Lab Start Up Services
At Universal Laboratory Logistics, we understand the complexities involved in starting a laboratory from scratch. Our comprehensive lab start-up services cover every aspect of the process, ensuring a smooth and efficient launch.
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From assisting in selecting the ideal location to establishing a robust quality management system, creating proforma and test menus, acquiring instruments and supplies, and conducting instrument and test validations, we handle it all.
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We also handle proficiency testing enrollment, CLIA and state applications, accreditation registration, and the development and maintenance of standard operating procedures.
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Additionally, we assist in personnel selection, training, and competency assessment, ensuring that your lab is staffed with qualified professionals.
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With Universal Laboratory Logistics, you can trust that your lab start-up will be handled with expertise and precision, allowing you to focus on delivering exceptional healthcare services.
1
Selecting the Physical Location of the Laboratory
Selecting a physical location for a laboratory requires careful consideration of multiple factors in an existing space or deliberate strategic planning of a new buildout.
2
Quality Management System (QMS) Setup
A laboratory Quality Management System (QMS) is of utmost importance as it ensures the laboratory operates efficiently, consistently, and in compliance with regulatory standards.
3
Proforma Analysis and Test Menu Creation
Creating your test menu based on your practice's specialty and building an accurate proforma aids in evaluation of the current and projected financial snapshots.
4
Instruments and Supplies Acquisition
Careful selection of instruments, equipment, supplies and vendors are determined by the types of tests ordered by the medical practice specialty and volume.
5
Instruments, Tests, and Equipment Validations
Instrument and test validations are essential steps and documentation required in the laboratory process to ensure the accuracy and reliability of test results prior to performing patient testing.
6
Proficiency Testing Enrollment
Participating in a proficiency program is critically important to the operation of the laboratory, a must for CLIA and regulatory compliance, and ensuring quality and accurate test results.
7
CLIA (Federal) and State Applications
Completing forms for federal and state licensure can be an overwhelming process for first time applicants. The importance of filling out the forms accurately determines time to testing and reimbursement.
8
Accreditation Registration
Registration with an accreditation agency demonstrates the laboratory meets recognized standards of quality and competence and provides assurance to stakeholders, such as patients, healthcare providers, and regulatory bodies, that the laboratory's test results are reliable and accurate.
9
Standard Operating Procedure (SOPs) Manuals
Standard operating procedures (SOPs) are crucial in the laboratory as they provide a documented, consistent, and standardized approach to performing tasks and testing.
10
Personnel Selection, Training and Competency
Hiring laboratory personnel requires careful consideration of their education, qualifications, experience and skills. Documented training and competency is required for all laboratory personnel.
