| Monday, January 01, 0001
Physician Office Resources: LabOratory September 2015
The Increase in Waived Testing In Physician Office Laboratories
By Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP), Technical Writer/Quality Advisor, COLA Resources, Inc.
Laboratory testing plays a critical role in health assessment, treatment, monitoring, and ultimately, the public’s health. Test results contribute to diagnosis and prognosis of disease, the monitoring of treatment and health status, and population screening for disease. An estimated 7-10 billion laboratory tests are performed each year in the United States and laboratory test results influence approximately 70% of medical decisions. Increasingly, these decisions are based on simple tests performed using devices that are “waived” from most federal oversight requirements, and are thus designated as waived tests.[i]
When these waived laboratory tests are performed at or near the site of patient care - such as in an emergency room or urgent care clinic, or at patient’s bedside - they fall under the definition of Point of Care Testing (POCT). Physician office laboratory testing also is included under the definition of POCT when these tests are performed, and the results are provided to the physician, while the patient is still present and diagnostic and treatment decisions can then be made utilizing this information.
The rapid growth of POCT testing is a prime driver for the increase in waived testing at physician office laboratories, and is a direct result of the convergence of several trends that are already impacting POL operations:
Technological advances that bring higher quality waived testing closer to the patient,
The decentralization of laboratory services, so that POLs can now perform testing previously confined to core laboratories
The Increased number and variety of tests classified as CLIA-Waived, and available to POLs
Growth of Drugs of Abuse/Pain Management Clinics performing drug testing in-house
Bringing Laboratory Services Closer to the Patient
The increased number of waived tests now available for physician office laboratory testing eliminates the need for trips to and from a central core laboratory (and specimen collection sites that are run by laboratories). These tests enable physicians to make more rapid diagnoses and treatment decisions on site, and they improve patient compliance with physicians’ recommendations.
Garnering information on site often allows immediate treatment, which avoids requiring the patient to make multiple trips to the physician office and pharmacy, saving time for both the patient and the clinician. Accurate diagnostic information at the point-of-care saves critical medical resources and improves both patient and clinician satisfaction. In light of the role of waived testing in the healthcare delivery system and their overall benefits, the availability of and timely access to these technologies will continue to be important to meet the needs of patients and clinicians for rapid and reliable testing[ii].
New Tests/Instruments = Increased Demand = Additional New Tests/Instruments
This demand for point-of-care capability has spurred the development of smaller, faster, and easier-to- use tests that are more sophisticated in design than tests traditionally found in smaller office laboratories.
Since the inception of CLIA 88 and the concept of waived testing, technological advances that simplified test processes and increased reliability of test results, has led to a dramatic increase in the number of approved waived tests from 9 to 119; and the number of test systems to over 1600.[iii]
Some of the waived now tests performed in the physician office include streptococcus testing, HIV testing, INR (coagulation) testing for Coumadin, and pregnancy testing. The ability to immediately treat the patient for these and other conditions, without having to send a sample to a central laboratory, can be critical to the patient’s well-being. As an example, a positive test for strep can allow the clinician to immediately prescribe antibiotics, catching an infection before it becomes severe, with potential health consequences (or ruling out strep and avoiding unnecessary use of antibiotics).
According to research, POC testing is growing faster than any other segment of the diagnostic industry with an average growth rate of 14% a year. Of this, CLIA- waived is the fastest-growing segment of this market.[iv] James H. Nichols, PhD, DABCC, FACB and Professor of Pathology at Tufts University School of Medicine and Director, Clinical Chemistry at Baystate Health System, estimates that the number of Waived labs had increased from 20% in 1992 to 63% of the more than 200,000 CLIA laboratories in 2009. Of these waived labs, 45% were POL’s. By 2014, waived labs comprised 69% of the 236,000 CLIA laboratories.
Pain Management / “Drugs of Abuse” Testing[v]
Pain management is one of the fastest-growing reasons for waived testing. With an increasing number of internists and anesthesiologists opening pain clinics, and primary care and family practice physicians opting to treat patient pain in house instead of referring out to specialists, the pain management opportunity is ever increasing. Pharmaceutical companies are encouraging physicians to perform drug tests to monitor prescription compliance and aid in risk management.
The number of free-standing and university-based clinics in the U.S. alone has increased from just 500 in 1998 to 2,000 in 2008. Each of those clinics on average treats approximately 400 chronic pain patients per month. Over 70% of these patients are prescribed some form of opiate medication.
Deaths caused by overdose of prescriptions drugs also are on the rise and, as a result, one of the prescribing guidelines, indicated by the National Pain Foundation, is to evaluate patients for the risk of abuse before starting opioid therapy. Drug testing helps the doctor in evaluating the patient’s drug history as well as aids them in avoiding or minimizing a possible reaction to other medications or narcotics. Physicians, not necessarily skilled in recognizing the signs for drug abuse or addiction and wanting to exercise caution, are also being proactive and instituting drug testing as a regular part of their patient evaluation.
The tests are even used to monitor patients and their adherence to a pain management protocol of narcotics prescribed. Testing is sometimes used to determine if in fact the patient is taking their prescribed medications.
What does all this mean for the physician office laboratory?
The continued expansion of testing classified as waived, including those involved with drugs of abuse, infectious disease screening, and chronic disease management, provides the opportunity for greater point-of-care testing by physician office laboratories, while the patient is present, facilitating immediate medical decisions, the initiation of treatment, and continued monitoring.
The growing utilization of waived testing in a physician office setting brings great benefits for patient care, but it also brings great responsibility to ensure that the results obtained are of the highest quality to realize these potential benefits. These responsibilities include ensuring adequate personnel training and competency assessment; performance of required quality control, maintenance, and calibrations of the instruments used; proper specimen collection, handling and labeling, and documentation of test results. This requires maintaining adequate oversight and accountability.
Efficient, quality-run physician office laboratories, able to provide a larger array of on-site testing that provides faster results, diagnosis and treatment decisions support the goals of patient-centered laboratory service.
[ii] Waived Testing and patient Safety: Future Trends. COLA Insights January/February 2015. Irwin Rothenberg
[iii] CMS.gov. Certificate of Waiver Laboratory Project / Requirements of waived Tests 2014.
[v] Alfa Rapid Medical Tests. CLIA Waived Medical Testing Explained. “Just What The Doctor Ordered” Why Are Doctors Testing? 2009. http://www.alfascientific.com/news-events/clia-waived-testing-explained
Irwin Z. Rothenbergis a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals. CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.