CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Editor: Frederick L. Kiechle, MD, PhD
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A. Physician office laboratories (POLs) are regulated under the Clinical Laboratory Improvement Amendments of 1988, which define a laboratory as “any site where clinical laboratory testing occurs.” The complexity model for test methods was introduced in CLIA ’88, and three categories were established: waived, moderate complexity, and high complexity. The more complicated the test, the more stringent the requirements. Most POLs perform waived testing predominantly, if not exclusively.
Waived testing is defined under CLIA ’88 as “simple laboratory examinations and procedures that are cleared by the FDA for home use, and employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly.” To perform waived tests, a laboratory must enroll in the CLIA program, pay applicable certificate fees, follow manufacturers’ instructions for tests that are FDA approved for waived testing, and be inspected if complaints or issues arise.
Waived laboratory testing performed in a POL must be performed according to the manufacturer’s instructions for quality control and test performance. This typically includes running controls on each new lot or shipment of test materials, and on each day of patient testing. If the manufacturer’s instructions are not followed, the laboratory is not in compliance with regulations and may not only jeopardize patients but also risk losing the ability to perform POC testing. If the POL develops its own procedures for performing the test or QC that deviate from the manufacturer’s instructions, regardless of how good those procedures may be, the test is then considered highly complex under CLIA ’88 rules, and all the requirements for a high-complexity laboratory come into play.
Physician office laboratories may choose to be accredited by COLA, a private entity that was granted deemed status by the Centers for Medicare and Medicaid Services in 1993 and by the Joint Commission in 1997. COLA’s laboratory program accredits physician offices, community hospitals, mobile clinics, and Veterans Administration and U.S. Department of Defense laboratories in the areas of chemistry, microbiology, hematology, immunology, and immunohematology/transfusion services.
Point-of-care testing for prothrombin time/International Normalized Ratio (PT/INR) is indicated for warfarin monitoring. Once the patient’s dose requirements and anticoagulation effects have been stabilized for one to two weeks, using a central laboratory, testing can be moved to a point-of-care device. POC PT/INR devices have not been approved for coagulation screening or testing for disseminated intravascular coagulation, nor have they been approved for use in the trauma/emergency department setting. POC PT/INR testing is limited to the stabilized patient for warfarin monitoring. Even when the manufacturer’s instructions are followed, problems may arise that result in inaccurate test results. Offices or clinics that perform POC INR testing should be aware of the potential problems and develop policies and procedures regarding when the patient should be referred for additional testing to confirm high, low, or unstable INR results from a POC test.