Lab Processes and Procedures / Laboratory Quality Control

Common Errors Found at Laboratories Performing Waived Laboratory Testing

COLA has identified common errors occurring at laboratories performing “waived” laboratory testing. The internationally respected clinical laboratory accreditor calls for increased education for Certificate of Waiver site personnel to ensure quality testing and mitigate any possible impacts to patient safety.

In its white paper entitled “Federal Government Questions Quality in Waived Testing,” COLA documents the growing role of waived testing, which consists of simple tests performed at the point-of-care that are waived from most federal oversight under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Since 1992, the number of waived tests has increased from eight to over 100 tests, representing some 1,600 test systems. During this same period, the number of laboratories issued a Certificate of Waiver has grown from 20% to 60% of the more than 209,000 laboratory testing sites in the United States, including pediatric, urology, family physician and internal medicine practices as well as urgent care clinics and other primary care sites. These waivers include requirements for personnel qualification and training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), quality assurance, and the need for routine inspection.

Because of this explosion in waived testing, approximately 74 percent of the nation’s laboratories fall outside the purview of routine government oversight according to the Center for Medicare and Medicaid Services (CMS).

In its white paper, COLA cites evidence which supports the conclusion that “significant quality problems exist in the largely unregulated labs relying on these tests,” with the potential to contribute to errors and even patient harm.

According to surveys performed by CMS, among the problems found at the more than 125,000 waived testing sites in the United States:

  • More than 20% do not routinely check product inserts or instructions for changes to the information.
  • More than 20% do not perform Quality Control testing as specified by manufacturers’ instructions.
  • Nearly half do not document the name, lot number, and expiration dates for tests performed.

According to COLA’s report, a persistent percentage of Certificate of Waiver sites do not meet minimal requirements, and are not aware of recommended practices to help ensure quality testing. Often, personnel performing waivered tests do not understand the potential negative impacts of improper sampling and testing technique and its relation to accurate results.

Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests are used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy, and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have innumerable unintended consequences.

“Studies conducted by the federal government have demonstrated that a persistent percentage of Certificate of Waiver sites do not meet minimal requirements, and are not aware of recommended practices to help ensure quality testing,” said Douglas Beigel, Chief Executive Officer of COLA. He said that more education was needed for Certificate of Waiver site directors and testing personnel about the importance of following manufacturers’ instructions, adhering to expiration dates, performing Quality Control testing, and proper documentation and recordkeeping.

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