When a new clinical lab prepares to open its doors, its owners and managers can find themselves focusing on many aspects, such as whether it has the right team members or equipment. However, you should also ensure it achieves licensing and accreditation, as these can have a major impact on your new lab’s credibility and help it avoid potential legal issues. Read on to learn about navigating the licensing and accreditation process for a lab.
Why Licensing and Accreditation Is Important
Before looking at the processes of earning licensing and accreditation, you must understand why these are so important. Many state laws often require that labs earn a license. This verifies that a lab meets basic operational standards. On the other hand, accreditation shows that a lab has a voluntary commitment to achieving excellence beyond the baseline. Together, these processes safeguard patient safety, protect public health, and ensure the integrity of diagnostic results—foundational elements in the healthcare industry.
Achieving licensing and accreditation also builds trust among patients and healthcare providers. Accredited labs are more likely to secure partnerships with hospitals, clinics, and research institutions, as these organizations prioritize working with facilities that uphold stringent quality standards.
From a legal and financial perspective, operating without proper licensure exposes labs to significant risks. Failure to comply with required regulations can lead to fines, legal penalties, and even forced closure. Ultimately, licensing and accreditation are pillars that contribute to a lab’s long-term success and reputation.
Research Licensing and Accreditation Standards
Before opening your lab, you should understand the standards for licensing and accreditation so you can comply with them. For example, you will likely need a Clinical Laboratory Improvements Amendments (CLIA) license from the Centers for Medicare & Medicaid Services (CMS).
Meanwhile, you will need to seek accreditation from groups like the National Accrediting Agency for Clinical Laboratory Sciences, the College of American Pathologists (CAP), or The Joint Commission. These organizations focus on ensuring labs meet specific performance, safety, and procedural standards tied to data management, staff qualifications, and testing processes. Researching these standards helps lab managers stay proactive while outlining the right steps to meet industry benchmarks.
Apply for a CLIA License and Undergo Assessments
Applying for a CLIA license is an official step where your lab registers with the CMS. Every application includes information about testing practices, including the complexity levels of the tests you plan to use. You must also submit information regarding your personnel, facility type, and on-site laboratory equipment.
After completing the application process, an inspection occurs to verify ongoing compliance. Whether you’re conducting waived testing or high-complexity testing, inspectors review operational workflows, lab conditions, and established quality control measures. Facilities performing moderate to high-complexity testing may also undergo proficiency testing to prove their accuracy.
Being prepared with full documentation and an understanding of regulations also supports your lab’s ability to meet the inspection standards. Successful approval of the CLIA application results in a certificate, allowing your facility to perform testing legally under the defined standards.
Determine If You Need a State License
Some states may also require your clinical lab to obtain additional licenses beyond CLIA certification. For example, laboratories in states such as New York, California, or Florida must obtain a state license due to stringent local regulations. State requirements can involve reporting systems or unique quality assurance measures.
Stable operations and efficient processes make a laboratory capable of meeting both federal and state licensing requirements. Positioning the lab to handle these demands early in the licensing process prevents disruptions to testing schedules or workflows.
Apply for Accreditation and Undergo an Assessment
After navigating the licensing process for your lab, you can focus next on achieving accreditation. Accreditation elevates the credibility of a clinical lab beyond basic licensure. When third-party accrediting organizations such as CAP or The Joint Commission assess laboratories, they tend to do it based on a higher bar for performance and process. Accreditation adds value to labs by recognizing their alignment with best practices at an industry level. The process can also enhance your lab’s reputation within its market and boost the productivity of your employees.
Once you have selected an accrediting agency, your lab should submit an application detailing its operational environment. This application requires you to provide descriptions of the equipment you use, hiring standards, and testing workflows. Accreditation surveys take place as part of the assessment, where inspectors examine compliance with agency standards.
During the assessment process, inspectors may observe sample handling by laboratory staff, evaluate your operating procedures, or request quality control data. Accreditation focuses on how a lab achieves its performance metrics. Detailed assessments of staff performance and interactions between team members contribute to an effective survey process.
Make Corrections and Learn the Final Decision
No matter how well you prepare your lab for an inspection, inspectors may still discover areas where you deviate from their standards. Common examples include inconsistencies in documentation. Surveyors typically document these deviations and report them to both the accrediting organization and the lab’s leadership team.
Addressing these identified areas in a timely manner reinforces confidence in compliance efforts. Lab owners must take the feedback from their surveys seriously, focusing on identifying the root causes of any non-compliance issues. Time-sensitive correction plans help your lab demonstrate timely actions to resolve observed gaps.
When a lab meets the identified standards following resolution efforts, accrediting organizations will likely issue certificates or formal notices of approval. For labs working toward accreditation within industries focused on diagnostics and research, this step builds credibility and improves long-term operational stability. It also helps labs position themselves as professional leaders and reliable diagnostic providers.
When your laboratory earns its license and accreditation, you will do a better job of earning the trust of future clients and conveying an image of operational integrity. Although this process can be challenging, you don’t have to do it alone. Lighthouse Lab Services has helped many clients with these key steps in starting a medical laboratory business. We can assist you in enrolling for certificates and preparing your lab for inspections so you can achieve certification quickly.
Contact us today to learn more!
