Laboratory Documentation and Compliance – A Fresh Approach

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: 

  • 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 by any facility that performs testing on human specimens for which the results are employed for assessment of health and/or diagnosis, prevention, or treatment of disease. 

Accreditation agencies provide voluntary oversight of laboratories and may impose additional requirements that may be more stringent but can never supersede CLIA. For compliance with each of the regulations, MyInspection™ Software provides the following: 

  • Guidance for required compliance documentation and retention of records
  • Storage space for unlimited number of documents
  • Ability to expand documentation as desired with supplemental document storage
  • Structure to accommodate required documents for required retention times
  • Tools to assist with information gathering and organization, e.g. fillable forms, logs, and charts
  • Ability to import institution-specific documents
  • Seek expert assistance, as required

 

Building Your Compliance System - Make It Easy!

Together, My Compliance Manual and MyInspection™ Software make interpreting CLIA requirements and some accreditation requirements easy.  The manual and the software are compatible and easy to navigate. Both tools are organized into sections based on compliance requirements. For example, one of the requirements addresses Personnel Qualifications and ongoing requirements for each lab staff member records. My Compliance Manual offers detailed policy, procedure, and business practices that guide you through the regulations. MyInspection™ Software includes electronic forms that can be completed or you can choose to utilize existing documents and import them into the correct section in the software. 

In practice, if you consider My Compliance Manual to be the source used for understanding overall requirements and MyInspection™ Software to document the requirements, you have almost completely built your compliance system.

There are always questions when it comes to the compliance and the inspection process. As the laboratory and it’s involved personnel seek compliance and support the internal compliance process, the availability of guidance or assistance from laboratory experts may be needed. Both My Compliance Manual and MyInspection™ Software offer built-in assistance and helpful hints tools. These include: 

  • Hints
  • Callouts – compliance items that are most often cited as noncompliant during inspections
  • Help – guidance for items required for compliance and information on how to create a compliance document (Fill out a form or import an existing document)
  • Development of specific files and an organized storage system for individual personnel files 
  • Development of specific files and an organized storage system for individual instruments

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Finally, want to speak to a real person regarding small compliance issues? Any user of My Compliance Manual or MyInspection™ Software may engage the services of My Expert for compliance assistance or advice. 

So, if the laboratory is seeking a fresh approach to compliance, the incorporation of My Compliance Manual, MyInspection™ Software and My Expert provides a unique, innovated, paperless, total compliance approach. 

 

References

https://wwwn.cdc.gov/clia. Accessed 3/12/18

 

Sheryl A. Whitlock, MA, MT(ASCP)BB

Director, Compliance

MyInspection™