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CRI Lab Quality Advisor

Assess the Quality of Your Waived Testing

Published September 2, 2015 9:30 AM by Irwin Rothenberg

According to CMS, there were 229,815 laboratories in the U.S. , in 2012, of which 150,256 were Certificate of Waiver sites. Stated another way, this means that some 65 percent of laboratories in the U.S. do not have any routine oversight. The number of waived tests has grown from just 9 tests in 1993 to 119 analytes using more than 5,400 test systems. From diabetes management and monitoring anti-coagulant therapies to screening for infectious disease, waived tests are now an integral part of patient care. Laboratory professional groups have long recognized the need for increased oversight of these waived tests, and unfortunately, evidence is mounting that significant quality problems exist in the largely unregulated labs relying on these.

According to a report from the Centers for Disease Control and Prevention, for example, 31-43 percent of waived labs do not follow manufacturer’s instructions. Some other examples of notable problems among the more than 150,000 waived testing sites in the U.S. include:

-              More than 20 percent do not routinely check the product insert or instructions for changes to the information
-              More than 20 percent do not perform Quality Control testing as specified by manufacturer’s Instructions
-              Nearly half do not document the name, lot number and expiration dates for tests performed

How can we deal with these issues using direct action that produces relevant measurable results within discrete time frames? I suggest the following five activities as effective strategies to assess the state of your waived testing, which engage your staff in this campaign for excellence:

1. Self-assessment of the waived testing performed
2. Competency assessment of staff performing waived testing
3. Proficiency testing for your waived test menu
4. Quality assessment of how your laboratory handles waived testing issues
5. Continuing education for your staff engaged in waived testing

Any or all of these can be carried out independently of the rest; you can choose which to use for your determination of quality performance; and all can be compartmentalized and measured within discrete time frames or events, including continuing education.=

The idea is that, to improve the quality of your waived testing, you choose the activities most suitable to your laboratory that achieve relevant measurable results and provide information you can act upon and measure improvement over time. Choose assessments that motivate and educate your staff. This promotes buy-in and commitment to continuous improvement.


The problem is most waived testing are performed by non-laboratorians.  The concept is that if done incorrectly there is little impact to the health outcome of the patient.  This is not true in most cases.  Putting the onus on the clinical lab is an issue as the managers of these testing sites do not take onus for the quality of their programs.  We have made the mistake of calling these areas labs and truly they are nursing or clinic areas doing waived tests.

May, Laboratory - Operations Director, KP September 18, 2015 2:39 PM
Panorama City CA

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