Laboratory Quality Management Systems and Compliance Consulting

Across the globe, the COVID19 pandemic has brought the importance of laboratory testing to the forefront. In order to properly contain the virus, testing needs to be rapid, accurate, and widely available to identify patients currently infected with the virus to initiate isolation and treatment. Equally important are serological tests, which will be key in identifying individual immunity as economies reopen and people return to work.

In order to meet this unprecedented demand for testing, existing laboratories need to adapt their work to maximize efficiency, while new labs will be looking to enter the sector. In the midst of this ramp up, compliance to College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) standards is still critical and required, but can be difficult to maintain considering the increased workload. At Freer Consulting, our extensive experience in compliance and Quality Management Systems allows us to support your continued compliance in the following ways:

  • Develop and update Quality Management Systems
  • Conduct internal audits
  • Facilitate training
  • Prepare personnel for external audits
  • Provide recommendations on operational efficiency

College of American Pathologists (CAP)

The CAP program is widely recognized by both labs and stakeholders, with accreditation ensuring that quality testing practices are followed, with accurate results. As part of the accreditation process, CAP provides a customized checklist of the specific requirements that apply to a lab. This allows the lab to adequately prepare for any CAP inspections. In quality terms, this preparation is very similar to an internal audit, where compliance with the requirements is assessed, with nonconformances acted upon, prior to any external inspections. 

Clinical Laboratory Improvement Amendments (CLIA)

The intent of CLIA is to ensure quality control in clinical laboratories and set the requirements for personnel working in labs. CLIA regulations provide a framework to assess the quality of a lab and reduce lab errors that can affect patient health, while also providing best practices for the industry. CLIA certification is required for all U.S. facilities that test human specimens. Continued certification is dependent on periodic inspections to ensure compliance with stated requirements.