USA. Improving the quality of laboratories doing simple tests

Citation

(2002), "USA. Improving the quality of laboratories doing simple tests", International Journal of Health Care Quality Assurance, Vol. 15 No. 5. https://doi.org/10.1108/ijhcqa.2002.06215eab.012

USA. Improving the quality of laboratories doing simple tests

USA

Improving the quality of laboratories doing simple tests

The Centers for Medicare and Medicaid services (CMS) has begun a new initiative designed to help physicians and other providers that perform simple laboratory tests provide better care to their patients. Laboratories performing these simple tests, known as "waived tests", are exempt from many of the federal regulations that apply to labs that do more complex testing. Waived tests are commonly performed in physician office laboratories, skilled nursing facilities, rural health clinics, and pharmacies, where on-site testing speeds the delivery of appropriate treatment.

CMS will be sending specially trained surveyors to a small, random sample of waived labs each year, using an approach that proved successful in a recently completed pilot programme. The laboratories will be notified in advance of the visits and encouraged to participate. Surveyors who find problems will work closely with lab personnel to help them better understand proper procedures and the implications for patient care of improperly performed tests. There are no fines or other sanctions associated with these surveys.

Tom Scully, CMS administrator said: "the goal of these surveys is to help physicians and other health care providers care for their patients with the aid of reliable test results without fear of new regulations or federal sanctions.

"In pilot studies, CMS has found that most providers welcome the educational approach and that testing practices improve in response to the program. This is consistent with our overall effort to work cooperatively with providers to improve quality."

All test systems that are waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) must be accurate and simple to perform. In recent years, the number of waived test devices has expanded greatly, as has the number of laboratories performing these tests. Waived laboratories now constitute 55 per cent of the 175,000 laboratories performing testing in the United States and are exempt from standards in the CLIA rules for laboratory personnel, quality assurance and quality control. They are required to have a certificate of waiver from CMS.

Recent reviews by CMS and others have found problems with the quality of some of the tests performed. For example, test strips for a testing device may be placed on the device upside down. Kits may not be stored properly, or may be used after the expiration date. These errors create the potential for inaccurate results that may have an adverse impact on patient care. CMS expects the new educational effort will improve the quality of simple testing performed by these laboratories.