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AACC Tells Congress to Look into Deficiencies at Near-Patient Test Sites, Recommend Improvements

NEW YORK (360Dx) – The American Association for Clinical Chemistry is urging Congress to investigate what it believes to be deficiencies at non-traditional sites performing near-patient testing.

In a position statement released today, the AACC asked Congress to direct the US Department of Health and Human Services to study the issue and recommend ways these sites can improve operations and ensure patients are getting reliable results.

The AACC noted that since 1993, the number of registered facilities outside the traditional lab and performing only waived testing has grown more than 170 percent from 67,294 facilities to 186,746 facilities. These non-traditional, waived testing facilities now represent 71 percent of all clinical lab sites, and these tests are being used to diagnose and screen for a variety of conditions, including diabetes, pregnancy, strep throat, and colon cancer.

"Many waived tests can be brought directly to the patient and, when performed with proper oversight, can greatly improve care by enabling patients to get quick results and treatment," AACC CEO Janet Kreizman said in a statement. "However, AACC is concerned that insufficient oversight and quality requirements for waived testing are compromising patient safety."

Regulators consider waived tests to be simple and with a low risk for error. Therefore, once tests have "waived" status, facilities that only perform these tests can operate with limited oversight, according to AACC, and are subject to little regulatory requirements as long as they follow manufacturers' instructions for tests. However, AACC noted that around one-third of waived testing sites don't have or don't follow test instructions, and have other "significant, widespread deficiencies."

Given the increasing utilization of near-patient testing, the AACC believes that the standard for sites performing such tests should be improved to ensure the public health. The association would like Congress to direct HHS to conduct a comprehensive assessment of waived testing sites and recommend ways to improve these facilities.

The AACC recommends that the Centers for Medicare & Medicaid Services conduct annual inspections of at least 2 percent of waived testing sites to identify and correct problems. The association further pointed out that individuals performing waived tests aren't often trained in laboratory medicine, and suggested testing sites hire qualified clinical lab professionals as consultants who can supervise and train personnel.

"We urge Congress, HHS, and CMS to evaluate current practices at waived testing facilities and to provide the support these sites need to ensure accurate testing and quality healthcare for all," Kreizman said.