COLA, an internationally respected clinical laboratory accreditation firm, has been recertified as meeting quality management system standards established by the International Organization for Standardization (ISO), an international standards-setting body composed of representatives from various standards organizations.
COLA accredits more than 7,000 clinical laboratories, and provides labs with a program of education, consultation, and accreditation. The organization is an independent, non-profit accreditor whose educational program and standards enable clinical laboratories and staff to meet the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and other regulations.
The recertification was performed by ISO registrar British Standards Institute (BSI), and covers COLA’s delivery and administration of its CLIA-equivalent accreditation program for medical laboratories, including on-site surveys, monitoring proficiency testing, and correcting citations through education and consultation. COLA continues to be the only healthcare accreditation organization deemed by the Centers for Medicare and Medicaid Services (CMS) that is also certified as satisfying the ISO 9001:2008 standard.
ISO 9001:2008 sets standards for the certification of a quality management system, for which an organization must demonstrate its ability to consistently provide products or services that meet customer needs and applicable statutory and regulatory requirements. It also aims to enhance customer satisfaction by offering a process for continuous improvement, as well as by assuring conformity to customer, statutory, and regulatory requirements.
COLA earned its original ISO designation in 2011 after an extensive audit that included more than 20 hours of the BSI auditor observing how the organization’s team members perform their work. The recertification process entailed another thorough review of COLA’s key management and accreditation processes, including observing COLA surveyors in action; reviewing enrollment process records; monitoring proficiency testing; and observing how the accreditor confirms correction of deficiencies noted during on-site surveys.
“By pursuing and receiving ISO recertification, COLA continues to demonstrate that we walk the walk and talk the talk,” says Douglas Beigel, CEO of COLA. “By participating in this rigorous review process, we are proving to the labs we serve that we are willing to engage in the same kind of thorough quality review process we perform for them. In doing so, we sharpen our ability to ensure that clinical laboratories meet the high standards doctors expect and patients deserve.”
COLA’s program is endorsed by the American Medical Association, the American Academy of Family Practitioners, and the American College of Physicians. It is also recognized by the Joint Commission. For more information, visit COLA.