OneWorld-Lab is dedicated to improving the quality of medical laboratories on a global scale. The company’s primary focus is to empower nation states to significantly and continually improve the accuracy and reliability of laboratory testing, even in primary healthcare settings, and to strengthen their entire lab infrastructure’s contribution to better patient care (government and private).
The OneWorld team creates and implements scalable, country-wide medical laboratory quality programming, standards, education and compliance solutions that empower client-countries. A strong distinction between OneWorld and other companies in this field is OneWorld’s education-based philosophy that seeks realistic, incremental, continual improvement through an intelligent balance of international rigor and local practicality. By taking a holistic approach to ground-up, step-wise quality improvement (customized for each client-country), the company seeks to create the bedrock for transformation in healthcare.
Mission
Cultivate and empower excellence in medical laboratory and clinical services, on behalf of every patient, in every country.
Mantra
“Education, Empowerment & Transparency On Behalf of Every Patient In Every Country” – because every patient, regardless of geographic location and economic means, deserves accurate test results.
Team
The OneWorld-Lab team has more than 6 decades of combined experience in a broad spectrum of global clinical laboratory and accreditation activities, including:
- Country-wide step-wise solutions with government agencies
- National standards creation and implementation
- Large-scale, current-state gap-analysis and infrastructure planning
- Web and software platform design and implementation
- Education and training materials creation and implementation
- Large-scale education, training and deployment of assessors
- ISO 15189 development and continued revision
- ILAC and other MRA accrediting body assessments per ISO 17011
- Individual laboratory accreditation assessments & pre-assessments
- Individual laboratory consultation and other development activities
Team members currently participate in the development of ISO standards for clinical laboratories and in-vitro diagnostic devices on the U.S. Technical Advisory Group (TAG) to ISO/TC 212. The ISO/TC 212 technical committee is responsible for the development and refinement of ISO 15189 Medical laboratories; particular requirements for quality and competence.
Local Talent
In full country implementation programs, OneWorld incorporates a 100% local team augmented with the expertise of OneWorld’s local and international management.
Exclusive International Licensee
OneWorld-Lab is the exclusive international licensee of COLA, the largest medical laboratory accreditation program in the world. As COLA’s international licensee, OneWorld-Lab has access to COLA’s proven processes, systems, curricula, and methodologies. COLA was the first accreditation program to be given deeming authority (recognition) by the U.S. Federal Government under the Clinical Laboratory Improvement Amendments of 1988 and was the first accrediting organization in the USA to offer an accreditation program based on ISO 15189.
COLA has performed more than 33,000 medical testing site assessments since its inception. COLA is an active member of the Clinical and Laboratory Standards Institute (CLSI) and the U.S. Technical Advisory Group (TAG) for ISO/TC 212. COLA maintains cooperative on-going relationships with CLMA, AACC, AABB, CLSI, ASCLS and many other laboratory professional groups, both national and international. COLA is approved for and provides accreditation to laboratories in all 50 United States and in its territories. COLA is accountable to CMS (U.S. Agency) for the quality and consistency of its surveys, record keeping, evaluation of laboratories, follow-up of deficiencies, reporting conditions of serious nature, thorough evaluation of complaints against accredited laboratories, and routine reporting of enrollments, closures, and denials of accreditation.
Ethics Policy
We are committed to the responsible use of OneWorld-Lab assets, to provide accurate, complete and objective information, to respect the confidentiality of information, to act in good faith and exercise due care in all we do, to comply with all rules and regulations, and to proactively promote ethical behavior. OneWorld-Lab employees, third-parties and volunteers must:
- Be patient-focused in all company activities and continually improve company operations, products and services with a goal to better protect the patient from harm.
- Be honest and ethical in their conduct, including ethical handling of actual or apparent conflicts of interest between personal and professional relationships.
- Comply with applicable government laws, rules and regulations.
- Maintain the confidentiality of information entrusted to them by its customers except when authorized or otherwise legally obligated to disclose.
- Deal fairly with OW customers, suppliers, competitors, volunteers, and employees.
- Provide constituents with information that is accurate, completely objective, relevant, timely, and understandable.
- Proactively promote ethical behavior as a responsible partner among peers in the work environment and with all company constituents.
- Prohibit improper or fraudulent influence over any customer or constituent including external auditors.
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