Point-of-Care Test Procedures and Result Reporting

Fundamentals of Point-of-Care and CLIA-Waived Testing

Point-of-care testing refers to diagnostic laboratory tests performed at or near the site of patient care. In an outpatient medical office, these tests allow the clinical team to obtain rapid information while the patient is being roomed or evaluated. Most point-of-care tests conducted by medical assistants fall under the CLIA-waived testing category. CLIA-waived tests are defined as simple laboratory procedures that carry a low risk of erroneous results. Even though these procedures are categorized as simple, medical assistants must adhere strictly to established protocols to avoid mistakes.

Ensuring accuracy begins before any specimen is collected. Medical assistants must verify the expiration date of test kits and reagents prior to performing any point-of-care test. It is essential to follow the manufacturer's instructions for storing and preparing test cartridges and reagents. For example, when test supplies are kept under refrigeration, the medical assistant must bring refrigerated supplies to room temperature before testing when the manufacturer's instructions require it. Testing with cold reagents when room temperature is required can impair the chemical reaction and produce inaccurate findings.

Quality control testing helps verify that point-of-care devices and reagents are performing within acceptable limits, but it does not guarantee the accuracy of every patient result. Medical assistants must perform external liquid control testing for new lots or shipments when required by the manufacturer or facility policy. Required quality control results must be documented in the facility's quality control record and confirmed to be acceptable before conducting any patient testing. If quality control results fall outside the acceptable range, patient testing must not be performed until the error is resolved.