Regulation compliance can stress clinical lab managers and workers. Lab business owners must diligently ensure that they follow federal- and state-level regulations. And in an ever-evolving industry, staying up-to-date can create challenges.
Your lab doesn’t have to go through the process alone. Find out ways consulting services can help your lab stay compliant.
Achieve CLIA Accreditation
A qualified lab consulting firm has industry experts that understand the Clinical Laboratory Improvement Amendments (CLIA) licensure. The FDA, CDC, and Centers for Medicare and Medicaid Services (CMS) oversee these federal standards. Your clinical lab must comply with CLIA if it provides test results that directly influence patient care.
Consulting firms have a team of experts with CLIA knowledge and experience in creating compliant laboratories. This expertise is a key way that consulting services can help your lab stay compliant.
Lab consultants can help you meet your CLIA goals. And if you want to expand your offerings and get CLIA certified for more complex diagnostic tests, use a specialist to get you on the right track.
Exceed Expectations With COLA or CAP
Boost your lab’s capabilities and industry credibility with further regulatory compliance. The Commission on Office Laboratory Accreditation (COLA) ensures compliance at the national level. Inspectors examine your lab at a deeper level compared to CLIA. For example, a COLA inspector will compare the performance of the old and new instruments in your lab.
The College of American Pathologists (CAP) accreditation demonstrates your lab’s excellence in maintaining cutting-edge best practices. The CAP uses an annually updated checklist created with the input from more than 500 pathologists to inform best practices. And CAP’s peer inspection process fosters collaboration between laboratories.
A qualified lab consulting firm can help you achieve your desired accreditation level. A specialized regulatory consultant can help you understand important aspects of CLIA and COLA applications.
Interpret Regulations and How They Apply to Your Lab
Finally, a professional lab consulting firm has the resources to help you understand federal and state regulations and how they apply to your laboratory. Rather than wondering about your lab’s position in updated requirements, a lab consultant can explain the complex information to you. Pharmaceutical consulting firms in particular can really narrow down the important parts in the process.
Specialists know the top deficiencies of labs across the country, and they can help you overcome the common and specific problems in your lab. For example, if you have a problem with specimen storage or lack the proper sample labeling techniques, the consultant can bring this to your attention and help you raise your standards.