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Laboratory Documentation and
Compliance - A Fresh Approach
By Sheryl A. Whilock, MA, MT(ASCP)BB, Director, Compliance - MyInspection™
Compliance documentation in the laboratory – how do
you keep it all straight? Can it be made simple and easy?
• Can it be intuitive?
• Can it be easy to retrieve?
• Best of all, can you reduce paper stored in binders?
The answer to all of these is YES! Build your
compliance system with MyInspection™ Software and
My Compliance Manual.
Regulatory compliance is the interpretation and
application of regulations and regulatory requirements.
Designated personnel must read, interpret, and
understand the required regulations. Seek guidance from
appropriate technical experts, if necessary. Required
steps for the compliance process include:
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• Assessment of the compliance status of the
laboratory
• Developing, gathering and organizing required
documentation
• Development of a workable system for maintaining
compliance
• Implementation of the system incorporating all
appropriate staff members
• Ongoing monitoring and adjustment, as necessary
MyInspection™ Software and My Compliance Manual
are tools that align with federal compliance requirements
known as Clinical Laboratory Improvement
Amendments of 1988 (CLIA) regulations. These
regulations are applicable to and must be complied with
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