The Certificate of Waiver is one of the most common registrations for physicians wishing to operate an in-house laboratory in their private practices.

The physician’s name that appears on the Certificate of Waiver is more than a formality to allow testing to take place. It is a declaration that you are a true, hands-on laboratory director.

There are more than 350,000 laboratories listed with CLIA, the governing body for regulatory accreditation. More than 120,000 of these are in the “waived” category.  Labs that are classified as “waived” perform only simple test, are not routinely inspected, and have minimal regulatory requirements. The majority of these types of labs are laboratories.

The problem that is growing among primary care providers with “waived” labs is that minimal requirements are being interpreted as no requirements. A recent government survey found that the following items were the most common problems encountered in “waived” laboratories:

• High staff turnover in “waived” sites
• Lack of formal education in healthcare
• Limited training on test procedures and Quality Assessment
• Lack of awareness of good laboratory practices
• Only partial compliance with the test manufacturer’s instructions for quality control.

The problems listed above, have increased to the point that CLIA has stepped up it’s scrutiny of "waived” labs. Where no routine inspections existed before, now CLIA is randomly inspecting 5% of "waived" labs on a yearly basis and inspecting on investigation of a complaint. These are some guidelines for “waived” labs that will help to assure your lab is meeting CLIA compliance.

• Use the most recent package insert of manufacturer's instructions. Kit instructions may change slightly from lot to lot - date the insert with the date the shipment was received as documentation.
• Perform quality control and/or calibration as specified by the kit manufacturer – most of the test kits receiving waived status after the publication of the CLIA 88 regulations have specific quality control requirements. Maintain the QC documentation for two years.
• Use the test kits/reagents in the form they are received; do not alter reagent strips by cutting them in order to test more samples per strip.
• Store and handle all test kits according the manufacturer's instructions.
• Never use outdated reagents.
• Document training of all testing personnel in their personnel file – training for each test and test method is required. Update the training records whenever a test method changes (either the method or the manufacturer).
• Inform the Laboratory’s surveying agency of any change in status of the lab (e.g., change in the medical director, practice name, address, etc.).
• Monitor room and refrigerator temperatures.
• Follow all OSHA regulations that pertain to laboratory testing (e.g., Bloodborne Pathogens regulations).

While some responsibilities of the Lab Director can be delegated to employees, the ultimate responsibility for the proper management of the “waived” lab rest with the physician’s name on the certificate. If problems arise, CLIA looks to that name for answers and proof that ongoing management of the laboratory is taking place.

About the Author

Barry Craig is the owner of Laboratory Consulting, LLC, a consulting firm that specializes in physician office laboratories. They offer on-site laboratory management and monitoring solutions as well as a copyrighted laboratory management system specifically designed for the physician office laboratory. Their website, www.onlinelabhelp.com offers articles and links to aid in the management of your in-house lab as well as information on their products and services.

© 2007 Laboratory Consulting, LLC

Other Resources

CLIA Compliance Made Simple from Laboratory Consulting, LLC

Tips on Waived Testing from the American Academy of Family Practice Physicians

Quick CLIA 101 & CLIA Compliance from the NIH

Information on Bloodborn Pathogen Regulations from OSHA.

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