Regulatory Inspection, Ready or Not?

In the U.S., the federal government regulates laboratories under the CLIA (Clinical Laboratory Improvement Act) statutes. These regulations call for biannual, unannounced, onsite inspections of laboratories performing moderately or highly complex testing. Governmental agencies or private agencies approved by the government perform these inspections.

Working with many laboratories across the country, Chi consultants see facilities that maintain a culture of inspection readiness at all times. However, we also receive calls from laboratories that struggle with the process. We have divided the characteristics of these two types of laboratories into the “Ready” and “Or Not” groups.


What are some of the factors that lead to consistent regulatory readiness?

  1. A culture of continuous quality that includes regulatory compliance. Laboratories with highly effective quality management programs include regulatory issues as part of their planning. This includes new and/or changing regulatory requirements. Regulatory compliance becomes part of the DNA of the laboratory.
  2. Including regulatory compliance as part of any change management process. Managers routinely make decisions about laboratory operations and institute changes. The laboratories that are consistently ready for an inspection include regulatory compliance as part of operational changes. For example, when considering staff reductions, will the new staffing levels still allow enough time to perform required maintenance and documentation? How will the staff changes impact the ability to perform and document staff training and competency? What will be the impact on turnaround time?
  3. Regular discussions with all staff about how regulatory requirements impact the daily operations of the laboratory. Regulatory readiness is the responsibility of everyone in the laboratory. Regular conversations about specific regulatory requirements and the staff role in meeting those requirements go a long way toward meeting the goal of consistent readiness.


Why do some laboratories struggle to maintain readiness for inspections?

  1. Relegating regulatory compliance to a “once every two years” activity. Some laboratories still breathe a sigh of relief as the inspectors leave the building, thinking, “Well, we don’t have to think about that for another two years!” In some cases, they really don’t think about it until about six weeks before their next inspection. By that time, the effort to “get ready” is overwhelming.
  2. Not keeping up with changes to regulatory standards. When laboratories do not keep current with requirements, deficiencies are inevitable. One good source of current data is the most commonly cited deficiency list issued by both governmental and private inspecting agencies. Often, these are the newest requirements. For example, several years ago CMS discovered that some laboratory personnel were using false documents to meet education and experience requirements. Soon after that, all of the regulatory agencies began asking for proof of education and experience. The agencies asked for copies of diplomas or transcripts to prove that the individual did indeed meet requirements. This deficiency still appears on the list of most common deficiencies since, in the past, laboratories were not required to have this proof.
  3. Placing responsibility for compliance with one or two individuals – lack of staff engagement. While having a designated Quality Supervisor/Manager is a good idea in larger facilities, this individual is not the only person responsible for compliance with requirements. Just as in smaller laboratories, the Laboratory Manager is not the only responsible person. Both the Laboratory Manager and Quality Supervisor should be educating staff on their responsibilities and monitoring compliance activities.

Chances are that your laboratory does not fall completely into either the “Ready” or “Or Not” categories. However, by making incremental changes to how the laboratory approaches regulatory compliance, everyone will be “Ready” the next time the inspection team arrives.

Nora Hess
Senior Consultant, Operations Management
Chi Solutions Inc.

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