer such tests must be CLIA-certified, have their lab operations and equipment inspected and comply with all CLIA performance standards. Examples of moderately complex diagnostic lab tests are:
- Complete blood counts
- Electrolyte profiles
- PSA screenings
Key factors to consider for selecting the right lab testing equipment
The first major consideration in making the transition is , which includes items like analyzers, test systems and test kits. To select the right lab equipment for the type and volume of tests desired, practices should weigh a number of variables. Does the equipment:
- Provide appropriate test menus?
- Provide adequate cost per test and time to test?
- Fit within the available physician space?
- Have the appropriate environmental infrastructure (electrical, plumbing, ventilation and internet connection) to support it?
- Require little or no maintenance?
- Carry a minimum one-year warranty?
- Require few additional consumables and supplies?
Once a practice selects the appropriate equipment, the next steps are entering into a sales or service agreement with the equipment vendor or supplier and training or hiring office personnel to run the equipment for the practice.
Primary staffing needs for offering moderately complex diagnostic lab tests
That leads to the second major consideration in making the transition, and that’s personnel. CLIA requires physician practices that perform moderately complex diagnostic lab tests to have on staff personnel who perform three roles:
- Lab director who oversees and is responsible for the testing operations.
- Lab technician who is properly trained to run the testing equipment.
- Lab technical consultant who ensures the accuracy, integrity and quality of tests and testing equipment and ensures testing operations comply with all CLIA standards
The cost of training and/or hiring new personnel combined with the cost of the testing equipment can add up to substantial one-time and ongoing expenses for a medical practice. The challenge for practices becomes how to make the transition from CLIA-waived tests to moderately complex tests a clinical and financial success rather than a drain on resources.
Keys to success for practices considering expanding lab capabilities
The first key to success is mindset. Practices should not view expanded lab test capabilities as value-added services with no return. Instead, practices must consider their expanded lab operations as a business within a business with its own plan for generating revenue and minimizing operating costs. For example, a practice should know prior to making the transition if the new lab tests it intends to offer are covered by its patients’ health insurance.
The second key to success is test volume. Do the volume of reimbursable diagnostic lab tests and the resulting revenue justify the cost of the equipment and the people who run it? A practice should know the answer to that question before signing a sales or service contract with an equipment vendor.
The third and most important key to success is clinical decision-making. Assuming the reimbursement dollars and test volume are there, do the diagnostic lab test results improve medical decision-making by practices at risk for patient health outcomes under value-based reimbursement plans?
Ideally, expanding into moderately complex lab tests should help a physician practice keep its patients – especially those with chronic medical conditions - as healthy as possible.