- Accreditation/Certification License Package
- Healthcare Reimbursement Consulting Services
- Laboratory Planning & Design Consulting Services
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the Federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.
Some states have additional regulations that apply to laboratory testing, with most of these state regulations exceeding the CLIA requirements. Many laboratories also require accreditation by the College of American Pathologists (CAP) or The Joint Commission, in addition to the federally mandated CLIA certification.
Whether you’re a biomedical or pharmaceutical firm seeking CLIA laboratory certification as part of your company’s commercialization strategy, or a diagnostic firm seeking CAP or JC accreditation as required to upgrade or expand service coverage, consider this package from a subject matter expert with over twenty years in the business.
The Overbrook Accreditation/Certification License Package:
- Gap Analysis of existing facilities, Standard Operating Procedures (SOPs), training and staff qualifications
- Application process assistance
- Development of required SOPs, training and competency assessments
- Action plan of requirements to meet standards
- Training of supervisory staff on newly-developed policies and standards per CLIA regulations
- Implementation of newly developed policies, training programs and procedures
- On-site assistance during the initial inspection
- Training on how to maintain CLIA certification, and how to be ready for the license renewal inspections (every two years).