As the lab industry is gearing up to observe Medical Laboratory Professionals Week—from April 22 to 26—COLA, Columbia, Md, has released a white paper on “waived” lab testing, detailing errors found in sites performing waived testing.
The lab accrediting organization has renewed its call for increased education for Certificate of Waiver site personnel to ensure quality testing.
In the updated paper, titled “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. COLA says evidence continues to mount 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.”
Research shows that since 1993, the number of CLIA-waived tests has increased from just nine tests to more than 5,400 test systems and 119 analytes. During this same period, the number of labs that have issued a Certificate of Waiver has grown from 20% to 60% of the nearly 230,000 lab testing sites in the United States.
The waived-testing quality issue has been exacerbated by technology advances that enable many tests to now be performed using mobile devices by personnel with limited experience and training, COLA says.
Among the problems at the approximately 150,000 US-waived testing sites, cited in the white paper:
- 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
|COLA accredits nearly 8,000 medical laboratories and provides the clinical laboratory with a program of education, consultation, and accreditation. The organization is an independent, nonprofit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements.
“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,” says said Douglas Beigel, CEO, COLA. “COLA continues to believe that more education is 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.”
Beigel also says that, based on communications COLA has had with individuals across the lab community, there is an expectation that CLIA’s scope may be revised in the near future in order to include previously-unregulated tests.
Beigel notes that a variety of educational resources for waived labs, including COLA’s own voluntary waived-testing program, are available.
“As we prepare for more than 35 million new patients to enter the health care system, it is critical that we ensure better patient outcomes by ensuring a culture of quality in the performance of waived tests,” Beigel says. “By encouraging the widespread use of these education tools by waived labs everywhere, laboratory and medical industry leaders, manufacturers, states, the CDC, CMS, and other stakeholders will be able to proactively manage this important health care issue.”