Clinical Laboratory Services
ProCaliber Group provides comprehensive setup services to clinical laboratories, including assistance with licensure, personnel verification, lab director services, policy and procedure development, QA plans, validation study design, and general guidance throughout the lab setup process. Our experienced consultants also provide professional remote and onsite support to laboratories seeking accreditation (CLIA, CAP, ISO15189, COLA) to ensure successful certification application and inspection.
01
Licensure Assistance
We assist laboratories in navigating the complex licensure process, providing customized documentation, requirements, and application procedures. Our consultants work closely with clients to ensure a smooth and efficient licensure application process.
02
Personnel Verification
We help laboratories establish robust personnel verification procedures to ensure that all staff members meet the necessary qualifications and certifications. Our consultants provide guidance on verifying credentials, conducting background checks, and maintaining personnel records in compliance with regulatory standards.
03
Clinical Lab Director Services
Our Clinical Lab Director Services are designed to assist laboratories of all sizes in finding experienced management professionals who can drive their success. We provide comprehensive support to labs in their search for skilled and knowledgeable full time or part time lab directors who can effectively lead their teams and navigate the complexities of the industry.
04
Policy and Procedure Development
We collaborate with laboratories to develop comprehensive policies and procedures that encompass all aspects of laboratory operations, including specimen handling, testing protocols, quality control measures, and safety protocols. Our consultants ensure that these policies and procedures align with regulatory guidelines and industry best practices.
05
Quality Assurance (QA) Plans
We assist laboratories in developing effective QA plans to monitor and evaluate the quality and accuracy of testing processes. Our consultants work closely with clients to establish quality indicators, implement quality control measures, and design internal auditing procedures to maintain compliance and improve overall laboratory performance.
06
Validation Study Design
We provide expert help in designing validation studies for Laboratory Developed Test (LDT) and established clinical assays. Our consultants assist in determining appropriate validation parameters, conducting validation experiments, analyzing data, and documenting the results in accordance with regulatory requirements.
07
Accreditation Support
We offer comprehensive support to laboratories seeking accreditation from recognized bodies such as CLIA, CAP, ISO15189, and COLA. Our consultants provide expert guidance throughout the accreditation process, assisting with documentation preparation, compliance assessments, and readiness for inspection. We work closely with laboratories to ensure a successful certification application and a smooth inspection process.
08
Remote and Onsite Support
Our team of experienced consultants provides professional support both remotely and onsite, depending on the specific needs of the laboratory. We are available to address queries, offer guidance, and provide hands-on assistance during critical stages of the laboratory setup, licensure, and accreditation processes.
At ProCaliber Group, we understand the unique challenges and requirements of clinical laboratories. With our in-depth knowledge and expertise, we strive to deliver tailored solutions that enable laboratories to establish efficient operations, maintain regulatory compliance, and provide accurate and reliable testing services to support patient care.