Things to Know About Medical Lab Inspections

Laboratories require carefully controlled conditions to safely and effectively conduct medical and other experiments and gain accurate results. These labs are highly regulated by the Department of Health and Human Services and states’ health departments, and they require regular inspections. As you set up your lab or prepare it for inspections, you may consider searching for medical lab inspection services Hazard KY.


Medical laboratories are inspected at least once per year. The inspector searches for lab safety regulation compliance. During inspections, lab workers and operators discuss new regulations and processes with the inspectors. You may also have to discuss your lab’s operations in detail so the inspector understands how to apply the safety standards. Additional safety training may be required if unsafe practices are identified.


First, the inspector conducts a thorough investigation of your lab’s activities. This may include your policies and procedures as well as your day-to-day operations. Next, the inspector will identify any inherent safety concerns within these activities. Your inspectors will then review your safety procedures and ways you prevent or address the safety concerns within your lab. Finally, the inspectors will share any additional safety requirements with you based on lab operation regulations and guidelines.


To prepare for your lab inspection, you need to know your testing complexity level. Some testing is waived, while other testing is moderate or highly complex. Your staff needs to understand CLIA requirements, which are found in the Code of Federal Regulations under Subpart Q. Your lab will assign individuals to complete these requirements based on their qualifications. You may also have to complete proficiency testing.

Quality control assessments should be conducted regularly, including on your daily activities. Any quality deficiencies should be addressed immediately and new procedures should be discussed to overcome these deficiencies.

All of your staff should be trained to complete compliance and competency assessments. Your lab should document every assessment as well as training, lab procedures and safety measures. You may also create an inspection checklist that can be reviewed regularly.

Whether you are setting up a new lab or preparing for a yearly inspection, consider working with lab inspection management consultants.


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