According to CMS, in 2012 there were 229,815 laboratories in the U.S., of which 150,256 were Certificate of Waiver sites.  Stated another way, this means that some 65% 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 in the United States. 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% to 43% of waived labs do not follow manufacturer’s instructions.   Some other examples of notable problems among the more than 150,000 waived testing sites5 in the U.S. include:

  • More than 20% do not routinely check the product insert or instructions for changes to the information;
  • More than 20% 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[i]

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, and  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 of these to use for your determination of quality performance; 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 that provide information you can act upon, and which measure improvement over time.     Choose assessments  that motivate and educate your staff;    this promotes buy-in and commitment to continuous improvement.

[i] COLA White Paper:  Federal Government Questions Quality in Waived Testing; the hard facts and What Can Laboratories Do Now?   2013.


Originally Published by ADVANCE for Administrators of the Laboratory Lab Quality Advisor Blog on September 2, 2015. 

About The Author

Irwin is Quality Advisor for COLA Resources, Inc (CRI®). where he provides a wide range of technical assistance to laboratories across the country. He previously held the position of Executive Director at Community Response, a community-based organization that provides HIV/AIDS support services in metropolitan Chicago. Prior to that position he was the Laboratory Manager of Crittenden Memorial Hospital, West Memphis, AR. He holds a Bachelor of Science degree from Brooklyn College, a Medical Technology degree from Good Samaritan School of Medical Technology, a Master of Science degree from Colorado State University, and a Master of Business Administration degree from the University of Memphis.

Related Posts

Send this to a friend